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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.
Newsletter Volume

E.V.I.dently: April 2016

MessageValue Assessment Through a Broader, Patient-Focused LensNPC has developed “Guiding Practices for Patient-Centered Value Assessment” to help...
Commentary and Testimony Page

NPC Comments on Revised PCORI Methodology Standards

March 28, 2016Dr. Joe SelbyExecutive DirectorPatient-Centered Outcomes Research Institute1828 L St., NW, Suite 900Washington, DC 20036 Dr. Robin...
YouTube Videos

2016 Comparative Effectiveness Research and the Environment for Health Care Decision-Making

This one-hour webinar highlights the results of NPC's annual survey of comparative effectiveness research (CER) stakeholders and includes a panel...
Newsletter Volume

E.V.I.dently January 2016

MessageThe Importance of Evidence, Value, Access and Innovation in 2016In his annual health care outlook, NPC President Dan Leonard explains why...
Press Release

NPC Comments on CMS’ Announcement to Allow Broader Access to Publicly Funded Databases

(Washington, DC, June 2, 2015)—The National Pharmaceutical Council (NPC) today commented on the Centers for Medicare and Medicaid Services’ (CMS)...
Press Release

State Medicaid Directors Share Views on Comparative Effectiveness Research And Its Impact on Policy in National Pharmaceutical Council Survey

(Washington, DC, April 16, 2015)—A new survey conducted on behalf of the National Pharmaceutical Council (NPC) shows that state Medicaid directors...
Press Release

NPC Highlights Stakeholder Views on Comparative Effectiveness Research and the Environment for Health Care Decision-Making

(Washington, DC, March 26, 2015)—A new survey of health care stakeholders reveals continued optimism that comparative effectiveness research (CER)...
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...
Commentary and Testimony Page

NPC Comments on Revised PCORI Methodology Standards

March 28, 2016Dr. Joe SelbyExecutive DirectorPatient-Centered Outcomes Research Institute1828 L St., NW, Suite 900Washington, DC 20036 Dr. Robin...
Commentary and Testimony Page

The Importance of Evidence, Value, Access and Innovation in 2016

Last year, in our 2015 Health Care Outlook published in Chain Drug Review, I highlighted the recent announcement by the U.S. Department of Health and...
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...
YouTube Videos

2016 Comparative Effectiveness Research and the Environment for Health Care Decision-Making

This one-hour webinar highlights the results of NPC's annual survey of comparative effectiveness research (CER) stakeholders and includes a panel...
YouTube Videos

Comparative Effectiveness Research and the Environment for Health Care Decision-Making

During a March 26, 2015 webinar, the National Pharmaceutical Council discussed the results of its annual stakeholder survey on comparative...
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...
Blog Post

Key Considerations for Cost Effectiveness Thresholds

While putting a price tag on the value of health care services and the life years gained is common in countries including the United Kingdom, Canada...
Blog Post

CER Tweets of the Week: JCER Editorial on Treatment Sequences in Oncology; JNCCN Discusses CER Database Analyses (December 14-18, 2015)

What were comparative effectiveness research (CER) stakeholders talking about on Twitter this week? Popular topics included the Journal of...
Blog Post

Can We Work Together to Ensure Patient Access to Treatments and Encourage Innovation?

Is it possible for all health care stakeholders to work together to develop solutions for containing costs that ensure patient access to care and...
Blog Post

Pharmaceutical Innovation’s Role in the Panorama of Health System Improvement and Population Health

When he announced the launch of the White House Precision Medicine Initiative, President Obama said, “If we have the opportunity to prevent hurt and...
cersurvey16

2016 Comparative Effectiveness Research and the Environment for Health Care Decision-Making

NPC's sixth annual survey of stakeholder views on comparative effectiveness research (CER) and the...

Developing Evidence that is Fit for Purpose: A Framework for Payer and Research Dialogue

A study published in the September 2015 issue of The American Journal of Managed Care introduces a...
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