Radar on Drug Benefits
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News Briefs: Plans, PBMs Are Blocking Access to Birth Control
A congressional panel found that major PBMs and health insurers are charging members cost sharing and imposing other coverage requirements on birth control products in violation of the Affordable Care Act. The “investigation identified more than 30 birth control products for which most health insurers and PBMs reviewed impose cost-sharing requirements or coverage exclusions,” according to a press release. Among the companies examined were CVS Health Corp., UnitedHealth Group, Elevance Health Inc., Cigna Corp., Humana Inc. and Prime Therapeutics, a PBM owned by a consortium of Blues affiliates. “From 2015 to 2021, companies denied exceptions requests on average four or more times out of ten,” the press release added.
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Once Nonexistent, Pipeline for RSV Vaccines is Now Crowded With Contenders
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.
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Mark Cuban Cost Plus Drugs Strikes First Deals with Insurer, Outside PBM
Mark Cuban Cost Plus Pharmacy, the online pharmacy and generic manufacturing startup backed by the eponymous billionaire investor, recently struck its first deals with a health plan, Pennsylvania’s Capital Blue Cross, and a PBM, Rightway Healthcare Inc. The direct contracting deal represents a major step for the startup, which has done most of its business so far as a direct-to-consumer retailer — and one drug pricing expert tells AIS Health, a division of MMIT, that the deals help Cost Plus moves toward its ambitious, disruptive goals.
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Payers May Balk at Newly Approved ALS Drug’s $158K Price
The FDA on Sept. 29 approved Relyvrio (sodium phenylbutyrate/taurusodiol), making it only the third medication to treat patients with amyotrophic lateral sclerosis (ALS). While ALS advocates and some clinicians applauded the agency’s decision, other providers have questioned the drug’s effectiveness, and some experts believe the drug is not cost-effective with its approximately $158,000 annual wholesale acquisition cost (WAC).
For instance, the nonprofit Institute for Clinical and Economic Review (ICER) found that Relyvrio, which was formerly known as AMX0035, would be cost-effective if it was priced at between $9,100 and $30,600 per year. And Bruce Booth, a former scientist who’s now a partner at the Atlas Venture biotechnology venture capital firm, wrote on Twitter that the $158,000 price for Relyvrio was “even more egregious than I thought!”
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New Bill Takes Aim at CMS’s National Coverage Determination Powers
The FDA’s controversial accelerated approval of Biogen Inc.’s Aduhelm (aducanumab) has yielded new fallout, as members of the U.S. House of Representatives have introduced a bill seeking to unwind CMS’s national coverage determination that limited access to the Alzheimer’s treatment — and prevent CMS from issuing restrictive NCD decisions on future drugs.
D.C. insiders tell AIS Health, a division of MMIT, that the bipartisan bill’s fate will likely depend on the outcome of the upcoming midterm elections. They add that the NCD bill represents a renewed effort by the pharmaceutical industry to flex its lobbying muscle after it faced an unprecedented defeat with the passage of Medicare drug price negotiation as part of the Inflation Reduction Act.
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