L'introduzione del vaccino anti-HPV bivalente adiuvato con AS04 nelle regioni italiane: impatto economico ed effetti sulla salute delle donne

Introduction: the impact of cervical cancer prevention, in particular through HPV female vaccination, has been published for many countries at the national level. However, to our knowledge no attempt has been made to address the impact at a regional level. Since the Italian health reforms of the early 1990s, introducing "managerialism", decentralization and quasi-market mechanisms, regional authorities have consequently been experimenting with different organizational and funding models to achieve an acceptable combination of equity, efficiency, freedom of choice and cost-containment. Methods: a Markov model, previously described and successfully adapted to the national scenario [La Torre, 2007], has been used to explore the impact of preventive cervical cancer vaccination with Cervarix™ at a regional level in Italy. Resource use was based on a standard therapeutic path applied to all regions. However we quantified the impact of the so-called "decentralization progress" by collecting regional data on: pap-test coverage, tariffs for treatments and cost of the vaccination course. We performed for each Italian region a cost-effectiveness analysis combined with a regional budget impact analysis. The regional analyses compared HPV vaccination, both of a single female cohort (12 years old) and a multiple female cohort (12+16 years old), plus screening to screening only. Results: 21 regional reports were produced presenting regional results on screening coverage, treatments costs, ICER and ICUR, net cost per subject vaccinated etc. Conclusions: national and regional analyses have two different aims: the former wants to address national regulatory agencies and needs to be representative of the national population whereas the latter deals with the real budget-holders, accountable in the eyes of patients. Furthermore in the Italian scenario, characterized by decentralization and local autonomy, a further level of detail is essential in order to describe the specific local settings and implications of a new health intervention

Abruzzo

In Abruzzo region 55,4% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 29 cases of cervicocarcinoma and 12 related deaths and thus results to be cost-effective (20.836 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 28 cancer cases and 12 deaths could be prevented, with a very similar cost-effectiveness ratio. In Abruzzo region, the net cost for woman vaccinated is 199 € for the single cohort and 202 € for the multiple cohort

Puglia

In Apulia region 43,9% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 127 cases of cervicocarcinoma and 52 related deaths and thus results to be cost-effective (13.471€/QALY). When the vaccination programme is extended to 16-year-old girls a further 133 cancer cases and 54 deaths could be prevented, with a very similar cost-effectiveness ratio. In Apulia region, the net cost for woman vaccinated is 137€ for the single cohort and 141€ for the multiple cohort

Trento

In Trento province 72,4% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering local tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 8 cases of cervicocarcinoma and 4 related deaths and thus results to be cost-effective (30.267 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 8 cancer cases and 3 deaths could be prevented, with a very similar cost-effectiveness ratio. In Trento province, the net cost for woman vaccinated is 197 € for the single cohort and 199 € for the multiple cohort

Sicilia

In Sicily region 39,6% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 169 cases of cervicocarcinoma and 68 related deaths and thus results to be cost-effective (15.534 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 181 cancer cases and 75 deaths could be prevented, with a very similar cost-effectiveness ratio. In Sicily region, the net cost for woman vaccinated is 171 € for the single cohort and 176 € for the multiple cohort

Veneto

In Veneto region 72,8% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 72 cases of cervicocarcinoma and 31 related deaths and thus results to be cost-effective (29.052 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 67 cancer cases and 28 deaths could be prevented, with a very similar cost-effectiveness ratio. In Veneto region, the net cost for woman vaccinated is 184 € for the single cohort and 188 € for the multiple cohort

Toscana

In Tuscany region 70,2% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 51 cases of cervicocarcinoma and 21 related deaths and thus results to be cost-effective (25.732€/QALY). When the vaccination programme is extended to 16-year-old girls a further 49 cancer cases and 21 deaths could be prevented, with a very similar cost-effectiveness ratio. In Tuscany region, the net cost for woman vaccinated is 169€ for the single cohort and 172€ for the multiple cohort

Sardegna

In Sardinia region 45,5% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 38 cases of cervicocarcinoma and 15 related deaths and thus results to be cost-effective (15.347 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 41 cancer cases and 18 deaths could be prevented, with a very similar cost-effectiveness ratio. In Sardinia region, the net cost for woman vaccinated is 148 € for the single cohort and 152 € for the multiple cohort

Campania

In Campania region 41,8% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 208 cases of cervicocarcinoma and 84 related deaths and thus results to be cost-effective (16.130 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 217 cancer cases and 89 deaths could be prevented, with a very similar cost-effectiveness ratio. In Campania region, the net cost for woman vaccinated is 182 € for the single cohort and 186 € for the multiple cohort

Umbria

In Umbria region 67,5% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 13 cases of cervicocarcinoma and 6 related deaths and thus results to be cost-effective (23.398 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 13 cancer cases and 5 deaths could be prevented, with a very similar cost-effectiveness ratio. In Umbria region, the net cost for woman vaccinated is 155 € for the single cohort and 159 € for the multiple cohort