ACPE UPN: 0475-0000-14-009-L04-P. A knowledge based activity.

Abstract

A strong competition exists in the drug market and similar drugs ("me-too") as well as generics are available in many therapeutic classes. On the side of the pharmaceutical industry, this allows each competitor to try to get a part of the market, especially in very profitable areas. The protection by a patent is a guarantee to have a situation of monopoly and at the end of this period there is the fear in regard to an expected fall in sales.

Drug manufacturers facing patent protection termination have developed strategies to maintain market share. These include marketing evergreening drugs (slow release formulations, single isomer of chiral molecules, or structural analogues/combinations of original patented drugs) and offering high rebates to hospitals that use brand name or evergreen drugs. By these ways, they try to keep their share of the market.

On the hospital side, we have to select the most useful drugs, taking into consideration their efficacy, safety and cost. The more similar the drugs are, the more important the economic factor becomes. Moreover, with a constant reduction of hospital length of stay, questions related to the continuity of care have to be considered carefully and the cost in the community should also be included in the decision process.

In this seminar, two specific aspects related to these questions will be addressed:

• the impact of patented drug extension strategies on healthcare spending; and,
• the limits of generic substitution and their consideration in formulary management.

Teaching Goals:

• to share with the delegates latest research findings on evergreening strategies,
• to present situations in which generic substitution can lead to an increased risk for the patient,
• to propose a risk analysis method to apply during the drug selection process,
• to discuss the limits of therapeutic equivalence in the daily practice. 

Learning Objectives:

At the end of the seminar the participants should:

• be able to estimate the impact of strategies developed by the pharmaceutical industry to prolong the life of their successful products,
• be sensitized to the importance of considering a societal perspective when economic choices have to be done,
• be able to analyse the risk of generic substitutions in specific therapeutic classes,
• appraise the limits of therapeutic equivalence.