Cost effectiveness analysis of the new pneumococcal conjugate vaccine (Synflorix TM ) compared to Prevnar

Transcription

1 CPHA 2009 Cost effectiveness analysis of the new pneumococcal conjugate vaccine (Synflorix TM ) compared to Prevnar Ismaila AS 1,2, Pereira JA 1, Robson RC 1, Rawson NS 1, Simpson SD 1, Standaert BA 3 1 Medical Affairs, GlaxoSmithKline, Canada 2 Clinical Epidemiology and Biostatistics, McMaster University, Canada 3 WW Commercial Strategy - Health Economics, GlaxoSmithKline Biologicals, Belgium June 9, 2009

2 Acknowledgments Key contributors to model development: Prof. Philippe de Wals and co-investigators Tom Taylor and Sandra Talbird from Research Triangle Institute

3 Outline Background Methods Results Sensitivity Analysis Conclusions

4 Outline Background Methods Results Sensitivity Analysis Conclusions

5 Background Streptococcus pneumoniae (Sp) is the leading cause of invasive bacterial infections, bacterial pneumonia and acute otitis media (AOM) in young children 1. In 2001, a 7-valent pneumococcal conjugate vaccine (Prevnar ) was licensed in Canada 1. In December 2008, a new 10-valent pneumococcal non-typeable Haemophilus influenzae protein-d conjugate vaccine (Synflorix TM ) was also licensed in Canada 2. 1 NACI: CCDR 2002;28-ACS-2:1-32; 2 Health Canada (NOD 2009)

6 Pneumococcal vaccines Vaccine serotypes Prevnar 4, 6B, 9V, 14, 18C, 19F, 23F Synflorix TM 4, 6B, 9V, 14, 18C, 19F, 23F 1, 5, 7F Cross-reactive serotypes 1,2 6A 19A 1 Vakevainen et al. (J Infect Dis 2001;184:789 93); 2 Jakobsen et al. (Infec & Immun 2003: )

7 Objective To evaluate the projected health outcomes, costs, and cost-effectiveness of routine vaccination with Synflorix TM compared with no vaccination and with Prevnar.

8 Outline Background Methods Results Sensitivity Analysis Conclusions

9 Model Description A static, deterministic, age-compartmental, and population based model Simulates both direct and indirect effect of vaccination at steady-state for only one year across whole population Three vaccination schedules were modeled: no vaccine, Prevnar (3+1) and Synflorix TM (3+1) Both health system and societal perspectives were considered

10 Input variables and data Models the entire population of Canada in 2006 (33.0 million) 1. The vaccinated population is children aged 2 to 13 months (348,000). Vaccination cost was set at parity ($70) per dose plus administration cost for both Prevnar and Synflorix TM. The model used Canada-specific epidemiological data Statistics Canada: (Oct. 2008). 2 Bettinger et al.: Can J Public Health Mar-Apr;98(2): MADO 2004 (Maladies infectieuses a declaration obligatoire). 4 Morrow et al., Can J Infect Dis Med Microbiol 2007;18: Petit et al.: Can J Infect Dis 2003;14: Robinson et al.: JAMA 2001;285(13): Scheifele et al.: Clin Infect Dis. 2000;31(1): Shariatzadeh et al.: Medicine 2005;84(3): Furlong et al.: Ann Med 2001;33(5):

11 Key model assumptions for base case: (Direct Effect) Direct effect (%) Disease Parameter Prevnar Synflorix TM IPD 1 Prevnar serotypes Same value Synflorix TM specific serotypes Cross protection on 6A (93, 98) (39, 90) (39, 90) Pneumonia 2 Hospitalizations 20.5 (4.4, 34.0) AOM 3,4 Sp vaccine serotype 57.2 (44, 67) AOM due to NTHi -11 (-34, 8.0) 1 Whitney et al: Lancet 2006;368(9546): Black et al.: Pediatr Infect Dis J. 2002;21(9): Eskola et al.: N Engl J Med 2001;344(6): Prymula et al.: Lancet Mar 4;367(9512): (9.7, 37.7) 57.6 (41.4, 69.3) 35.6 (3.8, 57.0)

12 Key model assumptions for base case: (Indirect Effect) Disease Prevnar Synflorix TM Herd effect (%) IPD (70, 80) 76.2 (70, 80) Pneumonia none none AOM none none 1. Hicks et al. J Infect Dis. 2007;196(9):

13 Outline Background Methods Results Sensitivity Analysis Conclusions

14 Annual burden of Pneumococcal disease in Canada: All ages IPD 222 Cases of meningitis 3,236 Cases of bacteraemia 937 GP visits for bacteraemia 611Deaths Pneumonia 79,577 Hospitalizations 148,715 GP visits 16,833 Deaths Otitis media 34,196 Hospitalizations 1,639,326 GP visits 1,385,230 ATB prescriptions Health system cost: $726 Million Total indirect cost: $2.2 Billion Projected from Canadian HE model ATB = antibiotics; IPD = invasive pneumococcal disease; GP= general physician

15 Base Case Results: Effectiveness Baseline Number of cases averted (% reduction) No Prevnar vs. Synflorix TM vs. Disease Vaccination no vaccination no vaccination IPD 3,458 1,425 1,810 AOM (GP visits) Antibiotic prescriptions Total Hospitalizations (41.2%) 1,639,326 70,370 (4.3%) 1,385,230 59,462 (4.3%) 113,773 6,127 (5.4%) (52.3%) 241,321 (14.7%) 203,916 (14.7%) 16,414 (14.4%) Synflorix TM vs. Prevnar 384 (11.1%) 170,951 (10.4%) 144,454 (10.4%) 10,287 (9.0%) Assumptions:3+1 schedule; all age groups; herd protection and serotype cross-protection for 6A, vaccination coverage is 100%; 85% of AOM visits generate antibiotic prescription

16 Base case results: direct and indirect costs Baseline Cost averted (savings in million) Disease No Vaccination Prevnar vs. no vaccination Synflorix TM vs. no vaccination Synflorix TM vs. Prevnar Vaccine cost + Admin fees Direct cost (Disease related) Healthcare system cost $0 -$112 -$112 $0 $726 $32 $56 $24 $726 -$80 -$57 $24 Indirect costs $2,195 $123 $170 $47 Societal costs $2,921 $43 $113 $71 Assumption: Cost of vaccine at parity ($70.00 per dose + admin fee)

17 Base-case results: cost-effectiveness results (healthcare system) Outcome No vaccination Prevnar Synflorix TM 3+1 regimen 3+1 regimen Direct cost $726.2M $806.5M $782.9M Incremental cost vs. $80.3M $56.7M No Vaccination Total QALYs lost 176, , ,736 Incremental QALYs 6,388 9,120 gained vs. no Vaccine Incremental cost per QALY gained No vaccination $12,565 $6,220 Synflorix TM vs. Prevnar -$8,614

18 Base-case results: cost-effectiveness results (societal perspective) Outcome No vaccination Prevnar 3+1 regimen Synflorix TM 3+1 regimen Total cost $2,921M $2,878M $2,807M Incremental cost vs. -$43M -$113M No Vaccination Total QALYs lost 176, , ,736 Incremental QALYs 6,388 9,120 gained vs. no Vaccine Incremental cost per QALY gained No vaccination -$6,669 -$12,436 Synflorix TM vs. Prevnar -$25,920

19 Outline Background Methods Results Sensitivity Analysis Conclusions

20 One way sensitivity: Tornado Diagram Synflorix TM versus Prevnar ) PHiD-CV % reduction in myringotomy (95% CI)* PHiD-CV efficacy vs. AOM due to NTHi (95% CI) Incidence - bacteraemia (-/+ 50%) PHiD-CV NTHi herd protection for CAP (0, 30%) Parameter Myringotomy procedures, AOM cases (-/+ 20%, 50%) Case fatality ratio - bacteraemia (-/+ 20%) Cost for O/P AOM (-/+ 20%) % AOM cases due to Sp, NTHi, other (18%, 41%, 41%; 56%, 22%, 22%) Disutility for myringotomy (-/+ 20%) Cost for myringotomy (-/+ 20%) Sensitivity Run 1 Sensitivity Run 2 -$12,000 -$10,000 -$8,000 -$6,000 -$4,000 -$2,000 $0 Cost per QALY Gained Results of 1-Way Sensitivity Analysis - Top 10 Parameters Only

21 Probabilistic Sensitivity Analysis Synflorix TM versus Prevnar Cost-effectiveness Plane $100,000,000 $50,000,000 Cost Difference $0-4,000-2, ,000 4,000 6,000 8,000 10,000 -$50,000,000 -$100,000,000 QALY Difference Individual Simulations Base Case Cost-effectiveness Threshold Results of 1,000 Monte Carlo Simulations; samples each of the models input parameters from an appropriate probability distribution

22 Base-case and Five other scenarios Base-case Scenario 1 Scenario 2 Scenario 3 Scenario 4 Scenario 5 All ages All ages All ages All ages <5y <5y Herd protection IPD On On on* Off Off On Cross protection 6A 6A, 19A 6A, 19A Off Off 6A Synflorix TM Costs ($1000 s) 782, , , , , ,178 QALYs lost 167, , , ,296 12,915 11,110 Prevnar Costs ($1000 s) 806, , , , , ,868 QALYs lost 170, , , ,934 13,506 12,475 Incremental Difference Costs ($1000 s) (23,536) (23,536) (44,287) (8,126) (7,421) (19,690) QALYs 2,732 2,732 7, ,365 Incremental cost-effectiveness ratio (Health System) Per QALY gained ($) (8,614) (8,615) (6,127) (12,736) (12,550) (14,422) Quadrant Q4 Q4 Q4 Q4 Q4 Q4 *Including Herd protection/serotype replacement on CAP and AOM related outcomes

23 Outline Background Methods Results Sensitivity Analysis Conclusions

24 Conclusions Because of the broader serotype coverage and substantial impact on AOM, Synflorix TM would prevent more pneumococcal related outcomes than Prevnar in Canada. Based on the base-case analysis, Synflorix TM would save about $71M in direct and indirect costs versus Prevnar in Canada. From both health care and societal perspective, Synflorix TM would be a cost-saving alternative to Prevnar at price parity.