Background

ACIP is a chartered federal advisory committee responsible for making recommendations on the safe and effective use of vaccines. The Committee makes these recommendations to the Centers for Disease Control and Prevention (CDC), and if adopted by the CDC Director and published in the respective Immunization Schedule, these recommendations enable Americans to access vaccines at no cost across most insurance programs.

The ACIP is formally chartered under the Federal Advisory Committee Act (FACA, 1972), which ensures that federal advisory committees operate with open and transparent procedures, maintain public records of proceedings and recommendations to facilitate transparency and objectivity, and hold regular and publicly announced meetings. The committee meets at least three times per year, in February, June, and October. Three weeks in advance of the scheduled June meeting, Secretary of Health and Human Services Robert F. Kennedy Jr announced  that he would remove all 17 sitting members of the committee, noting that 13 members were appointed in 2024 under the Biden administration and “a clean sweep [was] necessary to reestablish public confidence in vaccine science.” Two days later, Sec. Kennedy announced the names of eight new voting members on the social media platform, X (formerly Twitter), one of whom withdrew before the start of the June meeting, citing a review of his financial holdings and leaving the committee with seven sitting members.

ACIP Is the Bedrock of the US Vaccine Policy and Access System

In the sixty years since its establishment, the ACIP has emerged as the cornerstone of US vaccine policy and access systems. Using a rigorous review process that assesses vaccine product safety, efficacy, cost-effectiveness, and programmatic fit, ACIP issues evidence-based recommendations on immunization use, and its recommendations form the foundation for pediatric and adult immunization schedules. These schedules not only guide clinical practice but also trigger first-dollar coverage across most insurance programs.

Federal legislation has incrementally grown to require first-dollar coverage of ACIP-recommended vaccines for more insurance groups (Figure 1). This began with the Omnibus Budget Reconciliation Act in 1993, which tied inclusion in the Vaccines for Children Program to an ACIP resolution. In 2010, the Affordable Care Act requires commercial payers to cover all immunizations that have “in effect a recommendation” from the ACIP and further requires Medicaid expansion programs to cover ACIP-recommended products. These two pieces of legislation tied first-dollar coverage of vaccines for over two-thirds of the American population to ACIP recommendations. The remaining gaps in patient cost-sharing requirements were closed in 2022 with the passage of the Inflation Reduction Act, which eliminated all cost sharing for adult vaccines recommended by ACIP under Medicare Part D, and mandated that traditional Medicaid and CHIP plans cover all approved vaccines recommended by ACIP along with their administration without cost sharing. For more detailed information on US vaccine coverage requirements, see Avalere’s guidebook here.

Figure 1: Evolution of Immunization Coverage Requirements

RSV: Respiratory Syncytial Virus: VFC: Vaccines for Children

In addition to the direct impact ACIP recommendations have on insurance coverage and patient access, the Committee’s decisions also have an indirect impact on state immunization policies, provider counseling behavior, and quality reporting programs (see Figure 2).

State public health departments often rely on ACIP recommendations to drive public health outreach campaigns as well as to shape school and occupational vaccination requirements. ACIP guidance is further embedded in state immunization information systems, which track vaccine administration, and may also be configured for integration with provider electronic health records using the CDC’s clinical decision support for immunization tools.

ACIP recommendations also impact provider scope of practice and quality measurement. State legislators or boards of pharmacy often adapt local pharmacist and pharmacy technician authority to administer vaccination to reflect ACIP recommendations. Quality reporting programs (e.g., childhood immunization status and adult immunization status measures) incorporate adherence to ACIP schedules as performance indicators for providers and health plans.

In essence, ACIP recommendations shape which products are offered in US immunization programs, which patient populations can receive them at no cost, and how immunizations are tracked to assess risk of vaccine-preventable disease outbreaks.

Figure 2: Direct and Indirect Impacts of ACIP Recommendations

VICP: Vaccine Injury Compensation Program

The Committee Is Poised to Revisit the Pediatric Immunization Schedule

In addition to the seven new voting members who were introduced at this week’s meeting, there was also an announcement of two new ACIP work groups, which will add to the extant product-specific work groups and the traditional work group focused on reviewing and updating the child/adolescent and adult immunization schedules on an annual basis.

The first new work group will examine the cumulative effect of the childhood vaccine schedule. The second new work group will review products which have not been subject to review in more than seven years – an extant requirement per ACIP Policies and Procedures which has not been consistently observed. Combined, these work groups signal the reformulated committee’s intention to review previously-established schedules and potentially revise them following new evaluations.

The June meeting initiated this process with discussions on the use of thimerosal-containing influenza vaccines and the use of the measles, mumps, rubella, and varicella (MMRV) vaccine in children. After a presentation on the risks associated with thimerosal the committee voted five-to-one (one abstention) to eliminate the use of thimerosal-containing influenza vaccines. This discussion diverged from the ACIP’s traditional process, which has historically been guided by a structured review of the evidence across several clinical and programmatic domains using a framework called the ‘Evidence to Recommendation’ (EtR) framework.

Following the thimerosal discussion, the new chair, Dr. Martin Kulldorff, presented on the risk of febrile seizures associated with the MMRV vaccine and introduced recommendation language to eliminate MMRV as an option for vaccination in children under 47 months of age. This recommendation will be voted on at a subsequent meeting. It is unclear whether a dedicated WG will be established to support this review or whether it will fall under the remit of one of the newly established work groups.

Neither vote will significantly impact current immunization practices given the low utilization of both thimerosal-containing influenza vaccines and MMRV vaccines in children under four years of age. Still, these discussions may foreshadow additional re-evaluation of other recommendations, likely beginning with the pediatric immunization schedule which has been a major focus area for CDC and HHS leadership.

Real-world Impacts of New or Revised Recommendations Remain Uncertain

ACIP recommendations typically fall into one of three categories: routine recommendations, which are recommended for standard use in a broad population; risk-based recommendations, which are tailored for specific populations that may be at higher risk due to age, medical conditions, or occupation; and shared clinical decision making (SCDM) recommendations, which are designed for situations where a vaccine may benefit some but not all individuals in a given cohort. In the case of SCDM recommendations, the decision to vaccinate should be made jointly between the patient and the provider. All three recommendation types determine coverage requirements across insurance programs.

For patient populations no longer included in the scope of a given ACIP recommendation, payers may continue to voluntarily provide coverage and would be free to apply utilization management requirements—apractice that is not permitted for ACIP-recommended immunizations. For patient populations that are not covered by the scope of an ACIP recommendation, payers may rely on internal product review committees to determine coverage or they may turn to relevant medical societies to inform their coverage protocols. Additionally, while ACIP recommendations establish the minimum coverage requirement for state Medicaid programs, they are free to offer broader coverage.  As payer coverage policies evolve, vaccine access may vary across geographies, patient populations, and insurance programs. .

Conclusion

The current climate surrounding the ACIP is marked by considerable uncertainty, and further developments are likely to occur ahead of the next meeting in the fall. Further agency changes, such as the appointment and Senate confirmation of a CDC Director, could also shift the activities and objectives of the ACIP and the CDC staff who support the ACIP’s research efforts.

Further, given early withdrawals in participation from newly nominated members, additional membership could be solicited and approved in advance of other 2025 meetings.  Additionally, several recommendations from the April meeting remain unadopted and recommendations for other seasonally administered vaccines, like COVID-19, have not yet been voted on, raising questions about whether those recommendations may be revisited in future meetings. In the interim, payers, providers, and industry stakeholders will be monitoring the situation closely for any shifts in evidentiary standards or substantive revisions of existing recommendations.

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The U.S. Preventive Services Task Force (USPSTF) is an independent panel of 16 experts appointed by the Secretary of Health and Human Services (HHS) that voluntarily provide recommendations on preventive services for adults and children provided in or referred from the primary care setting. According to the USPSTF procedure manual, the Task Force evaluates specific interventions and issues recommendation with a letter grade (A, B, C, D, or Insufficient [I] statement) based on the strength of existing evidence and the net benefits of a preventive service. Under the Affordable Care Act (ACA), services that receive a USPSTF Grade A or Grade B must be covered by Medicare and third-party insurance carriers without member cost sharing.

The Agency for Healthcare Research and Quality (AHRQ) convenes USPSTF, oversees evidence reviews, and disseminates its recommendations. AHRQ contracts Evidence-based Practice Centers (EPCs) to develop evidence reviews. EPCs develop the analytic framework and conduct the systematic evidence review that informs the USPSTF recommendation. Once a topic is prioritized, the topic team includes USPSTF members (including one USPSTF chair or vice chair), AHRQ staff members (including at least one AHRQ medical officer), and evidence review team members (including a lead investigator from the EPCs).

Proposed Budget Cuts and Stakeholder Response

In a letter sent to HHS Secretary Robert F. Kennedy Jr. in April 2025, 45 former USPSTF chairs, members, and scientific directors expressed grave concerns about the Trump administration’s FY 2026 budget proposal.  The proposal includes merging the AHRQ into a new Office of Strategy and cutting AHRQ’s budget by $129 million.

This reorganization under HHS risks undermining the USPSTF’s independence and its capacity to conduct rigorous, conflict-of-interest free reviews, which to date have been the benchmark for USPSTF preventive care recommendations. Additionally, because Task Force members serve on a voluntary basis, AHRQ—through its “Effective Healthcare Program”—provides essential resource support by overseeing and managing the EPCs that conduct the systematic evidence reviews informing USPSTF recommendations.

Signers warned that because the USPSTF relies heavily on AHRQ for scientific, administrative, and dissemination support, the proposed reorganization and workforce reductions could seriously jeopardize the Task Force’s ability to produce and distribute evidence-based preventive care recommendations—guidance that mandates insurance coverage without patient cost-sharing and contributes to the prevention of chronic disease through primary care.

A JAMA viewpoint article by former USPSTF Chair Alex Krist and colleagues echoed these concerns, emphasizing that AHRQ is the only agency authorized to advance primary care —despite receiving only a small portion of national health spending—and that the cuts threaten to undermine the administration’s own health promotion goals.

Additionally, the USPSTF faces potential legal challenges in the Supreme Court (see Kennedy vs. Braidwood Management Inc. ), related to its authority under the ACA to set coverage requirements for preventive services under the US Constitution and the Religious Freedom Restoration Act.

Meanwhile, the Task Force continues to develop new recommendations on emerging health issues, currently working on recommendations for topics such as tobacco cessation, vision screening in children, and others. Additionally, USPSTF has announced its intention to provide recommendations on obesity management drugs such as semaglutide and tirzepatide, underscoring its ongoing critical role in shaping US preventive care policy.

Next Steps

Avalere Health’s cross functional team is uniquely capable of supporting stakeholders navigating the evolving landscape of USPSTF recommendations and submission processes. Understanding the access landscape for screening requires a partner with strategic foresight and deep expertise in evidence, policy, and quality frameworks. Leveraging expertise in evidence generation and planning, market strategy, and policy shaping, Avalere Health can provide strategic recommendations that meet individual client needs. To learn more about how Avalere Health can assist you connect with us.

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Per current regulatory procedures, first-in-class vaccines (i.e., new vaccine candidates that are designed to prevent diseases for which no alterative and effective treatments or preventions exist) undergo placebo-controlled testing. As the FDA has yet to publish a formal announcement detailing this proposed requirement, it is unclear what “new vaccines” might be subject to it (though the HHS spokesperson’s statement indicated seasonal influenza vaccines may be exempt). Below, we detail the current procedures for studying vaccine safety and effectiveness and discuss potential impacts in the context of two types of vaccines most likely to be affected (seasonal and next-generation vaccines), should this requirement be implemented.

Current Vaccine Study Procedures

Generally, FDA-approved immunizations require extensive, multi-phase clinical trials before they are approved for use in the United States. These trials often compare a vaccine candidate to a placebo; specifically, trials of first-in-class vaccine candidates use a placebo comparator to establish non-rare safety events and side effect profiles. For example, the first COVID-19 vaccines were compared to placebo across all phases of human study.

Next-generation vaccines, which we define here as those that improve upon available products, are studied in comparison to the current standard of care. For example, a higher valent candidate in an existing vaccine class (e.g., pneumococcal, meningococcal) would be studied compared to available vaccines to understand the safety, efficacy, and immunogenicity of the candidate. These trials are designed to measure incremental improvements in vaccine efficacy and be more sensitive to rare safety events than a placebo-controlled trial.

Updated versions of licensed seasonal respiratory vaccines often do not require additional clinical data, although live attenuated, intranasally administered influenza vaccines are studied in small samples (approximately 300 adults) as part of their supplemental Biologics License Application to verify strain attenuation. Historically, updated COVID-19 vaccines have been developed over a similar timeline and undergone similar regulatory approval processes, with some year-to-year variation given differences in manufacturing timeline needs for different platform technologies (e.g., mRNA). For example, in 2024, the Vaccines and Related Biological Products Advisory Committee selected new vaccine strains in June in anticipation of vaccine availability in early fall.

Potential Scenarios and Stakeholder Concerns

The types of immunizations that could be most affected by changes in clinical study requirements are (1) seasonal respiratory vaccines (e.g., COVID-19), which are updated versions of existing products, and (2) next-generation vaccines, which aim to improve upon existing products.

Seasonal Respiratory Vaccines: Seasonal respiratory vaccines are updated annually (to reflect the latest surveillance data on dominant virus strains), so the potential impact of regulatory changes may be most clearly understood in these products. While updated influenza vaccines are developed over the approximately six months between when the FDA determines US strain composition and the beginning of the annual respiratory virus season, the development of updated COVID-19 vaccines has historically taken place over a much shorter timeline. As these COVID-19 vaccines are updated versions of already-approved products, the FDA does not require additional clinical study. This allows the vaccines to be quickly deployed throughout the US.

Stakeholders have expressed concern that, if implemented, a requirement for placebo-controlled trials in seasonal vaccine updates could extend development timelines and affect availability. Phase III trials, which test vaccine safety and efficacy, can take between six and nine months on an accelerated timeline. Additional time required for manufacturing, lot testing, and lot release can further extend the development timeline into and beyond respiratory virus season, limiting timely vaccine availability.

Next-Generation Vaccines: Next–generation vaccines are developed to improve upon currently available products. These vaccines are studied against their FDA-approved predecessors to determine the magnitude of that improvement. In these trials, participants in both the experimental arm and the control arm receive an immunization against the disease target in question.

If placebo-controlled trials are required for approval of next-generation vaccines, some stakeholders have raised ethical concerns, given that participants randomized to a trial’s control arm would receive a placebo. These participants would thus be potentially exposed to a vaccine-preventable disease target despite the availability of an FDA-approved vaccine (Figure 1).

Figure 1. Current vs. Potential New Next-Generation Vaccine Study Comparisons

Looking Ahead

It is unclear how and when the FDA would issue updated guidance. Stakeholders should continue to monitor the evolving debate and proactively consider how future changes could affect vaccine development and regulatory planning.

As the federal and state vaccine policy landscape and funding continues to change, stakeholders should continue to remain adaptable to shifts in requirements from federal agencies, including the FDA. To learn how Avalere Health’s Vaccines Team can help you prepare flexible vaccine policy engagement and evidence generation strategies in the face of uncertainty, connect with us.

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Given the current structure of US immunization guidelines and policy development, it remains to be seen how the VIP will be integrated as it evolves. Below, we explore four outstanding questions that will help interpret the role and impact of the VIP within the vaccine ecosystem.

1.  How can the VIP inform US immunization policy, and how can it not?

In a press release announcing the launch of the VIP, CIDRAP Director Dr. Michael Osterholm alluded to environmental changes that may impact current science-based vaccine recommendation processes and safety and effectiveness data appraisals. This announcement follows a two-month delay of a scheduled Advisory Committee on Immunization Practices (ACIP) meeting and the cancellation of a Food and Drug Administration (FDA) advisory committee meeting to formulate strain composition for the 2025-2026 seasonal influenza vaccine. These deviations from longstanding vaccine evidence review and recommendation processes have raised concerns among immunization stakeholders, many of whom rely on ACIP recommendations to guide their vaccination policies and practices.

The ACIP formulates recommendations for vaccine use based on a robust review of clinical, safety, and cost-effectiveness data. These recommendations then require endorsement by the Director of the Centers for Disease Control and Prevention (CDC) and subsequently inform federal coverage policy. Most clinical societies adopt ACIP recommendations or leverage the clinical considerations for healthcare professionals and public health officials to develop protocols for specific patient populations.

2. How can VIP guidance augment existing immunization guidelines?

Several medical professional societies develop immunization guidelines. Specifically, the childhood and adolescent immunization schedules, which are reviewed and voted on annually by the ACIP, are subsequently approved by the American Academy of Pediatrics, the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG). The adult schedule is approved by AAFP, ACOG, the American College of Physicians, and the American College of Nurse Midwives.

Current society immunization guidelines mirror the ACIP’s recommendations and clinical considerations (e.g., vaccine use in special populations, like immunocompromised individuals). Absent these recommendations and additional guidance from the ACIP, societies may conduct their own guideline development processes for vaccination and look to the VIP to inform them. Conversely, the VIP may seek participation from these medical societies to inform its own vaccine evaluation and clinical guidance formulation.

3. How will the VIP review clinical and economic evidence for new products to inform guidance?

The ACIP maintains a systematic evidence review process to inform its vaccine use recommendations. Separately, guideline-developing medical societies also maintain their own evidence review processes, which may or may not align with federal advisory frameworks. While it is unclear how the VIP will review evidence going forward, it may draw from current examples to inform its own framework. A process that aligns more closely with current federal standards (e.g., the ACIP’s Evidence to Recommendations framework) may allow for more seamless integration into the existing policy environment, while aligning with any number of medical societies may support a centralized, accessible repository of guidance across provider types.

4. How will payers use VIP guidance in immunization coverage decisions?

Federal law anchors vaccine coverage without cost sharing to ACIP recommendations for most insurance coverage markets, with some exceptions:

• Medicare Part B: Vaccines explicitly stated in statute (i.e., pneumococcal, influenza, hepatitis B, and COVID-19) are covered without cost sharing.
• Vaccines for Children (VFC): Coverage under the VFC program is dependent on associated resolutions, which are voted on and approved by the ACIP. While these resolutions are also ACIP-driven, they are separate from recommendations for use.

VIP guidance on its own would not result in similar coverage mandates. If current vaccination recommendation processes change significantly, payers may turn to guidance from the VIP to inform their coverage policies. Payers may choose to cover immunizations regardless given their cost-effectiveness.

As VIP guidance would not trigger mandates for vaccine coverage without cost sharing, payers may continue to lean on ACIP recommendations and the immunization schedules to inform their coverage policies. However, if current policies were meaningfully changed, payers may increasingly rely on VIP guidance. More specifically, VIP guidance could provide clarity on populations recommended to receive an immunization based on their disease risk, informing how and for whom payers cover the immunization. Absent any federal coverage requirements, payers may also choose to implement cost sharing or other utilization management tactics.

How We Can Help

As the federal vaccine policy landscape continues to change, other non-governmental stakeholders are stepping in to address potential gaps. Stakeholders should continue to remain adaptable to shifting federal priorities and prepare to engage new and emerging voices in immunization. To learn how Avalere Health can help you prepare flexible vaccine policy engagement and evidence generation strategies in the face of uncertainty, connect with us.

The post Understanding the Scope of CIDRAP’s Vaccine Integrity Project appeared first on Avalere Health Advisory.

Key Themes

1. Federal policy uncertainty. Across multiple sessions, particularly those on maintaining and increasing access, attendees voiced questions and concerns about how federal actions could affect the future of vaccines. While there are no clear answers, experts noted that many vaccine policy proposals are emerging at the state level (e.g., bills influencing school requirements and exemptions) and in the courts (e.g., challenges to actions by the Trump administration).
2. Near-term policy priorities, constrained by feasibility. During a pre-conference workshop on strategies to eliminate human papillomavirus (HPV), attendees were asked to rank their top ten priority activities to increase HPV vaccine uptake. Many prioritized strengthening school entry vaccination requirements but expressed concern that doing so would not be feasible in the current policy landscape. This theme carried through the rest of the conference in sessions on topics from product development to public health implementation.
3. Novel access strategies to support a growing adult vaccine pipeline. While several combination vaccines for adults are approaching launch, adequate access to and uptake of these products requires ensuring that providers are (1) appropriately reimbursed and can afford to stock and administer them, (2) guided by clear and simple recommendations, and (3) capable of overcoming vaccine hesitancy with evidence-based messaging.
4. The need to address vaccine hesitancy. Many experts discussed strategies to combat the trend of declining vaccine confidence in some communities. For example, some noted a preference for the word “immunization” over “vaccine,” which could inform provider strategies to increase uptake among at-risk patient populations. Others noted the effectiveness of storytelling.

How We Can Help

Avalere Health’s vaccine experts engaged in sessions on evidence generation, policy, and market access. Our team brought unique perspectives into discussions on the evolving role of the Advisory Committee on Immunization Practices, vaccine pricing and access considerations, policy strategies, and messaging for communications and education to help stakeholders across the vaccine ecosystem prepare for and respond to the changing landscape.

To learn how Avalere Health can help you prepare flexible evidence, policy, and access strategies in the face of uncertainty, connect with us.

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All states are required to operate an NBS program. State public health programs are encouraged to screen for disorders included in the national Recommended Uniform Screening Panel (RUSP), but it is up to individual states to determine which conditions will be included on their screening panels.

Recommended Uniform Screening Panel

The federal Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) issues the RUSP and advises the Health and Human Services (HHS) Secretary on the most appropriate application of the NBS tests, technologies, policies, and guidelines.

The RUSP is a list of disorders that the Secretary recommends for states to screen as part of their state universal NBS programs. The panel includes 38 primary and 26 secondary rare conditions that can be detected either through laboratory screening of dried blood spots or point-of-care screening. According to Health Resources and Services Administration (HRSA), “non-grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without charging a co-payment, co-insurance, or deductible for plan years beginning on or after the date that is one year from the Secretary’s adoption of the condition for screening.”

Adding a condition to the RUSP is a multistep process that may take more than one year to complete. To add a condition to the RUSP, requestors must submit a comprehensive evidence package. The committee will then review and hold a preliminary vote on the recommendation, followed by external expert review of the evidence, after which the committee will review again and vote on the final recommendation to be adopted by the HHS Secretary.

Stakeholders interested in adding a rare disease to the NBS panel have two potential avenues: request a condition to be added to the RUSP at the federal level or engage with individual states to have a disease added to the state NBS program.

Table 1: Characteristics of NBS Programs

RUSP Alignment Legislation

Several states’ have laws that align their NBS program with RUSP, meaning that their state will screen newborns for any condition on the RUSP, implement a timeline for including a condition to the state panel, and ensure appropriate resource allocation to meet the recommendations. These laws expedite the process of adding disorders included on the RUSP to state panels once they are approved by the ACHDNC. There are currently 14 states that have enacted RUSP alignment legislation, with Tennessee and Alabama being the most recent ones (Figure 1).

Figure 1: States with RUSP-Aligned Newborn Screening Laws

Novel Approaches to Newborn Screening

It takes an average of 4.8 years for a patient with a rare or ultra-rare condition to receive an accurate diagnosis, and they may have to see more than seven specialists during this process. Of more than 10,000 known rare diseases, RUSP includes only 64.

Many researchers recognize the need to reduce the duration of patients’ diagnostic odyssey through implementation of novel approaches to NBS, such as rapid genomic sequencing. Multiple studies are evaluating the impact of adding genomic sequencing to NBS. In the United States, these studies include BeginNGS, BabySeq, and Early Check. Ex-US programs include 100,000 Genomes Project in the United Kingdom, Initiative on Rare and Undiagnosed Diseases in Japan, Genomics Health Futures Mission in Australia, and the Saudi Human Genome Program in Saudi Arabia.

There are several implications of genomic sequencing, including ethical considerations (e.g., privacy, types of results to be returned to parents, psychological impacts of knowing), impact on the overall healthcare system, implementation, governance, and social determinants of health. The initial results of the multiple studies indicate that some of these impacts may not be realized if genomic sequencing is implemented on a larger scale. Although further studies are required, the initial results are very promising.

Deeper Dive

Avalere applies our expertise in state policy assessment and evidence generation planning to help stakeholders meet their business objectives through effective commercialization.  To learn more about addressing unmet needs in rare disease and develop federal or state-specific engagement NBS strategies, connect with us.

The post Newborn Screening: Landscape and Rare Disease Developments appeared first on Avalere Health Advisory.

The Advisory Committee on Immunization Practices (ACIP) serves as the National Immunization Technical Advisory Group (NITAG) for the United States and advises the Centers for Disease Control and Prevention (CDC) on vaccines and immunizations. The CDC develops national immunization schedules based on the ACIP’s recommendations. The ACIP’s charter, which is updated biannually, details the statutory role and responsibility of the Committee. The Committee is tasked with reviewing and making recommendations for newly licensed vaccines, reconsidering recommendations for existing vaccines as necessary, and revising the list of vaccines in the Vaccines for Children Program. A notable recent charter amendment specified that the ACIP may review “vaccines and other immunobiological agents,” allowing for discretionary review of novel technologies such as preventive monoclonal antibodies. In the past year, eleven new members have joined ACIP, changing the expertise within the group.

To inform evidence-based recommendations which ultimately serve as the basis for federal coverage policies, the ACIP follows specific policies and procedures. Since 2010, the Committee has used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to assess vaccine data and the certainty of such findings. Beginning in 2018, ACIP Work Groups adopted the Evidence to Recommendation (EtR) framework, which helps to synthesize of evidence and structure discussions to inform recommendations votes. The EtR is designed to provide guidance on the criteria for decision-making for new or updated immunizations and is organized to account for data in seven domains detailed below. Qualitative and quantitative manufacturer-provided data can be applicable and eligible for inclusion in a product’s GRADE assessment and EtR review, though many EtR domains are most informed by CDC data.

Emerging Evidence Domains

With new ACIP members and novel products for the Committee to consider, manufacturers’ evidence should respond to evolving ACIP discussions through strategically tailored evidence generation. In recent meetings, the ACIP has pointed to emerging priority research areas within the established evidence domains to more comprehensively enhance the Committee’s considerations and deliberations:

• Public Health Problem: Epidemiology, clinical course, and overarching disease burden varies substantially by disease area. The ACIP has more recently expressed interest across disease areas to better understand the burden in specific settings (e.g., nursing homes), and in specific subgroups (e.g., high-risk disease groups). Examples of industry-led studies to fill these gaps include: (1) literature reviews characterizing unmet clinical need, (2) data related to timing of vaccination for certain populations, and (3) economic disease burden studies.
• Benefits and Harms: This domain relies on manufacturer data on a product’s clinical and safety profile. The ACIP has requested more robust data in specific higher-risk populations (e.g., immunocompromised individuals, comorbid populations, older adults). To meet requests, manufacturers can consider: (1) expanding clinical trial enrollment to recruit diverse populations, (2) stratifying trial results to better define and characterize high-risk populations groups, and/or (3) planning real world evidence studies to further understand vaccination in populations with unmet clinical need.
• Values and Preferences: This domain explores target population reactions to vaccination. The CDC has historically developed data supporting this. However, with new technologies and vaccine types (e.g., adult combination vaccines, therapeutic vaccines), manufacturers have opportunities to demonstrate how evolutions in the landscape may impact patient perceptions and preferences. The ACIP may value well-powered primary research on the target population’s perception of vaccines, including direct and indirect benefits for caregivers.
• Acceptability: The ACIP also accounts for provider- and stakeholder-related considerations, often reviewing evidence collected via provider surveys. While ACIP most often reviews CDC-driven studies in this field, manufacturers can contribute. For example, studies evaluating provider access, use, and preference of products can supplement CDC surveillance and monitoring.
• Resource Use: Under the resource use domain, ACIP evaluates the cost effectiveness of products, and has recently heavily focused on the costs of products. While ACIP has historically stratified these analyses by age group, it has also shifted to conduct analyses based on varying disease severity and risk. To inform cost effectiveness analyses, manufacturers must build models that align with ACIP guidance and are comparable to CDC-model parameter inputs.
• Equity: This is the newest EtR domain, and ACIP is still evolving its approach to it. Various members have expressed the importance of understanding equity in terms of disease burden and vaccine access, consistently requesting more data within specific sub-populations. Manufacturers can engage in studies (1) evaluating vaccine use by risk groups, socioeconomic strata, geographic region, and race, and (2) studying vaccine impact on caregivers for various demographics.
• Feasibility: The feasibility domain attempts to account for implementation barriers that should be considered for recommendation development. Manufacturers can provide data that support the use of novel vaccines in existing immunization schedules or highlight the challenges of existing schedules. Example studies include: (1) co-administration studies, (2) vaccine coverage rate models, and (3) studies demonstrating benefits to health system processes.

Figure 1: Studies Manufacturers Can Plan to Prepare for ACIP EtR Framework Reviews

Key Takeaways

Early in the pipeline, manufacturers should consider which evidence generation efforts should be prioritized for ACIP review and NITAG recommendations. As the ACIP continuously evolves and new members participate in discussions, evidence priorities should be responsive to evolving needs. Careful monitoring of ACIP actions can guide tailored evidence generation planning for optimal product review and effective recommendation development. Novel immunizations, such as monoclonal antibodies, combination vaccines, and therapeutic vaccines, merit additional targeted and nuanced strategies.

A Trusted Partner for Vaccine Support

Avalere’s experts in vaccine policy, evidence generation and strategy, and market access can help manufacturers effectively plan and conduct evidence generation activities, responding to evolving evidentiary needs. Activities may include supporting scientific narrative development ahead of launch, evidence packaging and submission for NITAG review, and go-to-market strategy for both medical affairs, market access, and policies teams. Connect with us to learn more.

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To characterize the post-IRA vaccine reimbursement landscape and update its previous 2023 white paper on Medicaid reimbursement in 2021, Pfizer commissioned Avalere to assess all 50 states, Puerto Rico, and Washington, DC to identify Medicaid fee-for-service (FFS) physician office and pharmacy vaccine reimbursement. Avalere focused its research and analysis on four vaccine products: 20-valent pneumococcal conjugate vaccine (PCV20), maternal respiratory syncytial virus (RSV), COVID-19, and shingles. The findings showed:

• Physician office vaccine product reimbursement is often equivalent to Medicare reimbursement rates. Therefore, rates are higher for Part B preventive vaccines (i.e., COVID-19, influenza, pneumococcal, and hepatitis B), and lower for vaccines not covered under Part B (e.g., shingles, RSV).
• Pharmacy product reimbursement under the pharmacy benefit is largely reimbursed via a “lesser of” methodology, which often leads to reimbursement at wholesale acquisition cost.
• More states permit pharmacy reimbursement for all assessed vaccines compared to 2021, representing an increase in pharmacy access to vaccination.
• Reimbursement for vaccine administration is variable and generally lower than Medicare amounts in both the physician and pharmacy settings.

Overall, Avalere’s findings show relatively few changes in the Medicaid reimbursement landscape compared to 2021. As stakeholders look to increase vaccine uptake among adults, ensuring adequate reimbursement would likely increase vaccine access for Medicaid beneficiaries.

Download the related white paper, ”50-State Comparison of Medicaid Adult Vaccine Provider Reimbursement in 2024.”

Funding for this research was provided by Pfizer. Avalere Health retained full editorial control. 

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Since Dr. Edward Jenner’s development of the first smallpox vaccine in 1796, vaccines have revolutionized public health, saving at least 154 million lives globally over the past 50 years. Available vaccines now protect against more than 20 infectious diseases.

The COVID-19 pandemic saw rapid development of vaccines using a novel platform—mRNA—resulting in an unprecedented initial dose administration just 11 months after identifying the virus’s genetic sequence. Researchers are now developing immunizations using innovative technologies and administration routes to combat emerging infectious diseases while continuing to develop vaccines for routine immunization across the life course. This rapid evolution demands novel solutions to market barriers and creative approaches to drive uptake.

To learn more about how Avalere’s vaccines experts can support you with influencing policy, shaping access channels, and translating evidence for strong recommendations, connect with us.

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As stakeholders prepare for the launch of combination vaccines, they must consider key questions surrounding product approval, recommendation development, coverage, and reimbursement pathways. In a white paper, Avalere discussed these questions and identified the below issues and considerations:

Table 1. Summary of Access Considerations for Combination Influenza-COVID-19 Vaccines and Key Stakeholders

Download the white paper: Adult Seasonal Combination Respiratory Vaccines: Policy Considerations.

To learn more about the landscape for adult combination vaccines, connect with us.

Funding for this research was provided by Pfizer. Avalere retained full editorial control.

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1. Climate change is impacting the vaccine industry and vaccination programs. In line with global efforts to curb greenhouse gas emissions, manufacturers are designing approaches to minimize their environmental footprint, and some payers have begun to incorporate manufacturing sustainability as a key consideration in their procurement practices. Climate change is also changing the distribution of disease, as mosquito- and other vector-borne illnesses such as dengue, chikungunya, and malaria increase in prevalence and expand into new geographies. Finally, climate events have begun to influence migration patterns. As populations shift, the scope of national immunization programs will need to evolve to accommodate these demographic changes. These changes unlock new opportunities for manufacturers of public health vaccines and create new demands for policymakers, who may need to expand immunization programs to accommodate larger populations and longer lists of antigens.
2. Vaccination programs are evolving to accommodate advances in adult immunizations. Historically, many vaccines were intended for children in an effort to prevent severe infectious diseases associated with outbreaks and early mortality. This pattern led to the development of immunization programs, information systems, and coverage pathways that optimized pediatric administration. With increasing prevention and control of those infections, new immunizations are often targeting illnesses and infections that primarily impact adults. As these novel products are reviewed for use, new challenges are likely to arise due to differences in pediatric and adult health conditions, health behaviors, and healthcare utilization. Moreover, this shift in product types will require a parallel change in the technical expertise of advisory committees, such as the Advisory Committee on Immunization Practices (ACIP), and the infrastructure used to administer vaccinations, to encourage effective implementation and equitable access.
3. Policy and access pathways for next-generation immunizations remain uncertain. In a panel on the Evolution of the ACIP, Elif Alyanak spoke with Centers for Disease Control and Prevention (CDC) experts about the future policy and access pathways for preventive drugs (e.g., monoclonal antibodies for primary or secondary prophylaxis) and therapeutic vaccines. Although language in the ACIP charter allows the committee to review immunoglobulins and immunizing agents, not all such products will fit neatly into the “vaccine” paradigm, and the ACIP is not staffed to review every next-generation candidate in the pipeline. Manufacturers must carefully consider a product’s anticipated indications as well as its storage and handling requirements, pricing, value proposition, and overarching launch timeline to forecast the most likely review and recommendation scenario. They should also engage proactively with both CDC and ACIP work groups, particularly as ACIP membership changes in the coming months.
4. Shared Clinical Decision Making (SCDM) is here to stay. The ACIP has issued different types of recommendations that reflect the strength of evidence in support of the product (i.e., Category A, Category B, permissive, catch-up, preferential, routine, and SCDM, respectively). ACIP often makes SCDM recommendations when individuals may benefit from vaccination, but broader vaccination is unlikely to have population-level impacts and may not be sufficiently supported by safety, efficacy, or implementation data to justify another type of recommendation. Commentary during the Evolution of the ACIP panel indicates that even with divergent opinions on the application and utility of SCDM recommendations, ACIP will likely continue to consider the recommendation type given the proliferation of novel vaccine types, their use in very targeted populations, and the limitations of modeling their cost effectiveness.
5. Pharmacy channels are growing in importance, but reimbursement remains a barrier. The pharmacy setting is an increasingly important site of care for vaccination, particularly for the adult population. The expansion of pharmacist scope of practice has enabled adults to receive vaccinations even if they do not have an established care relationship or access to a physician’s office. However, reimbursement incentives are inconsistent, and pharmacists cannot be reimbursed for vaccination in certain programs and care settings. Addressing these barriers will be critical to support access and uptake of novel and next-generation adult vaccines.

How We Can Help

The 2024 World Vaccines Congress allowed Avalere’s vaccine experts to participate in the evolving discussions about barriers and challenges affecting access to immunizations and considerations for how shifts in policy and product review can support market launch. Avalere’s experts in vaccine policy, access, and evidentiary review can help stakeholders across the vaccines ecosystem prepare for and respond to changes in the landscape. To learn how Avalere can support you on these issues as novel products prepare for market entry and advisory group review, connect with us.

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Figure 1. Example of a Provider Journey to Vaccinate an Adult Patient

ACIP: Advisory Committee on Immunization Practices; IIS: Immunization Information Systems 

Concerns about varied payment rates may contribute to provider uncertainty about timely reimbursement and could further factor into decisions about whether to continue stocking and administering vaccines over the long term. 

Policymakers and stakeholder advocates are considering potential reforms that aim to alleviate these challenges. The goal of these proposed reforms is to improve vaccine access across care settings and provider types and, ultimately, increase adult vaccination rates. As payment reform potentially becomes increasingly relevant with the launch of new vaccine delivery methods, advancing certain reforms may require coordinating alignment across partner advocates and additional evidence generation to garner policymaker support. 

Download the white paper, Examining Provider-Focused Vaccine Policy Reforms: Considerations for Patient Access. 

To learn more about Avalere’s vaccine work and efforts to expand vaccine access in adult populations, connect with us.   

Funding for this research was provided by the Adult Vaccine Access Coalition. Avalere retained full editorial control. 

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Implications of VRBPAC’s Recommendation

The October 5 meeting occurred as part of the regular lifecycle of decisions and recommendations on strain composition. WHO coordinates year-round global surveillance through its network of national influenza centers and regional collaborating centers. Twice a year, it convenes collaborating center leaders to review data generated via the global surveillance network to issue recommendations for the virus components for the northern hemisphere and southern hemisphere. It is then up to national regulators—such as the FDA in the US—to decide whether to adopt those recommendations. The FDA’s VRBPAC convenes biannually in March and October to select viruses for seasonal influenza vaccine composition.

Until 2012, influenza vaccines were all trivalent. The quadrivalent product was first introduced in response to two distinct influenza B virus lineages circulating. Only for the 2021–2022 season did the US market shift entirely to QIV.

During last week’s meeting, the expert panel met to consider WHO’s late September recommendation for the southern hemisphere influenza vaccine strain composition for the 2024 season. It endorsed WHO recommendations on components for the southern hemisphere trivalent influenza vaccine (TIV) and QIV. VRBPAC members and representatives from industry, government, and the WHO acknowledged that a complete switch to TIV is not practical for the southern hemisphere season. It also reaffirmed the WHO strain selection advisory committee’s recommendation that manufacturers and national regulators begin removing the B/Yamagata lineage component of influenza vaccines, which has gone undetected by WHO’s network of surveillance centers since 2020. WHO collaborating center leaders and VRBPAC advisors agreed that this points to a low threat of infection from that virus and to its possible extinction.

VRBPAC signaled to regulators and stakeholders its intention to change composition recommendations for the northern hemisphere vaccine for the 2024–2025 season as well. The vote to select and recommend those strains will occur in spring 2024 and would likely feature consideration of a move either toward all TIV or TIV/QIV in the US. VRBPAC and other national regulators often follow the strain selection recommendations issued by WHO, which likely indicates that similar TIV recommendations will be adopted by regulatory authorities in other key markets.

Policy Considerations

As this matter continues to unfold for the upcoming 2024–2025 influenza vaccine season, unanswered issues remain that will be determined over time.

1. Additional clarity from FDA on product-specific regulatory pathways toward TIV or alternate QIV: Product-specific detail on licensure requirements for TIV is needed. The agency may take a different approach to QIV composition in the future (i.e., the addition of an additional influenza A or different B lineage virus component), but changes would require more guidance on licensure requirements and additional data.
2. Vaccine manufacturing and supply: FDA advisors asked for more detail around the potential for disruption in supply for the 2024–2025 season should TIV vaccines be recommended. They also renewed calls for more modernized, more nimble influenza vaccine production processes.
3. Forecasting around the future of influenza B viruses: A recommendation to return to TIV underscores the unpredictable nature of influenza vaccine manufacturing and the critical value of better influenza virologic forecasting data.
4. Pricing: Influenza vaccine pricing has been responsive to changes in the composition of vaccines. Reintroduction of TIV vaccines into the US market signals the potential for differential pricing for TIV and QIV products. Avalere can help manufacturers navigate the access and payer landscape associated with this new market dynamic.

Navigating the Evolving Influenza Vaccine Landscape

Avalere’s experts in vaccine policy and commercial strategy can help manufacturers and other stakeholders analyze the policy and access implications of the shift to trivalent influenza vaccines and help companies develop strategies to differentiate their platforms in the evolving landscape. To learn how Avalere can support you with analysis, strategy development, and stakeholder engagement, connect with us.

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• Eliminating Vaccine Cost-Sharing in Medicare Part D: Effective January 1, 2023, all Medicare Part D plans are required to cover all Advisory Committee on Immunization Practices (ACIP)-recommended adult vaccines not covered under Part B with no cost-sharing, even if the beneficiary is in the deductible phase of the benefit.
• Mandating Medicaid Coverage of Adult Vaccines: Effective October 1, 2023, all state Medicaid programs are required to cover all ACIP-recommended adult vaccines and their administration without cost-sharing. This new policy aligns coverage for traditional Medicaid with that of the expansion population for whom vaccine coverage was already mandated.

As a result of these policy changes, most individuals in the US now have a pathway to no-cost coverage of all vaccines recommended by ACIP.

While coverage is now required across most markets, variation exists in federal policies governing which immunizations are subject to coverage requirements, the timeline for which coverage requirements must be in effect, and other elements impacting patient access. These variations can limit where and from whom individuals can receive their immunizations. To provide clarity on the vaccine coverage policy landscape, Avalere published a whitepaper summarizing key policies across markets.

While policy landscape evolution expanded the populations for whom coverage without cost-sharing is required, remaining policy variations could create barriers to coverage for certain populations, including under- and uninsured individuals. Going forward, it is likely that policymakers and other stakeholders will consider reforms aimed at populations that continue to encounter access challenges.

To learn more about vaccine coverage policies, connect with us.

Funding for this research was provided by Pfizer. Avalere retained full editorial control.

Download the white paper, “A Guide to Vaccine Coverage Policies.”

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Figure 1. Preventive Vaccine and Therapeutic Drug Regulatory and Access Pathways*

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Future Considerations for Vaccine Manufacturers and Other Stakeholders

In addition to voting on recommendations and preparing for the review of additional pipeline products, the committee’s discussions over the three-day meeting highlighted several topics that are important for vaccine manufacturers and stakeholders to consider.

• Safety of Respiratory Vaccines in Older Adults: With the new approval of RSV vaccines for adults, is the concurrent administration of RSV, Influenza, and COVID-19 safe and well characterized? What is the impact of effectiveness and the level of lasting protection for adults who receive multiple vaccines at the same time? What supplemental data would ACIP need from manufacturers and other stakeholders to address current gaps coadministration?
• Vaccine Cost-Effectiveness and Value: How does the committee use vaccine prices in its development of recommendations for use? What is considered the threshold for cost-saving vs. cost-effective vaccines? In the absence of a defined threshold to guide decision making, how has ACIP’s review of cost-effectiveness changed over time? Should manufacturers with pipeline vaccines adjust anticipated launch pricing based on the committee’s feedback on approved products and, if so, how?
• SCDM: How will an SCDM recommendation for older adult RSV vaccines impact individuals’ access and uptake? In practice, how well are such recommendations understood and implemented? Given coverage under Medicare Part D, how will pharmacies approach SCDM discussion with patients? What tools may support vaccine clinical decision making for patients and providers?
• Data in Immunocompromised/High-Risk Patients: What can be done to support ACIP’s calls related to clinical trial diversity in order to better represent and understand the safety and effectiveness of vaccines in older, high-risk, and pregnant populations? Given their increased susceptibility and severity of disease, what evidence can be collected to demonstrate the value of vaccination in these subgroups?
• Passive Immunizations: What criteria will be used to determine which future passive immunizations and monoclonal antibodies are reviewed by the ACIP? What preparation and planning is needed to understand the inclusion or exclusion of such products in federal programs such as Vaccines for Children?
• Complex Recommendations: As vaccine recommendations become more complex, particularly when multiple products are available, what strategies can be deployed to reduce implementation barriers and support patient/provider decision making?
• COVID-19: How will uninsured populations access COVID-19 prevention measures as previously government-purchased vaccine stockpiles are depleted? What policy and programmatic options exist to support patient access, and how will they be implemented? Can a simplified recommendation, harmonized with other seasonal adult vaccines like influenza, be expected for the fall?

How We Can Help

Avalere’s experts in vaccine policy, evidentiary review, and commercial strategy can help stakeholders appropriately prepare for ACIP review, and understand the implications of varying recommendation scenarios, including the impact on product coverage, reimbursement, and access. To learn how Avalere can support you in the strategic preparation of evidence and engagement ahead of advisory committee decision making, connect with us.

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To date, no statutory or regulatory definition of “vaccine” exists for the purposes of the Medicaid Drug Rebate Program (MDRP), creating uncertainty about product classification. Under the MDRP, manufacturers enter agreements with the Centers for Medicare and Medicaid Services (CMS) to provide mandatory rebates in exchange for product Medicaid coverage. Only products that meet the definition of a covered outpatient drug (COD), as defined in Section 1927(k)(2) of the Social Security Act, participate in the MRDP. Vaccines are explicitly excluded from the COD definition and are therefore excluded from the MDRP. As a result, states historically have not been required to cover vaccines for all Medicaid populations, though Medicaid-eligible children can access vaccines free of cost through the Vaccines for Children (VFC) program. For adults, the Inflation Reduction Act requires state Medicaid programs to cover adult vaccines without cost-sharing starting in October 2023. These pathways are intended to provide patient coverage without cost-sharing for all recommended vaccines. However, it is currently unclear to what extent these requirements apply to therapeutic vaccines, such as those used to treat cancer and infectious diseases, and novel, passive immunizations, which deliver antibodies created outside of an individual’s body to stimulate a disease-specific immune response.

Proposed Rule Would Define “Vaccine” for Purposes of the MDRP

On May 26, CMS issued a proposed rule to address drug classification and implement a variety of other programmatic updates in the MDRP. In the rule, CMS proposes defining “vaccine” for the purposes of the MDRP as “a product that is administered prophylactically to induce active, antigen-specific immunity for the prevention of one or more specific infectious diseases and is included in a current or previous [Food and Drug Administration] FDA-published list of vaccines licensed for use in the United States.”

As vaccines are explicitly excluded from the MDRP, any product that does not fall under the finalized definition of a vaccine would be included in the MDRP. CMS’s proposed definition excludes products that provide passive immunization, such as preventive immunoglobulins, as well as therapeutic immunizations (e.g., cancer vaccines). If this definition is finalized as proposed, it would have significant market implications for these novel products, including those currently on the market and the growing pipeline of products anticipated to launch in coming years.

Key Questions About the MDRP Rule and Vaccines

CMS requests comment on the proposed definition, soliciting feedback on whether it appropriately distinguishes between preventive and therapeutic vaccines as well as potential indirect consequences. Comments are due by July 25.

As stakeholders assess the impact of the proposed rule and develop a comment strategy, it will be important to consider key questions related to:

• Patient Access: How would coverage, cost-sharing, and utilization management for passive immunizations and therapeutic vaccines be affected if these products are included in the MDRP?
• Product Pricing: How will inclusion or exclusion from the MDRP affect manufacturer pricing strategy? What are the downstream impacts on pricing across other markets?
• Launch Strategy: How would this proposal impact how manufacturers engage with the FDA and Advisory Committee on Immunization Practices (ACIP)? If the ACIP recommends use of a product that may not be on the FDA’s list, what are the implications for Medicaid coverage?
• Influence on Other Programs: Could codifying a definition of vaccine for the purposes of MDRP set a precedent that could be applied to other programs such as VFC, 340B, and the Vaccine Injury Compensation Program?

How We Can Help

Avalere’s experts in vaccine policy and market dynamics can help stakeholders understand the direct and indirect implications of CMS’s proposal in the Medicaid market and beyond. To learn how Avalere can support you in developing CMS engagement strategies and comment letters to help shape a final rule, connect with us.

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Emily says, “This is such an exciting time for the vaccine community. The rapid development and deployment of immunizations were instrumental in helping the world to navigate its way out of the COVID-19 pandemic and showcased how immunizations save lives. I’m thrilled to join the dedicated team here at Avalere to help guide our clients through the many challenges and opportunities of today’s vaccine technology and policy landscape.”

Emily previously spent 15 years at the Centers for Disease Control and Prevention (CDC), where she held several policy leadership roles, including as the long-time director for influenza policy, as a senior leader for preparedness and response policy, and as the policy lead for several public health responses, including the COVID-19 response.

“The vaccine policy ecosystem is evolving rapidly in response to multiple converging factors and is challenging existing policy and access paradigms,” says Miryam Frieder, co-director of Avalere’s Policy Practice. “The industry’s got a robust and varied vaccines pipeline, and stakeholders are grappling with the transition to the commercial COVID-19 vaccine market, the implementation of vaccine-related provisions in the Inflation Reduction Act, and the development of new vaccine platforms and delivery modalities. Emily’s extensive experience across the CDC equips her to advise organizations leveraging her deep insight into the policy and legislative dynamics and the interagency collaboration that shapes the US vaccine landscape.”

Emily holds a bachelor’s degree in political science and a master’s degree in journalism from Northwestern University. She holds a doctorate in health policy and management from the Tulane University School of Public Health and Tropical Medicine, where she analyzed the cost-effectiveness of the influenza vaccination based on household income and researched influenza vaccination coverage among US adults.

The post Avalere Health Welcomes Emily Lobelo as Vaccine Policy Lead appeared first on Avalere Health Advisory.

Health Implications of US Water Quality

Passed in 1972, the Clean Water Act regulates water pollution and sets quality standards for surface waters, defined as all water naturally open to the atmosphere. The act establishes provisions to control sources of contamination—such as sewage treatment plants, agricultural runoff, industrial discharges, stormwater runoff, and improper medicine disposal—water contamination still occurs in the form of chemicals, heavy metals, microorganisms, radionuclides (such as uranium and radon), and harmful algal blooms.

Increased contaminants in water have been linked to health issues and are particularly harmful to vulnerable populations such as children, people who are immunocompromised, and older adults. Aging or corroding water systems may increase lead exposure, which can contribute to neurological damage and developmental issues. Recent literature shows higher rates of lead exposure among minority children than White children. Agricultural runoff and chemical pollution can also create harmful algal blooms that produce water toxins and threaten freshwater supplies.

Additionally, most Americans have been exposed to per- and polyfluoroalkyl substances (PFAS), a class of 14,000 human-made chemicals that resist decay. PFAS have been linked to cancer, liver problems, birth defects, and kidney disease, and one study estimates they could be contaminating drinking water for over 200 million Americans. Individuals at the highest risk of PFAS exposure include those in low-income and minority communities, who tend to live or work near high-polluting sites.

Climate change contributes to overall water quality in several ways. Rising temperatures can encourage the growth of harmful algae, and changes in precipitation patterns can increase sediment and nutrient runoff. A global increase in carbon dioxide emissions has altered ocean acidity, impacting marine life. Rising sea levels as a result of increased atmospheric warming may increase the risk of water-borne pathogens, create water access issues, and lead to higher levels of flooding. Flooding can threaten a region’s wastewater treatment systems, contribute to sewage issues, and overwhelm aging infrastructure. Overall, these environmental impacts are likely to increase the risk of water-related morbidity and mortality.

Water Access and Health Equity

Though most Americans have access to safe, clean drinking water, some communities still lack access to municipal wastewater systems and adequate drinking water. Underserved groups—including racial and ethnic minorities, low-income populations, immigrants, and rural communities—are at the highest risk of poor water quality and health-related complications. Many vulnerable communities were excluded from mid-20^th-century investments in modern water infrastructure and sanitation systems.

Some of these groups are still excluded from community water systems, leading them to rely on poor-quality water sources like private wells. Recent literature suggests one in nine Americans access drinking water from unregulated private wells, 23% of which show some level of water contamination. One study found significantly higher arsenic and uranium levels in regulated public drinking water in minority communities, even after accounting for socioeconomic status. These contaminants are associated with cancer, heart disease, and other health conditions. Furthermore, those without access to indoor plumbing often install their own systems, creating sewage exposure that increases the risk of waterborne disease.

A growing body of evidence focuses on water access and quality, with increasing attention to the link between water access and equity. One study used data from the American Community Survey and Environmental Protection Agency (EPA) to estimate how many households have incomplete plumbing or poor water quality, at the county level. The researchers found that 489,836 households lack complete plumbing, 1,165 community water systems are in “serious violation” of the Safe Drinking Water Act, and 21,035 Clean Water Act permittees are in “significant noncompliance.” Results were regionally clustered, with higher risk of these issues associated with indigeneity, rurality, income level, education, and age, consistent with other studies about the impact of inequitable water access among vulnerable populations.

Databases to Track Local Water Quality

Another major challenge in addressing water quality and access is the lack of consistent, standardized data collection. An overall dearth of research on the current state of water quality, the impacts of poor water quality on human health, and the disproportionate effects of water insecurity and contamination on vulnerable and underserved groups. Nevertheless, new tools are emerging to close the research gap.

The County Health Rankings model shows community health markers and indicators for future health and provides resources to help communities select and implement effective policies and programs. The model primarily measures health factors (e.g., health behaviors, clinical care, socioeconomic factors, physical environment) and health outcomes. Within these measures are two related to air and water quality: air pollution particulate matter and drinking water violations.

Another tool is the Environmental Working Group’s national Tap Water Database. In 2021, the group found that over 320 toxic substances have been detected in US drinking water systems, noting an additional 56 chemicals since the previous database update conducted in 2019. The national tap water database contains a report of toxic contaminants in drinking water by ZIP code and safety assessments. Researchers analyzed water contaminant tests from 50,000 water systems and found contamination from many pollutants, including PFAS and lead. While there are over 85,000 chemicals governed by the Toxic Substances Control Act, the EPA only regulates 90 contaminants found in drinking water and has not added a new substance to its regulated list since 2006. The presence of toxic substances in drinking water does not mean they are noncompliant with federal drinking water standards. EPA’s legal limits are relatively high and do not consider the effects of chemicals mixing with one another. Overall, regulations are slow to reflect scientific evidence.

Policy Landscape

The impact of source contamination and pollution could be mitigated by systemic improvements, such as stakeholder coordination, comprehensive water protections, and additional funding for infrastructure and management. Although the current level of federal funding for water infrastructure is only 14% of what it was in the 1970s, there is momentum toward improving water quality in the policy and regulatory arena.

For the first time in almost three decades, the EPA set legal limits for contaminants in drinking water. On March 14, 2023, the EPA set legal drinking water limits for six PFAS. The rapid regulation of PFAS signals a federal desire to address water contamination. The EPA set legal limits of four parts per trillion (ppt) for perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), but recent evidence shows that no level of water exposure is safe. The “advisory health limits” for these compounds are 0.02 and 0.004 ppt respectively, which is a significant reduction from the previous limit of 70 ppt. Despite attempts to phase out PFOS and PFOA, environmental and blood levels remain high because of the slow degradation process. However, the EPA’s move to limit PFAS focused on only six of 14,000 compounds, leading advocates to call for federal regulation of the entire chemical class.

At the global level, experts convened in March 2023 at the first global water conference in almost 50 years. Voluntary commitments to a new water action agenda came from more than 700 local and national governments, nonprofits, and businesses. Although these pledges will be monitored at future United Nations gatherings, they did not specify levels of funding. It will be difficult to hold stakeholders accountable without a formal global agreement like the Paris Climate Accords, more rigorous scientific data, and an international finance mechanism that treats water as a global common good. Public health experts and advocates critiqued the lack of representation at the conference; while the private sector and Northern hemisphere were well represented, few water experts and water insecure communities in the global South shared their perspectives. Progress for water equity will require stronger financial investments, accountability, incentives, and a more collaborative approach.

Opportunities

Stakeholders aiming to address poor water quality and ensure adequate access would benefit from collaboration with other groups to generate evidence and develop more robust research methods. Additionally, stakeholders can consider the following actions:

• Develop national water action plans
• Build capacity-building support
• Invest in water infrastructure
• Enforce primary drinking water standards
• Promote innovative water efficiency programs
• Encourage collaboration among health departments and providers
• Foster community collaboration to understand needs, priorities, and resources

For additional information on how climate change impacts human health and a more detailed list of recommendations by stakeholder type, download Avalere’s 2022 white paper.

Avalere has robust expertise in healthcare marketplace and regulatory trends, data collection and analytics, and strategy development. To learn more about how we can provide valuable insights to maximize the impact of your programs to advance health equity and improve patient and public health, connect with us.

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