Adult Seasonal Combination Respiratory Vaccines: Policy Considerations

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Summary

In a new white paper, Avalere considers key questions related to strain selection, ACIP recommendation, and coverage and reimbursement of adult combination vaccines in development.

Combination vaccines can provide protection against and potentially prevent multiple diseases through a single vaccination. Multiple adult combination vaccines are emerging in development pipelines and are expected to launch in the next decade, including products that confer protection against several respiratory illnesses such as influenza, COVID-19, and respiratory syncytial virus (RSV). Stakeholders have noted the potential benefits of adult combination vaccines, citing several advantages documented in the childhood market which has a variety of existing combination products. These benefits include improved vaccine coverage rates, timely vaccination for under vaccinated individuals, decreased shipping/stocking costs, and reduced costs associated with extra healthcare visits.

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

Issue Area Considerations  Key Stakeholders
Strain Selection Timeline • Stakeholders will need to consider how to approach strain selection for combination vaccines, as current influenza and COVID-19 processes vary
• Balancing strain selection timeliness with precision may be more consequential for combination vaccines due to differences in disease patterns and seasonal debut
• Stakeholders may explore streamlined approaches, e.g., a single review timeline based on vaccine type or platform
• WHO, TAG-CO-VAC
• FDA, VRBPAC
ACIP Review • ACIP will need to decide whether to form a new Adult Combination Vaccine WG or rely on existing WGs
• If relying on existing WGs, ACIP may need to establish new approaches to working and collaboration when two or more WGs are reviewing the same combination product
• ACIP and other stakeholders will also need to consider recommendation timing; a later recommendation for either component could impact payer coverage and patient access
• CDC, ACIP
Product Coverage and Reimbursement • Clarity is needed to understand if influenza/COVID-19 combination vaccine coverage will be limited to a certain window/season
• While Part B coverage is likely, CMS may need to clarify when product payment is anticipated
• CMS’s Center for Consumer Information and Insurance Oversight (CCIIO) may need to clarify whether commercial market coverage timelines for COVID-19 vaccines applies to combination products
• CDC and other stakeholders may need to assess strategies to provide access for uninsured adults
• Commercial insurers
• CMS
• CCIIO
• Medicaid agencies
• Managed care organizations
• CDC
Payment for Administration • Stakeholders may consider changes to facilitate multi-component billing for combination vaccines • AMA, CPT Editorial Panel
• CMS
• Providers

 

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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