ARFI Test Versus Biopsy to Assess Liver Fibrosis in Chronic HCV

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PMD69 What is the Most Cost-Effective Way to Set-Up Organised Cervical Cancer Screening in France? A Cost-Effectiveness Analysis Massetti M1, Leleu H2, Barre S3, De Bels F3 HEALTH EXPERTISE, Paris, France, 2Public Health Expertise, Paris, France, 3French Cancer Institut, Boulogne, France

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Objectives: Accordingly to the third Cancer plan, organized screening (OS) of cervical cancer (CC) among women aged 25-65 should be implemented in the forthcoming years in France. The most cost-effective way to implement OS in the French health care system in regard of this objective is yet to be determined.  Methods: A microsimulation model was developed with the French National Institute of Cancer (INCa) in collaboration with an expert board involving clinical experts and stakeholder representatives (French national health insurance, ministry of health, patients and professionals). A closed cohort of women eligible to CC screening and representative in terms of age and participation to individual screening (IS) is modelled on a lifetime horizon. Different OS strategies, additive to the existing IS, determining invitation and recall modalities, screening tests and algorithms and OS periodicity were assessed.  Results: OS based on primary HPV-testing every 5 or 10 years are the most efficient strategies. They dominate the actual IS-only situation due to the better sensitivity and specificity of the HPV-test over Pap-test and the longer period between CC screenings. HPV-testing every 3-years leads to major additional costs with little impact on health. The strategy based on primary p16/ Ki67 immunohistochemistry allows for the best results but generates important additional costs. Switching confirmation Pap-tests in positive women to p16/Ki67 immunohistochemistry appears to be a more interesting approach, providing better outcomes with little extra costs. OS scenarios based on Pap-test provide intermediate results but come with additional costs.  Conclusions: OS strategies based on HPV-test appear highly efficient although those results rely on the assumption that OS periodicity will be respected. Implementing such OS modalities will require major adaptations to the current CC screening organization. Pap-test based strategies might constitute simpler modalities to set-up OS while preparing the field to secure appropriate implementation of other OS screening modalities. PMD70 Assessing The Cost-Effectiveness of Transcatheter Aortic Valve Implantation in Inoperable Patients with Severe Aortic Stenosis in UK Ramos M1, Lamotte M1, Chevalier P1, Goodall G2 1IMS Health, Zaventem, Belgium, 2Edwards Lifesciences, Nyon, Switzerland

Objectives: Clinical trials have shown that transcatheter aortic valve implantation (TAVI) is an efficacious treatment option in patients with Severe Aortic Stenosis (SAS). This study aimed to assess the cost-effectiveness of TAVI compared with standard medical therapy (SMT) in inoperable patients with SAS, from the UK National Health Service (NHS) perspective.  Methods: A novel 9 health state Markov model, with monthly cycles, to simulate the clinical course of inoperable patients with SAS treated with TAVI or SMT, was developed using MS Excel. Health states were based on heart failure severity defined by the New York Heart Association (NYHA) classification and the history of stroke. The analysis accounts for direct costs (NHS perspective) only and the time horizon was set at 10 years which can be considered lifelong in these patients. Clinical data on the patient’s progression over time by NYHA class and event rates were taken from the PARTNER 1B-trial. Costs and utilities were health state and event specific and retrieved from literature. Annual discounting of 3.5% was applied. The outcome of the analysis was cost (£) per quality adjusted life year (QALY) gained. The analysis included one way and probabilistic sensitivity analyses to investigate the impact of parameter variability on model outputs.  Results: Compared with SMT, TAVI was associated with higher costs (£10,422) and more QALYs (0.711), resulting in an incremental costeffectiveness ratio of £14,668. Sensitivity analyses indicated that the key drivers of the model were cost of TAVI, cost of balloon valvuloplasty and mortality. The probability of TAVI to be cost-effective using a willingness to pay threshold of £20,000/ QALY versus SMT was 72%.  Conclusions: In the UK setting, TAVI can be considered a cost-effective treatment option versus SMT in inoperable patients with SAS. PMD71 Cost-Effectiveness of Sequential USE of ELF/ARFI Test Versus Biopsy to Assess Liver Fibrosis in Chronic HCV Soto M1, Sampietro-Colom L1, Lasalvia L2, Jimenez W3, Mira A3, Navasa M3 Clínic Barcelona, Barcelona, Spain, 2Siemens Healthcare, Tarrytown, NY, USA, 3Hospital Clinic Barcelona, Barcelona, Spain 1Hospital

Objectives: To estimate health outcomes and costs of testing strategies to assess liver fibrosis (LF) in HCV  Methods: A Markov model simulating LF progression in HCV was developed to estimate health outcomes and costs during lifetime for a cohort of 40-year-old men with abnormal levels of transaminases. The analysis was performed from the perspective of a University Hospital in Spain. Clinical data were obtained from published literature. Costs were sourced from administrative databases of the Hospital. Three different testing alternatives were studied: a single liver biopsy; annual ELF test followed by ARFI if ELF is positive; annual ELF without ARFI as a confirmation test. Deterministic and probabilistic sensitivity analyses were carried out to examine the robustness of the results.  Results: Annual sequential ELF/ARFI and annual ELF alone increased the number of quality-adjusted life years (QALYs) relative to biopsy by 1.06 and 1.48, respectively. Incremental costs were 14,244€  and 16,996€ , respectively. The corresponding cost-effectiveness ratios for sequential ELF/ARFI and annual ELF alone were respectively 13,400€  and 11,500€  per QALY. The sensitivity analysis showed that results were robust: the lowest ICER (5,800€  per QALY) was obtained when the discount rate was 0, whereas the highest ICER (21,400€  per QALY) occurred when the assumed cost of antivirals was high (72,000€  for a 12-week treatment). The remaining parameters of the model had a minor impact.  Conclusions: Testing for liver fibrosis annually with non-invasive methods resulted in a substantial reduction in the number of events (cirrhosis,

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hepatocellular carcinoma and fibrosis-related death) and a significant increase in QALYs for HCV patients, compared with a single liver biopsy. ELF test alone had the best health outcomes, but it was also the most costly of the strategies. In light of these results sequential ELF test/ARFI can be considered as an option providing a balance between proper care and costs. PMD72 Deep Brain Stimulation Compared to Device-Aided Infusion Therapies for Parkinson’s Disease with Early Motor Complications: A UK CostEffectiveness Analysis Green AL1, Fundament T2 of Oxford, Oxford, UK, 2HTA Consulting, Krakow, Poland

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Objectives: Deep brain stimulation (DBS) is an established surgical treatment option in patients with advanced Parkinson’s Disease (PD); the EARLYSTIM trial (Schuepbach et al 2013) has recently demonstrated its clinical benefit also in patients with early motor complications. Continuous sub-cutaneous apomorphine infusion (CSAI) and continuous duodenal levodopa-carbidopa infusion (CDLCI) are alternative treatment options in advanced PD. We sought to evaluate the costeffectiveness of DBS vs CDLCI and CSAI among PD patients with early motor complications, from a United Kingdom (UK) payer perspective.  Methods: A Markov model was built representing the progression of PD over time (as per the Unified Parkinson’s Disease Rating Scale (UPDRS)). Evidence sources were:systematic evidence review; the EARLYSTIM study; a UK Clinical Practice Research Datalink (CPRD) dataset. A mapping algorithm was developed to generate utility values based on UPDRS data. Incremental cost per quality-adjusted life-year (QALY) were calculated. One-way and probabilistic sensitivity analyses explored the effect of parameter uncertainty.  Results: Over 15-years, DBS was predicted to lead to lower mean costs than CDLCI or CSAI (DBS:£73,077; CDLCI:£278,241; CSAI:£98,325), resulting in cost differences of -£205,165/patient and -£25,248/patient for DBS vs CDLCI and CSAI, respectively. QALY gains/patient were also predicted to be highest in DBS, resulting in additional 0.52 and 0.68 QALYs compared to CDLCI (6.69;6.18), and CSAI (6.69;6.01), respectively. Consequently, of the three treatment options, DBS was the dominant therapy over CSAI and CDLCI. Results were robust in univariate and probabilistic sensitivity analysis, with DBS being the dominant intervention in all scenarios and 100% of PSA simulations.  Conclusions: This analysis indicates that compared with CDLCI/CSAI, DBS is the dominant intervention in PD patients with early motor complications, offering additional health benefits at lower incremental cost. Limitations include the lack of CDLCI/CSAI data in PD with early motor complications; still, this analysis supports the extended use of DBS among patients in this population. PMD73 Cost-Effectiveness of Mechanical Thrombectomy Using StentRetriever After Intravenous T-PA Compared with Intravenous T-PA Alone in The Treatment of Acute Ischemic Stroke Due to Large Vessel Occlusion in Spain de Andrés-Nogales F1, Álvarez M2, de Miquel MÁ3, Segura T4, Gil A5, Cardona P3, Casado MÁ1, Nogueira RG6, Dávalos A7 1Pharmacoeconomics & Outcomes Research Iberia, Pozuelo de Alarcón (Madrid), Spain, 2Medtronic Ibérica, S.A., Madrid, Spain, 3Hospital Univeritari de Bellvitge, L’Hospitalet de Llobregat, Spain, 4Complejo Hospitalario Universitario de Albacete, Albacete, Spain, 5Hospital Universitario de Cruces, Barakaldo, Spain, 6Emory University School of Medicine, Atlanta, GA, USA, 7Hospital Universitari Germans Trias i Pujol, Badalona, Spain

Objectives: To assess the cost-effectiveness of mechanical thrombectomy using a stent retriever and intravenous tissue plasminogen activator (IV t-PA) compared with IV t-PA alone in patients with acute ischemic stroke due to large vessel occlusion in Spain.  Methods: A Markov state transition model defined by the modified Rankin Scale score was developed to estimate health outcomes expressed as life years gained and quality adjusted life years (QALY), and costs over patients’ lifetime. The model presents an acute phase (0-90 days) and a rest of life phase (90+ days). The analysis was conducted from the Spanish National Health System perspective and a 3% discount rate was applied to health outcomes and direct medical costs. Clinical inputs were based on the SWIFT PRIME clinical trial. Resource utilization and utilities were obtained from available published data and endorsed by an expert panel. Costs were obtained from different Spanish sources and expressed in €  2016. Deterministic and probabilistic sensitivity analyses were performed to examine the robustness of the results.  Results: Stent-retriever thrombectomy after IV t-PA was associated with increased life years and QALYs gained (1.17 and 2.51, respectively) and with decreased costs of € 44,378, resulting in the combined therapy being dominant over IV t-PA alone. A net monetary benefit of € 119,744 was obtained considering a willingness-to-pay threshold of € 30,000/QALY gained in the Spanish setting. The combined therapy was also dominant in all sensitivity analyses, deterministic and probabilistic.  Conclusions: The present evaluation results in stent-retriever thrombectomy after IV t-PA being dominant over IV t-PA alone, meaning that it represents a more effective and less costly alternative compared to IV t-PA alone in the treatment of acute ischemic stroke patients in the Spanish setting. PMD74 Cost Effectiveness Analysis of A Flash Glucose Monitoring System for Type 1 Diabetes (T1DM) Patients Receiving Intensive Insulin Treatment in Europe and Australia Bilir SP1, Li H2, Wehler EA3, Hellmund R4, Munakata J1 1IMS Health, San Francisco, CA, USA, 2IMS Health, Fairfax, VA, USA, 3IMS Health, Plymouth Meeting, PA, USA, 4Abbott Diabetes Care, Alameda, CA, USA

Objectives: Regular glucose monitoring is important for insulin-treated T1DM patients. A novel, minimally-invasive flash glucose monitor (the FreeStyle Libre™ system, “FM”) has been developed to continuously measure glucose levels from interstitial fluid. Data transfers to a handheld reader from a wearable arm sensor without requiring routine lancing and blood samples for self-monitoring of blood