Key Policy and Access Themes from the World Vaccines Congress

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The World Vaccine Congress addressed the changing landscape of infectious diseases and vaccine types, approvals, recommendations, and reimbursement pathways.

At the 2024 World Vaccines Congress in Washington, Avalere’s vaccines experts participated in discussions on the rapidly evolving vaccine policy, access, value, and evidence landscape. The following list synthesizes key themes from those discussions.

  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.

Webinar | A Closer Look at Patient Support On June 6 at 2 PM ET, Avalere experts will explore how potential implications of the Inflation Reduction Act (IRA)’s out-of-pocket cap, in addition to other key regulatory and policy activities shaping benefit design and patient cost-share (e.g., EHB), could impact patient commercial and foundation assistance. Learn More
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