BRUSSELS, Belgium - The Organisation for Economic Cooperation and Development (OECD) has issued a study outlining special problems in economic evaluation of biotechnology products.

The just-published, wide-ranging study of the biotechnology sector by the Paris-based club of developed nations, titled “Economic aspects of biotechnologies related to human health,“ identifies some of the particular challenges faced by innovative biotechnology companies.

For instance, the OECD said, innovations may not be acknowledged for what they are: breakthrough biotechnology products suffer when the nature of the disease they can treat is not well understood, or when adequate instrumentation for measuring clinical success has not been developed. The clinical learning curve may be steeper for biotechnology products for all concerned, and as a result, early clinical or economic assessments may be misleading.

The difficulty of economic assessments at an early stage in the development of biotechnology-derived products is demonstrated, the OECD said, by the case of erythropoietin - which received a lukewarm welcome from many European regulatory authorities. The protein drug is a red blood cell booster.

In many jurisdictions where important and sometimes virtually irrevocable pricing and reimbursement decisions are made at the time the product is launched, promising developments may be curtailed because they are initially thought to give poor value for money, the OECD observed.

Problems also arise when pricing comparisons cannot easily be made, such as in situations where products could fill major gaps in therapy, but where no existing therapies can serve as a comparison for price setting.

High-cost and high-price “magic bullet“ biotechnology products may be singled out for detailed regulatory evaluation, the group warned, conceding that “a high price does not necessarily imply poor value for money. The main question is whether the benefits of improved health and reduction of other expenses justify the cost of new technology.“ *