To read the article, visit PharmaTimes.

Learn More
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

The post PharmaTimes article: Overcoming barriers to care using AI appeared first on Avalere Health Advisory.

The post AI for Health Plans: AI and Clinical Data in Action appeared first on Avalere Health Advisory.

The post OIG Requests Enhanced Oversight of Remote Patient Monitoring appeared first on Avalere Health Advisory.

In the Med Ad News article, “Forging an Access Pathway for Digital Therapeutics,” Brigit Kyei-Baffour discusses the effort to simplify clinician prescription processes and enhance patient access. She also describes innovative approaches that explore new payment and evaluation models that drive innovation in healthcare delivery.

To read the full article, visit Med Ad News’ blog, PharmaLive.com.

Learn More
Avalere works closely with manufacturers and payers to evaluate, develop, and refine patient support programs that are finely attuned to the current policy and market landscape. We also collaborate with digital therapeutics and digital health stakeholders to maximize patient access and affordability. To learn more about how Avalere can assist you, connect with us.

The post An Access Path for Digital Therapeutics appeared first on Avalere Health Advisory.

A New Era for Access and Affordability: Considerations for Patients and Manufacturers in a Post-IRA World

Moderator: Mark Gooding

Panelists: Anna Hyde, Arthritis Foundation; Valerie Reynolds, Genentech; and Eric Gascho, National Health Council

As Inflation Reduction Act (IRA) provisions are implemented in 2024 and 2025, manufacturers are rethinking how they approach patient support programs. The IRA has already transformed the landscape of Medicare Part D, including shifts in stakeholder financial liability throughout the benefit. The environment will continue to change in 2025 with the implementation of a $2,000 out-of-pocket (OOP) cap and introduction of the optional Medicare Prescription Payment Plan (MPPP) to help beneficiaries manage OOP costs throughout the year. As these changes are implemented, patients’ ability to access and pay for Part D products may shift.

The MPPP and OOP cap are expected to support Part D beneficiaries’ ability to pay for—and access—drugs. The MPPP will enable Part D beneficiaries who opt into the program to spread their OOP costs throughout the year. Decreased cost sharing via the cap will likely lead to higher utilization of Part D drugs and possibly improved medication adherence. However, despite these policies offering opportunity for greater affordability for some enrollees, new liabilities for plans may create additional pressures and hurdles for patients accessing and adhering to their treatments.

The panel discussion focused on both the challenges and opportunities that the evolving Part D landscape represents for beneficiaries. Panelists spoke about the need to educate patients and providers on the new Part D environment. While panelists acknowledged the efforts by advocacy groups and other stakeholders to prepare patients, there was agreement that additional work must be done across all stakeholder types to support access and affordability in 2025 and beyond.

Forging New Pathways to Reimbursement for Digital Therapeutics: Considerations for Payer Coverage

Moderator: Brigit Kyei-Baffour

Panelists: John Campbell, National Pharmaceutical Council; Dirk Soenksen, Ceresti Health; Beth Rogozinski, Oncoustics; Chris Koch, LeGen Medical Devices

Digital therapeutics are evidence-based therapeutic interventions that are often developed in combination with a device and/or therapeutic agent. They are designed to prevent, manage, or treat a variety of medical conditions and address challenges such as medication adherence and poor disease control. These products—which can be prescription or non-prescription—can help maximize the value of an asset by differentiating it, promoting clinical trial efficacy, efficiently collecting data,  and maximizing therapeutic potential, among other benefits.

Despite the unique benefits of digital therapeutics in disease management and prevention, these products face significant reimbursement barriers. There is no clear reimbursement policy for Medicaid or Medicare, and private payers have only just begun developing evaluation frameworks for digital products and services. With a variety of reimbursement routes applied across markets, it may be difficult for manufacturers to identify the optimal path. Further, digital technologies that demonstrate equivalence to the standard of care may not be reimbursed at a preferred price, as comparator technology may be relatively low-cost. Given this dynamic, demonstrating value is key for favorable reimbursement.

During the panel, experts discussed the current landscape of digital therapeutics, challenges to obtaining access from both coverage and reimbursement perspectives, regulatory considerations, and opportunities with regards to payment pathways. Panelists used examples of leveraging shared savings models and quality care programs such as accountable care organizations (ACOs). A major theme was the importance of education and awareness for all stakeholders involved—and particularly patients, providers, and payers—of digital therapeutics and their clinical and economic benefits.

Dive Deeper

Avalere works closely with manufacturers and payers to evaluate, develop, and refine patient support programs that are finely attuned to the current policy and market landscape. We also work closely with digital therapeutics and digital health stakeholders to maximalize patient access and affordability. To learn more about Avalere’s work, connect with us.

The post BIO International Convention Insights: Patient Assistance and Digital Therapeutics appeared first on Avalere Health Advisory.

However, the wide application of AI in healthcare raises questions about trust, privacy, and safety. How do we make sure that the data used for analyses are accurate and fit for purpose? Does AI reflect new or different biases compared to conventional methods? Can trial results data be reproduced without compromising privacy? Lastly, are the standards applied in the US consistent with those used in Europe? Until these challenges are addressed, adoption of AI in RWE will falter. 

Like any fast-evolving technology, regulations and standards lag significantly behind adoption of AI and how it is used in the life sciences industry. Medical organizations, professional societies, and technology groups all have created their own interpretations of AI-enabled tools, and every organization utilizes its own approach.   

One solution to this conundrum could be shared responsibility—stakeholders collaborating to address the challenges to support transparency in how and where data are collected, analyzed, and interpreted. Having a unified set of standards could mitigate potential bias and improve the use of RWE, accelerating the delivery of innovative therapies to patients who need them. 

Consultancies with expertise in federal and state policies, market access, and data strategies can serve as the bridge to connect manufacturers, plans, and providers to AI-enabled RWE. Experts in building interdisciplinary teams can encourage members with differing perspectives to come together for a common goal and fit-for-purpose use. To achieve the promise of AI improving health and patient outcomes, healthcare organizations will need to ensure the safe, ethical, and effective use of AI-based tools. 

To learn more about the role of AI in RWE and Avalere’s work supporting healthcare stakeholders interested in exploring and harnessing the potential of AI, connect with us.

The post A Collaborative Approach to Incorporating AI in RWE appeared first on Avalere Health Advisory.

Clearinghouses like Change Healthcare play an essential role in the timely transfer of information from medical providers to healthcare payers. While efforts have been made to restore connectivity, Change has reported that their claims processing services are still down. Recent communication from Change indicates that the outages are expected to be long term.

Impact on Life Sciences Sector

Claims clearinghouses, also known as “switches,” are a major component of the core data utilized by life sciences companies for commercial product tracking.  Especially impacted are medical claims, including those for infused pharmacy products. Major pharmacy claims datasets often rely on data collected directly from large chain pharmacies rather than intermediaries.

Clearinghouses typically provide data to data brokers in slightly different formats, resulting in variations in the information received by each broker from different partners. Regardless of the combination of clearinghouses partnered with the data broker, changes in the clearinghouse landscape can have multiple impacts including:

• Reduced volume as providers withhold claims in anticipation of a resumption of service.
• Disruption in reported product volumes trends due to a change in the mix of clearinghouses which either do or do not partner with each data broker.

Navigating the Impact of the Cyberattack

To mitigate the effects of the Change cyberattack, life sciences firms can:

• Partner with data providers on short-term strategy: Understand the plan each data broker has for comprehending and quantifying the changes resulting from this cyberattack.
• Understand data provenance: Work internally to gain a foundational understanding of from where the data provided by your data broker is sourced. This will allow your organization to be ahead of the curve as future changes in the data landscape occur.  Data aggregations where source is unknown may be attractive from a financial or data volume perspective but come with risk when market events, such as consolidation of data brokers, switches in provider and payer of intermediaries, or another cyberattack, occur.
• Engage with experts: Avalere has rich experience engaging with life sciences companies to help them understand the impact of market events on claims data trends.

To learn more about how to mitigate impacts from the Change Healthcare cyberattack, connect with us.

The post Repercussions of Cyberattack on Change Healthcare appeared first on Avalere Health Advisory.

Figure 1. DnA Capabilities Combine Digital Health and Evidence Generation to Advance Innovations in HEOR

The post Contextualizing Artificial Intelligence for HEOR in 2023 appeared first on Avalere Health Advisory.

The post Third Party to Assess Value of Digital Health Technology appeared first on Avalere Health Advisory.

• Leah Carlisle, Senior Healthcare Consultant: Strategy, Experience & Engagement, Fishawack Health
• Shelby Harrington, Principal, Evidence and Strategy
• Zachary Klein, Consultant I, Market Access
• Brigit Kyei-Baffour, Principal, Market Access

The post Maximizing Access & Uptake for Digital Health Technologies appeared first on Avalere Health Advisory.

Figure 1. Digital Health and RPM Developments, 2019–2024

Figure 2. Survey Results of Providers Currently Offering RPM to Patients

Figure 3. Remote Physiologic Monitoring Codes

The post Remote Monitoring Services Flexibilities Will Change as PHE Ends appeared first on Avalere Health Advisory.

Utilization of telehealth grew exponentially during the COVID-19 Public Health Emergency, pushing healthcare organizations to think differently about the mechanisms of delivering care. This also led to an influx of telehealth data that allowed researchers to generate evidence around telehealth’s impact on quality and value. While the evidence suggests that targeted and effective use of telehealth can reduce unnecessary and costly downstream services, improve care quality for individuals living with chronic conditions, and lower barriers to access care, the results have not been as compelling in some scenarios.

Promising Results in Patient Satisfaction and Chronic Condition Management

Several studies demonstrated that telehealth provides a quality of care that is comparable to and, in some cases, better than in-person care. A study of cancer patients receiving radiation oncology treatment observed no significant differences in patient satisfaction between patients who underwent a telemedicine consultation and those who attended an in-person office visit. Additionally, most survey respondents using telehealth said their confidence in their physician (90%) was the same or better via telehealth compared to an in-person visit. For patients with chronic diseases that require consistent treatment, telehealth can improve the quality of care by streamlining disease management. A study of individuals with type II diabetes found that remote patient monitoring combined with medication management resulted in significant improvements in glycemic control.

Bridging Geographic and Socio-economic Barriers to Equitable Care Access

Telehealth can serve as a powerful tool to advance equity by removing logistical and geographic barriers to care. For example, the travel time to see a specialist in certain geographic areas can contribute to differential health outcomes observed in rural and under-resourced communities. However, the nuances of how telehealth is delivered can have a major impact on whether those populations realize the possible gains. A study at the University of Rochester Medical Center demonstrated that vulnerable patients had the highest uptake of telehealth services and low rates of no-shows and cancellations. Conversely, a study in ophthalmic care found lower utilization of telehealth by these patients, particularly when it came to use of video visits vs. telephonic. These mixed results suggest that telehealth alone does not overcome other major systemic causes of healthcare disparities such as structural racism, cultural and linguistic non-inclusiveness, and lack of patient-centric care design.

Appropriate Telehealth Usage Promotes Healthcare Cost Reduction

Telehealth can serve as a vehicle to lower healthcare costs by reducing the need for downstream care in expensive hospital settings such as the emergency department. For example, a study investigating the City of Houston’s Emergency Medical Services telehealth initiative found that a physician videoconference consultation prior to transport reduced emergency department visits 7% over a one-year period. The reduction of unneeded healthcare utilization not only reduces patient and system costs but also improves efficiency and maximizes the number of patients caregivers can manage. Using remote consultations, specialized knowledge can be shared with locations that otherwise lack access to in-person experts, resulting in more appropriate utilization of healthcare services and higher quality comprehensive care delivery. Remote patient monitoring has also reduced costs in some cases, as in a study of patients with congestive heart failure using an implanted device that was shown to be highly cost effective.

The results of these studies indicate that telehealth could contribute to advancing equity and value. But given the variation in study results to date, more evidence is needed to determine how to optimize quality, patient-centric value, and overall cost-effectiveness, specifically to understand which clinical scenarios and populations are best suited to telehealth and to which telehealth modalities. Professional societies such as the American Society of Clinical Oncology, the American Academy of Neurology, American Academy of Pediatrics, American Medical Association, and the Alliance for Academic Internal Medicine have each released guidelines or practice resources for effective use of telehealth.

However, the disease- and specialty-specific guidance that provider and payer organizations need in order to implement high-value telehealth programs is still the exception rather than the rule. Investments in rigorous studies and real-world evidence generation by key stakeholders—including health plans, health systems participating in value-based care, patient advocacy organizations, and life sciences companies—can accelerate the development of these guidelines and ensure that telehealth’s potential is realized.

Avalere’s expertise in digital health, value-based care, and quality can help clients optimize their telehealth strategies. To learn more about the implications of telehealth for manufacturers, providers, and payers, connect with us.

The post Quality and Value in Telehealth: Progress and Potential appeared first on Avalere Health Advisory.

Figure 1. Definitions of Relevant Terms

The post Manufacturers’ Opportunities in Digital Therapeutics appeared first on Avalere Health Advisory.

Figure 1. Opportunities for the Use of Digital Health Tools Throughout the Patient Journey

Figure 2. Manufacturer Steps for Implementation of Digital Patient Support Tools

The post Leveraging Digital Health Tools to Advance Patient Support Solutions appeared first on Avalere Health Advisory.

The COVID-19 pandemic necessitated rapidly enhanced access to telehealth services and has changed how stakeholders such as patients, providers, healthcare systems, and manufacturers think about innovative ways to furnish healthcare services and coordinate care. For certain patient populations, the rapid increase in telehealth availability addressed a need that predated the pandemic. For those living in rural areas, those with transportation challenges, or those with other barriers to receiving in-person care, telehealth provides access that would not otherwise be available to them or would require significant effort and hardship. This is particularly true for care from specialty care providers. For example, only 3% of oncologists practice in rural areas.

In the first year of the COVID-19 pandemic, over 45 million Medicare Fee-for-Service visits were conducted via telehealth, representing over 44% of Medicare beneficiaries. Between March and August 2020, 13% of outpatient visits were conducted via telehealth. But in 2021, this number dropped to only 5%. Additionally, a Zoom survey found that nearly two-thirds of patients who used virtual care during COVID-19 would prefer being given both in-person and virtual care options going forward.

As the healthcare system adjusts to an endemic COVID-19 landscape, it is critical to consider how stakeholders can remain agile in adapting to these patient preferences through hybrid in-person/virtual models of care. The swift rise in telehealth utilization was reflected in growing significant private equity investment in telehealth and the rise of third-party organizations that furnished telehealth services for specific therapeutic areas, such as mental health or primary care. Now some organizations that were originally telehealth only have begun opening brick-and-mortar clinics, while other traditional health systems and private organizations that provide in-person care have begun contracting with third-party telehealth providers.

Optimizing Telehealth Utilization

This bricks-and-clicks model provides both in-person and remote care to patients. Clinicians typically make care decisions based on the clinical situation, quality outcomes, value, and patient preference, though in the case of selecting in-person vs. remote care, it is currently more of an art than a science. As providers and payers adjust to this hybrid delivery model, the selection of telehealth vs. in-person care is often driven by the organization’s capabilities and provider preferences.

Professional societies have recognized the need for guidance among their constituents. In July 2021, the American Society of Clinical Oncology published six standards and practice recommendations for telehealth in oncology, which range from patient selection to virtual participation in oncology clinical trials. The American Telehealth Association has also released statements and materials, noting its support for legislation that improves telehealth services across the healthcare ecosystem. Still, a significant need remains for additional research and studies on optimal care pathways—including quality outcomes, safety, and comparative effectiveness—across all therapeutic areas and conditions. Other specialty societies and professional associations have an opportunity to conduct research and develop guidelines on integrating telehealth into practice for their respective specialties.

Physicians cited clarity on reimbursement and integration into electronic health records as some remaining barriers for seamless telehealth adoption. Further, the end of the PHE could roll back many flexible telehealth policies that allowed expanded provider eligibility and audio-only services, and lifted geographic and site restrictions, among others. Organizations developing telehealth guidelines will have to account for the ways that additional regulations to make telehealth accessible and feasible may impact their recommendations.

Future Opportunities in Telehealth

While challenges to optimal adoption remain, determining the appropriate utilization of telehealth for the right patients at the right points in the care journey could reduce total cost of care—providing a major opportunity for organizations engaged in value-based payment models. This could be from lower costs of delivering services via telehealth that would have previously been in person, from diverting patients from more costly care settings, or from prevention of downstream complications by increasing patient/provider touchpoints earlier in their care journeys. This is particularly true for older populations, who adopted telehealth much more than was originally expected. Utilization trends among older populations observed before and after 2020 support continued usage of telehealth. Before COVID-19, fewer than 1% of Medicare beneficiaries utilized telehealth; during the first year of the pandemic, however, usage rates rocketed to nearly 40%. This is encouraging for hybrid delivery models that aim to keep older populations out of high-cost care settings.

Many health systems have piloted or are considering hybrid models of care that allow patients to receive both in-person and remote care. One of Mayo Clinic’s Hybrid Care Hotel goals was to efficiently deliver care while reducing costs, travel time, and hospital bed usage; evaluations found that the model produced positive experiences and encouraged strong recoveries for patients. Other studies have found increasing proliferation of hybrid models across both primary and specialty care settings and for the need to incorporate other digital health therapeutics into these encounters to improve patient outcomes and performance.

Implementation of an optimal hybrid model may look different across health systems and presents significant opportunity for innovative collaborations. As these models are implemented, it will be critical to consistently evaluate their impact on access, cost, and quality of care. Organizations can leverage Avalere’s industry-leading expertise in US healthcare policy, regulatory and reimbursement pathways, and market dynamics to develop strategies for navigating the telehealth landscape. Connect with us to learn more.

The post Bricks and Clicks: Telehealth and Hybrid Models of Care appeared first on Avalere Health Advisory.

Notes: *Comments due on proposed rule. **The Biden administration’s regulatory freeze may impact timeline.

Acronyms: CY: calendar year; EHR: electric health record; HHS: Department of Health & Human Services; HIE: health information exchange; HIN: health information network; HIPAA: Health Insurance Portability and Accountability Act; HIT: health information technology; ONC: Office of the National Coordinator; PBM: pharmacy benefit manager; RTBT: real-time benefit tool.

Key Topics in Digital Health

As the federal regulatory landscape changes to address and drive the availability and use of digital health technologies, organizations seeking to maximize innovation efforts should monitor and consider engaging on the following key topics.

Developing Interoperability Policies

Seamless data sharing between systems is crucial for the success of digital health technologies. Multiple regulatory provisions mandate this necessary data exchange:

• The ONC’s information blocking rule requires health IT vendors, networks, and providers to remove barriers to electronic health information sharing by April 5, 2021.
• The CMS’s Interoperability and Patient Access rule requires health plans that contract with federal health programs to allow their members free and fast access to their own claims and clinical information maintained by the plan by July 1, 2021. As part of the interoperability policy, the CMS finalized a separate rule to automate the prior authorization process by mandating Medicaid, CHIP, and Qualified Health Plans to allow electronic access to prior authorization decisions, but this latest rule is under review by the Biden administration, like several others subject to a regulatory freeze.
• As of May 1, 2021, the CMS will require hospitals to share notifications for admission, transfer, and discharge electronically.

As these rules are enforced and the interoperability of health data continues to develop, stakeholders should consider how to collaborate with the new administration to implement requirements and identify additional reforms necessary to promote the use of digital health technologies.

Expanding Coverage for Digital Health

Coverage pathways within Medicare were not designed to accommodate evolving digital health technologies, creating a barrier to more widespread access to—and appropriate reimbursement for—innovative new software, apps, and other digital health tools. In September 2020, the FDA launched its Digital Health Center of Excellence to modernize its regulation of digital health and develop a new approach to regulating software as a medical device. On April 19, the agency released a final rule excluding certain non-medical software functions from the definition of device. As the FDA updates its approach to digital health, the CMS issued a final rule entitled “Medicare Coverage of Innovative Technology” to create a new coverage pathway for innovative medical devices that the FDA deems “breakthrough.” The CMS may modify its coverage and reimbursement policies to promote closer coordination with the approvals process and to expand access. In particular, the CMS could consider testing new digital health approaches through a Center for Medicare and Medicaid Innovation demonstration under the newly appointed director, Liz Fowler. Stakeholders should consider opportunities to collaborate with the CMS and FDA to ensure any new regulatory and payment flexibilities are well informed and coordinated and reflect the utilization and impacts of these new tools.

Implementing Price Transparency Rules

Increasing healthcare price transparency was a strategic objective of the Trump administration—and is likely to continue to be a priority of the Biden administration—with rules regulating hospitals, health plans, and providers. Effective on January 1, 2021, a CMS hospital price transparency rule requires all hospitals to publish a list of their standard charges and 300 shoppable services, including payer-specific negotiated charges, in a machine-readable and -searchable, consumer-friendly format online. Before that, as part of an interim final rule that was effective November 2, 2020, the CMS required providers of COVID-19 diagnostic tests to publish its cash price for COVID-19 testing. Other rules mandate that electronic health records and Part D plans offer real-time benefits comparison tools to allow physicians—and eventually patients—access to real-time medication pricing information. Beginning in 2022, health plans must implement the tri-agency Transparency in Coverage rule, which will require group and individual market health plan sponsors to disclose negotiated prices for items, services, and prescription drugs. Stakeholders should consider how these transparency initiatives could impact contract negotiations, beneficiary and consumer decision-making, and the development of patient-facing applications and other tools that many seek to analyze and display newly public data.

The rapid evolution of the digital health landscape, combined with a new administration and Congress taking office, will make 2021 a pivotal year for digital health policy. These rules represent a paradigm shift in healthcare business operations and create multiple opportunities for stakeholders to develop tools, apps, and other digital health solutions for healthcare organizations and consumers. As regulatory compliance takes shape and policies evolve, organizations must develop advocacy and public policy strategies and anticipate how opportunities and threats will shape their markets.

To receive Avalere updates, connect with us.

Contributor

Julie Barnes, an Avalere senior advisor, is the founder and principal of Maverick Health Policy, a strategic consulting firm that advises private sector clients about federal government actions that impact the healthcare system. As a former healthcare attorney, Capitol Hill staffer, and regulatory adviser, Ms. Barnes informs business strategy and investments in several healthcare areas, including health information technology, data privacy and interoperability, value-based care, price transparency, telehealth, and public and private health insurance.

The post New Data-Sharing and Interoperability Mandates Create New Challenges appeared first on Avalere Health Advisory.

For the healthcare industry specifically, connecting devices to one another and the Internet opens the door to a host of possibilities for how healthcare stakeholders can interact. COVID-19 has disrupted conventional medical delivery, paving the way for technologies like the IoT to create significant change in the healthcare sector. Below we have highlighted some promising use cases for IoT specifically relevant to medical device and pharmaceutical companies.

Medical Device Use Cases

The IoT has opened a world of possibilities for medical devices. When connected to the Internet, ordinary medical devices have the potential to improve healthcare delivery and streamline operations.

• Remote Patient Monitoring: Remote patient monitoring enables providers to have real-time insight into patient behavior. IoT devices can automate and remotely collect various patient vital signs and behavioral data, thus supporting better patient care management. With real-time data available to providers, proactive intervention by the provider is supported with this newly available information on patient status. The examples listed below demonstrate the various uses for IOT across multiple care processes:
  • An IoT-connected blood pressure monitor can automatically send blood pressure results to the primary care doctor. This information is also made available to the patient via a digital portal. These data ensure that the patient’s current medication regimen is effective and allow for adjustments to be made between check-ups as needed, thereby reducing the number of visits required for monitoring and management.
  • The use of IoT can also extend to inpatient settings where the patient needs round-the-clock monitoring by supplementing existing monitoring equipment. For example, one such device is a digital ring that constantly monitors a patient’s vital signs and leverages artificial intelligence to identify irregularities to support providers in ongoing patient management in the hospital.
  • Continuous glucose monitors (CGMs) can be augmented to communicate with insulin pumps to maintain ideal glucose levels. This can also be taken a step further by having the CGM send information to an electronic health record system to inform the provider more robust insight into glucose levels.
• Inventory Tracking: IoT use in healthcare can help reduce the time spent seeking or tracking medications and equipment, freeing up more time for providers to dedicate to patient treatment. The information these devices provide can be used to inform better supply chain management decisions. Combining this asset with blockchain technology provides an extra layer of security and tracking through its immutable ledger system (i.e., the record cannot be changed).
  • Radio-frequency identification tags can be placed on items, providing real-time tracking of inventory. The tags help prevent theft, generate insights on the utilization of medical devices including conditions that result in malfunction, and inform users when devices may require maintenance.
  • Smart storage devices such as smart cabinets are being developed to assist with tracking how medications are dispensed. The data can be accessed via various connected devices (such as a tablet) and can help inform healthcare staff with inventory planning.

Pharmaceutical Use Cases

The end-to-end pharma value chain (i.e., drug development, clinical trials, manufacturing, and distribution) is laced with various operational challenges. IoT devices may provide an avenue to address some of these challenges. Below we discuss the use cases for drug development and discovery, clinical trials, medication adherence, manufacturing control, and supply chain.

• Drug Discovery and Development: IoT can support more efficient clinical research and testing compared to the traditional trial and error approach. In research and development, IoT-supported analytics help to reduce human errors, increase efficiency, and reduce waste. The IoT provides interconnectivity of data and increases real-time visibility during drug development. It also helps clinicians recognize behavioral patterns associated with patient outcomes more effectively than traditional approaches.
• Clinical Trials: Clinical trials require complex designs, accurate and consistent data collection, and clinical staffing for monitoring and evaluation. The benefits of IoT for clinical trials include patient engagement and empowerment, flexible trial design, faster patient enrollment and retention, higher data quality and integrity, real-time data capture, reduced operational expenses and remote patient monitoring. In a survey by Applied Clinical Trials, 35% of respondents answered that improvement in data quality was the biggest benefit of mobile devices and mHealth technology (IoT-enabled devices) in clinical trials.
• Manufacturing Control and Supply Chain Management: IoT devices provide the pharmaceutical industry with opportunities to improve the drug manufacturing process, proactive equipment maintenance, and improved supply chain management. Referred to as the Internet of Things for Pharmaceutical Manufacturing (IoT-PM), the IoT-PM has the potential to revolutionize operations in pharmaceutical manufacturing by allowing real-time and remote monitoring of manufacturing activities. These enhancements support waste minimization, reduced production cost and improved equipment utilization and efficiency. Thirty percent of the top 20 pharma companies have adopted IoT technologies in their manufacturing process at some level.
  • Sensors in the manufacturing plant can provide remote monitoring and real-time information on equipment like pressure gauges, pH probes, air compressors, and vacuum pumps. The information gathered can be used for planning maintenance and repair, minimizing downtime, forecasting demand of raw materials, and ensuring workplace safety. Machine learning can be applied to data generated from the IoT devices to analyze the equipment utilization, thereby providing a foundation for predictive maintenance of equipment.
  • Other examples of supply chain use cases for pharmaceutical companies include smart warehouse management systems, monitoring and controlling of ambient and drug-specific conditions, predictive modelling to optimize order fulfilment, real-time tracking of logistics and transportation, smart serialization through automatic identification and data capturing, and reverse supply chain traceability for hazardous waste.
  • Vaccines must be stored properly throughout the supply chain from manufacturing until administration. Guaranteeing vaccine quality and maintaining the cold chain is a shared responsibility among the manufacturers, distribution channels, public health staffs, and healthcare providers. With the recent development of COVID vaccines, it is important to minimize loss of vaccines at all cost. To this end, IoT sensors can help monitor temperatures of the vaccine container in real time. The system can send alerts if the temperature falls outside of acceptable bounds and activate other systems in order to better modulate the temperature.
• Medication adherence: About 125,000 deaths per year in the US are attributed to non-adherence of medication, and 33–69% of medication-related hospital admissions are due to poor adherence. Direct and indirect cost of non-adherence range from $100 billion to $300 billion a year. Non-adherence also has personal societal costs beyond financial ones, including poor health outcomes leading to increased morbidity and mortality, lost productivity, and compromised quality of life. IoT-enabled devices have a role to play in medication adherence through medication reminders to the patient, notification to providers, and remote medication adherence monitoring. Examples of IoT use cases for medication adherence include:
  • Smart pill bottles and smart pill dispensers that can enable better connection between patients and caregivers. They can remind patients to take their medications and alert caregivers when prescriptions are taken.
  • Another use case is a pillbox with a global system for mobile communications at its core, which allows real-time medication management and emails or text message reminders that can be sent to patients and caregivers if medication is missed.

The IoT has to address several challenges before widescale adoption can be achieved in the healthcare sector, which historically has been slow to adopt new technology. Some barriers that could limit adoption include lack of evidence, security and privacy, cost of implementation, and coverage issues. Successful implementation and adoption will rely on stakeholders establishing robust evidence of benefit and usability and formalizing multi-stakeholder collaborations. Life sciences organizations looking to leverage the IoT need to stay abreast of evolving security and privacy regulations and standards.

Healthcare IoT shows great promise to be a catalyst for innovation in the life sciences industry. From optimizing how therapies are developed to assisting patient adherence, IoT solutions are being developed to improve drug development, operational efficiency, and patient outcomes. Despite the existing barriers to adoption, there are a variety of benefits that the technology introduces to various stakeholders in the healthcare industry.

To learn more about Avalere’s work in this space, connect with us

The post IoT: Opportunities and Use Cases for Life Sciences Organizations appeared first on Avalere Health Advisory.