1. Estimated Reductions in Influenza-related Mortality among the Elderly through Direct-to-Consumer Advertising of Influenza Vaccine Mitesh S Patel* Matthew M. Davis # *University of Michigan Medical School, and # Child Health Evaluation and Research (CHEAR) Unit, Division of General Pediatrics, Division of General Internal Medicine, and Gerald R. Ford School of Public Policy, University of Michigan

2. Influenza Mortality Predominately and disproportionately impacts elderly Predominately and disproportionately impacts elderly Rates of annual influenza vaccination among the elderly are approximately 65% Rates of annual influenza vaccination among the elderly are approximately 65% Vaccination rates fall short of the Healthy People 2010 target of 90% and may be a concern on the national level Vaccination rates fall short of the Healthy People 2010 target of 90% and may be a concern on the national level

3. Direct-to Consumer (DTC) Advertising Spending on DTC advertising rose from $266 million in 1994 to $3.2 billion in 2003 Spending on DTC advertising rose from $266 million in 1994 to $3.2 billion in 2003 Effective method of increasing sales of prescription pharmaceuticals Effective method of increasing sales of prescription pharmaceuticals Could it be an effective method of increasing influenza vaccination rates and achieving mortality benefits? Could it be an effective method of increasing influenza vaccination rates and achieving mortality benefits?

4. Research Objective To examine the potential cost-effectiveness of a federal program of DTC advertising for influenza vaccination of elders To examine the potential cost-effectiveness of a federal program of DTC advertising for influenza vaccination of elders

5. Methods: Number Needed to Vaccinate Number Needed to Vaccinate (NNV) Number Needed to Vaccinate (NNV) Quantifies the number of people that must be vaccinated to prevent one all-cause death Quantifies the number of people that must be vaccinated to prevent one all-cause death Analogous to the Number Needed to Treat (NNT) Analogous to the Number Needed to Treat (NNT) NNV = 1 NNV = 1 ___________________________________________________________________________________________________________________________ ___________________________________________________________________________________________________________________________ (population mortality rate) x (vaccine efficacy against mortality) (population mortality rate) x (vaccine efficacy against mortality)

6. Methods: DTC Advertising and Pharmaceutical Sales DTC advertising in 1999 DTC advertising in 1999 Spending Change in Sales 24 Most heavily advertised drugs $1.338 billion 41.7% Rest of the Market $481 million 14.4% Net Difference $857 million 27.3% Findlay. Pharmacoeconomics. 2001.

7. Methods: Vaccination Rate Increase..

8. ?

10. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Costs DTC Advertising, $ Increase per year, % Vaccine Dose, $ Increase per year, % Vaccine Admin Fee, $ Increase per year, % 194.1 million 3 12.20 10 18.90 3 +/- 10% 5 - 15 1.5 – 6 Population Mortality Rate132.5/100,000

11. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Costs DTC Advertising, $ Increase per year, % Vaccine Dose, $ Increase per year, % Vaccine Admin Fee, $ Increase per year, % 194.1 million 3 12.20 10 18.90 3 +/- 10% 5 - 15 1.5 – 6 Population Mortality Rate132.5/100,000

12. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Costs DTC Advertising, $ Increase per year, % Vaccine Dose, $ Increase per year, % Vaccine Admin Fee, $ Increase per year, % 194.1 million 3 12.20 10 18.90 3 +/- 10% 5 - 15 1.5 – 6 Population Mortality Rate132.5/100,000

13. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Costs DTC Advertising, $ Increase per year, % Vaccine Dose, $ Increase per year, % Vaccine Admin Fee, $ Increase per year, % 194.1 million 3 12.20 10 18.90 3 +/- 10% 5 - 15 1.5 – 6 Population Mortality Rate132.5/100,000

14. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Vaccine Efficacy, % Year 200667.6156 – 76 (95% CI) Elderly Population, millions (Revaccinated Persons, %) Year 2006 Year 2007 Year 2008 Year 2009 Year 2010 Year 2011 Year 2012 Year 2013 Year 2014 Year 2015 37.2 (60.0) 37.8 (69.9) 38.7 (74.2) 39.8 (77.5) 40.2 (81.9) 41.1 (83.1) 42.6 (83.5) 44.0 (85.0) 45.3 (86.2) 46.8 (86.6)

15. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Vaccine Efficacy, % Year 200667.6156 – 76 (95% CI) Elderly Population, millions (Revaccinated Persons, %) Year 2006 Year 2007 Year 2008 Year 2009 Year 2010 Year 2011 Year 2012 Year 2013 Year 2014 Year 2015 37.2 (60.0) 37.8 (69.9) 38.7 (74.2) 39.8 (77.5) 40.2 (81.9) 41.1 (83.1) 42.6 (83.5) 44.0 (85.0) 45.3 (86.2) 46.8 (86.6)

16. Methods: Model Parameters Variable Base Case Estimate Range for Sensitivity Analysis Vaccine Efficacy, % Year 200667.6156 – 76 (95% CI) Elderly Population, millions (Revaccinated Persons, %) Year 2006 Year 2007 Year 2008 Year 2009 Year 2010 Year 2011 Year 2012 Year 2013 Year 2014 Year 2015 37.2 (60.0) 37.8 (69.9) 38.7 (74.2) 39.8 (77.5) 40.2 (81.9) 41.1 (83.1) 42.6 (83.5) 44.0 (85.0) 45.3 (86.2) 46.8 (86.6)

17. Methods: Primary Outcome Measures For each year 2006-2015 we estimated For each year 2006-2015 we estimated Reduction in mortality Reduction in mortality Cost per life-year saved = Cost per life-year saved = ∑ Year = x [cost (DTC + Vaccination)] - ∑ Year = (x-1) [cost (DTC + Vaccination)] Year=2006 Year=2006 Year=2006 Year=2006__________________________________________________ ∑ Year = x [life-years saved] - ∑ Year = (x-1) [life-years saved] Year=2006 Year=2006 Year=2006 Year=2006

18. Results: Base Case – First Year of Program #95% CI NNV Elderly lives saved Life-years saved

19. Results: Base Case – First Year of Program #95% CI NNV1,116 993 – 1,348 Elderly lives saved1,999 1,656 – 2,247 Life-years saved22,768 18,861 - 25,598

20. Results: Elderly Lives Saved

21. Year Overall Vaccination Rate (%) Overall Vaccine Efficacy (%) (95% CI) Cost of DTC Advertising Program (millions US$) Cost of Incremental Increase in Vaccination (millions US$) Incremental Life-Years Saved Cost Per Life-Year Saved (US$) (95% CI) 200671 67.61 (56 – 76) 194.169.422,768 11,573 (10,293 - 13,970) 200776 68.68 (57.07 – 77.07) 199.962.219,057 13,756 (12,259 – 16,555) 200879.75 69.15 (57.57 – 77.54) 205.950.514,324 17,900 (15,963 - 21,512) 200982.75 69.51 (57.90 – 77.90) 212.144.011,505 22,258 (19,860 – 26,721) 201085 69.99 (58.38 – 78.38) 218.435.48,552 29,685 (26,508 – 35,589) Results: Cost-Effectiveness of a 10-year DTC Program for Influenza Vaccine

22. Year Overall Vaccination Rate (%) Overall Vaccine Efficacy (%) (95% CI) Cost of DTC Advertising Program (millions US$) Cost of Incremental Increase in Vaccination (millions US$) Incremental Life-Years Saved Cost Per Life-Year Saved (US$) (95% CI) 201186.5 70.12 (58.51 – 78.51) 225.025.65,676 44,159 (39,440 – 52,921) 201287.75 70.16 (58.55 – 78.55) 231.723.54,790 53,291 (47,599 – 63,858) 201388.75 70.32 (58.71 – 78.71) 238.720.73,874 66,945 (59,809 – 80,183) 201489.5 70.45 (58.84 – 78.84) 245.917.02,925 89,884 (80,319 – 107,619) 201590 70.50 (58.89 – 78.89) 253.212.51,961 135,535 (121,121 – 162,255)

23. Results: Cost-Effectiveness of a 10-year DTC Program for Influenza Vaccine Year Overall Vaccination Rate (%) Overall Vaccine Efficacy (%) (95% CI) Cost of DTC Advertising Program (millions US$) Cost of Incremental Increase in Vaccination (millions US$) Incremental Life-Years Saved Cost Per Life-Year Saved (US$) (95% CI) 201186.5 70.12 (58.51 – 78.51) 225.025.65,676 44,159 (39,440 – 52,921) 201287.75 70.16 (58.55 – 78.55) 231.723.54,790 53,291 (47,599 – 63,858) 201388.75 70.32 (58.71 – 78.71) 238.720.73,874 66,945 (59,809 – 80,183) 201489.5 70.45 (58.84 – 78.84) 245.917.02,925 89,884 (80,319 – 107,619) 201590 70.50 (58.89 – 78.89) 253.212.51,961 135,535 (121,121 – 162,255) TOTAL 2,225360.995,434 27,096 (24,159 – 32,575)

24. Results: Overall Cost-Effectiveness

25. Study Limitations Mortality benefits of influenza vaccination Mortality benefits of influenza vaccination DTC advertising has only been studied for boosting pharmaceutical sales DTC advertising has only been studied for boosting pharmaceutical sales Medicare incurs greater program costs Medicare incurs greater program costs Annual cost per average beneficiary is $5,400 Annual cost per average beneficiary is $5,400 Average life expectancy of elders in hypothetical cohort is 11.7 years Average life expectancy of elders in hypothetical cohort is 11.7 years

26. Summary Overall the cost per life-year saved is about $27,000 for the 10-year DTC promotion of influenza vaccine for the elderly Overall the cost per life-year saved is about $27,000 for the 10-year DTC promotion of influenza vaccine for the elderly Sensitivity analysis Sensitivity analysis Worst case Worst case Cost per life-year saved < $40,000 Cost per life-year saved < $40,000 Total lives saved > 7,000 lives Total lives saved > 7,000 lives Total cost of DTC advertising over 10 years = $2.2 billion Total cost of DTC advertising over 10 years = $2.2 billion

27. Implications First study to suggest potential benefits of DTC advertising on public immunization efforts First study to suggest potential benefits of DTC advertising on public immunization efforts DTC advertising directed towards elders may DTC advertising directed towards elders may Induce demand for influenza vaccine Induce demand for influenza vaccine Raise vaccination rates towards the target of 90% Raise vaccination rates towards the target of 90% Achieve mortality benefits Achieve mortality benefits Be cost-effective for the Federal Government to pursue Be cost-effective for the Federal Government to pursue

28. Estimated Reductions in Influenza-related Mortality among the Elderly through Direct-to-Consumer Advertising of Influenza Vaccine Mitesh S Patel* Matthew M. Davis # *University of Michigan Medical School, and # Child Health Evaluation and Research (CHEAR) Unit, Division of General Pediatrics, Division of General Internal Medicine, and Gerald R. Ford School of Public Policy, University of Michigan