The Economic Committee for Healthcare Products (CEPS) – which is notably in charge of setting up the economic policy and policy for proper use of medicines (Article L. 162-17-3 of the French Social Security Code) – published its annual report 2014/2015 on 18  September 2015.

This 193-page long report is the occasion for CEPS to appraise its action carried out in 2014. CEPS states that it contributed to improve the balance of the French health insurance system up to  1.8 billion Euros in total in 2014 (1.4 billion in 2013), due to falls in prices and tariffs of medicines and medical devices, discounts owed on account of "products" clauses and exceptional legal discounts related to the treatment of the hepatitis C virus (HCV).

The report includes a new section concerning the "Functioning and results of CEPS", in the form of "Questions/Answers" which broaches, among other, price setting and negotiation, as well as CEPS' contribution to policies for proper use of medicines. The report notably provides information on the following points.

1.    Contractual discount clauses
CEPS makes a difference between three types of discounts paid by pharmaceutical companies to the French health insurance system owed on account of agreements on medicines.

  • The gross amount of discounts owed on account of clauses per products significantly increased for sales made in 2014 and amounted to 711 million Euros (546 million Euros in 2013), despite an overall decrease in the market. The net amount of these discounts corresponds to 519 million Euros, after deduction of the 192 million Euros of "product" discount funds used in 2013.
    In 2014, volume clauses accounted for 68% of discounts owed on account of clauses per products, first-pack discount clauses accounted for 13%, agreements on orphan medicines accounted for 10%, and treatment cost clauses for 8% (other clauses accounted for the remaining 1%).
  • Regarding annual regulation discounts, 175 companies exploiting reimbursable pharmaceutical specialties reached agreements with CEPS and have thus been exempted from paying the contribution de sauvegarde [safeguard contribution] (Article L. 138-10 of the French Social Security Code). The amount of discounts owed on account of the new regulation scheme specific to expenses related to treatment of the HCV under Provisional Authorisation for Use (ATU) (Article L. 138-19-4 of the French Social Security Code) amounted to 76.5 million Euros in 2014 (not including contributions collected in the absence of agreement with CEPS).
  • For 2014, the total of discounts owed on account of ATU/post-ATU discounts (Article L. 162-16-5-1 of the French Social Security Code) and which concern six products amounted to 205 million Euros.

CEPS states that the total amount of contractual discounts for 2014 amounted to 800.5 million Euros for medicines (using the net amount of discounts owed on account of clauses per products).

Regarding medical devices, CEPS states that discounts owed by companies for 2013 (notified in late 2014) accounted for almost 9.7 million Euros.

    2.    Post-registration studies

Post-registration studies can be requested by the French High Health Authority (HAS) and CEPS. They aim at better knowing medicines in terms of tolerance, efficacy, therapeutic strategy and are part of the medicine's assessment.

In total, 128 post-registration studies were on-going in 2014. CEPS states that it took over the post‑registration studies requested by the Transparency Commission in 10 cases and that it added specific clauses to some of them as the Committee considered "that these studies also had to be the base for performance agreements between CEPS and companies"CEPS notably requested that real-life studies be carried out and scientific committees established. CEPS thus states that it "maintains specific requirements in terms of real-life demonstration and may have to draw potential conclusions on price review".

3.    New Charter governing promotion

On 15 October 2014, CEPS and the French Pharmaceutical Industry Association (Leem) signed the new Charter on information via solicitation or prospection for promotion of medicines which replaces the Charter of Ethics for Pharmaceutical Sales Visits that had been in force since 2004.

CEPS' report states that the national observatory for promotional information established by CEPS and Leem is "being set up". Leem notably organises the invitation to tender in order to choose the "trustworthy third party" that will be in charge of processing and analysing data relating to promotional practices.

See Newsflash dated 16 October 2014 "New Charter in France for Pharmaceutical Promotion", Mikael Salmela and Hélène Bernhard.

    4.    Case files processed by CEPS

Companies can submit applications to CEPS for first registration, new registration, price changes, extension of indication and modification of the conditions of use. Price change case files may also be opened upon initiative of the Committee.

In 2014, 992 case files concerning reimbursable outpatient medicines were opened by CEPS itself (1,332 in 2013), corresponding to 4,243 pharmaceutical presentations[1]. The price change case files accounted for 52% of opened files. Furthermore, 70% of price reduction case files opened in 2014 concerned generic drugs.

918 case files were processed in 2014 – including 50% of price reduction case files – and 95% of these case files led to an agreement between the company and CEPS. The average application processing time for first registration to outpatient reimbursement increased in 2014: 123 days for case files brought to completion (89 in 2013) – more precisely 73 days for generic drugs and 226 days for brand-name drugs. As for the processing time for case files not brought to completion, it reached 336 days on average (319 in 2013).

Concerning medicines for inpatient use, 33 registration files were processed in 2014 (32 in 2013).

    5.    Comparison studies of European prices carried out by CEPS

For the first time, CEPS includes in its annual report two comparison studies of European prices that it carried out itself. CEPS compared prices in France with prices in four European States considered as comparable, i.e. Germany, the United Kingdom, Italy and Spain.

CEPS concludes that prices of generic drugs in France would be "in line with the European average" with an average price per standard unit of 17 cents (13 cents for the United Kingdom, 15 cents for Germany, 21 cents for Spain and 22 cents for Italy).

Concerning patented specialties (i) registered for outpatient reimbursement generating over 100 million Euros of turnover and (ii) registered for inpatient reimbursement generating over 50 million Euros of turnover, CEPS concludes that "French prices are in 20 cases out of 40 (50% of products) lower than the lowest European price and in 37 cases out of 40 (93% of products) lower than the average of the 5 countries".

However, CEPS rightly mentions that "authorities often establish discount systems (discounts related to products' sales volumes, for instance). Comparison of prices actually paid by health insurance funds is impacted". Yet, discounts have not been taken into account by CEPS as most of the time they are confidential. CEPS adds that "according to national systems, the price of the medicine may be unique or, on the contrary, a same medicine may have several prices: regional prices, prices negotiated by health insurance funds …", which makes the analysis more complex.

In particular, due to the significant difference that may exist between the medicine's face value and the real price taking discounts into account, comparison data thus provided by CEPS' report ought to be analysed with caution.