Medical Device Link.

MARKET PLACE

A lucrative target

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APPAMED, the association for French manufacturers of outpatient medical devices, has approximately 65 member companies from various sectors of the industry.¹ Seven million patients daily use products manufactured by APPAMED members, which represents approximately €1.3 billion in manufacturer turnover.

Medical devices have become a French Government target since it identified a few years ago that the rate of growth for the medical device industry is approximately 15% per year. A recent survey by the French National Health Insurance fund for salaried workers, CNAMTS,² shows that reimbursed medical devices amount to €3.5 billion, 50% of this for home care products. In terms of APPAMED products, the share is approximately €900 million (m): €270 m for wound dressings, €203 m for ortheses, €200 m for incontinence products and €250 m for self treatment.

To begin with the Government placed a tax on turnover, and on expenditures for promotion of reimbursed medical devices to physicians and nurses and training. This was followed by a cut in reimbursement prices and now another round of delistings, reclassifications and cuts in the reimbursement level of APPAMED members’ products is underway. The cuts were initially based on purely financial considerations. Now they are based on medical evaluations using a classical pharmaceutical industry approach and made from randomised clinical studies and subjective expert advice, which is not appropriate for these types of product. This process began in 2006 for wound care dressings, compression stockings and bandages and materials for diagnostic and self treatment. It has not finished yet. APPAMED and individual members have submitted files to the Commission d’Evaluation des Produits et Prestations (CEPP) outlining aspects that they believe should be taken into account during the evaluation of certain products.

Manufacturers live with a total lack of visibility about the future of their products. This presents an immense difficulty and challenge for them.

Making a fairer system

APPAMED is forming a workshop, called Evaluation Meeting (Rencontres de l’Evaluation), which will bring together CEPP experts, doctors, health economists and representatives from the industry to evaluate real product cases. In this way, these parties can discuss how best to understand the real value of a product and what methodologies are needed to evaluate them; they will also try to establish some reference methods. This project, shared with Haute Autorité de Santé, Agence Française de Sécurité Sanitaire des Produits de Santé, and other federations such as the trade association SNITEM, and the Fédérations de Hospitalisation Publique et Privé is in progress and the work shop is expected to begin operating in early 2009.

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Philippe Rouard is Director General of APPAMED, 37–39, rue de Neuilly, F-92582 Clichy, France, Tel. +33 1 4756 3005, e-mail: appamed@wanadoo.fr www.appamed.org