Medicare’s Aduhelm NCD Has Implication Outside of Alzheimer’s Disease
Medicare’s Aduhelm NCD Has Implication Outside of Alzheimer’s Disease
As a third installment of our Aduhelm coverage, we look at the recently announced draft National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS).
Approximately 6 months following the controversial FDA decision to grant the drug Accelerated Approval, CMS decided to take a unique interpretation of the Coverage with Evidence Development (CED) pathway by choosing to only to provide coverage for patients enrolled in CMS-approved randomized trials and in trial supported by the National Institute of Health. Furthermore, this coverage determination will be applied for all FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.
For Biogen, the coverage decision is unlikely to radically change the trajectory of physician demand in the short run – CMS has already received a number of comments on their decision either supporting it or asking for additional restrictions, suggesting that general product sentiments have not improved. This, combined with a very disappointing $1M in sales for fourth quarter 2021 and discussions about potential layoffs, suggests that the CMS decision is unlikely to lead to a turnaround until longer term data prove positive. It also creates additional hurdles for patient access by requiring trial enrolment which may not always be feasible.
For industry, this decision further demonstrates the increased attention being paid to post-marketing studies, particularly for products receiving FDA Accelerated Approval based on surrogate endpoints (and especially those with safety concerns). While the FDA has started to put more pressure on companies to produce their agreed-to follow up data following Accelerated Approval, CMS has now made a very public statement about the role of this post-marketing follow through in proving “reasonable and necessary” for coverage. Manufacturers pursing approvals based on questionable or unfamiliar surrogate endpoints will need to reinforce the role of these markers in driving clinical outcomes of relevance and engage with FDA and CMS early around these concepts.
For policymakers, this decision acts as a formal acknowledgement of CMS’ concern over the quality of data provided by Biogen, putting additional pressure and spotlight on the already contentious approval decision by the FDA. CMS may continue to establish an increasingly independent view of “reasonable and necessary” in these controversial decisions, despite a history of general alignment with FDA. This decision also puts more potential financial pressure on Medicaid to cover dual-eligible beneficiaries (those that receive both Medicare and Medicaid benefits) and could spur additional urgency to revisit Medicaid reimbursement reform.
Further reading on this topic can be found in these 2 articles: