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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

CER Tweets of the Week (April 7-11, 2014)

Collaboration was a popular topic among comparative effectiveness research (CER) stakeholders on Twitter this week. They tweeted about the National...
YouTube Videos

Webinar: CER Collaborative: Tools You Can Use

Collaborative members hosted a webinar explaining how to use the tools they developed to create greater uniformity and transparency when evaluating...
Blog Post

CER Tweets of the Week (March 31- April 4, 2014)

This week, health care stakeholders on Twitter highlighted the many activities and sessions at the Academy of Managed Care Pharmacy’s (AMCP) 26th...
Blog Post

4/8 Webinar on CER Collaborative: Tools You Can Use

The CER Collaborative--a group formed by the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes...
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...
Press Release

NPC, UMD Study: Factors That Cause Different Treatment Responses Are Not Well Understood or Studied

Washington, DC, November 4, 2013—Although researchers and health care providers widely recognize that individuals with stage IV prostate cancer react...
Press Release

National Pharmaceutical Council Statement on Appointment of PCORI Board Chair

Washington, DC, September 19, 2013—The National Pharmaceutical Council (NPC) today released the following statement regarding the Government...
Press Release

National Pharmaceutical Council Studies New Formulary Decision-Making Tool

Washington, DC, August 19, 2013—A National Pharmaceutical Council (NPC) study published in the peer-reviewed journal Pharmacy and Therapeutics...
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...
Commentary and Testimony Page

Living Up to Its Name? The Role of Patient-Centered Research

Anyone who has ever received bad news from his or her health care provider or held a loved one’s hand when a diagnosis was delivered can understand...
YouTube Videos

Webinar: CER Collaborative: Tools You Can Use

Collaborative members hosted a webinar explaining how to use the tools they developed to create greater uniformity and transparency when evaluating...
YouTube Videos

Use of Big and Real-World Data by Pharma: More than Data Warehousing

Real-world data—a subset of big data—is clinical data used for decision-making that did not come from a clinical trial. According to Aaron Galaznik,...
YouTube Videos

Engaging Patients in the Research Process

Dr. Dan Mullins, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, explains why it is important...
YouTube Videos

Engaging Patients in Research

National Pharmaceutical Council President Dan Leonard explains why it's important to include patients throughout the research process. He says that...
Blog Post

CER Tweets of the Week (April 7-11, 2014)

Collaboration was a popular topic among comparative effectiveness research (CER) stakeholders on Twitter this week. They tweeted about the National...
Blog Post

CER Tweets of the Week (March 31- April 4, 2014)

This week, health care stakeholders on Twitter highlighted the many activities and sessions at the Academy of Managed Care Pharmacy’s (AMCP) 26th...
Blog Post

4/8 Webinar on CER Collaborative: Tools You Can Use

The CER Collaborative--a group formed by the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes...
Blog Post

CER Collaborative Rolls Out New Resources to Aid Formulary Decision-Making

A newly published series of peer-reviewed articles developed by the CER Collaborative will help formulary decision-makers more effectively evaluate...

Research

When Is Evidence Sufficient for Decision-Making?

This study outlines influential factors that impact how quickly new medical evidence is adopted and...
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Commentary & Testimony