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Ayman Chit, M.Biotech , PhD Director, Health Outcomes and Economics, North America

The Importance of Quality Outcomes Data: Expected Cost Effectiveness of High-Dose Trivalent Inactivated Influenza Vaccine (HD-IIV3) in US Seniors. Ayman Chit, M.Biotech , PhD Director, Health Outcomes and Economics, North America. Conflict of Interest.

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Ayman Chit, M.Biotech , PhD Director, Health Outcomes and Economics, North America

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  1. The Importance of Quality Outcomes Data:Expected Cost Effectiveness of High-Dose Trivalent Inactivated Influenza Vaccine (HD-IIV3) in US Seniors Ayman Chit, M.Biotech, PhD Director, Health Outcomes and Economics, North America

  2. Conflict of Interest • I am a current employee of Sanofi Pasteur and past employee of GlaxoSmithKline • Both companies are influenza vaccine manufacturers • I own stock in both companies • This study was funded by Sanofi Pasteur

  3. Standard-Dose Trivalent Inactivated Influenza Vaccine (SD-IIV3) Effectiveness by Age1 Reference: 1. Monto AS, Ansaldi F, Aspinall R, et al. Influenza control in the 21st century: optimizing protection of older adults. Vaccine. 2009;27:5043-5053. 3

  4. High Dose (HD-IIV3) is Superior to Standard-Dose (SD-IIV3) Trivalent Inactivated Influenza Vaccine • FIM12 efficacy trial (>30,000 older adults) met its primary endpoint for superior efficacy • HD-IIV3 was 24.2% more effective than SD-IIV3 in preventing lab confirmed influenza in adults ≥65 years of age • Effectiveness assessments suggest benefits for the prevention of: • Hospitalization • Pneumonia • Other cardio-respiratory events • FIM12 also reaffirmed the safety of HD-IIV3 vaccine as demonstrated in previous studies. Reference: Greenberg D. ACIP 24 October 2013 Meeting. http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-oct-2013/04-Fluzone-Greenberg.pdf

  5. Study Objective • Given the various vaccine options available to US seniors we modeled each vaccine’s expected: • Public health impact • Budget impact • Cost-utility

  6. Model Overview • Interventions • High-dose trivalent inactivated influenza vaccine (HD-IIV3) • Standard dose trivalent inactivated influenza vaccine (SD-IIV3) • Standard dose quadrivalent inactivated influenza vaccine (SD-IIV4) • No vaccination • Model structure • Stochastic and static model that does not consider herd effects • 1 influenza season reflecting epidemiology from previous decade • Societal perspective • Outcomes • Symptomatic influenza • Hospitalized influenza • Influenza-related death • Productivity • Quality of life

  7. Model Inputs • Disease outcome rates • Influenza attack rate obtained from placebo arms of RCTs1,2,3 • Influenza-related hospitalizations and mortality rates obtained from CDC publications4,5 • Monetary costs • Health care costs obtained from Centers for Medicare & Medicaid Services (CMS) data • Vaccine prices obtained from Medicare price lists • Vaccine efficacy • SD-IIV3 efficacy obtained from published meta-analysis6 • SD-IIV4 efficacy estimated based on modified CDC methodology7 • HD-IIV3 relative efficacy obtained from FIM12 clinical trial • References • Govaert TM, Thijs CT, Masurel N, Sprenger MJ, Dinant GJ, Knottnerus JA. JAMA 1994; 272(21):1661-1665. • Edmondson WP, Jr., Rothenberg R, White PW, Gwaltney JM, Jr. Am J Epidemiol 1971; 93(6):480-486. • Rudenko LG, Arden NH, Grigorieva E, Naychin A, Rekstin A, Klimov AI et al. Vaccine 2000; 19(2-3):308-318. • Zhou H, Thompson WW, Viboud CG, Ringholz CM, Cheng PY, Steiner C et al. Clin Infect Dis 2012; 54(10):1427-1436 • MMWR, 2010 • Beyer WE, McElhaney J, Smith DJ, Monto AS, Nguyen-Van-Tam JS, Osterhaus AD. Vaccine 2013; 31(50):6030-6033. • Reed C, Meltzer MI, Finelli L, Fiore A. Vaccine 2012; 30(11):1993-1998

  8. Impact on Health Outcomes Outcomes prevented at the level of the entire US senior population Assuming 67% vaccine uptake rate in the HD-IIV3, SD-IIV4 and SD-IIV3 groups HD-IIV3 is expected to provide the highest public health benefit HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard-Dose Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  9. Impact on Costs Costs at the level of the entire US senior population Assuming 67% vaccine uptake rate in the HD-IIV3, SD-IIV4 and SD-IIV3 groups Increased expenditures on HD-IIV3 expected to be partly offset by reduced health services consumption and increased productivity HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard-Dose Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  10. Cost-Utility Analysis HD-IIV3 is a cost-effective alternative to SD-IIV3 and SD-IIV4 HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard-Dose Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  11. Probabilistic Sensitivity Analyses: HD-IIV3 vs. SD-IIV3 • 70.6% of simulations ≤ $100,000/QALY • 59.7% of simulations ≤ $50,000/QALY • HD-IIV3 dominates SD-IIV3 in 19.3% of simulations HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Trivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  12. Deterministic Sensitivity Analyses: HD-IIV3 vs. SD-IIV3 • Most influential variables were: • influenza-related death and hospitalization • relative vaccine efficacy (RVE) of HD-IIV3 against hospitalization and death GP: General Practitioner HD: High-Dose Vaccine HR: High risk IIV3: Trivalent Influenza Vaccine LR: Low risk QALY: Quality-Adjusted Life Year VE: Vaccine efficacy RVE: Relative vaccine efficacy VE: Vaccine efficacy

  13. Influential Variables Two-way sensitivity analysis on the two most influential variables: influenza-related hospitalization and death rates HD-IIV3 is expected to dominate SD-IIV3 and SD-IIV4 during severe influenza seasons Even during unusually mild influenza seasons, the vaccine is expected to be cost effective HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard-Dose Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  14. Limitations • Vaccine efficacy estimates: • No direct data are available on the efficacy of SD-IIV4 in seniors • Data on the efficacy of SD-IIV3 in preventing hospitalizations and death was derived from non randomized studies • No direct data on relative efficacy of HD-IIV3 in preventing death • Indirect benefits of the vaccines were excluded • Impact of influenza vaccination on reducing disability in the seniors was not included HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard Dose Quadrivalent Inactivated Influenza Vaccine

  15. Conclusions • HD-IIV3 is expected to achieve significant reductions in influenza-related morbidity and mortality compared to SD-IIV3 and SD-IIV4 • HD-IIV3 is a cost-effective alternative to both SD-IIV3 and SD-IIV4 in seniors • ICERs where highly influenced by rates of serious influenza complications (hospitalization and death) HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard Dose Quadrivalent Inactivated Influenza Vaccine

  16. Thank You

  17. Model Structure

  18. Deterministic Sensitivity Analyses: HD-IIV3 vs. SD-IIV4 • Most influential variables were: • influenza-related death and hospitalization • relative vaccine efficacy (RVE) of HD-IIV3 against hospitalization GP: General Practitioner HD: High-Dose Vaccine HR: High risk IIV4: Quadrivalent Influenza Vaccine LR: Low risk QALY: Quality-Adjusted Life Year VE: Vaccine efficacy

  19. Probabilistic Sensitivity Analysis: HD-IIV3 vs. SD-IIV4 • 81.9%of simulations ≤ $100,000/QALY • 70.3% of simulations ≤ $50,000/QALY • HD-IIV3 dominates SD-IIV4 in 34.4% of simulations HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

  20. Cost-Utility Analysis Cost-Effectiveness Frontier $11,460/QALY $17,325/QALY $13,660/QALY HD-IIV3 is a more efficient use of resources than SD-IIV3 and SD-IIV4 HD-IIV3: High-Dose Trivalent Inactivated Influenza Vaccine SD-IIV3: Standard-Dose Trivalent Inactivated Influenza Vaccine SD-IIV4: Standard-Dose Quadrivalent Inactivated Influenza Vaccine QALY: Quality-Adjusted Life Year

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