Presentation on theme: "Frank DeFelice, MPA Director Global HTA Public Policy, Merck"— Presentation transcript:
1 Health Technology Assessments and their Impact on Benefit Plans, Considering the Patient Perspective Frank DeFelice, MPADirector Global HTA Public Policy,MerckRoundtable Discussion on UHC in Latin Amercia & the Caribbean: Health Benefit PlansDecember 6, 2013
2 OutlineKey Challenges and Considerations for Universal Health Coverage (UHC)Underlying Success FactorsThe Role of HTA in achieving more optimal patient-centred health systemsHealth Plan Experience with HTALimitations to adopting HTA from other jurisdictions and Essential Elements when considering HTA developmentConclusions2
3 1. Key Challenges to Achieve Universal Coverage Achieving improved access to appropriate services in a fiscally constrained environmentScale of the need for basic health careDemographic changes (e.g. aging)Epidemiological changes such as chronic disease burdenEmerging health technologies …Siloed approach to health technologies, health system, societal impacts, and innovation
4 Underlying Success Factors for UHC: Local Tailoring, Partnership Approach and Evaluation Shared Goal: Expanding access while preserving incentives to innovation and sustainabilityEvery Country is unique and tailored approaches are requiredProgress on UHC will be enhanced by a partnership approach on priority policy areasStandardized evaluation metrics to be developed for stakeholder monitoring of progressEvidence from Research to underpin approachEnhanced data and health information systems are a necessity
5 2. The Role of HTA in Health Benefit Plans HTA has often been seen as a tool to address cost concerns in the health system.HTA when done effectively:addresses a wide range of elements including clinical, patient, and societal impacts.involves stakeholders in key parts of process design and implementationtakes a cross-health system approach (not solely focused on one technology)There are widely accepted best practice principles for HTA.Growing use of HTA globally with variation in approach (QALY-based v. relative assessment of value), application and how utilized (for guideline development, inform reimbursement)
6 HTA/CER System Development Canada – existing HTA evaluation at national and provincial levelUS – new CER system advancingMexico – existing HTA procedure for devices; under development for pharmaceuticalsAustralia – long established HTA systemBrazil – New HTA body put in place to improve transparencySouth Africa – HTA guidelines for pharmaceuticals put in place early 2011Russia – increasing academic community interest in HTAChina – increasing academic community and government interest in HTAJapan – increasing academic community and government interest in HTAKorea – existing HTA evaluation as part of P&R processTaiwan – existing non-mandatory HTA evaluation as part of P&R processThailand – existing HTA department, unclear impact on P&RTurkey – existing HTA evaluation for pharmaceuticals; unclear impact on P&REU – Pan-European assessment under consideration; EUnetHTA advancing ; reform of long-established HTA systems (UK, France, Germany)Established SystemSystem in developmentSystem under consideration666
7 Key HTA Principles: How Widely Are They Adopted?
8 Structure of HTA program + Key PrincipleCMS (US)NICE (UK)IQWiG (Germany)CADTH (Canada)Anvisa (Brazil)DHTA (Taiwan)HIRA (Korea)Structure of HTA program1The goal and scope of the HTA should be explicit and relevant to its use+++2HTA should be an unbiased and transparent exercise3HTA should include all relevant technologies4A clear system for setting priorities for HTA should existMethods of HTA5HTA should incorporate appropriate methods for assessing costs and benefits6HTAs should consider a wide range of evidence and outcomes7A full societal perspective should be considered when undertaking HTAs8HTAs should explicitly characterize uncertainty surrounding estimates9HTAs should consider and address issues of generalizability and transferabilityNotes:“+” 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.
9 Processes for conducting HTA Key PrincipleCMS (US)NICE (UK)IQWiG (Germany)CADTH (Canada)Anvisa (Brazil)DHTA (Taiwan)HIRA (Korea)Processes for conducting HTA10Those conducting HTAs should actively engage all key stakeholder groups++11Those undertaking HTAs should actively seek all available data+12The implementation of HTA findings needs to be monitoredUse of HTA in decision making13HTA should be timely14HTA findings need to be communicated appropriately to different decision makers15Link between HTA findings and decision-making processes needs to be transparent and clearly definedNotes:“+” 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.
10 What elements of HTA are being captured? EUnetHTA Core Model --
11 Achieving more Optimal HTA: Patient-Centred & Innovation integrated a. A focus on the patient is required in health system design andhealth policy development and this extendsto HTA programs and processes.b. Health care policy and program decision-making needsto factor in innovation impacts.If carried out in line with best practiceprinciples, HTA can be a useful tool to achievethe value to patients and societyand to encourage innovation.
12 Towards More Patient Centred Health Care: Putting the Patient First Accountability to:Patients,Citizens,SocietyInformed multi-stakeholderinvolvement including patients,providers, industry is essential
13 What Patient Centred should be The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care*.*Berwick, Don.”What patient centred should mean: Confessions of an extremist, Health affairsMarch 25,2011
14 What is Patient-Based HTA?* HTA Questions HTA ProcessesFocus onPatient’sProblemsAllowing patient participationTakePatient’sPerspectiveBuilding on patient-physician partnershipsAccommodatePatient’sPreferencesEmpowering patient to improve their health*Bridges, John F.P, and Jones C,. Patient-based HTA: A vision of the Future,IJHTAHC, 2007
15 Patient Based HTA**Bridges, John F.P, and Jones C,. Patient-based HTA: A vision of the Future,IJHTAHC, 2007
16 Patients and carers can contribute to HTA: How can patients’ perspectives in HTA be a route to robust evidence and fair deliberation?*Patients and carers can contribute to HTA:By providing evidence about their experiences and preferencesThrough participation in the HTA process*Facey et al. International Journal of Technology Assessment in Health Care, 2010,
17 Patient and Other Stakeholder Involvement Recognized High Level Pharmaceutical Forum (Europe)Highlights the key role of stakeholders including industryStakeholder involvement built in to the HTA process in Ireland (HIQA), Scotland (SMC), & England/Wales (NICE).Importance of Stakeholder involvement recognized in Canada, Australia, and the US.Patient Centred Focus of the Patient-Centred Outcomes Research Institute (PCORI) in the US
18 The full range of perspectives is needed Aim is to have the full range of perspectives considered in HTA processes, with objective assessment that considers all stakeholders views and inputs. This requires a transparent system and education for all stakeholders, including patient advocates and interested health professionals.Most systems invite some stakeholder participation but often exclude contribution at key stages of the evaluation process**A Comparative Analysis of the Role & Impact of HTA, CRA. Report for EFPIA,PhRMA, EuropaBio, and Medicines Australia, 2011
19 Quantifying Patients’ preferences and outcomes in HTA The number of instruments & approaches is growing…EuroQol EQ5D, SF-36, SF-6DDiscrete Choice Experiments*Analytic Hierarchy Process (AHP) –ranking of patient and provider preferences on different endpoints and relative weighting applied**OxPAQ participation & activity measureIncreasing call for patient relevant endpoints (Patient Reported Outcomes (PRO’s))***;Secondary Endpoints e.g. Health Related Quality of Life (HRQL), satisfaction, preferences less impactful***Greater understanding of the data required***.Qualitative aspects may need to be taken further into account*See Professor Mandy Ryan, Chair in Health Economics, Aberdeen University**Danner, M et al. Integrating patients’ views into HTA: AHP as a method to elicit patientpreferences (IQWiG based), IJHTAHC, October, 2011***ISPOR Panel on PRO’s Presentation PROs when & who, November, 2011
20 Patient Access varies considerably across HTA-utilizing nations International – Positive Reimbursement Percentages(Based on all CDR-approved drugs also available in other countries)Drug Reimbursement (Drug Type)Canada’s Reimbursement %International AvgInternational Positive Reimbursement Percentage51%64%First in class (positive reimbursement percentage)40%63%JODR Drugs (subset of “non-CDR” drugs)55%65%Canada CA Ireland IE Scotland SCTAustralia AU Italy IT Slovak Rep. SKAustria AT Israel IL Slovenia SIBelgium BE Japan JP Spain ESCzech Rep. CZ Republic of Korea KR Sweden SEDenmark DK Luxembourg LU Switzerland CHEstonia EE Netherlands NL Turkey TRFinland FI New Zealand NZ United Kingdom GBFrance FR Norway NO USA USGermany DE Poland PL Wales WLSGreece GR Portugal PT* Source: International Report on Access to Medicines 2009/10, Wyatt Health Management for Rx&D20
21 Summary of Key Considerations A patient focus requires:Patient voice in the processPatient Impact AssessedAppropriate value & weighting placed on patient perspective and outcomesTimely & Appropriate Access to Needed New MedicationTransparencyMulti-stakeholder involvement (patients, providers, industry…) in policy design and program implementationHealth Literacy (e.g. HTA Patient Training at LSE)Cross-health system impacts considered (beyond drug budgets)Productivity & Societal Impacts captured and given sufficient weightingInnovation Impact & Value Considered
22 3. Limitations when Considering HTA Development Based on other countries Transferability. Inappropriate transfer of HTA evaluations can result in incorrect decisions, patient access delays to medical advances, and to less efficient use of health care resourcesHTA Capacity(technical expertise & financial resources)Unique country context and prioritiesData capacityDifferences in Comparator, practice patterns of patient population, inadequate reporting…Health Information Systems lacking
23 When is Formal HTA Appropriate? Essential Elements* The health care system should be effective in providing quality services to all citizensThe use of HTA should have a clear objective and be predicated on the current capacity in the existing health systemThere should be adequate financial resources to establish and sustain the HTA systemThere should be an adequate HTA workforceThere should be well functioning health information systemsThere should be clarity in the purpose and process of a proposed HTA systemHTA should be tailored to ensure appropriate customization to the individual characteristics of a country*HTA in Emerging Markets. PhRMA International Position Paper,May 2013
24 4. Conclusions: HTA Development is moving forward but how it is used varies; let best practice principles guide the wayIncreased health care spending, health system reforms to broaden coverage, and growing need to access modern technology gives a strong impetus to HTA*HTA systems are constantly evolving even amongst early adoptersAlthough NICE remains a prominent model, it is also a model in transitionSome forms of HTA are converging but significant methodological issues remain*Despite some convergence of approaches, the motto appears to be “Globalize the evidence, localize the decision”*Adopting widely accepted best practice principles is preferable approach when developing HTA.*CRA,Latin America Industry Workshop Presentation, May 2013
25 Impact of HTA Considering the Patient Perspective Questions or Comments
27 Use of HTA by Private Plans HTA plays an increasing role in translating emerging technologies into clinical practice and policy.Private payers are important users of HTA whose decisions impact adoption and use of new technologies.Payers relied more extensively on HTAs for reviews of personalized medicine (64%) than for other technologies.Most payers (82%) valued expertise of reviewers and rigor of evaluation as HTA strengthsKey reported shortcomings for personalized medicine were limited availability of reviews (73%) and limited inclusion of nonclinical factors (91%), such as cost-effectiveness or adoption of technology in clinical practice.(HTA & private payers coverage of personalized medicine.Am J Manag Care. 2011;17(5 Spec No.):SP53-SP60)
28 Use of HTA among private plans in the US Insurers coverage and reimbursement policies have traditionally lacked sufficient transparencyThe Academy of Managed Care Pharmacy (AMCP) produced its first guidance document on evidence requirements to support formulary listing in 2000.WellPoint released a set of evidence requirements to improve transparency on the type of data required to make value-based, health-care decisions on drug therapy for its members.HTA in Health-Care Decisions in the United States, Value in Health, S. Sullivan et al, Vol 12, 2009
29 Use of HTA among private plans in the US* HTA will continue to evolve to accommodate the needs of health insurers.It will always be shaped in part by the political landscape that will in turn be influenced by public perceptions of HTA as either a system that improves patient care or simply restricts access to promising medical technologies.Such perceptions will influence the level of public financing of HTA, but they will not change the real need that payers have for controlling health spending at the same time ensuring access to effective medical technologies. The medical technology industries will need to grapple with the seeming paradox of meeting regulatory and licensing requirements while building an evidence-base necessary to satisfy health-care payers.The evidence summary reports by organizations such as the Cochrane Collaboration, UK-NICE, DERP, and the CADTH now are more similar than they are distinct. As a result, decision-makers in the United States have begun to rely on these sources in their HTA processes, and are thus less prone to develop ad hoc or nontransparent approaches to evidence appraisal.*HTA in Health-Care Decisions in the United States, Value in Health, S. Sullivan et al, Vol 12, 2009