Opportunity and Challenge

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Cory Reeves
5 years ago
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1 Opportunity and Challenge Implementation of Comparative Effectiveness Research: The Patient Protection and Affordable Care Act Dr. Ellen V. Sigal, Chair & Founder, Friends of Cancer Research

2 Comparative Effectiveness Research (CER) in Health Care Reform Patient Protection and Affordable Care Act Enacted March 2010 Establishes the Patient Centered Outcomes Research Institute (PCORI) Non-profit corporation outside Federal Government Board of Governors appointed by the Comptroller General (GAO) Directors of NIH and AHRQ; 17 members appointed by the Comptroller General; 3 members representing patients and health care consumers; 5 members representing physicians and providers, 3 members representing private payers; 3 members representing pharma, device, & diagnostic; 1 member representing quality improvement of independent health researchers; 2 members representing Federal Government or the states, including at least 1 member representing a Federal health program or agency. Dr. Ellen V. Sigal, Chair & Founder, Friends of Cancer Research

3 Patient Centered Outcomes Research Institute 15 Member standing Methodology Committee- (Appointed by Comptroller General) Also includes Directors of NIH and AHRQ Goal: to develop methodological standards for research Permanent or ad hoc advisory panels (Appointed by PCORI): Identify research priorities Establish the research project agenda Carry out randomized clinical trails Panels to include representatives of practicing and research clinicians, patients, and experts. The Institute may also include a technical expert of each manufacturer or each medical technology included under the panel s relevant topic Dr. Ellen V. Sigal, Chair & Founder, Friends of Cancer Research

4 Some Early Concerns / Risks to Cancer Care How to make sure this is set up well and scientifically rigorous. Meta-analysis has the potential for biased findings due to limitations in the data and methods. Cost Based Thresholds Impact Access UK NICE Patient-Physician Decisions Role of Quality of Life Assessment Will focus of limited research budgets shift from discovery to comparison of existing therapies?

5 Enhancing the Capacity for CER Data Generation: While CER generally should employ study methods as necessary, advanced infrastructure is needed to collect better data as a process of care. Data Collection: Efforts should be taken to develop an electronic interface to link disparate data sources that builds data over time. Data Analysis: Secondary analysis of data can help identify information gaps and generate hypotheses for further clinical study. Health Outcomes: Identifying characteristics that contribute to greater benefit and less toxicity- personalized medicine.

6 The need for coordination of new and existing CER efforts: Role of Federal Health Agencies in CER AHRQ & NIH- Leadership roles and preference for studies CMS, VA, FDA, DoD Interagency Government Collaboration Role of Private and Non-Profit Players Professional/Medical Societies: AACR, ASCO, NCCN, AACI Drug and Device Manufacturers Academic Research Centers Public/Private Partnerships: Reagan-Udall, FNIH- OMOP Commercial payors/ plans/ employers

7 The direction of future CER Studies in Oncology Institute of Medicine Identified Cancer-Related CER Priorities: Management strategies for localized prostate cancer $358k to Memorial Sloan Kettering (ARRA) Methods of breast and colorectal Screening $394k to Massachusetts General- CT Scan Colorectal Cancer (ARRA) $432k to Dana-Farber- Early Detection for Breast Cancer (ARRA) Use of imaging technologies in diagnosis, staging and monitoring patients Compare genetic and biomarker testing in preventing and treating breast, colorectal, prostate, lung and ovarian cancer and other Conditions for which promising biomarkers exist. $2m to Kaiser Research Institute- Genomic and Personalized Medicine for Colon Cancer (ARRA) Use of surgical resection, observation or ablative techniques in patients with liver metastases.

8 Implementation Not without Challenges United States Preventive Services Task Force Guidelines Guidelines from the task force (Nov. 09) recommended that: Mammograms begin at age 50 instead of age 40, and end at age 74. Recommendation for annual screenings change to every other year. Concern over possible coverage implications of recommendations. More research is necessary to more accurately capture an individual woman s risk of breast cancer. "What is clear is that there is a great need for more evidence, more research and more scientific innovation to help women prevent, detect, and fight breast cancer, the second leading cause of cancer deaths among women. - HHS Secretary Kathleen Sebelius (Nov. 09)

9 Moving Forward: The research community can influence the direction of CER both at an individual and organizational level The cancer community has a robust infrastructure for CER already and can and should serve as a model to all diseases. Be proactive moving forward, and make sure our voices are heard. If the experts that are versed in these topics don t stand up this could result in poor or negative outcomes. We must be forceful and engaged in all steps in this process to make sure the right questions are being asked, to get the best information possible for patients and their doctors.

Comparative Effectiveness in Health Care Reform. Carrie Hoverman Colla, Ph.D. Dartmouth Medical School Norris Cotton Cancer Center

Comparative Effectiveness in Health Care Reform Carrie Hoverman Colla, Ph.D. Dartmouth Medical School Norris Cotton Cancer Center Doctors and cancer patients often face uncertainty about which treatment