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	<title>RWE &amp; Patient-Centered Outcomes Insights and Analysis | Avalere</title>
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		<title>White Paper: The Cost of Opioid Use Disorder</title>
		<link>https://advisory.avalerehealth.com/insights/white-paper-the-cost-of-opioid-use-disorder</link>
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		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Mon, 19 May 2025 16:35:41 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://advisory.avalerehealth.com/?p=34466</guid>

					<description><![CDATA[<p>Download the white paper. In 2022, over six million people in the United States reported having an opioid use disorder (OUD). Past research has not yielded comprehensive estimates of the full societal burden of OUD or the impact of OUD treatments in limiting associated costs. To evaluate the costs of OUD and the benefits and&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/white-paper-the-cost-of-opioid-use-disorder">White Paper: The Cost of Opioid Use Disorder</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><a href="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/Avalere-Health-White-Paper_The-cost-of-opioid-addiction_OUD-in-the-United-States.pdf">Download the white paper.</a></p>
<p>In 2022, over six million people in the United States reported having an opioid use disorder (OUD). Past research has not yielded comprehensive estimates of the full societal burden of OUD or the impact of OUD treatments in limiting associated costs. To evaluate the costs of OUD and the benefits and cost savings associated with OUD treatment, Avalere Health conducted secondary research and modeled the costs and savings associated with treatment of OUD, nationally and by state.</p>
<p>This research (1) characterized the prevalence of OUD, (2) modeled the costs of OUD, and (3) modeled the net cost impact of four ambulatory OUD treatments: (a) behavioral therapy alone, (b) behavioral therapy plus methadone, (c) behavioral therapy plus transmucosal buprenorphine, and (d) behavioral therapy plus long-acting injectable (LAI) buprenorphine.</p>
<p><strong>Key Findings</strong></p>
<p><strong>OUD Prevalence:</strong> OUD cases per capita (the percentage of individuals per state with OUD) ranged from 0.75% to 2.99%. New Hampshire, Nevada, Massachusetts, and Kentucky had the highest rates of OUD (greater than 2.5%), while Wyoming, Hawaii, Washington DC, and Minnesota had the lowest (less than 1.0%).</p>
<p><strong>Cost Burden of OUD: </strong>The total average annual cost per OUD case is approximately $695,000 across all stakeholders analyzed. The annual cost per OUD case, excluding the patient burden, is approximately $163,000, spread across public and private stakeholders. Including lost quality and length of life, the patient burden of OUD is approximately $532,000 per year.</p>
<p>In 2024, the burden of state and local government costs per capita across states ranged from $137 to $524 (Figure 1).</p>
<p><strong>Figure 1.</strong> <strong>State and Local Government Cost of OUD Per Capita, 2024</strong></p>
<p><strong><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34499" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-map.png" alt="" width="1026" height="590" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-map.png 1026w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-map-300x173.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-map-1024x589.png 1024w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-map-768x442.png 768w" sizes="auto, (max-width: 1026px) 100vw, 1026px" />Costs to External Stakeholders:</strong> Annual costs to the federal government, state/local governments, private businesses, and society at large are driven by lost productivity for employers ($438 billion), employees ($248 billion), and households ($73 billion). Health insurance and costs for uninsured care are $111 billion, criminal justice costs are $52 billion, and other substance use treatment costs are $12 billion (Figure 2).</p>
<p><strong>Figure 2.</strong> <strong>Annual National Cost of OUD Excluding Patient Burden, 2024 ($ Billion)</strong></p>
<p><strong><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34500" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-pie.png" alt="" width="876" height="493" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-pie.png 876w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-pie-300x169.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-pie-768x432.png 768w" sizes="auto, (max-width: 876px) 100vw, 876px" />Treatment Benefits of OUD: </strong>Medications and behavioral therapy to treat OUD are associated with significant average cost savings per case (Figure 3). Estimated annual per-case savings net of treatment cost from ambulatory treatments are estimated to be:</p>
<ul>
<li>$144,000 for behavioral therapy alone</li>
<li>$271,000 for behavioral therapy plus methadone</li>
<li>$271,000 for behavioral therapy plus sublingual buprenorphine</li>
<li>$295,000 for behavioral therapy plus LAI buprenorphine</li>
</ul>
<p><strong>Figure 3.</strong> <strong>Cost Savings per OUD Case, Relative to Base Scenario, by OUD Treatment (95% Confidence Interval)</strong><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34501" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-chart.png" alt="" width="1281" height="750" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-chart.png 1281w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-chart-300x176.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-chart-1024x600.png 1024w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/5.16.25-chart-768x450.png 768w" sizes="auto, (max-width: 1281px) 100vw, 1281px" /></p>
<p><a href="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/Avalere-Health-White-Paper_The-cost-of-opioid-addiction_OUD-in-the-United-States.pdf">Download the white paper.</a></p>
<p><em>Funding for this research was provided by Indivior. Avalere Health retained full editorial control.</em></p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/white-paper-the-cost-of-opioid-use-disorder">White Paper: The Cost of Opioid Use Disorder</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>RWE Data Management Lessons Applicable to NIH Autism Database</title>
		<link>https://advisory.avalerehealth.com/insights/rwe-data-management-lessons-applicable-to-nih-autism-database</link>
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		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Wed, 14 May 2025 18:18:39 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://advisory.avalerehealth.com/?p=34494</guid>

					<description><![CDATA[<p>The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. recently announced plans to study the causes of autism, while the National Institutes of Health (NIH) is moving forward with developing a comprehensive real-world evidence (RWE) dataset to study autism spectrum disorder (ASD). At a recent NIH leadership meeting, newly appointed&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/rwe-data-management-lessons-applicable-to-nih-autism-database">RWE Data Management Lessons Applicable to NIH Autism Database</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. <a href="https://thehill.com/policy/healthcare/5243587-autism-vaccine-epidemic/">recently announced</a> plans to study the causes of autism, while the National Institutes of Health (NIH) is moving forward with developing a comprehensive real-world evidence (RWE) dataset to study autism spectrum disorder (ASD). At a recent NIH leadership meeting, newly appointed NIH Director Dr. Jay Bhattacharya, <a href="https://www.npr.org/2025/05/08/nx-s1-5391310/kennedy-autism-registry-database-hhs-nih-medicare-medicaid">introduced</a> the proposed NIH Real-World Discovery platform. The platform aims to integrate a variety of healthcare datasets into one platform, including CMS data, medical and pharmacy claims data, lab and genomic data, and data from smartphones and fitness trackers.</p>
<p>The current fragmented healthcare data landscape presents challenges when building comprehensive data infrastructures to understand specific therapeutic areas. Below, Avalere Health experts have identified four key challenges that both the NIH and life sciences companies should be aware of to maximize success when navigating the healthcare data landscape:</p>
<h3><span style="color: #000000;">Duplicative Data Sets</span></h3>
<p>Dr. Bhattacharya highlighted that the NIH routinely pays multiple times for the same data resource. Avalere Health <a href="https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025">has seen</a> that life sciences companies face a similar issue, often paying for identical claims from multiple data aggregators across various internal stakeholder groups, such as health economics and outcomes research, medical affairs, and commercial teams. Enhanced internal communication and coordination, with participation from procurement, can reduce the risk of duplication and may free up resources that could be put to alternative use.</p>
<h3><span style="color: #000000;">Siloed Data Acquisition Strategies</span></h3>
<p>To compare individuals diagnosed with ASD with the general population, large samples of individuals as controls will need to be incorporated into the NIH database. These control patients, as well as those diagnosed with ASD, may also present with comorbid conditions of potential interest to NIH researchers. Similarly, life sciences companies often purchase multiple datasets for discrete therapeutic areas, rather than investing in a data strategy that provides a comprehensive, population-wide view that serves the entire enterprise. Purchasing data with a focus on molecules or therapeutic areas may result in duplicated data costs.</p>
<h3><span style="color: #000000;">Data that is Not “Fit for Purpose”</span></h3>
<p><span style="color: #000000;">In recent years, several life sciences companies invested heavily in incorporating data from sensors and wearables into their research data portfolios. This approach is echoed in the recent NIH proposal. While sensor and wearable data can be valuable, there has been a decline in the utilization of this data, as oftentimes the established research questions are not aligned with the data’s structure or intended use. While there can be a desire to incorporate novel data into a portfolio, ensuring that data is “fit for purpose” remains crucial for both NIH and commercial stakeholders.</span></p>
<h3><span style="color: #000000;">Complex Datasets</span></h3>
<p><span style="color: #000000;">While the NIH ASD data platform aspires to address a variety of research questions, stakeholders should be cognizant of the nuances of highly complex datasets that source data from payers, physician systems, and pharmacy networks. Advanced analytics and artificial intelligence (including machine learning) applied to these datasets must be tailored to address these nuances effectively to avoid misinterpretation or incomplete analysis. </span></p>
<h3><span style="color: #000000;">How Avalere Health Can Help  </span></h3>
<p>Avalere Health’s experts in data optimization, evidence planning, and data comparison support clients in mapping current data assets, identifying data gaps and duplication, and recommending areas for improvement. To learn more about how Avalere Health can help you navigate your 2025 and beyond data strategy, <a href="https://pages.avalere.com/Insights.html?_gl=1*1k5y73v*_gcl_au*MTI5ODM0NjY2OC4xNzQzNjA5MTI3*_ga*Mzk4NTE4ODM1LjE3NDM2MDkxMjc.*_ga_1LKSE3H6ZT*czE3NDcyNDI3MjUkbzExJGcxJHQxNzQ3MjQyOTk0JGo1NyRsMCRoMA..">connect with us. </a></p>
<p>&nbsp;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/rwe-data-management-lessons-applicable-to-nih-autism-database">RWE Data Management Lessons Applicable to NIH Autism Database</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Manufacturers Must Adapt to Growing GLP-1 and GIP/GLP-1 RA Markets</title>
		<link>https://advisory.avalerehealth.com/insights/manufacturers-need-to-adapt-to-growing-glp-1-and-gip-glp-1-ra-markets</link>
					<comments>https://advisory.avalerehealth.com/insights/manufacturers-need-to-adapt-to-growing-glp-1-and-gip-glp-1-ra-markets#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Wed, 14 May 2025 17:21:21 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://advisory.avalerehealth.com/?p=34486</guid>

					<description><![CDATA[<p>Current Landscape Overview Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are an emerging drug class that are mostly indicated to improve glycemic control in patients with type 2 diabetes mellitus (T2D) and reduce body weight. For the GLP-1 RA products approved for glycemic control in T2D, some have expanded use to younger patients, and/or in additional&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/manufacturers-need-to-adapt-to-growing-glp-1-and-gip-glp-1-ra-markets">Manufacturers Must Adapt to Growing GLP-1 and GIP/GLP-1 RA Markets</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>Current Landscape Overview</strong></p>
<p>Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are an emerging drug class that are mostly indicated to improve glycemic control in patients with type 2 diabetes mellitus (T2D) and reduce body weight. For the GLP-1 RA products approved for glycemic control in T2D, some have expanded use to younger patients, and/or in additional at-risk comorbid adult populations. For branded products approved to reduce weight in obesity, some also have expanded use to younger patients, and/or additional at-risk adult populations. To date, one brand has not differentiated itself in all areas, which has opened the door for future evidence development. Additionally, as products expand their indications, focus is on not only the diagnoses of the populations, but also the action/effect of the GLP-1 product on disease pathophysiology. For specific alignment of comparison of FDA indications, see Table 1.</p>
<p><strong>Table 1. Differentiation in GLP-1 Products   </strong></p>
<p><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34487" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/GLP-1-chart.png" alt="" width="1158" height="751" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/GLP-1-chart.png 1158w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/GLP-1-chart-300x195.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/GLP-1-chart-1024x664.png 1024w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/GLP-1-chart-768x498.png 768w" sizes="auto, (max-width: 1158px) 100vw, 1158px" /></p>
<p><span style="font-size: 10px;">*Weight-related comorbidities may include but are not limited to hypertension, dyslipidemia, CVD, sleep apnea, and T2D. CKD: Chronic Kidney Disease; CVD: Cardiovascular Disease</span></p>
<p>Although several in-line GLP-1 and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs have approved indications beyond T2D and overweight/obesity, <a href="https://advisory.avalerehealth.com/insights/usp-dc-2025-updates-and-strategic-engagement-opportunities">US Pharmacopeia Drug Classification (USP DC) 2025</a> limits classification to categories/classes according to their primary diagnosis (e.g., antidiabetic; anti-obesity). This has downstream impacts on coverage of drugs by non-Part D plans that use USP classifications when designing their formularies. Manufacturers interested in expanding the number of USP DC categories and/or classes their product is on should submit additional evidence linking its mechanism of action to additional indications.</p>
<p>While currently approved GLP-1 and GIP/GLP-1 RAs have multiple on-label indications, many of them are also used off-label. To further explore on- and off-label use of these drugs, Avalere Health evaluated 2018–2023 commercial (42% population sample), Medicare fee-for-service (FFS) (100%), Medicare Advantage (25%), and Managed Medicaid (69%) pharmacy claims data to identify beneficiaries with a pharmacy drug claim for GLP-1 and/or GIP/GLP-1 RAs. FDA-approved labels were used to determine on- and off-label use.</p>
<p>GLP and GIP/GLP-1 RAs had 88% on-label use and 12% off-label use (Figure 1), which was consistent with uses at the brand level. In recent years, off-label use for weight loss has contributed to GLP-1 RAs shortages, limiting access for patients with diabetes.</p>
<p><strong>Figure 1. On- and Off-label Use of</strong> <strong>GLP-1 and GIP/GLP-1 RAs*</strong></p>
<p><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34490" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-1.png" alt="" width="433" height="557" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-1.png 433w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-1-233x300.png 233w" sizes="auto, (max-width: 433px) 100vw, 433px" /></p>
<p><span style="font-size: 10px;">*GLP-1 and GIP/GLP-1 RAs include: Bydureon, Byetta, Victoza, Ozempic, Rybelsus, Adlyxin, Saxenda, Wegovy, Zepbound, Trulicity, Mounjaro; **Overlap in beneficiaries is possible if beneficiaries switched insurance types over time.</span></p>
<p><strong>Current Pipeline</strong></p>
<p>The current pipeline for GLP-1 RAs is robust with <a href="https://clinicaltrials.gov/">1,465 clinical trials</a> in various stages. While the majority of these studies focus on T2D, other conditions of interest include CVD, overweight/obesity, T1D, endocrine disorders associated with insulin metabolism.</p>
<p>The pipeline for dual RAs, such as GIP/GLP-1 RAs, is much less robust with, only <a href="https://clinicaltrials.gov/">27 clinical trials</a> in Phase 1–Phase 4. These dual RAs are being evaluated mainly in T2D, T1D, overweight/obesity, and few other possible indications (Figure 2). Manufacturers may expect significant levels of competition, specifically within the GLP-1 RA class, and will need to differentiate their assets and value proposition to remain competitive and maintain and/or grow their market share.</p>
<p><strong>Figure 2. GLP-1 and GIP/GLP-1 RAs Pipeline</strong></p>
<p><em><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34491" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-2.png" alt="" width="1036" height="510" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-2.png 1036w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-2-300x148.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-2-1024x504.png 1024w, https://advisory.avalerehealth.com/wp-content/uploads/2025/05/glp-fig-2-768x378.png 768w" sizes="auto, (max-width: 1036px) 100vw, 1036px" />Source:</em> clinicaltrials.gov</p>
<p><strong>Value Differentiation and Connection to Coverage</strong></p>
<p>New entrants to this crowded market will need to differentiate themselves through a strong payer value story that spans beyond T2D, overweight/obesity, CVD indications. In addition, both new and established manufacturers in this space should consider studying additional indications to further differentiate themselves from current or future competitors. A strong value proposition will have downstream impacts on securing favorable coverage and formulary placement, which will be addressed in our next insight.</p>
<p>With expertise in market access within competitive therapeutic areas, life cycle management, and strategic evidence generation, Avalere Health is equipped to help manufacturers with evidence generation, product differentiation, value proposition, and other strategies that strengthen their market positioning. For more information on how Avalere Health can assist you, please <a href="https://pages.avalere.com/Keep-In-Touch.html">connect with us</a>.</p>
<p>This Insight is the second of a series exploring GLP-1 manufacturing, evidence, product pipeline, and coverage. Look out for our next Insight about GLP-1 insurance coverage of marketed products, coming in June.</p>
<p><strong>Data Source</strong></p>
<p>For this analysis, Avalere used commercial and Managed Medicaid claims data from Inovalon’s proprietary “Medical Outcomes Research for Effectiveness and Economics” (MORE<em>2</em>) Registry®, accessed by Avalere via an Agreement with Inovalon, Inc. Avalere also utilized the 100% Medicare FFS claims, accessed by Avalere via a research collaboration with Inovalon, Inc. and governed by a research-focused CMS Data Use Agreement (DUA).</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/manufacturers-need-to-adapt-to-growing-glp-1-and-gip-glp-1-ra-markets">Manufacturers Must Adapt to Growing GLP-1 and GIP/GLP-1 RA Markets</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>National Kidney Month: Setting the Stage for 2025 Changes</title>
		<link>https://advisory.avalerehealth.com/insights/national-kidney-month-setting-the-stage-for-2025-changes</link>
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		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Tue, 25 Mar 2025 17:44:18 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=34124</guid>

					<description><![CDATA[<p>Avalere experts have identified four major themes in the policy, regulatory, and market landscape to monitor for the remainder of 2025. Uncertain Policy and Regulatory Environment Like many aspects of the US healthcare system, the outlook for kidney care in 2025 will be informed by the newly reconfigured federal government. The first Trump administration introduced&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/national-kidney-month-setting-the-stage-for-2025-changes">National Kidney Month: Setting the Stage for 2025 Changes</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Avalere experts have identified four major themes in the policy, regulatory, and market landscape to monitor for the remainder of 2025.</p>
<p><img loading="lazy" decoding="async" class="alignnone size-full wp-image-34125" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.25-kidney-month.png" alt="" width="960" height="576" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.25-kidney-month.png 960w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.25-kidney-month-300x180.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.25-kidney-month-768x461.png 768w" sizes="auto, (max-width: 960px) 100vw, 960px" /></p>
<p><strong>Uncertain Policy and Regulatory Environment</strong></p>
<p>Like many aspects of the US healthcare system, the outlook for kidney care in 2025 will be informed by the newly reconfigured federal government.</p>
<p>The first Trump administration introduced the <a href="https://advisory.avalerehealth.com/insights/policy-and-market-access-trends-in-kidney-care">Advancing American Kidney Health initiative</a> in 2019, which established specific goals to reduce the number of individuals developing end-stage renal disease (ESRD) while increasing home dialysis and kidney transplants. This initiative also created the mandatory <a href="https://advisory.avalerehealth.com/insights/mandatory-kidney-care-model-introduces-financial-incentives-and-risks">ESRD Treatment Choices model</a> and the voluntary Kidney Care Choices model through the Centers for Medicare &amp; Medicaid Innovation (CMMI).  In March 2025, the Trump administration <a href="https://www.cms.gov/newsroom/fact-sheets/cms-innovation-center-announces-model-portfolio-changes-better-protect-taxpayers-and-help-americans">announced</a> its intention to end the ETC model two years early, at the end of 2025.</p>
<p>In addition to CMMI initiatives, stakeholders should monitor federal rulemaking for potential changes to the ESRD payment system under Medicare. These include potential refinements to <a href="https://advisory.avalerehealth.com/insights/how-the-transitional-drug-add-on-payment-adjustment-tdapa-works">payment</a> <a href="https://advisory.avalerehealth.com/insights/tpnies-adjustment-promotes-access-for-innovative-esrd-technologies">designations</a> that were introduced or refined under the first Trump administration as well as broader reforms to the transplant system that have been underway over the past several years.</p>
<p><strong>Transplant System Reforms</strong><strong><br />
</strong></p>
<p>Research continues to demonstrate both the improved clinical outcomes and robust cost savings that kidney transplantation offers for patients with ESRD compared to dialysis. Despite its benefits, patients with ESRD often experience a wait time of <a href="https://www.kidneyfund.org/kidney-donation-and-transplant/transplant-waiting-list#:~:text=How%20long%20do%20people%20usually,may%20be%20shorter%20or%20longer.">three to five years or more</a> waiting for a kidney transplant.</p>
<p>In November 2024, CMS finalized the <a href="https://www.cms.gov/priorities/innovation/innovation-models/iota">Increasing Organ Transplant Access model</a>, a two-sided risk, mandatory payment model for selected transplant hospitals aimed at boosting transplant volume, improving organ use, and increasing the number of living donors. The model is scheduled to begin on July 1st, 2025, and run for six years. It is designed to incentivize increased rates of kidney transplantation and address persistent health equity gaps present in the current landscape of care.</p>
<p>One of the Biden administration’s final initiatives was ending the national organ transplant system’s nearly 40-year “contract monopoly” by awarding modernization contracts to 14 vendors to manage various system functions for the first time in the program’s history. These changes to the Organ Procurement Transplantation Network (OPTN) follow the enactment of the 2023 <a href="https://www.congress.gov/bill/118th-congress/house-bill/2544">Securing the U.S. OPTN Act</a>, which aims to promote increased competition for the management of the OPTN by allowing multiple grants, contracts, or cooperative agreements to operate it.</p>
<p><strong>Advancements in Transplant Research</strong></p>
<p>Recent innovations in kidney transplant research, particularly in xenotransplantation, offer promising solutions to the shortage of human donor organs. Xenotransplantation involves transplanting organs, tissues, or cells from one species to another, with pig organs being the primary focus due to their anatomical and physiological similarities to human organs.  Recently, the FDA has <a href="https://www.kidneyfund.org/article/fda-greenlights-first-clinical-trials-genetically-modified-pig-kidney-transplants-humans">approved </a>two companies to begin clinical trials for transplanting these genetically modified animal organs to patients with kidney failure, with the goal of alleviating human organ shortages and saving lives.</p>
<p>To date, doctors have performed three kidney transplants with an organ from a genetically modified pig (the first surgery of its kind performed in the world). The approach is intended to provide a longer-term, viable solution for patients that can address health disparities in organ failures and access.</p>
<p>Additionally, new research is supporting the expansion of kidney donations to include organs from deceased donors who received dialysis due to severe acute kidney injury (AKI). While it is known that kidneys affected by AKI are at a higher risk of delayed graft function (a condition where the transplanted kidney does not function immediately), there is still uncertainty about whether using kidneys from donors with a history of AKI leads to reduced life expectancy or long-term organ dysfunction.</p>
<p><strong>Expanded Use of GLP-1s and SGLT2s in CKD</strong></p>
<p>Recently expanded indications for existing drugs present new opportunities in the CKD space for early intervention and proactive management of kidney disease. Both GLP-1s and SGLT2s have emerged as significant therapeutic agents in managing CKD, offering benefits beyond their initial indications for diabetes and heart failure, respectively. GLP-1s have demonstrated potential in slowing CKD progression, as seen in the FLOW trial <a href="https://www.nejm.org/doi/10.1056/NEJMoa2403347">results</a> published in May 2024, indicating that these agents could decelerate kidney function decline in individuals with Type 2 diabetes and CKD. In January 2025, the FDA approved Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and CKD. SGLT2 inhibitors have shown efficacy in reducing the risk of kidney failure and other major kidney outcomes by <a href="https://journals.lww.com/kidney360/fulltext/2024/05000/sglt2_inhibitors_and_kidney_protection__mechanisms.23.aspx?utm_source=chatgpt.com">30–40% over two to three years</a>, irrespective of diabetes status.</p>
<p><strong>Looking Ahead</strong></p>
<p>While the future of kidney care offers promising advancements in early detection, prevention, and treatment, transplantation, as well as a shift into value-based care, it remains to be seen how leadership decisions at the US Department of Health and Human Services will impact chronic disease in these next four years. While it is expected that stakeholders will continue to tackle the associated challenges in care coordination and disease management, the reorganization of CMMI’s risk-based portfolio may shift the kidney care landscape.</p>
<p>Avalere is monitoring these developments and will continue to leverage its expertise across policy, market access, data analytics, and quality disciplines to assess how kidney care policy and markets evolve in the coming months. To learn more about the evolving kidney care space and how Avalere can help your business drive access and continuity of care in this dynamic time, <a href="https://pages.avalere.com/Insights.html">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/national-kidney-month-setting-the-stage-for-2025-changes">National Kidney Month: Setting the Stage for 2025 Changes</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Disease Registries Offer Solutions in Rare Disease</title>
		<link>https://advisory.avalerehealth.com/insights/disease-registries-offer-solutions-in-rare-disease</link>
					<comments>https://advisory.avalerehealth.com/insights/disease-registries-offer-solutions-in-rare-disease#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Mon, 24 Mar 2025 15:27:33 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=34117</guid>

					<description><![CDATA[<p>Components and Considerations for Disease Registries Disease registries are tools to collect, store, retrieve, analyze, and disseminate clinical and outcomes data for a predefined patient population. Registries can be sponsored by professional medical societies, patient advocacy organizations, government agencies, non-profit organizations, private companies, or healthcare facilities. While there is no centralized source that lists all&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/disease-registries-offer-solutions-in-rare-disease">Disease Registries Offer Solutions in Rare Disease</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>Components and Considerations for Disease Registries</strong></p>
<p>Disease registries are tools to collect, store, retrieve, analyze, and disseminate clinical and outcomes data for a predefined patient population. Registries can be sponsored by professional medical societies, patient advocacy organizations, government agencies, non-profit organizations, private companies, or healthcare facilities. While there is no centralized source that lists all registries available in the United States, the <a href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/list-registries">National Institutes of Health</a> and <a href="https://iamrare.org/find-a-study/">National Organization for Rare Disorders</a> have a comprehensive list of registries for both prevalent and rare diseases. Over forty of them were designed specifically for rare and ultra-rare diseases.</p>
<p>Establishing a disease registry is a multi-step process that requires a clear purpose and scope, assembly of a multidisciplinary team, a thoughtfully designed data collection, establishing governance and oversight plan, and analysis and dissemination of findings. The patient population to be enrolled in the registry must be clearly defined before enrollment begins. Participants may enter a registry during a normal course of care such as through <a href="https://advisory.avalerehealth.com/insights/newborn-screening-landscape-and-rare-disease-developments">newborn screening</a> programs, through recruitment into a research study, or through voluntarily participation in a self-identified registry.</p>
<p>Disease registries serve many purposes and have the potential to support researchers and manufacturers with drug development programs, inform the design of interventional and observational studies, enhance understanding of the natural history of a disease, and support the selection of appropriate endpoints and biomarkers that are associated with clinically meaningful outcomes. Furthermore, registries provide additional insights into an intervention (e.g., drug, device) and its efficacy and safety in populations underrepresented in clinical trials.</p>
<p>Multiple stakeholders can be involved in establishing disease registries, including regulatory agencies, patient advocacy groups, clinicians, key opinion leaders, scientists, payers, patients, and their caregivers. Collaboration between these stakeholders can drive not only research and development of new treatments but also lead to public policy changes and promote access to treatments. Various organizations around the world, including the <a href="https://rarediseases.org/">National Organization for Rare Disorders</a> in the United States recognize the challenges associated with data collection and clinical trial recruitment for rare and ultra-rare diseases, and have thus become advisors and supporters of rare disease registries.</p>
<p><strong>Registries for Rare and Ultra-Rare Disease</strong></p>
<p>While drug developers in the <a href="https://advisory.avalerehealth.com/insights/ebook-rare-disease-biotechnology-landscape">rare and ultra-rare disease space</a> face many unique challenges, registries can help address some of them (Table 1).</p>
<p><strong>Table 1. Registry Benefits for Rare and Ultra-Rare Diseases</strong></p>
<p>&nbsp;</p>
<table id="insight">
<thead></thead>
<tbody>
<tr>
<td style="text-align: left;">Disease heterogeneity</td>
<td style="text-align: left;">Rare diseases, even within the same category (e.g., leukodystrophies, mitochondrial disorders), vary greatly in their clinical presentation, severity, progression, prior exposure to different treatments, etc. Registries can help aggregate data on genotypically similar but phenotypically different conditions.</td>
</tr>
<tr>
<td>Disease natural history</td>
<td style="text-align: left;">Registries provide consistent updates on the patient’s status throughout a predefined schedule that offers consistent, high-quality data on the natural progression of the disease. In addition, as more treatments extending the life span of patients with rare diseases become available, registries provide opportunities to learn more about the disease trajectory.</td>
</tr>
<tr>
<td>Establish the patient base for small, geographically dispersed populations</td>
<td style="text-align: left;">Data is typically collected in multiple institutions and geographic regions, providing comprehensive information on patients with rare and ultra-rare diseases who are dispersed throughout the country. Registries also support the shaping of the patient base for evaluating treatments, devices, and other medical interventions for clinical trial development programs.</td>
</tr>
<tr>
<td style="text-align: left;">Support development of biomarkers and clinically meaningful endpoints</td>
<td style="text-align: left;">Registries may involve the collection and storage of biospecimens that can be further studied as potential biomarkers for the establishment of clinically meaningful endpoints. Considering the lack of knowledge about many rare and ultra-rare conditions coupled with the lack of established and approved biomarkers, registries can help manufacturers overcome some of the barriers associated with limited data availability and limited knowledge.</td>
</tr>
</tbody>
</table>
<p>Although registries provide significant opportunities, they do face headwinds:</p>
<ul>
<li>Disease registries lack the randomization factor, which has the potential to produce a skewed sample and biased data.</li>
<li>Many registries exist in silos and there may be duplicate registries for the same condition, meaning that there is no centralized repository for the already small patient populations’ data.</li>
<li>There is significant variability in the depth and consistency of patient participation in registries.</li>
</ul>
<p>Coordination of efforts among all stakeholders involved in registries, proper data management, standardized data collection methods, participant education, and confidentiality assurances are among the most important areas when planning and implementing disease registries. Before establishing a registry or leveraging an existing registry, drug manufacturers and diagnostics companies should have a comprehensive plan in place to ensure the data is of the highest quality and that the registry’s approach aligns with their clinical development program goals.</p>
<p><strong>Deeper Dive</strong></p>
<p>At Avalere, we apply our expertise in evidence generation planning and market access strategies to help stakeholders meet their business objectives through effective commercialization.  To learn more about addressing unmet needs in rare and ultra-rare disease and develop comprehensive clinical development programs and evidence generation strategies, <a href="https://pages.avalere.com/Keep-In-Touch.html">connect with us</a>.</p>
<p>&nbsp;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/disease-registries-offer-solutions-in-rare-disease">Disease Registries Offer Solutions in Rare Disease</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Telehealth in Medicare: Shifts Before and After COVID-19</title>
		<link>https://advisory.avalerehealth.com/insights/telehealth-in-medicare-shifts-before-and-after-covid-19</link>
					<comments>https://advisory.avalerehealth.com/insights/telehealth-in-medicare-shifts-before-and-after-covid-19#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Thu, 13 Mar 2025 19:10:13 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=34040</guid>

					<description><![CDATA[<p>COVID-19 pandemic accelerated this trend with the rapid adoption of telehealth as a viable alternative to in-person visits. This shift was especially pronounced in primary care, where telehealth emerged as a critical tool for continuity of care during the public health emergency (PHE). In March 2020, Congress passed the Coronavirus Preparedness and Response Supplemental Appropriations&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/telehealth-in-medicare-shifts-before-and-after-covid-19">Telehealth in Medicare: Shifts Before and After COVID-19</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>COVID-19 pandemic accelerated this trend with the rapid adoption of telehealth as a viable alternative to in-person visits. This shift was especially pronounced in primary care, where telehealth emerged as a critical tool for continuity of care during the public health emergency (PHE).</p>
<p>In March 2020, Congress passed the Coronavirus Preparedness and Response Supplemental Appropriations (CARES) Act, which expanded telehealth flexibilities within the Medicare program. Since then, Congress has extended these flexibilities multiple times, most recently through the December 2024 American Relief Act. On March 11, 2025, the House of Representatives passed a continuing resolution, which now sits with the Senate for consideration, that would temporarily extended the following telehealth flexibilities through September 2025:</p>
<ul>
<li>Waiving of in-person visit requirement prior to establishing mental health care</li>
<li>Allowance of non-behavioral/mental health care in the home</li>
</ul>
<p>To assess how this impending expiration might impact the primary care market, Avalere used Medicare claims data to analyze changes in primary care telehealth utilization by code type and specialty before and after the PHE. The code type analysis explored differences in trends between new and established patient volume, and the specialty-level analysis investigated whether certain primary care specialties—including general practice, family, geriatric, internal medicine, nurse practitioner, pediatrics, physician assistants, and preventive medicine—were more or less likely to adopt telehealth during the PHE.</p>
<p><strong>Primary Care Telehealth Use in Medicare by Code Type and Specialty</strong></p>
<p>In 2019, telehealth accounted for a minimal portion of Medicare primary care services. Figure 1 shows that only 0.13% of primary care Evaluation and Management (E/M) codes were provided via telehealth, with established patient claims (CPT codes 99212–99215) at 0.15% and new patient E/M codes (99202–99205) at less than 0.1%. The remaining volume was considered in-office (in person).</p>
<p><strong>Figure 1: Telehealth Use in Medicare as a Share of All Primary Care Visits, by E/M Code Type</strong></p>
<p><img loading="lazy" decoding="async" class="alignnone wp-image-34042 size-full" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-1-e1741297940379.png" alt="" width="960" height="352" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-1-e1741297940379.png 960w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-1-e1741297940379-300x110.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-1-e1741297940379-768x282.png 768w" sizes="auto, (max-width: 960px) 100vw, 960px" /></p>
<p>By 2023, telehealth usage increased significantly, with approximately 2% of all Medicare E/M services occurring in the telehealth setting. Among office visits, established patient visits rose to 1.9%, and new patient visits climbed to 0.6%. While these figures represent nearly a 10x increase across all code types, the majority of E/M primary care services remain concentrated in the office setting.</p>
<p>Telehealth adoption has also varied across primary care specialties, as shown in Figure 2. In 2019, telehealth utilization was below 1% across all specialties, with preventive medicine showing the highest adoption at 0.61%, and family practice the lowest at 0.01%.</p>
<p><strong>Figure 2: Telehealth Use in Medicare as a Share of All Primary Care Visits, by Primary Care Specialty</strong></p>
<p><img loading="lazy" decoding="async" class="alignnone wp-image-34041 size-full" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-2-e1741298043929.png" alt="" width="960" height="360" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-2-e1741298043929.png 960w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-2-e1741298043929-300x113.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/03/3.7.-FS-graphic-2-e1741298043929-768x288.png 768w" sizes="auto, (max-width: 960px) 100vw, 960px" /></p>
<p>By 2023, the average utilization across all primary care specialties rose to 2.4%. Preventive medicine was most likely to shift to virtual care with, 7.0% of services delivered via telehealth, while family practice was least likely at 1.7%. Unlike in 2019, when no specialty exceeded 1% utilization, all primary care specialties now provide at least 1.5% of care virtually, an increase of over 1.9 million telehealth appointments across primary care, underscoring a subtle yet significant shift in how care is delivered.</p>
<p>When considering the volume of visits represented in this increase (see Table 1), 0.5% of all primary care visits represents 443,694 patient encounters in 2023.</p>
<p><strong>Table 1. Volume of Primary Care Telehealth Visits, by Specialty, 2023</strong></p>
<table id="insight">
<thead>
<tr>
<th style="text-align: left;">Primary Care Specialty</th>
<th>Number of Claims</th>
<th>Share of Total</th>
</tr>
</thead>
<tbody>
<tr>
<td>Internal Medicine</td>
<td>25,675,296</td>
<td>28.9%</td>
</tr>
<tr>
<td>Family Practice</td>
<td>25,477,685</td>
<td>28.7%</td>
</tr>
<tr>
<td>Nurse Practitioner</td>
<td>22,473,319</td>
<td>25.3%</td>
</tr>
<tr>
<td>Physician Assistant</td>
<td>13,536,561</td>
<td>15.3%</td>
</tr>
<tr>
<td>General Practice</td>
<td>999,556</td>
<td>1.1%</td>
</tr>
<tr>
<td>Geriatric Medicine</td>
<td>367,993</td>
<td>0.4%</td>
</tr>
<tr>
<td>Pediatric Medicine</td>
<td>173,989</td>
<td>0.2%</td>
</tr>
<tr>
<td>Preventive Medicine</td>
<td>34,413</td>
<td>0.04%</td>
</tr>
<tr>
<td><strong>Total</strong></td>
<td><strong>88,738,812</strong></td>
<td>100%</td>
</tr>
</tbody>
</table>
<p><strong>What’s Next </strong></p>
<p>While the pandemic served as a catalyst for its adoption, telehealth has become a well-established access option within the care continuum. After a significant spike in telehealth utilization at <a href="https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/198331/hp-issue-brief-medicare-telehealth.pdf">43% of primary visits in April 2020</a>, utilization has normalized and in-person visits remain dominant, particularly for new patient evaluations. Despite its persistent utility in improving access for a portion of Medicare beneficiaries, these telehealth flexibilities within the Medicare program remain temporary. Congress continues to pass extensions of these flexibilities, as opposed to legislation that would make the flexibilities permanent. As policymakers and providers continue to refine telehealth strategies, the challenge will be to balance concerns around growing Medicare utilization and costs while maintaining availability for individuals who would not otherwise receive care.</p>
<p><strong>Connect With Us</strong></p>
<p>To learn more about how the state and federal policy landscape impacts site of care decisions made by patients, providers, and payers, <a href="https://pages.avalere.com/Insights.html?_gl=1*smmq5e*_gcl_au*NDQ4OTc3ODA3LjE3Mzc0MTg0NzQ.*_ga*MTM4MjYyODI3Ny4xNzI5NTE2MzAx*_ga_1LKSE3H6ZT*MTc0MTIwODkyNS4yODUuMS4xNzQxMjA4OTU3LjI4LjAuMA..">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/telehealth-in-medicare-shifts-before-and-after-covid-19">Telehealth in Medicare: Shifts Before and After COVID-19</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Stakeholders Can Influence Patient-Centered Value Research During Public Comment Period</title>
		<link>https://advisory.avalerehealth.com/insights/stakeholders-can-influence-patient-centered-value-research-during-public-comment-period</link>
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		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Fri, 07 Mar 2025 16:34:07 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=34047</guid>

					<description><![CDATA[<p>The Blueprint for Patient-Centered Value Research is now open for public comment from March 4 to April 4, 2025, offering stakeholders an opportunity to provide input on how patient perspectives could be integrated into value assessment and health technology assessment (HTA) for those that choose to use the blueprint as part of their real-world evidence&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/stakeholders-can-influence-patient-centered-value-research-during-public-comment-period">Stakeholders Can Influence Patient-Centered Value Research During Public Comment Period</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span data-contrast="auto">The </span><a href="https://valueresearch.org/what-we-do/advancing-hta/"><i><span data-contrast="none">Blueprint for Patient-Centered Value Research</span></i></a><span data-contrast="auto"> is now open for public comment from March 4 to April 4, 2025, offering stakeholders an opportunity to provide input on how patient perspectives could be integrated into value assessment and health technology assessment (HTA) for those that choose to use the blueprint as part of their real-world evidence framework</span><b><span data-contrast="auto">.</span></b><span data-contrast="auto"> This comment period enables the public to provide input on how patient engagement, health equity, and real-world evidence can be incorporated into decision-making frameworks that impact coverage, reimbursement, and access. The Blueprint is voluntary and its influence will depend on stakeholder adoption.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p aria-level="3"><b><span data-contrast="none">The Blueprint’s Role in Advancing Patient-Centered Value Research</span></b><span data-ccp-props="{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}"> </span></p>
<p><span data-contrast="auto">The </span><a href="https://valueresearch.org/who-we-are/about-ivi/"><span data-contrast="none">Center for Innovation &amp; Value Research</span></a><span data-contrast="auto"> (the Center), formerly known as the Innovation and Value Initiative, is a nonprofit organization focused on improving patient access to high-value care through advancements in HTA methodologies, patient preference research, and health equity initiatives</span><b><span data-contrast="auto">.</span></b><span data-contrast="auto"> The </span><i><span data-contrast="auto">Blueprint for Patient-Centered Value Research</span></i><span data-contrast="auto"> provides a framework for embedding patient voices throughout the research process, influencing how payers, policymakers, and manufacturers define and assess value in healthcare through a patient-centered lens.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p><span data-contrast="auto">The Blueprint emphasizes:</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><b><span data-contrast="auto">Core principles</span></b><span data-contrast="auto"> of patient-centricity, health equity, and transparency</span><span data-ccp-props="{&quot;335559739&quot;:0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><b><span data-contrast="auto">Methodologies</span></b><span data-contrast="auto"> for integrating patient preferences into HTAs and value assessments</span><span data-ccp-props="{&quot;335559739&quot;:0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"><b><span data-contrast="auto">Real-world applications</span></b><span data-contrast="auto"> for ensuring patient-centered insights inform coverage and reimbursement decisions</span><span data-ccp-props="{&quot;335559739&quot;:0}"> </span></li>
</ul>
<p aria-level="3"><b><span data-contrast="none">Incorporating Stakeholder Input</span></b><span data-ccp-props="{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}"> </span></p>
<p><span data-contrast="auto">The public comment period allows stakeholders to provide feedback on the Blueprint’s proposed frameworks and methodologies. Stakeholder input is crucial for ensuring that patient-centered research aligns with broader healthcare innovation, regulatory policies, and value-based care models.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p aria-level="3"><b><span data-contrast="none">How to Engage</span></b><span data-ccp-props="{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}"> </span></p>
<p><span data-contrast="auto">Stakeholders, including life sciences companies, payers, and advocacy groups, can engage by submitting written feedback before April 4, 2025. Comments could meaningfully impact the framework’s approach by addressing:</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Integration of patient engagement strategies at different stages of value assessment</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Considerations for health-related social needs, access, and heterogeneous outcomes across different subpopulations </span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">The optimal role of real-world evidence in HTA frameworks</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">The Blueprint’s alignment with payer coverage and reimbursement decision making</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Suggestions to enhance clarity and usability of the Blueprint and to ensure it is inclusive and patient-centered</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Potential unintended consequences, biases, or burdens in the proposed Blueprint</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></li>
</ul>
<p aria-level="3"><b><span data-contrast="none">Maximizing Impact</span></b><span data-ccp-props="{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}"> </span></p>
<p><span data-contrast="auto">Organizations looking to participate in the comment process should ensure that their feedback is strategic, evidence-based, and aligned with their broader policy and market access goals. Given the Blueprint’s potential impact on HTA frameworks, payer coverage decisions, and patient-centered research methodologies, life sciences companies, payers, and advocacy organizations have an opportunity to proactively shape its final recommendations.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p><span data-contrast="auto">We can help prepare and position your public comment in a timely manner to ensure your organization’s priorities are effectively represented.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p><span data-contrast="auto">To discuss how we can support your comments or your organization’s patient-centered research strategy, </span><a href="https://pages.avalere.com/Insights.html?_gl=1*biyw0r*_gcl_au*NDQ4OTc3ODA3LjE3Mzc0MTg0NzQ.*_ga*MTM4MjYyODI3Ny4xNzI5NTE2MzAx*_ga_1LKSE3H6ZT*MTc0MTM1OTcxNS4yODkuMS4xNzQxMzU5Nzc0LjEuMC4w"><span data-contrast="none">connect with us today</span></a><span data-contrast="auto">.</span><span data-ccp-props="{&quot;335559738&quot;:240,&quot;335559739&quot;:240}"> </span></p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/stakeholders-can-influence-patient-centered-value-research-during-public-comment-period">Stakeholders Can Influence Patient-Centered Value Research During Public Comment Period</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Opportunities to Move the Needle on US Behavioral Healthcare in 2025</title>
		<link>https://advisory.avalerehealth.com/insights/opportunities-to-move-the-needle-on-us-behavioral-healthcare-in-2025</link>
					<comments>https://advisory.avalerehealth.com/insights/opportunities-to-move-the-needle-on-us-behavioral-healthcare-in-2025#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Fri, 28 Feb 2025 17:32:37 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=33995</guid>

					<description><![CDATA[<p>Background Despite policy efforts over the last three decades to enhance access to and quality of US behavioral healthcare (see Figure 1), patients still face unmet needs and suboptimal outcomes. There is a continuum of services addressing behavioral health conditions and substance use disorders (SUDs), but access remains fragmented and is complicated by barriers such&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/opportunities-to-move-the-needle-on-us-behavioral-healthcare-in-2025">Opportunities to Move the Needle on US Behavioral Healthcare in 2025</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>Background</strong><br />
Despite policy efforts over the last three decades to enhance access to and quality of US behavioral healthcare (see Figure 1), patients still face unmet needs and suboptimal outcomes. There is a continuum of services addressing behavioral health conditions and substance use disorders (SUDs), but access remains fragmented and is complicated by barriers such as narrow provider networks, provider shortages, limited reimbursement for services and products, and high patient out-of-pocket costs for specific treatments.</p>
<p><strong>Figure 1: Mental Health Parity and Addiction Equity Act (MHPAEA) Timeline</strong></p>
<p><img loading="lazy" decoding="async" class="alignnone wp-image-34000 size-full" src="https://advisory.avalerehealth.com/wp-content/uploads/2025/02/revised-behav-health-e1740763907140.png" alt="" width="960" height="354" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2025/02/revised-behav-health-e1740763907140.png 960w, https://advisory.avalerehealth.com/wp-content/uploads/2025/02/revised-behav-health-e1740763907140-300x111.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2025/02/revised-behav-health-e1740763907140-768x283.png 768w" sizes="auto, (max-width: 960px) 100vw, 960px" /></p>
<p>Behavioral health stakeholders are at a critical turning point in 2025: policies finalized in 2024 are now being implemented, groundbreaking treatments are emerging, and key stakeholders are navigating growing regulatory and financial pressures. Yet, with these challenges come significant opportunities to drive improvements in access, equity, and innovation.</p>
<p><strong>2024 Parity Rule</strong></p>
<p>A major shift comes with the <a href="https://www.cms.gov/newsroom/press-releases/departments-labor-health-and-human-services-treasury-issue-final-rules-strengthening-access-mental?mkt_tok=MTU4LUxVTy03OTMAAAGVfLlsAD9Jc0aB8zhx22MJj8bHcflb_2RHHlVKNXmmt1mub_Hs7JGTWLGLNopcQ0XGh0Eq0PtVW3WVEQQpYPDyDloqgP7l1q66DJHSjo12"><strong>Mental Health Parity and Addiction Equity Act </strong></a>, which was passed in 2008 but not been enforced. In 2024, the Biden administration <a href="https://advisory.avalerehealth.com/insights/mental-health-parity-rule-industry-reactions-and-implications">finalized a new rule</a> imposing stricter requirements to ensure that behavioral health benefits truly match medical benefits. While patient advocacy groups applauded the rule, employer groups and payers are grappling with potential compliance challenges and the risk of litigation over enforcement ambiguities. For stakeholders, stronger parity enforcement may lead to expanded coverage in the therapeutic area, potentially increasing access.</p>
<p><strong>Psychedelic Treatment Landscape</strong></p>
<p>Meanwhile, the landscape for ketamine treatment and the broader psychedelic category is evolving rapidly with the Food and Drug Administration’s (FDA) recent approval of <a href="https://www.jnj.com/media-center/press-releases/spravato-esketamine-approved-in-the-u-s-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression">Spravato for monotherapy use</a> in patients with treatment-resistant depression. Regulatory uncertainties remain, however. The FDA has granted breakthrough therapy designations to psilocybin-assisted therapy for major depressive disorder (MDD) and post-traumatic stress disorder (PTSD), yet its recent rejection of a MDMA-based PTSD therapy over safety and data concerns signals a cautious stance. The agency’s decision raises the bar for future approvals, emphasizing the challenge of balancing innovation with patient safety.</p>
<p>Meanwhile, <a href="https://apnews.com/article/colorado-psilocybin-psychedelic-therapy-legal-ptsd-veterans-99fc5a0703d85daa0903d5a2b2acc9be">Colorado’s 2025 rollout</a> of a new psilocybin regulatory framework could set a precedent for state or even federal policy. The development of next-generation psychiatric treatments poses risks and opportunities for stakeholders, emphasizing the importance of clinical engagement and policy advocacy.</p>
<p><strong>Investment in Behavioral Health</strong></p>
<p>Over the past five years, there has been increased demand for virtual care, policy shifts expanding mental health coverage, and heightened investor interest in behavioral health, all coalescing in a surge of behavioral health investments in 2025.</p>
<p>In its <a href="https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other">Calendar Year 2025 Medicare Physician Fee Schedule Final Rule</a>, CMS finalized three new HCPCS codes providing Medicare payment for supply, onboarding, and use of “digital mental health treatment devices.” Venture capital flowed into digital behavioral health startups during the pandemic, but many companies continue to face <a href="https://bhbusiness.com/2025/02/25/digital-mental-health-startups-face-profitability-pressure-as-investor-landscape-shifts/">reimbursement</a> challenges and sustainability concerns.</p>
<p>The competitive landscape for branded MDD drugs is also becoming more intense, and manufacturers are positioning new therapies in response to shifting payer policies. At the same time, employer demand for behavioral health solutions continues to grow.</p>
<p><strong>New Administration and Congress</strong></p>
<p>The new Trump administration will play a role in reshaping behavioral health policy priorities. While the Biden administration focused on behavioral health parity enforcement and expanding Medicaid funding, the new administration could bring different approaches. On February 13, President Trump issued an executive order <a href="https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/">Establishing the President&#8217;s Make America Healthy Again Commission</a> that aims to address the rising burden of chronic and mental health conditions, which drive 90% of US healthcare costs. The initiative seeks to investigate root causes, improve public health, and reduce economic and national security risks linked to poor health outcomes.</p>
<p>Additionally, Congressional dynamics will be pivotal while bipartisan efforts to expand behavioral health coverage continue. Funding debates and broader healthcare policy shifts could stall progress. Changes in federal policy could impact drug pricing negotiations, Medicaid funding for treatment, and the long-term commercial viability of novel therapies.</p>
<p><strong>Future Opportunities</strong></p>
<p>Despite ongoing uncertainties, 2025 marks a significant period for behavioral healthcare policy and innovation. Payers and policymakers are focused on implementing new coverage pathways for emerging treatments, while providers aim to reduce emergency department visits for behavioral health crises and address disparities in access and affordability. Industry stakeholders emphasize the importance of maintaining telehealth flexibilities and expanding digital solutions to support continuity of care. As a result, many in the healthcare ecosystem anticipate that the coming year will bring notable developments that could shape long-term behavioral health policy and infrastructure.</p>
<p>Avalere supports stakeholders across the behavioral healthcare spectrum, and can partner with stakeholders as they:</p>
<ul>
<li>Shape mental/behavioral health policy initiatives</li>
<li>Identify systemic pain points and identify collaborative solutions</li>
<li>Engage in or create opportunities for shared dialogue across stakeholders</li>
<li>Advocate for broader access to innovative, life-saving treatments</li>
</ul>
<p>For further information and to connect with industry experts, <a href="https://pages.avalere.com/Keep-In-Touch.html?_gl=1*1r7tuii*_gcl_au*NDQ4OTc3ODA3LjE3Mzc0MTg0NzQ.*_ga*MTM4MjYyODI3Ny4xNzI5NTE2MzAx*_ga_1LKSE3H6ZT*MTc0MDY4ODQxMC4yNzMuMS4xNzQwNjkwMTMzLjI1LjAuMA..">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/opportunities-to-move-the-needle-on-us-behavioral-healthcare-in-2025">Opportunities to Move the Needle on US Behavioral Healthcare in 2025</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>eBook: Rare Disease Biotechnology Landscape</title>
		<link>https://advisory.avalerehealth.com/insights/ebook-rare-disease-biotechnology-landscape</link>
					<comments>https://advisory.avalerehealth.com/insights/ebook-rare-disease-biotechnology-landscape#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Tue, 18 Feb 2025 14:35:16 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=31501</guid>

					<description><![CDATA[<p>The post <a href="https://advisory.avalerehealth.com/insights/ebook-rare-disease-biotechnology-landscape">eBook: Rare Disease Biotechnology Landscape</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<div class="wpb-content-wrapper"><div class="vc_row wpb_row vc_row-fluid wpex-relative"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper">
	<div class="wpb_text_column wpb_content_element" >
		<div class="wpb_wrapper">
			<p><span data-contrast="auto">Download the new resource <a href="https://advisory.avalerehealth.com/wp-content/uploads/2024/02/Rare_Disease_2025-002.pdf">here</a>.</span></p>
<p>Rare diseases are not so rare. This is a commonly used phrase in the rare disease community. There are more than 10,000 known rare conditions that affect more than 30 million Americans and more than 400 million people worldwide. This diverse and complex disease area poses challenges not only to patients but their caregivers, regulators, pharmaceutical manufacturers, policymakers, and other stakeholders. Considering that less than 10% of these conditions have any treatment options available, there is a significant unmet need in this space.</p>
<p>In this edition of the eBook, <a href="https://avalerehealth.com/"><span data-contrast="none">Avalere Health</span></a> experts discuss issues and considerations associated with rare-disease drug development, ex-US policy considerations, US federal and state-level programs and initiatives, the economic burden associated with rare diseases, and opportunities for a cohesive quality strategy in these conditions.</p>
<p><span data-contrast="auto">The eBook includes the following chapters:</span><span data-ccp-props="{}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Manufacturer Considerations for Rare Disease Drug Development</span><span data-ccp-props="{}"> </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">The Impact of European Policy and Advocacy on Progress in Rare Disease</span><span data-ccp-props="{}"> </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1">Newborn Screening: US Landscape and Rare Disease Development</li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1">Rare Disease Advisory Councils: Opportunities for Engagement</li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Assessing the Total Economic Burden of Rare Disease</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1">The State of Quality in Rare Disease</li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Case Studies</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:&#091;8226&#093;,&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" aria-setsize="-1" data-aria-posinset="7" data-aria-level="1">Every Patient Possible</li>
</ul>
<p><span data-contrast="auto">Download the free <a href="https://advisory.avalerehealth.com/wp-content/uploads/2024/02/Rare_Disease_2025-002.pdf">Rare Disease eBook</a>.</span></p>
<p><span data-contrast="auto">Want to learn more? Join our<a href="https://avalerehealth.com/news/thought-leadership/rare-disease-day-webinar-from-patient-empowerment-to-market-impact/"> <strong>Rare Disease Day webinar: From patient empowerment to market impact</strong> </a>on February 28 at 10AM ET. We will explore headwinds and tailwinds for shortening the diagnostic odyssey, what it means to live with a rare disease or be a caregiver to someone affected by it, and how manufacturers can navigate evolving market dynamics to ensure successful commercialization of treatments while securing patient access.</span><a href="https://avalerehealth.com/news/thought-leadership/rare-disease-day-webinar-from-patient-empowerment-to-market-impact/"><span data-ccp-props="{}"> Click here to register.</span></a></p>

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</div><p>The post <a href="https://advisory.avalerehealth.com/insights/ebook-rare-disease-biotechnology-landscape">eBook: Rare Disease Biotechnology Landscape</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Evidence Generation and Access at the San Antonio Breast Cancer Symposium</title>
		<link>https://advisory.avalerehealth.com/insights/evidence-generation-and-access-at-the-san-antonio-breast-cancer-symposium</link>
					<comments>https://advisory.avalerehealth.com/insights/evidence-generation-and-access-at-the-san-antonio-breast-cancer-symposium#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Mon, 23 Dec 2024 22:13:54 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=33735</guid>

					<description><![CDATA[<p>At the December 2024 San Antonio Breast Cancer Symposium (SABCS), Avalere’s oncology advisory experts connected with leading industry and academic experts to discuss the future of oncology, particularly in the areas of prevention, diagnosis ,and therapy for breast cancer and premalignant breast disease. Key themes emerged from our conversations with therapeutic, diagnostic, and device companies:&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/evidence-generation-and-access-at-the-san-antonio-breast-cancer-symposium">Evidence Generation and Access at the San Antonio Breast Cancer Symposium</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>At the December 2024<a href="https://sabcs.org/"> San Antonio Breast Cancer Symposium</a> (SABCS), Avalere’s oncology advisory experts connected with leading industry and academic experts to discuss the future of oncology, particularly in the areas of prevention, diagnosis ,and therapy for breast cancer and premalignant breast disease. Key themes emerged from our conversations with therapeutic, diagnostic, and device companies:</p>
<ol>
<li><strong>Screening to Advance Patient-Centric Outcomes.</strong> Risk reduction and early detection was a central theme at SABCS. Stakeholders discussed replacing traditional age-based screening with risk-based screening, with a focus on minimizing false positives from screenings. Stakeholders also considered the use of predictive models to improve harm-benefit ratios for risk-based screening. Studies continue to demonstrate that cancer affects not only the patient, but their families and caregivers. Prioritizing patient and caregiver experiences when tailoring the treatment, disease monitoring, and recovery process can lead to better patient-centered outcomes.</li>
<li><strong>Innovations through Precision Medicine.</strong> Precision medicine to treat breast cancer continues to be in the spotlight. Several discussions showcased innovative approaches in breast cancer disease monitoring, particularly with regards to minimal residual disease and the use of circulating tumor DNA as an early indicator of tumor recurrence. These advancements align with the desire to for more risk reduction and early detection tools. As evidence-based interventions continue to be a pillar in routine healthcare and public health settings, they will even be more impactful as tools to inform market access strategies and healthcare decision making.</li>
<li><strong>Advancements in Clinical Trials</strong>. Several workshops and sessions detailed the results of trials focused on recent innovative treatments, advanced dose optimization strategies, and new technologies. These included the use of liquid biopsy and tumor detection technology in various patient populations to identify cancer and create treatment plans for better outcomes. While clinical trials remain the gold standard for assessing the safety and efficacy of these treatments, real world evidence demonstrating the impact of these new innovations will be pivotal to support adoption and differentiation from comparators, incorporating patient preference, tolerability profile, total cost of care, and clinical effectiveness.</li>
</ol>
<p><strong>How We Can Help </strong></p>
<p>The San Antonio Breast Cancer Symposium allowed Avalere’s oncology experts to bring their unique perspectives to the evolving discussions about breast cancer treatment innovations, barriers, and challenges. Demonstrating the impact of real-world evidence, access, value, and policy strategies can help stakeholders across the oncology ecosystem prepare for and respond to changes in the landscape. To learn how Avalere can support you as you prepare for market entry or seek to further differentiate in-market offerings, <a href="https://pages.avalere.com/Insights.html?_gl=1*1ivb34x*_gcl_au*OTk1MjU5MjI3LjE3Mjk1MTkxNDQ.*_ga*MTM4MjYyODI3Ny4xNzI5NTE2MzAx*_ga_1LKSE3H6ZT*MTczNDk5MTU3My4xMzEuMS4xNzM0OTkxNTk2LjM3LjAuMA..">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/evidence-generation-and-access-at-the-san-antonio-breast-cancer-symposium">Evidence Generation and Access at the San Antonio Breast Cancer Symposium</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>NORD Summit Reveals 2025 Rare Disease Priorities</title>
		<link>https://advisory.avalerehealth.com/news/nord-summit-reveals-2025-rare-disease-priorities</link>
					<comments>https://advisory.avalerehealth.com/news/nord-summit-reveals-2025-rare-disease-priorities#_comments</comments>
		
		<dc:creator><![CDATA[mgomez@avalere.com]]></dc:creator>
		<pubDate>Mon, 11 Nov 2024 16:51:39 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=33557</guid>

					<description><![CDATA[<p>Each year, NORD’s Breakthrough Summit brings together more than 900 attendees to share the latest developments in the rare disease community. This year, the NORD Summit’s theme, “Equitable Access to Innovation,” was woven into the sessions. Rising out of this overarching theme were three major topics consistently mentioned as both priorities and persistent gaps in&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/nord-summit-reveals-2025-rare-disease-priorities">NORD Summit Reveals 2025 Rare Disease Priorities</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Each year, NORD’s Breakthrough Summit brings together more than 900 attendees to share the latest developments in the rare disease community.</p>
<p>This year, the NORD Summit’s theme, “Equitable Access to Innovation,” was woven into the sessions. Rising out of this overarching theme were three major topics consistently mentioned as both priorities and persistent gaps in the rare disease care environment. The topics were: Ensuring patient centeredness in care planning, delivering access to innovative therapies, and narrowing the focus on innovation. Avalere experts Shelby Harrington, RN, Mariia Salova, Nicole Betor, and Jasmine Nicole Namata shared their perspectives on the Summit with MedAd News.</p>
<p>To read about developments at the NORD Breakthrough Summit, visit <a href="https://www.pharmalive.com/nord-breakthrough-summit-reveals-2025-priorities/#:~:text=Rising%20out%20of%20this%20overarching,narrowing%20their%20focus%20on%20innovation.">MedAd News</a>.</p>
<p><strong>Learn More</strong><br />
Avalere applies our expertise in FDA regulatory strategy and evidence generation planning, access strategies for rare disease treatments, and strategizing impacts of IRA implementation to help healthcare stakeholders meet their strategic business objectives for approval and lifecycle management. To learn more about how Avalere can help you with clinical development planning, value, and access strategies for rare and ultra-rare disease assets, <a href="https://pages.avalere.com/Keep-In-Touch.html?_gl=1*ovyfpw*_gcl_aw*R0NMLjE3MjcyODQ1MTUuQ2p3S0NBanc2YzYzQmhBaUVpd0FGMEVIMUZyNjdzcjI4MHphQUNrSFdNNHVBQkl3cEwxMm5EdHZyaUtKY0ZfT252emlIeS0xaUprYnlob0NvRDhRQXZEX0J3RQ..*_gcl_au*NzE2OTQ0MzA4LjE3MjY0OTM4OTI.*_ga*NDYxMTg3NTM1LjE3MTAxNjM0MTY.*_ga_1LKSE3H6ZT*MTczMTA5NDA1MS4yNjkuMS4xNzMxMDk0NjE5LjUyLjAuMA..">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/nord-summit-reveals-2025-rare-disease-priorities">NORD Summit Reveals 2025 Rare Disease Priorities</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Avalere Published in PM360: Research that Reflects Reality</title>
		<link>https://advisory.avalerehealth.com/news/avalere-published-in-pm360-research-that-reflects-reality</link>
					<comments>https://advisory.avalerehealth.com/news/avalere-published-in-pm360-research-that-reflects-reality#_comments</comments>
		
		<dc:creator><![CDATA[mgomez@avalere.com]]></dc:creator>
		<pubDate>Mon, 11 Nov 2024 16:44:53 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=33547</guid>

					<description><![CDATA[<p>Leveraging real-world data (RWD) leads to the generation of real-world evidence (RWE) data. RWE holds the promise of combining the benefits of clinical experience with the scientific rigor of qualitative and quantitative research methods. Avalere experts Shelby Harrington, RN, and Taylor Schwartz describe the benefits of utilizing RWE in “Research that Reflects Reality: The Gap&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/avalere-published-in-pm360-research-that-reflects-reality">Avalere Published in PM360: Research that Reflects Reality</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Leveraging real-world data (RWD) leads to the generation of real-world evidence (RWE) data. RWE holds the promise of combining the benefits of clinical experience with the scientific rigor of qualitative and quantitative research methods. Avalere experts Shelby Harrington, RN, and Taylor Schwartz describe the benefits of utilizing RWE in “Research that Reflects Reality: The Gap Between Clinical-Trial Results and Real-World Data.”</p>
<p>To read the article, visit <a href="https://www.pm360online.com/research-that-reflects-reality/">PM360</a>.</p>
<p><strong>Learn More</strong><br />
Our team includes published researchers, pharmacists, and physicians as well as statisticians, health economists, and other public health experts. We apply our perspective to a wide range of datasets, giving clients real-world information and analysis needed to achieve their objectives. To learn more about how Avalere’s team can support your business, connect with us.</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/avalere-published-in-pm360-research-that-reflects-reality">Avalere Published in PM360: Research that Reflects Reality</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Rethinking Evidence Strategy in HEOR Budget Planning</title>
		<link>https://advisory.avalerehealth.com/news/rethinking-evidence-strategy-in-heor-budget-planning</link>
					<comments>https://advisory.avalerehealth.com/news/rethinking-evidence-strategy-in-heor-budget-planning#_comments</comments>
		
		<dc:creator><![CDATA[mgomez@avalere.com]]></dc:creator>
		<pubDate>Tue, 10 Sep 2024 19:01:32 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=33240</guid>

					<description><![CDATA[<p>For many of those who focus on generating value propositions through HEOR, Fall is the time for budget planning for the upcoming fiscal year. With so many changes influencing the healthcare landscape, revisiting and advancing an organization’s evidence needs is necessary to more accurately build an effective value-based commercialization strategy. The article, “Rethinking Evidence Strategy&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/rethinking-evidence-strategy-in-heor-budget-planning">Rethinking Evidence Strategy in HEOR Budget Planning</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>For many of those who focus on generating value propositions through HEOR, Fall is the time for budget planning for the upcoming fiscal year. With so many changes influencing the healthcare landscape, revisiting and advancing an organization’s evidence needs is necessary to more accurately build an effective value-based commercialization strategy. The article, “Rethinking Evidence Strategy in HEOR Budget Planning,” was authored by Nicole Betor, Nancy El Hoyek, Laura Housman, Josie Lloyd, and Taylor Schwartz.</p>
<p>To read the article, visit <a href="https://www.pharmafocusamerica.com/strategy/rethinking-evidence-strategy">Pharma Focus America</a>.</p>
<p><strong>Learn More</strong><br />
Avalere leverages our staff’s deep expertise in evidence generation planning, data partnership evaluation, and HEOR to help clients develop their annual research agendas and conceptualize studies that meet their business objectives. To explore how Avalere can partner with you to ensure your evidence generation strategies reflect current market trends and future business needs, <a href="https://pages.avalere.com/Insights.html">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/rethinking-evidence-strategy-in-heor-budget-planning">Rethinking Evidence Strategy in HEOR Budget Planning</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Updated Negotiation ICR Presents New Industry Evidence Needs</title>
		<link>https://advisory.avalerehealth.com/insights/updated-negotiation-icr-presents-new-industry-evidence-needs</link>
					<comments>https://advisory.avalerehealth.com/insights/updated-negotiation-icr-presents-new-industry-evidence-needs#_comments</comments>
		
		<dc:creator><![CDATA[cturner]]></dc:creator>
		<pubDate>Mon, 05 Aug 2024 16:15:53 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<category><![CDATA[ira]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=32795</guid>

					<description><![CDATA[<p>Background The first round of Medicare drug price negotiation is concluding and maximum fair prices for the first 10 selected Part D drugs will be released by September 1. In parallel, the Centers for Medicare &#38; Medicaid Services (CMS) is preparing to implement changes for initial price applicability year (IPAY) 2027 and beyond. On July&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/updated-negotiation-icr-presents-new-industry-evidence-needs">Updated Negotiation ICR Presents New Industry Evidence Needs</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>Background</strong></p>
<p>The first round of Medicare drug price negotiation is concluding and maximum fair prices for the <a href="https://advisory.avalerehealth.com/insights/cms-selects-first-10-drugs-for-medicare-negotiation">first 10 selected Part D drugs</a> will be released by September 1. In parallel, the Centers for Medicare &amp; Medicaid Services (CMS) is preparing to implement changes for initial price applicability year (IPAY) 2027 and beyond.</p>
<p>On July 2, CMS issued an initial Information Collection Request (ICR) detailing the negotiation data elements and drug price negotiation process for Medicare Part D drugs for IPAY 2027. The ICR includes substantial updates to Section I, “Evidence About Alternative Treatments,” of the Negotiation Data Elements Form. These updates likely reflect learnings and <a href="https://advisory.avalerehealth.com/insights/how-can-manufacturers-help-shape-medicare-negotiations">feedback from stakeholders</a> during the IPAY 2026 negotiation process and reflect consideration from CMS to incorporate input into future IPAY program elements. The changes increase the scope of requested information from manufacturers and will require <a href="https://advisory.avalerehealth.com/insights/what-evidence-is-needed-for-medicare-drug-price-negotiation">refined evidence strategies</a> to ensure optimal preparation.</p>
<p><strong>Key Changes to IPAY 2027 Initial Negotiation Data Elements ICR</strong></p>
<p>CMS greatly expanded Section I, which now includes more than 30 questions organized in categories by the most likely relevant stakeholder, including:</p>
<ul>
<li>Manufacturer-Focused Input (Q30–Q37)</li>
<li>Patient- or Caregiver-Focused Input (Q38–Q44)</li>
<li>Clinical-Focused Input (Q45–Q51)</li>
<li>Health Research-Focused Input (Q52–Q58)</li>
<li>Other Public Input (Q59–Q62)</li>
</ul>
<p>Although each category has a specific stakeholder listed, CMS emphasizes that these are illustrative, and any interested party can respond to any or all questions in Section I.</p>
<p>In the Manufacturer-Focused Input section, the <a href="https://advisory.avalerehealth.com/insights/do-drug-manufacturers-have-the-evidence-needed-for-price-negotiation">topics present in the IPAY 2026 ICR</a> and outlined in the <a href="https://advisory.avalerehealth.com/healthcare-trends/inflation-reduction-act">Inflation Reduction Act</a> (IRA) <a href="https://www.congress.gov/bill/117th-congress/house-bill/5376/text">statute</a> are retained, including Prescribing Information, Comparative Effectiveness, Therapeutic Advance, Specific Populations, and Unmet Medical Need. While these topics remain consistent, many questions have been split into multiple sub-questions, and the overall word count for responses has been increased. CMS has also added questions asking respondents to identify <a href="https://advisory.avalerehealth.com/case-study/understanding-the-impact-of-therapeutic-alternative-selection-in-ira-negotiations">therapeutic alternatives</a>; provide Medicare-specific disease prevalence, treatment utilization, and healthcare resource utilization (HCRU) data; present patient experience data; and submit an evidence dossier to complement Section I responses. Lastly, CMS specifies that it “prefers publicly available, peer reviewed literature” and “reserves the right to review submitted materials for relevance.”</p>
<p><strong>Evidence Requested in Section I of the IPAY 2027 Initial ICR</strong></p>
<p>For each indication, manufacturers can now submit evidence on:</p>
<ul>
<li>Relevant Therapeutic Alternatives</li>
<li>Use in Clinical Care &amp; Relevant Clinical Outcomes</li>
<li>Clinical Comparative Effectiveness</li>
<li>Medicare-specific Indication Prevalence</li>
<li>Medicare-specific Drug Utilization</li>
<li>Medicare-specific Healthcare Resource Utilization</li>
<li>Therapeutic Advance versus Alternatives</li>
<li>Addressing Unmet Medical Need</li>
<li>Impact on Specific Populations of Interest</li>
<li>Patient Experience, Preferences, and Disease Burden</li>
<li>Health Equity, Access, and SDOH Considerations</li>
</ul>
<p>To further support responses to each of the ICR questions, manufacturers can also submit:</p>
<ul>
<li>IRA-Specific Evidence Dossier</li>
<li>Visual Representations (e.g., tables, charts, graphs)</li>
</ul>
<p><strong>Impact on Manufacturers’ Evidence Planning &amp; Packaging</strong></p>
<p>Ultimately, these changes have mixed implications for manufacturers. The evidence requested in the ICR has notably increased, resulting in greater resource demands during ICR response preparation. CMS’s specified preference for peer-reviewed literature may require additional dissemination to ensure evidence submitted is in the public domain before negotiation. Manufacturers will likely need to dedicate more resources towards ICR response submission activities and begin these activities sooner than previously planned. Further, the newly requested Medicare-specific prevalence, utilization, and HCRU data will likely require new evidence generation and subsequent publication. Manufacturers should look for opportunities to efficiently generate evidence that fills existing gaps, for example by conducting a Medicare-specific real-world evidence study across a range of outcomes and comparators relevant to negotiation.</p>
<p>Despite the increased effort, these ICR updates bring greater opportunities to communicate a cohesive and effective treatment value story tailored specifically to CMS. The opportunity to submit an evidence dossier is a new avenue to facilitate effective communication about the existing evidence base for a product. The dossier can be used as a tool to complement the value narrative throughout the ICR questions and should be strategically designed to ensure relevance and impact to CMS. The new organization of the ICR is more straightforward and reduces ambiguity around where specific information should be submitted. This should assist manufacturers in the development of the ICR response, particularly as it pertains to the data and evidence appropriate for each question.</p>
<p><strong>Key Takeaways</strong></p>
<p>This ICR is open to public comments through September 3, after which CMS will review and release a revised version in Fall 2024. While CMS may implement changes to the document following public comment, it is important that manufacturers with direct or <a href="https://advisory.avalerehealth.com/insights/which-therapeutic-areas-are-likely-to-be-affected-by-ira-negotiation">competitor impacts</a> in the <a href="https://advisory.avalerehealth.com/insights/opportunities-to-prepare-for-year-2-of-medicare-negotiation">next round of negotiation</a> begin early evidence preparation according to this ICR. Necessary activities may include:</p>
<ul>
<li>Assessing the existing evidence base, particularly from a CMS lens</li>
<li>Developing CMS-specific product value messaging</li>
<li>Preparing an IRA-specific dossier to complement ICR response submission</li>
</ul>
<p>For those with expected negotiation or <a href="https://advisory.avalerehealth.com/insights/should-competitors-of-negotiated-drugs-review-their-evidence-strategy">competitor impacts</a> in IPAY 2028 and beyond, there are greater opportunities to revamp evidence strategies to optimize negotiation outcomes. This may include:</p>
<ul>
<li>Conducting an evidence gaps analysis and feasibility assessment to fill those gaps with meaningful evidence generation</li>
<li>Revising early lifecycle evidence planning to account for and integrate negotiation-related evidence needs</li>
<li>Developing and executing an evidence publication strategy that introduces meaningful evidence into the public domain</li>
</ul>
<p><strong>A Trusted Partner for CMS Engagement</strong></p>
<p>IRA will continue to have <a href="https://advisory.avalerehealth.com/insights/ira-negotiation-creates-ripple-effects-across-drug-markets">wide-reaching impacts</a> across the prescription drug market. An effective <a href="https://advisory.avalerehealth.com/webinars/demystifying-ira-drug-price-negotiation">IRA negotiation</a> response strategy requires evidence planning informed by a CMS negotiation evaluation lens. With expertise in policy, evidence generation and strategy, and market access, Avalere’s multidisciplinary team can help manufacturers effectively respond to these new evidence needs. <a href="https://pages.avalere.com/Insights.html">Connect with us</a> to learn more.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/updated-negotiation-icr-presents-new-industry-evidence-needs">Updated Negotiation ICR Presents New Industry Evidence Needs</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Rethink Evidence Strategy this HEOR Budget Planning Season</title>
		<link>https://advisory.avalerehealth.com/insights/rethink-evidence-strategy-this-heor-budget-planning-season</link>
					<comments>https://advisory.avalerehealth.com/insights/rethink-evidence-strategy-this-heor-budget-planning-season#_comments</comments>
		
		<dc:creator><![CDATA[avalere_wp]]></dc:creator>
		<pubDate>Thu, 18 Jul 2024 21:10:42 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=32650</guid>

					<description><![CDATA[<p>Health economics and outcomes research (HEOR) is no longer a “one-and-done,” cookie-cutter process. The needs of specific assets at different points in the product life cycle can vary significantly based on a variety of factors, including market dynamics, the policy environment, and even the targeted disease itself and its impact on patients. In a recent&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/rethink-evidence-strategy-this-heor-budget-planning-season">Rethink Evidence Strategy this HEOR Budget Planning Season</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span data-contrast="auto">Health economics and outcomes research (HEOR) is no longer a “one-and-done,” cookie-cutter process. The needs of specific assets at different points in the product life cycle can vary significantly based on a variety of factors, including market dynamics, the policy environment, and even the targeted disease itself and its impact on patients. In a recent series on the top </span><a href="https://advisory.avalerehealth.com/insights/2023-top-trends-in-health-economics-and-outcomes-research-2"><span data-contrast="none">trends in HEOR</span></a><span data-contrast="auto">, Avalere experts identified some of the biggest influences on evidence generation needs, such as the </span><a href="https://advisory.avalerehealth.com/insights/should-competitors-of-negotiated-drugs-review-their-evidence-strategy"><span data-contrast="none">Inflation Reduction Act</span></a><span data-contrast="auto"> (IRA) and other policy changes, increased use of </span><a href="https://advisory.avalerehealth.com/insights/reevaluating-value-assessment-for-heor-in-2023"><span data-contrast="none">value assessment</span></a><span data-contrast="auto"> to inform coverage, reimbursement, and utilization management decisions, and the continued shift towards </span><a href="https://advisory.avalerehealth.com/webinars/valuing-the-patient-perspective-patient-centered-hta"><span data-contrast="none">patient-centered care</span></a><span data-contrast="auto">. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">As life sciences companies consider their HEOR budgets for the coming year, leaders have the opportunity to revisit their portfolio’s research and evidence needs in order to support their company’s overall commercialization strategy. Considering the five specific elements below will ensure a robust HEOR strategy that prepares your organization for the upcoming year and sets you up for success in the years beyond. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><b><span data-contrast="auto">1. Examine your evidence generation plan from a stakeholder’s perspective. </span></b></p>
<p><span class="TextRun SCXW55758153 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW55758153 BCX0">The healthcare market is </span></span><a class="Hyperlink SCXW55758153 BCX0" href="https://advisory.avalerehealth.com/insights/establishing-value-in-an-uncertain-and-dynamic-landscape" target="_blank" rel="noreferrer noopener"><span class="TextRun Underlined SCXW55758153 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW55758153 BCX0" data-ccp-charstyle="Hyperlink">constantly evolving</span></span></a><span class="TextRun SCXW55758153 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW55758153 BCX0">, so your evidence generation plan must be evaluated annually</span><span class="NormalTextRun SCXW55758153 BCX0"> and updated to reflect these new dynamics. </span><span class="NormalTextRun SCXW55758153 BCX0">Consider the important stakeholders </span><span class="NormalTextRun SCXW55758153 BCX0">for your asset portfolio</span><span class="NormalTextRun SCXW55758153 BCX0">: </span><span class="NormalTextRun SCXW55758153 BCX0">payers, providers, and patients. Understand what </span><span class="NormalTextRun SCXW55758153 BCX0">each stakeholder expects and needs from your evidence</span><span class="NormalTextRun SCXW55758153 BCX0">, and </span></span><a class="Hyperlink SCXW55758153 BCX0" href="https://advisory.avalerehealth.com/insights/2023-top-heor-trends-heor-as-a-differentiator-vs-commodity" target="_blank" rel="noreferrer noopener"><span class="TextRun Underlined SCXW55758153 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW55758153 BCX0" data-ccp-charstyle="Hyperlink">incorporate those evidence needs</span></span></a><span class="TextRun SCXW55758153 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW55758153 BCX0"> into your research plans. </span></span><span class="EOP SCXW55758153 BCX0" data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><b><span data-contrast="auto">2. Assess value assessment needs based on each product’s stage in the life cycle. </span></b></p>
<p><span data-contrast="auto">Value assessment in the US, such as ICER, the IRA, and other policy changes are shifting evidence needs </span><a href="https://advisory.avalerehealth.com/insights/rwe-considerations-throughout-product-development-cycle"><span data-contrast="none">across the product life cycle</span></a><span data-contrast="auto">. Pre-launch assets may need economic modeling and value assessment planning to prepare for a potential review by the Institute for Clinical Effectiveness Research and other health technology assessment bodies. In-line products, meanwhile, will need to generate evidence to prepare for potential </span><a href="https://advisory.avalerehealth.com/insights/what-evidence-is-needed-for-medicare-drug-price-negotiation"><span data-contrast="none">Medicare price negotiation</span></a><span data-contrast="auto"> late in their life cycle.</span></p>
<p><b><span data-contrast="auto">3. Expand your capabilities with innovative data partnerships or data sources. </span></b></p>
<p><span data-contrast="auto">Consider how your evidence generation capabilities can be improved through </span><a href="https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025"><span data-contrast="none">innovative data partnerships and new data sources</span></a><span data-contrast="auto">. Data on </span><a href="https://advisory.avalerehealth.com/offering/health-equity-and-social-determinants-of-health-research"><span data-contrast="none">social determinants of health</span></a><span data-contrast="auto">, for example, may uncover details of patient access challenges or biomarker lab data  that can be used to identify and target specific patient sub-populations. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><b><span data-contrast="auto">4. Remember that patient-centered research is paramount. </span></b></p>
<p><span data-contrast="auto">Stakeholders increasingly expect manufacturers to infuse the </span><a href="https://advisory.avalerehealth.com/insights/heor-trends-patient-centricity"><span data-contrast="none">patient perspective </span></a><span data-contrast="auto">into evidence-generation strategies. Evidence can be used to better understand the experiences of patients with a particular condition, for example, or to describe how innovative treatments can </span><a href="https://advisory.avalerehealth.com/insights/assessing-the-total-economic-burden-of-rare-disease"><span data-contrast="none">directly and indirectly impact</span></a><span data-contrast="auto"> that experience. Conducting patient preference studies and exploring health disparities research can highlight existing barriers to care or provide insights to determine what patients need for successful care. Ensuring your evidence generation plans </span><a href="https://advisory.avalerehealth.com/insights/infusing-the-patient-perspective-into-value-assessment"><span data-contrast="none">incorporate the patient perspective</span></a><span data-contrast="auto"> will ensure you can communicate patient needs to healthcare decisionmakers. </span></p>
<p><b><span data-contrast="auto">5. Consider HEOR’s integral relationship to other aspects of the business. </span></b></p>
<p><span data-contrast="auto">Research agendas are traditionally intended to support market access, but a well-planned strategy considers the potential uses by other aspects of the business. With forethought, your research can have greater impact and produce a higher return on investment if used to support field teams speaking to providers about improving treatment protocols, marketing teams seeking to reach a target patient population, or patient support programs that need to understand patient needs and barriers to access. Incorporating a broader set of business needs in your research agenda can improve business efficiency and provide additional value across the organization.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><b><span data-contrast="auto">Learn More</span></b><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">Avalere leverages our staff’s deep expertise in evidence generation planning, data partnership evaluation, and HEOR to help clients develop their annual research agendas and conceptualize studies that meet their business objectives. To learn more about how Avalere can partner with you to ensure your evidence generation strategies reflect current market trends and future business needs, </span><a href="https://pages.avalere.com/Keep-In-Touch.html"><span data-contrast="none">connect with us</span></a><span data-contrast="auto">. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/rethink-evidence-strategy-this-heor-budget-planning-season">Rethink Evidence Strategy this HEOR Budget Planning Season</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Mental Health Treatment Integration Can Offer Cost Savings</title>
		<link>https://advisory.avalerehealth.com/insights/mental-health-treatment-integration-can-offer-cost-savings</link>
					<comments>https://advisory.avalerehealth.com/insights/mental-health-treatment-integration-can-offer-cost-savings#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Wed, 03 Jul 2024 15:27:04 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<category><![CDATA[Future of Health Plans]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=32594</guid>

					<description><![CDATA[<p>Mental health continues to represent one of the largest and most pressing challenges to the American healthcare system. In 2021, over one in five US adults experienced a mental illness, and 5.5% experienced a serious mental illness. Americans face significant barriers in accessing mental healthcare, with downstream implications for overall health outcomes, comorbidities, and system&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/mental-health-treatment-integration-can-offer-cost-savings">Mental Health Treatment Integration Can Offer Cost Savings</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Mental health continues to represent one of the largest and most pressing challenges to the American healthcare system. In 2021, <a href="https://www.nami.org/about-mental-illness/mental-health-by-the-numbers/#:~:text=22.8%25%20of%20U.S.%20adults%20experienced,represents%201%20in%2020%20adults.">over one in five US </a>adults experienced a mental illness, and 5.5% experienced a serious mental illness. Americans face significant barriers in accessing mental healthcare, with downstream implications for overall health outcomes, comorbidities, and system expenditures.</p>
<p>Avalere conducted two analyses investigating the relationship between mental health conditions, comorbidities, and overall spending. Avalere also conducted a third analysis highlighting geographic variations in reimbursement in mental health treatments.</p>
<h2>Analysis 1: Comorbidities of Major Depressive Disorder (MDD) with Anhedonia</h2>
<p>Avalere investigated the types of comorbidities linked with anhedonia in patients with MDD. Anhedonia is the inability to experience joy or pleasure, which is a common but underdiagnosed symptom of mental health conditions like depression. Anhedonia is a predictor of negative long-term outcomes such as suicide and poor response to treatments. There continues to be unmet needs in treatment options for patients with anhedonia, which is a high-risk and core symptom of MDD.</p>
<p>Avalere identified the top eight primary and secondary diagnoses among patients with MDD with anhedonia among Medicare fee-for-service (FFS) beneficiaries in calendar year (CY) 2022. These comorbidities are:</p>
<table id="insight">
<thead>
<tr>
<th style="text-align: center;">Primary</th>
<th style="text-align: center;">Secondary</th>
</tr>
</thead>
<tbody>
<tr>
<td>Hypertension</td>
<td>Hypertension</td>
</tr>
<tr>
<td>Disorders of Lipoid Metabolism</td>
<td>Disorders of Lipoid Metabolism</td>
</tr>
<tr>
<td>Anxiety and Other Psychiatric Disorders</td>
<td>Anxiety and Other Psychiatric Disorders</td>
</tr>
<tr>
<td>Bipolar Disorder</td>
<td>Thyroid Disorders</td>
</tr>
<tr>
<td>Diabetes with Complications</td>
<td>Diabetes with Complications</td>
</tr>
<tr>
<td>Thyroid Disorders</td>
<td>Chronic Obstructive Pulmonary Disease,<br />
Bronchiectasis, and Other Asthma</td>
</tr>
<tr>
<td>Dementia, Except Alzheimer’s Disease</td>
<td>Coronary Artery Disease</td>
</tr>
<tr>
<td>Schizophrenia and Other Psychosis</td>
<td>Dementia, Except Alzheimer’s Disease</td>
</tr>
</tbody>
</table>
<p>In Medicare FFS, common comorbidities such as hypertension and diabetes were chronic conditions expected with the age of the population. However, mental health disorders such as anxiety, bipolar disorder, or schizophrenia were also prevalent. This indicates a linkage between MDD with anhedonia and these mental health diseases, highlighting the need for an integrated treatment approach. This analysis demonstrates that creating access to integrated mental healthcare may increase the availability of health services and enhance patient outcomes.</p>
<h2>Analysis 2: Expenditures Associated with Major Depressive Disorder</h2>
<p>Another Avalere analysis focused on MDD, a serious mental health condition characterized by a persistent and intense feeling of sadness or a lack of interest in external stimuli that impacts daily functioning and quality of life. Avalere’s analysis demonstrated significant increases in medical expenditures for patients with comorbidities when those patients did not receive adequate mental healthcare for MDD.</p>
<p>In all comorbidity subgroups analyzed (diabetes, schizophrenia and bipolar disorder, and congestive heart failure), total expenditures in the adequately treated group were better controlled in the 12 months following diagnosis compared to the inadequately treated group. Specifically, total expenditures related to the comorbid condition were 6.6%–8.5% lower in the adequately treated group within the same 12-month period.</p>
<p>This analysis demonstrates that mental health conditions currently place a significant economic burden on the US healthcare system. Addressing the cost of mental health conditions and comorbidities requires an integrated care approach with mental health screening, early intervention, and collaborative care.</p>
<h2>Figure 1: Baseline Comparison for All-Cause Medical Expenditures by Comorbidity</h2>
<p><img loading="lazy" decoding="async" class="alignnone wp-image-32595 size-full" src="https://advisory.avalerehealth.com/wp-content/uploads/2024/07/mental-health-insight-graphic.png" alt="" width="960" height="576" srcset="https://advisory.avalerehealth.com/wp-content/uploads/2024/07/mental-health-insight-graphic.png 960w, https://advisory.avalerehealth.com/wp-content/uploads/2024/07/mental-health-insight-graphic-300x180.png 300w, https://advisory.avalerehealth.com/wp-content/uploads/2024/07/mental-health-insight-graphic-768x461.png 768w" sizes="auto, (max-width: 960px) 100vw, 960px" /></p>
<p><span style="font-size: 10px;">Adequate: Patient had four psychotherapy visits in the first 12 weeks after diagnosis and filled antidepressant prescription for at least 84 of the first 144 days; </span><span style="font-size: 10px;">Inadequate: Patient did not meet psychotherapy or prescription criteria; </span><span style="font-size: 10px;">Baseline Mean: 12 months preceding the initial diagnosis of MDD; </span><span style="font-size: 10px;">Index Date: The date on which the first MDD diagnosis was made; </span><span style="font-size: 10px;">Post-index Mean: 12 months following the initial diagnosis</span></p>
<h2>Analysis 3: Geographic Variations in Reimbursement</h2>
<p>Reimbursement affects access to innovative mental treatments and services. Avalere’s analysis compared utilization trends among Medicare FFS Part B beneficiaries in 2021 and 2022 to understand differences in administration of a newer, branded MDD drug. Findings demonstrated that there were geographic differences in reimbursement: Medicare payment was highest in Pacific and East Coast states (Texas and Arkansas were notable exceptions, with higher payment). These findings indicate that patients residing in these areas may have greater access to specific treatments, based on provider willingness and capacity to prescribe.</p>
<h2>Next Steps</h2>
<p>Mental health has often been viewed independently of other health conditions, but these findings reveal its association with other high-cost conditions. Avalere’s research also exposes the significant barriers that many Americans face in treating their mental health, and the overall system expenditures that the associations between this lack of access and mental and physical comorbidities create. This analysis highlights that fostering broader access to mental healthcare that is consistent, thoughtful, and integrated with broader physical care delivery will create a path for overall improvement of patient outcomes and reduction in system burden and expenditure.</p>
<p>Avalere experts can help you understand the dynamics in the mental health space, the potential impacts on your business, and opportunities for involvement. To learn more about how Avalere can help, <a href="https://pages.avalere.com/Insights.html?_gl=1*h9l49b*_ga*MTEwMDEyMzkwLjE3MTI5Mjc2MTU.*_ga_1LKSE3H6ZT*MTcxNzE2MzcxOS40My4xLjE3MTcxNjM3MzEuNDguMC4w">connect with us</a>.</p>
<h2>Methodology</h2>
<p>Avalere performed this analysis using 100% Medicare FFS claims, accessed by Avalere via a research collaboration with Inovalon, Inc., and governed by a research-focused CMS data use agreement. This includes the 100% sample of Medicare Part A and Part B Medicare FFS claims data.</p>
<p>&nbsp;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/mental-health-treatment-integration-can-offer-cost-savings">Mental Health Treatment Integration Can Offer Cost Savings</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Establishing Value in an Uncertain and Dynamic Landscape</title>
		<link>https://advisory.avalerehealth.com/news/establishing-value-in-an-uncertain-and-dynamic-landscape</link>
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		<dc:creator><![CDATA[cturner]]></dc:creator>
		<pubDate>Thu, 13 Jun 2024 17:51:15 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=32343</guid>

					<description><![CDATA[<p>Recent US and global policy developments (i.e., Joint Clinical Assessment, Inflation Reduction Act, FDA Data Requirements), evolving stakeholder expectations, and enhanced focus on sustained access have intensified manufacturer requirements for  demonstrating value. Against this landscape, life science companies need to evolve their value demonstration strategies to be successful in this dynamic environment.  At ISPOR 2024&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/news/establishing-value-in-an-uncertain-and-dynamic-landscape">Establishing Value in an Uncertain and Dynamic Landscape</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span data-contrast="none">Recent US and global policy developments (i.e., Joint Clinical Assessment, Inflation Reduction Act, FDA Data Requirements), evolving stakeholder expectations, and enhanced focus on sustained access have intensified manufacturer requirements for </span> <span data-contrast="none">demonstrating value. Against this landscape, life science companies need to evolve their value demonstration strategies to be successful in this dynamic environment.</span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><span data-contrast="none">At ISPOR 2024 in Atlanta, Avalere Health presented the session, “</span><b><span data-contrast="none">No Longer Business as Usual: Establishing Value in an Uncertain and Dynamic Landscape</span></b><span data-contrast="none">,” which delved into methods for creating a coherent value strategy amidst this changing policy landscape. </span><a href="https://www.evidencebaseonline.com/navigating-uncertainty-redefining-healthcare-value-in-an-evolving-healthcare-landscape/"><span data-contrast="none">The article</span></a><span data-contrast="none">, published by </span><i><span data-contrast="none">The Evidence Base</span></i><span data-contrast="none">, provides a deep dive into the information shared during this session, including challenges and actionable strategies for life sciences companies. </span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><span data-contrast="none">To read the full article, visit </span><a href="https://www.evidencebaseonline.com/navigating-uncertainty-redefining-healthcare-value-in-an-evolving-healthcare-landscape/"><span data-contrast="none">The Evidence Base</span></a><span data-contrast="none">. </span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><span data-contrast="none">To learn more about how Avalere can assist you, </span><a href="https://pages.avalere.com/Insights.html"><span data-contrast="none">connect with us</span></a><span data-contrast="none">.</span><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}"> </span></p>
<p><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p>The post <a href="https://advisory.avalerehealth.com/news/establishing-value-in-an-uncertain-and-dynamic-landscape">Establishing Value in an Uncertain and Dynamic Landscape</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Five Data Strategy Questions Pharma Should Ask For 2025</title>
		<link>https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025</link>
					<comments>https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Wed, 01 May 2024 16:10:23 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=31961</guid>

					<description><![CDATA[<p>As the data landscape has evolved in recent years, the market for acquiring and accessing data has become increasingly crowded, characterized by high fragmentation and multiple vendors offering diverse data types. This abundance of options has led companies to procure multiple data sources, often resulting in the acquisition of redundant and overlapping data. Consequently, pharmaceutical&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025">Five Data Strategy Questions Pharma Should Ask For 2025</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>As the data landscape has evolved in recent years, the market for acquiring and accessing data has become increasingly crowded, characterized by high fragmentation and multiple vendors offering diverse data types. This abundance of options has led companies to procure multiple data sources, often resulting in the acquisition of redundant and overlapping data. Consequently, pharmaceutical companies are spending substantial sums annually on redundant data from various sources.</p>
<p>Below, Avalere experts have identified the top five data strategy questions for life science companies to consider for 2025 and beyond to ensure efficient use of budget and resources.</p>
<h2>What are the questions I’m looking to answer with data?</h2>
<p>Different therapeutic areas require different constellations of data providers. An oncology therapeutic that requires a specific genomic signature to be prescribed will require laboratory data with detailed results. A GLP-1 for obesity will require electronic medical record data with weight measurements and could benefit from the addition of consumer data to look at shopping purchases. There is no one-size-fits-all solution appropriate for every therapeutic area.</p>
<h2>What is my willingness to pay for granularity on each additional patient journey?</h2>
<p>Data pricing models vary significantly between one another. The marginal cost of visibility into each incremental percentage point of patient coverage increases dramatically. For compounds still in early development, a data set with a smaller portion of the patient population can provide sufficient visibility into the patient experience to inform key decisions. However, identifying patients with rare diseases, where each added patient in a data set can translate into very high insight value, may increase a company’s willingness to pay for more complete datasets.</p>
<h2>What other data am I buying?</h2>
<p>Like many purchases, patient data can cost less when bought in bulk. By leveraging a single data vendor across multiple therapeutic areas, significant discounts can be achieved. However, long-term contract commitments can limit flexibility if the buyer’s needs change. A good data strategy can help maintain the balance between discounts and flexibility. Being nimble in your business strategy should translate into a flexible data strategy.</p>
<h2>What are other internal stakeholders purchasing?</h2>
<p>Within many large pharma companies, different departments may purchase essentially identical sets of data from multiple vendors. In a recent project, for example, Avalere identified a client’s data purchase resulted in having 100% medical claims data overlaps between two vendors. Strong internal communication and coordination, with a strong role for procurement, can reduce the risk of duplication and may free up resources that could be put to better use.</p>
<h2>What is my tokenization strategy? And do I have one?</h2>
<p>Tokenization refers to the process of hashing and encrypting patient data to allow for the de-identification of personal identifiable information. Additionally, tokenization allows for interoperability between patients, allowing them to be linked across multiple datasets. However, utilizing multiple tokenization vendors in the same data ecosystem leads to interoperability challenges. For example, if a company utilizes Vendor A Token for their external claims data and Vendor B for its internal patient hub and specialty pharmacy data, this difference in tokenization causes issues with interoperability between datasets.</p>
<h2>How Avalere Can Help</h2>
<p>Avalere’s experts in data rationalization, evidence planning, and data comparison support clients in mapping a company’s current data assets, identifying data gaps and duplication, and recommending areas for improvement. To learn more about how Avalere can help you navigate your current, 2025 and beyond data strategy,<a href="https://pages.avalere.com/Insights.html"> connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/five-data-strategy-questions-pharma-should-ask-for-2025">Five Data Strategy Questions Pharma Should Ask For 2025</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>CMMI Quality Pathway Prioritizes Patient-Centered Value</title>
		<link>https://advisory.avalerehealth.com/insights/cmmi-quality-pathway-prioritizes-patient-centered-value</link>
					<comments>https://advisory.avalerehealth.com/insights/cmmi-quality-pathway-prioritizes-patient-centered-value#_comments</comments>
		
		<dc:creator><![CDATA[Leah Keller]]></dc:creator>
		<pubDate>Tue, 30 Apr 2024 19:55:22 +0000</pubDate>
				<category><![CDATA[Insights & Analysis]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=31948</guid>

					<description><![CDATA[<p>New Initiative Prioritizes Quality-Focused Models In April 2024, the leaders of the Center for Medicare and Medicaid Innovation (CMMI) published a blog post outlining their vision for improving quality and advancing patient-centered care via a new initiative called the Quality Pathway. The Quality Pathway would prioritize the design, evaluation, and expansion of payment models based&#8230;</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/cmmi-quality-pathway-prioritizes-patient-centered-value">CMMI Quality Pathway Prioritizes Patient-Centered Value</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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										<content:encoded><![CDATA[<h2>New Initiative Prioritizes Quality-Focused Models</h2>
<p>In April 2024, the leaders of the Center for Medicare and Medicaid Innovation (CMMI) published a <a href="https://catalyst.nejm.org/doi/full/10.1056/CAT.24.0132">blog post</a> outlining their vision for improving quality and advancing patient-centered care via a new initiative called the Quality Pathway. The Quality Pathway would prioritize the design, evaluation, and expansion of payment models based on their impact to quality and redefine how quality has been measured to date by emphasizing patient-reported outcomes, achievement of patient-centered goals, and patient experience.</p>
<p>This is a significant change in thinking for CMMI. CMMI’s mandate is to test innovative payment and service delivery models and expand those that either (1) improve quality while maintaining cost, or (2) reduce cost while maintaining quality (though ideally achieving both aims). To date, only models that have demonstrated cost improvement have been selected for expansion.  Furthermore, the definition of quality has largely focused on utilization-based measures that could be calculated using claims data. While convenient and less burdensome for providers, CMMI acknowledges that the claims-centered measurement strategy fails to capture <a href="https://advisory.avalerehealth.com/videos/embedding-patient-centric-principles-in-research-quality-and-care-delivery">important dimensions of quality</a>, most notably patient-centeredness.</p>
<h2>Implementation Challenges</h2>
<p>In the announcement and in subsequent comments from CMS at the Annual CMS Quality Conference, leaders acknowledged that this strategic turn will be an operational challenge.  Measuring quality in a patient-centered way will require working with new data sources and types—such as electronic health record (EHR) data and digital patient-reported data—which raises concerns of additional data collection burden placed on providers, existence of appropriate and validated metrics, and the state of data standardization and interoperability.</p>
<p>It will also require more creative ways of determining appropriate comparison groups quality outcomes, given that, unlike claims data, these new data points and sources may not be readily available from historical sources or from providers or patients outside the model participants. Moreover, CMMI will be tasked with determining what outcomes truly matter to patients and should be prioritized and measured for a given clinical population (a sizeable challenge, given that each outcome identified is not a one-size-fits-all variable).</p>
<h2>Similarities with FDA Guidance</h2>
<p>For pharmaceutical companies, these themes are familiar. There are clear similarities in concept and approach to the Food and Drug Administration’s (FDA) <a href="https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development">patient-focused drug development</a> initiative and guidance.  And like the FDA guidance, key stakeholders are concerned about both what to measure and how to measure patient-centered aspects of performance. The patient-focused drug development initiative emphasizes that manufacturers should determine very early in the development process which outcomes and aspects of treatment matter most to patients, and then decide the best way to measure their product’s impact on those factors. In many cases, this will require developing and validating new clinical outcome assessments, just as new patient-reported outcome measures will need to be developed for CMMI demonstrations.</p>
<h2>Opportunities for Manufacturers</h2>
<p>Quality Pathway represents a compelling opportunity to engage with providers and payers in researching and developing approaches to defining <a href="https://advisory.avalerehealth.com/videos/embedding-patient-centric-principles-in-research-quality-and-care-delivery">patient-centered quality</a> for key therapeutic areas of interest. Drug manufacturers can create a clear continuum of patient-centered quality by defining, measuring, and improving on the same key concepts from drug development through care delivery and payment models.</p>
<p>To ensure that quality-focused innovation models measure what is truly important to patients, researchers must understand both the total burden of a condition on patients’ and caregivers’ lives, as well as their preferences and priorities for treatment. These are also the same key questions that manufacturers need to answer to drive patient-focused drug development and to support <a href="https://advisory.avalerehealth.com/webinars/valuing-the-patient-perspective-patient-centered-hta">patient-centered value assessments</a>—putting manufacturers in the ideal position to make major contributions to the evidence base that CMMI will look to when designing their models. Studies that seek to understand the full impact of a disease on the daily living, mental health, social functioning, and economic functioning of both patients and caregivers should be a priority for all manufacturer health economics and outcomes research teams.</p>
<p>The announcement of the CMMI Quality Pathway also underscores the importance of manufacturers having a clear and compelling quality strategy for each therapeutic area. Both payers and providers face significant and increasing pressure to meet quality and value metrics from regulatory agencies and for value-based contracts. A given health system likely has accountability for dozens of quality metrics across programs such as the Merit-based Incentive Payment System (MIPS), Hospital Value-based Purchasing program, NCQA’s HEDIS®, the Medicare Shared Savings Program, and multiple commercial or managed care contracts. There are varying degrees of financial and reputational impact to the system from these measures. Manufacturers that understand which measures are highest priority for their health system and payer clients, and how their therapies can support success on those measures can build a strong <a href="https://advisory.avalerehealth.com/insights/whats-next-for-patient-centered-value">value message</a> into their market access activities.</p>
<p>A quality strategy should also look to the measurement landscape to determine if there is a measurement gap. For example, do validated measures exist for the concepts that research has determined should be measured? If not, what is the plan to fill those gaps?  While CMMI acknowledged that new measures need to be developed, it has historically looked to academia, professional societies, and private entities to develop measures. Manufacturers can play an important role in partnering with these stakeholders to identify and fill measurement gaps.</p>
<p>While it remains to be seen how CMMI will put the Quality Pathway into action and the effect it will have on payment models, the premise of elevating quality over cost is encouraging. The ultimate win for patients will be a health care system that prioritizes discovery of treatments that address their most pressing needs aligned with a payment system that incentivizes delivering those treatments in a patient-centered model.</p>
<h2>Connect With Us</h2>
<p>Avalere’s subject matter experts help clients understand perspectives and develop strategies to improve quality and optimize patient access to care. To learn more about Avalere’s work in quality, <a href="https://advisory.avalerehealth.com/services/patient-centered-outcomes">patient-centered research, and clinical outcomes,</a> and how we can help you work with CMMI, <a href="https://pages.avalere.com/Insights.html">connect with us</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/insights/cmmi-quality-pathway-prioritizes-patient-centered-value">CMMI Quality Pathway Prioritizes Patient-Centered Value</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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		<title>Discussing Value at Asembia and ISPOR</title>
		<link>https://advisory.avalerehealth.com/videos/discussing-value-at-asembia-and-ispor</link>
					<comments>https://advisory.avalerehealth.com/videos/discussing-value-at-asembia-and-ispor#_comments</comments>
		
		<dc:creator><![CDATA[cturner]]></dc:creator>
		<pubDate>Thu, 18 Apr 2024 21:02:19 +0000</pubDate>
				<category><![CDATA[Videos]]></category>
		<guid isPermaLink="false">https://avalere.com/?p=31871</guid>

					<description><![CDATA[<p>Learn more about our presence at Asembia 2024.</p>
<p>The post <a href="https://advisory.avalerehealth.com/videos/discussing-value-at-asembia-and-ispor">Discussing Value at Asembia and ISPOR</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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										<content:encoded><![CDATA[<p>Learn more about our presence at <a href="https://advisory.avalerehealth.com/conference/asembia-conference">Asembia 2024</a>.</p>
<p>The post <a href="https://advisory.avalerehealth.com/videos/discussing-value-at-asembia-and-ispor">Discussing Value at Asembia and ISPOR</a> appeared first on <a href="https://advisory.avalerehealth.com">Avalere Health Advisory</a>.</p>
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