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WASHINGTON (AP) — Medicare said Thursday it is considering a reduction in enrollment premiums, after officials blocked an earlier decision to severely limit coverage for an expensive new Alzheimer’s drug that is expected to make increase program costs.
The agency is “reviewing this and still following the process,” spokeswoman Beth Lynk said of a potential premium reduction, as Medicare announced its final coverage decision for Aduhelm, a drug whose benefits have been widely questioned in the medical community. .
Officials said Medicare would maintain earlier drug coverage restrictions of $28,000 per year, paying Aduhelm only when used in clinical trials approved by the Food and Drug Administration or the National Institutes of Health. .
The expected cost of Aduhelm was a major driver behind the $22 increase in Medicare Part B premium this year to $170.10 per month. This price hike is already being paid for by more than 56 million Medicare beneficiaries enrolled in the program’s outpatient coverage. Lawmakers have called for a rollback, and Health and Human Services Secretary Xavier Becerra has already ordered Medicare to reevaluate.
Thursday’s coverage decision illustrates the impact a single drug can have on individual and taxpayer budgets. It comes as legislation allowing Medicare to negotiate prescription drug prices remains stalled in the Senate, under President Joe Biden’s stalled social and climate agenda.
That leaves Democrats with nothing to show for their midterm promises to cut prescription drug costs unless they can overcome internal disagreements. Most Medicare beneficiaries have their premiums deducted from their monthly Social Security checks. And despite a sharp rise in the cost of living, they are feeling the bite of inflation.
Medicare’s decision on Aduhelm included an important caveat. Officials said that if this drug or any other similar drug in its class were to receive what is called “traditional” FDA approval, then Medicare would open up broader coverage for patients. Such approval is granted when a drug has clear clinical benefit.
This was not the case with Aduhelm. It received what is called a “fast track” approval last year due to its potential promise. But the manufacturer Biogen is required to conduct a follow-up study to definitively answer whether Aduhelm really slows the progression of Alzheimer’s disease. If this study is successful, the FDA would grant full approval.
It would also open up Medicare coverage.
Dr. Lee Fleisher, chief medical officer of the Centers for Medicare & Medicaid Services, said “there will be prompt access for Medicare beneficiaries” to Alzheimer’s drugs that receive traditional FDA approval. , after demonstrating a clear benefit.
Aduhelm hit the market as the first new drug for Alzheimer’s disease in nearly two decades. Initially priced at $56,000 a year, it was expected to quickly become a blockbuster drug, generating billions for Cambridge, Massachusetts-based Biogen.
But although the company cut the price in half – to $28,000 per year – Aduhelm’s rollout was disastrous.
Pushback from politicians, doctors and insurers left the company with just $3 million in Aduhelm sales last year. Doctors have been hesitant to prescribe it, given weak evidence that the drug slows the progression of Alzheimer’s disease. Insurers blocked or restricted coverage due to the drug’s high price and uncertain benefits.
The CMS decision means that in order for Medicare to pay, patients taking Aduhelm will have to be part of clinical trials to assess the drug’s safety and effectiveness in slowing the progression of early-stage dementia.
Tamara Syrek Jensen, head of CMS’s coverage and analysis unit, said “it’s the status quo” regarding the limitations the agency initially imposed on Aduhelm in January.
The limits remained in place despite massive lobbying by the Alzheimer’s Association to change Medicare’s stance, including outreach to members of Congress, online advertising, and social media campaigns directed against the agency. .
The association, the largest group of its kind, has received contributions from drugmakers, including Biogen.
The group’s CEO said he was “very disappointed” after reviewing Medicare’s decision.
“To deny access to FDA-approved treatments for Alzheimer’s disease is wrong,” Harry Johns said in a statement. “At no time in history has CMS imposed such drastic barriers to accessing FDA-approved treatments for people facing life-threatening illness.”
Aduhelm has generated controversy since the FDA approved it against the recommendation of outside advisers.
The drug, given intravenously in a doctor’s office, has not been shown to reverse or significantly slow Alzheimer’s disease. But the FDA said its ability to reduce plaque clumps in the brain is likely to slow dementia.
Many experts say there is little evidence to support this claim. And a federal watchdog and congressional investigators are conducting separate investigations into how the FDA reviewed the drug.
Alzheimer’s disease is a progressive neurological disease with no known cure. The vast majority of American patients are old enough to be eligible for Medicare, which covers more than 60 million people, including those ages 65 and older and people with disabilities under 65.
The reason Aduhelm falls under Medicare’s outpatient benefits, and not its pharmacy drug program, is that it’s administered in a doctor’s office. Beneficiary premiums are set to cover approximately 25% of the cost of outpatient care.
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