Mark McClellan, who has served both as FDA commissioner and a CMS administrator, said it appears CMS is trying to make the registry less cumbersome, but that it must provide more details. The group said it supports collecting information on how such treatments work, but not as a requirement for coverage of an FDA-approved drug.īiogen's shares were 2.6% higher, while Eli Lilly was up 1.3%.ĭuke University economist Dr. "We continue to believe that registry as a condition of coverage is an unnecessary barrier," the Alzheimer’s Association said in a statement. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. In April, Lilly said it believed Medicare would back down from its registry requirement as more evidence emerged showing that clearing amyloid brain plaques can help patients. "We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS' promise of broad coverage to all Medicare beneficiaries," a Lilly spokesman said in a statement. Lilly called on CMS to revise its decision and urged the agency to provide full Medicare coverage for FDA-approved Alzheimer's medicines, saying the move would set a precedent for all new medicines. Historically, such programs have limited access to patients in underserved communities, the company added. "Until CMS announces the registry design and details, it is difficult to understand how a registry will impact patient access to Leqembi," Eisai said in a statement. The CMS decision would apply to all Alzheimer's treatments that reduce a protein called beta amyloid from the brain, including Eli Lilly and Co's (LLY.N) donanemab, which recently reported positive results from its late-stage trial. It would require doctors to submit evidence on how the drug works in routine practice, and collect information in an "easy-to-use" portal maintained by the Centers for Medicare and Medicaid Services (CMS) upon traditional approval. The agency said the registry requirement would broaden access to the drug. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. The decision marks the first time that Medicare has required data-collection through a so-called registry for the intended use of a drug that has been deemed safe and effective by the U.S. Medicare health plan said on Thursday it would limit reimbursement for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) Alzheimer's drug Leqembi to patients whose doctors participate in a health agency database should the drug win full approval, a move advocates say will hinder its use. Compare costs for specific Part D plans.įor more information on Medicare costs, including those pertaining to home health care, hospice care, skilled nursing care, and mental health services, see “Detailed Medicare Cost information for 2023” on the Medicare.June 1 (Reuters) - The U.S. The Part D monthly premium varies by plan (higher-income consumers may pay more). Part D: (Medicare Prescription Drug Coverage) premium Medicare Part C is better known as “Medicare Advantage.” The Part C monthly premium varies by plan. After your deductible is met, you typically pay 20% of the Medicare-approved amount for most doctor services (including most doctor services while you’re a hospital inpatient), outpatient therapy, and durable medical equipment (dme). The standard Part B premium amount is $164.90 (or higher depending on your income).
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