InESHINGTON – On Thursday, Medicare finalized its plan to limit the coverage of the controversial, expensive Alzheimer’s drug Aduhelm for patients in clinical trials.
This decision marks the end of an intense campaign of pressure from drug manufacturers and some groups of patients who wanted Medicare to cancel its original offer and pay for the drug for more patients. Because clinical trials usually end in major medical centers, this decision is likely to mean that some interested patients will not be able to access the drug. However, Medicare does not explicitly require patients to be treated in hospital clinics as an initial proposition.
The decision has implications not only for the manufacturer Aduhelm, Biogen as well. The decision to cover does not apply to Aduhelm and applies to all medications in the class, including future treatments that Eli Lilly began submitting to FDA approval.
But in a major change from the original proposal, Medicare officials have created a kind of label for drugs that, unlike Aduhelm, demonstrate clinical benefits to patients before they are approved. Medicare will cover these medications for a wider group of patients.
They’ll still need to gather some data, but the possible research design is much more flexible – a significant win for Lily.
“This long-term path must be agile and responsive to any new drugs in this class that are under development and demonstrate clinical benefits,” Lee Fleischer, Medicare’s chief physician, told reporters.
Ever since the Food and Drug Administration approved Aduhelm last summer, doctors and scientists have raised questions about whether it actually works, state overseers have begun investigating whether the FDA has followed proper procedures to approve it, and experts in policy areas question whether it is effective enough to justify. its a great price tag.
Medicare representatives even increased premiums for the entire program to anticipate the potential flow of patients taking expensive medications. But the new restrictions mean the drug will put less financial burden on the Medicare program. Health Minister Xavier Besera said he plans to decide soon whether to reduce Medicare premiums for the elderly following Medicare’s decision to cover for Aduelma.
Aduhelm’s limited coverage policy is unprecedented because Medicare almost always covers medications when the FDA approves them. Aduhelm was different because the agency approved treatment without a guarantee that patients would indeed see a slower decline in cognitive ability. The process that led to the drug’s approval is the subject of numerous investigations following a STAT report that Biogen has extensive feedback from the FDA.
The decision to cover Aduhelm underscores the fierce power struggle between Medicare and the FDA over Americans ’access to Aduhelm, but Medicare officials have indeed given the FDA a serious concession. The design and setup of clinical trials requested by Medicare will be overseen by the FDA or the National Institutes of Health, not Medicare itself.
Medicare will also limit those who can get the drug, people who have mild forms of cognitive impairment or mild dementia, and who have amyloid plaques, proteins on which Aduhelm is developed in their brain. The patient population is narrower than that approved by the FDA for treatment because the FDA did not require proof of the presence of amyloid plaques. Unlike the original proposal, Medicare also decided to allow patients with other diseases, such as Down syndrome, to participate in trials.
The narrow coverage policy is a major blow to Biogen, which hoped Medicare patient access to the market could boost meager drug sales.
The controversial tool that Medicare used to cover Aduhelm is called “Evidence-Based Coverage”. It is possible that Biogen or other drugmakers may sue Medicare for the decision, arguing that Medicare has no legal authority to require further research to prove that companies’ drugs benefit patients, said Sean Tunis, director of Rubix Health, who helped develop the CED process. during his time at the Medicare Centers and Medicaid Services.
“In a sense, the CED process has never been challenged before, because it has not benefited anyone,” Tunisia said. Typically, CED tools have been used to regulate the coverage of new indications of drugs or devices that would not otherwise be covered.
“Biogen is carefully considering its options and will provide updates as we further assess the impact of this decision on business,” the company said in a written statement.
Although many Americans with Alzheimer’s are also Medicare beneficiaries, this decision could have even broader implications, as most major insurers follow the example of the federal government when it comes to setting their own drug coverage policies.