Guidance letter for CEPS to negotiate drug prices with manufacturers

The Economic Committee for Health Products (CEPS) received on August 17 the guidance letter to negotiate drug prices with manufacturers. The document seems to rule out any new legislative project dedicated to innovative treatments against cancer, preferring negotiations with the laboratories. The target set by CEPS ministers is clear – to get a good final price (net of discounts, some of which are confidential).

“The taking devices into account the investments planned by the framework agreement cannot result in a loss of efficiency or excessive budget impact”. In other words, open factories in France will not be allowed to charge high prices.

The letter also mentioned the possibility of “performance contracts”, which will be to not reimburse the treatment in question if its effectiveness is proven, a posteriori.

MAP have provided some interpretation on 6 points:

  1. We anticipate further price revision based on new appraisals (including class such as anti-TNF) by HAS, which for some of them could even drive to de-reimbursement
  2. Net price is the ultimate goal, as mentioned above and not anymore the facial price (which would be protected), therefore to allow sustainability of the Social Security system and access to innovation, we see schemes with rebates from 1st box taking place, instead of above caps in previous price / volume agreement
  3. Product combination, whereas before 1+1 (prices) could equal 1.2 to 1.4 would be now 1+1=1. In addition, we foresee that in oncology the addition of a 3rd or a 4th drug which would enhance efficacy of previous one’s could drive a price revision of all drugs involved in the treatment
  4. We see very little potential for performance contracts, as a high level of various unknown items might take place (duration, endpoints, design, monitoring, etc.) it may apply very selectively, maybe to some orphan drugs
  5. High mention of the CEESP (New Medico Economic Commission) appraisals (efficiency) that CEPS has to take in consideration for finalising price agreement
  6. A big effort has to be provided by the Committee on Medical Devices and Diagnostics to catch up with resource, to close the delay gap and revision of devices subject to coverage

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Published on 14. September 2016 in News France