Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
Nicole DeFeudis Editor Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization. The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.” “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.” Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million ...
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 ...
A new report by Edelman reveals an East-West divide in how people around the world view pharmaceutical businesses’ trustworthiness and their commitment “to do what is right.” Now in its second year, Edelman’s report found that people living in China, which is the world’s second largest and fastest growing pharma market, reported the highest level of trust in the industry (89%). China was closely followed by India, the world’s largest producer of generic medicines, where 86% of people trust the pharma industry. However, the numbers drop significantly in the West. In the U.K., 60% of people trust the pharma industry to do what is right, and the number dips to 55% in Germany and 52% in France. In the U.S., the world’s largest pharma market, 54% of people trust the pharma industry. The lowest ranking comes from Japan, home of Big Pharmas Eisai and Takeda, which registered a score of ...
Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare’s controversial coverage policy for new Alzheimer’s treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer’s disease. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the ...
March 22 (Reuters) – Roche (ROG.S) and Eli Lilly and Co (LLY.N) are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval. The effort, unveiled in a statement on Wednesday, comes as Lilly as well as Eisai (4523.T) and Biogen (BIIB.O) are gearing up to sell drugs aimed at slowing the advance of the mind-robbing illness, but their use will require a diagnosis at earlier disease stages than is the norm today. Roche Holding AG would recruit several hundred volunteers with early signs of dementia over the next 18 to 24 months with trial data potentially ready for a U.S. regulatory filing in 2025, Bruce Jordan, leader of Personalized Healthcare Solutions at Roche Diagnostics, told Reuters. The U.S. Food and Drug Administration has asked Roche to recruit a significant number of patients at primary care facilities ...
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