NPC Reflects on Changes in 2010

It’s been a year of great change not only for the biopharmaceutical industry, but for the National Pharmaceutical Council as well. With these changes come great opportunities, and with the groundwork we set in 2010, NPC is well-positioned to address these opportunities in the coming year.

The most significant change was the passage of health reform legislation and establishment of the Patient-Centered Outcomes Research Institute (PCORI), which will develop and fund comparative effectiveness research (CER). NPC commented throughout the policy process on the guiding principles for the PCORI, and all the concepts espoused by NPC were incorporated into the final legislation. These included recommendations to ensure that CER will encompass all health care services, be rigorous and transparent, consider the needs of subpopulations, and utilize a full range of types and sources of evidence (see NPC’s key considerations document).

Now that the PCORI Board of Governors has been named, NPC is actively working to develop research and materials aimed at understanding related CER science and policy issues. Among these efforts, NPC developed the Patient-Centered Outcomes Research Institute Resource Guide, a well-received and widely shared document that outlined PCORI’s concepts and provided biographical information for each member of the Board of Governors.

CER Highlights in 2010

  • Patient-Centered Outcomes Research Institute established under the Patient Protection and Affordable Care Act
  • American Recovery and Reinvestment Act set out $916.9 million in obligated funding for CER projects
  • Multiple stakeholder involvement seen in CER efforts
  • Shifted from awareness of CER to definable action
  • Multiple public and private entities are actively engaged, including National Institutes of Health, the Agency for Healthcare Research and Quality, and the Institute of Medicine, among others
  • Many conferences held on CER
  • More than 1,500 peer reviewed articles on CER published
  • Guidance documents for how CER should be conducted published by the Agency for Healthcare Research and Quality, International Society for Pharmacoeconomics and Outcomes Research, Center for Medical Technology Policy, and others
  • CER now entails a broad spectrum of activities: analysis of current evidence, conduct of new studies, and dissemination of the information to influence care decisions

To foster a better understanding of the issues related to CER among health care stakeholders, NPC hosted, sponsored and participated in several conferences, town halls and corporate roundtables this year. In June, NPC brought together the Health Industry Forum, America’s Health Insurance Plans, and the BlueCross BlueShield Association as sponsors of a symposium on CER. This well-attended event brought in leading experts to discuss the challenges with conducting and communicating CER, as well as how policy makers, payers, and patients consider the research findings.

This event was followed in October with the successful Health Affairs issue and briefing on CER. This standing room only event, sponsored by NPC and other health care organizations, featured leading CER experts, and the policy journal included two NPC-sponsored research articles focused on evidentiary standards and observational research.

Supporting our educational efforts, NPC saw several research initiatives published this year, many of which generated public interest through presentations at a variety of conferences. One research initiative, the Good ReseArch for Comparative Effectiveness (GRACE) principles, has even been endorsed by technical groups such as the International Society for Pharmacoepidemiology (ISPE) and featured in leading peer-reviewed journals. Other research focused on the value of health outcomes continued to be broadly disseminated among policy makers, payers, and member companies. Additionally, NPC significantly increased the number of projects under way, and these are closely aligned with and support our overarching goals.

This year NPC also enhanced our infrastructure and communications tools via our updated website,, featuring an interactive members section, videos and regularly updated features. In October, we publicly launched the CER Daily Newsfeed, the only daily, consolidated source of news and information on CER. We also strengthened our staff with the addition of Dr. Robert (Bobby) Dubois as our Chief Science Officer. Already, Bobby has implemented a number of changes and is helping to move NPC’s policy research forward, particularly in the area of CER methodologies.

Clearly, we were busy in 2010, but our efforts have helped to prepare us for 2011 and the anticipated growth in CER and for answering the many related policy and methodology questions through sound and credible research.

We wish you all a safe and wonderful holiday season and New Year, and are excited about what the future will bring for NPC and our members.

Dan Leonard, NPC President