So far, Luce has noticed "a more formalized approach of bringing real evidence from trials to bear on the coverage process," he says. "The government is looking at real evidence from clinical trials, and in particular, for evidence that the products work in a real-world scenario."
Honored to play such an integral role in shaping the future of Medicare, Luce says he expects to see huge shifts in the healthcare landscape, and many improvements for the millions of elderly and disabled Americans whom Medicare insures.Pharm Exec: What kinds of changes can we expect to see from drug companies as a result of the MMA?
The landscape has shifted. The drug companies are now looking at evidence to ensure that the products have real-life applications, instead of just being effective and safe in clinical trial settings. Increasingly, they are being asked to provide better information about their drugs' safety and effectiveness, in terms of how they will be used in the real world.
Right now, the clinical trials of drugs and most medical devices—or at least the invasive ones that require FDA approval—do not have real-life applications. Scientists who conduct clinical trials are very focused on research settings and they have a very careful protocol. And patients, typically, are not typical patients; they don't have multiple diseases. Traditionally, they have been middle-aged white males, not people of lower socio-economic conditions, or the elderly.
If the studies included the aforementioned populations, would the research be more accurate?
Even if the research was conducted in those populations, the clinical trial settings and the formalization of the research (with these careful protocols and very careful inclusion criteria) are still very different from real-world patients and real-world doctors.
How will the MMA reconcile this?
What is different is that Medicare and managed care are asking for better evidence that these products are actually safe once they're in the real world. They want to ensure that they're actually effective compared with other products and other kinds of services that the patient could have.
What is a more efficient way of evaluating drugs?
One technique is [the use of] patient diaries. When necessary, they are used in trials for what we call patient-reported outcomes. The idea is that only patients can tell you about their quality of life—how they are feeling and whether they sleep at night, whether they have pain, and so forth. I mean, we can't really give tests for pain, or say, sleeplessness. Diaries also can be used in post-marketing clinical trials.
What role does post-marketing play in this?
Drug companies always have done continued research. But it hasn't been too formalized and the research designs have not really been good. They've been focused mostly on marketing just to increase product uptake. But from a scientific standpoint, it has been a very soft science in essence.
What has changed, and what continues to change, is that Medicare and the other major payors, like Medicaid and managed care, are really expecting more continued formal research into the real-world application.
What are the challenges pharma companies will face with new post-marketing studies?
Obviously, one of the big obstacles is changing the mindset of both the pharmaceutical industry itself and the medical establishment. Neither party, including physicians, managed care professionals, and prescription drug plans (PDPs), has a good history and track record of performing clinical trials that provide better evidence about the true effectiveness and safety of the product in the real world.