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PSY30 Povero M, Pradelli L AdRes HE&OR, Turin, Italy Biologic treatments for moderate to severe naïve psoriatic patients: a budget impact analysis in Italy Objective Evaluate the current prescription trend of biologics for the treatment of Adalimumab Persistence Biologics currently reimbursed in Italy for psoriasis include tumor necrosis 40% 0% 0 A deterministic Markov model was developed to simulate the evolution of 6 12 18 24 30 36 42 0% 0 6 12 18 24 30 36 42 48 Ustekinumab 100% 0.81 0.6 1.03 1st line† 0 0.48 0.42 post 1st line‡ 0.93 80% 60% 40% S tj 20% S tj−1 0% 1st line ─ median=5.3 years 2nd line ─ median=1.8 years 3rd line ─ median=2 years Time on therapy (months) 0 6 12 18 24 30 36 42 Persistence persistence curves (Figure 1) specific for each drug according to the formula 1st line ─ median=3.4 years 2nd line ─ median=1.8 years 3rd line ─ median=1.5 years Time on therapy (months) 0.28 Persistence Transition probabilities (switch between lines) were calculated applying 40% 20% 80% Demographic, epidemiological and clinical data from literature [2, 3, 1]. Ustekinumab 0.74 0.74 0.64 0.51 Malignancy* 60% 48 Infliximab 100% bio-naïve psoriatic patients in Italy for 3 years: pswitch tj :=P T ≤ tj T > tj−1 =1 − 1st line ─ median=3.6 years 2nd line ─ median=3.7 years 3rd line ─ median=2.3 years Time on therapy (months) 20% the interleukin-12/23 inhibitor ustekinumab [1]. Infliximab 80% 60% factor (TNF)-α inhibitors adalimumab, etanercept, and infliximab, as well as Etanercept MACE 80% hypotheses, including the introduction of infliximab biosimilars. Methods Cumulative AEI rates Etanercept 100% Persistence psoriasis in Italy and estimate the impact of alternative market Adalimumab 100% 1.88 1.67 Infections• 60% 2.77 0.95 40% 1st line ─ median=20.1 years 2nd line ─ median=15.4 years 3rd line ─ median=8.7 years Time on therapy (months) 20% 0% 48 0 6 12 18 24 30 36 42 0.42 0.42 0.45 0.36 Mortality* 48 0 Events/100 PYs 1 2 3 where S(·) is the survival distribution (time on therapy) for each treatment [4, 5]. Adverse events of interest (AEI) and mortality (Figure 2) were modeled for Figure 1. Persistence of Biologic Therapy in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) for each biologic considered in the analysis. each biologic drug (1st, 2nd and 3rd line), basing on published data from The 3-years resulting AEI (current vs alternative scenario) Psoriasis Longitudinal Assessment and Registry (PSOLAR) [6, 7, 8]. All costs were calculated from the perspective of National Health Service: Hospitalization costs were calculated as average of Italian DRGs weighted for event-related frequency [9, 10]. Current scenario Alternative scenario 30 100% 27 80% 48.3% 24 The cost of a dermatological visit was considered every two months and in Savings (alternative vs current) 21 Drug costs [1] included eventually administration costs [13]. The current Italian market mix of biologic treatments (Figure 4) was 40% 20.5% 11.8% compared with the total substitution of infliximab with its biosimilars 0% 12 20% 3 expenses of the remaining biologics, proportionally to their current shares. 0 13 7 4 6 2 MACEs biological treatment annually. Malignancy € 60,000,000 € 50,000,000 € 683 2.92% € 713 € 663 € 684 € 665 € 40,000,000 € 671 Annual savings per patient corresponds to about € 670; regional analysis (Figure 6) do not show significant differences: 95% CI € 629 ─ 672, p=0.10. € 637 € 684 infliximab biosimilars lead to estimated savings of almost 2 millions in 3 years (Figure 5). Regional savings per patient (alternative vs current scenario) 3.76% Total cost results in about 45.7 million Euro for 3 years in the current scenario; increasing in ustekinumab market shares and the introduction of Figure 4. Current Italian market mix of biologic treatments [14] Cumulative total cost (alternative vs current scenario) Adverse events, generally rare, are reduced in the alternative scenario: -21% of infections, -48% of MACEs and -12% of malignancies (Figure 3). 48.8% 80% 100% Figure 3. Resulting total adverse events of interest (AEI): comparison between current and alternative scenario. In the next three years, 515 bio-naive patients are expected to start a new 4.5% 60% Infections Results Adalimumab Etanercept Infliximab Ustekinumab 27,1% 40% 17 6 combined with ustekinumab increasing its market share to 40% at the 19.6% 20% 15 9 Current scenario (2014 market share mix) 60% 18 case of therapy switch [11, 12]. Figure 2. Cumulative unadjusted incidence of adverse events of interest per 100 patient-years (PYs). * Rates were based on patients who never exposed to a given biologic therapy. • Rates were based on patients who were exposed to a given biologic therapy within 91 days of the event. † Patients who began a new biologic and had never received any biologic in the past. ‡ Patients who began a new biologic therapy and had never received that specific biologic in the past. MACEs: Major adverse cardiovascular events, AEI: Adverse events of interest. 1.76% € 30,000,000 € 628 € 691 € 652 € 672 € 621 € 618 Conclusions € 20,000,000 The cost of biologically treated psoriasis depends almost entirely on drug € 652 € 602 € 10,000,000 € 732 acquisition and administration. Changes in the current prescribing scenario, with adoption of the most persistent biologic (ustekinumab), can lead to € 605 €0 valuable savings through lower cost of maintenance phase, avoided reinductions, and reduced visits. Ustekinumab market increase accounted for 50% of total savings, while the remainder came from biosimilars substitution. Acknowledgements The study was funded by Janssen-Cilag SpA, Italy € 532 Total cost (€) Visits/AEI (€) Drugs (€) Current scenario Alternative scenario Year 1 8,213,471 8,068,714 60,053 52,910 8,153,419 8,015,804 Current scenario Alternative scenario Year 2 23,633,741 22,942,480 139,960 126,190 23,493,781 22,816,290 Current scenario Alternative scenario Year 3 45,685,039 43,968,431 262,179 238,411 45,422,860 43,730,019 Total savings (alternative vs current scenario) Figure 5. Budget impact results: total cumulative cost in the current and alternative scenarios for 3-years analysis. € 602 National mean € 668, p=0.10 Figure 6. Annual cost per patient: regional trend in Italy. References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Informatore Farmaceutico 2015. Ultimo accesso febbraio 2015. www.codifa.it Popolazione italiana residente al 1 gennaio 2014, ultimo accesso febbraio 2015 http://demo.istat.it/ Icen M, Crowson CS, McEvoy MT et al. Trends in incidence of adult-onset psoriasis over three decades: A population-based study. JAAD 2009, Volume 60, Issue 3, Pages 394–4012009. Menter A, Papp K, Frueger GG et al. Persistence of biological therapy in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). EADV 20144, P1590. C0168Z03 (PSOLAR) August 23, 2013 data cut, Janssen ─ data on file Papp K, Gottlieb AB, Naldi L et al. Experience with ustekinumab in patients with psoriasis enrolled in a large, multicenter, prospective, disease-based registry (Psoriasis Lonfitudinal Assessment and Registry [PSOLAR]). JAAD 2014. Kalb R, Fiorentino D, Lebwohl M et al. Serious infection events in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) Study: Current status of observation. AAD 2014, P8159. Bissonnette R, Gottlieb AB, Kerdel F et al. Major Adverse Cardiovascular Events (MACE) among new users of biologic therapies in the Psoriasis Longitudinal Assessment and Registry. AAD 2014, P8154. Tariffe DRG regionali correnti. Ultimo accesso febbraio 2015. Rapporto annuale sull’attività di ricovero ospedaliero. Dati SDO 2013 Il trattamento della psoriasi nell'adulto, Linee Guida 2013 Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale. DM 18 ottobre 2012, Gazzetta Ufficiale Serie Generale del 281-2013 13. Benucci M, Iannazzo S, Sabadini L. Analisi di budget impact dell’utilizzo di rituximab nel trattamento dell’artrite reumatoide in Italia. Farmeconomia e percorsi terapeutici 2009; 10(1): 19-31. 14. Janssen data on file ─ MS nazionali e stime regionali gennaio-settembre 2014 ISPOR ─ Milan 2015