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Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system with a very high economic impact. Peginterferon beta-1a is the first approved pegylated interferon beta-1a for the treatment of relapsing-remitting multiple sclerosis (RRMS). Its efficacy and safety were demonstrated in the placebo-controlled ADVANCE trial. A complete path to the assessment of a new health technology requires, in addition to a clinical evaluation, also an economic evaluation. In Italy, two economic evaluations were conducted and recently published. The objective of this article is focused on the two Italian economic analyses in order to describe the methods used, to summarize the main results, and to give a comprehensive picture of the pharmacoeconomic profile of peginterferon beta-1a in Italy in approved indication. The two analyses were conducted to evaluate such profile; the former was a cost-effectiveness analysis, the latter was a budget impact analysis: 1) The cost-effectiveness analysis – developed through a lifetime Markov model – compared peginterferon beta-1a with injectable first-line treatments for RRMS in Italy from the perspective of the Italian National Healthcare Service (NHS) and from the societal perspective. Efficacy data were derived from a published Network Meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. From the Italian NHS perspective, peginterferon beta-1a was dominant in one case, while in all others its incremental cost-effectiveness ratio (ICER) was between €10,580/QALY and €22,023/QALY. From the societal perspective, peginterferon beta-1a was dominant versus every comparator. 2) The budget impact analysis estimated – using a simple decision analytic model from the perspective of the Italian NHS – the financial impact due to the introduction of peginterferon beta-1a on the Italian drug market. The cumulative budget impact over 3 years was a cost saving of approximately €3.1 million. Based on the results of both analyses, the adoption of peginterferon beta-1a for the treatment of RRMS is not only clinically effective, but also economically efficient and financially sustainable from the Italian NHS perspective.

BACKGROUND: Peginterferon beta-1a is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (RRMS). The efficacy and safety of peginterferon beta-1a was demonstrated in the placebo-controlled ADVANCE trial.OBJECTIVE: The objective of this study was to assess the cost-effectiveness of peginterferon beta-1a as compared with injectable first-line treatments for RRMS in Italy.METHODS: The cost-effectiveness analysis was developed through a Markov model with lifetime simulation in the perspective of the Italian National Healthcare Service (NHS). It was added an alternative scenario to take into account the Italian societal perspective. Outcomes were measured in terms of life years (LYs), quality adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER). The natural progression of the disease was informed by the published literature and previously published modelling exercises. The efficacy of treatments was simulated as reduction of disability progression (EDSS) and relapse rate. Efficacy data were derived from a published network meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A 3.5% discount rate was applied to costs and outcomes. One-way and probabilistic sensitivity analyses were developed and cost-effectiveness acceptability curves generated.RESULTS: Peginterferon beta-1a was more effective than the comparators in terms of survival (19.94 vs.19.68-19.81 discounted LYs, respectively), and QALYs (9.07 vs. 8.06 and 8.55 discounted QALY, respectively). In the perspective of the Italian NHS, the ICER was € 11,111/QALY vs. interferon beta-1a 30 µg, € 12,604/QALY vs. interferon beta-1a 22 µg, € 10,580/QALY and € 16,702/QALY vs. interferon beta-1b 250 µg and € 22,023/QALY vs. glatiramer acetate 20 mg. Peginterferon beta-1a dominated interferon beta-1a 44 µg. In the societal perspective, peginterferon beta-1a was dominant due to being more effective and with a lower social cost compared to first-line injectable treatments (interferon beta -1a, interferon beta-1b, glatiramer acetate) for RRMS. The outcomes of the sensitivity analyses confirmed the trend of the base case results.CONCLUSIONS: Peginterferon beta-1a shows a favourable pharmaco-economic profile for the treatment of RRMS. Even if an official threshold for the cost-effectiveness does not exist in Italy, the ICER values obtained were far below the commonly accepted thresholds (30,000-50,000 €/per QALY gained).[Article in Italian]