Newly Approved Vaccines Face a Fragmented Policy Landscape

During the COVID-19 pandemic, vaccine technology made a huge leap forward with the introduction of messenger RNA (mRNA) vaccines. COVID-19 vaccines developed by BioNTech/Pfizer and Moderna use mRNA instead of weakened viruses or virus fragments to teach the body’s immune system how to respond when presented with an infection.

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a fragmented insurance and policy landscape.

Alexandra Fix

“Different federal policies dictate coverage across different markets and for different populations,” Alessandra Fix, associate principal at Avalere Health, said in an interview.

In the commercial market, the Affordable Care Act requires plans to cover many vaccines without cost-sharing. It also requires coverage without cost sharing in the Medicaid expansion market.

Within Medicare, the Inflation Reduction Act of 2022 (IRA) requires plans to cover vaccines that have been recommended by ACIP with no patient out-of-pocket costs. Prior to the IRA, plans could impose cost-sharing. And as of October 2023, state Medicaid programs have to cover adult vaccines recommended by Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) for nearly all populations. The committee’s recommendations help to guide safe use of vaccines and related biological products.

“ACIP recommendation is the biggest driver of both provider behavior in terms of what vaccines they are recommending to patients and payer coverage,” Fix said.

Last year, the first two vaccines to prevent respiratory syncytial virus (RSV) were approved for older adults with a separate approval for infants of one of them. RSV is a common respiratory virus that usually causes mild, cold-like symptoms, but it can lead to serious respiratory illness and increased hospitalizations.

GSK’s Arexvy, approved for adults in early May 2023. The second adult vaccine was approved a few weeks later. Pfizer’s Abrysvo is a bivalent RSV prefusion F (preF) vaccine that is composed of two preF proteins selected to optimize protection against RSV A and B strains. The FDA also approved Abrysvo to prevent RSV in infants.

Both Arexvy and Abrysvo have been recommended by ACIP for both populations and would qualify for coverage under the IRA.

Additionally, Fix said the first the first monoclonal antibody to prevent RSV in infants — Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip), which was approved in July 2023 — is expected to go through a vaccine access pathway even though it is not a vaccine.

“It will be treated like a vaccine, meaning is included in the vaccines for children program, and uninsured children and Medicaid eligible children can access it,” she said.

Coverage would also be required for Penbraya, a Pfizer vaccine approved in October 2023 to prevent meningococcal infection in adolescents and young adults. Penbraya combines the components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine). ACIP voted to recommend Penbraya.

Coverage for Travel Vaccines

Coverage for vaccines needed for traveling outside the United States is a little more complicated, however. Last year, the FDA approved Ixchiq as the first FDA-approved vaccine to prevent the mosquito-borne virus chikungunya virus for adults aged 18 years and older. Developed by Valneva, Ixchiq was granted accelerated approval Nov. 9, 2023.

The Centers for Medicare and Medicaid Services has interpreted the IRA coverage as applying to travel vaccines, especially in the Medicaid market, Fix said.

For examples, Prime Therapeutics, the pharmacy benefit manager of many of the Blue Cross plans, includes Arexvy, Abrysvo and Penbraya on its Prime Standard offering and the Vaccine Network. A spokesperson said that health plans may also cover these vaccines on the medical side as well. But Ixchiq is not included on the Prime Standard offering, however, health plans may cover it on the medical side.

Fix said gaps exist in insurance coverage for vaccines. Some people may be enrolled in commercial plans that are grandfathered in and don’t have to adhere to the ACA requirement. Those without insurance have to pay full out of pocket cost if they wanted to receive the vaccine. “There are some limited state-based safety net programs, but they’re not comprehensive,” she said.

Coverage for COVID Vaccines

For COVID-19 vaccines, the FDA-approved and ACIP-recommended vaccines are covered the same way, meaning nearly all insured patients will have a pathway to coverage without cost-sharing.

There is some nuance, Fix said, in that different policies govern COVID-19 vaccine coverage and the timeline for when new COVID-19 vaccines must be covered. For example, the American Rescue Plan requires Medicaid coverage without cost sharing with the federal government picking up the costs through September 2024, after which coverage is required by the IRA. It is matched by the federal government through the Federal Medical Assistance Percentages (FMAPs), which are used to determine the matching funds for state expenditures for certain services.

But with the planned sunset of Bridge Access program at the end of this year, there is a coverage gap for uninsured adults, with will be no comprehensive adult safety net program in the United States, Fix said.

The Bridge Access is an HHS program that is administered by the CDC to provide COVID-19 vaccines for those without insurance. Through this program, the CDC has contracted with more than 20,000 retail pharmacies and will additionally ship and fund administration of vaccines to state and local health departments. A separate programs, Vaccines for Adults (VFA) program, has been proposed in both the FY 2023 and 2024 Presidential Budgets, which would cover all recommended vaccinations at no cost for uninsured adults. This proposal has not yet been enacted into law.

This story first appeared on Managed Healthcare Executive.