Cases in which a newly approved drug is more effective than the cheaper alternatives already available are the exceptions rather than the rule.
This is the conclusion reached in a study by Mariam Ujeyl et al. in the current issue of Deutsches Δrzteblatt International.
Research into 39 proprietary medicinal products (PMPs) launched on the German market in 2009 and 2010 shows that there were frequently insufficient data available on efficacy when approval was granted. The legal requirements of the licensing procedure have never yet required direct data comparing a new drug to a commercially available drug.
The researchers' evaluations also show that for around half of approvals the only trials presented compared the new drug with a placebo, not an effective comparator drug.
This can give rise to room for interpretation regarding pricing when new drugs are marketed. The authors do not even rule out the possibility that these more expensive PMPs may actually be inferior to the alternatives already on the market.
- Ujeyl M, Schlegel C, Walter S, Gundert-Remy U. New drugs: evidence relating to their therapeutic value after introduction to the market. Dtsch Arztebl Int, 2012; 109(7): 117%u201323
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