It's not revolutionary to suggest that the blockbuster drug model is passé. Industry watchers have been theorizing for some time that specialty drugs are where it's at, that personalized healthcare is the future, that all the easy disease targets have already been hit. Pharma can no longer expect--or even hope--that new blockbusters will save them from mega-patent expirations.
But In Vivo has taken a detailed look at a quite different pressure on the blockbuster model: the payer. Exhibit A is the current head-to-head battle between the old standby clotbuster Plavix, set to go off patent soon, and Eli Lilly's brand-spanking-new Effient.
The stepped-up FDA warning of interactions between Plavix and popular heartburn meds was initially set off not by the agency itself, but by data from insurer Aetna and pharmacy benefits manager Medco Health Solutions. That data could boost Effient in the short run. But Medco now is taking the unusual step of conducting its own head-to-head study of the two blood thinners--the idea being that if it can prove Plavix works as well as Effient, it can save lots of money for clients once Plavix goes off patent.
To that end, Medco will be screening patients for a genetic marker that identifies those who properly metabolize the drug. That's designed to help Plavix, because the drug just doesn't work in some one-third of patients without the marker. Medco will then compare Plavix's efficacy in 14,000 of those selected patients to Effient in 14,000 other Medco members to see if there's a difference in outcomes.
This study won't cost Medco that much because it already collects outcomes data, In Vivo reports. Compared with what Lilly spent to study Effient, the expense is probably pretty trivial. And if Medco is prepared to do this sort of work on Plavix, it no doubt would do the same to push other soon-to-go-off-patent meds over newly approved branded drugs.
- read the In Vivo post