Avastin/Lucentis study may reverberate through industry

NORWALK, Conn. According to IMS Health, a new clinical trial that began this year by a research institute may change the relationship between payers and the pharmaceutical industry, the Financial Times reported.

The National Eye Institute has sponsored a $16 million head-to-head trial of Genentech’s drugs Avastin and Lucentis. Lucentis is approved to treat age-related macular degeneration and Avastin is used to treat cancer but, both drugs are very similar and physicians have been using Avastin off-label for AMD.

The problem with the off-label use is the cost, as a single dose of Lucentis costs $2,000 while a bottle of Avastin can be split up to cost only $40-$75 per injection.

IMS argues that if CATT, the Institute’s study, shows Avastin to be as safe and effective for AMD as Lucentis, it may pave the way for an increasing number of payers to take comparative drug studies out of the hands of the pharmaceutical companies, especially as databases of patients make it much easier to conduct such tests.

But it warns that the move may create a disincentive for companies to study such areas, and creates untested areas of who would approve Avastin for AMD following a late-stage Phase 3 clinical trial which was conducted without any of the usual early-stage testing regulators usually require.

The study is expected to conclude in 2010 and has no involvement with Genentech.