It is expected to limit 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 to treat Alzheimer’s disease — that the Food and Drug Administration may approve in the future.
The agency’s proposed policy to restrict reporting on Aduhelm was complied with with strong opposition from some patient groups and drug manufacturers. Congressmen from both parties also questioned CMS’ proposal to limit coverage of Aduhelm and similar drugs in the future.
The final policy allows a broader range of patients enrolled in trials to receive Medicare coverage for future treatments, which, unlike Aduhelm, receive traditional FDA approval. More than 6 million older Americans are believed to have Alzheimer’s disease, although Aduhelm has only been approved to treat patients with milder stages of the disease.
Biogen, the manufacturer of Aduhelm, called CMS’s decision unprecedented and said it effectively denies all Medicare members access to the drug and may limit coverage for future approved treatments.
“As additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid beta targeting therapies,” the company said in a statement, noting that it is making its checks 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 FDA’s approval path, thereby undermining FDA’s peer-reviewed scientific assessment,” she said.
More than 10,000 comments
The agency made this decision based on evidence and a thorough analysis of public feedback, CMS Administrator Chiquita Brooks-LaSure said in a statement. More than 10,000 comments on the proposed policy were submitted.
“CMS has a responsibility to ensure that people on Medicare have equitable and equitable access to therapies that are appropriate and necessary for use in the Medicare population,” she said. “Through this decision, we are creating a path for people on Medicare to quickly access drugs that the FDA determines have shown clinical benefit and encourage manufacturers and investigators to ensure that clinical trials recruit participants from different races.” .”
The agency weighed the potential for patient benefits against the importance of serious unknown factors that could lead to harm, said Dr. CMS Chief Medical Officer Lee Fleisher in a statement.
“This treatment shows promise; however, there is currently insufficient evidence demonstrating improved health outcomes to say that it is appropriate and necessary for people on Medicare, which is an important consideration for CMS when determining national coverage. ‘ Fleischer said.
Medicare has never before required participants to participate in a clinical trial for an already FDA-approved drug used for its intended purpose.
were patient advocates quick to denounce Medicare’s final policy.
“It is unscrupulous and reprehensible that CMS would force Alzheimer’s patients to play by different rules than patients with other diseases such as cancer and HIV,” George Vradenburg, co-founder of UsAgainstAlzheimer, said in a statement.
Global Alzheimer’s Platform Foundation President John Dwyer likened the final decision to a “blanket denial of coverage” and said it will limit access.
“This decision will impact the future of Alzheimer’s treatments for at least the next 10 years and will be a devastating blow to the more than 6 million Americans with Alzheimer’s who have depended on CMS to approve coverage for these treatment options,” he said into a statement.
Controversial from the start
The FDA’s approval of Aduhelm last June raised many questions and concerns about the procedure, the drug’s effectiveness and its annual cost. Biogen initially put the price at around $56,000 per year.
The approval was also a driving force behind a massive increase in Medicare Part B premiums for 2022. The standard monthly payment rose to $170.10 for the more than 63 million insured members from $148.50 last year .
About $10 of the premium increase can be attributed to Aduhelm, a CMS official told CNN in November. The remainder comes from a general increase in healthcare pricing and utilization, as well as congressional actions that limited the rise in 2021 Part B premiums amid the coronavirus pandemic.
Though Medicare hadn’t decided at the time whether it would cover the drugs, its actuaries needed to make sure the program would be adequately funded in the event.
Biogen later cut the drug’s price by about half to $28,200 a year. That prompted Health Secretary Xavier Becerra to take the unusual step of ordering the agency to reevaluate a significant increase in Medicare Part B premiums, which it continues to do. Aside from the implications for Medicare, the drug’s approval process has spurred scrutiny from several congressional committees and the FDA’s inspector general.
It’s unclear how many patients will eventually receive the drug. About a month after Aduhelm’s initial approval, the FDA restricted the group of patients who could receive it to those with mild cognitive impairment or milder disease states. It’s also unknown how many doctors will prescribe it based on questions about its results.