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Game-Changing EU-Level HTA Regs Must Allow For Lessons To Be Learned

 
• By Francesca Bruce

EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.

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Joint clinical assessments mean big change for Europe's pricing and reimbursement landscape
Key Takeaways
  • EU-level joint clinical assessments (JCAs), which are similar to member-state level relative effectiveness assessments, are now applicable for new oncology medicines and advanced therapies.
  • The JCAs will mean a big change to the pricing and reimbursement landscape in Europe as all member state pricing and reimbursement authorities will have to consider the outcome of the assessments in their decision making.
  • It is important that lessons can be learned as soon as issues with the system arise, according to the pharmaceutical industry.
  • Companies are worried about the shortage of slots that will be available for scientific advice.

The landmark Health Technology Assessment (HTA) Regulation and the EU-level joint clinical assessments (JCAs) that represent a huge shift in the region’s pricing and reimbursement landscape became applicable on 12...

JCAs are like relative effectiveness assessments that individual member state authorities carry out but which will be conducted on an EU-level with member states being obliged to consider them in...

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