Incorporating Health Technology Assessment (HTA) in Clinical Trials

Drug development is an increasingly costly enterprise, and one that affects health-care costs to a growing extent. Because governments and reimbursement agencies have been faced by the challenge of controlling soaring health-care expenditures, there has been a growing demand for sponsors to provide evidence of value to support funding, coverage, and reimbursement decisions or price negotiations after a novel agent is approved by regulatory agencies.

The use of health technology assessment (HTA) to inform such decisions is well established in North America, Australia, and in many European countries, and is rapidly growing in other parts of the world. Historically, HTA is performed upon completion of clinical trials and as a subsequent step to drug approval by regulatory agencies.

Given the central role played by clinical trials in generating evidence that can inform clinical practice and reimbursement decisions, HTA is likely to become an integral component of such trials. Therefore, sponsors and clinical trialists need to be increasingly aware of the methods and procedures that may be required in order to obtain useful economic data from clinical trials.

In this webinar, the speakers will:

• Provide an overview of the current use and potential of HTA as a component of clinical trials aimed at regulatory approval of novel agents in various medical fields
• Introduce the general concept of HTA and cost-effectiveness in healthcare
• Discuss how these aspects are becoming an important requirement for market access and how the relevant additional elements can be incorporated and collected in a phase III clinical trial
• Illustrate the presentation with several examples, including clinical trials in which the authors have actively taken part as principal investigators and analysts
• Make tentative conclusions about future directions and the impact of HTA data in the drug-development process

Speakers

Everardo Saad, MD, Senior Medical Expert, IDDI

Dr. Saad, IDDI’s Senior Medical Expert, has over 15 years of experience in Medical Oncology and clinical trial designs. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.

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Oriana Ciani, PhD, Postdoctoral Research Fellow, University of Exeter Medical School; Research and Teaching Fellow, Centre for Research on Health and Social Care Management (CeRGAS), Bocconi University, Milan

She holds an MSc in Biomedical Engineering from Politecnico di Milano and postgraduate degree in Healthcare Management and Economics from Bocconi University. She received her PhD from the University of Exeter with a thesis focusing on the evaluation of surrogate end points in clinical trials and reimbursement policy. Her research interests are centered on the use of evidence synthesis techniques to inform policy decisions and incorporation of economic evidence to inform healthcare policies evaluation.

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Rod Taylor, MSc, PhD, Professor of Health Services Research, University of Exeter Medical School; Director, Exeter Clinical Trials Unit; Senior Investigator, National Institute for Health Research (NIHR), UK

He was the first Director of Technology Appraisals at the National Institute for Health and Care Excellence (NICE), in the UK. He graduated at University of Glasgow, and his postgraduate qualifications include a PhD in Clinical Physiology and an MSc in Medical Statistics. His main research interests include clinical trial design for complex interventions, the use of surrogate outcomes in clinical trials and reimbursement policy, development and evaluation of secondary prevention and rehabilitation strategies for heart disease, and the evaluation of the comparative effectiveness of medical devices.

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