It is expected to restrict the number of people who can receive the drug. The coverage policy would also apply to other drugs in this class (monoclonal antibodies that target amyloid, or plaque, for the treatment of Alzheimer’s disease) that the Food and Drug Administration may approve in the future.
The policy proposed by the agency to restrict the coverage of Aduhelm was complied with with intense opposition from some patient groups and drug manufacturers. Congressional lawmakers from both parties also questioned CMS’s proposal to limit coverage of Aduhelm and similar drugs in the future.
The final policy allows a broader swath of study patients to receive Medicare coverage for future treatments that, unlike Aduhelm, receive traditional FDA approval. More than 6 million older Americans are believed to have Alzheimer’s disease, although Aduhelm has been approved to treat only those with milder stages of the disease.
Biogen, the manufacturer of Aduhelm, He called CMS’s decision unprecedented, saying it effectively denies all Medicare enrollees access to the drug and may limit coverage for approved treatments in the future.
“When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeted therapies,” the company said in a statement, noting that it is considering its options.
The decision sets a dangerous precedent, said Nicole Longo, a spokeswoman for PhRMA, a leading pharmaceutical industry group.
“CMS has further complicated matters by taking the unprecedented step of applying different standards for drug coverage depending on the FDA approval pathway taken, undermining the scientific evaluation of FDA experts,” he said.
More than 10,000 comments
The agency made this decision based on evidence and a thorough analysis of public input, Chiquita Brooks-LaSure, CMS administrator, said in a statement. More than 10,000 comments were submitted on the proposed policy.
“CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” he said. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs that the FDA determines have demonstrated clinical benefit and encourages manufacturers and trial administrators to ensure that clinical trials recruit participants racially. diverse”.
The agency weighed the potential benefits for patients against the importance of serious unknown factors that could result in harm, Dr. Lee Fleisher, CMS chief medical officer, said in a statement.
“There is potential for promise with this treatment; however, there is currently insufficient evidence demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making coverage determinations.” national, – said Fleisher.
Medicare has never before required members to participate in a clinical trial of a drug already approved by the FDA that is being used for its intended purpose.
Patient advocates were he was quick to criticize the final Medicare policy.
“It is inconceivable and reprehensible that CMS would force Alzheimer’s patients to follow a different set of rules than patients with other diseases such as cancer and HIV,” UsAgainstAlzheimer co-founder George Vradenburg said in a statement.
Global Alzheimer’s Platform Foundation President John Dwyer likened the final decision to an “outright denial of coverage,” saying it will restrict access.
“This decision will affect the future of Alzheimer’s treatments for at least the next 10 years, dealing a severe blow to the more than 6 million Americans with Alzheimer’s who relied on CMS to approve coverage to label these treatment options. treatment,” he said in a statement.
controversial from the start
The approval of Aduhelm by the FDA last June raised many questions and concerns about the process, the drug’s effectiveness and its annual cost. Biogen initially priced it at around $56,000 a year.
About $10 of the premium increase is due to Aduhelm, a CMS official told CNN in November. The rest comes from a general increase in health care prices and usage, as well as action by Congress that capped Part B premium growth for 2021 amid the coronavirus pandemic.
Although Medicare had not yet decided at the time whether it would cover the drug, its actuaries had to make sure the program was adequately funded in the event it did.
It’s unclear how many patients will ultimately receive the drug. About a month after initially approving Aduhelm, the FDA narrowed the group of patients who could receive it to those with mild cognitive impairment or milder states of the disease. Also, it is unknown how many doctors will prescribe it due to doubts about its results.