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1.3.2 Healthcare and Pharmaceuticals
- 1. Hector Castro MD, PhD Senior Technical Director Dec 13, 2017 Essential Medicines List and Reimbursement - Opportunities and challenges-
- 2. SAFEMed Content • The challenges for reaching sustainable Universal Care Coverage (UHC) • Health System Functions • Potential policy solutions: • Health Technology Assessment (HTA) • The use of MCDA • Pricing • Centralized procurement • Conclusions
- 3. SAFEMed The challenge of reaching (sustainable) UHC Total Health Expenditure Breadth: Who is covered? Height What proportion of costs are covered? Extend the base Reduce copays Include services Public Health Expenditure Source: The World Health Report (OMS, 2008), modified by HE, Castro 2014
- 4. SAFEMed Decision-making in health and health care “Decision-making in health care is a complex process taking (should take) place along a continuum that moves from evidence generation to deliberation and communication of the decision made” (Goetghebeur et al, 2008)
- 5. SAFEMed However…“Clinical care given to patients frequently departs from best practice; the fast adoption of new technologies without certainty about its clinical and cost-effectiveness, but also the slow adoption of those proven to be effective and “good value for money”, leads to inefficiency” Decision-making in health and health care Rawlins (1999)
- 6. SAFEMed The Health System Functions 6 Stewardship/Governance PurchasingPoolingRevenue collection Efficiency and Equity in Purchasing Provision Financial AccessibilitySufficient, equitable and efficient revenue collection Provision Resource Generation Financing Rules and implementation by organizations Rules and implementation by organizations Rules and implementation by organizations What services? To whom? At what cost and quantities? Payment
- 7. SAFEMed The Health System Functions - Potential policy solutions- 7 Health Technology Assessment (HTA) The use of MCDA for choosing the list Price control Centralized negotiations/ procurement Others
- 8. SAFEMed What is Health Technology Assessment– HTA ? Health technology assessment is the systematic evaluation of properties, effects, and/or impacts of health care technology. It may address the direct and indirect consequences of health care technologies. Its main purpose is to inform technology-related policy making in health care. HTA contributes to answering questions from decision makers in areas and organizations related to health policy and/or practice. INAHTA definition
- 9. SAFEMed The heritage of HTA Currently more than 54 agencies in 33 countries…and growing as we speak
- 10. SAFEMed Advisory HTA agencies Regulatory HTA agencies AT AU BE CH DE NL NO Eng, Sco, IRL, Col FI NZ SE CA FR • Physicians • Health economists • Pharmacists, clinical pharmacologists • Epidemiologists The role of some HTA agencies •Government/insurance fund representatives • Consumers and public (AU, SE, Eng) •Industry (Eng)
- 11. SAFEMed The potential use of MCDA In recent years Multi Criteria Decision Analysis (MCDA) has emerged as a tool to support complex decision-making in health care, moving beyond evidence generation and cost implications. Multi- criteria methods are designed to help people make better choices when facing complex decisions involving several dimensions. “MCDA are especially helpful when there is a need to combine “hard data” with subjective preferences or make trade- offs that involve multiple decision-makers” (Dolan, 2010). In theory, MCDA allows a structured and objective consideration of factors that are both measurable and value-based in an open and transparent manner (Baltussen et al, 2006).
- 12. SAFEMed Weighting criteria of the MCDA Core Model Cluster Scientific criteria Relative weight Low High Should not be considered Disease impact D1 Disease severity 1 2 3 4 5 0 D2 Size of population affected by disease 1 2 3 4 5 0 Context of intervention C1 Clinical guidelines for intervention 1 2 3 4 5 0 C2 Comparative intervention limitations (unmet needs) 1 2 3 4 5 0 Intervention outcomes I1 Improvement of efficacy/effectiveness 1 2 3 4 5 0 I2 Improvement of safety & tolerability 1 2 3 4 5 0 I3 Improvement of patient reported outcomes 1 2 3 4 5 0 Type of Benefit T1 Public health interest (e.g., prevention, risk reduction) 1 2 3 4 5 0 T2 Type of medical service (e.g., symptom relief, cure) 1 2 3 4 5 0 Economics E1 Budget impact on health plan (cost of intervention) 1 2 3 4 5 0 E2 Cost-effectiveness of intervention 1 2 3 4 5 0 E3 Impact on other spending (e.g, hospitalization, disability) 1 2 3 4 5 0 Quality of evidence Q1 Adherence to requirements of decision making body 1 2 3 4 5 0 Q2 Completeness and consistency of reporting evidence (meeting scientific reporting standards and consistency with sources) 1 2 3 4 5 0 Q3 Relevance and validity of evidence (relevant to decision- makers & meeting scientific standards) 1 2 3 4 5 0 Weighting criteria of the MCDA Core Model Cluster Scientific criteria Relative weight Low High Should not be considered Disease impact D1 Disease severity 1 2 3 4 5 0 D2 Size of population affected by disease 1 2 3 4 5 0 Context of intervention C1 Clinical guidelines for intervention 1 2 3 4 5 0 C2 Comparative intervention limitations (unmet needs) 1 2 3 4 5 0 Intervention outcomes I1 Improvement of efficacy/effectiveness 1 2 3 4 5 0 I2 Improvement of safety & tolerability 1 2 3 4 5 0 I3 Improvement of patient reported outcomes 1 2 3 4 5 0 Type of Benefit T1 Public health interest (e.g., prevention, risk reduction) 1 2 3 4 5 0 T2 Type of medical service (e.g., symptom relief, cure) 1 2 3 4 5 0 Economics E1 Budget impact on health plan (cost of intervention) 1 2 3 4 5 0 E2 Cost-effectiveness of intervention 1 2 3 4 5 0 E3 Impact on other spending (e.g, hospitalization, disability) 1 2 3 4 5 0 Quality of evidence Q1 Adherence to requirements of decision making body 1 2 3 4 5 0 Q2 Completeness and consistency of reporting evidence (meeting scientific reporting standards and consistency with sources) 1 2 3 4 5 0 Q3 Relevance and validity of evidence (relevant to decision- makers & meeting scientific standards) 1 2 3 4 5 0 The potential use of MCDA
- 13. SAFEMed The potential use of MCDA -coverage decision-making-
- 14. SAFEMed The potential use of MCDA -coverage decision-making- Literature review of intervention(s) of interest Published sources, public domain and other information Source: adapted from Goetghebeur et al (2012) HTA report for each intervention of interest Synthesised data organised into MCDA matrix Contextualisation of decision-making criteria Adopt or adapt EVIDEM core criteria Panel perspective Weighting of MCDA decision-making criteria Appraisal of intervention(s) of interest Scoring intervention(s) with respect to MCDA criteria Discussion Feedback on process, policy implications Preparatory stage By investigators/ researchers Panel With decision-makers (relevant health care Stakeholders) SAME AS HTA
- 15. SAFEMed Most beneficial intervention Value = 1* Least beneficial intervention Value = 0 A B C D Contextualimpact QUANTITATIVE MODEL ∑ (Weights X Scores) OPPORTUNITY COSTS & BUDGET MANAGEMENT High value: invest Low value: disinvest Valueofinterventions A C D B RANKING QUALITATIVE MODEL (e.g., cultural context) $1M $0.1M $0.1M $1M BUDGET IMPACT *Linear model for Value; Weights: 6 direct weights elicitation techniques available in EVIDEM v3.0; Scores: generic constructed scales for each criterion (holistic comparability) Deliberation, communication and implementation Investment based on relevance and manage opportunity costs by means of a financial analysis The potential use of MCDA -coverage decision-making-
- 16. SAFEMed Pricing and reimbursement approaches Price regulation • International reference pricing • Internal reference pricing • Value based pricing. Need to align market authorization and HTA Reimbursement • Benefits packages • Centralized negotiation/ procurement • Managed entry agreements
- 17. SAFEMed Limitations of IRP: – Data not always available – Collusion of market prices – Price opacity – Inflexible – Requires infrastructure Pricing and reimbursement approaches -Limitations-
- 18. SAFEMed Price ($) Ex factory cost ($) Current treatment Un regulated IRP VBP Pricing and reimbursement approaches -The future-
- 19. SAFEMed – Opportunities for Managed Entry Agreements (MEAs): ▫ Global trend to reach universal healthcare coverage ▫ Budget constraints ▫ Population transition towards more chronic conditions ▫ Increasing social pressure and mood of accountability ▫ Uncertainty of marginal benefit vs marginal cost of new drugs Thus there is an opportunity for payers and developers to share risks Pricing and reimbursement approaches -The future-
- 20. SAFEMed Pricing and reimbursement approaches -MEAs-
- 21. SAFEMed MEAs international experience- Europe From: Ferrario and Kanavos, 2013
- 22. SAFEMed » Whenever thinking on UHC important to considered who is going to be covered, but also what services, at wat cost and level of co-payment. » Reaching UHC is challenging, but is not only about adding more money to the pot is also about being efficient and choosing wisely. » HTA, MCDA, pricing, MEAs and procurement/ negotiation sole or combined may increase technical and allocation efficiency. » Ukraine is undertaking a regulatory practice that takes into consideration best regulatory practices » Important to also consider additional institutional arrangements or strengthening. i.e. • ex- ante risk adjustment mechanism for pooling? • Separation of roles HTA, DMB, CPB? How to finance these institutions? • Use of MCDA for priority setting (topic selection and also for decision- making)? • Further mechanisms for strategic purchasing. i.e. DRGs, prospective payments, other financial incentives and non financial incentives? Conclusions