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340B Audit ‘Protections’ Needed Prior To Dispute Resolution Final Rule, Lilly Tells OMB

 
• By Cathy Kelly

Lilly wants White House Office of Management and Budget to delay final rule until there are regulatory controls against duplicate and diverted discounts. OMB has also held three meetings over past few months with organizations representing 340B providers.

More Evidence That Legislative Clarity Is Needed For 340B Program • Source: Shutterstock

A final rule revising the 340B administrative dispute resolution process should not be released until federal regulators issue guidance or regulations affirming manufacturer protections against providing duplicate 340B and Medicaid discounts on the same drug and providing discounts on drugs diverted to ineligible patients, Eli Lilly and Company urged the White House Office of Management and Budget during a 22 January meeting.

Manufacturers are granted the right to audit 340B hospitals and other providers by law and audits are to be conducted...

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Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 
• By Neena Brizmohun

Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

 
• By Francesca Bruce

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.