ANNOUNCING REAL-WORLD EVIDENCE COLLABORATIONS
PPD and HealthCore Build on Existing Collaboration to Include PPD’s Evidera Business Unit, Expanding Real-World Research Capabilities
August 25, 2017 – PPD and HealthCore are building upon their existing collaboration to include Evidera, PPD’s peri- and post-approval business unit. The addition of Evidera will help enable the companies to address post-marketing safety commitments in Europe and the US, and expand the relationship to include other studies evaluating outcomes in real-world settings.
PPD and HealthCore first established this collaboration in 2015 to enable both companies to further expand their research services in the pre- and post-approval research market. PPD’s acquisition of Evidera, a leading provider of evidence-based solutions, in 2016, introduces new possibilities for collaboration and greater levels of real-world evidence development.
The collaboration now combines PPD’s global operations capabilities and expertise in clinical trial design and implementation, Evidera’s ex-US capabilities in health economics and outcomes research (HEOR) and epidemiology and knowledge of global real-world evidence requirements and HealthCore’s US-based strengths in pragmatic clinical trials, HEOR, drug safety, innovative real-world research designs and robust research-enabled electronic health care data environment.
“HealthCore is proud of our strong twenty-year presence within the US,” said Mark Cziraky, vice president of research at HealthCore. “Partnering with PPD and Evidera in this way instantly globalizes our capabilities.”
“We are excited to bring our respective scientific expertise and experience together to design the best possible studies,” said Radek Wasiak, vice president and general manager of real-world evidence at Evidera. “We will leverage HealthCore data where appropriate, Evidera’s knowledge of data sources and real-world evidence methods, and PPD’s global operations capabilities to collect data. We are actively collaborating on several studies, and seek to expand the breadth, scope and impact of the current collaboration over time.”
As payers and providers increasingly require real-world evidence of product performance, this collaboration promises to help enable biopharmaceutical companies to address these requirements in pre- and post-approval settings, and generate evidence in a manner that is both quick and cost effective.
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PPD and HealthCore collaborate to deliver enhanced pre- and post-approval research services
WILMINGTON, NC and WILMINGTON, DE — June 15, 2015
Pharmaceutical Product Development, LLC (PPD) and HealthCore, Inc., have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients demonstrate more quickly and cost effectively how their products will perform and benefit patients in the real world.
The collaboration brings together two well-respected organizations and aligns complementary strengths to address the need for real-world evidence, one of the faster-growing aspects of clinical research. It combines PPD’s clinical trial design, health economics and outcomes research (HEOR), medical affairs research and epidemiology services with HealthCore’s strengths in HEOR, innovative real-world research designs and its robust research-enabled electronic health care data environment.
“The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies’ ability to provide high-quality evidence of how products will perform for patients in a real-world setting,” said Michael Pollock, vice president of real-world outcomes at PPD. “With the collaborative expertise of PPD and HealthCore, particularly in planning, designing and implementing pragmatic clinical trials, we hope to set a new standard for the quality, cost and speed of real-world evidence generation that can help optimize patient outcomes and enable our clients to better demonstrate the true value of their products and the return on their investments in new product development.”
The collaboration allows life sciences companies to engage in one contract with combined services from PPD and HealthCore that has the potential to cover product research in both pre- and post- approval settings. Both PPD and HealthCore will be able to provide biopharmaceutical companies analyses of medical claims data and electronic health records necessary to understand the utilization and impact of their products and to design appropriate pragmatic clinical trials that address payers’ needs.
“By combining clinical and economic information and leveraging our access to large health care provider networks, we will have a much more robust view of how patients use and react to different therapies,” said Marcus Wilson, president of HealthCore. “This gives us an opportunity to produce relevant information that can facilitate decisions and speed to market those products that provide the most value to patients, payers and life sciences companies alike.”
The majority of post-approval pharmaceutical research includes HEOR, as life sciences companies seek to generate real-world outcomes as part of their cost-effectiveness analyses. Payers are requesting more real-world evidence to help them analyze product safety and effectiveness. As a result, companies are undertaking more pragmatic clinical trials and other Phase IV studies to meet the payer need for real-world outcomes data and to support appropriate reimbursement.
“There’s a certain level of efficiency and understanding that the two companies will gain from working together on research designs at an earlier point in the development process,” said Mark Cziraky, vice president of research for HealthCore. “This approach allows us to evolve the evidence while operationally offering seamless, one-stop research shopping to life sciences companies.”
Eli Lilly and Company, Anthem, Inc. and HealthCore, Inc. create research collaboration to improve health outcomes
INDIANAPOLIS, IN — Dec. 8, 2014
Eli Lilly and Company, Anthem, Inc. and HealthCore, Inc. announced today that they have formed a five-year, real-world evidence research collaboration intended to improve health outcomes for patients.
The companies will jointly develop and conduct research projects in health outcomes and real-world evidence in areas of mutual interest. Each party will bring distinct and valuable contributions to the collaboration, including the U.S. provider and patient environment, research capabilities, therapeutics and methods expertise, and integrated, re-searchable data.
“Delivering high-quality outcomes for patients is a goal Lilly shares with Anthem and with all stakeholders in the healthcare system,” said Tim Garnett, senior vice president and chief medical officer at Eli Lilly and Company. “The need has never been greater to translate an ever-increasing amount of complex data into targeted and meaningful information that enables better decision-making by patients, healthcare professionals and industry.”
The collaboration allows the organizations to explore research opportunities across disease states and incorporate surveys and other information from providers and patients. “
This collaboration with Lilly and ultimately patients and providers as well, will enable us to answer fundamental questions in science and clinical care,” said Dr. Sam Nussbaum, Anthem chief medical officer and executive vice president. “By using this research and knowledge to address gaps in care, we can improve patient health and reduce the human and financial impact of illness.”
Payers, physicians, and patients are looking for the most holistic evidence package for any technology, and this includes both clinical trial information as well as real-world evidence. This evidence will enable better decision-making and optimize health outcomes. However, several peer-reviewed studies have demonstrated that it takes an average of 17 years for research evidence to reach clinical practice.
“We’re looking at practical approaches to accelerate the speed at which we can develop evidence in the general population, as well as specific populations, so that we can get this information in the hands of
clinicians and benefit patients earlier,” said Mark Cziraky, vice president of research at HealthCore, the
outcomes research subsidiary of Anthem, Inc.
Boehringer Ingelheim, WellPoint and HealthCore Announce First Project
Under Multi-Year Research Collaboration. First collaborative research project to identify gaps in non-valvular atrial fibrillation research, development and treatment
RIDGEFIELD, Conn. and WILMINGTON, Del. — Nov. 14, 2014
Boehringer Ingelheim Pharmaceuticals, Inc.(BIPI), WellPoint and HealthCore, announced today that the companies are commencing a research project to identify and address unmet medical needs across populations of mutual interest.
The first stage of the project will focus on non-valvular atrial fibrillation (NVAF) and will examine disease prevalence, treatment complications, such as hospital readmissions, and the use of evidence-based guideline. This project is the first under the parties’ five-year research collaboration agreement, signed earlier this year.
Information gathered through the NVAF project is intended to provide the basis for the collaborative development of healthcare interventions, which can be evaluated within WellPoint’s affiliated health plans and provider networks.
“This collaborative approach allows us to look at problems collectively,” said Mark Cziraky, vice president of research of HealthCore, a wholly-owned subsidiary of WellPoint. “It’s this holistic approach to identifying the needs of all stakeholders that will allow us to produce the kind of information used to develop therapies and interventions that provide the most value to members, providers, insurers and medical product developers and manufacturers.”
The five-year collaboration will enable HealthCore, WellPoint and BIPI to generate real world evidence and develop health economic and outcomes data to inform the development and evaluation of new medicines, guidelines and interventions. Together, the companies plan to explore issues related to appropriate use of existing and new therapies
and interventions and the impact these have on clinical and economic outcomes that matter the most to patients. BIPI and HealthCore are focusing on NVAF first because the entry of newer anticoagulant therapies, after more than five decades of warfarin use, presents an important opportunity to understand how NVAF is being managed in a new era of treatment.
“At Boehringer Ingelheim, our mission is to create medicines that offer real value to patients, payers and providers in an ever-changing healthcare environment,” said Jeff Huth, senior vice president, Managed Markets, Boehringer Ingelheim Pharmaceuticals, Inc. “In order to best serve patients and key customers, we must better understand how medications are being used in real clinical settings, how disease management is evolving, where there are gaps in care and adherence, and whether medical guidelines are being followed.”
WILMINGTON, Del. — February 2, 2011
AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), today announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease.
The research, which will include prospective and retrospective observational studies on disease states as well as comparative effectiveness research, will analyze how medicines and treatments already on the market are working in a number of disease areas, with a special emphasis on chronic illnesses. It also will provide insight into the types of new therapies most needed for treating and preventing disease.
“We are seeking to answer a fundamental question with this research: How can we improve overall patient health while lowering the total cost of care – especially in the treatment of chronic diseases?” said James W. Blasetto, MD, AstraZeneca vice president of U.S. strategic development. “In doing so, the research will help drive the development and delivery of medicines with clear value to patients and payers, creating an opportunity to change the focus of the healthcare conversation from cost to value.”
Dr. Blasetto also noted that AstraZeneca, and HealthCore will seek to expand the collaboration into a broader healthcare consortium with public and private organizations, accelerating efforts to integrate community health information and enhance community health. The agreement reflects the growing interest among healthcare decision-makers to assess clinical and cost effectiveness through comparative effectiveness research and related “real-world” analyses.
Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.
A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.
“With this partnership, we will identify, evaluate and incorporate new data into the existing research environment, allowing us to combine our collective data, analytics, disease expertise, and scientific rigor to produce real-world studies that can help improve health and reduce costs,” said HealthCore President Marcus Wilson. “AstraZeneca, with its deep expertise in chronic disease and progressive views on collaboration, makes it an ideal partner in this initiative.”
“In an era of advancing medical knowledge in pharmacogenomics and the dawn of personalized medicine, it will be increasingly important to understand why drugs are more effective in certain individuals,” said WellPoint Chief Medical Officer Dr. Sam Nussbaum. “While we want to focus on prevention, the mainstay of treatment of chronic illness is the effective use of drug therapy to reduce the consequences of these illnesses. This collaboration with AstraZeneca and, ultimately, provider partners, will enable us to answer fundamental questions of clinical science and, most important, clinical care. This will allow improved health and well being and ultimately reduce the human and financial impact of illness.”
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
About HealthCore, Inc.
HealthCore, Inc., based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the “real world” safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to www.healthcore.com.
About Anthem, Inc.
Anthem is working to transform health care with trusted and caring solutions. Our health plan companies deliver quality products and services that give their members access to the care they need. With over 73 million people served by its affiliated companies, including nearly 40 million enrolled in its family of health plans, Anthem is one of the nation’s leading health benefits companies. For more information about Anthem’s family of companies, please visit www.antheminc.com/companies.
For more information about HealthCore’s Research Collaborations, please contact one of our experts:
Mark Cziraky, VP, Research
Brooke Paige, Staff VP, marketing, communication and alliance management