Health technology assessment. The pharmaceutical industry perspective.

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations.