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Role of HEOR in Decision Making: Global Knowledge for Local Application

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Role of HEOR in Decision Making: Global Knowledge for Local Application Role of HEOR in Decision Making: Global Knowledge for Local Application September 20, 2018 Role of HEOR in Decision Making: Global Knowledge for Local Application Dan Malone, RPh, PhD, FAMCP Darrin Baines, PhD Sherif Abaza, MBA Ola Ghaleb Al Ahdab, PhD University of Arizona Bournemouth University Syreon Middle East Ministry of Health and Prevention Tucson, AZ, USA Poole, United Kingdom Egypt United Arab Emirates Role of HEOR in Decision Making: Global Knowledge for Local Application Dan Malone, RPh, PhD, FAMCP University of Arizona Tucson, AZ, USA United States Pharmaceutical Value Frameworks Daniel C Malone, PhD, FAMCP Professor, University of Arizona United States Healthcare Spending High Costs of Oncology Drugs In 2015, growth in oncology expenditures was 23.7% due to increases in utilization (9.3%) and unit costs (14.4%)1 Median Monthly Cost for New Cancer Drugs at Time of Approval2 3 1. Express Scripts. 2015 Drug Trend Report, March 2016. http://lab.express-scripts.com/lab/drug-trend-report. 2. ASCO. The State of Cancer Care in America, 2016: A Report by the American Society of Clinical Oncology. Journal of Oncology Practice. 2016;12(4):339-383. 3. Tefferi A, et al. Mayo Clin Proc. 2015;90(8):996-1000. Can we afford drugs for rare diseases? 99 Harvard Business Review $750,000 per year for SMA treatment United States Pharmaceutical Value Frameworks • American Society for Clinical Oncology (ASCO) • Memorial Sloan Kettering Cancer Center (MSKCC) DrugAbacus • National Comprehensive Cancer Network (NCCN) Evidence Blocks • Institute for Clinical and Economic Review (ICER) • American College of Cardiology / American Heart Association ACC/AHA Framework Label Thresholds Qualifying Statements High < $50,000 / QALY gained Better outcomes at lower cost (dominant) or threshold value Intermediate $50,000 to $150,000 / QALY gained Low > $150,000 / QALY gained Uncertain Insufficient data to draw conclusions Not Value not assessed by guideline assessed committee Source: Journal of the American College of Cardiology 2014; 63(21):2305-2322 ACC/AHA Framework • Association developed framework • Focusses on guidelines to drive physician/patient decision making • Limited to cardiovascular conditions • Not drug specific American Society of Clinical Oncology ( ASCO) Framework – Version 2.0 Source: Journal of Clinical Oncology: Published Ahead of Print on May 31, 2016 as 10.1200/JCO.2016.68.2518 ASCOA SCOValue ValueFramework: Framework: Summary Summary Advanced disease scoring schematic Clinical Benefit (pts vary) Toxicity (20 pt max) Bonus (pts vary) Yes HR for death Calculate HR Score reported? for death Number of grade 1/2 No AEs Data showing No 100 pt max QoL benefit or long- • <10% (0.5 pts) term survival Yes • ≥10% (1 pt) Median OS advantage? Calculate OS Score Number of grade 3/4 reported? AEs • <5% (1.5 pts) No No max • ≥5% (2 pts) Yes Yes Report HR for PFS Calculate HR Score Calculate Score Results reported? for PFS • % difference between regimens x 20 (20 pt max) No 80 pt max • Subtract from clinical Apply bonus points: benefit if more toxic, add Yes 1. Tail of the curve (20 pt Median PFS if less toxic max) Calculate PFS Score reported? 2. Palliation bonus (10 pts) 3. QoL bonus No No max (10 pts) 4. Treatment-free interval Yes bonus Symptomatic (no max) RR reported? Calculate RR Score unresolved toxicities at 1 year 70 pt max (deduct 5 points) AE = adverse event; OS = overall survival; PFS = progression-free survival; RR = response rate. Schematic based on Schnipper LE, et al. J Clin Oncol. 2016;10.1200/JCO.2016.68.2518. ASCO Framework • Focus on Provider – Patient decision process • Goal: • “standardized approach to assist physicians and patients in assessing value of a new drug treatment for cancer as compared to one or several prevailing standards of care” • Limited to oncology directed treatments (“pharmaceuticals”) • Sophisticated algorithm to calculate “net health benefit score” Source: Journal of Clinical Oncology: Published Ahead of Print on May 31, 2016 as 10.1200/JCO.2016.68.2518 ASCO Frameworks • Net Health Benefits • Net Health Benefits (Advanced Cancer) • Clinical benefits (Adjuvant Cancer) • Hazard ratio for death • Clinical benefits • Median overall survival • Hazard ratio for death • Hazard ratio for progression- • Median overall survival free survival • • Median progression-free Hazard ratio for disease-free survival survival • Median disease-free survival • Response rate • Toxicity • Toxicity • Bonus points • Bonus points • Tail of the curve • Tail of the curve • Palliation of symptoms • Cost • Quality of Life • Treatment-free interval • Cost Clinical Benefits (Advanced Disease) Outcome Calculation method Hazard ratio for death 1-HR X 100 Overall survival (OS) Difference in percentage survival X 100 Hazard ratio for progression- 1-HR X 100 X 0.8 free survival (PFS) Median progression-free Difference in percentage PFS X 100 X 0.8 survival (PFS) Response rate (complete RR X 100 X 0.7 response + partial response) Note: Only one attribute is allowed Source: Journal of Clinical Oncology: Published Ahead of Print on May 31, 2016 as 10.1200/JCO.2016.68.2518 Toxicity Calculate toxicity for each relevant adverse event from clinical trial experience Grade 1 or 2 Toxicity Grade 3 or 4 Toxicity Frequency < 10% > 10% < 5% > 5% Points 0.5 points 1.0 points 1.5 points 2.0 points • Sum all toxicity scores across the events for each treatment arm • Toxicity score = Difference in toxicity scores X 20 • If treatment is more toxic than comparator – subtract score from clinical benefit score • If treatment is less toxic than comparator – add score to clinical benefit score Source: Journal of Clinical Oncology: Published Ahead of Print on May 31, 2016 as 10.1200/JCO.2016.68.2518 Tail of the Curve Bonus Points (Advanced Disease) • Identify the time point on the survival curve that is 2X the median OS or PFS of the comparator regimen. • If >50% improvement in patients alive at this time point • Assuming > 20% survival with comparator • + 20 points if Overall Survival (OS) • + 16 points if Progression-Free Survival (PFS) Source: Journal of Clinical Oncology: Published Ahead of Print on May 31, 2016 as 10.1200/JCO.2016.68.2518 ASCO Value Framework: Presentation of Results ASCO results reflect a cost-consequence analysis • Results • Clinical benefit, not score • Toxicity (points for each regimen), not score • Net Health Benefit (NHB) score • Bonus points are not included • Cost (for each regimen) • There is no single measure of value (eg, value-based price, ICER) Schnipper LE, et al. J Clin Oncol. 2016;10.1200/JCO.2016.68.2518. ASCO Value Framework: Pros and Cons Pros Cons • Methodological transparency, • Calculator not yet available (only algorithm available score sheet, which is more • User can conduct own analysis, challenging to use) not reliant upon framework • Trial comparator and endpoints can developer have a significant impact on clinical • May encourage cost discussion benefit score between providers and patients • NHB score not meaningful by itself • Includes points for patient QOL and cannot be compared across drugs • Includes patient out-of-pocket costs • Toxicity points may not capture value (in addition to total acquisition • Does not include medical costs costs) • Difficult to use with single-arm trials MSKCC DrugAbacus: Summary The DrugAbacus price is a value-based price based on the user’s preferences regarding the price components Higher Price Cost of Population Dollars per Unmet Price Toxicity Novelty develop- Rarity burden of Prognosis Abacus life year need Component ment disease price (good value if actual price Measure Measure Measure of lower than Non- Life year Frequency High, Measure Measure of based on based on cost based Abacus price) modifiable gain (LYG) and medium, or based on LYs lost due # of median on size of Price from severity low based incidence to the treatments survival clinical Component clinical trial of AEs on MOA of disease disease in NCCN without the Actual trials (MSKCC) guidelines treatment Price X X X X X X X = User WTP User max User User User User User User Modifiable Abacus Price per LYG: discount multiplier multiplier multiplier multiplier multiplier multiplier Component $12,000 – from 0% – from 1.0 – from 1.0 – from 1.0 – from 1.0 – from 1.0 – from 1.0 – price (user) $300,000 30% 3.0 3.0 3.0 3.0 3.0 3.0 (poor value if actual price higher than Patient treatment Product development Disease Patient Abacus price) outcomes characteristics characteristics need Lower Price MSKCC DrugAbacus: Pros and Cons Pros Cons • Online availability and easy-to-use • Lack of methodological user-friendly tool transparency, not easy to replicate • Focus on value-based price analyses potentially useful to payers and • Not up to date, new drugs on market have not been policymakers incorporated • Wide range of value metrics • Toxicities are underweighted included in the tool, captures broader societal perspective • Does not include QOL • Allows users to conduct an • Does not include full regimen costs (only costs of listed drug) analysis reflective of their own preferences regarding the value • User preferences can be modified to justify almost any price metrics ICER – Institute for Clinical and Economic Review A non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system. Source: https://icer-review.org/ ICER’s EvaluationICER’s ProcessEvaluation Process Figure 1. New Conceptual
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