Infographics

Impact of CT outcomes on time to market and list price of orphan medicines in France

January 20, 2025

*Data analysed from RADAR, CRA’s orphan drug data repository that includes pricing and HTA outcomes of all orphan drugs granted an EMA approval between July 2013 and December 2023

More innovative medicines have a shorter assessment time by the CT
ASMR rating achieved vs. average time from EMA approval to outcome of CT assessment

Key takeaways:

  • Products considered innovative (ASMR 1, 2 & 3s) are rare, with an average of 3 products per year, and take the shortest time to be assessed by the  CT – this shows higher alignment on the product’s value and CT’s willingness to accelerate patient access to innovative medicines
  • Average time to reimbursement is broadly similar for ASMR 4-5s and mixed ASMRs, although longer time may be needed for reimbursement of mixed ASMRs given higher complexity

 

Mixed ASMR ratings complicate and extend the negotiation timeline with CEPS
ASMR rating achieved vs. average time from CT assessment to price negotiated

Key takeaways:

  • Duration of price negotiations is similar across ASMR 2-4s, with lowest duration of price negotiation for ASMR 5s, albeit sometimes leading to no agreement and withdrawal from reimbursement
  • Mixed ASMR ratings take the longest to negotiate price on average, reflecting the complexity of negotiating prices of products with different levels of therapeutic benefit across patient populations
  • The Accord Cadre did not have visible impact on negotiation duration

 

Higher ASMR ratings command higher list prices, on average 6x more than ASMR5
ASMR rating achieved vs. price negotiated (list)


Key takeaways:

  • There is a correlation between negotiated list price and ASMR rating, with average annual treatment costs for ASMR 1-2s reaching close to €300,000 and average annual treatment costs for ASMR 3s being 50% lower at €200,000
  • In comparison, average annual treatments costs for ASMR 4s drop another 50% to €100,000, while ASMR 5s average annual treatment costs are the lowest, averaging just about €50,000
  • Finally, average annual treatment costs of mixed ASMRs vary highly between €11,000 and €460,000, showing greater variability

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