Beating the Comparative Effectiveness Drum Keeping Time with the National Pharmaceutical Council

Celebrating its 60^th year, the National Pharmaceutical Council (NPC) has played a key role in defining and enacting solutions to some of pharma’s most pressing issues. NPC is not a formal trade association, nor is it an academic think tank, its mandate lies somewhere in between. Now, it is committed to a specific focus on Comparative Effectiveness Research (CER) to ensuring collaboration with member companies, PCORI and other government agencies, and patient advocacy organizations to spread the word, ignite conversation and provide a steady drumbeat of new ideas that policymakers will follow in enacting forward-looking legislation.

NPC has stepped out of the shadows in recent years to raise its public profile, drawing attention to the issues it believes deserve discussion. As Pat Adams, Vice President of Business and External Operations at NPC notes, “There was recognition that it’s all well and good to do good work but if nobody notices it, it doesn’t make a difference.”

This was also around the time that NPC began forging ahead of everyone else on the issue of CER. Back in 2007, it started to look at what it would take to put together a large-scale CER program in the United States. The organization also weighed in on opportunities to shape the public debate, providing, in one instance, analysis on reports from the Federal Coordinating Council for Comparative Effectiveness Research (FCCCER) established in 2009 under the American Recovery and Reinvestment Act that established consensus on a definition, criteria, and strategic framework for CER. Additionally, NPC flexed its muscle in providing tools to help member companies develop and evaluate different studies involved in CER, thereby demystifying it for R&D teams.

The NPC’s work has been helpful to the Patient Centered Outcomes Research Institute (PCORI), with which NPC has a close ongoing relationship. “We brief them on how our industry views the issues that they’re undertaking in a constructive fashion,” said Dan Leonard, President of NPC. In an unprecedented move among industry organizations, NPC in 2011 published an article in Health Affairs suggesting how PCORI might go about prioritizing its research. Now, PCORI uses its public funding to look at issues that have been posed by NPC research, for example, studying heterogeneity to understand why medications work on one individual and not another.

NPC is also focusing on the Accountable Care Organizations facilitated by health reform and how they manage medications to reduce overall costs. As Robert Dubois, Chief Science Officer at NPC put it, “Now as providers take on this more holistic responsibility for improving economics and quality, pharma can have a different dialogue, which is, yes, a drug may be more or less expensive, but let’s look at the episode cost and the re-hospitalizations, the need for surgery, etc.  For providers, their bonus is going to be influenced by the frequency of hitting quality benchmarks. Again, drugs can be influential in that regard.” As of last year, NPC has teamed up with the American Medical Group Association (AMGA), Premier Health alliance, and seven provider institutions to examine the role of pharmaceuticals in a more value-based health care system.

While it remains focused on specific issues and how they impact health care in the US, NPC also looks elsewhere for insight and new ways of tackling the same questions. Internationally, NPC has looked at differences in how the UK’s NICE and other government bodies analyze and assess health technologies, establish and implement evidence standards for harmonization, and how CER and other initiatives are effectively executed. In considering the ever increasing role of biotechnology in modern health care practice, NPC is planning to champion studies looking at how biologics and more specialized medicine impact individual treatment effects.

When asked about what to expect moving forward with CER, the NPC says new and interesting developments are under way. “In the next three years, you will see real activity.  There has been preparation the last couple of years on the appropriate way to position CER as a policy tool, and now they’re actually going to start doing it.  So the next couple of years, you will see research projects coming out which we hope will be influential,” said Dubois, particularly in shaping the activities of PCORI and other influential governmental bodies.

Secondly, NPC noted collaboration between pharma companies and payers– such as Pfizer and Humana, and AstraZeneca and Wellpoint to leverage big data in studying comparative effectiveness.  Lastly, providers are combining health information technology with CER to implement what is now being called rapid learning systems, where patients receiving treatments are compared in real-time.