Lilly downplays expectations for an US FDA accelerated approval of donanemab, given expectations that Medicare will persist in its plan to withhold coverage for Alzheimer's drugs outside of clinical trials. Policy experts are divided on whether the decision sets a precedent for future accelerated approvals.
The Centers for Medicare and Medicaid Services’ recently-proposed national coverage determination restricting reimbursement for amyloid-directed monoclonal antibody drugs for Alzheimer’s disease to use in clinical trials undermines the commercial value of an accelerated approval in the class, according to Eli Lilly and Company.
Lilly no longer believes an accelerated approval from the US Food and Drug Administration for its Alzheimer’s drug candidate donanemab...
The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.
Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.
Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.
Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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