The Cost of Patients With Relapsing-Remitting Multiple Sclerosis Who Develop Neutralizing Antibodies While Treated With Interferon Beta

Paolicelli, Damiano; Iannazzo, Sergio; Santoni, Laura; D’Onghia, Mariangela; Direnzo, Vita; Iaffaldano, Antonio; Puma, Elisa; Lecce, Vincenzo Di; Trojano, María

doi:10.1016/j.jval.2015.09.2925

Cited by 3 publications

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“…Analisi di costo-efficacia dell'utilizzo di peginterferone beta-1a nel trattamento della sclerosi multipla recidivante remittente in Italia beta-1a vs interferone beta e GA nella prospettiva del payer. L'analisi è stata presentata come poster al 18° congresso europeo dell'I-SPOR (Milano, 2015). Peginterferone beta1a è risultato dominante, perché più efficace e meno costoso, rispetto a tutte le altre terapie iniettive per il trattamento di prima linea della SMRR (interferone beta e GA) [75].…”

Section: Analisi DI Costo-efficacia Dell'utilizzo Di Peginterferone Bunclassified

“…I risultati indicano che una minore immugenicità si traduce anche in un minor impatto economico sia nella prospettiva del SSN che in quella della società. L'incremento annuale del costo di gestione di un paziente che sviluppa NAb è pari a € 1.111 nella prospettiva del SSN italiano e pari a € 3.100 nella prospettiva della società italiana [78]. Come spesso accade per le valutazioni farmacoeconomiche di nuovi trattamenti, la mancanza di evidenze pubblicate, prima dello sviluppo dell'analisi, ha impedito l'inclusione di simili dinamiche nel modello di costo-efficacia.…”

Section: Analisi DI Costo-efficacia Dell'utilizzo Di Peginterferone Bunclassified

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[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

Iannazzo¹,

Santoni²,

Saleri³

et al. 2016

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cronicità e la progressione della malattia con ricadute e disabilità crescente incidono sulla qualità di vita del paziente e sui costi per la società. L'esordio della malattia nella fase giovaneadulta coincide con il pieno della vita affetIntroduzIone L'organizzazione mondiale della sanità (OMS) ha definito la sclerosi multipla (SM) una delle malattie sociali maggiormente costose. L'esordio nella fase giovane-adulta, la AbstrActBACKGROUND: 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). Keywords Cost-effectiveness; Peginterferon beta-1a; Multiple SclerosisAnalisi di costo-efficacia dell'utilizzo ...

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Section: Analisi DI Costo-efficacia Dell'utilizzo Di Peginterferone Bunclassified

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

Iannazzo¹,

Santoni²,

Saleri³

et al. 2016

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“…Patients with NAbs show a significant increase of the relapse incidence rate ratio (IRR = 1.38; p = 0.0247) and a significant decrease of the time to the first relapse (IRR = 1.51; p = 0.0111) [69]. This means that a low immunogenicity results in a low economic impact from the perspective of both the NHS and the society: the annual increment of the management cost of a patient who develops NAbs is equal to €1111 from the perspective of the Italian NHS and to €3100 from the perspective of the Italian society [70].…”

Section: Discussionmentioning

confidence: 95%

The economic profile of peginterferon beta-1a in the treatment of relapsing-remitting multiple sclerosis in Italy

Centonze

Iannazzo

Santoni

et al. 2017

Mult Scler Demyelinating Disord

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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.

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“…I risultati indicano che una minore immugenicità si traduce anche in un minor impatto economico sia nella prospettiva del SSN che in quella della società. L'incremento annuale del costo di gestione di un paziente che sviluppa NAb è pari a € 1.111 nella prospettiva del SSN italiano e pari a € 3.100 nella prospettiva della società italiana [46]. Anche questa valutazione, come tutte le analisi di proiezione economica, è affetta da alcune limitazioni, derivanti dall'aver adottato delle assunzioni, che, in quanto tali, potrebbero essere affette da incertezza.…”

Section: Analisi DI Sensibilitàunclassified

[Budget impact analysis for peginterferon beta-1a in relapsing remitting multiple sclerosis in Italy]

Iannazzo¹,

Santoni

Saleri

et al. 2016

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BACKGROUND: Peginterferon beta-1a, injected every two weeks, is the first approved pegylated interferon beta-1a for the treatment of relapsing remitting multiple sclerosis (RRMS). The objective of this analysis was to estimate the economic impact due to the introduction of peginterferon beta-1a in Italy.METHODS: This analysis was conducted with a three-year time horizon with the support of a simple decision-analytic model adopting the perspective of the Italian National Healthcare Service (NHS). Healthcare costs sustained by the Italian NHS to manage the RRMS population (drug treatment, monitoring, relapse management, adverse events management) were calculated over 3 years and compared in two scenarios: the base scenario where interferons-beta and glatiramer acetate (GA) are used to treat RRMS patients, and an alternative scenario where peginterferon beta-1a can also be used to treat RRMS patients. The target population was approximately 35,500, 37,500 and 39,500 patients at year 1, 2 and 3 respectively, based on the published literature and market data. The efficacy of treatments was simulated as a reduction of relapse rates and was derived from a Network Meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A one-way sensitivity analysis was developed.RESULTS: According to current price and described assumptions, it was estimated that the introduction of peginterferon beta-1a would result in a decrease of total costs when compared with the base scenario. The cost in the base scenario was estimated to be € 321.5, € 339.7 and € 357.8 million in years 1, 2, and 3, respectively. In the alternative scenario, the same costs resulted in about € 321.1, € 338.6 and € 356.2 million, respectively. The cumulative budget impact over three years period was approximately a cost saving of € 3.1 million (about 0.3% saving).CONCLUSION: The adoption of peginterferon beta-1a for the treatment of RRMS would be viewed as economically sustainable by the Italian NHS.[Article in Italian]

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The Cost of Patients With Relapsing-Remitting Multiple Sclerosis Who Develop Neutralizing Antibodies While Treated With Interferon Beta

Cited by 3 publications

References 0 publications

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

The economic profile of peginterferon beta-1a in the treatment of relapsing-remitting multiple sclerosis in Italy

[Budget impact analysis for peginterferon beta-1a in relapsing remitting multiple sclerosis in Italy]

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