The agency’s proposed policy to limit Aduhelm coverage was met with strong opposition from certain groups of patients and drug manufacturers. Congressional lawmakers from both parties also challenged the CMS proposal to limit coverage of Aduhelm and similar drugs in the future. The final policy allows a wider range of patients participating in studies 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 for the treatment of only those with milder stages of the disease. Biogen, the maker of Aduhelm, described the CMS decision as “unprecedented” and said it was effectively denying access to the drug to anyone on Medicare and could limit coverage for future treatments. “Once additional data becomes available from this new class of treatments, Biogen urges the CMS to reconsider its current decision on all FDA-approved amyloid-beta targeted therapies,” the company said in a statement, noting that it was considering its options. The decision sets a dangerous precedent, said Nicole Longo, a spokeswoman for PhRMA, a leading group in the pharmaceutical industry. “The CMS has further complicated matters by taking the unprecedented step of implementing different standards for drug coverage depending on the FDA approval path followed, undermining the scientific evaluation by FDA experts,” he said.
More than 10,000 comments
The agency made the decision based on the data and a thorough analysis of the public comments, CMS administrator Chiquita Brooks-LaSure said in a statement. More than 10,000 comments on the proposed policy were submitted. “The CMS has a responsibility to ensure that people with Medicare have fair and adequate access to treatments that are reasonable and necessary for use in the Medicare population,” he said. “Through this decision, we create a pathway for people with Medicare to have quick access to drugs that the FDA deems to have shown clinical benefit and encourages manufacturers and test administrators to ensure that clinical trials employ racially diverse participants.” The agency weighed the potential for benefits for patients in relation to the importance of serious unknown factors that could cause harm, Dr Lee Fleischer, chief medical officer of the CMS, said in a statement. “It is possible to promise this treatment; however, there is currently not enough evidence to suggest improved health outcomes to say that it makes sense and is necessary for people with Medicare, which is a key element of the CMS in determining of national coverage. said Fleischer. Medicare has never before required registrants to take part in a clinical trial for a drug that has already been approved by the FDA and is being used for its intended purpose. Patient advocates rushed to disapprove of Medicare’s final policy. “It is unconscious and reprehensible that the CMS would force Alzheimer’s patients to play by a different set of rules than patients with other diseases such as cancer and HIV,” said UsAgainstAlzheimer co-founder George Vradenburg. The president of the Alzheimer’s Global Platform Foundation, John Dyer, likened the final decision to a “flat denial of coverage”, saying it would restrict access. “This decision will affect the future of Alzheimer’s treatment for at least the next 10 years, representing an overwhelming blow to the more than 6 million CMS-dependent Alzheimer’s Americans approving label coverage for these treatment options.” He said in a statement.
Controversial from the beginning
Aduhelm approval by the FDA last June raised many questions and concerns about the process, the effectiveness of the drug and its annual cost. Biogen initially priced it at about $ 56,000 a year. The approval was also the driving force behind a huge increase in Medicare Part B premiums for 2022. The standard monthly payment jumped to $ 170.10, from $ 148.50 last year, for the more than 63 million registered. About $ 10 million of the premium increase is due to Aduhelm, a CMS official told CNN in November. The rest comes from a general increase in prices and the use of health care, as well as from the action of the Congress that limited the increase of the premiums of Part B for 2021 in the midst of the coronavirus pandemic. Although Medicare had not yet decided at this time whether it would cover the drug, its actuaries had to make sure the program had adequate funding if it did. Biogen later reduced the price of the drug by about half to $ 28,200 a year. This prompted Health and Human Services Minister Xavier Becerra to take the unusual step of ordering the agency to re-evaluate a significant increase in Medicare Part B premiums, which it continues to do. In addition to the impact on Medicare, the drug approval process has prompted investigations by several congressional committees and the FDA inspector general. It is not clear how many patients will eventually receive the drug. About a month after Aduhelm was first approved, the FDA reduced the number of patients who could receive it to people with mild cognitive impairment or milder disease. It is also unknown how many doctors will prescribe it due to questions about its effects.
