Comparative Effectiveness with the Gloves Off

Comparative effectiveness—the mostly clinical study of how one medication works against another (or against placebo)—jumped in recognition at the beginning of this year, when the Obama Administration funded $1.1 billion worth of studies, to be conducted over the next several years. Although that effort has been vastly overshadowed by the broad-based debate over healthcare reform since then, NIH and the Agency for Healthcare Research and Quality (AHRQ) are proceeding with their planning. Congress, meanwhile, attempting to appease Obama critics who want to “keep the government out of healthcare” (as if!), stipulated in deliberations this summer that any comparative effectiveness results would only be advisory, and not mandated, for physicians.

Now, however, private enterprise is stepping in. Giant PBM Medco Health Solutions announced the initiation of a new study making a head-to-head comparison of Bristol-Myers Squibb’s heart drug Plavix (clopidrogel)—a years-old blockbuster drug—and newly introduced Effient (prasugel) from Eli Lilly, which was approved this summer. According to Medco, most people are genetically programmed to take advantage of Plavix, but 25% are not (and Effient may be the better choice for them). Medco will enroll more than 14,000 patients and, in a two-year trial, determine whether the patients who can take advantage of Plavix show any benefit over those taking Effient.

Why is Medco undertaking this effort? Dr. Robert Epstein, Medco chief medical officer, is unusually blunt: “Plavix is going generic in 2011 and if found to be equally effective as Effient for patients [with a particular gene], the study provides the evidence that would allow these patients to opt for a lower cost treatment.” Sales of Plavix were almost $4 billion in 2008. Ironically, a few days before the Medco announcement, market research firm Cutting Edge Info noted that Eli Lilly and Daiichi Sankyo used its own comparative effectiveness study (the Triton study) to justify a substantially higher price for Effient vs. Plavix.

Drug-to-drug comparisons are not new (but they are not all that common either). But it is rare for the economics of the drugs to be the motivation for the trial. And, if you think about it, this trial is as much about targeted therapies as about drug efficacy—also a rare situation for such a widely prescribed drug. Although the Medco news release didn’t say anything about the cost of the trial, I’m betting that it will be fairly economical: Medco simply enrolls a sufficient number of existing customers (my emphasis), gets the genetic profile, and then tracks their outcomes in the same systems that they would use to send out reminder notices. Lilly’s Triton trial involved over 13,000 patients at 707 trial sites in 30 countries.

Medco continues to pioneer innovative healthcare practices. Earlier this year it gave some results of its Therapeutic Resource Centers, which monitor patient adherence and medical conditions (Pharmaceutical Commerce, June, p. 14) for a variety of diseases states. This new trial is part of what Medco calls the Genetics for Generics strategy—which hints at more such studies to come.

As IT technologies and healthcare reimbursement-processes advance, the ability to draw meaningful patient outcomes from the systems used to deliver medicines gets easier. And the economic incentives get stronger. Expect more of these comparative effectiveness studies to originate in the benefit or payer community.