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Revisiting Accelerated Approval: A Provocative Rebate Proposal

 
• By Michael McCaughan

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

stopwatch and bills
Will faster development mean bigger Medicaid discounts for pharma? • Source: Shutterstock

A new recommendation to Congress from a commission responsible for controlling costs in the US Medicaid program is a very small idea in the context of the broader drug pricing debate – but one that could have larger implications for drug development by prompting a closer look at the Accelerated Approval pathway.

During its April meeting, The Medicaid and CHIP Payment and Access Commission formally endorsed a proposal to set:

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340B Reform Advocates Hail CBO Report, But ‘Scoreable’ Savings Still In Doubt

 
• By Michael McCaughan

The 340B program increases federal health care costs by encouraging the use of costlier medications, the Congressional Budget Office said. But the agency also did not provide a specific estimate of the impact.

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 
• By Francesca Bruce

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

Stakeholders Warn Medicare Payment Proposals For Cell, Gene Therapy Could Hamper Access

 
• By Cathy Kelly

CMS proposals would reduce Medicare payments for cell and gene therapy manufacturing and preparation, which will further disincentivize outpatient or community-based treatment, advocates and sponsors said.

Canada, Britain And Australia Push For Greater International Regulatory Alignment

 
• By Eliza Slawther

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

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ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 
• By Sarah Karlin-Smith

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

US FDA Appears To Be Managing MAHA Well By Feeding Instead Of Receiving Priorities

 
• By Ramsey Baghdadi

The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.