PARIS, Feb 2 (APM) - The French social affairs inspectorate (IGAS) has recommended that France draws up a strategy that goes beyond only applying cost-effectiveness evaluations to health products and adopts a similar approach to health strategies and care organisations.

In a report made public on Friday evening, IGAS inspectors reviewed various criticisms of cost-effectiveness evaluations, including that they are too complicated and only provide “basic information that does not affect the decision”. However, they also pointed out that “it would be unreasonable not to look into the relative efficiency of health interventions”.

“The tension between these two comments certainly explains the ineffectual aspect and ambiguities of progress in the development of economic evaluations in France and other countries. It is necessary to change this situation,” the report said.

IGAS pointed out that it is not the job of “cost-effectiveness evaluations to solve the dilemma facing the decision-maker; its purpose is to avoid uninformed decisions”. But IGAS said such assessments were necessary for “optimum resource allocation”.

Consequently, the principles of this evaluation should be “set out” and decision-makers should have “a policy” to apply in this field.

One of the main points is the extent to which cost-effectiveness evaluations are used. They currently “contribute to setting the price of health products and to the development of vaccine strategies. However, in several European countries, they are also used to define the range of care the community provides,” IGAS said.

They could also be used to restrict the reimbursement of certain treatments to patient subgroups, or to the “most efficient care pathways”.

IGAS said it is necessary to develop a “reference system to interpret the results” of cost-effectiveness evaluations.

However, this reference system should not be based on an “efficiency threshold set beforehand” that would lead to refusing an intervention whose cost-benefit ratio lies above the threshold. It is a kind of “utopia” and such an arbitrary system would be “difficult to justify”. Further, the “English example shows such thresholds are constantly being bypassed”.

“For all that, a reference system appears necessary to back up and justify the decisions”. IGAS is in favour of “comparisons with works of reference (that) would provide the decision-maker with useful assessment criteria”.

IGAS also suggests the indicative reference values should “vary from one therapeutic field to the next … depending on the seriousness of the disease, according to whether or not therapeutic alternatives exist, depending on the service level (ASA) in the case of medical devices and on the level of improvement of clinical benefit (ASMR) in the case of drugs…

“The French national authority for health (HAS) could be placed in charge of forming and updating an efficiency repository”: a database reporting the incremental cost-effectiveness values of products evaluated previously to “reveal benchmarks”.

Concerning the use of cost-effectiveness tests to fields where it is not yet used sufficiently, IGAS makes a series of proposals. For medical devices that are mainly not subjected to this evaluation because of low turnover, the threshold above which HAS is to perform an efficiency review could be lowered to 10 million euros (as opposed to the current 20 million euros sales in the second year).

It also suggests “balancing” HAS’s capacity to carry out cost-effectiveness assessments between drugs and those developed for other health interventions, “particularly in the field of good practice and prevention recommendations”.

Having noted that the regional health agencies (ARS) are short of economic skills, IGAS recommends setting up cost-effectiveness analysis units at the inter-regional level.

In addition, “where relevant” it proposes to apply “the medico-economic evaluation methodology to hospital investment files examined by the inter-ministerial committee in charge of healthcare provision performance and modernisation (COPERMO).

For economic reasons, IGAS recommends “targeting economic evaluations at major health challenges”.

First, it recommends “not extending (evaluation by the economic and public health evaluation commission - CEESP) to ASMR IV drugs (drugs for which the Transparency Commission - CT - issues a clinical benefit ranking of ASMR IV: minor benefit). Medico-economic appraisal is above all relevant for major innovations that claim a high price level”.

IGAS said the French economic committee for health products (CEPS) “has other tools that use up fewer resources, to regulate the price and budgetary impact of minor innovations”.

The authors claim that the evaluation of a drug when it is initially registered for reimbursement “lacks reliability” because it is not based on real life data.

Consequently, cost-effectiveness evaluations when a drug is initially registered for reimbursement should be “centred on the identification of efficiency markers” and on “uncertainty areas” to be clarified. This would lead to “setting a price with appropriate conditionality leading to the re-evaluation of the efficiency and actual budgetary impact” along with a “clause specifying the product will definitely require further evaluation”.

They cite a Swedish example where “re-evaluation of drugs allows validating hypotheses made at the time of first evaluation depending on real life data and that may lead to de-listing products”.

IGAS said that drawing up a national health cost-effectiveness strategy should be based on the set up of a “national evaluation programme”. The priorities could be set out “by the Department of Research, Evaluation and Statistics (DREES)” with regional programmes set up by the regional health agencies.

The report suggests the current cost-effectiveness evaluations could be improved through information on health inequality reduction, studies of the budgetary impact of the products or interventions assessed and an assessment of the efficiency of a product compared with that of other products or alternatives.

“To evaluate the efficiency of a health product, the choice of comparator (made by) the pharma company should be the subject of a discussion with CEESP representatives … as soon as possible”.

Within HAS, the IGAS inspectors consider it is desirable to tighten up the co-ordination among the various commissions in charge of evaluating the health products: the CT, and the national committee evaluating medical devices and health technologies (CNEDIMTS), on the one hand, and CEESP, on the other. They also suggest that the vaccination advisory committee (CTV), currently reporting to the High Committee for Public Health (HCSP) which assesses the efficiency of vaccine strategies, should in fact report to HAS.

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