(Vienna, 9 April 2010) In an extensive collaboration with the European Medicines Agency on the topic of assessing the relative efficacy of drugs, in cooperation with Ao. Univ. Prof. Dr. Brigitte Blöchl-Daum and Univ. Prof. Dr. Hans Georg Eichler, there is also particular focus on the increasing importance of cost coverage and its effect on current developments of medication.
The decision on the registration of drugs is based on the assessment of quality, safety and efficacy. If the benefits of the new drug outweigh its disadvantages, it will usually be approved. In contrast, in the decision for cost coverage by health insurance funds or other payers in the healthcare sector it is a key issue whether a new drug offers a therapeutic advantage over the other substances on the market ("relative efficacy" or RE). Over the past decade the role of the payer has become increasingly important so, for a new substance, market access no longer depends only on approval but more and more also on cost coverage. But this also means that in the development of a new drug the trend is towards replacing the proof of efficacy compared to placebo with the proof of efficacy compared to the current standard therapy.
The article which just appeared in "Nature Reviews Drug Discovery" (impact factor 28.690) describes the current discussion about RE and the scientific and methodological challenges posed by its assessment. It also discusses the influence of RE on the future development of new drugs. The joint first authors of this work are Brigitte Blöchl-Daum and Hans Georg Eichler (currently active as Senior Medical Officer of EMA in London), both from the Department of Clinical Pharmacology.
» Hans-Georg Eichler, Brigitte Bloechl-Daum*, Eric Abadie, David Barnett, Franz König & Steven Pearson: “Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.” Nature Reviews Drug Discovery 9, 277-291 (2010) *corresponding author
Biographical info: Ao. Univ. Prof. Dr. Brigitte Blöchl-Daum is a specialist doctor for internal medicine and clinical pharmacology and the Deputy Director of the Department of Clinical Pharmacology. Since 2005 Prof. Blöchl-Daum has acted as the Austrian delegate to the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). This body also elected her in 2006 to the Scientific Advice Working Party (SAWP) of EMA's Committee for Medicinal Products for Human Use (CHMP). This working group (SAWP) gives advice to research-conducting pharmaceutical companies in the development of pharmaceuticals that are subject to the centralised procedure. In her capacity as Deputy Chairperson of the Evaluation Commission for Medicinal Products in the Federation of Austrian Social Insurance Institutions, Prof. Blöchl-Daum is involved in issues related to the registration of pharmaceuticals and to cost coverage by the healthcare system.