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PIN64 Cost-Effectiveness of Dolutegravir/Abacavir/Lamivudine in Hiv-1 Treatment Naive Patients in France Pialoux G1, Marcelin A2, Cawston H3, Guilmet C3, Laurisse A4, Finkielsztejn L4, Aubin C5 1APHP, Hôpital Tenon, Paris, France, 2AP-HP Hôpital Pitié-Salpêtrière, Paris cedex 13, France, 3MAPI, Nanterre, France, 4ViiV Healthcare France, Marly-le-Roi, France, 5Glaxo Smith Kline, Marly-le-Roi, France
Objectives: To evaluate the cost-effectiveness of an integrase inhibitor (INI), dolutegravir (DTG), in combination with abacavir(ABC)/lamivudine(3TC) in France, in treatment-naïve (TN) HIV adult patients. Methods: The ARAMIS microsimulation Markov model, including HIV health states with and without opportunistic infection, evaluates costs and effects of first line options including INIs (raltegravir [RAL], elvitegravir/c), protease inhibitors (PI) (darunavir [DRV/r], atazanavir/r, lopinavir [LPV/r]), efavirenz (EFV) and rilpivirine at a life time horizon with a monthly cycle length. Efficacy and safety data were derived from phase III studies (SPRING 2, FLAMINGO and SINGLE including comparators RAL, DRV/r and EFV respectively) and network meta-analyses for other comparators. Treatment algorithms were based on French guidelines and experts opinion accounting for patient’s treatment history, including INI resistance status. Costs, from a collective perspective included routine HIV and opportunistic infection care, and death. Results: The model showed DTG/ABC/3TC was more effective than all other recommended regimens: patients stayed longer on first line, and lived longer and healthier (incremental life years ranged from 0.305 to 0.71 and QALYs from 0.085 to 0.28 versus RAL and LPV/r). With the exception of EFV, DTG was dominant compared to all strategies, with the largest cost savings for INIs (incremental costs of -€ 21,556 for RAL). The cost per QALY gained (ICER) for DTG compared to EFV was € 6,939 (incremental QALYs and costs of 0.10 and +€ 692, respectively). Deterministic sensitivity analyses (DSA) showed that DTG was dominant compared to INIs and PIs in all DSA. Compared to EFV, the ICER was most sensitive to time horizon, resistance parameters, and late failure probability. Conclusions: DTG/ABC/3TC is cost-effective in the management of HIV TN patients in France. These results are mainly explained by the lower price of DTG/3TC/ABC compared to INIs and PIs, DTG’s superior efficacy and high barrier to resistance. PIN65 Cost Effectiveness Analysis of The Use of Daclatasvir for the Treatment of Hepatitis C Virus (Hcv) Genotypes 3 in Cirrhotic Patients Within the Italian National Health Service Restelli U1, Bonfanti M1, Alberti A2, Lazzarin A3, Nappi C4, Croce D1 1LIUC University, Castellanza, Italy, 2Università degli studi di Padova, Padova, Italy, 3University Vita-Salute San Raffaele, Milan, Italy, 4Bristol Myers Squibb S.r.l., Roma, Italy
Objectives: The development of new highly effective therapies for the treatment of hepatitis C virus (HCV), leads to the opportunity to eradicate this infection. In a context characterized by a high prevalence of this pathology (i.e. Italy) the investigation of the most efficient therapies to allocate resources to, is crucial. The aim of the study was to investigate the cost-effectiveness of Daclatasvir+Sofosbuvir+Rib avirine therapy, compared with Sofosbuvir+Ribavirine+Peginterferone therapy for the treatment of HCV genotype 3 infection in cirrhotic patients within the Italian National Health Service. Methods: A published cohort-based Markov simulation model (Monarch model) was used to perform lifetime horizon analyses assuming the Italian National Health Service point of view. The model simulates the natural history of HCV infection and its complications. Patient cohorts were defined based on selected clinical studies and eligibility criteria defined by the Italian Medicines Agency. The comparator was selected considering EASL guidelines published in 2015. The costs considered (2015) were direct medical costs, including adverse events costs. Utility values were influenced by health status and adverse events (anemia, rash, insomnia, headache, fatigue, nausea, diarrhea). Both costs and utility values were discounted using a 3% rate. Results: Daclatasvir+Sofosbuvir+ Ribavirine for 24 weeks (100% sustained virological response – registry trial) would lead to a per capita increase of quality adjusted life years (QALYs) (12.46 vs. 12.10) and costs (56,318 € vs. 41,881 € ) compared with Sofosbuvir+Ribavirine+Peginterferone for 12 weeks (92.06% sustained virological response – PROTON, ELECTRON, LONESTAR studies). The incremental cost effectiveness ratio (ICER) is 39,614 € / QALY. Conclusions: Daclatasvir+Sofosbuvir+Ribavirine therapy is likely to be cost effective compared with Sofosbuvir+Ribavirine+Peginterferone in genotype 3 HCV infected cirrhotic patients, leading to an ICER below the 40,000 € /QALY threshold identified by the Italian Association of Health Economics. PIN66 Cost Effectiveness of Bedaquiline for Patients With Multi-Drug Resistant Tuberculosis in South Korea
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with 13,961,659KRW (1,100 KRW= 1 USD) additional cost spent compared to a patient in SR alone with an incremental cost-utility ratio (ICUR) of 11,638,656KRW/QALY. Bedaquiline plus SR had a 80% probability of being cost-effective at a willingness to pay threshold of 26,000,000KRW when compared with SR alone. Conclusions: The results of this study indicate that bedaquiline is a cost-effective option for the treatment of MDR (including XDR-TB patients) in the Korean settings when compared to standard treatment alone. PIN67 Assessment of Compliance and Avoided Costs After Implementation of Equivalent Terapeutic Program for Candida Infection Treatment Izquierdo MJ1, Romero L2, Sánchez Chorro JL3 1Servicio Extremeño de Salud, Mérida, Spain, 2Hospital Infanta Cristina, Badajoz, Spain, 3Extremadura Health System, Mérida, Spain
Objectives: The main objetive was to evaluate the cost reduction by introduction of equivalent therapeutic program after the accord in the Central Pharmaceutical Commission in Extremadura. Methods: Retrospective observational study between March 2013 and March 2014. We agree that micafungin was the preferential echinocandin for the same indication. Caspofungin was restricted for empiric treatment of fungal infection in patients with fever and neutropenia and Anidulafungin was used in patients with hepatic dysfunction. To quantify the avoided costs we extracted consumption data and costs of antifungals from the Pharmacy Department Multibase v.3. Program (Dominion) and compared them with the same period the previous year. Results: Regarding avoided costs for the period of the study, echinocandins costs were reduced by 353.965 euros, a 24,35 % less than previous year. In the first period, the echinocandin most used was caspofungin (51,23%) because the prescription wasn´t restricted and the physician could use anyone. In the second period, we observed a 31,63% increase in use in micafungin, the echinocandin that we evaluated the most efficient in our protocol. The use of caspofungin and anidulafungin decreased a 11,92% and 19,71% respectively. These use involved a decrease in cost too, 255.836 and 254.896 euros less about anidulafungin and caspofungin use respectively. These results are consistent with the recommendations contained in our program (first line use of micafungin in nonimmunosuppressed patients with candida infection). Conclusions: Our therapeutic program compliance was good at our hospitals, resulting in a significant decrease in echinocandins expenses. Maybe, the implementation of these type of programs in the management of high-cost drugs resulted in significant cost reductions and therefore in a more rational use of healthcare budgets. PIN68 Cost Analysis of Residual Viremia Detected by Two Real-Time Pcr Assays For Response-Guided (Dual Or Triple) Therapy of Hcv Genotype 1 Infection Paolini D1, Lunghi G2, Aghemo A2, Dionisi M1, Colombo M2, Torresani E2 Diagnostics S.p.A., Monza, Italy, 2Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy
1Roche
Objectives: The duration of current standard dual and triple therapies for HCV-G1 is determined by assessment of early viral kinetics. We conducted a cost analysis to determine the main cost of treatment for a patient with HCV-G1 with dual or triple therapy, where the duration of the therapy (24 or 48 weeks) is guided by HCVRNA assay. Methods: HCV-RNA was assessed by two widely used real-time PCRbased assays, Cobas Ampliprep/Cobas TaqMan (CAP-CTM) and Real-Time HCV (ART). Considering the dual therapy (PegINFα -2b and RBV) at week 12 of treatment, 16% of patients (27/169) were eligible to receive a shorter duration of therapy (24 weeks) according to CAP-CTM and 9% (16/169) to ART: 26 patients achieved SVR with CAPCTM and 15 with ART. Considering the triple therapy (TPV, PegINFα -2a and RBV) at week 12 of treatment, 60% of patients (31/52) were eligible to receive a shorter duration of therapy (24 weeks) according to CAP-CTM and 25% (13/52) to ART: 30 patients achieved SVR with CAP-CTM and 13 with ART. The cost analysis was conducted from the perspective of the Italian National Health Service (NHS). Only drugs (TPV, PegINFα -2b, PegINFα -2b and RBV) and tests (CAP-CTM and ART) costs were considered. Ex-factory prices (included all discounts) and National Tariffs were considered to appraise drug consumptions and tests, respectively. Costs were assessed in Euros in 2015. Results: Considering the dual therapy, the overall main treatment cost per patient with CAP-CTM (€ 9,743.63) was lower than with ART (€ 10,053.46). Taking into account the triple therapy, the overall main treatment cost per patient was lower with CAP-CTM (€ 31,630.69) than with ART (€ 33,463.24). Conclusions: CAP-CTM HCV-RNA assay was cost-saving from the Italian NHS perspective compared to ART HCV-RNA assay in dual (-€ 309.83 cost per patient) and triple (-€ 1,832.55 cost per patient) HCV therapy.
PARK H1, Ku H2, Sohn HS3, Seo H4, Lee H5, Lim K5, Kwon J1 National University, Daegu, South Korea, 2Sungkyunkwan University, Suwon, South Korea, 3Cha University, Seongnam-si, South Korea, 4Seoul Metropolitan Seobuk Hospital, Seoul, South Korea, 5Janssen Korea Ltd., Seoul, South Korea
PIN69 High-Dose Inactivated Influenza Vaccine can Reduce Costs and Improve Outcomes Compared to Standard-Dose Inactivated Influenza Vaccine in Canadian Seniors
Objectives: Bedaquiline is a newly introduced agent for the treatment of multidrug-resistant tuberculosis (MDR-TB) and this study aimed to evaluate the cost effectiveness of adding bedaquiline to a standard regimen (SR) to treat patients with MDR-TB, including extensively drug resistant tuberculosis (XDR-TB) in comparison with standard regimen alone in South Korea. Methods: A cohort based decision analytic model developed in a previously published study from the UK was used with the following parameters: a 20 year time horizon, and a 5% discount rate for cost and effectiveness to evaluate incremental cost-effectiveness ratios (ICER) of bedaquiline plus SR and SR alone. Key parameters on clinical data were based on the published Phase 2trial of bedaquiline and other parameters for recurrence, cured, lost follow-up, surgery, death, cost and health utility were based on Korean data if available, otherwise the international literature data were applied. Univariate and probabilistic sensitivity analyses were conducted. Results: A patient on bedaquiline plus SR regimen had 1.20 quality adjusted life years (QALYs) longer
Chit A1, Becker DL2, Diazgranados CA1, Maschio M2, Yau E3, Drummond M4 1Sanofi Pasteur, Swiftwater, PA, USA, 2Optum, Burlington, ON, Canada, 3inVentive Health Clinical, Burlington, MA, USA, 4University of York, Heslington, York, UK
1Kyungpook
Objectives: Adults ≥ 65 years account for most seasonal influenza-related hospitalizations and deaths. A recent head-to-head RCT (FIM12, NCT01427309) demonstrated that a high-dose influenza vaccine (HD) was 24.2% more efficacious than a standarddose influenza vaccine (SD) in preventing laboratory-confirmed influenza-like illness among 31,989 adults ≥ 65 years. A cost-utility analysis (CUA) of HD vs. SD in FIM12 participants was performed. Methods: Health-care resource utilization data collected in the FIM12 study utilized resources (medications, non-routine medical visits, emergency room visits, and hospitalizations) were summarized across vaccine arms and unit costs were applied, using standard Canadian cost sources (in CAD), to each resource item (including vaccines; HD $31.82; SD $5.82) to estimate the mean total direct medical and societal costs associated with each vaccine. Health outcomes data
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from the trial were mapped to quality of life data from the literature to estimate the effectiveness of each vaccine. The time horizon was one year’s influenza season for costs and a lifetime for quality-adjusted life years (QALYs). Results: The average per-participant direct medical costs (including vaccine cost) and societal costs were $47 and $60 lower in the HD arm. Hospitalizations represented over 91% of the total cost and were less frequent in the HD arm (7.7% of HD participants reported ≥ 1 hospitalization versus 8.4% in SD arm) and average length of stay (LOS) across all participants was shorter in the HD arm (0.49 days vs 0.56 days). HD was associated with 0.0004 more QALYs per participant and, due to cost savings, dominated SD in the CUA. Conclusions: Despite the higher price of HD vs. SD, the total direct medical and societal costs were lower per HD vaccinee. This was driven by a reduction in the number of hospitalizations and in the LOS for those hospitalized. HD dominated SD in the CUA. PIN70 Health Economic Evaluation of Different Vaccination Strategies Against Varicella and Herpes Zoster in Germany Damm O1, Horn J2, Mikolajczyk R2, Greiner W1, Siedler A3, Weidemann F3, Wichmann O3, Kretzschmar M4, Ultsch B3 1School of Public Health, Bielefeld University, Bielefeld, Germany, 2Helmholtz Centre for Infection Research, Brunswick, Germany, 3Robert Koch Institute, Berlin, Germany, 4University Medical Centre Utrecht, Utrecht, The Netherlands
Objectives: Infection with varicella-zoster virus (VZV) causes two distinct vaccinepreventable diseases: varicella and herpes zoster (HZ). Universal childhood varicella vaccination is recommended in Germany since 2004. However, country-wide vaccination against HZ has not been introduced yet. The objective of this study was to estimate the cost-effectiveness of different VZV vaccination strategies in Germany from a societal perspective: (i) additional introduction of routine HZ vaccination in the elderly, (ii) discontinuation of universal varicella vaccination, or (iii) a combination of both previously mentioned options. Methods: The health economic analysis was based on an age-structured model of VZV transmission and vaccination in Germany. The time horizon of the dynamic model was 100 years. Treatment costs of varicella and HZ were estimated from health insurance claims data. A 3% discount rate was used for future costs and health effects. All vaccination strategies were evaluated assuming the existence or non-existence of exogenous boosting. When assuming exogenous boosting, universal childhood varicella vaccination might cause an increased HZ incidence in the elderly. Results: Compared to current universal two-dose childhood varicella vaccination, the incremental cost-effectiveness ratio of additional HZ vaccination (base-case: vaccination at 60 years of age and waning of vaccine-induced immunity) was EUR 50,978 and EUR 47,720 per quality-adjusted life year (QALY) when assuming the existence and non-existence of exogenous boosting, respectively. Discontinuation of universal varicella vaccination led, irrespective of additional HZ vaccination, to both cost-savings and QALY gains when considering exogenous boosting. When exogenous boosting was discarded, cost-savings came along with QALY losses. Conclusions: The economic benefit of universal childhood varicella vaccination depends strongly on the existence of exogenous boosting. Further research is needed to measure the extent of exogenous boosting and its impact in health economic evaluations. Additional HZ vaccination can be considered as a marginally cost-effective intervention when considering a cost per QALY threshold of EUR 50,000. PIN71 Cost-Effectiveness of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir for Patients With Chronic Hcv in the Netherlands Gaultney J1, de Knegt RJ2, Fassler P3, Visser S3, Johnson S4 1Mapi Group, Houten, The Netherlands, 2Erasmus MC, Rotterdam, The Netherlands, 3AbbVie B.V., Hoofddorp, The Netherlands, 4Medicus Economics, LLC, Milton, MA, USA
Objectives: Chronic hepatitis C virus (HCV) is a considerable public health concern due to its significant impact on morbidity, mortality and healthcare costs in the Netherlands. Clinical studies of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r/DSV) with and without ribavirin have demonstrated high sustained viral response (SVR) rates for treatment of genotype 1 (GT1) and 4 (GT4) HCV patients. This study aims to evaluate the health economic value of OBV/PTV/r/DSV versus sofosbuvir in combination with pegylated interferon and ribavirin (SOF+PR) using a cost-utility analysis for HCV treatment-naïve patients with GT1 or GT4 in the Netherlands. Methods: A Markov model with a lifetime horizon was developed based on previous published disease models and adapted to Dutch societal perspective. SVR rates, adverse events, regimen duration were gathered from published phase 3 trials. Transition probabilities, health state utilities resource use and costs were derived from literature, publically available sources and expert opinion. Baseline characteristics (e.g., age, fibrosis distribution) were based on the OBV/ PTV/r/DSV trials. Total costs and QALYs were calculated per treatment option along with respective incremental cost-effectiveness ratios. Results: In treatment-naïve GT1 patients with or without cirrhosis, OBV/PTV/r/DSV dominates SOF+PR at higher incremental QALYs (range: 0.09 to 0.51) and lower incremental costs (range: € -2,992 to € -13,077). For treatment-naïve GT4 patients, OBV/PTV/r/DSV dominates SOF+PR at higher incremental QALYs (0.04) and lower incremental costs (€ -7,862). The results were robust to parameter uncertainty. Probabilistic sensitivity analysis shows OBV/ PTV/r/DSV is cost-effective vs SOF+PR in 72% to 80% of simulations for GT1; 88% for GT4 patients respectively. Conclusions: At higher incremental health benefits and lower incremental costs, OBV/PTV/r/DSV dominates SOF+PR in treatment-naive GT1 and GT4 HCV patients. OBV/PTV/r/DSV improves the morbidity and economic impact of treating GT1 and GT4 HCV patients in the Netherlands. PIN72 Cost-Effectiveness Analysis of Quadrivalent Influenza Vaccine in Spain Garcia Rojas A1, Ortiz de Lejarazu RL2, Reina J3, Callejo D4, Cuervo Uría J4, Morano Larragueta R5
1Servicio
de Epidemiología y Prevención, Las Palmas, Spain, 2Valladolid National Influenza Center, Servicio de Microbiología e Inmunología. Hospital Clinico, Valladolid, Spain, 3University Hospital Son Espases, Palma de Mallorca, Spain, 4BAP Health Outcomes Research S.L., Oviedo, Spain, 5GlaxoSmithKline, Madrid, Spain
Objectives: Influenza, an acute viral infection causing annual epidemics, has a major impact on healthcare systems and society, but can be effectively prevented using vaccination. The World Health Organization currently recommends that influenza vaccines should include at least two virus A and one virus B lineages (trivalent vaccines; TIVs). A new quadrivalent vaccine, offering broader protection against influenza by including an additional virus B strain, received regulatory approval and is now recommended by several immunization committees (Advisory Committee on Immunization Practices (USA), Joint Committee on Vaccination and Immunisation (UK)). The present study was undertaken to estimate the cost-effectiveness of replacing TIVs with the quadrivalent influenza vaccine in Spain. Methods: A static, lifetime, multi-cohort model with a oneyear cycle time was developed to assess the costs and health outcomes associated with trivalent vs. quadrivalent vaccines. The model followed the lifetime of a cohort vaccinated each year according to local health authority recommendations. Information on circulating influenza virus strains, obtained from the National Epidemiology Centre, allowed the determination of whether the B strain included in TIVs matched the circulating one. The cost-effectiveness analysis was conducted from a societal perspective. The costs and outcomes were discounted at 3% and the robustness of the results was tested using one-way and probabilistic sensitivity analyses. Results: Compared with TIVs, the quadrivalent influenza vaccine reduced the number of influenza cases, as well as influenza-related complications and deaths. The incremental cost-effectiveness ratio (ICER) was 8,748 € /QALY. One-way sensitivity analysis showed virus A circulation and mismatch with the B lineage included in TIVs as main drivers for ICER. Using probabilistic sensitivity analysis, ICER was below 30,000 € /QALY in 96% of the simulations. Conclusions: Replacing TIVs with quadrivalent influenza vaccine for national immunization programs in Spain could improve prevention by avoiding virus B mismatch and provide a cost-effective healthcare intervention. PIN73 Broad Access to Treatment is Cost-Effective for Patients with Chronic Hepatitis C in England Treharne C1, Howells R2, Rosenberg W3 1Abacus International, Bicester, UK, 2Abacus International, Manchester, UK, 3Royal Free Hospital, London, UK
Objectives: Chronic Hepatitis C (CHC) is an infectious disease associated with significant morbidity and mortality. Early access to treatment may mitigate the rise in CHC-related morbidity and mortality and prevent onward transmission. We have examined the cost-effectiveness of providing broad access to treatment compared with limiting treatment to patients with advanced fibrosis. Methods: A Markov model with a lifetime horizon was constructed to assess the relative costs and outcomes of treating a population of patients with CHC regardless of fibrosis stage compared with restricting treatment until patients developed F3 or F4 (METAVIR system) fibrosis. Cycle length was 6 months, and costs and benefits were discounted at an annual rate of 3.5%. Published literature provided cost, natural history, and utility data. Patients entered the model at fibrosis stages F0-F4 (F0= no fibrosis; F4= compensated cirrhosis) reflective of the current distribution of fibrosis scores in the UK. In each cycle, patients remained in their current health state, achieved a sustained virologic response (equivalent to a cure), experienced disease progression or died. Advanced liver disease states (decompensated cirrhosis, hepatocellular carcinoma, and transplantation) were associated with excess mortality. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY). Results: Preliminary results indicate that treating all patients compared with the restricted treatment strategy is associated with incremental costs of £4,098 and incremental QALYs of 1.44 per patient, resulting in an ICER of approximately £2,855. Conclusions: Treating all patients is costeffective compared with restricting treatment to patients with advanced fibrosis only. The latter strategy is unlikely to mitigate the future burden of HCV-related healthcare or significantly reduce onward transmission. Treating all patients aligns closely with the NHS Five Year Forward View strategy which strongly emphasises prevention and public health, and would facilitate strategies to raise awareness and treatment of HCV. PIN74 Cost-Utility Analysis of Dolutegravir/Abacavir/Lamivudine (Dtg/Abc/3tc) as a Single Tablet Treatment of Naïve Hiv Infected Patientss Parrondo J1, Moreno S2, Losa JE3, Berenguer J4, Martinez-Sesmero JM5, Grasset E6, CenozGomis S6 1GSK - Spain, Madrid, Spain, 2Hospital Ramón y Cajal, Madrid, Spain, 3Hospital Universitario Fundación Alcorcón (HUFA), Alcorcón - Madrid, Spain, 4Hospital General Universitario Gregorio Marañón, Madrid, Spain, 5Complejo hospitalario de Toledo, Toledo, Spain, 6ViiV HealthCare Spain, Madrid, Spain
Objectives: One significant innovation of combination antiretroviral therapy (cART) has been the introduction of a once-daily fixed-dose combination to either maintain or increase treatment adherence. DTG/ABC/3TC is a highly efficacious and well-tolerated once-daily regimen for HIV-infected patients. The objective of the study was to assess the cost-utility (C/U) of treatment initiation with DTG/ABC/3TC single tablet regimen (STR) in ART-naïve HIV infected patients. Methods: A microsimulation model was developed to compare, from the Spanish Health System perspective, the C/U of treatment inititation with DTG/ABC/3TC vs. the treatment initiation with any of the following regimens: Emtricitabine/Tenofovir/Efavirenz (FTC/TDF/EFV), and Darunavir/r (DRV/r) or Raltegravir (RAL) with Emtricitabine/Tenofovir (FTC/TDF) or Abacavir/Lamivudine (ABC/3TC) over a lifetime horizon. One million subjects were simulated using data