Cost safety modeling strategy-fcd_sep2016
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Cost-safety modeling provides an adjunct to cost-effectiveness analyses by additionally considering safety. The document discusses the developer's experience building cost-safety models for three medical devices at the request of a CRO. Stakeholders were interested in forecasting costs and safety given their own inputs. The conclusion is that cost-safety modeling will become increasingly demanded by risk-averse stakeholders and user-friendly models backed by rigorous methods can provide credibility.
Cost safety modeling strategy-fcd_sep2016
- 1. Cost-safety modeling STRATEGY Occasionally useful adjunct to cost- effectiveness Frederic C. Daoud, MD, MSc, Epidemiologist 1
- 2. BACKGROUND 2Frederic C. Daoud, MD, MSc, Epidemiologist
- 3. Usual models • To summarize data for regulatory submissions, price justification, clinical presentation: – Risk-Effectiveness, – Risk-Benefit, – Cost-effectiveness and – Budget-Impact 3Frederic C. Daoud, MD, MSc, Epidemiologist
- 4. Cost-safety vs Cost-effectiveness • For centuries: "Above all do not harm" ("Primum non nocere"): physicians’ doctrine for centuries • Past decades: Societal demand for improved efficacy and drive for innovation partially inreased focus on efficacy and reduced focus on safety. 4Frederic C. Daoud, MD, MSc, Epidemiologist
- 5. Safety vs. Effectiveness • For centuries: "Above all do not harm" ("Primum non nocere"): physicians’ doctrine for centuries • Past decades: Societal demand for improved efficacy and drive for innovation: Priority focus frequently shifted from safety to efficacy. • Risk-benefit modeling not always intuitive or consensual. 5Frederic C. Daoud, MD, MSc, Epidemiologist
- 6. Recent return to safety regardless of efficacy combined with costs • Legal clinician and institution commitments predominantly about patient safety and budget constraints. • Rarely about efficacy or effectiveness. • Result: GROWING RISK-AVERSION. 6Frederic C. Daoud, MD, MSc, Epidemiologist
- 7. MY RECENT EXPERIENCE 2013 - 2016 7Frederic C. Daoud, MD, MSc, Epidemiologist
- 8. Our CRO asked to develop cost-safety models without efficacy constraints • Three cases with very different types of medical devices – cost-safety model – Jointly with budget impact model. 8Frederic C. Daoud, MD, MSc, Epidemiologist
- 9. Stakeholders asked for versions where they could plug-in their own inputs • Want to forecast their cost-to-safety and budget impact given their own inputs. • Events held as relevant: – treatment-adverse effects – Serious, cost-drivers (death, re-operations, etc.) – Those modifying decision to using the treatment given unacceptable risk among recruitment 9Frederic C. Daoud, MD, MSc, Epidemiologist
- 10. Conclusion • Cost-safety modeling will become increasingly demanded by risk-avert stakeholders • User-friendly models (MS Excel) backed by state-of-the-art template (Bugs, Treeage) and publication useful for credibility • Fundamental need to set up task-forces with Regulatory affairs, Medical Affairs and Market Access. 10Frederic C. Daoud, MD, MSc, Epidemiologist
- 11. Cost-safety models included • Three cases with very different types of medical devices – cost-safety model – Jointly with budget impact model. 11Frederic C. Daoud, MD, MSc, Epidemiologist