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Paying for Protection: Medicare Rebates May Make Protected Classes Less Safe for Sponsors

 
• By Ramsey Baghdadi

Democrats failed in their first attempt to impose price controls in Medicare Part D. But, led by California Rep. Waxman, they may have found a new approach that seems less threatening than price negotiations-rebates for products used by dual eligible patients. And the drugs most likely to be affected are in Part D's six protected classes.

Be careful what you wish for. The drug industry may want to keep that proverb in mind heading into 2009.

For any drug company playing in the Medicare Part D program, two critical developments took place in July:

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Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

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.

Colorado Board Adopts Medicare Maximum Fair Price For Enbrel, Assumes Amgen ‘Amenable’

 
• By Cathy Kelly

The state’s prescription drug affordability board could be the first to recommend an upper payment limit for a prescription drug.

MSD Works To Reverse English Funding Refusal For Winrevair; Reimbursement Plans Progress Elsewhere

 
• By Neena Brizmohun

MSD is gearing up to demonstrate the value of its pulmonary arterial hypertension drug, after England’s health technology assessment institute provisionally said the product was not cost-effective. Meanwhile, the company told the Pink Sheet about Winrevair’s reimbursement status across Europe.

China NHSA Releases Preliminary Innovative Drug List For First Time

 
• By Xu Hu

China’s NHSA in August released for the first time a preliminary list of innovative drugs under commercial insurance, along with a preliminary list of products under the National Reimbursement Drug List.

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US FDA’s ARIA Analysis Adds Earlier Scan To Biogen/Eisai Leqembi Label

 
• By Bridget Silverman

Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
• By Sue Sutter

The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.

New US FDA AI Councils Will Focus On Internal, External Policy

 
• By Sarah Karlin-Smith

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.