Radar on Drug Benefits

As the pharmaceutical industry hurtles toward completing a COVID-19 vaccine, payers and PBMs have begun to draft vaccine distribution plans based on emerging guidance from federal public health leaders. Insurance industry leaders say that they anticipate the government and its chosen distributor, McKesson Corp., will handle most of the early work in distributing vaccines, but that payers should anticipate taking a role in educating members and directing inoculations to appropriate populations in later stages.

Official federal vaccine guidance will originate with the Advisory Committee on Immunization Practices (ACIP), the Centers for Disease Control and Prevention’s (CDC) vaccine policy body. ACIP generates ongoing public health and distribution guidelines for vaccinations, including the annual rules for influenza vaccines. According to a Sept. 22 report in the Wall Street Journal, ACIP has opted to defer issuing formal guidance for initial COVID-19 vaccine distribution until clinical trials have advanced further. On a related point, ACIP generally waits to issue guidance until vaccines have been approved by the FDA. ACIP’s next meeting is scheduled for Oct. 28-30, and the panel may release guidance at that point.

The Trump administration’s long-awaited executive order that seeks to tie U.S. drug prices to costs in other countries may represent more presidential campaign talking points than real policy that will take effect quickly. But analysts expect that the overarching issue of drug pricing will stick around, regardless of which candidate wins on Nov. 3.

For example, the executive order signals that the administration could pursue price caps for select Medicare Part B and D drugs in a possible second term. The order calls for demonstration projects to test “most favored nation” pricing in Parts B and D.

✦ HHS on Sept. 9 issued guidance that authorizes state-licensed pharmacists to order and administer COVID-19 vaccines to people ages 3 and up — when they’re authorized or licensed by the FDA and made available to the public. “Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people,” said Assistant Secretary for Health ADM Brett P. Giroir, M.D. To qualify for vaccine administration, pharmacists or registered pharmacy interns must meet a variety of requirements, such as completing a training program. Read more about the guidance at https://bit.ly/3if2tDR.

✦ The CEOs of nine pharmaceutical companies on Sept. 8 issued a “historic pledge” aimed at bolstering public confidence that they will develop and test potential COVID-19 vaccines “in accordance with high ethical standards and sound scientific principles.” The pledge — signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc. Pfizer Inc. and Sanofi — comes amid mounting worries that the Trump administration will put political pressure on drug companies to seek premature approval of a vaccine for the coronavirus. Among other promises, the companies said they will only submit a vaccine for FDA approval or emergency use authorization after it demonstrates safety and efficacy through a well-designed Phase 3 clinical study. Read the pledge at https://bwnews.pr/2FfEvtn.

For medications with both brand-name and generic versions, an overwhelming majority of Medicare Part D plans encouraged the use of generics over their brand-name equivalents in 2019, according to a study published in Health Affairs. By analyzing Part D formulary coverage and tier placement of matched brand-name drugs and generics, the researchers found that 84% of Part D plan-product combinations covered the generic only in 2019, while 15% covered both brand-name and generic versions. In 2019, of the 1,361 drug products analyzed, there were 98% of products for which generics were placed on a lower cost-sharing tier than their brand-name counterparts in at least one plan in 2019.

Carrying out another directive from President Trump’s Medicare-focused executive order issued last fall, CMS on Aug. 31 released a proposed rule that aims to fast-track Medicare coverage of certain innovative FDA therapies once they are approved. Although the rule applies to Medicare fee for service, it has implications for Medicare Advantage organizations that are required to cover Medicare Parts A and B approved services.

According to a CMS fact sheet on the rule, CMS is proposing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT), for medical devices that are granted breakthrough designation by the FDA. The MCIT proposal would allow for national Medicare coverage on the same day as a breakthrough device receives FDA approval. CMS proposes a coverage duration of four years, which it suggests will “encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients.”