The prescription and insurance coverage of the Alzheimer’s disease drug Aduhelm is progressing slowly, and the drug maker Biogen is Cut the price of treatment in half Work hard to promote sales. The price reduction is due to the Medicare and Medicaid Services Center’s decision on the coverage of drugs in 2022.
When Aduhelm received accelerated approval in June, and Biogen sets a wholesale price of approximately US$56,000 per year. The dosage of the drug is determined by the weight of the patient. For an average weight of 74 kilograms (approximately 163 pounds), Aduhelm’s new wholesale price will be $28,200. The price change will take effect on January 1.
Aduhelm is an antibody designed to remove amyloid plaques in the brain.drug Approval covers its use in patients with mild Alzheimer’s disease or mild dementia——Before the disease progresses. Of the approximately 5.8 million Americans with Alzheimer’s disease, an estimated 1 to 2 million people have mild cognitive impairment or mild dementia, and are eligible for treatment with Biogen drugs. But sales have been slow. The financial report shows that Sales in the third quarter Of drugs totaled only US$300,000 in the third quarter.
Biogen is controversial because of Aduhelm’s price tag.The Institute for Clinical and Economic Review (ICER), the drug pricing regulator, stated in a report August report There is not enough evidence to prove the benefits of Aduhelm, and it recommends lowering the price to avoid the financial burden of drugs on Medicare and Medicaid service centers and patient budgets. Taking into account the uncertainty of the benefits of the drug, ICER’s proposed annual price is between US$3,000 and US$8,000.
The new price of Aduhelm in the US is still much higher than ICER’s preferred cost. But Biogen sees price cuts as a way to improve its access to new drugs. Biogen said that with insurance coverage and diagnostic and professional centers that can use the therapy, it is estimated that 50,000 patients may begin treatment with Aduhelm by 2022. In Monday’s announcement, Biogen CEO Michel Vounatsos stated that Aduhelm did not provide treatment for too many patients due to appropriate economic considerations, and that the disease progression of these patients exceeded the extent to which they could benefit from the treatment. He added that the challenge of giving patients access to new medicines “must be addressed in a way that is considered sustainable for the U.S. healthcare system.”
CMS is currently evaluate The coverage of Aduhelm. The agency’s proposed decision memorandum will expire on January 12; the final decision is expected to be made in three months. But Biogen’s price cut comes after CMS has included the cost of the drug in next year’s premiums. Aduhelm is part of Medicare B and covers doctor services, outpatient services, durable equipment, and prescription drugs. According to the law, Medicare premiums must cover 25% of the estimated cost of Part B for participants 65 years and older.
last month, CMS says the minimum premium will rise 14.5% next year, The agency attributed in part to rising prescription drug costs, especially citing Uncertainty of Aduhelm coverage. CMS needs to set aside an emergency reserve fund to cover increased expenditures, including medication costs.
Clinical evidence of the benefits of Aduhelm is in preparation, but will not be provided soon. last week, Biogen revealed its post-marketing clinical trial plan, which is a requirement for accelerated approval of the drug. This global study is expected to take approximately four years. But the uncertainty surrounding the drug has put pressure on its prospects in other markets.Last week, the European Medicines Agency Suggest rejection Biogen’s marketing authorization application is based on the lack of a link between amyloid reduction and patient improvement, as well as the safety risks caused by brain swelling and bleeding. Biogen said it would appeal the agency’s opinions.
At the same time, Biogen is preparing to cut costs for the entire company. The company said that due to the entry of multiple sclerosis generic drugs into the market, this will erode the current sales of the company’s best-selling MS drug, as well as the slow market absorption of Aduhelm, so these measures need to be taken. Biogen estimates that these measures will save approximately US$500 million each year. The company said that details are being finalized and will be disclosed in the first quarter of 2022.
Photo: Ivelin Radkov, Getty Images
