Ayman chit m biotech phd director health outcomes and economics north america
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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

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

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


Standard dose trivalent inactivated influenza vaccine sd iiv3 effectiveness by age 1

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


Ayman chit m biotech phd director health outcomes and economics north america

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


Study objective

Study Objective

  • Given the various vaccine options available to US seniors we modeled each vaccine’s expected:

    • Public health impact

    • Budget impact

    • Cost-utility


Model overview

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


Model inputs

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


Impact on health outcomes

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


Impact on costs

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


Cost utility analysis

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


Probabilistic sensitivity analyses hd iiv3 vs sd iiv3

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


Deterministic sensitivity analyses hd iiv3 vs sd iiv3

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


Influential variables

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


Limitations

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


Conclusions

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


Ayman chit m biotech phd director health outcomes and economics north america

Thank You


Ayman chit m biotech phd director health outcomes and economics north america

Model Structure


Deterministic sensitivity analyses hd iiv3 vs sd iiv4

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


Probabilistic sensitivity analysis hd iiv3 vs sd iiv4

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


Cost utility analysis1

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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