Evolving Approaches to Measuring the Value of New Health Technologies in the US
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The document summarizes a presentation given by Dr. Steven Pearson of the Institute for Clinical and Economic Review (ICER) on developing a framework for assessing the value of medical treatments for US health insurers. ICER has created a framework that considers clinical effectiveness, additional benefits, affordability, and other factors to determine a treatment's "clinical care value" and "health system value." ICER engaged stakeholders including insurers, manufacturers, and patient groups to gather input on the framework. ICER aims for the framework to facilitate more transparent and consistent discussions between payers and manufacturers about a treatment's value.
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Evolving Approaches to Measuring the Value of New Health Technologies in the US
- 1. Measuring Attributes of Value: A Framework for Payer Assessments of Treatments in the US DrSteven D Pearson Institute for Clinical and Economic Review Lunchtime Seminar 23 September 2014 • London, Office of HealthEconomics
- 2. Measuring Attributes of Value A Framework for Payer Assessments of Treatments in the United States… “Nonsense on Stilts” or “Fit for Purpose” for the UK? Copyright ICER 2014
- 3. How the US does it today • Current practice in the US – Nearly all drugs are funded for all FDA indications – Prices are set at discretion of manufacturers with standard % discounts for some public insurers – Clinicians have little accountability for quality and even less for the financial impact of treatment decisions – Insurers manage use through • Patient cost-sharing using tiered formularies in which tier placement is determined by price, not “value” • Delegation of negotiating and drug delivery to pharmacy benefit management companies • Prior authorization to restrict use beyond FDA indications • Step therapy (“fail first”) policies Copyright ICER 2014
- 4. So what’s the problem in the US? Copyright ICER 2014
- 5. We Face a Crisis in Healthcare
- 6. Per Capita Annual Growth in Rx and Total Health Spending, 1992–2012 three-year weighted average Source: National Health Expenditure Accounts and U.S. Census Bureau What Crisis?
- 7. Where is the money going?
- 8. Most recent trend: Back to high growth in drug costs?
- 9. Costly, High-Use Drugs on the Horizon PREVALENCE 5.4 million 26 million 71 million 2.7 million ANNUAL COST $35,000 $7,000 $10,000 ~$100,000 Diabetes High Cholesterol Hepatitis C Alzheimer’s
- 10. What’s the problem in the US? • Payers (insurers) in the US becoming less able to pass on cost increases –from any source --to patients or purchasers • The most important payer, Medicare*, is prohibited from considering costs and no dominant approach to judging value exists across private payers or state Medicaid programs • Ongoing disconnect between the view of value between payers and manufacturers • The current scientific and business model for manufacturers is trending toward more high-cost drugs – Payers often do not believe these drugs offer good value to the health care system – Manufacturers worry that payers will tighten their unclear evidence standards ever further and use existing policy tools to restrict access *Editor’s note: Medicare is a taxpayer-funded federal program that covers those 65 and older (and a few others). Medicaid, funded jointly by the state and federal governments, covers the indigent, including some of those 65 and older. Copyright ICER 2014
- 11. Is there a solution out there? • Comparative effectiveness research hobbled by exclusion of consideration of costs • Early efforts of physician specialty societies meeting resistance – American College of Cardiology (cost/QALYs) – American Society of Clinical Oncology (unclear) • Attempt at public shaming over cost of sofosbuvir • More intensive application of existing policy tools – Narrow coverage policies, step therapy, etc. – Increasing cost-sharing for patients – Raising health insurance premiums • Political and policy gridlock Copyright ICER 2014
- 12. The ICER value framework project • The framework includes – Content • A list of elementsto consider – Measurement options • Methods to measure or judge each element – Assessment process • Process by which to integrate measurements and other information in an assessment of overall value • Long range goals – Improve the reliability and consistency of value determinations by payers – Provide the basis for more transparent dialogue between manufacturers, payers, and other stakeholders over considerations of value Copyright ICER 2014
- 13. ICER policy development group • Insurers and Pharmacy Benefit Management Companies – OmedaRx – Kaiser Permanente – Aetna – WellPoint – Premera – America’s Health Insurance Plans (AHIP) • Patient Organizations – FamiliesUSA • Purchasers – Marriott – Maine Health Management Coalition • Manufacturers – National Pharmaceutical Council (NPC) – Covidien – Lilly – GSK – Philips – Amgen – Biotechnology Industry Organization – Merck Copyright ICER 2014
- 14. A value framework for the US payer • Working backwards from the foreseeable actionable use of value in the US system – Used in tiered formularies, VBID – Consistent with clinician and public vernacular – “High” and “Low” value ratings are actionable Copyright ICER 2014
- 15. Elements in a payer assessment of value: Clinical Care Value Comparative Clinical Effectiveness Additional Benefits Contextual Considerations Incremental cost per outcomes achieved Clinical Care Value Copyright ICER 2014
- 16. Elements in a payer assessment of value: Clinical Care Value and Health System Value Managing Affordability Health System Value Clinical Care Value Copyright ICER 2014
- 17. Comparative Clinical Effectiveness • Magnitude of the comparativenet health benefit – How important and patient centered are the outcomes measured? • Level of certainty in the evidence on net health benefit • Measurement options – Disaggregated • Specific clinical outcomes, e.g. disease-specific mortality – Aggregated • QALYs • Need for a categorical summary • ICER Matrix, HAS or IQWiGdegrees of “added clinical benefit” • Incorporation of level of certainty remains a challenge Comparative Clinical Effectiveness Additional Benefits Contextual Considerations Incremental cost per outcomes achieved Clinical Care Value Copyright ICER 2014
- 19. Additional Benefits • Are there benefits of treatment that extend beyond patient-specific healthimprovement? – Reduction in care needed from friends and family, earlier ability to return towork • Will the treatment expand the population that will benefit from treatment? – Allows sicker patients or those with comorbidities to be treated • Does the treatment offer a new or different mechanism of action when significantvariation of treatment effect suggests that many patients who do not achieveadequate outcomes on other treatments may benefit? • Are there other practical advantages related to preparation, storage, or deliveryof the treatment? Comparative Clinical Effectiveness Additional Benefits Contextual Considerations Incremental cost per outcomes achieved Clinical Care Value Copyright ICER 2014
- 20. Contextual Considerations • No other acceptable treatments exist • High severity and/or priority condition • Vulnerable population (e.g. children) • Consensus among professional statementson appropriate use Comparative Clinical Effectiveness Additional Benefits Contextual Considerations Incremental cost per outcomes achieved Clinical Care Value Copyright ICER 2014
- 21. Incremental cost per outcomes • Relative measure – Cost per a single desired clinical outcome • e.g. additional stroke prevented or long-term cancer remission achieved – Cost per aggregated health measure • QALY Comparative Clinical Effectiveness Additional Benefits Contextual Considerations Incremental cost per outcomes achieved Clinical Care Value Copyright ICER 2014
- 22. Clinical Care Value and Health System Value • Affordability = implied risk of clinical opportunity costs andimpact on sustainable access to health insurance – Budget impact on the organization – Impact on overall health care costs measured by potentialimpact on insurance premiums • Managing affordability for interventions of high clinical carevalue is an action step – Changing the payment mechanism (longer terms) and/or price (lower) – Prioritizing Rx populations to reduce immediate cost impact – Finding savings in other areas – Sharing the costs with government or other funders Managing Affordability Health System Value Clinical Care Value Copyright ICER 2014
- 23. Determining Value • Define the elements of value • Measure/judge the elements of value • Integrate the elements of value in a value assessment Copyright ICER 2014
- 24. A “value flowchart” for payers Comparative Clinical Effectiveness AdditionalBenefits ContextualConsiderations regarding the illness and therapy Incrementalcost per outcomes achieved First value rating: “Clinical Care Value” Affordability Second value rating: “HealthSystem Value” Copyright ICER 2014
- 25. High Clinical Care Value andHigh Health System Value: Comparative Clinical Effectiveness AdditionalBenefits Contextual Considerations regarding the illness and therapy Incremental cost per outcomesachieved First value rating: “Clinical Care Value” Affordability Second value rating: “Health System Value” Superior Less important Less important Below comparator or threshold($100K/QALY) High Can be broughtbelow threshold(0.5-1% PMPM) High Incremental Important Important Belowcomparator or threshold($100K/QALY) High Can be brought belowthreshold (0.5-1% PMPM) High Comparable More important Important Below comparator High Can be brought belowcomparator (0.5-1% PMPM) High Copyright ICER 2014
- 26. A test case: Sovaldivs. previous triple Rx Sovaldivs.previoustriple therapy Comparative Clinical Effectiveness AdditionalBenefits Contextual Considerations regarding the illness and therapy Incremental cost per outcomesachieved First value rating: “Clinical Care Value” Affordability Second value rating: “Health System Value” SVR 90% vs. 70% Shorterduration 1.Vulnerable populations 2.Professional guidelines encourage use Costper SVR = $100K Cost per QALY < $50,000 Rx for allknown diagnosed would increasedrug budgets by >10% PMPM by over 15% in first year Superior Less important Less important Below comparator or threshold? High Can be broughtbelow threshold? Low if unable to modulate budget impact High if can reduceshort- term budget impact Copyright ICER 2014
- 27. Low ClinicalCare Value Comparative Clinical Effectiveness AdditionalBenefits Contextual Considerations regarding the illness and therapy Incremental cost per outcomesachieved First value rating: “Clinical Care Value” Superior More important More relevant Incremental cost/key outcome “far higher” than comparator; or Cost/QALY > threshold($150K) Low Incremental More important Morerelevant Cost/key outcome > comparator; or Cost/QALY > threshold ($100-150K) Low Comparable More important More relevant Cost/key outcome > comparator; Cost/QALY not relevant ifclinically comparable Low Promising but Inconclusive More important More relevant Cost/key outcome > comparator; or Cost/QALY > lower threshold ($50K) Low Copyright ICER 2014
- 28. ICER framework vs. NICE • A categorical, part quantitative, part qualitative multi-criteria decision analytic approach • A continuous relative index with potential for internal quantitative weighting and/or some discretion for consideration of social values at the margins • These two approaches are not mutually exclusive Copyright ICER 2014
- 29. ICER framework vs. NICE Attribute ICER value framework NICE Comprehensive in addressing multiple elements of value Consistent across payers Consistent across conditions Transparent Addresses affordability “Cookbook” or “one size fits all” Copyright ICER 2014
- 30. Concluding Thoughts for the US • The conceptual view of value by payersin the US today is dominated by comparative clinical effectiveness and budget impact. • The conceptual view of value by manufacturersin the US is dominated by comparative clinical effectiveness and additional benefits, with a vague nod to cost-effectiveness and disavowal of responsibility for affordability. • If the ICER value framework can convince US payers to integrate cost-effectiveness into their assessments of value, while encouraging manufacturers to think of affordability as a joint challenge, (some) progress will have been achieved. Copyright ICER 2014
- 31. This seminar is one in a series of Lunchtime Seminars that OHE sponsors each year. The Office of Health Economics is a research and consulting organisation that has been providing specialised research, analysis and expertise on a range of health care and life sciences issues and topics for more than 50 years. To keep up with the latest news and research, subscribe to our blog, OHE News. Follow us on Twitter @OHENews, LinkedInand SlideShare. OHE’s publications may be downloaded free of charge for registered users of its website. Office of Health EconomicsSouthside, 7th Floor105 Victoria StreetLondon SW1E 6QT United Kingdom +44 20 7747 8850 www.ohe.org About this seminar