Budget Impact Analysis of Paliperidone Palmitate 3-Monthly for The Treatment of Schizophrenia In Italy

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VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1

A suspected diagnosis of BC or GOC in a woman’s medical history is associated with an increased risk of developing depression, anxiety, and adjustment disorders. PMH6 Severe Depression as a Risk Factor for Osteoporosis: A Real World Data Study Conducted in Italy Heiman F, Moretti R, Pegoraro V QuintilesIMS, Milan, Italy

Objectives: Depression is a common mental disorder, with more than 300 million people suffering from it. The presence of a relationship between depression and osteoporosis has been shown by a previous real world data study conducted in Italy. The objective of this analysis is to investigate whether the association observed could have been confused by antidepressants use or by time dependent confounders’ presence.  Methods: This was a retrospective analysis based on data extracted from Italian IMS Health Longitudinal Patient Database. Three cohorts have been defined: the cohort of incident depressed patients, consisting of individuals with a diagnosis of depression (index date) during the period January 2004 - December 2010. The cohort of non-depressed patients, containing subjects with a first contact with the general practitioner (Index date) during the period January 2004 - December 2010, and that were not included in the previous cohort (free from depression). The cohort of depressed patients using antidepressants, identified within the first cohort. Patients of all cohorts must not have an osteoporosis diagnosis or a depression diagnosis during the five years period preceding the Index Date. Extended multivariate Cox models were performed controlling for antidepressants use and for other time dependent confounders.  Results: No association was found between depression and osteoporosis during the follow-up period (HR 1.024, p= 0.26), while a higher incidence of osteoporosis of about 7% (HR 1.07, p= 0.0010) was observed among antidepressants users when compared to non-users. Focusing on patients with antidepressants, the risk of developing osteoporosis increased by 13% for each antidepressant prescribed and by 14% (HR 1.141, p= 0.0012) at antidepressant switch.  Conclusions: Results from this study suggest that patients receiving a higher number of antidepressants and those needing pharmacological treatment changes have an increased risk of osteoporosis. Thus, this study suggests an association between a severe status of depression and osteoporosis.

MENTAL HEALTH – Cost Studies PMH7 Budget Impact Analysis of Long-Acting Parenteral Antipsychotic Drug Flufenazine In The Treatment of Schizophrenia In Russia: A Hospital Perspective Vaskova L, Musina N, Tiapkina M Sechenov First Moscow State Medical University, Moscow, Russian Federation

Objectives: the purpose of the study was to develop an instrument for the the budget impact analysis of atypical long-acting injectable flufenazine (FLU LAI) as an alternative to typical antipsychotics (TA) chlorpromazine (CHL). Methods: the study was based on Ying Jiao Zhao meta-analysis of 18 antipsychotics used in the long-term treatment of schizophrenia. The comparison of FLU LAI versus CHL revealed differences of statistical significance, FLU LAI was superior to chlorpromazine (OR= 0.31, 95% CI 0.11–0.88) by relapse rate. The developed model-based evaluation instrument enabled to estimate the budget impact of FLU LAI for schizophrenia patients in a single Moscow hospital with 198 inhabitants, who were treated in January – December 2015. In budget impact analysis it was assumed that drug consumption (estimated in DDD/100 bed-days) per 1 treated patient remains unchangeable, while the proportion of patients, treated with FLU LAI and CHL, will change from the initial. Exchange rate in the analyzed period was € 1 = 68 RUB.  Results: the total annual budget for medicines for 198 patients was estimated at € 21,288. Initially 8.5% of patients (n= 17) were treated with FLU LAI and 13% (n= 26) with CHL. If the proportion of patients, receiving FLU LAI, increases by 1% while the proportion of patients, receiving CHL decreases by the same 1%, the total costs of medicines will decrease by 0.1% (€ 21.5). If the proportion of patients treated with FLU LAI increases by 5% and 10% (as an alternative CHL decreases in the same proportion) the budget economy will be 0.5% (€ 107.5) and 1% (€ 215).  Conclusions: FLU LAI is associated with a lower cost of treatment per DDD dose and is considered to be more effective versus chlorpromazine by relapse rate. Increase by 10% proportion patients, receiving FLU LAI, saves up to 1% of annual budget for medicines in a single hospital. PMH8 Budget Impact Analysis of Ziprasidone Use In The Treatment of Schizophrenia In Russia Krysanov I1, Ermakova V2, Tiapkina M2 1Institute of Medical and Social Technologies, Moscow National University of Food Production, Moscow, Russia, 2Sechenov First Moscow State Medical University, Moscow, Russian Federation

Objectives: to evaluate the financial consequences of ziprasidone use from the perspective for Russian National Healthcare system.  Methods: budget impact analysis (BIA) was performed from two perspectives: Russian National Health system and a patient. Costs of atypical antipsychotics (AA) and rehospitalization costs of patients treated with ziprasidone (ZIP), quetiapine (QUE), aripiprazole (ARI), paliperidone (PAL), paliperidone depot (PAL LAI) and risperidone depot (RIS LAI) were calculated for median duration of treatment 48 weeks. The target population was determined using Russian statistical epidemiology data, and a national treatment guidelines. Exchange rate mean in 2017 - € 1 =  62.5 RUB.  Results: the most effective drug was ZIP with the lower risk ratio (RR) of rehospitalization -17.08% versus 43.28% for RIS LAI, 53.36% for PAL, PAL LAI, QTP and 83.75% for ARI. With the drug cost - € 1,444.34 (90271 RUB) ZIP was more expensive only compared to QTP , total costs for schizophrenia therapy for 1 patient was the lowest for ZIP – € 1,626.37 (101648 RUB) – cost saving vary from 9.7% versus QTP to 54.7% versus PAL LAI. In

the BIA for cohort of Russian schizophrenia patients (140,713 inhabitants, 25% from all schizophrenia patient population) total budget for ZIP will estimate at 228.9 mln €  (14303 mln RUB) and will decrease by € 24.6-55.4 mln (1536 or -3464 mln RUB) versus different trade name of QTP; by € 182.1 mln (11381 mln RUB) vs ARI; by € 93.2 mln (5824 mln RUB) vs PAL and by € 274.8 mln (17174 mln RUB) vs PAL LAI. The most influential variables in the sensitivity analysis were costs of drug, dosage regimen and RR of rehospitalization.  Conclusions: funding ziprasidone (the most effective in case of rehospitalization rate) is an effective use of financial resources in the Russian public health – total budget saving estimated from 9.7% to 54.7%. PMH9 Allowing Methadone’s Prescription To General Practitioners: A Positive Impact on The French Healthcare Insurance Expenditures Berard I1, Benazet F1, Cohen S2, Verstraete O2, Amory D1 1NEXTEP, PARIS, France, 2Bouchara-Recordati, PUTEAUX, France

Currently, Methadone (opioid agonist treatment for opioid dependent people) prescription in France is allowed only for hospital physicians working in specialized healthcare centers. In the last 20 years, many French experts have requested the ability for General Practitioners (GPs) to prescribe methadone, to improve patient’ care and management as it is already the case for buprenorphine. Objectives: The objective of the study was to demonstrate the economic impact for the French Healthcare insurance of the authorization to describe methadone given to GPs in addition to hospital physicians.  Methods: A Budget impact analysis (BIA) was conducted to demonstrate the financial difference between the current scenario (1) and a new scenario (2) integrating the authorization of methadone prescription by GPs as of January 1, 2018.  Results: The study showed cost savings could be generated by a gradual transfer from health centers to general practices, as GP’s annual cost is three times less expensive than health centers annual cost - Despite a lower price of Methadone, the scenario 2 will lead to additional expenses induced by a broader access to the treatment - Savings are also generated by the fact that a large number of patients treated under scenario 2 are less likely to be infected by HCV or HIV.  Conclusions: Allowing GPs to prescribe methadone would lead to significant cost savings for the French Health insurance, around € 40 million between 2018 and 2022. Besides, it would extend the access of opioid substitution treatment (OST) adapted for injecting drug users and/or nonresponders to another OST. PMH10 Budget Impact Analysis of Paliperidone Palmitate 3-Monthly for The Treatment of Schizophrenia In Italy Povero M, Pradelli L AdRes HEOR, Torino, Italy

Objectives: To estimate the impact of paliperidone palmitate 3-monthly (PP3M) with respect to paliperidone palmitate 1-monthly (PP1M) and other long-acting therapy (LAT) treatments (aripiprazole LAT, olanzapine pamoate and risperidone microspheres) for the treatment of schizophrenia in Italy.  Methods: The impact is estimated from a third party payer perspective, so only direct health costs (treatment, disease, relapse and adverse events) are considered. Patients eligible for PP3M treatment are considered: about 80% of PP3M patients come directly from PP1M, the remaining part is equally distributed between aripiprazole and risperidone. The model includes the per label required treatment-specific induction phase via PP1M. Upon relapse, according to clinical practice, patients switch to subsequent lines of therapy (oral treatment with clozapine mostly). Patients may be in stable disease, experiencing relapse, experiencing acute (prolactin-related disorders and extrapyramidal symptoms) or permanent (weight gain and diabetes) adverse events, or die. Data from Phase III PSY3011 and PSY3012 trials are used to retrieve clinical outcomes for PP1M and PP3M. Efficacy data of other LAIs and oral medicines are obtained by applying relative risks elaborated from published literature data. The economic inputs derive from official prices (for all considered drugs) and publications related to the Italian context.  Results: For the next 3 years, 2235, 6320, and 9316 patients, respectively, are estimated to switch to PP3M; Total savings in 3 years amounts to €  425,500 (€  17,340 year 1, €  127,000 year 2 and €  281,160 year 3). About 40% of the savings is due to decreasing in drug costs while the rest is due to a reduction in the number of relapses.  Conclusions: Based on budget impact analysis, the introduction of PP3M in Italy is completely sustainable by the National Healthcare System, as it is a cost saving option compared to the actual mix of treatment (aripiprazole, olanzapine and risperidone). PMH11 Cost Consequence of Introducing Paliperidone Palmitate 3-Monthly For The Maintenance Treatment of Schizophrenia In The English National Health Service (NHS) Ming T1, Rao B2, Bird A1 1Janssen UK, High Wycombe, UK, 2Curo Consulting, Marlow, UK

Objectives: The objective was to estimate the budget impact of introducing paliperidone palmitate 3-monthly for the maintenance treatment of schizophrenia to the English NHS setting.  Methods: A 1-year budget impact model was developed based on epidemiological estimates of adults who had previously experienced two relapses of schizophrenia. An English real world data study informed the number of hospital admissions and length of stay. Two scenarios were simulated: 1) the current setting, in which patients were prescribed their current antipsychotic drugs, and 2) the proposed setting, including potential displacement of current antipsychotics from switching treatment to paliperidone palmitate 3-monthly. The budget impact analysis incorporated drug acquisition, drug administration and hospitalisation costs. Univariate sensitivity analyses were conducted, including analyses assessing the impact of differential rates of displacement.  Results: The current estimated annual cost of schizophrenia in the English NHS adult population with two relapses was approximately £660m, with 46,479 admissions and 1,389,985 bed days. Assuming a displacement of 25% oral anti-psychotic and risperidone long acting injectable (RLAI) patients, and 70% of paliperidone palmitate 1-monthly patients,