University of Michigan
Department of Pediatrics
Evidence-Based Pediatrics Web Site

Question

• Strep pneumo causes a considerable amount of illness in the pediatric population. Recently a vaccine has been developed against several serotypes that have shown to be able to generate immunogenicity in infants and children. Is it cost-effective to administer this vaccine as a four shot series to healthy infants?

Clinical Bottom Lines

1. This vaccination series is believed to be able to prevent more than 12,000 cases of meningitis and bacteremia, 53,000 cases of pneumonia, 1 million episodes of otitis media, and 116 deaths due to pneumococcal infection.
2. Before accounting for vaccine costs, this program could save $342 million in medical and $415 million in work loss and other costs from averted pneumococcal disease.
3. Vaccination of healthy infants would result in net savings for society if the vaccine costs less than $46 per dose and net savings for the health care payer (i.e. HMO) if the vaccine costs less than $18 per dose.
4. Currently, at the manufacturer's list price ($58 per dose), the program would cost society $80,000 per life-year saved or $160 per otitis media episode prevented or $3200 per pneumonia case prevented, $15,000 for bacteremia  prevented and $280,000 for meningitis episode prevented. 
5. At its current listed price, the vaccine is not cost-effective but has the potential to be. 

Summary of Key Evidence

1. A hypothetical birth cohort of 3.8 million infants is followed, using computer simulation, through a series of vaccinations at 2, 4, 6, and 12-15 months. The cost of these vaccinations is compared to a similar birth cohort that does not receive vaccinations and therefore experiences the cost of pneumococcal diseases: otitis media (simple and complex), pneumonia, bacteremia, and meningitis.¹
2. The incidences of the various illnesses is extrapolated from current CDC data and the costs are calculated using current health care charges and certain outcome assumptions agreed upon by a panel of ten experts.
3. Costs of disease were analyzed along several variables iincluding overestimating and underestimating the incidence of each type of pneumococcal associated disease as well as in terms of life-year saved.
4. Money saved was then examined from the point of view of society and the health care payer (i.e. HMO).
5. Costs were also compared to other preventative health practices (e.g. varicella vaccination, Hep B vaccination, and mammography).

Additional Comments

• Studies sponsored by manufacturer of vaccine (Wyeth-Lederle Vaccines).
• Some of the assumptions made may not have been the cheapest. For example, it was assumed that survivors of meningitis that were deaf would receive cochlear implants. Are implants cheaper than schools for the deaf that teach lip reading/sign language?
• This cost analysis does not take into account the less tangible value of preventing morbidity/mortality associated with pneumococcal disease.
• Current prospective studies are underway (namely Northern California Kaiser Permanente randomized trial involving 37,000 infants examining efficacy of vaccine and incidence of disease.
• Future studies need to review effects of vaccine on incidence of morbidity and mortality caused by resistant strains of pneumococci and whether non-vaccine strains will become more aggressive.
• Marketing of this vaccine must be worded carefully. This vaccine can decrease the number of otitis cases but it is not the “magic bullet” against otitis that parents could assume it would be.

Citation

1. Lieu TA,. Ray GT, Black SB, Butler JC, Klein JO, Breiman RF, Miller MA, Shinefield HR. Projected Cost-effectiveness of Pneumococcal Conjugate Vaccination of  Healthy Infants and Young Children. JAMA 2000; 283(11):1460-68.
2. Shinefield HR, Black S, Ray P. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatric Infectious Disease Journal 1999; 18:757-763.

CAT Author: Ada T. Lin, MD

CAT Appraisers: John G. Frohna, MD

Date appraised: March 23, 2000