New Technology Diffusion Essential to Personalized Medicine: An Interview With Dr Gary Owens

The Last Word

Does the following statement ring a bell?

“Scientific knowledge about best care is not applied systematically or expeditiously to clinical practice. It now takes an average of 17 years for new knowledge generated by randomized controlled trials to be incorporated into practice, and even then application is highly uneven.”

It should. Published in the March 2001 Institute of Medicine report, Crossing the Quality Chasm: A New Health System for the 21st Century, and faithfully quoted ever since, this statement would hold a high place if we were to compile a compendium of “Medical Platitudes We Love and Never Implement.” This mantra has a special significance to oncology personalized medicine, which cannot abide a glacial movement of innovation from bench to bedside. Correcting the situation requires vigilance by all stakeholders, from pharma to oncologist, payer to large employer, who must work together to ensure the timely uptake of new treatment options. Lives literally depend on it.

So went our conversation with Dr Gary Owens, president of Gary Owens Associates and a renowned authority on payer acceptance of oncology innovation. He identified diffusion as the essential companion to innovation in driving the success of personalized medicine. As former pharmacy and therapeutics committee chairman at a large Blue Cross plan, Dr Owens’ stance holds a special irony as he urges the fast uptake of expensive new cancer technologies – provided the evidence of value is there, of course. His payer’s keenly honed skills to avoid costly new technologies that lack meaningful improvement make his admonition to step up the pace of diffusion compelling. He points out that researchers have refined cancer innovation so adeptly, living up to its premise of drilling down to disease specifics, that other healthcare stakeholders have been caught unprepared to respond and implement many discoveries, hurting patient interests. He maintains that pharma should take the lead in stepping up awareness of new products and their value propositions.

He points up the difference between the incremental improvements of recent conventional drug innovation versus the brilliant, highly targeted therapies that work in small cancer populations. The very core of personalized medicine in oncology demands a lightning response, not years between approval and utilization, he says. Cancer demands a change in the rate of diffusion of its special new technologies, if personalized medicine is to meet its goals in cancer treatment.

Dr Owens pointed out the specific dynamics in play. Cancer drug/biologics innovation targets increasingly narrow patient subsets. The cost of treatment is high, and the window of opportunity to employ these agents is correspondingly smaller than ever. Consequently, word needs to get out immediately to the practicing physician and the payer, and pharma should lead the momentum-generating activity. He describes a typical scenario and its implications for the patient and indeed the entire healthcare stakeholder community.

“Instead of a drug being developed to target non–small cell lung cancer (NSCLC),” he stated, “it might target nonsquamous NSCLC, then be refined a step further for patients with ALK mutations. When you do that, it comes with a price tag for the agent that is sometimes 6 figures for a year’s therapy, or larger. When you think about that, if these drugs are being misused because the diagnostics are not being applied properly, the waste factor multiplies rather rapidly, doesn’t it? The value proposition goes out the window if the test isn’t used properly.”

But diffusion doesn’t end there, he cautions. “Not only does the technology have to diffuse into the community and be used,” he observed, “it has to become part of the guidelines itself. These have to turn around quickly enough to help guide therapy. We can’t take the scenario where it takes the guidelines 2 years to catch up with the innovation, then another year or 2 after that for people to actually be using it routinely without failing in clinical practice. Pharma is going to have to help drive that. If they are going to base their pricing and their value propositions off these limited populations, then they have to drive the application of the technology that will help us identify these populations.”

Here is a realist, totally familiar with manufacturers, clinicians, researchers, and patients, calling for the manufacturer to pitch in with the rest of the healthcare community. He knows this curious community of healthcare stakeholders, their historical mutual distrust, and their need to pool their resources and redefine responsibilities in the rapidly changing, research-driven oncology field. In reviewing each stakeholder’s interests being served by avoiding overuse/misuse, he dismisses the notion that it is naive to expect pharma to want to limit product usage to only the appropriate patients. Patients don’t like it, making their physicians not like it. Payers don’t like it, nor do employers footing the bill for their employees’ medical plans.

His point is well taken. Ultimately, the very crowding of the oncology field with expensive, targeted drugs makes it essential to their reception for all parties to help validate their use as thoroughly as possible. Overuse is no longer fashionable, and it no longer pays! The undeserved bounty of excess utilization was unavoidable in the blockbuster drug era, before tailoring drug to patient was possible. Thankfully, that train is leaving the station. It is in everyone’s interest to treat an enriched patient population, and overuse of these precious products no longer serves pharma’s or anyone’s interests, lest these products be abandoned as “too risky to be practical.” That is the market dynamic guiding the matter of diffusion.

The new era of personalized medicine has brought with it technology that makes waste usage of new products as unwanted as their slow uptake into clinical practice. That efficiency was always the premise for personalized medicine. The pace of personalized medicine’s discoveries changed everything. The call now for expedient diffusion from an expert on payer and oncology manufacturer practices should help inform the matter. The situation augurs for an era of interstakeholder collaboration. This is a very good prospect, long overdue and badly needed by cancer patients, who stand to benefit from this, not from interstakeholder distrust and isolation. The positive tone of personalized medicine is a fresh breeze blowing through healthcare, and nowhere stronger than in oncology treatment.

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