May 11 (Reuters) – Widespread adoption of the Alzheimer’s drug Rekumbi could cost U.S. Medicare plans $20 a year in the future, according to a study led by researchers at the University of California, Los Angeles (UCLA). It has been revealed that it could increase from $100 million to $5 billion.
Rekenbi, sold by partners Eisai (4523.T) and Biogen (BIIB.O) at an annual list price of $26,500, was approved this year under the U.S. Food and Drug Administration’s accelerated pathway. Subsequent study results showed a 27% slower rate of cognitive decline compared to placebo in patients with early-stage disease.
The Centers for Medicare and Medicaid Services (CMS), the agency that administers health insurance for people 65 and older, currently only covers the drug for patients enrolled in clinical trials.
The agency said the coverage would be expanded if Lekembi and similar drugs that remove a toxic protein called amyloid from the brain get standard FDA approval. The FDA plans to make a decision by July 6 whether to grant standard approval based on evidence of clinical efficacy for Lekhembi.
Most of the estimated 6 million Americans with Alzheimer’s disease have health insurance through Medicare.
UCLA researchers estimated that a lower limit of 86,000 patients receiving Rekembi would cost $2 billion per year, and approximately 216,000 eligible patients treated with the drug would cost $2 billion annually. estimated at $5.1 billion.
Eisai and Biogen estimate that Rekembi will be used to treat about 100,000 US patients in its first three years on the market.
The cost of treating these patients “could put a burden on Medicare programs and their beneficiaries, and they could face higher premiums as Medicare pays for the drugs,” said the research project manager and lead author of the paper. Julia Cave Albanas, one of the authors, said in a statement.
Rekembi is approved for patients in the early stages of brain-wasting disease. UCLA’s estimates assume that only a limited number of people will be able to access the drug due to limitations in the healthcare system and other barriers.
Anti-amyloid drugs can cause dangerous brain swelling and bleeding, requiring close monitoring of patients through neurological consultations and MRI scans, contributing to new cost estimates.
According to Medicare estimates published in the journal JAMA Internal Medicine, out-of-pocket costs for patients without additional health insurance can reach $6,600 annually, which is about the median income of Medicare beneficiaries. Equivalent to one-fifth.
UCLA researchers published a similar analysis last year for Eisai and Biogen’s early anti-amyloid drug Aduhelm, which found that if a quarter of eligible adults received the drug, Medicare’s annual costs would be estimated at $7 billion to $37 billion.
In response to these projections, Medicare announced a record 15% increase in premiums covering doctors and outpatient services in 2021. Adhelm was slashed in price, and this price increase was tapered after CMS introduced tougher coverage limits.
UCLA’s Aduhelm spending projections are based on an estimate that between 1.1 and 5.7 million Medicare beneficiaries have mild cognitive impairment or mild dementia with amyloid plaques.
Study author John Muffy, Ph.D., said the latest study “considered limitations in the capacity of the health care system, such as the difficulty of accessing primary care physicians and specialists and the difficulty of being tested and formally diagnosed with cognitive impairment. By putting it in, we’ve taken the previous method one step further.” A PET scan is then obtained to assess for amyloid plaques. ”
The researchers cautioned that the analysis is based on extrapolations of brain scan results and cannot explain changes in the health system’s capabilities.
(This May 11 article has been amended to change the wording of some of Dr. Mafi’s quotes in paragraph 15)
Reporting by Deena Beasley Editing by Bill Berkrot
Our criteria: Thomson Reuters Trust Principles.
