CMS kicks off 9-month process on whether to limit coverage to Biogen's new Alzheimer's drug
The Centers for Medicare & Medicaid Services late Monday opened a formal process, rarely done for new therapeutics, to carefully review whether it will limit coverage nationwide for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease, including Biogen’s newly approved Aduhelm.
While it remains unlikely that CMS won’t end up paying for Aduhelm (Medicare officially draws the line at care that is “not reasonable and necessary,” but CMS denies only about 3% of claims submitted by hospitals and physicians), the stakes are high as Biogen expects that about 80% of patients eligible for Aduhelm are covered by Medicare, and private insurers are likely to follow the federal government’s lead.
Although CMS maintains that the cost of the treatment will not factor into its final decision, it may be difficult for the agency to avoid discussing the repercussions of the $56,000 price tag for Biogen’s drug, considering how quickly it could push Medicare into insolvency if Aduhelm is used widely.
A proposed decision from CMS is due in 6 months, with a final one coming 3 months later, and CMS says it will review the clinical evidence such as published clinical studies (of which there aren’t any for Aduhelm), professional society guidelines, and public comments (a pair of 2-hour listening sessions are slated for later this month) to make its determination.
CMS is soliciting public comments that include scientific evidence and that address the following questions regarding the treatment of individuals with Alzheimer’s disease with monoclonal antibodies directed against amyloid:
- Which health outcomes are important, and what degree of improvement in them is meaningful for patients receiving treatment?
- What characteristics of patients with Alzheimer’s disease are important to optimizing the likelihood of positive health outcomes from treatment?
- What issues of equity and inclusion must be accounted for in the diagnosis and treatment of Alzheimer’s disease?
- What health care providers should be included as part of the patient’s treatment team? Should medical specialists be included in the care team of patients receiving treatment? If so, which specialists should be included in the care?
- In what setting(s) should treatment and care be given?
CMS said it has already initiated its own discussions with not only Biogen, but the Alzheimer’s Association — which has raised concerns about the 9-year timeline for Biogen’s confirmatory trial — Duke University’s Margolis Center for Health Policy, and Johns Hopkins University.
But such national determinations to limit coverage for FDA-approved drugs are rare. And even when the process begins, they often don’t end up leading to limits. For instance, with CAR-T cell therapies, CMS debated whether to restrict coverage to only when it is offered in a CMS-approved registry or clinical study, but eventually decided against such a limit. CMS came to a similar conclusion to not limit national coverage for Dendreon’s cancer treatment Provenge, which ended up being a commercial dud.
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