Epidemiological impact and cost-effectiveness of universal vaccination with Bexsero® to reduce meningococcal group B disease in Germany

Abstract

Bexsero, a new vaccine against serogroup B meningococcal disease (MenB), was licensed in Europe in January 2013. In Germany, Bexsero is recommended for persons at increased risk of invasive meningococcal disease, but not for universal childhood vaccination. To support decision making we adapted the independently developed model for England to the German setting to predict the potential health impact and cost-effectiveness of universal vaccination with Bexsero(®) against MenB disease. We used both cohort and transmission dynamic mathematical models, the latter allowing for herd effects, to consider the impact of vaccination on individuals aged 0-99 years. Vaccination strategies included infant and adolescent vaccination, alone or in combination, and with one-off catch-up programmes. German specific data were used where possible from routine surveillance data and the literature. We assessed the impact of vaccination through cases averted and quality adjusted life years (QALY) gained and calculated costs per QALY gained. Assuming 65% vaccine uptake and 82% strain coverage, infant vaccination was estimated to prevent 15% (34) of MenB cases over the lifetime of one birth cohort. Including herd effects from vaccination increased the cases averted by infant vaccination to 22%, with an estimated 8461 infants requiring vaccination to prevent one case. In the short term the greatest health benefit is achieved through routine infant vaccination with large-scale catch-up, which could reduce cases by 24.9% after 5 years and 27.9% after 10 years. In the long term (20+ years) policies including routine adolescent vaccination are most favourable if herd effects are assumed. Under base case assumptions with a vaccine list price of €96.96 the incremental cost-effectiveness ratio (ICER) was >€500,000 per QALY for all considered strategies. Given the current very low incidence of MenB disease in Germany, universal vaccination with Bexsero(®) would prevent only a small absolute number of cases, at a high overall cost.

Clinical and economic burden of invasive meningococcal disease: Evidence from a large German claims database

“…Although other studies cannot be directly compared to ours due to, e.g., diverging reimbursement practices in different countries, differences regarding study design, and IMD case definitions and study populations, most revealed substantial short-term excess costs associated with IMD as observed in our study. Christensen et al [34] derived the costs of acute IMD episodes from the diagnosis related group system used for inpatient billing in Germany in 2013 and estimated costs of € 5,045 and € 4,798 per IMD case aged < 16 years and 16+ years, respectively. However, the actual mean hospital costs in our study were substantially higher with costs of € 9,620.…”

Cost-effectiveness of alternative strategies for vaccination of adolescents against serogroup B IMD with the MenB-FHbp vaccine in Canada

“…Although vaccinating a cohort of 150,000 infants could be expected to (Pouwels et al 2013), Italy (Gasparini et al 2016), England , and France (Lecocq et al 2016) all found an infant immunization program not to be cost-effective. However, when the authors of the English study included more "favourable" assumptions, including quality-of-life losses for family and network members, 1.5% discounting, and the value of litigation costs, results showed that a routine infant vaccination could be cost-effective with a lower vaccine price (Christensen et al 2016). In our analysis, in order to obtain a cost per QALY of $135,000 (considered the highest limit of cost-effectiveness according to the WHO guidelines (Walker et al 2010)), the disease incidence would have to be 4.65 times higher (even more if using the most recent data (Public Health Agency of Canada 2017)) or a vaccine price of $11 per dose.…”

“…A population-based study of infants in the UK estimated a 2-dose MnB vaccine effectiveness of 82.9% against MnB cases (Parikh et al 2016), while a UK model estimated 95% MnB vaccine efficacy to prevent IMD among carriers (Christensen et al 2016). A 75% to 100% seroresponse rate in adolescents was reported in clinical trials of a 2-dose regimen of the MenB-FHbp vaccine (Vesikari et al 2016).…”

Economic evaluation of meningococcal vaccines: considerations for the future

“…The JCVI has applied a QALY adjustment factor (QAF) of 3 (relevant QALY gains are multiplied by 3) [18] to long-term sequelae associated with MenB IMD, which was employed in 2 studies identified in the literature search. Studies of HU loss typically address only the patient and his or her sequelae, but more recent assessments have included QALY losses for caregivers to reflect the wider impact of IMD on the network of individuals surrounding the patient [13,19].…”

“…A number of recent cost-effectiveness estimates of vaccines targeting serogroup B IMD have been outside the range of acceptable willingness-to-pay for a quality-adjusted life-year (QALY) threshold using standard methods. However, methods vary among countries (which can lead to differing conclusions among decision-making bodies), and it has been argued that standard approaches may not fully capture the impact of vaccines [12][13][14][15][16].…”