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Economics and precision medicine. Two sides of the same coin?

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di Chiara Demartini, University of Pavia and Fondazione IRCCS Policlinico San Matteo
Slide utilizzate nella lecture del ciclo "La medicina di precisione: opportunità terapeutiche e responsabilità pubblica", tenuta in Fondazione Giannino Bassetti a giugno 2018.
Qui report e video: https://www.fondazionebassetti.org/it/focus/2018/08/la_sostenibilita_economica_del.html

Published in: Science
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Economics and precision medicine. Two sides of the same coin?

  1. 1. Economics and precision medicine. Two sides of the same coin? Chiara Demartini University of Pavia Fondazione IRCCS Policlinico San Matteo Fondazione Giannino Bassetti – 7 June 2018 1
  2. 2. 2
  3. 3. Agenda oThe PM momentum oThe «revolution» of PM oFunding issues oEconomic incentives to PM oSustainability of PM oEconomic challenges in PM 3 C. Demartini – Economics and precision medicine – 7 June 2018
  4. 4. A definition of PM 4 Although the US National Research Council explicitly includes the concepts of precision and accuracy in its definition of precision medicine, and we can paint both concepts in a genomic context, neither quite captures the essence of precision medicine as currently defined. The current definition — understanding disease at a deeper level in order to develop more targeted therapy — clearly requires genomic tools that are both accurate (the genome is represented faithfully) and precise (repeating the same test multiple times leads to the same result). (Ashley, 2016: 508; Nature Reviews Genetics) C. Demartini – Economics and precision medicine – 7 June 2018
  5. 5. PM momentum Some conferences around the world on PM (in 2018 only!) 5
  6. 6. PM momentum Some conferences around the world on PM (in 2018 only!) 6
  7. 7. PM momentum Some conferences around the world on PM (in 2018 only!) 7
  8. 8. PM as a revolution? Efficacy of treatment Prevention Advancing science inequality Profits for industries Patient autonomy Economic growth New patients for old drugs Healthcare efficiency limited health value of genetic information economic cost Exagge- ration of benefits Marcon et al. (2018; Genetics in Medicine) 8 increase d inequali ties increase d inequali ties increase d inequali ties increase d inequali ties
  9. 9. To fund or not to fund? GB: £600 mio US2016: $215 mio China: $9.2 billions (in 15 yrs) Can: $200 mio Italy: € 5 mio 9 EU: €2.4 billions (in 3 yrs) C. Demartini – Economics and precision medicine – 7 June 2018
  10. 10. UK Precision Medicine Catapult: what went wrong? The Catapult has been set up to build on the UK’s expertise in the field of precision medicine and to help UK businesses to develop world-leading products and services. Belfast Cardiff Glasgow Manchester Oxford Leeds Cambridge http://www.phgfoundation.org/blog/UK-precision-medicine-catapult-what-went-wrong-%3F 10
  11. 11. How economics can shape PM PM Innovation incentives Price Access Biomarkers and Diagnostics Stern et al. (2017; Science) 11
  12. 12. Innovation incentives BIOMARKER MARKET REDUCTION 12 C. Demartini – Economics and precision medicine – 7 June 2018 What can we do to foster innovation?
  13. 13. Incentives for «orphan» diseases FDA definition: orphan diseases are those affecting fewer than 200,000 people 13 BIOMARKER C. Demartini – Economics and precision medicine – 7 June 2018
  14. 14. Incentives for «orphan» diseases TAX CREDITS (50% of trial costs) EXTENDED MARKET EXCLUSIVITY (7 yrs) EXPECTED PROFITABILITY 14 2015: 47% of approved new drugs were ORPHAN DRUGS Growth strategies Off-label use or further trials for larger population Cumulative innovation (new orphan drugs) C. Demartini – Economics and precision medicine – 7 June 2018
  15. 15. Incentives for non-orphan diseases 15 BIOMARKER INCENTIVE Fast track Priority review Breakthrough therapy Accelerated approval pathway 1 2 C. Demartini – Economics and precision medicine – 7 June 2018
  16. 16. How economics can shape PM PM Innovation incentives Price Access Biomarkers and Diagnostics Stern et al. (2017; Science) 16
  17. 17. Pricing Low competition → high prices Prices reflective of high-tech industry Higher efficacy → higher prices vs comparator High R&D → drug selection 17 C. Demartini – Economics and precision medicine – 7 June 2018
  18. 18. How economics can shape PM PM Innovation incentives Price Access Biomarkers and Diagnostics Stern et al. (2017; Science) 18
  19. 19. Biomarkers and Diagnostics 19 CYSTIC FIBROSIS LUNG CANCER CLINICAL TRIAL (PREDICTIVE) ENRICHMENT C. Demartini – Economics and precision medicine – 7 June 2018
  20. 20. Biomarkers and Diagnostics 20 CLINICAL TRIAL (PREDICTIVE) ENRICHMENT DRUG EFFECTIVENESS (by enriching a subpopulation of 25% of the overall disease population → sample size efficiency of 16x) HIGHER PRICES (to the segmented population) SAVINGS FOR PAYERS (incentives for additional demand for biomarkers to reduce the excess of use of high-cost drugs) COMPANION DIAGNOSTICS (in-house vs outsourcing)
  21. 21. How economics can shape PM PM Innovation incentives Price Access Biomarkers and Diagnostics Stern et al. (2017; Science) 21
  22. 22. Access • PM pipeline (effects on trial costs and time-to-market) 22 C. Demartini – Economics and precision medicine – 7 June 2018 (AIFA, 2017) (Chandra et al., 2018; NBER)
  23. 23. A fifth pillar? Sustainability • New financial instruments, like mortgages, to spread the costs of high-value, high-price treatments over time (Cochrane, 1995; Montazerhodjat et al., 2016; Stern et al., 2017) • Large insurance pools → risk sharing (or patients cherry-picking or rationing?) • AIFA → Outcome-based (PbR) reimbursement (risk to be borne by pharma industry) 23 C. Demartini – Economics and precision medicine – 7 June 2018 Metastatic melanoma avg annual costs: from €3,500 to €50,000 (OSMED, 2014)
  24. 24. A fifth pillar? Sustainability • Resourses invested in PM vs public health → Systemic approaches 24 C. Demartini – Economics and precision medicine – 7 June 2018 (Bayer, 2016; Forward)
  25. 25. A fifth pillar? Sustainability • Informed decision making: is cost-effectiveness the adequate criterion? • Value-based HTA → ELSI: ethical, legal, and social implications → MCDA: multiple criteria decision analysis 25 C. Demartini – Economics and precision medicine – 7 June 2018 INEQUALITY
  26. 26. To sum up: Economic challenges in PM Sustainability PPP (private- public partnership) Market development PricingDecision making (in)equality Systemic and interdisciplinary approaches 26 C. Demartini – Economics and precision medicine – 7 June 2018
  27. 27. Grazie per l’attenzione! mariachiara.demartini@unipv.it 27

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