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Framing the Debate- Untangling the Potential Impact of Comparative Effectiveness Research on Innovation

Investment in comparative effectiveness research (CER) -- including $1.1 billion of new federal funding appropriated in the American Reinvestment and Recovery Act and the creation of the Patient-Centered Outcomes Research Institute -- has sparked interest from a range of stakeholders on how this research will be structured, disseminated, and used. At the core of this debate is the important question of how CER investments will shape incentives for bringing new therapies to market -- the effect on pharmaceutical innovation investment decisions. It is critical that policy makers and the public understand the links between public policies in this area and product development decisions that may impact development and access to new pharmaceutical technology. To address this issue, researchers convened a roundtable of public and private payers, clinicians, and academic researchers. Researchers then integrated that expert insight into their own market research and constructed a framework of topics and questions that policymakers and stakeholders must consider in anticipating the full impact of CER on innovation:

  • CER Generation: How does the way in which CER is generated affect the knowledge and attitudes of payers, providers, and patients toward using the information in decision-making?
  • CER Application: What is the role of CER findings on public and private payer coverage decisions? What types of CER do physicians currently use when making treatment choices? Is the availability of CER in key therapeutic areas associated with further specificity and differentiation in the type of recommendations presented in clinical guidelines?
  • Pharmaceutical Development and Societal Health Outcomes: How does the integration of CER into clinical practice affect the types and timing of product development investment decisions made in the development and commercialization of medical products? Do different policy constructs shaping clinical practice lead to different product investment decisions?

Potential Comparative Effectiveness Research Impact on Innovation

  • Untangling the potential impact of CER on innovation must be multi-dimensional and will require better understanding of the type of CER that will be developed and how it will be used by an array of decision-makers.
  • When policymakers change how government evaluates medical products, they will change the kinds of studies that are developed to support registration and marketing. This framework is meant to help guide policy and commercial decision-making to achieve an appropriate balance.
  • A CER framework should encourage innovation as well as improve health outcomes for patients. To ensure those goals, we need to address how CER will be generated, disseminated, and integrated by key healthcare stakeholders.
Blog Post

Specialty Pharmaceutical and Patient Care: Are We at a Tipping Point?

Last month, the Academy of Managed Care Pharmacy (AMCP) Foundation hosted a symposium, “Specialty Pharmaceutical and Patient Care: Are We at a...
Blog Post

CER Tweets of the Week: #OHRP’s Informed Consent Guidelines, @AHRQNews On Real-World Primary Care Evaluation (November 10-14)

This week on Twitter, comparative effectiveness research (CER) stakeholders shared the New England Journal of Medicine’s (@NEJM) paper on the concept...
Blog Post

CER Tweets of the Week: #ISPORAmst, PCORI and Health Affairs to Talk Patient Engagement (November 3-7)

What were comparative effectiveness research (CER) stakeholders tweeting about this week? We saw a lot of chatter about the International Society for...
Commentary and Testimony Page

NPC Comments on PCORI Proposal for Peer Review of Primary Research and Public Release of Research Findings

November 7, 2014Dr. Joe SelbyExecutive DirectorPatient-Centered Outcomes Research Institute1828 L St., NW, Suite 900Washington, DC 20036Dear Dr....
Press Release

NPC Study Outlines When & How Health Decision-Makers Should Consider Individual Patient Differences

Washington, DC (July 29, 2014)—New research led by the National Pharmaceutical Council (NPC) can assist health care stakeholders to understand when...
Press Release

Specialty Medications: Shifting the Focus From “How Much” We Spend to “How Well” We Spend

Washington, DC, June 9, 2014—As health care decision-makers grapple with how to ensure access to specialty medications, the University of Michigan...
Press Release

NPC Annual Stakeholder Survey: Comparative Effectiveness Research Is Important, But Impact on Health Care Decision-Making Is Still on the Horizon

(Washington, DC, May 19, 2014)—A new survey of health care stakeholders reveals continued optimism for the use of comparative effectiveness research...
Press Release

CER Collaborative Improving Health Outcomes Through New Comparative Evidence Tools

(Washington, DC, March 24, 2014)—Three peer-reviewed articles published in Value in Health offer important guidance to aid formulary decision-makers...
Commentary and Testimony Page

NPC Comments on PCORI Proposal for Peer Review of Primary Research and Public Release of Research Findings

November 7, 2014Dr. Joe SelbyExecutive DirectorPatient-Centered Outcomes Research Institute1828 L St., NW, Suite 900Washington, DC 20036Dear Dr....
Commentary and Testimony Page

The State of CER and the Environment for Health Care Decision Making

This month, NPC released its third annual survey on stakeholders’ views on comparative effectiveness research (CER), “The State of Comparative...
Commentary and Testimony Page

Keeping Our Eye on the CER Ball

Until the cherry blossoms begin to bloom later next month, most of the water cooler conversations in Washington will focus on the federal budget....
Commentary and Testimony Page

Leveling the Playing Field? Could a Landmark Decision Alter the CER Communications Landscape?

A growing chorus of voices is publicly sharing data on the effectiveness of treatment options, but one viewpoint has long been shut out of key areas...
YouTube Videos

Health Technology Assessments and Specialty Medications

David Grainger, senior director, global public policy, Eli Lilly and Company, says that there are often challenges in conducting health technology...
YouTube Videos

Differences in Global Health Technology Assessment

David Grainger, senior director, global public policy, Eli Lilly and Company, describes how health technology assessment (HTA) informs policy and...
YouTube Videos

Incorporating Patient Views Into Health Technology Assessments

David Grainger, senior director, global public policy, Eli Lilly and Company, explains that many health technology assessments are incorporating...
YouTube Videos

Real-World Impact of Comparative Effectiveness Research Findings on Clinical Practice

National Pharmaceutical Council Chief Science Officer Robert W. Dubois, MD, PhD, discusses a peer-reviewed study suggesting that changes are needed...
Blog Post

Specialty Pharmaceutical and Patient Care: Are We at a Tipping Point?

Last month, the Academy of Managed Care Pharmacy (AMCP) Foundation hosted a symposium, “Specialty Pharmaceutical and Patient Care: Are We at a...
Blog Post

CER Tweets of the Week: #OHRP’s Informed Consent Guidelines, @AHRQNews On Real-World Primary Care Evaluation (November 10-14)

This week on Twitter, comparative effectiveness research (CER) stakeholders shared the New England Journal of Medicine’s (@NEJM) paper on the concept...
Blog Post

CER Tweets of the Week: #ISPORAmst, PCORI and Health Affairs to Talk Patient Engagement (November 3-7)

What were comparative effectiveness research (CER) stakeholders tweeting about this week? We saw a lot of chatter about the International Society for...
Blog Post

CER Tweets of the Week (October 27-31): #mindqualitygap, PCORnet's First Pilot Trial

Health care stakeholders tweeted from the October 30 conference, “Mind the Gap: Improving Quality Measures in Accountable Care Systems,” co-sponsored...

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