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Medicaid Spending On Accelerated Approvals ‘Outsized’ Relative To Use

 
• By Cathy Kelly

A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.

Accelerated Approvals Burning Through Budgets? • Source: Alamy

Medicaid programs paid $2.2bn to $2.6bn on a net basis for drugs approved through the US Food and Drug Administration’s accelerated approval pathway from 2015 through 2019, representing between 6.4% to 9.1% of annual spending on all drugs over that period, according to an analysis in JAMA Health Forum.

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African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

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FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.