Dataset Information

Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.

ABSTRACT:

Introduction

In January 2013 a novel type of multicomponent protein-based vaccine against group B meningococcal disease was licensed by the European Medicines Agency. With the widespread use of the meningococcal serogroup C conjugate vaccines, serogroup B remains now the major cause of bacterial meningitis and septicaemia in young children in Europe. The aim of this study is to investigate the health and the economic outcomes of MenB vaccine introduction into the Italian routine mass vaccination programme.

Methods

The present work is structured in two main parts. Firstly, we assess the epidemiological burden of group B meningococcal disease using official hospitalisation and notification data from two of the most populated Italian regions (Lombardia and Piemonte) during a 6-year study period (2007-2012). Secondly, we evaluate the cost-effectiveness of the immunisation programme in Italy from the public health payer perspective under base case parameters assumptions and performing a comprehensive sensitivity analysis to assess the robustness and the uncertainty of our model results.

Results

MenB serotype is responsible for 59% of the 341 cases of Invasive Meningococcal Disease in Lombardia and Piemonte. Incidence rate for MenB infection is estimated to be 0.21/100,000/y resulting at the highest level in children ?4 years of age. Although the new MenB vaccine can potentially prevent about one third of the disease cases in the Italian population, model results show this strategy is unlikely to be cost-effective (ICER value over €350,000/QALY) with a vaccine that prevents disease only. These results are robust under most of the sensitivity scenarios except when allowing for lower discount rates.

Discussion

The introduction of the novel vaccine into the routine immunisation schedule needs to be carefully evaluated. The new MenB vaccine has the potential to reduce the disease burden at the population level. However, from the Italian Health Service perspective, the immunisation programme is unlikely to be cost-effective at the current incidence levels and vaccine price.

SUBMITTER: Tirani M

PROVIDER: S-EPMC4395261 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.

Tirani Marcello M Meregaglia Michela M Melegaro Alessia A

PloS one 20150413 4

<h4>Introduction</h4>In January 2013 a novel type of multicomponent protein-based vaccine against group B meningococcal disease was licensed by the European Medicines Agency. With the widespread use of the meningococcal serogroup C conjugate vaccines, serogroup B remains now the major cause of bacterial meningitis and septicaemia in young children in Europe. The aim of this study is to investigate the health and the economic outcomes of MenB vaccine introduction into the Italian routine mass vac ...[more]

PMID: 25874805

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Project description:BackgroundCurrently in Japan, both 23-valent pneumococcal polysaccharide vaccine (PPSV-23) and 13-valent pneumococcal conjugate vaccine (PCV-13) are available for the elderly for the prevention of S. pneumoniae-related diseases. PPSV-23 was approved in 1988, while the extended use of PCV-13 was approved for adults aged 65 and older in June 2014. Despite these two vaccines being available, the recently launched national immunisation programme for the elderly only subsidised PPSV-23. The framework of the current immunisation programme lasts for five years. The elderly population eligible for the subsidised PPSV-23 shot for the 1st year are those aged 65, 70, 75, 80, 85, 90, 95 and ≥ 100. While from the 2nd year to the 5th year, those who will age 65, 70, 75, 80, 85, 90, 95 and 100 will receive the same subsidised shot.MethodsWe performed economic evaluations to (1) evaluate the efficiency of alternative strategies of PPSV-23 single-dose immunisation programme, and (2) investigate the efficiency of PCV-13 inclusion in the list for single-dose pneumococcal vaccine immunisation programme. Three alternative strategies were created in this study, namely: (1) current PPSV-23 strategy, (2) 65 to 80 (as "65-80 PPSV-23 strategy"), and (3) 65 and older (as "≥ 65 PPSV-23 strategy"). We constructed a Markov model depicting the S. pneumoniae-related disease course pathways. The transition probabilities, utility weights to estimate quality adjusted life year (QALY) and disease treatment costs were either calculated or cited from literature. Cost of per shot of vaccine was ¥ 8,116 (US$74; US$1 = ¥ 110) for PPSV-23 and ¥ 10,776 (US$98) for PCV-13. The model runs for 15 years with one year cycle after immunisation. Discounting was at 3%.ResultsCompared to current PPSV-23 strategy, 65-80 PPSV-23 strategy cost less but gained less, while the incremental cost-effectiveness ratios (ICERs) of ≥ 65 PPSV-23 strategy was ¥ 5,025,000 (US$45,682) per QALY gained. PCV-13 inclusion into the list for single-dose subsidy has an ICER of ¥ 377,000 (US$3,427) per QALY gained regardless of the PCV-13 diffusion level. These ICERs were found to be cost-effective since they are lower than the suggested criterion by WHO of three times GDP (¥ 11,000,000 or US$113,636 per QALY gained), which is the benchmark used in judging the cost-effectiveness of an immunisation programmne.ConclusionsThe results suggest that switching current PPSV-23 strategy to ≥ 65 PPSV-23 strategy or including PCV-13 into the list for single-dose subsidy to the elderly in Japan has value for money.

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Dataset Information

Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.

Introduction

Methods

Results

Discussion

Publications

Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.

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