Sharing similar characteristics with vaccines, vaccine-like products are intended or may be indicated for the prevention of infectious diseases, especially diseases for which no vaccine is currently available. They remain in a “grey zone” between traditional drugs and vaccines, however, which impacts their coverage and access under current US insurance requirements and public health programs. Current vaccine-like products—including monoclonal antibodies and immunoglobulins administered prophylactically and which are indicated for narrow populations—have not historically been included in traditional vaccine access pathways, such as the Vaccines for Children Program. Given provider and patient impact, the addition of vaccine-like products to such programs may have implications for uptake and public health, especially among pediatric populations.

Leveraging Vaccine Access Pathways for Vaccine-Like Products Would Lower Patient Cost Sharing

Stakeholders evaluating the potential public health impact of vaccine-like products may benefit from considering the implications of both pathways for coverage and access. Should vaccine-like products be covered and accessed like traditional drugs, patients may face increased coverage variability, which in turn could increase health disparities between those who can access such products and those who face access challenges. As the pipeline of vaccine-like products grows, expanding coverage and access policies to accommodate them without patient access barriers will help facilitate their broad public health impact.

Coverage Pathways Will Determine Overall Patient Out-of-Pocket Costs and Access

Under today’s policies, novel “vaccine-like” prophylactic products are likely to be covered and accessed through similar pathways as traditional drugs, which pose a range of potential coverage and access barriers, possibly exposing patients to higher out-of-pocket costs, limiting uptake and public health impact.

Coverage: The same coverage requirements for vaccines do not apply to traditional drugs. Section 2713 of the Public Health Service Act requires non-grandfathered group health plans and issuers in the group and individual markets to cover immunizations for routine use in children and adolescents that have in effect an Advisory Committee on Immunization Practices recommendation.

Utilization Management: Payers have also imposed utilization management techniques for vaccine-like products by implementing policies aligned with professional guidelines rather than the Food & Drug Administration label, limiting coverage to select populations.

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

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Read the related blog post by the authors on Health Affairs.