Monday, December 17, 2012

The evolving role of payers in the R&D ecosystem

Payers, including the federal Centers for Medicare and Medicaid Services (CMS), are taking an increasingly visible seat at the decision-making R&D table, long before they get asked to pick up the tab. They're mining their vast databases and partnering with pharmaceutical companies to help them develop personalized medicines faster. In a Partnering for Cures panel discussion moderated by Ceci Connolly of PricewaterhouseCoopers, experts discussed the evolving role of payers in the R&D ecosystem, focusing on meaningful outcomes, the role of patients, reimbursement, the potential for the Patient-Centered Outcomes Research Institute (PCORI), and how to reduce costs.

Panelists began the discussion by providing insight into the term “value.” Shari Ling of CMS pointed out that in order for there to be value in today’s healthcare system, “outcomes must be meaningful.” Kim Popovits of Genomic Health, Inc. agreed and highlighted the importance of turning data into something actionable. Freda Lewis-Hall of Pfizer brought up a theme heard throughout the Partnering for Cures meeting, that “at the end of the day, outcomes for patients are our currency. Fundamentally, it is all about whether you have significantly affected, improved, and impacted the outcome for the patient that is going to receive the treatment that you are developing.”

The conversation then moved toward the role evidence plays in the R&D spectrum. Patient outcomes dominated the conversation. “Perhaps a meaningful outcome would be the patient’s ability to function,” said Ling. “These are outcomes that are important to patients, but we have no data source so we are a little constrained.” She commented that some of the outcomes measured may not be the most meaningful to the patients. Ling also noted, “Decisions for coverage are predicated on what’s reasonable and necessary to achieve better health outcomes.” Lewis-Hall saw potential for organizations such as PCORI to create tools that can harmonize not only the methodology for data collection and analysis but also a lexicon definition of values so that standards may be developed.

Other panelists focused more on the health economics of the payers’ role. Mark Tykocinski of Jefferson Medical College acknowledged the enormous service PCORI is providing with coding, but reminded the audience and speakers that we need to be aware of where the financial cutoffs are and perhaps question if evidence-based care is worth the costs. Tykocinski spoke of the dangers of continuing down the same path, arguing that “we are seeing a hyper-segmentation of disease categories. With different therapeutics applied to them, the unit costs of individual therapeutics will go through the roof.”

On reimbursement, Popovits called for new innovative approaches to rewarding for quality and revamping how disease is treated, with a greater focus on diagnostics. She argued that this year alone, $80 billion will be spent on cancer therapeutics, “a disease we still do not fully understand.” With an average efficacy of a cancer therapeutic at only 25 percent, this constitutes “a $60 billion waste.”

In closing, Connolly asked each panelist to identify one priority for moving forward. Russell Teagarden, formerly of Medco Health Solutions, Inc., said that there needs to be a “concentrated effort on social learning so we learn [that] … we all have a part in healthcare.” Popovits cited value-based reimbursement and incentives to get there. Ling wished for more effective communications across parties in the R&D ecosystem. Lewis-Hall wanted to see active participation of the payer community in helping find unmet needs and ultimately the implementation of new diagnostic devices, therapies, and treatment paradigms. Tykocinski suggested that the role of physicians will be totally different in the next few years, and it is time to put art back into medicine.

This panel aptly portrayed the complex nature of the payer world. Though there was disagreement among panelists on specific solutions and key points when thinking about coverage, they all agreed on the importance of developing standards for value decisions, and that collaboration among payers, agencies, and companies in the drug development stages was key. In today's R&D ecosystem, payers have the drive to change the current structure of payment and reimbursement and need support on how best to take action.

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