Response to Michael Wonder's comments on the article 'Assessment of the therapeutic value of new medicines marketed in Australia'.

Agnes I Vitry

doi:10.1186/2052-3211-6-8

Abstract

The main aim of our study was to demonstrate that 'new' was not equivalent to 'innovative' with regards to therapeutic value of new medicines in the context of pervasive beliefs that new medicines bring 'therapeutic innovation and better health outcomes'. The current approval system allows the registration of medicines that may be less effective or less safe than existing medicines but may be heavily promoted as 'newer' and explicitly or implicitly 'better' medicines. This may expose patients to serious adverse effects without additional

Highlights

We thank Michael Wonder for his comments on our article ‘Assessment of the therapeutic value of new medicines marketed in Australia’ which give us the opportunity to clarify some points further
The valuation of therapeutic innovation has mainly been addressed by funding agencies such as the Pharmaceutical Benefits Scheme (PBS) in Australia that requires evidence for efficacy, safety and cost-effectiveness of a new medicine against an appropriate comparator
The two main sources of information we used in our study to inform our assessment of the therapeutic value of new medicines were the French independent medical journal Prescrire, and the Pharmaceutical Benefits Advisory Committee (PBAC)’s assessments

Summary

Introduction

We thank Michael Wonder for his comments on our article ‘Assessment of the therapeutic value of new medicines marketed in Australia’ which give us the opportunity to clarify some points further. Wonder comments that we are ‘rather vague’ on what comparisons should be made to determine the therapeutic value of a medicine. The valuation of therapeutic innovation has mainly been addressed by funding agencies such as the Pharmaceutical Benefits Scheme (PBS) in Australia that requires evidence for efficacy, safety and cost-effectiveness of a new medicine against an appropriate comparator.

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Conclusion