Exploring The Potential Value of Improved Care for Secondary Hyperparathyroidism (SHPT) with A Novel Investigational Calcimimetic Therapy

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(UTI) compared with oral fosfomycin.  Methods: Decision-tree economic model of the treatment pathway for adult women with signs and symptoms of uncomplicated UTI in primary care in England; from presentation up to two treatment rounds. Patients experienced recovery, persistence, pyelonephritis and/or hospitalisation. Taking account of antibiotic resistance levels. Aggregating costs of prescriptions, primary and secondary care treatment and diagnostics. Comparing: fosfomycin 3g once, nitrofurantoin 50mg qid 7 days, nitrofurantoin modified release 100mg bid 7 days, nitrofurantoin 100mg qid 3 days, pivmecillinam 200mg tid 7 days, pivmecillinam 400mg bid 3 days, pivmecillinam 200mg bid 7 days, trimethoprim 200 mg bid 7 days, trimethoprim 200mg once. Outcome measures: estimated treatment cost and number of cases resolved, persisting, developing pyelonephritis and requiring hospitalisation per 1,000 patients treated. Cost-effectiveness in terms of cost per UTI resolved.  Results: Using central estimates of costs, effectiveness and resistance, trimethoprim 200mg bid 7 days was estimated to be both the cheapest (£60 per patient) and most cost-effective (£69 per UTI resolved) treatment. Probabilistic sensitivity analysis showed that the three most cost-effective treatments also had the least uncertainty around their estimates: trimethoprim 200mg bid 7 days (median= £65 per resolution, interquartile range (IQR)= £40), fosfomycin 3g stat (median= £73, IQR= £39) and nitrofurantoin 100mg bid 7 days (median= £78, IQR= £40). This ranking was not sensitive to alternative resistance rates or estimated three-day treatment effectiveness.  Conclusions: Trimethoprim 200mg bid is likely to be the most cost-effective first-line treatment for uncomplicated UTI in women (three days is currently recommended). If the resistance rate is expected to be higher than the 14.9% tested here, or where adherence to a multi-dose treatment regimen is an issue, a single 3g dose of fosfomycin is likely to be the next most cost-effective solution. PUK15 Cost-Effectiveness of Solifenacin for The Treatment of Overactive Bladder From A Us Private Payer and Medicare Advantage Perspective Ng DB1, Wielage R2, Klein TM2, Klein RW2, Gooch K1 Pharma Global Development, Inc., Northbrook, IL, USA, 2Medical Decision Modeling Inc., Indianapolis, IN, USA

1Astellas

Objectives: Antimuscarinics are oral treatment options for overactive bladder (OAB) that reduce symptoms and improve patients’ quality of life. Antimuscarinics are generally well tolerated, but differences in their efficacy and tolerability profiles have been observed. Solifenacin and fesoterodine are among the newest antimuscarinics. This analysis assessed the cost effectiveness of solifenacin and fesoterodine, the most recently approved antimuscarinics, from the US private payer and Medicare Advantage perspectives.  Methods: A Markov cost-effectiveness model was developed to simulate OAB course, management, and adverse effects of OAB treatment in simulated cohorts of patients over a 3-year time horizon. Incontinence and micturition average daily frequencies were stratified in five bands: incontinence (0, > 0-1, > 1-2, > 2-3, > 3), micturitions (≥ 8, > 8-10, > 10-12, > 12-14, > 14). Transition probabilities between bands were derived from a mixed treatment comparison. Therapy began with an oral OAB agent, followed by switch to another oral OAB agent or discontinuation. Tibial nerve stimulation, sacral neuromodulation, or onabotulinumtoxinA were third-line treatments. EQ-5D equivalent utilities were mapped from demographics, incontinence, and micturition frequencies. OAB-related comorbidities and treatment-related adverse events triggered utility decrements and added costs. The primary outcome was cost per quality-adjusted life year (QALY). Secondary outcomes were costs per strata improvement in incontinence and micturition. One-way and probabilistic sensitivity analyses were performed.  Results: Incremental costs per QALY for solifenacin were US $44,954 and US $45,656 from the private payer and Medicare Advantage perspectives, respectively. The incremental costs per incontinence and micturition strata improvement for solifenacin were US $10,048 and US $6,200 from the private payer perspective and US $9,402 and US $5,953 from the Medicare Advantage perspective, respectively. Based on a willingness-to-pay threshold of US $50,000 per QALY, solifenacin was cost-effective in 77% of probabilistic samples.  Conclusions: Results suggest that compared to fesoterodine, solifenacin is a cost-effective antimuscarinic option for treatment of OAB from US private payer and Medicare Advantage perspectives. PUK16 Cost-Minimisation Analysis of Sucroferric Oxhydroxide and Sevelamer Carbonate in Patients on Dialysis with Secondary Hyperparathyroidism in Six European Countries van Stiphout J1, Vrouchou P2, Braunhofer PG2, Schwenkglenks M1, Szucs TD1, Blank P1 1European Center of Pharmaceutical Medicine - University of Basel, Basel, Switzerland, 2Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland

Objectives: Chronic kidney disease (CKD) patients on dialysis often require Vitamin D receptor agonists (VDRAs) therapy for managing secondary hyperparathyroidism (SHPT). In a post-hoc analysis, the oral phosphate binder sucroferric oxyhydroxide (SFOH) had no apparent interaction with oral VDRAs. In contrast, the widely used oral phosphate binder sevelamer carbonate (SEV) showed potential interactions with oral VDRAs but no interactions with intravenous (IV) VDRAs. A cost minimization analysis (CMA) estimated the economic impact of using SFOH vs SEV in dialysis patients receiving VDRA agents in six European countries.  Methods: The CMA assumed similar efficacy for SFOH and SEV, and that patients received either SFOH (1.5 g/day [3 tablets/day]) and oral VDRAs (0.28 μ g/day) or SEV (6.4 g/ day [8 tablets/day]) and IV VDRAs (1.84 μ g/day or 200 IC/day). SFOH and SEV dosage was derived from two phase 3 trials (NCT01324128/NCT01464190). Drug acquisition costs were based on list ex-manufacturer prices. Costs for the administration of IV VDRAs and treatment of adverse events were not included.  Results: Annual treatment cost per patient for SFOH and (SEV) were: Austria € 1,963 (€ 1,673), France € 1,584 (€ 1,683), Germany € 1,825 (€ 1,683), Italy € 2,068 (€ 1,518), Switzerland € 3,253 (€ 3,370); UK € 2,872 (€ 3,270). Annual treatment costs per patient for oral and (IV) VDRAs were: Austria: € 113 (€ 1,960), France: € 88 (€ 2,649), Germany: € 158 (€ 2,057), Italy: € 32 (€ 1,791), Switzerland: € 113 (€ 2,988) and UK: €  192 (€ 1,465). SFOH treatment with

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oral VDRAs resulted in annual cost savings per patient compared to SEV with IV VDRAs: Austria: € 1,556, France: € 2,661, Germany: € 1,757, Italy: € 1,208, Switzerland: € 2,993, UK: €  1,671. The magnitude of the results was confirmed in sensitivity and scenario analyses.  Conclusions: The CMA suggests that cost savings could be generated by using SFOH instead of SEV and, in consequence allowing SFOH patients to use oral VDRAs and avoid more costly IV VDRAs. Real-world data are needed to confirm these findings. PUK17 Exploring The Potential Value of Improved Care for Secondary Hyperparathyroidism (SHPT) with A Novel Investigational Calcimimetic Therapy Stollenwerk B1, Iannazzo S2, Cooper K3, Belozeroff V4 (Europe) GmbH, Zug, Switzerland, 2SIHS SRL, Torino, Italy, 3Amgen, Inc., Thousand Oaks, CA, USA, 4Amgen Inc, Thousand Oaks, CA, USA

1Amgen

Objectives: Healthcare decision makers are increasingly interested in the economic value of emerging therapies. We assessed the potential value of a new investigational intravenous calcimimetic (etelcalcetide) administered during dialysis sessions for the treatment of secondary hyperparathyroidism (SHPT) in adult patients on hemodialysis in the United States (US). In a comparative, double-blind trial, etelcalcetide showed superior reduction of parathyroid hormone levels compared to cinacalcet and allowed for flexible dose schedule. However, since the realworld doses of cinacalcet are different than the trial doses, we estimated a range of plausible doses for etelcalcetide to define a range of prices where economic value could be demonstrated.  Methods: We used a Markov model to estimate the costutility of etelcalcetide compared to cinacalcet. This model was based on data from etelcalcetide trials and previously published cost-effectiveness models in SHPT, and allowed extrapolation of treatment effects on mortality, cardiovascular events, fracture and parathyroidectomy. Four dosing scenarios were explored: trial mean dose; trial efficacy assessment period mean dose; estimated real-world mean dose (based on published data and an open label extension study data); estimated real world most common dose (same sources as previous). To determine the value-based price range, we used the cinacalcet wholesale acquisition cost (WAC) price of $0.83 per mg and assumed a willingness-to-pay threshold of $150,000 per quality-adjusted life-year (QALY) for the US.  Results: The estimated potential doses ranged from 30.0 mg to 57.8 mg per day for cinacalcet and from 2.5 mg to 7.0 mg per administration for etelcalcetide. Cost-effectiveness analysis supports value-based prices for etelcalcetide from $17.82/mg - $35.30/mg.  Conclusions: Cost-effectiveness analysis is one method to estimate the range of prices for new therapies that may represent good value for money. It also enables the exploration of different doses that may be used in actual clinical practice. PUK18 Assessing The Cost-Utility of Etelcalcetide: A Markov Model Stollenwerk B1, Iannazzo S2, Akehurst R3, Adena M4, Briggs A5, Dehmel B6, Parfrey P7, Belozeroff V6 1Amgen (Europe) GmbH, Zug, Switzerland, 2SIHS SRL, Torino, Italy, 3BresMed Health Solutions, Sheffield, UK, 4Datalytics Pty Ltd, Bruce ACT, Australia, 5University of Glasgow, Glasgow, UK, 6Amgen Inc, Thousand Oaks, CA, USA, 7Memorial University, St. John’s, NF, Canada

Objectives: Etelcalcetide is a novel intravenous calcimimetic to treat secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis. In three randomized controlled trials, a head-to-head trial against the oral calcimimetic cinacalcet and in 2 trials against placebo (in addition to phosphate binders and vitamin D; PBVD), etelcalcetide demonstrated superior reduction of parathyroid hormone (PTH). The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide.  Methods: We developed a Markov model that captures mortality, cardiovascular events and fractures, as well as subjects’ persistence status. Treatment effects of etelcalcetide on clinical outcomes were taken from a published extrapolation approach that linked the biochemical response to hard outcomes from the EVOLVE trial. Parathyroidectomy was modelled as an outcome only and not as a separate health state. Potential comparators were cinacalcet and PBVD. Consistent with the approach of modelling persistence explicitly, we used censored hazard ratios (published lag-censored hazard ratios with censoring 6 months after stopping medication). Where possible, input parameters were aligned with previously published cinacalcet cost-effectiveness models. To test the functionality of the model, we applied crude averages of published drug prices and event costs across five European countries. As the etelcalcetide price currently does not yet exist, a range of prices was applied: same weekly costs as for cinacalcet, based on the efficacy assessment phase of the head-to-head trial, 15% higher and 30% higher.  Results: Compared with cinacalcet, the incremental costeffectiveness ratio of etelcalcetide was € 21,220/QALY, € 43,329/QALY and € 65,438/ QALY; compared with PBVD it was € 30,553/QALY, € 35,312/QALY and € 40,070/QALY. The undiscounted incremental QALY gain was 0.089 vs. cinacalcet and 0.412 QALYs vs. PBVD.  Conclusions: Based on an uncertain price, our model points towards etelcalcetide being cost-effective in Europe. Considering the value of etelcalcetide for the treatment of SHPT, the model can serve as a starting point for countryspecific assessments.

URINARY/KIDNEY DISORDERS – Patient-Reported Outcomes & Patient Preference Studies PUK19 The Effect of Therapeutic Drug Monitoring in Patients Compliance: An Improvement in Drug Efficacy and Corresponding Reduction in Toxicity Using Aminoglycosides Okoro KI UNIVERSITY OF NIGERIA, NSUKKA, ENUGU STATE, Nigeria