by Edouard Hubert

PARIS, Mar 12 (APM) - French health minister Marisol Touraine will launch a working group on health technology assessment (HTA) on Friday, and the chair of the group has been entrusted to Dominique Polton, adviser to the director general of the National Health Insurance Fund for Employees (CNAMTS), APM has learned from corroborating sources.

The ministry announced on Tuesday in its weekly agenda that Touraine would launch the “opening of the working group on drug evaluation chaired by Dominique Polton” on Friday morning.

The scope of the working group is likely to be extended to cover all health products including medical devices, APM has learned from several sources.

One source, who has seen the invitation sent to participants, said the work is presented as the extension of two French social affairs inspectorate (IGAS) reports: a report by Muriel Dahan on the relative therapeutic index (index thérapeutique relatif - ITR) that was never made public, and one by Marine Jeantet and Alain Lopez on cost-effectiveness assessment, published at the end of January (APMMA 41316).

A few elements have leaked from Dahan’s report that was submitted to Touraine in autumn 2013. In particular, she had considered that the set up of the ITR, promoted by the chairman of the board of the French national authority for health (HAS) to replace the current therapeutic value (SMR) and clinical benefit ranking (ASMR) system, was not urgent and would need to be done gradually. She mentioned its possible set up in the context of the social security funding law (LFSS) for 2016, namely, the text that will be discussed in Parliament in autumn 2015.

Several participants in the Friday meeting who have been questioned by APM made known their desire that the possibility of merging SMR and ASMR into a single tool should be the subject of clarification on the part of the government.

The report by Jeantet and Lopez called for the development of cost-effectiveness assessment beyond medical products alone, and particularly for the development of a “reference system for interpreting the assessment results” while avoiding basing this on an “effectiveness threshold determined beforehand”.

The fact that chairman of the working group has been entrusted to Polton could give it a particularly economic dimension. President of the health accounts commission from summer 2014 on and adviser to the CNAMTS director general since the start of 2014, she was previously director of the institute for research and information in health economics (IRDES) from 1997 to 2005 and director of strategy, studies and statistics at CNAMTS from 2005 to 2013.

The agenda for the meeting on Friday, once the minister has opened it, involves organisation of the group’s work. According to a source familiar with the file, the group’s conclusions will need to be submitted before the end of June.

The set up of this working group comes at a time when the French economic committee for health products (CEPS) and the French pharmaceutical industry body (LEEM) need to renegotiate their framework agreement before the end of the year. Even though CEPS does not work directly on health product evaluation, any change upstream has consequences on its activity.

In addition, the health and medical technology industry strategic contract signed by several representatives of the government and pharma and medical device executives in July 2013 comprised a measure (No. 12) aiming to “ensure legibility and predictability of health product evaluations to facilitate rapid access to innovations of quality in compliance with security requirements”.

It planned the set up in September 2013 of an “inter-ministerial working group on the efficiency of the market access procedures for drugs and medical devices” accompanied by “consultation of the stakeholders, and particularly of the pharma and medical device executives, as and when”.

According to competent sources, the meeting on Friday should gather representatives of the various departments of the ministry, LEEM, medical device manufacturers’ union (SNITEM), France’s drugs regulator ANSM, the national cancer institute (INCA), HAS, CEPS, CNAMTS, the national union of complementary health institutions (UNOCAM), doctors’ and pharmacists’ associations, CISS (health collective comprising some 30 associations), UFC-Que choisir (the French consumer protection association), the French independent prescribing guide Prescrire, and the biostatistician and director of INSERM Unit U669 (adolescent mental health) Bruno Falissard. (INSERM is the French national institute for medical research).

Questioned by APM on Tuesday, the ministry of social affairs, health and women’s rights said the methodology and schedule of the working group would be presented at the meeting on Friday.

eh/aki/hlc