- Email: [email protected]
3tc) as a Single Tablet Treatment of Naïve Hiv Infected Patientss
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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
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from SPRING-2, SINGLE and FLAMINGO trials, each one of them went through a Markov chain to emulate each patient life from initial treatment to death. The health states included were: living with HIV with or without opportunistic infections, long-term chronic diseases and death. Transition probabilities for each 1-month cycle, were obtained from clinical trials. Utilities and direct health-care costs (€ 2015) were obtained from literature and national databases. A 3% annual discount was applied to costs and health outcomes. Sensitivity analysis with 0% and 5% discount rates were performed. Results: Treatment initiation with DTG/ ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67,210.71€ /QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-152,411.73€ /QALY), and vs. RAL + FTC/TDF or ABC/3TC (-182,480.19€ / QALY). All the sensitivity analyses performed showed the consistency of these findings. The main driver of cost was ATR-treatment (about 80%) followed by the costs of care (around 14%). Conclusions: With the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ART-naïve HIV infected patients from the Spanish Health System perspective. PIN75 Cost-Effectiveness of Ledipasvir/Sofosbuvir for the Treatment of Genotype 1 Or 4 Chronic Hepatitis C in England and Wales Howells R1, Treharne C2 International, Manchester, UK, 2Abacus International, Bicester, UK
1Abacus
Objectives: Ledipasvir/sofosbuvir (LDV/SOF; Harvoni) is a new oral single table regimen for the treatment of chronic hepatitis C (CHC) in adults. This study assessed the cost-effectiveness of LDV/SOF compared to current treatment options and ‘no treatment’ in England and Wales. Methods: A Markov model with a lifetime horizon was constructed in Microsoft Excel® to assess cost-effectiveness of LDV/SOF. Cost-effectiveness was assessed separately for treatment-naïve (TN) and experienced (TE) patients with CHC genotype 1 (GT1) or 4 (GT4). Cycle lengths were monthly (first 18 cycles), three-monthly (until year 2), and yearly (year 3 onwards; half-cycle correction applied from year 3). Costs and utilities were discounted at 3.5%; data were sourced from published literature. Patients could enter the model in a non-cirrhotic or cirrhotic disease state. For each cycle, patients remained in their current health state, achieved a sustained virological response (equivalent to a cure), progressed to more severe disease or died. General population mortality was applied in each health state. An excess mortality risk was associated with advanced liver disease (decompensated cirrhosis, hepatocellular carcinoma, and liver transplantation). Cost-effectiveness was assessed using the incremental cost-effectiveness ratio (ICER), expressed as cost per quality adjusted life year (QALY). Results: In GT1 TN patients without cirrhosis (8 weeks LDV/SOF treatment) and GT4 TN patients without cirrhosis (12 weeks LDV/SOF treatment), LDV/SOF was cost-effective for all comparators with ICERs of £8,894 and £22,676 versus the next most effective non-dominated option, respectively. In GT1 or GT4 TN patients with cirrhosis, TE patients without cirrhosis, and TE patients with cirrhosis, 12 week LDV/SOF was associated with ICERs of £4,518, £16,566, and £5,435 versus no treatment, respectively; all active comparators were dominated or extendedly dominated. Conclusions: LDV/SOF represents a cost-effective option versus established practice for GT1 and GT4 TN and TE patients with and without cirrhosis. PIN76 Testing for Ns5a Resistance in Order to Optimize Antiviral Therapy With Simeprevir And Sofosbuvir 12 Weeks Appears Cost-Effective in Non-Cirrhotic Genotype 1 Hepatitis C Virus Treatment Experienced Patients Westerhout KY1, Bouwmeester W1, Duchesne I2, Sbarigia U3, Pisini M2, Treur M1 International, Rotterdam, The Netherlands, 2Janssen EMEA, Beerse, Belgium, 3Janssen Global Services, Beerse, Belgium
1Pharmerit
Objectives: Sustained virologic response (SVR) of NS5A inhibitor-containing regimens is reduced in genotype-1 hepatitis C virus (HCV) patients with NS5A resistance. The long-term persistence of NS5A resistance limits re-treatment options (Wyles et al, 2015). Latest EASL treatment guidelines recommend simeprevir+sofosbuvir with/without ribavirin (SMV+SOF±R) for re-treating patients failing a NS5A inhibitor-containing regimen. This study investigates the cost-effectiveness of NS5A resistance-testing (before treatment) to optimize treatment choice and avoid the need for re-treatment. Methods: An existing lifetime Markov model was used to estimate disease progression for HCV genotype 1 patients in the UK. Patient subgroups were identified by cirrhosis stage and prior treatment experience. NS5A resistance-testing pre-treatment and subsequent treatment with SMV+SOF or sofosbuvir+ledipasvir (SOF+LDV±R) in patients with or without NS5A resistance, respectively, was compared to a ‘no testing’ scenario where all patients received SOF+LDV±R. SVR rates of SOF+LDV±R in patients with/ without NS5A resistance were obtained from pooled phase II/III studies. SMV+SOF SVR rates, not impacted by NS5A resistance, were sourced from the OPTIMIST studies. Patient characteristics, HCV progression, mortality, resource utilization, unit costs and quality of life data were obtained from published sources. Results: Testing for NS5A and optimizing therapy to SMV+SOF (for patients with NS5A resistance pre-treatment) yielded 0.127 additional QALYs and increased costs with ~£2000 per patient (both 3.5% discounted), resulting in an incremental costeffectiveness ratio (ICER) of ~£15K versus ‘no testing’ in treatment experienced patients without cirrhosis. In these non-cirrhotic patients, optimizing therapy to receive 24 weeks of SOF+LDV±R in NS5A positive patients led to an ICER of > 100K compared to optimizing with 12 weeks of SMV+SOF. Conclusions: NS5A resistance testing pre-treatment and subsequent optimizing therapy with SMV+SOF 12 weeks instead of SOF+LDV±R 12 weeks appeared to be cost-effective in treatment-experienced HCV patients without cirrhosis and with NS5A resistance. Optimizing with SOF+LDV±R 24 weeks was not deemed cost-effective.
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PIN77 Economic evaluations in infectious disease: which infections, what settings and what type of economic evaluations were reported in papers published in 2014? Martin A Crystallise Ltd., London, UK
Objectives: To determine the focus of economic evaluation papers relevant to infectious diseases that were indexed in the PubMed database and published in 2014. Methods: An evidence surveillance process was established based on a systematic search of PubMed, using key words relevant to economic modelling in healthcare or disease and limited to studies published in English, in humans, and with abstracts. Articles were included if they analysed the cost-effectiveness of interventions, healthcare service design or methodological issues related to one or more infectious disease. We included all studies with a publication date of 2014 that were indexed in PubMed up to 8 June 2015. Results: The search identified 2,772 articles published in 2014. Of these, 148 were conducted in patients with infectious diseases. Most (32 articles) were in HIV-infected people, 14 articles were in those with hepatitis C, 13 in tuberculosis, 9 in human papilloma virus infection, 7 in pneumonia, and 6 each in influenza and hepatitis B. Twenty-five analyses were set in African countries, mainly on HIV (11 articles) and malaria (4). The 24 analyses in Asia were more diverse, with only 3 each on HIV and tuberculosis. The 30 European analyses were also diverse, with 5 on hepatitis C, 4 each on HIV and pneumonia, and 3 on hospital-acquired infections. Of the 35 North American analyses, 8 related to hospital-acquired infections, 6 to hepatitis C, 4 to hepatitis B, and only 2 each on HIV or tuberculosis. Cost-utility analyses were reported in 58 articles and cost-effectiveness in 43, and only 11 abstracts stated that indirect costs were modelled. Conclusions: Infectious diseases were the most common disease class to be evaluated for cost-effectiveness in our search for studies published in 2014, with a geographical focus that reflects the relevant epidemiology. Despite potential societal costs from pandemics or chronic infection, evaluations rarely considered indirect costs. PIN78 Pharmacoepidemiologic Modeling of Treatment Hiv-Infected Patients With Rilpivirine/ Tenofovir/ Emtricitabin (Single Tablet Regimen) in Russia Yagudina R, Kulikov A, Babiy VV, I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: To obtain potential pharmacoepidemiologic outcomes of rilpivirine/ tenofovir/ emtricitabin (single tablet regimen) in treatment of naïve patients with HIV-1 RNA< 100 000 copies/ml in the Russian Federation. Methods: The developed model was by nature a mathematical one. It was based on published data from international researches (efficacy data), from local researches in Eastern Europe (data on probability of death and disease progression, sexual behavior), and from researches in the Russian Federation (data on HIV-infected patient population, life expectancy etc.). The model included analysis of viral transmission via sexual contact and/or injection drug use. The influence of character of sexual contact, condom effectiveness and efficacy of three schemes of highly active antiretroviral treatment was taken into account. The time-horizon was 5 years. Results: Treatment of naïve HIV-infected patients with rilpivirine/ tenofovir/ emtricitabin leads to potential smaller number of new infected persons in long term perspective than with efavirenz + tenofovir/ emtricitabin (multi-pill regimen) and lopinavir + tenofovir/ emtricitabin (multi-pill regimen) by a term of order 13% (9570 new HIV-patients less) and 10% (7262 new HIV-patients less), respectively. Conclusions: Obtained results approves the use of rilpivirine/ tenofovir/ emtricitabin (single tablet regimen) in similar to analyzed patient populations due to the potential lower number of new HIV-patients as compared to multi-pill regimens: efavirenz + tenofovir/ emtricitabin and lopinavir + tenofovir/ emtricitabin. PIN79 The Epidemiological and Cost Burden of Herpes Zoster (Hz) and PostHerpetic Neuralgia (Phn) in the Uk Taieb V1, Schwarzbard J1, Butt T2, Gama J2, Gauthier A1, Gallagher E2 Pasteur MSD, Maidenhead, UK
1Amaris, London, UK, 2Sanofi
Objectives: This retrospective database analysis aimed to update epidemiological and cost estimates related to HZ and PHN in adults from the perspective of the UK National Health Service (NHS). Methods: Adults (18+) diagnosed with HZ between 2006 and 2013 were identified from The Health Improvement Network (THIN) linked to the Hospital Episode Statistics (HES) database. Unit costs were assigned from the British National Formulary, PSSRU Unit Costs of Health and Social Care and NHS Payment Grouper. Results: 27,362 patients with HZ were identified, corresponding to an incidence of 4.12% in the adult population. Average age at HZ diagnosis was 60.4. 137,674 HZ cases occurred in immunocompetent patients aged 50 or more. 21% of HZ patients developed PHN at least 3 months after HZ diagnosis. The mean duration of PHN was 13 months. In the first month of diagnosis, the mean cost of HZ per patient was £65.5 (61% visits, 29% medications, 10% hospitalisations). The mean cost of PHN per patient was £921 (63% visits, 37% medications and less than 1% hospitalisations), the mean monthly cost was £58.7. The total cost associated with incident cases of HZ and PHN over a year was estimated at £52,543,827 in the UK. PHN was the most important driver of cost (72% of total). Conclusions: This study re-affirms the significant burden of HZ and PHN on the UK health care system and shows that the mean age of HZ onset is significantly lower than current recommended age for HZ vaccination. PIN80 Public Health and Economic Benefits of Quadrivalent Influenza Vaccine in Panama Jamotte A1, Caicedo Navas AG2, Macabeo B3, Lopez JG4, Moreno B5, Franco D5, Garcia LN6, Isaza de Molto Y6
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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
VA L U E I N H E A LT H 1 8 ( 2 0 1 5 ) A 3 3 5 – A 7 6 6
from SPRING-2, SINGLE and FLAMINGO trials, each one of them went through a Markov chain to emulate each patient life from initial treatment to death. The health states included were: living with HIV with or without opportunistic infections, long-term chronic diseases and death. Transition probabilities for each 1-month cycle, were obtained from clinical trials. Utilities and direct health-care costs (€ 2015) were obtained from literature and national databases. A 3% annual discount was applied to costs and health outcomes. Sensitivity analysis with 0% and 5% discount rates were performed. Results: Treatment initiation with DTG/ ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67,210.71€ /QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-152,411.73€ /QALY), and vs. RAL + FTC/TDF or ABC/3TC (-182,480.19€ / QALY). All the sensitivity analyses performed showed the consistency of these findings. The main driver of cost was ATR-treatment (about 80%) followed by the costs of care (around 14%). Conclusions: With the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ART-naïve HIV infected patients from the Spanish Health System perspective. PIN75 Cost-Effectiveness of Ledipasvir/Sofosbuvir for the Treatment of Genotype 1 Or 4 Chronic Hepatitis C in England and Wales Howells R1, Treharne C2 International, Manchester, UK, 2Abacus International, Bicester, UK
1Abacus
Objectives: Ledipasvir/sofosbuvir (LDV/SOF; Harvoni) is a new oral single table regimen for the treatment of chronic hepatitis C (CHC) in adults. This study assessed the cost-effectiveness of LDV/SOF compared to current treatment options and ‘no treatment’ in England and Wales. Methods: A Markov model with a lifetime horizon was constructed in Microsoft Excel® to assess cost-effectiveness of LDV/SOF. Cost-effectiveness was assessed separately for treatment-naïve (TN) and experienced (TE) patients with CHC genotype 1 (GT1) or 4 (GT4). Cycle lengths were monthly (first 18 cycles), three-monthly (until year 2), and yearly (year 3 onwards; half-cycle correction applied from year 3). Costs and utilities were discounted at 3.5%; data were sourced from published literature. Patients could enter the model in a non-cirrhotic or cirrhotic disease state. For each cycle, patients remained in their current health state, achieved a sustained virological response (equivalent to a cure), progressed to more severe disease or died. General population mortality was applied in each health state. An excess mortality risk was associated with advanced liver disease (decompensated cirrhosis, hepatocellular carcinoma, and liver transplantation). Cost-effectiveness was assessed using the incremental cost-effectiveness ratio (ICER), expressed as cost per quality adjusted life year (QALY). Results: In GT1 TN patients without cirrhosis (8 weeks LDV/SOF treatment) and GT4 TN patients without cirrhosis (12 weeks LDV/SOF treatment), LDV/SOF was cost-effective for all comparators with ICERs of £8,894 and £22,676 versus the next most effective non-dominated option, respectively. In GT1 or GT4 TN patients with cirrhosis, TE patients without cirrhosis, and TE patients with cirrhosis, 12 week LDV/SOF was associated with ICERs of £4,518, £16,566, and £5,435 versus no treatment, respectively; all active comparators were dominated or extendedly dominated. Conclusions: LDV/SOF represents a cost-effective option versus established practice for GT1 and GT4 TN and TE patients with and without cirrhosis. PIN76 Testing for Ns5a Resistance in Order to Optimize Antiviral Therapy With Simeprevir And Sofosbuvir 12 Weeks Appears Cost-Effective in Non-Cirrhotic Genotype 1 Hepatitis C Virus Treatment Experienced Patients Westerhout KY1, Bouwmeester W1, Duchesne I2, Sbarigia U3, Pisini M2, Treur M1 International, Rotterdam, The Netherlands, 2Janssen EMEA, Beerse, Belgium, 3Janssen Global Services, Beerse, Belgium
1Pharmerit
Objectives: Sustained virologic response (SVR) of NS5A inhibitor-containing regimens is reduced in genotype-1 hepatitis C virus (HCV) patients with NS5A resistance. The long-term persistence of NS5A resistance limits re-treatment options (Wyles et al, 2015). Latest EASL treatment guidelines recommend simeprevir+sofosbuvir with/without ribavirin (SMV+SOF±R) for re-treating patients failing a NS5A inhibitor-containing regimen. This study investigates the cost-effectiveness of NS5A resistance-testing (before treatment) to optimize treatment choice and avoid the need for re-treatment. Methods: An existing lifetime Markov model was used to estimate disease progression for HCV genotype 1 patients in the UK. Patient subgroups were identified by cirrhosis stage and prior treatment experience. NS5A resistance-testing pre-treatment and subsequent treatment with SMV+SOF or sofosbuvir+ledipasvir (SOF+LDV±R) in patients with or without NS5A resistance, respectively, was compared to a ‘no testing’ scenario where all patients received SOF+LDV±R. SVR rates of SOF+LDV±R in patients with/ without NS5A resistance were obtained from pooled phase II/III studies. SMV+SOF SVR rates, not impacted by NS5A resistance, were sourced from the OPTIMIST studies. Patient characteristics, HCV progression, mortality, resource utilization, unit costs and quality of life data were obtained from published sources. Results: Testing for NS5A and optimizing therapy to SMV+SOF (for patients with NS5A resistance pre-treatment) yielded 0.127 additional QALYs and increased costs with ~£2000 per patient (both 3.5% discounted), resulting in an incremental costeffectiveness ratio (ICER) of ~£15K versus ‘no testing’ in treatment experienced patients without cirrhosis. In these non-cirrhotic patients, optimizing therapy to receive 24 weeks of SOF+LDV±R in NS5A positive patients led to an ICER of > 100K compared to optimizing with 12 weeks of SMV+SOF. Conclusions: NS5A resistance testing pre-treatment and subsequent optimizing therapy with SMV+SOF 12 weeks instead of SOF+LDV±R 12 weeks appeared to be cost-effective in treatment-experienced HCV patients without cirrhosis and with NS5A resistance. Optimizing with SOF+LDV±R 24 weeks was not deemed cost-effective.
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PIN77 Economic evaluations in infectious disease: which infections, what settings and what type of economic evaluations were reported in papers published in 2014? Martin A Crystallise Ltd., London, UK
Objectives: To determine the focus of economic evaluation papers relevant to infectious diseases that were indexed in the PubMed database and published in 2014. Methods: An evidence surveillance process was established based on a systematic search of PubMed, using key words relevant to economic modelling in healthcare or disease and limited to studies published in English, in humans, and with abstracts. Articles were included if they analysed the cost-effectiveness of interventions, healthcare service design or methodological issues related to one or more infectious disease. We included all studies with a publication date of 2014 that were indexed in PubMed up to 8 June 2015. Results: The search identified 2,772 articles published in 2014. Of these, 148 were conducted in patients with infectious diseases. Most (32 articles) were in HIV-infected people, 14 articles were in those with hepatitis C, 13 in tuberculosis, 9 in human papilloma virus infection, 7 in pneumonia, and 6 each in influenza and hepatitis B. Twenty-five analyses were set in African countries, mainly on HIV (11 articles) and malaria (4). The 24 analyses in Asia were more diverse, with only 3 each on HIV and tuberculosis. The 30 European analyses were also diverse, with 5 on hepatitis C, 4 each on HIV and pneumonia, and 3 on hospital-acquired infections. Of the 35 North American analyses, 8 related to hospital-acquired infections, 6 to hepatitis C, 4 to hepatitis B, and only 2 each on HIV or tuberculosis. Cost-utility analyses were reported in 58 articles and cost-effectiveness in 43, and only 11 abstracts stated that indirect costs were modelled. Conclusions: Infectious diseases were the most common disease class to be evaluated for cost-effectiveness in our search for studies published in 2014, with a geographical focus that reflects the relevant epidemiology. Despite potential societal costs from pandemics or chronic infection, evaluations rarely considered indirect costs. PIN78 Pharmacoepidemiologic Modeling of Treatment Hiv-Infected Patients With Rilpivirine/ Tenofovir/ Emtricitabin (Single Tablet Regimen) in Russia Yagudina R, Kulikov A, Babiy VV, I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: To obtain potential pharmacoepidemiologic outcomes of rilpivirine/ tenofovir/ emtricitabin (single tablet regimen) in treatment of naïve patients with HIV-1 RNA< 100 000 copies/ml in the Russian Federation. Methods: The developed model was by nature a mathematical one. It was based on published data from international researches (efficacy data), from local researches in Eastern Europe (data on probability of death and disease progression, sexual behavior), and from researches in the Russian Federation (data on HIV-infected patient population, life expectancy etc.). The model included analysis of viral transmission via sexual contact and/or injection drug use. The influence of character of sexual contact, condom effectiveness and efficacy of three schemes of highly active antiretroviral treatment was taken into account. The time-horizon was 5 years. Results: Treatment of naïve HIV-infected patients with rilpivirine/ tenofovir/ emtricitabin leads to potential smaller number of new infected persons in long term perspective than with efavirenz + tenofovir/ emtricitabin (multi-pill regimen) and lopinavir + tenofovir/ emtricitabin (multi-pill regimen) by a term of order 13% (9570 new HIV-patients less) and 10% (7262 new HIV-patients less), respectively. Conclusions: Obtained results approves the use of rilpivirine/ tenofovir/ emtricitabin (single tablet regimen) in similar to analyzed patient populations due to the potential lower number of new HIV-patients as compared to multi-pill regimens: efavirenz + tenofovir/ emtricitabin and lopinavir + tenofovir/ emtricitabin. PIN79 The Epidemiological and Cost Burden of Herpes Zoster (Hz) and PostHerpetic Neuralgia (Phn) in the Uk Taieb V1, Schwarzbard J1, Butt T2, Gama J2, Gauthier A1, Gallagher E2 Pasteur MSD, Maidenhead, UK
1Amaris, London, UK, 2Sanofi
Objectives: This retrospective database analysis aimed to update epidemiological and cost estimates related to HZ and PHN in adults from the perspective of the UK National Health Service (NHS). Methods: Adults (18+) diagnosed with HZ between 2006 and 2013 were identified from The Health Improvement Network (THIN) linked to the Hospital Episode Statistics (HES) database. Unit costs were assigned from the British National Formulary, PSSRU Unit Costs of Health and Social Care and NHS Payment Grouper. Results: 27,362 patients with HZ were identified, corresponding to an incidence of 4.12% in the adult population. Average age at HZ diagnosis was 60.4. 137,674 HZ cases occurred in immunocompetent patients aged 50 or more. 21% of HZ patients developed PHN at least 3 months after HZ diagnosis. The mean duration of PHN was 13 months. In the first month of diagnosis, the mean cost of HZ per patient was £65.5 (61% visits, 29% medications, 10% hospitalisations). The mean cost of PHN per patient was £921 (63% visits, 37% medications and less than 1% hospitalisations), the mean monthly cost was £58.7. The total cost associated with incident cases of HZ and PHN over a year was estimated at £52,543,827 in the UK. PHN was the most important driver of cost (72% of total). Conclusions: This study re-affirms the significant burden of HZ and PHN on the UK health care system and shows that the mean age of HZ onset is significantly lower than current recommended age for HZ vaccination. PIN80 Public Health and Economic Benefits of Quadrivalent Influenza Vaccine in Panama Jamotte A1, Caicedo Navas AG2, Macabeo B3, Lopez JG4, Moreno B5, Franco D5, Garcia LN6, Isaza de Molto Y6