Butler James R G, McIntyre Peter, MacIntyre C Raina, Gilmour Robin, Howarth Ann L, Sander Beate
National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australia.
Vaccine. 2004 Mar 12;22(9-10):1138-49. doi: 10.1016/j.vaccine.2003.09.036.
Pneumococcal conjugate vaccine, 7 valent (PCV7) is the most costly vaccine yet considered for publicly funded programs. In mid 2001, Australia funded PCV7 for high-risk groups only (indigenous children and children with certain underlying medical conditions). World wide, non-industry-funded studies and studies using cost-utility measures are sparse. We undertook an independent economic analysis of PCV7 compared with no vaccination in the non high-risk Australian childhood population using cost-utility and cost-effectiveness measures.
The incidence of invasive pneumococcal disease (IPD), non-bacteraemic pneumonia and otitis media was estimated using representative urban Australian data, or by extrapolation from comparable industrialised countries. A decision-analytic model was developed for a hypothetical birth cohort using the age-specific vaccine coverage from the Californian randomised controlled trial of PCV7. Health outcomes were measured by life-years saved and deaths and disability-adjusted life-years (DALYs) averted. In line with government guidelines, only direct costs were considered in 1997-1998 Australian dollars.
For a birth cohort of 250,000, the gross cost of vaccination is $ 78.6 million. Subtracting treatment cost savings, the net cost (discounted) is $ 61.7 million. In undiscounted terms, vaccination prevents 13.7 deaths, 11.2 (82%) from IPD and the remainder from non-bacteraemic pneumonia. The discounted cost per death avoided is $ 5.0 million, per life-year saved $ 230,130 and per DALY averted $ 121,100, giving a break-even vaccine price of $ 15.40 per dose. These estimates are most sensitive to the unit cost per dose of vaccine, estimates of incidence and vaccine efficacy against non-bacteraemic pneumonia and the discount rate. The cost per DALY reduced to $ 81,000 with a discount rate of 3% rather than 5% and to $ 90,000 with the most favourable assumptions concerning pneumonia reduction.
With a vaccine price of $ 90 per dose, mid-range estimates of impact against non-bacteraemic pneumonia, and discount rate of 5%, a PCV7 program for infants not at high risk of IPD is at the upper limit of cost per DALY previously approved under Australian pharmaceutical funding guidelines. The impact of PCV7 against non-bacteraemic pneumonia is poorly defined, but its importance to cost-effectiveness in resource rich and resource poor settings warrants further studies or analysis to give greater precision to this outcome.
7价肺炎球菌结合疫苗(PCV7)是迄今考虑用于公共资助项目的最昂贵疫苗。2001年年中,澳大利亚仅为高危人群(土著儿童和患有某些基础疾病的儿童)提供PCV7疫苗。在全球范围内,非行业资助的研究以及使用成本效用指标的研究很少。我们采用成本效用和成本效益指标,对澳大利亚非高危儿童群体接种PCV7疫苗与不接种疫苗进行了独立的经济学分析。
采用澳大利亚城市代表性数据或通过对可比工业化国家进行外推,估计侵袭性肺炎球菌病(IPD)、非菌血症性肺炎和中耳炎的发病率。利用PCV7疫苗加利福尼亚随机对照试验中按年龄划分的疫苗接种率,为一个假设的出生队列建立了决策分析模型。通过挽救的生命年数、避免的死亡数和伤残调整生命年数(DALYs)来衡量健康结果。按照政府指导方针,仅考虑以1997 - 1998年澳元计算的直接成本。
对于一个25万的出生队列,疫苗接种的总成本为7860万美元。减去节省的治疗成本,净成本(贴现后)为6170万美元。按未贴现计算,疫苗接种可预防13.7例死亡,其中11.2例(82%)由IPD导致,其余由非菌血症性肺炎导致。避免每例死亡的贴现成本为500万美元,每挽救一个生命年为230130美元,每避免一个DALY为121100美元,盈亏平衡的疫苗价格为每剂15.40美元。这些估计对每剂疫苗的单位成本、发病率估计以及疫苗对非菌血症性肺炎的效力和贴现率最为敏感。贴现率为3%而非5%时,每减少一个DALY的成本降至81000美元;在关于肺炎减少的最有利假设下,降至90000美元。
疫苗价格为每剂90美元、对非菌血症性肺炎影响的中等估计值以及贴现率为5%时,针对IPD非高危婴儿的PCV7疫苗项目处于澳大利亚药品资助指导方针先前批准的每DALY成本上限。PCV7对非菌血症性肺炎的影响界定不清,但其在资源丰富和资源匮乏环境中对成本效益的重要性值得进一步研究或分析,以便更精确地确定这一结果。