Think a friend or colleague should be getting this newsletter? Share this link with them to sign up. The Food and Drug Administration fully approved the Alzheimer's antibody treatment Leqembi on Thursday, a pivotal decision that will expand access to the drug. The key news for patients is that Medicare will now pay for Leqembi. For months, the program for seniors refused to cover the treatment outside clinical trials, effectively blocking access for most patients because they cannot afford the $26,500 annual price set by Eisai before insurance coverage. Medicare will now pick up the majority of the bill for beneficiaries who are diagnosed with mild cognitive impairment or mild Alzheimer's disease, though patients could still face thousands of dollars in annual out-of-pocket costs. Patients also need to have a doctor who is participating in a registry that collects data on the drug's benefits and risks to be eligible for coverage. The registry is controversial. The Alzheimer's Association is worried the data-collection requirement will create unnecessary red tape. But the Centers for Medicare and Medicaid Services has set up a nationwide, free-to-use portal that is supposed to make it easy for doctors to enter the required information. Just how much demand there will be for Leqembi is still unclear. It is the only drug on the market that slowed cognitive decline in a clinical trial. But Leqembi also carries risks of brain swelling and bleeding. Patients and their doctors will have to weigh the benefits against those risks.
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The Food and Drug Administration on Thursday fully approved the Alzheimer's treatment Leqembi, a pivotal decision that will expand access to the expensive drug for older Americans. Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply. Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare. |
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Sales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said. Wall Street is still chewing over the Food and Drug Administration's Thursday approval of Eisai and Biogen's Leqembi. Analysts believe a Medicare coverage requirement and new guidance on Leqembi's prescription label could potentially weigh on sales of the drug – at least in the near term. |
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U.S. public health officials say the risk of locally transmitted malaria in the country remains low as cases in Florida and Texas raise questions. The Florida Department of Health said two cases of locally acquired malaria have been reported in Sarasota County, bringing the nationwide total to seven. The CDC and health experts say the new locally acquired cases shouldn't warrant panic about widespread malaria transmission in the country. |
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Moderna on Wednesday struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company will develop those drugs "exclusively for the Chinese people," a spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China which could be worth around $1 billion, citing unnamed sources. |
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