Another Paradigm Change for Pharma
There seems to be more than a fair share of pharma news these days with significant forward implications.
This blog for example looks at a recent news story related to the comparative effectiveness of blood thinners Plavix and Effient. Plavix (BMS & SA) is a top selling drug, but with generic status pending while Effient (Eli Lilly) was just recently granted approval.
Drug interaction issues aside (I find Cyps interesting, but don't expect others to), Derek and the linked blog point to the paradigm changing implications. Comparative effectiveness is seen as being much needed to both deliver the best care and control costs in healthcare. Much of the discussion around comparative effectiveness relates to post market clinical trials being performed / required. Pharma firms like to do some pre and post market comparative effectiveness to help position their products in the market, but don't much care to relaese the data if things don't look to benefit them.
But heres the change. The Plavix vs. Effient evaluation is coming from the health insurers.
"The In Vivo people point out, though, that this story isn't being driven by the usual players. It's not the FDA that's pushed to find this out, and it's not even Eli Lilly. It's Medco and Aetna. They studied their insurance claims data to see if the numbers supported the proton pump inhibitor/Plavix interaction, found that they did, and publicized their findings - and that led to an actual observational trial from BMS and Sanofi, which confirmed the problem."
So we have the move toward more adoption of electronic health records (which will and has to happen), and the push for comparative effectiveness information, and the massive (but not systematically organized) data repositories of the health care providers all coming together. Does anyone doubt that in the coming years comparative effectiveness will be predominently evaluated by data mining health records post market. Sure, findings here will likely be confirmed clinically in a controlled setting (at least at first), but this is a major coming paradigm change from the way things are done now. There will be winners and losers, but this makes me-too medications less of a gimme revenue source in the coming years.
It could also provide an added business model / revenue stream to healthcare providers as pharma companies pay to mine their data. Yeah, Hipaa will put some large barriers up, but the ultimate result of serving the public good necessitates the data mining being done (by someone anyway - though perhaps not big pharma).
Home Coverage Team