Medicare Examines Whether To Cover Pricey Alzheimer’s Drug Aduhelm
The Centers for Medicare and Medicaid Services doesn't expect to make a final decision on the $56,000-a-year drug until next year. And some Democratic lawmakers want to review the FDA's controversial approval process for the treatment.
AP:
Medicare Evaluating Coverage For $56,000 Alzheimer's Drug
Medicare on Monday launched a formal process to decide whether to cover Aduhelm, the new Alzheimer’s drug whose $56,000-a-year price tag and unproven benefits have prompted widespread criticism and a congressional investigation. A final decision isn’t likely until next spring, said the Centers for Medicare and Medicaid Services, or CMS, although an initial ruling could come in six months. Currently Medicare is making case-by-case determinations on whether to cover the medication, which is administered intravenously in a doctor’s office. (Alonso-Zaldivar and Perrone, 7/12)
Stat:
Medicare Starts Process That Could Limit Access To New Alzheimer’s Drug
The process, called a National Coverage Determination analysis, ensures that coverage for the drug is uniform across the country instead of leaving decisions to regional contractors. The tool is rarely used for drugs, and Medicare announced its decision to use it much more quickly than is typical — in just 12 days after receiving a formal request instead of the previous record of 36 days, according to Washington Analysis. Notably, if Medicare were going to pay for any Alzheimer’s patient’s treatment with Aduhelm, it likely would not need to use the tool. But its decision has enormous consequences since most of the patient population for the $56,000 therapy is covered by the federal health care program. (Cohrs and Silverman, 7/12)
The Wall Street Journal:
Medicare To Review Coverage For New Alzheimer’s Drug Aduhelm
There are a range of possibilities for what a national coverage decision could look like, including unrestricted coverage, non-coverage, or deferring to Medicare contractors, CMS said. The FDA’s approval of Aduhelm has drawn criticism from some doctors and health economists who contend the drug’s benefit is unproven and its estimated annual $56,000 per patient cost could add billions of dollars in government spending. (Walker, 7/12)
Stat:
Democrats Demand Docs About Biogen, FDA Coordination On Aduhelm
Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and pricing of its controversial new Alzheimer’s drug. The letter is the latest move in a congressional investigation into Aduhelm’s approval and pricing spearheaded by House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.). The request prominently references a STAT investigation that revealed Biogen had an off-the-books meeting with a prominent FDA regulator ahead of the drug’s unprecedented approval, and that the back-channel relationship between the two started earlier and was far more extensive than disclosed. (Cohrs, 7/12)
