Lilly, Eisai and Genentech argue against CMS’s class-wide approach in its coverage for amyloid-directed monoclonal antibodies, predicting research on their in-development for Alzheimer’s drugs will provide confirmatory evidence of clinical benefit in the months ahead.
The Centers for Medicare and Medicaid Services should only condition Medicare coverage for monoclonal antibody drugs for Alzheimer’s disease on further evidence generation when confirmatory evidence is absent, instead of imposing additional clinical trial research requirements prospectively on all drugs in the class, Eli Lilly and Company urged in comments to the agency.
“We believe that CMS should finalize an NCD that provides for Medicare coverage of all anti-amyloid mABs in a core...
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
