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males, 10% and 7% were children and females respectively. Majority of the males (79%) were between the ages of 15-35 years of age. On an average the direct cost incurred to treat the injured cases (103) was PKR13,000 excluding subsidy of at least PKR53,000. The total cost was PKR66,000 (USD805) and this cost shall be considered as minimum cost. CONCLUSIONS: Motorcycle accidents are incurring huge economic burden on society. The morbidity and mortality can be reduced by legislative action concerning helmet use, licensing and rigid enforcement of traffic laws. Rehabilitation services for the victims to get fully recovered may also be provided to reduce the future economic loss. PMS25 ECONOMIC EVALUATION OF PHARMACOLOGICAL THROMBOPROPHYLAXIS IN HIP SURGERY PATIENTS IN MEXICO Muciño-Ortega E, Gutiérrez-Colín CI, Galindo-Suárez RM Pfizer S.A. de C.V., Mexico City, Mexico
OBJECTIVES: Orthopedic surgery has been associated with significant risk of develop deep vein thrombosis (DVT). The objective of this study was to estimate the cost-effectiveness of thromboprophylaxis therapies for prevention of DVT associated in patients undergoing hip surgery from an institutional perspective (Mexican Social Security Institute, IMSS). METHODS: Economic and health consequences of thromboprophylaxis were assessed through a six-state Markov model (one-year time horizon, one-week cycles). Effectiveness measure was reduction in DVT (per 1000 patients). Effectiveness was estimated by local meta-analysis. Doses of alternatives compared were: warfarin (basecase, 5mg 30d); dalteparin (not listed in Mexican formulary, 5000 IU/day 30d); acenocoumarol (4 mg/day 30d); enoxaparin (40 mg/day 30d); nadroparin (5700 IU/day 30d) and unfractionated heparin (UFH) plus warfarin (10000 IU/day 10d⫹warfarin 5 mg/day 20d). No prophylaxis was assessed too. Resource use and unit costs were extracted from IMSS databases (dalteparin cost was provided by the manufacturer). Costs included outpatient and inpatient services, medication costs, imaging and laboratory tests. Univariate sensitivity analysis was performed. Acceptability curves were constructed. RESULTS: DVT cases per alternative were: warfarin 61 (CI 95% 60 – 62); dalteparin 33 (32–34); acenocoumarol 80 (78 – 82); enoxaparin 57 (56 –58); nadroparin 67 (66 – 68); no prophylaxis 212 (205–219) and UFH 229 (223–235). Per patient annual cost (2011 US$) were: warfarin $3071.34 ($3049.23- $3093.44); dalteparin $2,980.42 ($2958.14$3002.71); acenocoumarol $2966.93 ($2940.92–$2992.94); enoxaparin $3668.54 ($3631.18 –$3705.90); nadroparin $3291.15 ($3260.60 –$3321.70); no prophylaxis $3466.68 ($3407.63–$3525.73) and UFH $3356.00 ($3311.59 –$3400.41). Warfarin was dominated by dalteparin, Dalteparin is cost-saving, compared to enoxaparin, nadroparin, UFH and no prophylaxis. Regarding warfarin, ICER (per DVT case avoided) of enoxaparin and acenocoumarol resulted in $149.30 ($146.24-$152.36) and $5.49 ($5.38-5.61), respectively. Acceptability curves showed that results were robust. CONCLUSIONS: At IMSS, dalteparin would be a cost-saving or cost-effective therapy for thromboprophylaxis in patients undergoing hip surgery. PMS26 COST-EFFECTIVENESS OF DENOSUMAB VERSUS ORAL BISPHOSPHONATES IN THE UNITED STATES FOR POST-MENOPAUSAL OSTEOPOROSIS (PMO) Parthan A1, Deflin MM1, Yurgin N2, Huang J2, Taylor DC1 1 OptumInsight, Medford, MA, USA, 2Amgen, Inc., Thousand Oaks, CA, USA
OBJECTIVES: Cost-effectiveness of denosumab versus oral bisphosphonates in PMO from a US third party payer perspective was evaluated. METHODS: A lifetime cohort Markov model was developed with seven health states: well, hip fracture, vertebral fracture, other osteoporotic fracture, post hip fracture, post vertebral fracture, and dead. During each cycle, a patient could fracture, remain healthy, remain in a post fracture state or die. Relative fracture risk reduction, background fracture risks, mortality rates, utilities, medical and drug costs were derived using published sources. Expected costs and quality-adjusted life years (QALYs) were estimated for denosumab, risedronate, ibandronate, and generic alendronate in the overall PMO population and high risk subgroups: 1) 2 of the 3 risks i.e., ⬎70years-old, bone mineral density T-scoreⱕ-3.0 and prevalent vertebral fracture, and 2) ⱖ75 years-old. Costs and QALYs were discounted at 3% annually. Extensive sensitivity analyses were conducted. RESULTS: In the overall PMO population, total lifetime costs for alendronate, risedronate, denosumab, and ibandronate were $55,500, $58,200, $58,800 and $59,800, respectively. Total QALYs were 8.33, 8.33, 8.37 and 8.32, respectively. The incremental cost-effectiveness ratio (ICER) for denosumab versus generic alendronate was $103,000/QALY. Risedronate was dominated by alendronate and ibandronate was dominated by denosumab. In high risk subgroup (a), total costs for alendronate, denosumab, risedronate and ibandronate were $60,900, $62,200, $64,100 and $66,600, respectively. Total QALYs were 7.27, 7.32, 7.27 and 7.26, respectively. Denosumab had an ICER of $28,200/QALY versus generic alendronate and dominated all other strategies. Denosumab dominated all strategies in women ⱖ75 years. Results between denosumab and generic alendronate were most sensitive to the relative risk of hip fracture for denosumab and the cost of denosumab. CONCLUSIONS: In each PMO population examined, denosumab represented good value for money compared to branded bisphosphonates. Furthermore, denosumab was either cost-effective or dominant compared to generic alendronate in the high-risk subgroups. PMS27 THE COST-EFFECTIVENESS OF DENOSUMAB FOR THE PREVENTION OF OSTEOPOROTIC FRACTURES IN THE SETTING OF THE UNITED STATES Jiang Y1, Hay J2 1 USC School of Pharmacy, Los Angeles, CA, USA, 2University of Southern California, Los Angeles, CA, USA
OBJECTIVES: The study compares the cost-effectiveness of denosumab (Prolia®; Amgen, Thousand Oaks, CA) to generic alendronate in preventing osteoporotic fracture among elderly women in the US setting. METHODS: This study utilized the published literature, government data and organization websites to obtain model parameters and parameter ranges. It used a “backward induction model” to analyze incremental cost per quality adjusted life year (QALY) saved from a societal perspective. The model evaluated women from age 50 to 95, using 5 year time intervals for intermediate results. The willingness-to-pay cut-off threshold used was $150,000/QALY. One-way sensitivity analyses and probabilistic sensitivity analyses were conducted to examine the robustness of the findings. RESULTS: When it was assumed that a patient could suffer at most one hip fracture, the discounted cost of denosumab therapy was $15,797 more than alendronate therapy, and the increased QALY was 0.007. This leads to an incremental cost-effectiveness ratio (ICER) average estimate of $2,111,647. When a patient was assumed to have at most two hip fractures and potentially experience other fractures after the first hip fracture (e.g., fractures of the wrist, spine, etc.), denosumab therapy would average 0.013 more QALYs than alendronate therapy, and the ICER was estimated to be $1,176,275. One-way sensitivity analyses did not change the base case results substantially. Probabilistic sensitivity analyses suggested that the probabilities were very small of the ICER meeting conventional willingness-to-pay cut-off ratios in both one-hip-fracture-model and two-or more-fractures-models. CONCLUSIONS: In the base case, due to the high acquisition cost, denosumab was not found to be cost-effective for the prevention of osteoporotic fractures compared with generic alendronate. A large change in probability of hip fracture or probabilities of all fractures could make it cost-effective, but this would likely require new predictive tools or biomarkers to target denosumab therapy to very high-risk patients. PMS28 ECONOMIC EVALUATION OF THE USE OF ANTI TNF’S AND TOCILIZUMAB FOR THE TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) IN MEXICO Lechuga D1, Alva M1, Carlos F2 1 Roche Mexico, Mexico City, Mexico, 2R A C Salud Consultores S.A. de C.V., Mexico City, Mexico
OBJECTIVES: Juvenile Idiopathic Arthritis (JIA) is defined as arthritis (diagnosed by limitation in mobility, pain, pressure and local heat) in 1 or more joints for more than 6 weeks without an apparent etiology, prior to age 16 of age. In particular, the presentation systemic JIA (sJIA) is manifested clinically as chronic arthritis accompanied by intermittent fever, rash, anemia, hepatomegaly and/or splenomegaly and pericarditis and/or pleuritis, in both genders during all pediatric stages. To evaluate the cost-effectiveness of different biological therapies and identify which one is dominant for the treatment of sJIA in Mexico. METHODS: It was done an evaluation of cost-effectiveness of using Tocilizumab, Etanercept, Adalimumab, Infliximab and placebo as a treatment for sJIA in a model of decision time horizon of 12 weeks. Costs are expressed in US dollars. RESULTS: Tocilizumab demonstrated superior effectiveness in patients achieving 71.6% ACR Pedi 70, with a cost per patient of $ 2,022, followed by Etanercept, Infliximab and Adalimumab with 24.8% at a cost of $ 1,260, $ 2,621 and $ 2,760 respectively in the base case. The expected cost to achieve one patient reaching an ACR Pedi 70 was significantly lower with tocilizumab than with the rest of the alternatives. The decision to use Tocilizumab for the treatment of sJIA would reduce the cost of getting a patient to achieve an ACR Pedi 70 in almost half the cost per response ratio calculated for Etanercept and reducing this value by about three-quarters compared with the estimated cost with Infliximab or Adalimumab. The results show that Tocilizumab is cost-effective ($ 1,886) and the dominant alternative compared to Etanercept ($ 2,702), Infliximab ($ 11,898) and Adalimumab ($ 12,835). CONCLUSIONS: The costeffectiveness analysis showed that tocilizumab is cost-effective and is the dominant strategy over Infliximab, Adalimumab and Etanercept for the treatment of sJIA in Mexico. PMS29 COST-EFFECTIVENESS OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM, LIMITED FASCIECTOMY, AND PERCUTANEOUS NEEDLE FASCIOTOMY IN THE TREATMENT OF DUPUYTREN’S CONTRACTURE Malone DC, Armstrong EP University of Arizona, Tucson, AZ, USA
OBJECTIVES: To determine the cost-effectiveness of treating Dupuytren’s contracture with collagenase clostridium histolyticum (CCH), limited fasciectomy (LF), and percutaneous needle fasciotomy (PNF). METHODS: A Markov decision model was constructed based on published reports of effectiveness, adverse consequences, population-based preferences, and medical costs for the treatment of Dupuytren’s contracture – a debilitating condition of the hands. The study perspective was from that of a US payer, such as a commercial insurer. The Markov model classified patients as either experiencing 1) clinical success after treatment; 2) treatment failure –resulting in the need for revision procedures; 3) disease progression; or 4) death. The model used yearly cycles over a 30-year period and took into account recurrence rates and common side effects with each treatment. Clinical trials evaluating the efficacy of the three approaches to treatment defined clinical success inconsistently. As a consequence, the primary analysis assumed equal efficacy across the treatments. Probabilistic sensitivity analysis was conducted using a Monte Carlo simulation with distributions for efficacy, adverse events, and costs. A societal discount rate of 3% was used for both cost and effect. The results are presented in terms of cost per quality-adjusted life years (QALYs). RESULTS: The estimated mean (SD) costs over the 30-year period for CCH, LF, and PNF were $4,489 (418), $18,345 (294), and $14,970 (599), respectively. The number of QALYs for CCH
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was 14.10, 14.05 for LF, and 14.02 for PNF. Both LF and PNF were dominated by CCH. Sensitivity analysis confirmed the model was sensitive to changes in clinical efficacy. Cost-effectiveness acceptability curves indicated that CCH was most likely to be cost-effective across a wide range of willingness to pay, including values over $100,000 per QALY gained. CONCLUSIONS: CCH was less expensive and was associated with slightly more QALYs than LF and PNF for treatment of Dupuytren’s contracture. PMS30 COST-EFFECTIVENESS OF BISPHOSPHONATES IN REDUCING HIP FRACTURES IN THE UNITED STATES Toliver J1, Blanchette CM2 1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 2IMS Health Consulting Group, Alexandria, VA, USA
OBJECTIVES: The cost of hip fractures associated with osteoporosis have become a growing burden on the US health care system. Cost-effective treatments are needed to prevent hip fractures in postmenopausal women with osteoporosis and reduce the amount of resources consumed by these preventable events. The objective of this study was to develop a decision tree model to assess the cost-effectiveness of four treatment options: alendronate, risedronate, ibandronate and a “no treatment group” for the prevention of hip fractures. METHODS: A decision tree model was developed from the third-party payer perspective using published efficacy results from randomized controlled trials. Patients were assumed to have osteoporosis, aged ⱖ 65 years, be fully adherent and unable to change or discontinue medication therapy. The incidence of hip fracture was estimated from the literature. Medication costs were assigned from published wholesale acquisition costs (WAC) by First DataBank. The mean cost of hip fractures and all direct costs associated with 12-month post-fracture treatment were estimated from the literature. All costs were adjusted to 2011 dollars. RESULTS: Alendronate 70 mg once weekly dominated the “no treatment” and the ibandronate treatments. The risedonrate 35 mg to alendronate 70 mg incremental cost-effectiveness ratio (ICER) demonstrated that for every $469,553 spent one additional hip fracture would be avoided. These results were consistent throughout the one-way sensitivity analysis, which varied the cost per hip fracture and the efficacy of each medication. When the incidence of hip fracture was assumed to be 3.57%, risedronate also dominated the” no treatment” and ibandronate groups. CONCLUSIONS: Alendronate 70mg once weekly was dominate in preventing hip fractures compared to risedonrate, ibandronate and no treatment. The risedronate to alendronate ICER demonstrated that the cost to avoid one hip fracture was $469,553 – typically beyond most payers’ willingness to pay. PMS31 COST-EFFECTIVENESS ANALYSIS OF GOLIMUMAB FOR THE TREATMENT OF RHEUMATOID ARTHRITIS Desai RJ, Rao J, Biddle AK University of North Carolina, Chapel Hill, NC, USA
OBJECTIVES: Rheumatoid arthritis (RA) affects ⬃1.3 million Americans, accounting for 9 million physician visits and ⬎250,000 hospitalizations annually. Drug therapy is costly but essential. This study evaluates the cost-effectiveness of golimumab, a recently approved TNF-␣ inhibitor (TNF-I) compared with existing agents (infliximab, etanercept, adalimumab), when given in combination with methotrexate (MTX) from a third-party payer perspective. METHODS: A Markov model was constructed to follow a hypothetical cohort of 10,000 patients with active RA who received one of the four TNF-I and MTX across patient life-time. The primary effectiveness outcomes were the American College of Rheumatology (ACR)-20 response rates mapped to health assessment questionnaire-scores to derive qualityadjusted life-years (QALYs). ACR-20 rates were derived from a systematic review of efficacy trials. Long-term drug withdrawal rates were derived from observational studies. Data for drug, administration, monitoring, toxicity and RA-related direct costs were derived from the literature. Incremental costs (2011 US$) per QALY were compared between TNF-Is. One-way and probabilistic sensitivity analysis (PSA) techniques were employed to examine effects of various assumptions and parameter uncertainty. RESULTS: Golimumab⫹MTX generated the highest per-person QALYs (3.75 QALY), whereas infliximab⫹MTX strategy generated the least QALYs (3.57). Infliximab⫹MTX resulted in the least direct costs of $317,455 over the patient’s life-time compared to etanercept⫹MTX ($324,855), adalimumab⫹MTX ($323,503) and golimumab⫹MTX ($324,159). The base-case incremental cost-effectiveness ratios (ICERs) foretanercept⫹MTX, adalimuamab⫹MTX, and golimumab⫹MTXcompared to infliximab⫹MTX were $69,211, $44,465 and $38,255/ QALY, respectively. Golimumab⫹MTX dominated etanercept⫹MTX, while the ICER for golimumab⫹MTX vs adalimumab⫹MTX was $16,729/QALY. In one-way sensitivity analyses, these results were robust to a range of assumptions except for dosing of infliximab and long-term withdrawal rates. In the PSA, the probability of golimumab being cost-effective at the commonly accepted $50,000/QALY threshold was 0.29. CONCLUSIONS: Golimumab appears to be a cost-effective treatment option for RA compared to existing TNF-Is. PMS32 THE COST EFFECTIVENESS OF CELECOXIB VERSUS NSAIDSⴙPPI IN THE TREATMENT OF OSTEOARTHRITIS IN ALGERIA; AN UPDATE TO THE NICE MODEL USING DATA FROM THE CONDOR TRIAL Mould JF1, Meklati M2, Khris M3, Kherraf SA3 1 Pfizer, Inc., New York, NY, USA, 2Pfizer, Inc., Dubai Media City, Dubai, United Arab Emirates, 3 Pfizer, Inc., Oued Esmar, Oued Esmar, Algeria
OBJECTIVES: Nonsteroidal antiinflammatory drugs (NSAIDs) plus a proton pump inhibitor (PPI) are in widespread use for rheumatic diseases in Algeria, but can
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cause peptic ulcers and gastrointestinal bleeding and perforation. The National Institute for Health and Clinical Excellence (NICE) health economic model for assessing the cost-effectiveness of celecoxib compared to multiple NSAIDS⫹PPI in the treatment of osteoarthritis has been updated using new adverse event (AE) risks from the CONDOR trial. In light of this new information, this study aimed to evaluate the incremental cost-effectiveness ratio (ICER) of celecoxib compared to different NSAIDS ⫹PPI. METHODS: The NICE model was adapted for this study to update the relative risks of adverse events; using data from the CONDOR trial for patients above 65yrs. Patients could initiate treatment with celecoxib, NSAIDs (diclofenac, naproxen, ibuprofen) plus omeprazole. Conditional probabilities of the model were obtained from published clinical trials and effectiveness measure was the Quality-Adjusted life years gained (QALY). The analysis was conducted from the healthcare payer’s perspective. Resource use and costs were obtained from official Algerian databases. Probabilistic sensitivity analysis (PSA) was performed and acceptability curves were constructed. RESULTS: Celecoxib showed on the six-months period lower expected costs per patient (US$422.84) compared to naproxen⫹PPI (US$445.79) and ibuprofen⫹PPI (US$775.11). The lowest expected costs resulted for diclofenac⫹PPI (US$257.10). On the other hand, celecoxib was associated with higher effectiveness (0.398 QALYs), followed by ibuprofen⫹PPI (0.393 QALYs) and naproxen⫹PPI (0.392 QALYs). Likewise, celecoxib has an ICER of US$343.81 per QALY compared to diclofenac which is below 1 GDP per capita for Algeria (US$7,300). Acceptability curves showed the same results with a mean of 65.5% of certainty. CONCLUSIONS: (DISCUSSION): The results suggest that when new AE risks are used, celecoxib remains a cost-effective treatment for OA when compared to diclofenac plus a PPI and cost-saving when compared to naproxen⫹PPI or ibuprofen⫹PPI. PMS33 COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS OF VISCOSUPPLEMENTATION WITH ORTHOVISC™ (HYALURONAN) IN KNEE OSTEOARTHRITIS, FROM THE BRAZILIAN PRIVATE HEALTH CARE SYSTEM PERSPECTIVE Rezende MU1, Hernandez AJ1, Namba MM2, Fernandes RA3, Takemoto MLS3, Santos PML3, Repsold DM4, Silva RC4, Andrade PC4 1 University of São Paulo, São Paulo, SP, Brazil, 2Federal University of Paraná, Curitiba, PR, Brazil, 3ANOVA - Knowledge Translation, Rio de Janeiro, RJ, Brazil, 4Johnson & Johnson Medical Brasil, São Paulo, SP, Brazil
OBJECTIVES: Osteoarthritis is a major cause of musculoskeletal pain and inability to work. Evidence shows that clinical improvement after viscosupplementation (VS) is able to delaying the average time until total knee arthroplasty (TKA) indication. This study aimed to conduct cost-effectiveness and budget impact analysis (BIA) of viscosupplementation with Orthovisc™ (Hyaluronan) versus conservative treatment in Kellgren & Lawrence(K&L) grades II and III knee osteoarthritis (KOA) from the Brazilian private health care system perspective. METHODS: A 3-year time horizon Markov simulation model was developed to project costs and outcomes associated to KOA progression. Patients could start in ‘Orthovisc™ Treatment’ (conservative treatment ⫹ Orthovisc™) or ‘Conservative Treatment’ states and then transit (6-month cycle duration) in states ‘TKA’, ‘Post-operative’ and ‘Death’ according to transition probabilities extracted from systematic review. Only direct medical costs were considered and collected from Brazilian private official databases. Outcome was expressed as ‘avoided TKA procedure’. BIA was developed for a hypothetical private health insurance cohort of 10,000 patients over 50 years. Univariate sensitivity analyses were performed for main parameters. A 5% annual discount rate was applied for costs and benefits. RESULTS: For a hypothetical 1000 patient’s cohort in a 3-year time horizon, 34TKA were performed in Orthovisc™ group versus 164TKA in conservative treatment group, avoiding 130 TKA procedures. Total costs per group were 17,367,259BRL and 17,494,500BRL for Orthovisc™ and conservative treatment groups, respectively, with an incremental cost of -127,241BRL. Sensitivity analysis showed cost-saving results for years 2 and 3. BIA showed savings of 180,401BRL for the private health insurance and 99TKA avoided in a 3-year time horizon. CONCLUSIONS: Viscosupplementation treatment, based on a Markov simulation model using Orthovisc™ data, in K&L grades II and III KOA showed to be cost-saving regarding avoided TKA in a 3-year time horizon over conservative treatment at Brazilian private health care system, leading to reduction in costs and surgical procedures. PMS35 THE COST-EFFECTIVENESS OF PEGLOTICASE IN THE TREATMENT OF REFRACTORY CHRONIC GOUT Wang BCM1, Garrison L2 1 Adjility Health, New York, NY, USA, 2University of Washington Department of Pharmacy, Seattle, WA, USA
OBJECTIVES: Refractory Chronic Gout (RCG) affects approximately 4% of patients with gout. It is characterized by failure to achieve normal serum uric acid levels or adequately control gout signs and symptoms with xanthine oxidase inhibitors at the maximum medically appropriate dose, or by contraindication to the use of these drugs. Pegloticase was recently launched in the US for treatment of RCG. METHODS: We developed a two-part sequential model: 1) the first 6 months represented as a decision tree; and 2) the remaining years as separate empirical forecasts. We modeled the severity of RCG as a combination of flares/year and tophi status. We used data from two replicate, randomized, double-blind, placebo-controlled trials (C0405 and C0406), which were conducted between June 2006 and October 2007 in 56 rheumatology practices. The comparator group is placebo. To model disease progression, we employed a vector autoregression methodology to approximate Markov Chain transition probabilities. We estimated utility regressions from NHWS and use a blended cost of $2600/vial. RESULTS: For a 20-year time