CMS finalized their coverage determination for Aduhelm to cover the drug for patients enrolled in clinical trials who meet the outlined coverage criteria.

The criteria differs only slightly from the initial proposal in January, despite the aggressive pressure from manufacturers to cover the drug for all Medicare beneficiaries. Similar to the initial proposal, the final decision limits coverage to beneficiaries with mild forms of cognitive impairment or mild dementia and have amyloid plaques present in their brain that enroll in clinical trials; however, the final proposal does not limit whether patients with comorbidities can enroll in approved clinical trials, which may allow patients with Down Syndrome to participate. A notable difference from the initial proposal is that the NCD will not apply to treatments that have been approved through the regular, rather than accelerated, approval pathway, as these treatments would have been required to show a clinical benefit. To read the full decision, click here.

MedPAC discussed Medicare Part B and D spending trends and high prices in their April public hearing.

The hearing included three sessions on drug spending, which focused on: (1) the high prices of Part B drugs; (2) new Part D data of rebates and discounts; and (3) segmentation within the Part D market. The meeting was a follow-up of the October meeting when they began to discuss possible solutions to high prices and spending.  All of the final proposals and recommendations are expected in MedPAC’s June report. To review the related materials, click here.  

Patients for Affordable Drugs (P4AD) released a report on lockstep price hikes and patent gaming of two blockbuster drugs.

The report focuses on two blood thinners, Bristol Myer Squibb and Pfizer’s Eliquis and Johnson & Johnson’s Xarelto, which were Medicare’s most costly and third most costly drugs in 2020, respectively. The two drugs have increased their prices by over 111% since they entered the market about ten years ago. Their prices are significantly higher in the US than any other country; Eliquis is five times and Xarelto is up to ten times more expensive in the US than other countries. To read the full report, click here.

CIDSA Experts in the News

Stacie Dusetzina spoke on the Health Podyssey, a Health Affairs podcast, about her recent analysis of non-LIS Part D beneficiaries’ prescription drug adherence. The study found that, for some treatments, more than 50% of beneficiaries are not filling their prescriptions due to high cost. To listen to the full podcast, click here.