1. Pink Sheet
  2. >>Market Access
  3. >>Health Technology Assessment

‘Unbalanced’ EU HTA Timelines Exacerbated By Rare Disease & Cancer Drugs

 
• By Eliza Slawther

As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs.

deadline

Last month, the European Commission published a draft implementing act for joint clinical assessments (JCAs), one of the key new processes that will be introduced under the Health Technology Assessment Regulation ((EU) 2021/2282), which is set to apply from January 2025.

Since then, many industry stakeholders, including the R&D-based pharmaceutical industry body EFPIA, have criticized several aspects of the proposed JCA process

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
Start Free Trial

Already a subscriber?

More from Health Technology Assessment

More from Market Access

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.