April 13, 2015 katharina.janus

New on the Health Affairs Blog: Crossing boundaries in comparative-effectiveness research in France

This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, to be held in Berlin, Germany on January 29 and 30, 2015. For more information or to request your personal invitation contact info@centerforhealthcaremanagement.org or follow @HCMatColumbia.

Incorporating Cost-Effectiveness Analysis Into Comparative-Effectiveness Research: The French Experience
By Lise Rochaix


When making decisions about the allocation of scarce resources, should societies or communities take into account the cost-effectiveness of the various options available to them? In almost all aspects of our lives, policymakers and economists would answer yes to this question; in health care, however, the answer is less clear, and varies from country to country.

A 2009 Commonwealth Fund report examined the experience of four countries in setting prices and/or choosing reimbursement levels for drugs and medical devices. The study compared the countries’ relative production and use of comparative-effectiveness research (CER) in these decisions, better known outside the U.S. as “health technology assessments.”

Of the four countries, two—Australia and the U.K.—routinely incorporated cost-effectiveness analysis (CE) into CER to inform decisions about reimbursement of new drugs, while the other two—France and Germany—used only clinical-effectiveness evidence for both pricing and reimbursement decisions of drugs and devices.

Legal Mandates Impact Nations’ Use Of CE

In the U.S., the Patient Protection and Affordable Care Act of 2010 created the Patient Centered Outcomes Research Institute (PCORI), whose purpose, as defined by law, is to help patients, clinicians, purchasers, and policymakers make better-informed health decisions through the funding and dissemination of CER. Notably, PCORI’s founding legislation explicitly prohibits the inclusion of cost-effectiveness analyses.

However, while the U.S. has moved away from incorporating CE into CER, other countries are moving in the other direction. The experience in Germany has recently been documented.

This blog summarizes the French experience, where the French Haute Autorité de Santé (HAS) has received legal mandates to steadily incorporate CE into its CER activities. These experiences provide insights for other public and private payers struggling with how and whether to follow a similar path.

France’s Use Of CE In Pricing Decisions For Drugs And Devices

In France, the Ministry of Health is in charge of pricing new drugs and devices and reassessing existing prices, while the national health insurance decides on coverage and sets co-pay levels. Among other functions, HAS issues advice to the Ministry of Health and the national health insurance, based on the comparative clinical value of drugs and medical devices. Initially, HAS advice did not incorporate CE, but that changed with a 2008 law requiring the agency to do so in its price reassessments.

This law led to the establishment of the economic evaluation and public health committee (Commission d’Evaluation Economique et de Santé Publique — CEESP), alongside HAS’s existing committees in charge of comparative clinical effectiveness for drugs and medical devices. The justification for initially restricting CE to advice on price reassessments of existing drugs and devices was that advice had to be given in a very short time period in order not to stall innovation. This obstacle was overcome with the requirement that manufacturers should anticipate and produce CE models for HAS, based on the agency’s methodological guidelines for economic evaluation.

But the true obstacle was the fear that budgetary considerations might influence clinical-effectiveness advice. The explicit split between clinical effectiveness and cost effectiveness, with two separate committees handing in their advice to the Ministry of Health at the same time but independently, mediated that fear.

Subsequently, a 2012 law required CEESP to use cost-effectiveness analysis for advice on pricing of both existing and new drugs and devices. It also made CEESP a legal committee, which gives more weight to its CE advice (called “efficiency advices”), now routinely produced. In addition to analyzing CE models submitted by drug and device manufacturers, CEESP, which comprises representatives of eight social sciences beyond economics, also informs pricing decisions with an analysis of other nonclinical (e.g., social or ethical) issues.

Looking Forward: CE In Coverage Decisions?

The next step could involve introducing CE into HAS advice on reimbursement decisions. France covers a larger basket of goods and services than most other European countries, and this is becoming a matter of concern. A December 2014 report from the French board of auditors in health matters (Inspection Générale des Affaires Sociales) recommends that CE analyses should be used not only in pricing but also for decisions regarding the type of goods and services covered by the national health insurance and the level of co-pay that will apply.

In many ways, the experience of incorporating cost-effectiveness analysis into comparative-effectiveness research at HAS corroborates the conclusion of the afore-mentioned Commonwealth Fund report: “All CER entities have gradually come to appreciate the need to consider ‘value’ when judging the relative worthiness of clinical interventions.”


Leave a Reply

Your email address will not be published. Required fields are marked *