ALK Immunohistochemical Test In The Detection Of Patients Affected By ALK+ Non-Small Cell Lung Cancer: Clinical And Budget Impact

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Objectives: Current treatments for cervical dysplasia involve removal of affected cervical tissue. This may lead to side effects such as bleeding, infection and preterm delivery. This analysis sought to determine the clinical and cost impact of a tissue-preserving procedure using a novel photodynamic therapy under investigation for treatment of cervical dysplasia (Cevira®, Photocure, Oslo, Norway) as compared to loop electrosurgical excision procedure (LEEP) and cold knife conization (CKC).  Methods: A budget impact model was developed from the perspective of a US payer with 5 million covered lives. The model captured Medicare allowable costs for cervical cancer screening, subsequent colposcopy with biopsy for abnormal screening results, treatment of cervical dysplasia, and side effects from treatment using 2016 reimbursement rates. Clinical data for screening, follow-up biopsy and treatment outcomes were from published data. A scenario analysis determined the impact of treatment modality, including a non-surgical method like Cevira®, on preterm birth and associated costs.  Results: In a US health plan with 5 million covered lives, 810,525 women 18 – 44 years would present for cervical cancer screening. Of those, 7,972 women would have abnormal screening and subsequent biopsy that is CIN2/3. The per patient cost to screen and treat at 24 months follow-up was $222 for photodynamic therapy, compared to $220 for LEEP and $222 for CKC. When incorporating costs related to the increased risk of preterm birth for LEEP and CKC, per patient costs were lowest for photodynamic therapy ($268) as compared to LEEP ($322) and CKC ($378).  Conclusions: The per patient cost to screen and treat using tissue-preserving procedures like Cevira® is similar to current treatment strategies but has the clinical benefit of sparing normal cervical tissue, leading to lower rates of procedure-related side effects. Further benefit may be derived from reduction in preterm births and its associated costs and intangible impact on morbidity. PMD27 Do Budget Impact Analyses For Screening Of Cancers Follow International Guidelines? A Systematic Review Jahn B1, Todorovic J1, Bundo M1, Sroczynski G1, Conrads-Frank A1, Rochau U1, Chhatwal J2, Mauskopf J3, Siebert U4 1Department of Public Health, Health Services Research and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, 2Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, 3RTI Health Solutions, RTI International, Durham, NC, USA, 4UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria. Department of Health Policy and Management, Harvard T.H. Chan School of Public Health. Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA

Objectives: Budget impact analyses (BIA) assess the financial consequences of the implementation of new health care technologies. BIAs are increasingly required by decision makers for budgetary planning. Our study aims to systematically review published BIA, applied methods and if international BIA guidelines are followed in evaluating cancer screening programs.  Methods: A systematic literature search was conducted in MEDLINE and EconLit for BIA evaluating cancer screening programs, published in English language 2010-2016. Standardized evidence tables were used to extract main characteristics of the analysis and model along the ISPOR BIA Task Force guidelines including cancer type, model structure, definition of population size/characteristics, perspective, time horizon, included costs, source of epidemiologic and clinical data, consideration of health impact, validation, and uncertainty analysis.  Results: Ten studies were identified. Three studies evaluated screening for breast cancer, two for colorectal and cervical cancer and one for lung, prostate and skin cancers. Model designs varied from several types of decisionanalytic models (60%) to simple cost calculators (40%). The ISPOR guidelines recommend using a simple BIA model structure such as a cost calculator approach as long as important conditions are credibly captured. The time horizon ranged from one to 20 years; six studies applied a one-year time horizon. Projections beyond one year are recommended by ISPOR guidelines, because cost and population parameters might change. All studies included direct condition-related costs and two studies additionally included indirect cost. Health impact was reported in 40% of the studies. Uncertainty analysis was not always sufficiently reported. Only 40% of the studies reported validation to some extent.  Conclusions: BIA studies evaluating cancer screening programs show a substantial variability in the scope of guidelines consideration. Applied time horizon, reporting validation and uncertainty analysis are areas for improvement. Best practice recommendations need to be followed for assisting sound health plan decision making. PMD28 A Budget Impact Analysis Of Transcatheter Aortic Valve Implantation In France Goodall G, Candolfi P, Sohlberg A Edwards Lifesciences, Nyon, Switzerland

Objectives: Transcatheter aortic valve implantation (TAVI) is a minimally invasive alternative to surgical replacement of the aortic valve (sAVR) and the only option for those considered at too high risk for conventional surgery. Currently in France only 2 devices are available and these only reimbursed for inoperable and high risk patients. We present here budget impact analyses (BIA) to identify the cost to the healthcare system of expanding coverage to treat intermediate risk patients as well.  Methods: An Excel model with a 5 year time horizon was used to account incremental costs for TAVI from the perspective of the compulsory health insurance (l’Assurance maladie obligatoire). The current total number of procedures (TAVI in inoperable and high risk and all sAVR) were derived from the PMSI (Programme de médicalisation des systèmes d’information) from 2012 to 2015. Based on this data and information on reimbursed TAVI devices from the LPPR the population eligible for TAVI was projected. Using procedural and patient management costs from an associated cost-effectiveness model the total budget impact between 2017 and 2022 was calculated and sensitivity analyses performed.  Results: At a price for TAVI set to achieve an ICER per life year gained of approximately € 10,000, the 5 year incremental cost was estimated at € 295 million. When accounting no change in the price the budget impact over 5 years was € 22 million (€ 0.49 to € 7.3 million annually)

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representing an incremental investment of only € 1000 per patient.  Conclusions: TAVI is considered a high cost technology and yet the incremental budget impact required to give access to an additional 22,000 patients is very modest. With improved quality of life with TAVI and recent clinical data indicating improved survival with TAVI versus sAVR it is hoped this analysis will support effective decision making. PMD29 Budget Impact Analysis of Supra-Ciliary Microstent Device Utilization In Primary open Angle Glaucoma Patients In A Spanish Hospital Outpatient Setting Ferrufino C1, Kowal S2, Morris L3, Patel K4, Falla E4, Bouchet C5 1QuintilesIMS, Fairfax, VA, USA, 2QuintilesIMS, Seattle, WA, USA, 3Alcon Laboratories, Fort Worth, TX, USA, 4QuintilesIMS, London, UK, 5Alcon Laboratories, Inc, Fort Worth, TX, USA

Objectives: Minimally Invasive Glaucoma Surgery (MIGS) devices fill an unmet need in therapy between topical pharmacological medicines and more invasive filtration procedures. This study evaluates the budget impact of using a new supraciliary microstent (Alcon Laboratories) device in Spanish hospitals as a stand-alone procedure or in conjunction with cataract surgery primary open angle glaucoma (POAG) patients where previous treatments have failed.  Methods: A budget impact model (BIM) from a Spanish hospital outpatient perspective was developed using Microsoft® Excel®. Population and cost estimates were derived from published sources. POAG disease characteristics were obtained from the literature and an online survey of 40 practicing glaucoma/cataract specialists in Spain. Comparators and market share data were obtained from independent market research. Resource use assumptions associated with each intervention were obtained through survey results and from interviews with four key opinion leaders. Costs included published device costs, post-procedure follow-up care, and facility costs.  Results: An estimated 227,248 trabeculectomy, laser assisted trabeculoplasty or MIGS POAG interventions will occur over five years, 21,452 of which will use supra-ciliary microstent. The use of supra-ciliary microstent will have a low budget impact of 5.3% in the first year (€ 1,116,370) and an average budget impact of 8.2% over five years, with cost increases primarily driven by patients shifting from lower cost laser trabeculoplasty procedures. However, total intervention costs for supra-ciliary microstent (€ 1774) are lower than total intervention costs for the other included MIGS procedures (trabecular micro-bypass generation 1: € 1829; subconjunctival gelatin stent: € 2744) and similar to the common, but invasive trabeculectomy surgery (€ 1762). MS cost offsets were driven by decreases in procedure-related resource use and postprocedure follow-up care. Univariate sensitivity analyses confirm that model results are robust.  Conclusions: The introduction of supra-ciliary microstent will have a minimal budget impact in Spain while increasing access to a valuable, minimally invasive treatment alternative for glaucoma. PMD30 A Budget Impact Analysis Of Increasing Peritoneal Dialysis (PD) In Adults Experiencing Unplanned Start Dialisys (Urgent Start) In Brazil Tannus G1, Sansone D2, Farah D3, Ramirez MG4, Fonseca M3 Life Sciences International, Miami, FL, USA, 2AxiaBio, São Paulo, Brazil, 3Federal University of São Paulo, São Paulo, Brazil, 4Baxter, Mexico city, Mexico 1Axia.Bio

Objectives: This study investigates the budget impact of variable distribution of adult patients experiencing unplanned start (urgent start) Peritoneal Dialysis (PD) and Haemodialysis (HD) in Brazil.  Methods: An Excel-based budget impact model was developed to assess dialysis-associated costs when changing dialysis modalities between PD and HD from the Brazilian public payer perspective. For this exercise, as the total number of performed urgent start procedures specifically listed, we have used to estimate target population the quantity of acute renal treatment hospitalizations registered at DATASUS (Brazilian public heath database) in 2016: 23,077 hospitalizations. The analysis incorporates the current modality distribution of PD (0%) and HD (100%) and evaluates a proposal to adopt 100% PD in a one year time horizon. Complications rate from each dialysis modality came from a previously published retrospective study, where the following differences between PD and HD was found respectively: Catheter reinsertion (1% vs. 24,4%); Catheter-related infection (0% vs. 11%); Bleeding (0% vs. 3,7%); thrombosis (0% vs. 7,3%) and peritonitis (2,1% vs. 0%). Costs of dialysis methods and complications were estimated from the official 2017 Brazilian public health care reimbursement list (SIGTAP - Sistema de Gerenciamento da Tabela do SUS). Alternative scenario included the prevalence of changing dialysis urgent start from HD to PD in order to analyse the economic impact of this adoption. As this analysis refers to an urgent procedure and in-hospital expenses, the economic impact of adoption and dialysis method-related complication reductions and was measured over 30 days of catheter insertion.  Results: The change from HD to PD resulted a cumulative saving of BRL$ 3,260,135.79 for the Brazilian public health care system over a 1 year time frame.  Conclusions: This exercise shows that increasing the uptake of PD regimen could potentially reduce dialysis methodassociated complications and costs for urgent start therapy in Brazil. PMD31 ALK Immunohistochemical Test In The Detection Of Patients Affected By ALK+ Non-Small Cell Lung Cancer: Clinical And Budget Impact Paolini D1, Tiseo M2, Dionisi M3, Demma F4, Furneri G4, Akkermans M5, Marchetti A6 1Roche Diagnostics S.p.A., Monza, AZ, USA, 2Azienda Ospedaliera - Universitaria di Parma, Parma, Italy, 3Roche Diagnostics S.p.A., Monza, Italy, 4EBMA Consulting SRL, Melegnano, Italy, 5Roche Diagnostics International Ltd, Rotkreuz, Switzerland, 6University of Chieti, Chieti, Italy

Objectives: A phase III trial (Profile 1014) showed that patients with advanced ALK positive non-small-cell lung cancer (NSCLC) treated with crizotinib had longer progression-free-survival than patients treated with standard-chemotherapy. To ensure identification of ALK+ patients, the Italian Drug Agency (AIFA) suggested a testing algorithm based on fluorescence-in-situ-hybridization (FISH) or immunohistochemical

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techniques (IHC). The aim of this study was to evaluate the clinical/economic impact of adopting an immunohistochemical test (Ventana ALK, D5F3) as an option for detecting ALK protein expression in advanced NSCLC patients.  Methods: A budget impact model was developed by adopting the Italian NHS perspective and a time horizon of 5 years, in order to compare two scenarios: current ALK D5F3 adoption rate (28%; Base Scenario) vs increased use of D5F3 (60%; Alternative Scenario). The outcomes evaluated were: the number of identified ALK+ patients; the cost for ALK testing (FISH/ IHC); the cost per identified ALK+ patients.  Results: The estimated number of newly diagnosed, advanced NSCLC ALK+ patients eligible to first-line treatment was 1,252 per year, of whom 53% were assumed to have access to ALK testing in the two scenarios. A more extensive use of D5F3 in the Alternative Scenario determined a decrease in diagnostic costs of about € 19,000, vs the Base Scenario. If these savings were allocated to test more NSCLC patients (75% vs 53%), an incremental cost per identified ALK+ patient of € 67 would be required, leading to 20% overall survival gain in the Alternative Scenario vs the Base Scenario (30,1 vs 25,0 months).  Conclusions: The use of ALK D5F3 immunohistochemical test is cost saving for the Italian NHS due to a test cost lower than FISH and a comparable detection rate. These savings could be re-invested to test a greater number of patients, leading to more efficient identification, use of target therapy, and improvement of clinical outcomes of ALK+ patients. PMD32 Budget Impact Analysis (BIA) Of Mechanical Thrombectomy In Acute Phase Of Ischemic Stroke (AIS) Pochopien M, Fundament T, Niesyczynski G, Lembas A, Plisko R HTA Consulting, Krakow, Poland

Objectives: To estimate financial consequences of reimbursement of mechanical thrombectomy (MT) using a stent retriever in patients with AIS in Poland.  Methods: Analysis was performed from two perspectives: public payer and public payer + patient in 2-year time horizon (2017-2018). Two scenarios were considered: with and without reimbursement of MT. Target population was defined as patients with AIS eligible for MT who are contraindicated to intravenous tissue plasminogen activator (IV-rt PA) or are treated with IV rt-PA (and MT is added). Size of target population and market share for MT were estimated by compilation of following sources: National Health Found stats on Diagnosis Related Groups (DRG), data from stroke clinical center and clinical expert opinion. Cost data, treatment effectiveness and mortality were also included and data were input in accordance with economic analysis. One-way sensitivity analysis was performed for the key input parameters. All estimations were done with constructed Excel model.  Results: Total number of target population is 8,748 in 2017 and 9,792 in 2018. This include all patients treated with IV-rt PA and those with contraindications for IV-rt PA but eligible for MT. In scenario without MT total annual expenditures in 1st and 2nd year will be 151.2 mPLN and 192.1 mPLN from public payer perspective (152.2 mPLN and 195.4 mPLN from public payer + patient). In scenario with MT reimbursement estimated number of patients treated with MT will be 514 in 2017 and 1,150 in 2018. This will result with increase in total expenditures by 22.5 mPLN and 50.3 mPLN in 1st and 2nd year of analysis regardless of perspective.  Conclusions: Positive decision of reimbursement of mechanical thrombectomy, using a stent retriever, will bring additional cost incurred by public payer or public payer and patients. PMD33 Economic Analysis of The Use of Non-Invasive Prenatal Test (NIPT) For Prenatal Screening of Trisomy 21, 18, 13 In Pregnant Women Paolini D1, Camurri L2, Dionisi M3, Speranza G3, Prefumo F4 Diagnostics S.p.A., Monza, AZ, USA, 2Medi Saluser, Parma, Italy, 3Roche Diagnostics S.p.A., Monza, Italy, 4Spedali Civili Brescia, Brescia, Italy

1Roche

Objectives: The cell-free DNA Non-Invasive Prenatal Test (NIPT) is highly accurate in the detection of common fetal autosomal trisomy (i.e. T21, T18, T13) in pregnant women. NIPT is performed on a blood sample of the pregnant woman, which contains cell-free DNA that originates from the lysis of maternal and placental cells. The aim of this study was to evaluate the financial impact on the Italian NHS payer’s perspective of the use of the screening NIPT, in comparison to current clinical practice (i.e. first and second trimester combined ultrasound and biochemical screening tests; chorionic villus sampling and amniocentesis as invasive diagnostic tests).  Methods: A budget impact analysis, with 3-year-time horizon, was developed within the Italian NHS perspective. The economic analysis was implemented on short-term period until child birth, and the target population was represented by Italian singleton-pregnant screened women (447,616). In relation with clinical and economic outcomes, this analysis compared two scenarios: current clinical practice vs introduction of NIPT as a second-level screening test after current clinical practice.  Results: In the light of clinical results, NIPT reduced the number of invasive tests performed by 79%. The overall trisomy detection rate remained constant for T21 and T18 between the two scenarios, and it decreased by 2% in T13. Economic results highlighted that NIPT reduced total testing costs per year by € 4.1 million (from million € 43.7 to € 39.6), due to the decrease of testing costs (by € 3.5 million), and ancillary-care costs (by € 665,418). Moreover, the cost savings was €  9.22 per screened woman.  Conclusions: The introduction of NIPT as a second-level screening test might be a valuable solution for the NHS. It can produce a cost-savings due to a lower number of performed invasive tests than in current clinical practice. These savings could be re-invested in other area improving patient management in women’s health. PMD34 Changes in acute medication cost observed in cluster headache patients treated with sphenopalatine ganglion (SPG) stimulation: a U.K. NHS-specific analysis based on data from the pathway R1 registry Pietzsch JB1, Lund N2, Weber SA3, Gaul C4 1Wing Tech Inc., Irvine, CA, USA, 2University of Copenhagen, Glostrup, Denmark, 3Cellogic GmbH, Berlin, Germany, 4Migräne und Kopfschmerzklinik Königstein, Königstein im Taunus, Germany

Objectives: On-demand stimulation of the sphenopalatine ganglion (SPG) by means of an implantable neurostimulation system has been shown to be a safe and clinically promising therapy for the treatment of chronic cluster headache. Our objective was to estimate changes in cluster headache medication cost observed in patients treated with the ATI PULSANTE Neurostimulation System, using baseline and 12-month utilization data from the recent Pathway registry and United Kingdom drug costs for reference.  Methods: Detailed patient-level data of n= 71 chronic cluster headache patients followed through 12 months in Pathway R1 (NCT01677026) were analyzed to assess weekly utilization of acute cluster headache medications at baseline and 12 months. Cost estimates for all drug/dosage combinations were developed based on current 2017 pharmaceutical prices published in the British National Formulary (BNF 73, 2017), and used the lowest priced product and largest available package size in each instance to determine cost.  Results: In the patients receiving SPG stimulation treatment, overall weekly medication costs per patient were reduced by 54.8% from £197.60 to £89.42 (-£108.20) from baseline to 12 months. Under a steady-state assumption, the observed drug cost reductions resulted in annualized acute drug cost savings to the U.K. National Health Service (NHS) of £5,626 (reduction from £10,276 to £4,650 per year).  Conclusions: Our analysis suggests that SPG stimulation for the treatment of chronic cluster headache is associated with pronounced reductions in acute cluster headache medication usage, leading to sizable annual savings in medication costs for the United Kingdom’s NHS. On the basis of prior clinical studies investigating SPG therapy, these reductions stem from both effective treatment of attacks with stimulation, and also a reduction in attack frequency observed in stimulation-treated patients. PMD35 Healthcare Costs Of Patients With Acute And Chronic Graft-Versus-Host Disease Following Allogeneic Haematopoietic Stem Cell Transplantation In Belgium: A Retrospective Data Collection And Analysis Strens D1, Schoemans H2, Renard M2 1Realidad bvba, Grimbergen, Belgium, 2UZ Leuven, Leuven, Belgium

Objectives: Graft-versus-host disease (GvHD) presents a major challenge to successful allogeneic stem cell transplantation (aSCT). Extracorporeal photopheresis (ECP) is a promising alternative to standard immunosuppressive therapies but it was not available at the participating study centre in Belgium. A retrospective analysis was undertaken of resource use and treatment costs with available therapies in patients who developed steroid-refractory or steroid-dependent acute (aGvHD) or chronic GvHD (cGvHD) following aSCT.  Methods: Data were collected on number, duration and cost of hospitalisations, GvHD-related diagnostic procedures, and treatment for the management of symptoms and complications of GvHD. A hypothetical date was identified (the index date; ID) at which clinicians would have referred patients to ECP had it been available. Costs were analysed prior to the potential referral for ECP and compared with those after referral.  Results: The study group comprised 26 patients with aGvHD (n= 17) or cGvHD (n= 9), all eligible for ECP treatment had it been available. The costs of GvHD management at the centre were primarily driven by high inpatient hospitalisation costs. Average monthly inpatient cost was € 2,687 per patient prior to the ID and € 2,689 between the ID and the end of the study. Average monthly outpatient cost was € 753 per patient prior to the ID and € 542 between the ID and end of the analysis.  Conclusions: This analysis, undertaken in a small number of patients, suggests that the management of patients with GvHD following aSCT is associated with high healthcare burden in Belgium, primarily related to hospitalisations. A significant unmet need remains for effective GvHD therapies and options such as ECP should be considered. Accessibility to ECP is limited in Belgium and not reimbursed. A similar retrospective analysis is planned to confirm potential changes in healthcare utilisation and costs with ECP treatment. PMD37 Cost-Effectiveness Analysis Of Primary HPV Screening With Dual-Stain Cytology Triage In The Cervical Cancer Screening Program Of Belgium Vandeweyer K1, Tjalma W2 1Roche Diagnostics Belgium, Brussels, Belgium, 2Antwerp University Hospital, Edegem, Belgium

Objectives: Previously we have shown that primary HPV screening with dual-stain cytology triage reduced the incidence of cervical cancer 36 % and the mortality by 40 %. Our objective is to determine the cost-effectiveness of dual-stain cytology triage in the 2017 cervical cancer screening program of Belgium.  Methods: The age group for the cervical cancer screening program is 25-65 years with a 3- years interval. Current practice is liquid based cytology (LBC) with reflex HPV testing for ASCUS. The proposed practice is primary HPV screening with reflex dual-stain cytology. The calculations are based on the honorarium of 2017. The cost calculation is based on screening, diagnostics and treatment.  Results: The cost for a HPV test is 35 € , for dual-stain cytology is 60 €  and for LBC is 28,41 € . The transition from the current practice to the proposed practice will lead to an increase in costs the first three years (4.1 M € , 4.7 M €  and 4.7 M € ) and a decrease in the fourth (14.3 M € ) and fifth (14.8 M € ) year. Likewise screening in the 6th, 7th and 8th years will have an increase of respectively 2.2 M € , 3.5 M €  and 3.5 M € . The 9th and the 10th year there is a decrease of 13.5 M €  and 14 M € .  Conclusions: Primary HPV screening program with dual-stain cytology triage can lead to a 5-years screening interval with a budget cost reduction after 5 years of almost 15 M € . PMD38 Multiplatform Tumor Profiling Delivers Value Based Health Care In Refractory Cancer Patients Russell KJ1, Dean A2, Muckle G3, Hussain T3, Hernandez A1, Voss A1, Spetzler D4 1Caris Life Sciences, Basel, Switzerland, 2St John of God Hospital, Subiaco, Australia, 3Champions Oncology, Inc, London, UK, 4Caris Life Sciences, Phoenix, AZ, USA

Objectives: Caris Molecular Intelligence® (CMI) is a multiplatform tumor profiling service helping patients with refractory cancer who are past standard of care