Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in AIS Health RADAR on Drug Benefits, in “Once Nonexistent, Pipeline for RSV Vaccines Is Now Crowded with Contenders,” by Leslie Small. (Read the full version – subscription required.)

Following is an excerpt:

For decades, a successful vaccine for respiratory syncytial virus (RSV) — which sends thousands of infants and older adults to the hospital each year — has remained elusive. Yet several heavyweight pharmaceutical companies are now poised to fill the void, as they’re nearing the finish line in the development of RSV vaccines that could ultimately comprise a multibillion-dollar market. Coverage of the new vaccines, according to an industry expert, will hinge on the all-important Advisory Committee on Immunization Practices (ACIP), which requires payers to fully reimburse any inoculation that it recommends. …

Market Value Could Reach $10 Billion …

Compared to other drugs, "vaccines are very different when it comes to coverage," says Richard Hughes IV, a member of the law firm Epstein Becker Green, speaking about no vaccines or companies in particular. Once the FDA approves a Biologics License Application for a vaccine, ACIP has one year to review the vaccine and decide whether to recommend it. "The ACIP has become very important to payer coverage decisions, because the ACA [Affordable Care Act] requires coverage of all vaccines that the ACIP recommends," Hughes tells AIS Health, a division of MMIT. Under the ACA, that requirement applies to commercial health plans and the Medicaid expansion population, and now with the passage of the Inflation Reduction Act, it also applies to the traditional Medicaid population.

The requirement that payers cover ACIP-recommended vaccines without cost sharing also applies even when there are multiple vaccines for the same disease available, Hughes notes. In other words, health plans won’t be able to prefer one ACIP-recommended vaccine over another in their coverage guidelines. "Now, if the ACIP makes a preferential recommendation, that obviously will have an impact on other vaccines in the market, and that would impact provider behavior," he says, "and it’s really about the choice of vaccine that the provider makes and that the provider keeps in stock."

There’s “no one-size-fits-all answer” to the question of how long the ACIP’s review process will take within its yearlong deadline, Hughes says. But through its working group, the ACIP has been evaluating the RSV vaccines that it will likely have to decide whether to recommend, “so I would expect that this would happen…probably within a few months of licensure,” he adds. …

Sometimes, there can be ambiguity in terms of how ACIP’s recommendations are translated into coverage policy, Hughes points out. One example is when the ACIP decides that the health economic evidence doesn’t support a full routine recommendation for a given vaccine but says that it should be given if both provider and patient decide it’s in the patient’s best interest — called a “shared clinical decision-making recommendation.” Some payers weren’t covering shared clinical decision making-recommended vaccines, so the CDC released guidance clarifying that those vaccines are, in fact, required to receive full coverage.

Regarding Medicare, an RSV vaccine would be covered under Part D, Hughes says. That presents a challenge, access-wise, since some seniors don’t have Part D coverage.

Furthermore, because pharmacies rather than physicians are designated as in-network providers under Part D, “there’s a real disincentive” for physician offices to purchase, store, administer and bill for an RSV vaccine, he points out. That’s less than ideal because it would be advantageous for physicians to be able to administer the influenza, pneumococcal, COVID-19 and RSV vaccines in the same visit. “Pharmacies are very important” as a vaccine access point, “but I view it as a real potential barrier if you can’t get the coadministration opportunity in the physician office,” Hughes says.

Ultimately, the RSV vaccines in development represent a major step forward for public health, according to Hughes. “RSV is a significant source of respiratory illness seasonally, and it’s been a disease that we’ve wanted a vaccine to prevent for a very long time.”



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