Medicare said on Tuesday it would limit coverage of a $ 28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, an important development in the nation’s tug-of-war over the true value of new drugs that offer tempting but insurmountable opportunities prices.
The first decision from the Centers for Medicare and Medicaid Services means that in order for Medicare to pay, patients taking Biogens Aduhelm medicine must be part of clinical trials to evaluate the drug̵[ads1]7;s effectiveness in slowing the development of early dementia, as well as its safety. . Medicare’s national coverage decision will be final by April 11, following a public comment period and further evaluation by the agency.
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“Alzheimer’s disease is a devastating disease that has affected the lives of millions of American families,” Medicare administrator Chiquita Brooks-LaSure said in a statement. “CMS has been and continues to be committed to providing the American public with a clear, reliable, evidence-based decision made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
The requirement for clinical trials applies to the whole class of drugs where Aduhelm is a pioneer, monoclonal antibodies that act against amyloid, a kind of protein that forms plaque that is characteristic of Alzheimer’s disease.
Biogen strongly rejected Medicare’s decision. The company said in a statement that the decision “denies the daily burden of people living with Alzheimer’s disease.” Randomized clinical trials “will exclude almost all patients who may benefit.” The company said clinical trials could take months to years to set up and “hundreds of Alzheimer’s patients … develop daily from mild to moderate disease stages, where treatment may no longer be an option.”
The Alzheimer’s Association called it “shocking discrimination against anyone with Alzheimer’s disease,” but Vermont Independent Senator Bernie Sanders applauded the decision as “an important step forward” in curbing “outrageous” drug prices.
MEDICARE DISTRIBUTED TO EVALUATE PREMIUM INCREASE AFTER THE PRICE SHOT AT BIOGEN ALZHEIMERS Drug
Biogen’s first launch price of $ 56,000 a year for Aduhelm led to an increase of almost $ 22 in Medicare’s monthly “Part B” outpatient treatment premium, the largest ever in dollars, but not as a percentage. Medicare attributed about half of this year’s increase to contingency planning for Aduhelm. Confronted with skepticism about its drugs, Biogen recently reduced the price to $ 28,200, but Medicare registrants were already hooked on the $ 170.10 premium. Health and Human Services Secretary Xavier Becerra has asked Medicare to reconsider the premium increase.
Medicare officials stressed on Tuesday that they did not take into account the costs of the coverage decision, but rather whether Aduhelm is “reasonable and necessary” to treat Alzheimer’s patients registered in the program. “While there may be potential for promise with this treatment, there is also potential for harm,” said Dr. Lee Fleisher, Medicare’s chief medical officer. “This damage can range from headaches, dizziness and falls, to other potentially serious complications such as cerebral haemorrhage.” Clinical studies will try to determine the balance between risk and benefit, he said.
Medicare’s payment rates will be determined through another process, officials said. The program will pay for drug costs and other services for patients in agency-approved studies.
Still, the high price of Aduhelm and the fact that most of the 6 million Americans with Alzheimer’s are old enough to be covered by Medicare stretched the boundaries.
THE BIOGHY HALF THE PRICE OF ALZHEIMER’S Drug ADUHELM
“Biogen came on the market with an eye-catching price tag,” said Tricia Neuman, a Medicare expert at the Kaiser Family Foundation. “Even after they halved the price of the drug, it is still more than $ 28,000, which is not insignificant. At that price, there is clearly a problem with the Medicare program, premiums and deductibles.”
Aduhelm has sparked controversy since it was approved by the Food and Drug Administration in June last year, which went against the recommendation of the agency’s external advisers.
The drug, administered by IV at a doctor’s office, has not been shown to significantly reverse or reduce Alzheimer’s. But the FDA said its ability to reduce lumps of plaque in the brain is likely to slow dementia.
Many experts say there is little evidence to support that claim. And a federal watchdog and congressional investigators are conducting separate investigations into how the FDA evaluated the drug. Of particular concern are several undocumented meetings between FDA reviewers and business executives prior to drug approval.
Biogen has defended its medication and pricing. But in announcing the price cut in the days before the Christmas holidays, the company acknowledged that costs had become a stumbling block.
SAMSUNG BIOLOGICS SAYS REPORT ON BIOGEN AGREEMENTS FALSE
“Too many patients are not offered the choice of Aduhelm due to financial considerations, and they therefore go beyond the point of taking advantage of the first treatment to address an underlying pathology of Alzheimer’s disease,” said CEO Michel Vounatsos at the time. “We recognize that this challenge must be addressed in a way that is perceived as sustainable by the US health care system.”
Some insurance companies have stopped paying for the drug, while several medical centers across the country have either been reluctant to decide to use it or said they do not plan to prescribe it yet.
Biogens Vounatsos said this week that the company now has around 220 websites that treat patients with Aduhelm. In October, the company said that a total of 120 sites had infused at least one patient.
Biogen said in June, shortly after FDA approval, that around 900 locations in the United States have the equipment and expertise to immediately begin administering the drug, which requires a monthly infusion.
The FDA has said that Aduhelm is suitable for patients with mild symptoms or early stage of Alzheimer’s. But that agency has asked Biogen for more research.
Because the drug is administered in a physician’s office, Medicare pays for it under Part B outpatient benefit, which is partially funded by enrollment premiums.
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The economic impact of high-cost medications tends to be heaviest on patients with serious illnesses such as cancer, rheumatoid arthritis or multiple sclerosis. But with Aduhelm, the pain would spread among Medicare recipients in general, not just Alzheimer’s patients who need the drug. This made the drug a case study of how expensive treatment can turn the needle on public spending and affect household budgets.
Alzheimer’s is a progressive neurological disease without a known cure. The vast majority of American patients are old enough to qualify for Medicare, which covers more than 60 million people, including those 65 and older, and the disabled under 65.