According to reports, Medicare will limit its coverage for an Alzheimer’s drug that costs $28,000 a year and whose benefits have been widely questioned.
This is a major step forward in the nation’s tug-of-war over new medicines with tantalizing potential and yet comes at high prices, Foxnews reported.
Centers for Medicare and Medicaid Services determined initially that Medicare would have to pay for patients taking the Aduhelm medication if they participated in clinical trials evaluating its effectiveness and safety in slowing early-stage dementia.
“Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families,” Medicare administrator Chiquita Brooks-LaSure stated
“CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
After a public comment period and further evaluation by Medicare, the national coverage determination would be finalized by April 11.
The requirement for clinical studies applies to the entire class of drugs of which Aduhelm is a pioneer, monoclonal antibodies that work against amyloid, a kind of protein that forms plaques characteristic of Alzheimer’s disease.
Medicare’s decision has been strongly disapproved by Biogen.
In a statement, the company said the decision “denies the daily burden of people living with Alzheimer’s disease.”
Clinical trials conducted on a random basis “will exclude almost all patients who may benefit.”
It is estimated that clinical trials can take from months to years to set up, and that “hundreds of Alzheimer’s patients…are progressing each day from mild to moderate disease stages, where treatment may no longer be an option.”
According to the Alzheimer’s Association, the decision was ” shocking discrimination against everyone with Alzheimer’s disease.”
However, Vermont Independent Sen. Bernie Sanders hailed the decision as “an important step forward” in efforts to curb “outrageous” drug costs.
Medicare’s monthly Part B premium for outpatient care increased by nearly $22 as a result of Biogen’s initial launch price of $56,000 a year; the highest ever in percentage terms but not in dollar terms.
In this year’s Medicare increase, about half is attributed to contingency planning for Aduhelm.
Biogen recently cut the drug’s price to $28,200 amid skepticism, but Medicare enrollees had already been charged a $170.10 premium.
Going forward, Medicare will reevaluate the increase in premiums after Xavier Becerra, the Secretary of Health and Human Services, ordered it.
Aduhelm is considered “reasonable and necessary” for treating Alzheimer’s patients enrolled in the program, according to Medicare officials. The decision was not based on cost, they said.
“While there may be the potential for promise with this treatment, there is also the potential for harm,” Dr. Lee Fleisher, Medicare’s chief medical officer, stated.
“This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds.” He stressed that clinical trials will be conducted to determine the risk/benefit ratio.
Medicare’s payment rates will be determined through a different process, the officials said.
The program will pay drug costs and other services for patients in agency-approved trials.
Regardless, Aduhelm’s high price and about 6 million Americans with Alzheimer’s old enough to qualify for Medicare slowed down the limits.
“Biogen came to market with an eye-popping price tag,” said Tricia Neuman, a Medicare expert said.
“Even after they slashed their drug’s price in half, it is still more than $28,000, which is not insignificant. At that price, it is clearly an issue for the Medicare program, premiums, and out-of-pocket costs.”
As of last June, Aduhelm had sparked controversy after it was approved by the Food and Drug Administration, against the recommendations of its outside advisers.
The Alzheimer’s treatment, administered by IV in an office setting, hasn’t shown to reverse or significantly slow the disease.
Its ability to reduce plaque clumps in the brain may lead to a slower progression of dementia disease, according to the FDA.
Nonetheless, many experts disagree with that statement.
Additionally, a congressional investigator and a federal watchdog are conducting separate probes into how FDA approved the medication.
FDA reviewers and company executives met a number of times before the drug was approved, but none of these meetings were recorded.
Meanwhile, the company defended its pricing and medication.
Although the price cut was announced despite this, the company acknowledged that costs had become a problem.
“Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer’s disease,” CEO Michel Vounatsos explained.
“We recognize that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system.”
Several insurance companies have refused to pay for the drug, and several medical centers have said they don’t plan to prescribe it for now or are slow to make a decision.
About 900 clinical sites in the U.S. have the equipment and expertise to begin administering the drug immediately after FDA approval, Biogen previously noted in June.
Biogen’s Vounatsos recently announced that the company now treats patients with Aduhelm at around 220 sites.
The company reported in October that at least one patient had been infused at 120 sites.
The FDA has approved Aduhelm for the treatment of mild symptoms or early stages of Alzheimer’s disease.
This agency, however, has requested additional research from Biogen.
Part B of Medicare pays for this drug because it is administered in a doctor’s office. Part B is partially funded by enrollee premiums.
Patients who suffer from serious diseases such as cancer, rheumatoid arthritis, or multiple sclerosis are typically the ones facing the biggest financial burden from high-cost drugs.
But, Aduhelm would have a widespread impact on Medicare recipients in general, not just Alzheimer’s patients who need the drug.
As a result, it became a case study for how one expensive drug can affect government spending and household budgets.
There is no known cure for Alzheimer’s disease.
In the United States, most patients are old enough to qualify for Medicare, which covers more than 60 million individuals, including older adults and disabled individuals under 65.