On April 3, 2009, public testimony on comparative effectiveness
research was given at a meeting of the National Advisory Council
for Healthcare Research and Quality. The testimony represents
the views of the presenter and not necessarily those of the Agency
for Healthcare Research and Quality (AHRQ) or the Department
of Health and Human Services (HHS).
The Council provides advice and recommendations to the Director,
AHRQ, and to the Secretary, HHS, on priorities for a national
health services research agenda.
April 2, 2009
Public Comment Submission to:
Coordinator of the National Advisory Council
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, Maryland 20850
Delivery via E-mail
Re: Submission of Public Comments on Comparative Effectiveness Research to AHRQ's National Advisory Council
Dear Ms. Queenan:
AstraZeneca Pharmaceuticals LP (AstraZeneca) is pleased to submit the following comments on Comparative Effectiveness Research (CER) to the Agency for Healthcare Research and Quality's (AHRQ) National Advisory Council (NAC) for consideration at their meeting on Friday, April 3, 2009.
AstraZeneca is a leading global healthcare company dedicated to the research and development of new medicines in therapeutic areas including cardiovascular, gastrointestinal, oncology, respiratory, and neuroscience. AstraZeneca is committed to the discovery of drugs that will allow patients to lead longer, healthier and more productive lives, and to supporting scientifically robust research that improves the delivery of effective, high-quality care to patients. AstraZeneca is also committed to patient health; including helping ensure that patients have access to the most appropriate therapies in the most appropriate setting.
Healthcare reform is a top priority for our nation's policy makers. As a company that puts "patient health first," AstraZeneca believes that today's discussions – whether about healthcare coverage or healthcare costs - are important steps toward enhancing patient health and improving the quality of healthcare in the United States.
AstraZeneca believes CER, the comparison of one diagnostic or treatment option to one or more others, is an important component of healthcare reform. The goal of CER is to conduct or support research to evaluate and compare the clinical outcomes, effectiveness, risk and benefits of two or more medical treatments and services that addresses a particular medical condition. CER offers the promise of improving healthcare quality and outcomes by making it easier for patients and their doctors to choose the best treatment or treatments through evidence-based decisions. Yet, given today's financial challenges and political dynamics, AstraZeneca is concerned that CER could be used to deny coverage or reduce payments for interventions, thus limiting patient access to treatment options.
At AstraZeneca, we are committed to ensuring that patients and their health care providers have the best information available to support their decisions regarding treatment. In support of that commitment, we have been, and continue to be, engaged in CER activities. To ensure patients and their health care providers receive the most value from CER, AstraZeneca is proud to share the principles that guide our discussions related to this issue:
Focus on improving individual patient outcomes rather than short-term, population-based cost control.
Drive, Not Limit Innovation
Encourage the development of innovative healthcare interventions and not be utilized as the sole rationale for product approval, coverage, pricing, or reimbursement decisions.
Research Across All Interventions
Employ rigorous, transparent research methodologies applied across the range of healthcare interventions and treatment modalities.
In addition, AstraZeneca believes:
- The current decentralized approach to conducting CER in public and private settings has yielded highly useful information in an efficient manner.If CER is centralized, it should be a public/private partnership, funded from both public and private sources, focus on the patient, and be distinct from any organization making coverage and policy decisions.
- Funds applied to CER should focus on diseases where there is a significant burden to the patient and the health system. For example, the impact of providing better care to patients with chronic diseases such as diabetes, asthma and heart disease, could be profound if the breadth of research includes comparative benefit designs, prevention programs, delivery systems and medical and behavioral interventions.
- CER offers the promise of improving healthcare quality and outcomes by making it easier for patients and their doctors to choose the best treatments.
- CER, when focused on clinical-effectiveness and not short-term cost-effectiveness, will encourage the development of innovative interventions.
AstraZeneca thanks you for the opportunity to comment on CER. We look forward to continuing to engage in a thoughtful dialogue around this important component of the future of our healthcare delivery system in the US. Please do not hesitate to contact me at (302) 885-4287 or Frank.Kondrad@AstraZeneca.com if you have any questions.
Director, Health Care Relations
External Medical Relations
Policy, Legal and Scientific Affairs,
1800 Concord Pike
Wilmington, DE 19850-5437
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