Lawmakers worry Medicare Alzheimer’s plan won’t ensure access to new treatments

Lawmakers worry Medicare Alzheimer’s plan won’t ensure access to new treatments


Rep. Nanette Barragan (D-CA) speaks alongside US Department of Transportation Secretary Pete Buttigieg after a tour of the Ports of Los Angeles and Long Beach during a press conference at the Port of Long Beach on January 11, 2022 in Long Beach, California.

Patrick T. Fallon | AFP | Getty Images

Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer’s treatments for seniors.

Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work.

The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still “very unclear” how seniors will access the new treatments.

Medicare has promised to cover Alzheimer’s antibody treatments on the same day the medications receive full approval by the Food and Drug Administration.

The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can’t administer at home on their own, such as infusions.

Under this policy, seniors could receive coverage for Eisai and Biogen’s antibody-infusion treatment Leqembi as soon as this summer. The FDA is expected to make a decision on Leqembi July 6.

Leqembi slowed cognitive declined by 27% in a clinical trial, though the treatment also carries risks of brain swelling and bleeding.

But Medicare will require patients to visit a doctor who participates in a so-called registry that collects real-world data on how the drug works.

Eshoo and Barragan told Brooks-LaSure that they are worried the registry could present a barrier to care.

CNBC Health & Science

Read CNBC’s latest health coverage:

Brooks-LaSure said last week that CMS will help set up a national registry to make it easy for doctors and clinicians to enter the required data on patients who are taking the drug.

But the lawmakers said CMS has published no details about how the required registry will actually work. The agency has not said when the registry will be live, what data must be collected, and how patients can find doctors who are participating in the system, Eshoo and Barragan said.

“At minimum, Congress, doctors, and patients deserve to have the answers to the above questions immediately,” they said.

Medicare needs to clearly define how the registry will work and make sure the system is not burdensome to patients and doctors, they added.

The lawmakers called on CMS to ensure that the registry does not create disparities in access for Black, Hispanic and Native Americans as well as people living in rural areas.

What’s more, Eshoo and Barragan said Medicare should consider dropping the registry requirement altogether.

“There needs to be clarity and transparency about the standards for coverage for FDA-approved treatments for deadly diseases with unmet medical needs,” the lawmakers said. “Please do not allow CMS’s demand for additional evidence generation be a barrier to patient care.”



Source

Shares of breast cancer therapy developer Olema Pharmaceutical could more than double from here
Health

Shares of breast cancer therapy developer Olema Pharmaceutical could more than double from here

Wall Street is optimistic that Olema Pharmaceutical could be developing the next major breakthrough breast cancer treatment. Earlier this month, the company announced promising clinical data for its lead candidate palazestrant, an oral medication that is being evaluated in several trials for estrogen receptor-positive, or ER+, breast cancer. Shares of the clinical-stage biopharmaceutical company are up […]

Read More
This biotech stock has jumped nearly 50% in 3 months. Its CEO says business is ‘growing substantially’
Health

This biotech stock has jumped nearly 50% in 3 months. Its CEO says business is ‘growing substantially’

It’s been a stellar few months for shares of San Francisco-based biotech company Rigel Pharmaceuticals, which has approved treatments for rheumatology and oncology — as well as potential new drugs in the pipeline. The stock has jumped about 50% in just the last three months, earning it a spot on CNBC’s list of top performing […]

Read More
We’re raising our Eli Lilly price target — what a difference a quarter makes
Health

We’re raising our Eli Lilly price target — what a difference a quarter makes

Eli Lilly shares jumped Thursday after the drugmaker posted a strong third quarter, driven by sales of its popular GLP-1 medications. The company also raised its full-year sales outlook for the second time in a row, inspiring confidence in the trajectory of the franchise. Revenue in the three months ended Sept. 30 jumped 54% year […]

Read More