 | Fri, Feb 17, 2023 | | | |
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Think a friend or colleague should be getting this newsletter? Share this link with them to sign up. Medicare is facing growing pressure to abandon its restrictive coverage policy of Alzheimer's treatments and provide broad access to promising new drugs like Eisai's Leqembi. A group of 20 senators wrote the Medicare administrator on Friday calling for the agency to take immediate action, warning that 2,000 people with early Alzheimer's slip past eligibility for Leqembi because their disease has progressed. The senators' letter comes after House lawmakers, the Alzheimer's Association and the American Academy of Neurology have all called on Medicare to provide broad coverage of Leqembi, which Eisai has priced at $26,500. Eisai's U.S. CEO Ivan Cheung told CNBC that the company expects full FDA approval for Leqembi this summer, which should broaden Medicare coverage and make the drug somewhat easier to access. As the race to fight Alzheimer's gains speed, Bertha Coombs writes that Eli Lilly is making a push to recruit Black patients, part of a broader FDA effort to make sure clinical trials reflect the diversity of the U.S. population. Moderna, meanwhile, published mixed data on its flu vaccine candidate this week. Meg Tirrell has that story for us.
Feel free to send any tips, suggestions, story ideas and data to me at spencer.kimball@nbcuni.com.
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Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve its Alzheimer's treatment Leqembi this summer, which would expand access to the pricey new antibody under Medicare.
U.S. CEO Ivan Cheung said the FDA, which granted accelerated clearance in January, could give full approval as soon as July if the company gets an expedited "priority review" for demonstrating a significant improvement in how early Alzheimer's is treated. "We're literally talking about maybe like five months away, so we are moving with urgency definitely with CMS right now," Cheung told CNBC in an interview Thursday. The Centers for Medicare & Medicaid Services is the federal agency that will determine how broadly Leqembi, which Eisai has priced at $26,500 a year, is covered for patients diagnosed with early Alzheimer's. |
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U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. "Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient," the senators told Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure in a letter. The group included 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, R-W.V. |
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The mRNA giant's seasonal flu vaccine met the study's immune response goals against influenza A, the more common type, but missed against influenza B. Moderna says it's already tweaked the vaccine's formula to improve protection against B strains, but in the meantime expects earlier-than-anticipated results from a phase 3 efficacy trial — what Moderna President Dr. Stephen Hoge told us is the more important dataset — now by the end of the first quarter. Also key: the vaccine's tolerability profile, especially as Moderna's long-term plan is to package protection against multiple respiratory viruses into one mRNA shot. In this trial, more participants experienced side effects like headache, muscle pain and fatigue on the Moderna shot than the standard flu vaccine comparator, but Moderna noted they were mainly low-grade. Still, the stock declined on the news. |
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The Covid pandemic pushed Eli Lilly to think out of the box to keep its clinical trials going back in 2020. They developed mobile labs which now are helping the drugmaker push into communities of color that have often been underrepresented in drug trials. Lilly and rival Pfizer are finding direct appeals to patients is bearing fruit. |
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The Food and Drug Administration's independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the lifesaving treatment. Emergent BioSolutions' Narcan is the most commonly sold treatment for opioid overdoses. The FDA is expected to make a decision by March 29 on whether to allow people to buy the 4 milligram nasal spray without a prescription. The agency is not required to accept its advisors recommendation, though it typically does so. "There is no reason to keep this as a prescription, let's get it out there and save some lives," said Elizabeth Coykendall, a paramedic at PM Pediatrics in Raleigh, North Carolina, and a temporary voting member of the FDA committee. |
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Moderna CEO Stéphane Bancel will testify before the Senate health committee in March over the company's price for its Covid-19 vaccine when the shots are sold on the private market. Sen. Bernie Sanders, chairman of the health panel, confirmed in a statement on Wednesday that Bancel would appear aat 10 a.m. ET on March 22. The Moderna CEO stirred controversy last month when he said the company could increase the price of the shots to $110 to $130 a dose, significantly higher than the $26 the U.S. government pays for the omicron boosters. Sanders sent a letter to the CEO calling the proposed price hike "outrageous." |
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| Radioligand therapy, also called radionuclide or radiopharmaceutical therapy, is a targeted form of cancer treatment that delivers radiation directly to cancer cells. While other forms of cancer treatment can target any rapidly dividing cells in the body, radioligand therapy's precision helps limit damage to healthy, surrounding tissue. It's an effective form of treatment that many experts and patients are excited about, but there's a significant catch — the medication expires within days after it's manufactured. Pharmaceutical company Novartis believes the returns will be worth the challenge of mastering this race against time. |
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