A REVIEW OF PRICING OF ORPHAN DRUGS FOR LEUKEMIA IN THE UNITED STATES VERSUS ENGLAND

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therapy / ibrutinib at $79,508. Finally, the use of ibrutinib only, as first line therapy without any preceding treatment, was the most costly at $99,262.  Conclusions: Based on this analysis it may be concluded that the best first-line option for the management of patients with CLL, when considering the cost of ibrutinib as second-line treatment option, is bendamustine + rituximab as this combination offers the best budget impact with the lowest cost per year. The advantage of this combination in first-line is that it delays second-line treatment with costly ibrutinib. PSY23 COST-EFFECTIVENESS ANALYSIS OF USTEKINUMAB FOR THE TREATMENT OF ADULTS WITH MILD-TO-MODERATE PLAQUE PSORIASIS REFRACTORY TO OTHER BIOLOGIC AGENTS IN MEXICO Salazar A , Aguirre A , Flores R Janssen, Mexico, Mexico .

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The prevalence of psoriasis (PsO) globally is 1-3%, is also one of the 15 most common skin diseases in Mexico and affects ~2.5 million people. According to the Mexican Consensus for the Management of Biological Therapy in PsO there is both doctors and patients report limited satisfaction with the results of current treatments.Objectives: Develop a cost-effectiveness analysis for ustekinumab as treatment for adults with MtSPsO who failed to TNFs.  Methods: A cost-effectiveness analysis was performed from a payers perspective, namely the Mexican Social Security Institute through a decision-tree model and budget impact model. The horizon time was set as 1 year in order to compare patients who failed to Adalimumab (ADA) or etanercept (ETA) and switch to Ustekinumab (USTE) 45 mg or ADA or ETA depending on previous treatment. Only direct costs are considered. The results are presented in incremental cost per patient that reaches a PASI improvement of at least 75% (PASI75). An exchange rate of $17 MXN per USD was applied. Probabilistic sensitivity analyses was performed in order to test the robustness of the model.  Results: The cohorts switching to ustekinumab generated the highest PASI75 (29% and 33%, ADA and ETA respectively). In particular the cohort switched from ADA-> USTE is a dominant alternative) for the treatment of adults with MtSPsO refractory to other biological agents. The incremental cost of the alternatives vs ADA-> USTE were $5,102 for ADA-> ETA, $12,339 and $12,389 for ETA-> USTE and ETA-> ADA respectively , all with ICERs above the recommended willingness to pay in Mexico of 1 times the GDP per capita. Robustness of model was confirmed by sensitivity analysis.  Conclusions: The use of ustekinumab in patients who failed to TNFs is a more effective and cost-saving alternative compared to current biologic agents in Mexican health care. PSY24 ECONOMIC MODEL TO EXAMINE THE COST BENEFIT ASSOCIATED WITH RESOLUTION OR IMPROVEMENT OF CARCINOID SYNDROME SYMPTOMS FOLLOWING TREATMENT WITH ABOVE-STANDARD DOSE OF OCTREOTIDELAR IN PATIENTS WITH NEUROENDOCRINE TUMORS BASED ON DATA FROM A RETROSPECTIVE CHART REVIEW STUDY AT THREE LARGE TERTIARY ONCOLOGY CENTERS IN THE UNITED STATES Huynh L 1, Totev T 2, Vekeman F 3, Neary M 4, Duh M S 1, Kulke M 5, Benson A 6 Group, Inc., Boston, MA, USA, 2Analysis Group Inc., Boston, MA, USA, 3Groupe d’analyse, Ltée, Montréal, QC, Canada, 4Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 5Dana-Farber Cancer Institute, Boston, MA, USA, 6Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA .

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Objectives: A retrospective chart review study was performed (NET 3-Center) that included 239 neuroendocrine tumor (NET) patients who received above-standard dose of octreotide-LAR for carcinoid/hormonal syndrome. Administration of 40mg/4 weeks (51%), 30mg/3 weeks (18%), and 60mg/4 weeks (18%) were the most common above-standard doses. Patients who had reported carcinoid syndrome symptoms (CSS; diarrhea/flushing) experienced resolution/improvement (diarrhea:79%, flushing:81%) ≤ 1 year. A cost model was developed to examine economic savings associated with CSS resolution/improvement observed in NET 3-Center study and assess model robustness.  Methods: CSS and treatment data came from NET 3-Center. Resource utilization and cost for another sample of patients came from claims database analysis. For NET 3-Center patients, the period after initiation of octreotideLAR (index date) was divided into days with/without CSS; costs were calculated for each period. Total healthcare costs included inpatient, outpatient, emergency department, and pharmacy services. Annual total healthcare costs post-index date were compared for patients with CSS resolution/improvement vs. those without. Sensitivity analysis included indirect cost for patients < 65 years.  Results: 136 patients had diarrhea/flushing ≤ 3 months prior to index date; 108(79%) patients experienced CS symptom resolution/improvement ≤ 12 months of index date. Patients with CSS resolution/improvement had lower mean annual total healthcare costs/patient by $14,766(P= 0.03) than patients without resolution/improvement. Resolution/improvement of diarrhea drove cost savings. Among 107 patients with diarrhea, 85(79%) experienced resolution/improvement post-index date. Patients with resolution/improvement of diarrhea had lower mean annual total healthcare costs/patient by $18,740(P= 0.01) than patients with diarrhea. Including indirect cost for patients < 65 years old brought additional cost savings of $273/patient (mean difference: $15,039;P= 0.033) among patients with diarrhea/flushing and $358/patient (mean difference: $19,098;P= 0.012) among patients with diarrhea.  Conclusions: The cost model was robust and showed statistically significant mean annual total healthcare cost savings in patients having CSS resolution/improvement. Future studies using alternative data sources for costs are needed to further validate the model’s assumptions. PSY25 A REVIEW OF PRICING OF ORPHAN DRUGS FOR LEUKEMIA IN THE UNITED STATES VERSUS ENGLAND Smith C 1, Joo Hyeon K 1, Briceno V 1, Pompilus F A 1, Shukla V 1, Seoane-Vazquez E 2 College of Pharmacy & Health Sciences, Boston, MA, USA, 2MCPHS University, Boston, MA, USA .

1Massachusetts

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Objectives: The market for orphan drugs presents challenges in balancing incentives for innovation with accessibility for patients. We assessed availability and prices of United States (US) Food and Drug Administration (FDA) orphan-designated drugs approved for treatment of leukemia in the US and England.  Methods: Regulatory information for leukemia drugs with FDA orphan designation was collected from the FDA, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. Generic and brand drug names, dosing, administration, and US pricing were collected from the Lexicomp online database. The National Institute for Health and Care Excellence database was then used to determine dosage and pricing for leukemia drugs in England. Prices were converted to cost per treatment or cost per year, as appropriate, to allow for comparison. Descriptive statistics, chi square, and paired t-test were used for the analysis.  Results: As of 31Dec2014, there were 38 active ingredients (28 chemical entities and 10 biologic) with a total of 43 orphan drug designations available in the US for treatment of leukemia, as compared to 29 drugs with 35 indications available in England (p< 0.003). A higher percentage of drugs had orphan designation in the US than in England (p< 0.001). Of the 6 drugs with orphan designation in both countries, ofatumumab (FDA approval in 2009; +53.0% more expensive in the US), dasatinib (2006; 72.4%), nilotinib (2007; 36.3%), and idelalisib (2007; 50.0%) were more expensive in the US. Two drugs, obinutuzumab (2013; -4.8%) and fludarabine (1990;-109.1%) were more expensive in England. The difference in prices was not statistically significant.  Conclusions: More orphan drug treatment options for patients with leukemia were available in the US, whereas England provides a smaller number of drugs typically at a lower price than the US. PSY26 COMPARISON OF SUGAMMADEX AND NEOSTIGMINE USE IN TERMS OF COST SAVINGS IN HOSPITALS IN TURKISH HEALTHCARE SETTING Tatar M 1, Tuna E 2, Senturk A 2, Alanoglu Z 3, Aypar U 1, Degirmenci S 4, Ulus P 5 1Hacettepe University, Ankara, Turkey, 2Polar Health Economics and Policy Consultancy, Ankara, Turkey, 3Ankara University Faculty of Medicine, Ankara, Turkey, 4Medicana International, Ankara, Turkey, 5Merck Sharp & Dohme Pharmaceuticals Turkey, Istanbul, Turkey .

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Objectives: Sugammadex and Neostigmine have been subject to several studies comparing their clinical and cost effectiveness. In settings where patients have full neuromuscular recovery (Train-of-four ratio ≥  0.9) prior to extubation, the economic impact of Sugammadex is related to a reduction in recovery and operating room (OR) staff times. In settings where full neuromuscular recovery is not verified, economic impact primarily derives from avoided complications of residual neuromuscular blockade. This study aimed to determine the potential cost impact of use of Sugammadex in Turkish hospitals.  Methods: A budget impact model for hospitals was adapted to the Turkish healthcare setting. The model compared Neostigmine and Sugammadex with different combinations with Rocuronium and Vecuronium and at different blockade levels. The clinical efficacy data relating to OR time and residual blockade occurrence and complications were compiled from clinical studies. The model was populated with cost data from the Ministry of Health (MoH) hospitals. The value of staff time was calculated from the salary data of MoH and the cost of the products were calculated from the Social Security Institution’s price tariff. The timeline of the model was one year.  Results: At the institutional level, the annual cost saving was 1,186TL if all patients had full neuromuscular recovery in the OR prior to extubation. When full neuromuscular recovery is not verified prior to extubation, 75,896.35TL cost saving from treatment of complications was estimated for Sugammadex versus Neostigmine.  Conclusions: Although cost of acquiring Sugammadex is considerably higher than Neostigmine, the cost offsets for hospitals might be substantial. Real world data are needed to understand economic outcomes in clinical practice as the magnitude of offsets depends on assumptions concerning the frequency and intensity with which events are clinically managed. PSY27 INCREMENTAL HEALTH CARE COST PRIOR TO AND POST FIRST DIAGNOSIS OF MYASTHENIA GRAVIS IN THE COMMERICALLY AGED INSURED SAMPLE Gordon B D , Noone J M , Blanchette C M , Zacherle E University of North Carolina at Charlotte, Charlotte, NC, USA .

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Objectives: Myasthenia Gravis (MG) is a rare autoimmune disorder affecting neuromuscular communication and voluntary muscle contraction. The disease is characterized by muscle weakness, exacerbated through movement and alleviated with periods of rest. Estimated US prevalence is 20/100,000 with an estimated annual health plan cost of $15,675. Among commercially insured MG patients we assessed characteristics and incremental increases in patient expenditure prior to and following first diagnosis.  Methods: To complete our study we used a large commercial claims database from 2010-2014. MG patients were identified using ICD-9 code 358.0 and were indexed at first diagnosis. MG patients were evaluated for 1 year (six months prior and 6 months post diagnosis) to assess clinical characteristics, costs and utilization. Bivariate statistics were used to assess differences between pre and post period costs and utilization.  Results: We identified 677 MG patients. On average male and female patients were of a similar age range. Pre to post period patient visits and costs were statistically significant (p =  < 0.01). MG patients experienced an incremental increase in total cost ($17,293 – $24,611, p= 0.01), in-patient cost ($12,868 – 20,601, p= 0.01), office visit cost ($3161 - $4336, p= 0.01), and pharmacy cost ($2294 - $3183, p= 0.01), from pre to post diagnosis. Patients diagnosed with MG also had a higher rate of office and pharmacy visits during the post period (12 - 13.83, p= 0.01 and 13.29 – 15.34, p= 0.01, respectively).  Conclusions: Among MG patients there was an incremental increase in utilization and cost between the 6 months prior to and 6 months post first diagnosis. This increase was in part due to drug therapy, but must include other clinical factors as the majority of the increase was in inpatient costs. Further investigation into comparative treatment pathways will hopefully lend insight into the best ways to improve patient quality of life while decreasing costs.