Medicare Part D Coverage For Humira Biosimilars Has Inspector General’s Attention

Office of Inspector General analysis could add momentum to reforms of the rebating system.

syringes_full_of_dollars
An Important Test Case For The Viability Of Biosimilars • Source: Shutterstock

The Department of Health and Human Services Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By 

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

More from Pink Sheet

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By 

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.