Deena Beesley

(Reuters) – Eisai Co. OTC:) Ltd. said on Friday it was still planning to apply for an expedited U.S. authorization pathway for its Alzheimer’s drug after Medicare severely limited coverage.

After a lengthy review and pressure campaign by patient advocacy groups and patient advocates, the Centers for Medicare and Medicaid Services announced that it will only pay for Biogen Inc’s Aduhelm and similar drugs for patients who are enrolled in valid clinical trials.

Medicare provides coverage for nearly 64 millions Americans over 65. The decision to deny Medicare could impact 85% people who would otherwise take medications because of their age.

A monoclonal antibody, Eisai’s lecanemab like Aduhelm is used to destroy beta-amyloid. It’s a protein fragment that builds up in Alzheimer’s patients brains. Japanese drugmaker Eisai said that it expected Phase III trial results will confirm earlier-stage data currently under review by U.S. Food and Drug Administration.

Similar drugs are being developed at Eli Lilly and Co (NYSE:) – although they did not respond immediately to queries about their accelerated FDA applications – as well as Roche Holding AG, (OTC:), who isn’t seeking an accelerated FDA review.

Biogen’s Aduhelm was approved by the FDA on June 1. It is the first Alzheimer’s medication in the class, and it has been the U.S.’s first approval in twenty years.

CMS announced that Alzheimer’s medications approved through the FDA traditional process on the basis of “a direct measure clinical benefit” would still be considered standard treatment without limitations.

Biogen is also partnering with Eisai. It stated that it expects to submit a rolling FDA request for lecanemab under the accelerated path by mid-year. The company also said that it expects to see results in the Phase III, 1,800 patient trial this fall.

Eisai stated that if the results prove positive, it thinks the large study can meet Medicare’s “high-level of evidence” requirements for coverage.

This study aims to prove that lecanemab slows cognitive and functional decline by at least 25%

In a recent interview, Eisai’s U.S. Chairman, Ivan Cheung said that it was a “disease-modifying drug.” You expect to see a separation of the untreated and treated groups, which will improve over time.

Lilly stated in a statement that it thinks Medicare restrictions for FDA-approved drugs are inappropriate, unnecessarily restrictive, and unnecessary.

In mid-2023, it expects to receive results from the Phase III trial of donanemab experimental Alzheimer’s disease drug. Lilly indicated in February that the FDA would expedite its review of Phase III trial of experimental Alzheimer’s drug donanemab.

Roche is developing gantenerumab, a fourth antibody that targets amyloids. Roche expects Phase III trials to be completed later in the year.

The idea that removing amyloid plaques is reasonably likely to slow cognitive and functional decline in people living with early Alzheimer’s is known as the “amyloid hypothesis,” a theory that has led to long history of drugs that tried and failed to clear the plagues or help patients.

In a recent interview, Greg Rippon (neuroscience and Alzheimer’s Disease medical leader at Roche’s Genentech Unit) explained that this theory was supported by an analysis of all inherited forms Alzheimer’s Disease, which are all due to mutations in Amyloid Processing.

According to him, more recent research has shown that amyloid buildup is an indicator of other brain disorders that can accelerate neurodegeneration in patients suffering from Alzheimer’s.

    “Obviously, it comes down to clinical data and demonstrating that clinical benefit and that’s where a lot of skepticism is centered,” Rippon said.