Npc | Evidence. Value. Innovation
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Additional resources online: NPC MEMBERS
2 0 0 9
www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
on
OUR MISSION
ati
Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
ov
Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
Inn
Bristol-Myers Squibb Company www.bms.com
Evid
Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
e
Bayer HealthCare Pharmaceuticals pharma.bayer.com
Val u
AstraZeneca LP www.astrazeneca-us.com
ence
contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
Patients
Additional resources online: NPC MEMBERS
2 0 0 9
www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
on
OUR MISSION
ati
Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
ov
Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
Inn
Bristol-Myers Squibb Company www.bms.com
Evid
Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
e
Bayer HealthCare Pharmaceuticals pharma.bayer.com
Val u
AstraZeneca LP www.astrazeneca-us.com
ence
contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
Patients
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE) Initiative, and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medicine Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporates in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington, DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE), and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medical Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporated in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE) Initiative, and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medicine Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporated in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington, DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work. Dan Leonard, President, leads NPC in bringing the biopharmaceu-tical industry’s technical expertise and applied scientific knowledge to considerations of evidencebased medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceuticals Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
Additional resources online: NPC MEMBERS
2 0 0 9
www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
on
OUR MISSION
ati
Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
ov
Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
Inn
Bristol-Myers Squibb Company www.bms.com
Evid
Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
e
Bayer HealthCare Pharmaceuticals pharma.bayer.com
Val u
AstraZeneca LP www.astrazeneca-us.com
ence
contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
Patients
2 0 0 9
www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
on
OUR MISSION
ati
Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
ov
Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
Inn
Bristol-Myers Squibb Company www.bms.com
Evid
Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
e
Bayer HealthCare Pharmaceuticals pharma.bayer.com
Val u
AstraZeneca LP www.astrazeneca-us.com
ence
contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
Patients
Additional resources online: NPC MEMBERS
2 0 0 9
www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
on
OUR MISSION
ati
Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
ov
Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
Inn
Bristol-Myers Squibb Company www.bms.com
Evid
Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
e
Bayer HealthCare Pharmaceuticals pharma.bayer.com
Val u
AstraZeneca LP www.astrazeneca-us.com
ence
contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
Patients
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE) Initiative, and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medicine Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporates in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington, DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE), and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medical Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporated in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work.
OUR APPROACH
NPC is a policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC focuses on research development, information dissemination, education and promotion of the critical issues of evidence, innovation and the value of medicines for patients. The issues we select for examination and the researchers and academics we partner with position NPC as a uniquely credible and trusted voice in the biopharmaceutical research and health policy communities. NPC is working to: l Ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice; l Demonstrate and promote the contribution of innovative medicines to optimizing health and wellness for patients and the entire health care system through scientific analyses and fact-based communications; l Maintain a focus on the issues related to advancing the science and research aspects of the biopharmaceutical industry and preserving and improving an environment supportive of innovation.
In shaping NPC’s research agenda and professional programming, we access the expertise of health outcomes researchers, clinicians, market experts, and other industry leaders. The resulting research and educational events demonstrate how the appropriate use of biopharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. In carrying out our patient-centric mandate, NPC engages with a targeted range of stakeholders, focusing on research standards and methods for evidence generation, interpretation, and application that will improve patient outcomes while sustaining and enhancing innovation and the value of biopharmaceuticals. For more than half a century, we have actively responded to changes in the biopharmaceutical environment and contributed to informative research in this arena. As we look to the future, NPC will continue to anticipate the issues, produce strong, evidence-based research and education, build new partnerships, and demonstrate the benefits of new medicines to patients and to society.
Robust Research Agenda Focused on Evidence, Value, Innovation
NPC’s research agenda has three core areas of focus: evidence, value and innovation. Evidence – Current efforts focus on Comparative Effectiveness Research (CER), including examining international models for possible lessons learned as the United States continues its exploration into the development of a CER framework. Recent NPC research in this arena includes published reports on:
variety of health care stakeholders, including patients, clinicians, payers and policy makers.
National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.?, The Current Evidence-Based Medicine Landscape, Principles of Good Practice for Comparative Effectiveness Observational Studies (GRACE), and Health Technology Assessment Organizations in Other Countries and U.S. Implications. Value – As the United States looks for ways to ensure more value from medicines, NPC has undertaken several studies examining this issue. The research we conduct and commission is focused on enhancing understanding of the overall clinical and economic value of prescription medications and the contributions of those medications to improved health and productivity among patients. Examples include recent studies on Value-Based Insurance Design to raise awareness and understanding of its value as health reform initiatives progress, and on Health and Productivity as a Business Strategy, which will contribute to understanding the full costs of health care for employers. Innovation – NPC believes strongly in the importance of fostering an environment that sustains and enhances innovation to ensure the continued discovery and development of new medicines to improve patient health. This focus on innovation cuts across all streams of NPC-sponsored research. One recent study, for example, focused on how pharmacogenomics may impact the future costs, risks and returns on research and development, as well as incentives to invest in new research.
NPC educational events include: Town Hall Meetings – explore emerging issues of importance to the biopharmaceutical industry, such as valuebased insurance design and evidence-based medicine, and help member companies and other health care stakeholders better understand and translate research findings into everyday life; some are videotaped and made available to member companies as educational tools; Corporate Roundtables – brief member companies and key stakeholders on industry issues, emerging trends, and related research;
NPC-sponsored research publications are available online at www.npcnow.org.
Topical Educational Events
NPC’s professional programming advances the public dialogue by drawing on the biopharmaceutical industry’s science base and expertise as a resource for reducing uncertainty in care decisions and improving outcomes for patients. Topical educational events seek to introduce the industry’s perspective and expertise to inform the discussion and generate momentum around key issues. NPC’s Annual Forum, held each fall in Washington, DC, offers a substantive program on issues of interest to the biopharmaceutical industry and a
Forums/Symposiums – feature recognized health care and biopharmaceutical industry leaders; recent events include NPC’s “Entering a New Era of Evidence,” and an NPCsponsored symposium at ISPOR on mapping the current CER landscape. NPC often works in partnership with other organizations – among them the Center for Medical Technology Policy (CMTP), Pragmatic Approaches to Comparative Effectiveness (PACE) Initiative, and the Institute for Clinical and Economic Review (ICER) – to contribute strategic and scientific input on critical issues such as comparative effectiveness research. And NPC researchers, members, and staff also play a prominent role on professional educational programs sponsored by other organizations addressing key stakeholder issues, including the U.S. Chamber of Commerce, Health Industry Forum, and the Translational Medicine Alliance.
More Than Half a Century of Expertise
1950s National Pharmaceutical Council incorporated in New York City (1953) NPC focuses on educating states about the problem of unauthorized substitution of non-FDA-approved products at the pharmacy level
1960s NPC launches annual pharmacy internship program with American Pharmacists Association (1959)
NPC develops “Compilation on State Welfare Drug Programs,” which would later become the annual “Pharmaceutical Benefits Under State Medical Assistance Programs” (1963) NPC moves its headquarters to the metropolitan Washington, DC area (1965)
NPC works with states to examine open drug programs versus closed formularies; electronic data processing systems developed through this effort were later adapted by the federal government and acknowledged in the publication, “Medicaid Management Information System”
1970s
1980s
1990s
As non-FDA-approved drugs remain a factor, NPC expands educational efforts with consumer organizations, medical and pharmacy students and their related organizations, and federal agencies
NPC sponsors first national symposium on the issue of medication compliance, featuring then Surgeon General C. Everett Koop; produces several major publications and develops widely viewed public service announcement with professional tennis player Arthur Ashe focusing on noncompliance
NPC hosts educational forums to increase public awareness and understanding of pharmaceuticals, the industry, and related issues; to assist member companies in speaking about the value of pharmaceuticals, produces video, “Spread the Word,” that receives a Telly Award for excellence in communications (1993)
2000s NPC launches Managed Care Health Outcomes Project; findings suggest that closed formulary restrictions might have unintended consequences on the quality of health outcomes (1996)
NPC develops research papers focusing on the contribution of new drugs to improved health and reduced medical spending, and on the clinical needs of subpopulations
NPC hosts first annual member forum (1999)
NPC launches educational project, Your Pharmacy Benefit, to help consumers understand, choose and use the pharmacy benefits under private insurance and Medicare Part D (2006)
NPC NOW NPC turns focus to evidence-based medicine and comparative effectiveness research issues; grows staff resources to address new industry challenges (2007) NPC rapidly expands research portfolio, partnerships, and communications activities in the areas of evidence, value and innovation (2009)
www.npcnow.org
Dan Leonard, President, leads NPC in bringing the biopharmaceutical industry’s technical expertise and applied scientific knowledge to considerations of evidence-based medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceutical Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
NPC Leadership NPC leadership and staff bring a variety of experience from within the biopharmaceutical industry, government health and regulatory agencies, academia, and advocacy groups to our work. Dan Leonard, President, leads NPC in bringing the biopharmaceu-tical industry’s technical expertise and applied scientific knowledge to considerations of evidencebased medicine, comparative effectiveness reviews, evaluation and application. A veteran association executive and communications strategist with more than 20 years of experience in strategic communications, legislative management, politics and broadcast journalism, his previous health care industry experience includes serving as executive vice president of advocacy and professional services for America’s Health Insurance Plans (AHIP). Gary Persinger, Vice President, Health Services Research, coordinates NPC’s research and other activities related to the value of medicines and the contribution of innovation to value. He also provides expertise on research design and data analysis for NPC’s research portfolio. As NPC initiated its focus on evidence-based medicine and comparative effectiveness, he developed projects to establish a sound basis for this new focus. Prior to joining NPC, Mr. Persinger served as Vice President for Research and Information Services at the Pharmaceutical Research and Manufacturers of America.
Les D. Paul, MD, MS, Vice President, Clinical and Scientific Affairs, is responsible for coordinating NPC’s strategic focus on evidence-based medicine (EBM) for health care decision making, helping to facilitate dialogue between the biopharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. Dr. Paul also provides clinical and scientific expertise for NPC’s other research projects. Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Prior to joining NPC, his professional experience included senior medical affairs positions at Novartis Pharmaceuticals Corporation, AstraZeneca, and Medco Health Solutions. Patricia L. Adams, Vice President, Business Operations and External Affairs, is responsible for the overall operations of NPC, including member relations, external affairs, educational programs, and communications. Ms. Adams works closely with the NPC President and the scientific staff to ensure the smooth operation of research activities and educational programs for public and private payers and health care policymakers.
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
Additional resources online: NPC MEMBERS
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www.npcnow.org
Eli Lilly and Company www.lilly.com Johnson & Johnson www.jnj.com Merck & Co., Inc. www.merck.com Novartis Pharmaceuticals Corporation www.novartis.com
NPC sponsors, participates in and promotes scientific analyses of the appropriate use of biopharmaceuticals, and the clinical and economic value of improved health outcomes through innovation. NPC actively participates with a variety of health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based applications and tools.
NPC’s monthly electronic newsletter focused on evidencebased medicine and related research relevant to the biopharmaceutical industry
NPC’s strategic focus is on evidence-based medicine (EBM) for health care decision making to ensure that patients have access to high quality care.
Pfizer Inc www.pfizer.com sanofi-aventis www.sanofi-aventis.com Schering-Plough Corporation www.schering-plough.com Takeda Pharmaceuticals North America, Inc. www.tpna.com Teva Neuroscience www.tevaneuroscience.com
1894 Preston White Drive | Reston, VA 20191-5433 www.npcnow.org
1894 Preston White Drive Reston, VA 20191-5433 Evidence-Based Medicine Ensuring patients receive appropriate care based on individual needs and conditions through decision making that uses the best available scientific and clinical knowledge
1501 M Street, NW Suite 650 Washington, DC 20005 Phone: 703.620.6390 Fax: 703.476.0904 www.npcnow.org
www.npcnow.org
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OUR MISSION
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Eisai Inc. www.eisai.com
E.V.I.dently Evidence. Value. Innovation
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Daiichi Sankyo, Inc. www.daiichisankyo-us.com
The National Pharmaceutical Council (NPC) is the credible and trusted voice of the biopharmaceutical industry on the critical issues of evidence, the value of medicines for patients, and innovation.
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Bristol-Myers Squibb Company www.bms.com
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Boehringer Ingelheim Pharmaceuticals, Inc. www.boehringer-ingelheim.com
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Bayer HealthCare Pharmaceuticals pharma.bayer.com
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AstraZeneca LP www.astrazeneca-us.com
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contains a wealth of information about the biopharmaceutical industry’s most pressing issues, including a research and publications library and daily news updates
Abbott Laboratories www.abbott.com
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