Radar on Drug Benefits

By a seven to two margin, an FDA advisory committee on Sept. 7 voted that there was enough evidence to support the approval of AMX0035, an oral medication that Amylyx Pharmaceuticals, Inc. is developing for amyotrophic lateral sclerosis (ALS). The vote represented a reversal for the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC), which on March 30 had recommended against the medication’s approval.  

Despite the committee's decision, David Rind, M.D., chief medical officer of the nonprofit Institute for Clinical and Economic Review (ICER), tells AIS Health that Amylyx may have trouble getting the drug covered due to the medication’s likely high cost and lack of clear effectiveness.   

A federal judge on Sept. 7 ruled that the Affordable Care Act’s requirement that individual and group health plans must cover pre-exposure prophylaxis (PrEP) medications to prevent HIV violates the religious freedom of objecting employers. The ruling is not likely the final salvo in a case that challenged the ACA’s entire preventive service coverage mandate, but it did spark outcry from one advocacy group representing HIV-positive patients. 

The case in question, now known as Braidwood Management Inc., et al  v. Becerra, argues that Section 2713 of the ACA — which mandates coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices and the Health Resources and Services Administration — is unconstitutional. It also challenges coverage mandates for specific preventive care, namely PrEP and some contraceptive methods, on religious freedom grounds.  

While an unprecedented number of Medicare Advantage Prescription Drug plans earned a 5-star rating for 2022 largely because of flexibilities granted during the COVID-19 public health emergency, Blue Cross & Blue Shield of Rhode Island (BCBSRI) credits a performance-based pharmacist intervention model with dramatically improving its drug-related scores and contributing to a 5-star summary rating for both of its contracts.

For 2022, CMS allowed plans to use the better of the two years’ rating (2021 or 2022) for most measures because all contracts qualified for the “extreme and uncontrollable circumstances policy.” Plans will not have that flexibility for the 2023 star ratings due out this fall.

Centene Corp. agreed to pay Washington $19 million to resolve allegations that it overcharged the state’s Medicaid program for pharmacy benefit management services. As part of the resolution, Centene will pay an additional $13 million to the federal government “for administration of Medicaid in Washington state,” according to a press release from Washington’s attorney general. The agreement with Washington is Centene’s 11^th such settlement with a state regarding how its PBM subsidiary Envolve administered pharmacy benefits in Medicaid.  

The public will likely need annual COVID-19 vaccinations in the future, similar to how the flu is treated, White House officials said during a recent press briefing. “It is becoming increasingly clear that, looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population,” said Anthony Fauci, M.D., the president’s chief medical adviser. Ashish Jha, the White House’s coronavirus response coordinator, said the U.S. is able to pursue this strategy because it now has vaccines available that match the dominant strain circulating — a first since the pandemic started. However, some “vulnerable groups” might continue to need more frequent vaccination against COVID-19, Fauci said on Aug. 6.  

The FDA on Aug. 19 approved the first and only rapid-acting oral drug for major depressive disorder (MDD), a treatment that is being hailed by its manufacturer as a “potential game-changer” for people struggling with the difficult-to-treat condition. 

One pharma analyst expressed optimism about the drug’s ability to disrupt the MDD treatment market. However, experts from the PBM sector predict that payers may not embrace the drug warmly given how many generics are available to treat depression.