Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

The Centers for Medicare and Medicaid Services has taken action to limit prescribing and use of the new and controversial Biogen Alzheimer’s disease treatment Aduhelm (aducanumab).

In a highly unusual decision about a treatment approved by the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS) has taken action to limit prescribing and use of the new and controversial Biogen Alzheimer’s treatment Aduhelm (aducanumab). Defining CMS National Coverage (NCD) has done this by applying the requirement for coverage with evidence development (CED) to medication, using a process that has been directed primarily in recent years to a limited number of approved medical products, particularly medical devices and diagnostics. If the proposal is finalized, only patients able to enroll in post-approval trials will have access to the drug.

The goal of the NCD process is to gather more evidence to demonstrate the drug’s ability to improve the health of patients with mild cognitive impairment due to Alzheimer’s disease. CMS’s policy will allow access to the drug only to individuals who are able to enroll in a clinical trial, most of which occur at academic research institutes that CMS will identify and list on its website. Under the accelerated approval granted to Aduhelm by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in June 2021, Biogen is required to conduct at least one Phase IV trial to demonstrate that the drug’s ability to reduce amyloid in the brain has a broader benefit for patients’ cognitive ability, And that the serious side effects of the drug are limited. Biogen loudly objected to the CMS proposal, noting that it could take years to design and launch post-approval studies, and that such trials would only enroll a limited number of patients. CMS also notes that its CED requirements will apply to additional monoclonal antibodies targeting amyloid beta in Alzheimer’s disease.

Aduhelm entered the market last year amid growing controversy over its approval despite limited evidence of its effectiveness. The controversy turned into outrage when Biogen set the price of the new treatment at $56,000 a year. At this level, Medicare spending on the drug would have been expected to exceed any other drug even if a small portion of the roughly 6 million Alzheimer’s disease patients in the United States would seek treatment. In December 2021, after a year of poor absorption of the drug, Biogen halved its asking price to $28,200 a year in an effort to boost prescribing — and avoid negative non-communicable diseases from CMS. However, even that reduced cost continued to promise huge medical care expenses. Many health centers and leading doctors said they still do not prescribe the drug due to its limited evidence of effectiveness, known side effects and continued high cost. The Institute for Clinical and Economic Review (ICER) calculates that Aduhelm would be cost-effective if it was priced between $3,000 and $8,000 a year.

When making national coverage decisions, the CMS is supposed to assess whether a medical product or process is “reasonable and necessary” and not bring cost into the equation. But the fact that so many Medicare patients are potential users of the new drug made that difficult, before Biogen slashed its price, CMS announced a massive 15% increase in premiums for Medicare Part B, which administers injections like Aduhhelm. CMS explained that about half of the premium increase is designed to protect the program from higher spending on new Alzheimer’s treatment. After Biogen’s cost cut, HHS Secretary Xavier Becerra said CMS would reassess the scope of the premium increase, although the Medicare Trust’s uncertain financial position could prevent any significant rate adjustment.

CMS maintains that its CED decision stems from a comprehensive review over the past six months of all relevant published evidence and feedback from stakeholders. The agency chose the CED process to get more evidence about whether this new treatment provides any improvement or mitigation from the effects of Alzheimer’s disease. CMS will accept further public comment on this proposal for 30 days and announce a final coverage decision by April 11, 2022. Alzheimer’s disease groups have loudly advocated for Medicare coverage for Aduhelm as the only available treatment for the widespread debilitating condition.

It will be interesting to see how CMS’ proposal affects other biopharmaceutical companies testing their Alzheimer’s treatments. Eli Lilly is running clinical trials directly comparing donanimab with Aduhelm, while Isai and Roche are pressing ahead with additional treatments. These and other sponsors will now have to calculate the impact of bringing new drugs to market that will be subject to CED requirements.

Meanwhile, the scientific and medical community continues to criticize Aduhelm’s approval. The European Medicines Agency (EMA) recently recommended against approving the drug, and objections have been raised in Canada to the pending review. CMS has gone through with its process to significantly reduce Aduhelm’s prescribing and expense on the drug, but the debate is far from over.

About the author

Jill Wechsler pharmaceutical technology Washington editor.

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