SN4: What is an innovative drug?

ACPE UPN: 0475-0000-14-008-L04-P. A knowledge based activity.

Abstract

On the 20^th July 2012 the European Medicines Agency (EMA) recommended the first gene therapy for approval. Also in 2012, 47 new drugs were approved, plus 19 orphan drugs. These new drugs always come with a promise of improving patient’s lives, and also with an invariably high price tag. They are new, they are expensive, and they’ve shown a positive risk/benefit ratio through a very demanding regulatory process. Are these new drugs really innovative? Are they changing the course of diseases in a meaningful way? Is the innovation of these drugs following standard economics regarding pricing? How do innovative drugs compare with innovation in other areas, such as the telecom industry, or the car industry? These questions should be answered so that the hospital pharmacist can better understand their role in hospital drug policy, keeping the focus on the needs of patients in a setting of shrinking resources.

Teaching Goals:

• to analyse recently approved drugs, with a focus on how innovative they really are in terms of patient outcomes,
• to appraise the concept of innovation in drugs, from several points of view (technological, pharmacological, therapeutic),
• to compare the cost of new/innovative drugs compares with the cost of innovation in other areas of the economy, as well as the underlying economic mechanisms.

 Learning Objectives:

After the presentation the participant should be able:

• to recognise the degree of therapeutic innovation of recently approved drugs,
• to describe the basics of the economic mechanism behind pricing of drugs, in comparison with other areas of the economy,
• to appraise therapeutic choices in the prevailing scenario of shrinking budgets.