Industry Perspective on the Globalization of Health Technology Assessment Health Technology Assessment International Symposium The University of Tokyo Graduate School of Public Policy September 6, 2012 Donald Yin, PhD Associate Vice President & Head Global Health Outcomes Merck Sharp & Dohme Corp.
Agenda Principles for better health care Globalization of HTA Key principles Merck position on HTA Conclusions
Global Principles for Better Health Care Fair access Access to essential health care services and the contributions of individuals towards the cost of these services should be in line with the views of society about fairness. Efficiency The health care system should deliver the maximum improvement in health outcomes given the available resources. Innovation The health care system should encourage appropriate product, diagnostic, therapeutic, administrative and contracting innovation and its optimal application. Responsiveness to society Services delivered and the level of funding should reflect citizens views, based on high quality information. Source: Global Principles for Better Health Care: A Guide for Policy Makers, 2002
Selected Centers for HTAs have existed for a long time 1950s 1980 1990 1999 2000 s s 2001 2002 2003 2004 2005 2006 PBAC Australia Pharmacoeconomic (PE) requirements added in 1993 PHARMAC New Zealand CT France US Office of Technology Assessment (1972 1995) NICE England/Wale s PE requirements added in 2005 CVZ Netherlands PE requirements added in 2005 SMC Scotland CDR Canad a LFN Sweden PE requirements added in SLV 2003 Norway IECS* AHRQ & DERP Argentina CENENTE C Mexico *Although IECS was founded over 10 years ago, formalized HTAs were not used until 2003 PE: Pharmacoeconomics IQWiG Germany DECIT- CGATS Brazil HIRA
HTA Use Is Growing Across Key Markets Over the last 30 years, many countries and particularly those in the European Union (EU) have established HTA systems or are currently developing or considering them. Essentially, HTA has become hard-wired into the reimbursement or coverage decision. HTA agencies typically involve several functions: Coordinating assessments and producing and disseminating reports Advising decision-makers on the reimbursement and pricing of health technologies Taking decisions themselves Emerging markets are implementing HTA bodies in Asia Pacific and Latin America regions It is important to establish key HTA principles of good practice.
Many countries are deploying HTA, but the approach varies significantly by country Canada: major input to provincial formulary decisions - CADTH US: Public sector: DERP for Medicaid programs; AHRQ systematic reviews of CER; Private sector: Hospitals and managed care uses P&T committees. Some commercial plans are also looking at evidence based approaches which incorporate cost effectiveness studies. UK: National Institute for Health and Clinical Excellence (NICE) analyses used to develop positive or negative evaluations of new treatments. Brazil: New MOH group (CITEC) established where companies must now submit costeffectiveness or costbenefit analyses for formulary access Cost-effectiveness Mandatory today and major input Major input in near future Germany: Introduction of AMNOG legislation increases importance of comparative effectiveness evaluations conducted by IQWiG Australia: Required by PBAC to determine reimbursement South Korea: Pharmacoeconomic data has become part of the price negotiation/review process - Reimbursement based on incremental improvements associated with the costeffectiveness of the product
Common HTA Factors in Evaluating New drugs/vaccines Unmet Medical Needs Clinical Benefits & Risks (efficacy, safety, effectiveness) Patient Benefit Disease Burden Budget Impact Cost-Effectiveness Innovative Characteristics of New Product Availability of Alternatives Equity Considerations/Access Public Health Impact
Key Principles for HTA Principles 1-4: Structure of HTA Principles 5-9: Methods of HTA Principles 10-12: Processes for Conduct of HTA Principles 13-15: Use of HTA in Decisionmaking
Key Principles: How Widely Are They Adopted?
Key Principle Structure of HTA program 1 The goal and scope of the HTA should be explicit and relevant to its use 2 HTA should be an unbiased and transparent exercise 3 HTA should include all relevant technologies 4 A clear system for setting priorities for HTA should exist Methods of HTA 5 HTA should incorporate appropriate methods for assessing costs and benefits 6 HTAs should consider a wide range of evidence and outcomes 7 A full societal perspective should be considered when undertaking HTAs 8 HTAs should explicitly characterize uncertainty surrounding estimates 9 HTAs should consider and address issues of generalizability and transferability CMS (US) NICE (UK) IQWiG (Germany) CADTH (Canada) Anvisa (Brazil) DHTA (Taiwan) HIRA (Korea) ++ ++ ++ ++ + ++ ++ ++ ++ ++ ++ + ++ ++ ++ + + + ++ + ++ ++ + ++ + + ++ ++ ++ ++ + ++ ++ + ++ + ++ + + ++ + Notes: + signifies that the organization supported the principle in question in written guidelines or other form, regardless of whether they actually follow it. ++ means that the organization implemented the principle in published reports, and decisions based on these reports demonstrate adoption of the specific principle.
Key Principle CMS (US) NICE (UK) IQWiG (Germany) CADTH (Canada) Anvisa (Brazil) DHTA (Taiwan) Processes for conducting HTA 10 Those conducting HTAs should actively engage all key stakeholder groups ++ ++ ++ ++ ++ 11 Those undertaking HTAs should ++ ++ ++ ++ + + actively seek all available data 12 The implementation of HTA findings needs to be monitored + Use of HTA in decision making ++ 13 HTA should be timely ++ + ++ + + + 14 HTA findings need to be communicated appropriately to different decision makers ++ ++ ++ + 15 Link between HTA findings and decision-making processes needs to be transparent and clearly defined + + ++ ++ HIRA (Korea) Notes: + signifies that the organization supported the principle in question in written guidelines or other form, regardless of whether they actually follow it. ++ means that the organization implemented the principle in published reports, and decisions based on these reports demonstrate adoption of the specific principle.
What Could We Do With These Principles? Identify and encourage best practices Make an example of entities that do it well. Cite studies that are well executed. Engage with international HTA bodies Encourage standard setting for HTA. Advocate for: independence, stakeholder engagement, transparency. Participate in development of new HTA organizations and processes Through experts and with governments, encourage new processes that align with HTA principles.
Basic Merck Position on HTA (1) Merck supports HTA conducted using sound scientific methods and appropriately applied to improve health outcomes for patients and achieve efficiencies in health care. Merck is committed to improvement in the evidence base and the infrastructure for HTA. There is no single optimal HTA model HTA needs to fit the local health care system. Countries creating HTA entities should make them: independent (keeping the science separate from budget considerations); with transparent processes and, broad stakeholder engagement.
Basic Merck Position on HTA (2) The best assessments of effectiveness and value appraisals: Be science-based Consider a full array of alternative interventions Consider a broad range of methodologies, selecting those fit for purpose Are patient-centered Define value broadly economically and socially To encourage innovation, treatments that can demonstrate value need to be: encouraged in medical practice, and reimbursed commensurate with their value.
Merck Principles for HTA Structure Analytical Methods Independence of Analysis Focus on Priority Health Care Issues Evaluation of Reviews Science based Fit for Purpose Explicit and Relevant Goal and Topic All Relevant Technologies Included All Relevant Reliable Data Considered Value Defined Broadly Conduct of Assessments Application in Decision Making Transparency of Process Broad Stakeholder Engagement Sensitivity to Individual Variation Periodic Updating Disclosure of Sources of Bias and Uncertainty Responsiveness to New Data and Methods Timely Findings Effectively Communicated to Decision Makers Decisions Congruent with Findings Reward for Innovation
The Natural History Of HTA Development (Source: OHE/UW PhRMA Emerging Markets Research Project; Jan. 2011) EMERGENCE CONSOLIDATION EXPANSION WHY? Convergence of needs, demands and supply Key individuals Champions of HTA Receptive policy/political environment Early success draws interest of more decision makers Expansion of demand for HTA Formalizing priority setting HTA as part of political discourse Increased demand for diversified products WHAT? HOW? AND THEN WHAT? Narrow interpretation of HTA (cost) Focus on high intensity technology (e.g. Imaging) Modest resources Minimal scientific capacity Knowledge Transfer minimal Efforts directed towards policymakers by means of personal communication Broadening of scope More focus on pharma Shift from specific technologies to care process for management of health conditions Modest addition of resources Research partnerships Progression of KT Broadening of target audience Further broadening of scope (Rx, public health, delivery models) Existing practices and new interventions Significant increase in resources Expansion of scientific partnerships Clinical Practice Guidelines Specialization of KT instruments and increased resources for KT
Points to Consider for Emerging HTA Systems Role of HTA in the health care system? Scope of HTA: applied to medicines only or all health technologies and interventions? Perspective of value broad or narrow? HTA and marketing authorization, timing of HTA Infrastructure, manpower and training HTA processes and stakeholder engagement Budgetary resources for technologies with positive HTA Patient preferences and needs matter in choice of medicine
Conclusions Global principles for better health care include fair access, efficiency, innovation and responsiveness to society. HTA is a multidisciplinary field of policy analysis used to make evidence-based decisions. The key principles for HTA have been well established. However, the adoption of these principles vary widely in different systems. Merck supports HTA conducted using sound scientific methods and appropriately applied to improve health outcomes for patients and achieve efficiencies in health care. We are committed to improvement in the evidence base and the infrastructure for HTA.