Medicare will limit coverage of expensive Alzheimer’s drug

By Ricardo Alonso-Zaldivar | Related press

WASHINGTON – Medicare on Tuesday said it will limit coverage on a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s battle for the disease. The fair value of new drugs offers tantalizing possibilities but comes at a prohibitive price.

The initial decision from the Centers for Medicare and Medicaid Services means that in order to be paid by Medicare, patients taking Biogen’s Aduhelm will have to participate in clinical trials to evaluate the drug’s effectiveness in slowing progression. development of early-stage dementia as well as drug safety. . Medicare’s nationwide coverage decision will become final by April 11, after a period of public comment and further review by the agency.

“Alzheimer’s disease is a devastating disease that has impacted the lives of millions of American families,” Medicare administrator Chiquita Brooks-LaSure said in a statement. “CMS has been and remains committed to providing the American public with a clear, reliable, evidence-based decision that is made only after thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

The requirement for clinical studies applies to the entire drug class of which Aduhelm is the pioneer, a monoclonal antibody active against amyloid, a plaque-forming protein characteristic of Alzheimer’s disease.

Biogen strongly disagrees with the Medicare decision. The company said in a statement that the decision “needs to negate the daily burden of people living with Alzheimer’s disease.” Randomized clinical trials “will rule out almost all patients who might benefit.” The company says clinical trials can take months to years to set up, and “hundreds of Alzheimer’s patients… are progressing each day from mild to moderate stages of disease where treatment can be discontinued. is another option.”

Biogen’s initial launch price of $56,000 a year for Aduhelm resulted in a nearly $22 increase in Medicare “Part B” monthly premiums for outpatient care, the largest since ​to date in dollars but not as a percentage. Medicare attributes about half of this year’s increase to contingency planning for Aduhelm. Facing skepticism about its drug, Biogen recently slashed the price to $28,200, but Medicare enrollees are ready for a $170.10 premium. Health and Human Services Secretary Xavier Becerra directed Medicare to reassess the premium increase.

Medicare officials emphasized Tuesday that they do not include cost in coverage decisions, but rather whether Aduhelm is “reasonable and necessary” to treat Alzheimer’s patients enrolled in the plan. “While there may be potential promise with this treatment, there is also the potential for harm,” said Dr. Lee Fleisher, medical director of Medicare. “This harm can range from headaches, dizziness and falls, to other potentially serious complications like bleeding in the brain.” Clinical trials will try to determine the balance between risks and benefits, he said.

Officials said Medicare payment rates will be determined through a different process. The plan will pay for drugs and other services to patients in agency-approved trials.

However, Aduhelm’s high price tag and the fact that most of the 6 million Americans with Alzheimer’s disease are old enough to be covered by Medicare have stretched the limit.

“Biogen hits the market at an attractive price point,” said Tricia Neuman, a Medicare specialist at the nonpartisan Kaiser Family Foundation. “Even after they cut their drug price in half, it’s still over $28,000, not insignificant. At that price, it’s clearly a problem for the Medicare plan, premiums, and out-of-pocket costs. ”

Aduhelm has been controversial since it was approved by the Food and Drug Administration last June, which goes against the recommendation of the agency’s external advisers.

The drug, given intravenously in a doctor’s office, has not been shown to reverse or significantly slow Alzheimer’s disease. But the FDA says its ability to reduce plaque in the brain has the potential to slow dementia.

Many experts say that there is little evidence to support that claim. And a federal watchdog and congressional investigators are conducting separate investigations into how the FDA looks at the drug. Of particular concern were several undocumented meetings between FDA reviewers and company executives during the drug approval process.

Biogen has defended its drugs and prices. But when it announced the price cut a few days before the Christmas holidays, the company admitted that cost had become an obstacle.

CEO Michel Vounatsos said: “Too many patients are not offered the Aduhelm option due to financial considerations and are therefore progressing beyond the benefit of the first treatment to address their underlying medical condition. Alzheimer. “We recognize that this challenge must be addressed in a way that is considered sustainable for the U.S. health care system.”

Some insurance companies have balked at covering the drug, while several health centers across the country have been slow to decide on its use or say they don’t plan to prescribe it right now.

Biogen’s Vounatsos said this week that the company now has about 220 sites treating patients with Aduhelm. In October, the company said a total of 120 sites had infused at least one patient.

Biogen said in June, shortly after FDA approval, about 900 facilities in the US had the equipment and expertise to start administering the drug immediately, which would require monthly infusions.

The FDA has said Aduhelm is suitable for patients with mild symptoms or early-stage Alzheimer’s disease. But that agency asked Biogen to do more research.

Because the drug is administered in a doctor’s office, Medicare pays for the drug under the Part B outpatient benefit, which is partially funded by subscription premiums.

https://www.ocregister.com/2022/01/11/medicare-will-limit-coverage-of-pricey-alzheimers-drug/ Medicare will limit coverage of expensive Alzheimer’s drug

Huynh Nguyen

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