Center for Medicare and Medicaid Services Plan review Biogen’s new Alzheimer’s disease drug and decide whether to cover it. However, the benefits of this expensive drug are still uncertain.
On Monday, CMS opened a national coverage determination analysis for Biogen’s Aduhelm, which is the agency’s process of determining coverage for medical insurance, which is the first new treatment for Alzheimer’s disease in decades .drug Obtained FDA approval Through the accelerated path in early June.
The drug is only used for Mild patients A neurodegenerative disease, which targets amyloid plaques on the patient’s brain. But the specific role of amyloid in Alzheimer’s disease is still unclear, so it is unclear whether removing this protein accumulation will improve the disease outcome.Confirmatory clinical trials of this drug may require Another eight years To finish.
Despite the lack of proven benefits, the wholesale price of the drug is US$56,000.
CMS usually makes underwriting decisions without considering the cost, but Aduhelm’s high price tag may significantly push up medical insurance expenditures, according to Caesars Family Foundation report.
The report shows that if in 2017, among the nearly 2 million medical insurance beneficiaries covered by CMS that can treat Alzheimer’s disease, even if a quarter of them are prescribed Aduhelm, the total amount of this new drug in only one year The expenditure will be close to 29 billion U.S. dollars. In comparison, the total medical insurance expenditure for all Part B drugs in 2019 was US$37 billion.
CMS administrator Chiquita Brooks-LaSure said in the press release: “We want to consider the coverage of new treatments by medical insurance very carefully based on existing evidence.” “That’s why our process will include listening to many stakeholders, including Patient rights groups, medical experts, states, issuers, industry professionals, and family members and caregivers of people with this disease.”
After CMS completes the national coverage determination analysis (including the review of scientific evidence and public opinions), CMS will issue the recommended determination, which will be open to the second 30-day public comment period. The agency is expected to issue the proposed decision within six months and the final decision within nine months.
The Alzheimer’s Association, a non-profit organization dedicated to accelerating global research, promoting early detection, and maximizing the quality of medical care, welcomed the news with applause.
“We welcome the National Coverage Determination (NCD) analysis announced today, consistent with the Alzheimer’s Association position, “The Association Said in a statement Publish to its website. “Non-communicable diseases will help prevent regional and community-level differences due to insurmountable barriers, especially for those who face greater challenges in accessing medical services.”
In particular, the association supports noncommunicable disease results including “evidence development coverage” to ensure that confirmation data is collected within a time frame for “decision makers, payers, healthcare providers and patients and their families Provide information for decision-making.”
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