[Budget impact analysis for peginterferon beta-1a in relapsing remitting multiple sclerosis in Italy]
DOI:
https://doi.org/10.7175/fe.v17i2S.1231Keywords:
Budget Impact Analysis, Peginterferon beta-1a, Multiple SclerosisAbstract
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]
References
MSIF - Multiple Sclerosis International Federation. Atlas of MS 2013. Disponibile online su: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf (ultimo accesso novembre 2015)
AISM – Associazione Italiana Sclerosi Multipla. Bilancio sociale AISM 2014. Disponibile online su: http://bilanciosociale.aism.it (ultimo accesso novembre 2015)
Pugliatti M, Rosati G, Carton H, et al. The epidemiology of multiple sclerosis in Europe. Eur J Neurol 2006; 13: 700-22; http://dx.doi.org/10.1111/j.1468-1331.2006.01342.x
Solaro C, Allemani C, Messmer Uccelli M, et al. The prevalence of multiple sclerosis in the north-west Italian province of Genoa. J Neurol 2005; 252: 436-40; http://dx.doi.org/10.1007/s00415-005-0670-x
Granieri E, Malagu S, Casetta I, et al. Multiple sclerosis in Italy. A reappraisal of incidence and prevalence in Ferrara. Arch Neurol 1996; 53: 793-8; http://dx.doi.org/10.1001/archneur.1996.00550080115019
Totaro R, Marini C, Cialfi A, et al. Prevalence of multiple sclerosis in the L’Aquila district, central Italy. J Neurol Neurosurg Psychiatry 2000; 68: 349-52; http://dx.doi.org/10.1136/jnnp.68.3.349
Nicoletti A, Patti F, Lo Fermo S, et al. Possible increasing risk of multiple sclerosis in Catania, Sicily. Neurology 2005; 65: 1259-63; http://dx.doi.org/10.1212/01.wnl.0000180628.38786.85
Ranzato F, Perini P, Tzintzeva E, et al. Increasing frequency of multiple sclerosis in Padova, Italy: a 30 year epidemiological survey. Mult Scler 2003; 9: 387-92; http://dx.doi.org/10.1191/1352458503ms920oa
Granieri E, Casetta I, Govoni V, etal. The increasing incidence and prevalence of MS in a Sardinian province. Neurology 2000; 55: 842-8; http://dx.doi.org/10.1212/WNL.55.6.842
Pugliatti M, Sotgiu S, Solinas G, et al. Multiple sclerosis epidemiology in Sardinia: evidence for a true increasing risk. Acta Neurol Scand 2001; 103: 20-6; http://dx.doi.org/10.1034/j.1600-0404.2001.00207.x
Millefiorini E, Cortese A, Di Rezze S, et al. The prevalence of multiple sclerosis in central Italy. Mult Scler 2010; 16: 1432-6; http://dx.doi.org/10.1177/1352458510373263
Chiao E, Meyer K. Cost effectiveness and budget impact of natalizumab in patients with relapsing multiple sclerosis. Curr Med Res Opin 2009; 25: 1445-54; http://dx.doi.org/10.1185/03007990902876040
Olesen J, Gustavsson A, Svensson M, et al.; CDBE2010 study group; European Brain Council. The economic cost of brain disorders in Europe. Eur J Neurol 2012; 19: 155-62; http://dx.doi.org/10.1111/j.1468-1331.2011.03590.x
Ponzio M, Gerzeli S, Brichetto G, et al. Economic impact of multiple sclerosis in Italy: focus on rehabilitation costs. Neurol Sci 2015; 36: 227-34; http://dx.doi.org/10.1007/s10072-014-1925-z
Kobelt G, Berg J, Lindgren P, et al. Costs and quality of life of multiple sclerosis in Italy. Eur J Health Econ. 2006; 7 Suppl 2: S45-54; http://dx.doi.org/10.1007/s10198-006-0385-7
Steinberg S, Faris R, Chang C, et al. Impact of Adherence to Interferons in the Treatment of Multiple Sclerosis. Clin Drug Investig 2010; 30: 89-100; http://dx.doi.org/10.2165/11533330-000000000-00000
Hu X, Liu S, LaVallee N, et al. Pharmacokinetics, safety, and tolerability of Peginterferon Beta-1a delivered by Single-use Autoinjector and pre-filled syringe. 65th Annual Meeting American Academy of Neurology. San Diego, 2013
Calabresi PA, Kieseier BC, Arnold DL, et al.; ADVANCE Study Investigators. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol 2014; 13: 657-65; http://dx.doi.org/10.1016/S1474-4422(14)70068-7
Fantelli V, van de Vooren K, Garattini L, Budget Impact Analysis: stato dell’arte in letteratura e proposta per una definizione in Italia. QF 2011; 15. Disponibile su: http://www.quadernidifarmacoeconomia.com/archivio-qf/qf15/237-n15-valeco.html (ultimo accesso novembre 2015)
Tarricone R. Valutazione economica: definizioni, principali tecniche di valutazione e ruolo della Budget Impact Analysis. Convegno Health technology assessment in oncologia. Roma, 10 novembre 2011
Sullivan SD, Mauskopf JA, Augustovski F, et al. Principles of good practice for budget impact analysis II: Report of the ISPOR task force on good research practices - budget impact analysis. Value Health 2014; 17: 5-14; http://dx.doi.org/10.1016/j.jval.2013.08.2291
IMS Health. Aprile 2014 - Marzo 2015. Dati IMFO. ©IMS Health S.p.A. Tutti i diritti riservati
Tolley K, Hutchinson M, You X, et al. A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis. PLoS One 2015; 10: e0127960; http://dx.doi.org/10.1371/journal.pone.0127960
Furneri G, Scalone L, Ciampichini R, et al. Utilization of disease modifying agents in multiple sclerosis: analysis from an Italian administrative database. Value Health 2012; 15: A281; http://dx.doi.org/10.1016/j.jval.2012.08.498
Agenzia Italiana del Farmaco. Determina 15 giugno 2015. Riclassificazione del medicinale per uso umano «Plegridy» (peginterferone beta-1a), ai sensi dell’articolo 8, comma 10, della legge 24 dicembre 1993, n. 537 (Determina n. 767/2015). GU Serie Generale n.148 del 29-6-2015
Ministero Della Salute. Decreto 23 dicembre 2003. Regime di rimborsabilità e prezzo di vendita della specialità medicinale «Avonex» - interferone beta 1A autorizzata con procedura centralizzata europea. (Decreto /C/N.257/2003). GU n.11 del 15-1-2004
Agenzia Italiana del Farmaco. Determinazione 8 novembre 2011. Regime di rimborsabilità e prezzo di vendita della specialità medicinale AVONEX (interferone beta 1A) (Determinazione/C n. 2699/2011). GU Serie Generale n.272 del 22-11-2011
Agenzia Italiana del Farmaco. Determinazione 13 novembre 2007. Regime di rimborsabilità e prezzo di vendita di nuove confezioni del medicinale «Betaferon» (interferone beta 1 b) autorizzate con procedura centralizzata europea dalla Commissione europea (Determinazione/C n. 174/2007). GU n.279 del 30-11-2007 - Suppl. Ordinario n. 250
Ministero Della Sanità. Decreto 3 maggio 2000. Regime di rimborsabilità e prezzo di vendita della specialità medicinale “Betaferon”. (Decreto n. 103/2000). GU n.127 del 2-6-2000
Agenzia Italiana del Farmaco. Comunicato. Autorizzazione all’immissione in commercio della specialità medicinale per uso umano «Copaxone». GU Serie Generale n.106 del 9-5-2005
Agenzia Italiana del Farmaco. Determinazione 21 luglio 2009. Regime di rimborsabilità e prezzo di vendita del medicinale per uso umano «Rebif» (Determinazione 299/2009) (09A09243). GU n.196 del 25-8-2009 - Suppl. Ordinario n. 154
Agenzia Italiana del Farmaco. Determinazione 14 novembre 2011. Regime di rimborsabilità e prezzo di vendita del medicinale Rebif (interferone beta-1a) (Determinazione/C 2729/2011) (11A15146). GU n.274 del 24-11-2011
Agenzia Italiana del Farmaco. Determinazione 9 marzo 2009. Regime di rimborsabilità e prezzo di vendita del medicinale «Extavia» (interferone beta - 1b). (Determinazione n. 262/2009). GU n.66 del 20-3-2009
Gruppo Neurologi Sclerosi Multipla della Regione Emilia-Romagna e CReVIF — Centro Regionale Valutazione e Informazione sui Farmaci. Percorso Regionale (Emilia-Romagna) di Diagnosi e Terapia della Sclerosi Multipla. Regione Emilia-Romagna, 2011. Disponibile online su: http://salute.regione.emilia-romagna.it/documentazione/ptr/elaborati/128_sclerosi_multipla.pdf (ultimo accesso novembre 2015)
Percorso Diagnostico Terapeutico Assistenziale Sclerosi Multipla – Regione Lazio. Decreto del Commissario ad Acta 13.11.2014, n. 386
Ministero Della Salute. Decreto 18 ottobre 2012. Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale (13A00528). GU Serie Generale n.23 del 28-1-2013 - Suppl. Ordinario n. 8
ISTAT. Indice dei prezzi al consumo per famiglie operai e impiegati. Disponibile su: http://rivaluta.istat.it (ultimo accesso novembre 2015)
Avonex_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/ 103628s5129s5177s5194s5224lbl.pdf
Plegridy_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/ 2014/125499s000lbl.pdf
Rebif_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/ 103780s5178s5179lbl.pdf
Copaxone_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/ 020622s057lbl.pdf
Betaferon_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/ 103471s5186lbl.pdf
Extavia_Prescribing Information. Disponibile su: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/ 125290s0000lbl.pdf
Ivanova JI, Bergman RE, Birnbaum HG, et al. Impact of medication adherence to disease-modifying drugs on severe relapse, and direct and indirect costs among employees with multiple sclerosis in the US. J Med Econ 2012; 15: 601-9; http://dx.doi.org/10.3111/13696998.2012.667027
Paolicelli D, D’Onghia M, Pellegrini F, et al. The impact of neutralizing antibodies on the risk of disease worsening in interferon b–treated relapsing multiple sclerosis: a 5 year post-marketing study. J Neurol 2013; 260: 1562-8; http://dx.doi.org/10.1007/s00415-012-6829-3
Paolicelli D, Iannazzo S, Santoni L, et al. The Cost of Patients With Relapsing-Remitting Multiple Sclerosis Who Develop Neutralising Antibodies While Treated With Interferon Beta. ISPOR. Milano, 2015
Lee AW. Review of mixed treatment comparisons in published systematic reviews shows marked increase since 2009. J Clin Epidemiol 2014; 67: 138-43; http://dx.doi.org/10.1016/j.jclinepi.2013.07.014
Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health 2011; 14: 417-28; http://dx.doi.org/10.1016/j.jval.2011.04.002
Iannazzo S, Santoni L, Saleri C, et al. Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management. Farmeconomia. Health Economics and Therapeutic Pathways 2016;17(Suppl 2): 13-36; http://dx.doi.org/10.7175/fe.v17i2S.1230
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