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A Cost-Effectiveness Analysis of Biosimilar Infliximab (Inflectra®) For The Treatment of Psoriatic Arthritis In Nine European Countries
A540
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fractures, and it helps to restore the bone marrow density to normal levels. We assessed the cost-effectiveness of drug therapy to prevent osteoporotic fractures in postmenopausal women with osteopenia in Korea. Methods: A Markov cohort simulation was conducted for lifetime with a hypothetical cohort of postmenopausal women with osteopenia and without prior fractures. They were assumed to receive calcium/vitamin D supplements only (control arm) or drug therapy (i.e., raloxifene or risedronate) along with calcium/vitamin D (treatment arm) for 5 years. The Markov model includes fracture-specific and non-fracture specific health states (i.e. breast cancer and venous thromboembolism), and all-cause death. Published literature was used to determine the model parameters. Local data were used to estimate the baseline incidence rates of fracture in those with osteopenia and the costs associated with each health state. Results: From a societal perspective, the estimated incremental cost-effectiveness ratios (ICERs) for the base cases that had T-scores near the threshold of osteoporosis (i.e., -2.0 ~ -2.4) and began drug therapy at the age of 55, 60, or 65 years were $16,472, $6,741, and -$13,982 per quality-adjusted life year (QALY) gained, respectively. Sensitivity analyses for medication compliance, risk of death following vertebral fracture, and relaxing definition of osteopenia resulted in ICERs reached to $24,227 per QALY gained. Conclusions: ICERs for the base case and sensitivity analyses remained within the World Health Organization’s willingness-to-pay threshold, which is less than per-capita gross domestic product in Korea (about $25,700). Thus, we conclude that drug therapy for osteopenia would be a cost-effective intervention, and recommend that the Korean National Health Insurance consider expanding its coverage to include drug therapy for osteopenia. PMS54 Cost-Effectiveness Analysis of Once-Yearly Injection of Zoledronic Acid For The Treatment of Osteoporosis In Japan Moriwaki K1, Mouri M2, Hagino H3 1Kobe Pharmaceutical University, Kobe, Japan, 2Kanagawa Academy of Science and Technology, Kawasaki, Japan, 3Tottori University, Yonago, Japan
Objectives: The purpose of this study was to estimate the cost-effectiveness of once-yearly injection of zoledronate for the treatment of osteoporosis in Japan. Methods: A patient-level state transition model was developed to predict the outcome of patients with osteoporosis who have experienced a previous vertebral fracture. Efficacy of zoledronate was derived from the HORIZON-Pivotal Fracture Trial. Lifetime costs and quality-adjusted life years (QALYs) were estimated in the patients who received zoledronate plus basic treatment and those who received basic treatment alone. The incremental cost-effectiveness ratio (ICER) of zoledronate therapy compared to basic treatment alone was calculated. Results: For the patients 70 years with T-score of -2.0, -2.5, and -3.0, the ICER of zoledronate compared to basic treatment alone was estimated to be $57,721, $32,362, and $13,905 per QALY, respectively. Applying a societal willingness to pay (WTP) of $50,000 per QALY, the probability that zoledronate therapy become cost-effectiveness compared to basic treatment alone was estimated to be 30.6%, 88.5%, and 100% for patients with T-score of -2.0, -2.5, and -3.0, respectively. According to the results of scenario analyses, the ICERs of zoledronate in patients with T-score of -2.0 who had an additional clinical risk factor ranged from $18,752 to $39,439 per QALY and were below an equivalent WTP. Conclusions: Zoledronate for the treatment of osteoporosis in Japanese women with T-score of less than -2.5 who have experienced a previous vertebral fracture was cost-effective compared to basic treatment alone. In addition, for the patients with T-score of -2.0 who had an additional risk factor, zoledronate could also be cost-effective. These findings would aid clinical decision makings in the management of osteoporosis in Japan.
PMS55 Direct Costs, Work Productivity Loss, And Effectiveness of Treatment Of Rheumatoid Arthritis (RA) Patients Through A TreatTo-Target (T2T) Approach: A Real-World Administrative Database Analysis Princic N1, Chu B2, Skup M3, Kalabic J4, Garg V5 Health Analytics, Cambridge, MA, USA, 2Truven Health Analytics, Santa Barbara, CA, USA, 3AbbVie Inc., North Chicago, IL, USA, 4AbbVie Deutschland GmbH & Co, Ludwigshafen, Germany, 5AbbVie Inc, North Chicago, IL, USA
1Truven
Objectives: To compare direct healthcare costs, work productivity loss, and treatment effectiveness for RA patients treated with T2T compared to usual care in real-world. Methods: Patients ≥ 18 years old diagnosed with RA during January 2005-2014 were identified in MarketScan® U.S. claims databases. The index event was first use of a biologic and/or non-biologic disease-modifying antirheumatic drug > 6 months following diagnosis. Patients were continuously enrolled 6-months pre- and ≥ 12-months (baseline year) after index. A subset linked to the Health and Productivity Management database were identified for assessing work productivity loss. Patients were categorized as being treated with T2T if they had > 3 visits to a rheumatologist and achieved low disease activity (LDA) during the baseline year. LDA was estimated using a claims-based algorithm1. Healthcare costs, work productivity loss, and treatment effectiveness were measured over five post-baseline years among patients with T2T in their first year compared to a matched cohort with usual care. Results: Of 80,509 eligible patients, 10.4% (N= 8,333) were treated per T2T and 13.5% were followed for five years post-baseline. Over five years, compared to usual care, patients with T2T incurred $14,758 less in direct healthcare costs, had a significantly lower proportion of short-term disability claims (26.2% vs. 15.8%; p< 0.001), and significantly lower work hours lost/ month (mean 4.6 [SD= 12.5] vs. mean 2.2 [SD= 7.9]; p< 0.001). During each of the 5 post-baseline years, 43-45% of T2T patients achieved LDA which was significantly higher (p< 0.001) than for patients with usual care (28-32%). Cumulative time in LDA over five years was 1,220 days for the T2T cohort versus 1,087 days for the usual care cohort (p< 0.001). Conclusions: This analysis demonstrates that T2T is a cost-effective treatment strategy for RA
patients compared to usual care in a large national payer database. 1Curtis et al. Arthritis Res Ther, 2011, 13(5), R155 PMS56 Cost And Cost Per Responder In Spain of Adalimumab, Methotrexate And Apremilast In The Treatment of Methotrexate-Naïve Patients With Psoriatic Arthritis Morell A1, Ramírez E1, Llorente I1, García-Vicuña R1, Blasco AJ2 1Hospital Universitario de la Princesa, Madrid, Spain, 2Independent Researcher, Madrid, Spain
Objectives: A recently published study has evaluated the relative efficacy of adalimumab, apremilast and methotrexate, and their incremental cost per responder (CPR) in the treatment of methotrexate-naïve patients with psoriatic arthritis (PsA) in the United States of America. To the best of our knowledge, the CPRs of these treatments have not been estimated in Spain. This research aims to compare the cost and the CPRs of adalimumab, apremilast and methotrexate in methotrexatenaïve patients with PsA in Spain. Methods: The efficacy of the treatments (NNT for achieve a ≥ 20% improvement in American College of Rheumatology component scores, ACR20) was obtained from a Bayesian network meta-analysis of 3 phase 3 randomized controlled trials (RCT) previously published. The official Spanish prices were considered to calculate the drug costs. Drug costs (in terms of 2016 euros) for 16 weeks were determined based on the dosing regimens of the RCT, and annual costs based on the dosing regimens recommended in the summary of products characteristics. The incremental costs per ACR20 responder were estimated for each of the therapies. Results: The NNTs relative to placebo were 2.63 for adalimumab, 6.69 for apremilast, and 8.31 for methotrexate. The 16 week costs were € 3,628 for adalimumab, € 2,597 for apremilast, and € 5 for methotrexate. The 16 week incremental costs per ACR20 responder were € 9,542 for adalimumab, € 17,377 for apremilast, and € 38 for methotrexate. The annual costs are € 11,791 for adalimumab, € 8,430 for apremilast, and € 9.5-19 for methotrexate. In clinical practice, these costs may be different because of price changes (e.g., price negotiations with pharmaceutical companies) and changes in the dosing regimens used (e.g., dose tapering). Conclusions: According the official Spanish prices, the most efficient treatment (in terms of incremental cost per ACR20 responder) for methotrexate-naïve patients with PsA was methotrexate because of its low price, followed by adalimumab. PMS57 A Cost-Effectiveness Analysis of Biosimilar Infliximab (Inflectra ®) For The Treatment of Ankylosing Spondylitis In Nine European Countries Rencz F, Brodszky V, Péntek M, Gulacsi L, Baji P Corvinus University of Budapest, Budapest, Hungary
Objectives: Biosimilar infliximab (Inflectra®) has been approved by the European Medicines Agency for the treatment of severe active ankylosing spondylitis (AS) in adult patients since 2013. Currently in most European countries, the price of biosimilars is considerably lower compared to the reference product. We aim to compare cost-effectiveness of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab and biosimilar infliximab for the treatment of AS in nine European countries (Belgium, France, Germany, Hungary, Italy, the Netherlands, Spain, Sweden and the UK). Methods: A probabilistic Markov model was developed to compare the cost-effectiveness of selected biological treatment sequences to standard care or to other biological sequences in AS patients who have responded inadequately to conventional therapy. Model outcomes were based on the reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. The model included costs of drugs, monitoring, administration and hospitalisation from third-party payer perspective. A five-year time horizon was adopted, and both costs and benefits were discounted at country-specific discount rates. Results: The incremental cost-utility ratios (ICUR) of biosimilar infliximab versus standard care were as follows: € 34,977/QALY (Belgium), € 41,948/QALY (France), € 55,309/QALY (Germany), € 28,191/QALY (Hungary), € 33,454/QALY (Italy), € 34,437/QALY (the Netherlands), € 37,361/QALY (Spain), € 51,431/QALY (Sweden) and € 47,880/QALY (the UK). Compared to standard care, the originator infliximab was dominated by the biosimilar infliximab in all countries. The inclusion of additional biologicals to the treatment sequence resulted in higher cost-utility ratios. ICURs of biosimilar infliximab-etanercept-adalimumab sequence ranged from € 40,672/ QALY to € 79,678/QALY and between € 42,329/QALY and € 84,412/QALY for the biosimilar infliximab-certolizumab pegol-golimumab sequence. The results were the most sensitive to changes in the perspective of the analysis, utility weights and time horizon (10-year). Conclusions: Biosimilar infliximab is a cost-effective alternative to the originator product for the treatment of adults with severe active AS that may increase the affordability of, and thus the access to biological treatments in Europe.
PMS58 A Cost-Effectiveness Analysis of Biosimilar Infliximab (Inflectra®) For The Treatment of Psoriatic Arthritis In Nine European Countries Rencz F, Brodszky V, Péntek M, Gulacsi L, Baji P Corvinus University of Budapest, Budapest, Hungary
Objectives: Biosimilar infliximab (Inflectra®) has been approved by the European Medicines Agency for the treatment of active and progressive psoriatic arthritis (PsA) in adult patients since 2013. Currently in most European countries, the price of biosimilars is considerably lower compared to the reference product. We aim to compare cost-effectiveness of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab, ustekinumab and biosimilar infliximab for the treatment of PsA in nine European countries: Belgium, France, Germany, Hungary, Italy, the Netherlands, Spain, Sweden and the UK. Methods: The analysis was based on a probabilistic Markov model of selected biological treatment sequences
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compared to the standard care or to other biological sequences in patients with PsA with inadequate response to previous disease-modifying antirheumatic drug therapy. Transition probabilities between health states were derived from randomized controlled trials. The model included costs of drugs, monitoring, administration and hospitalisation from third-party payer perspective. A five-year time horizon was adopted, and both costs and benefits were discounted at country-specific discount rates. Results: The incremental cost-utility ratios (ICUR) of biosimilar infliximab-standard care treatment sequence versus standard care were as follows: € 50,103/QALY (Belgium), € 60,141/QALY (France), € 79,730/QALY (Germany), € 40,897/ QALY (Hungary), € 48,059/QALY (Italy), € 49,212/QALY (the Netherlands), € 53,602/QALY (Spain), € 74,773/QALY (Sweden) and € 68,697/QALY (the UK). Compared to standard care, the originator infliximab was dominated by biosimilar infliximab in all countries. The inclusion of additional biologicals to the treatment sequence resulted in higher cost-utility ratios. ICURs of biosimilar infliximab-secukinumab-etanercept sequence ranged from € 54,946/QALY to € 104,113/QALY and between € 67,487/QALY and € 121,203/QALY for the biosimilar infliximab-ustekinumab-certolizumab pegol sequence. The results were the most sensitive to changes in the perspective of the analysis, utility weights and time horizon (10-year). Conclusions: Biosimilar infliximab is a cost-effective alternative to the originator product for the treatment of adults with PsA that may increase the affordability of, and thus the access to biological treatments in Europe. PMS59 Cost-Utility of Denosumab For The Treatment of Postmenopausal Osteoporosis In Colombia
A541
Objectives: To evaluate the trajectory of productivity loss in patients diagnosed with lumbar disc herniation or spinal stenosis before and after surgery. Methods: Patients who underwent surgery for spinal stenosis or lumbar disc herniation during 2000–2012 were identified from the national spine surgery register “Swespine”. Additional data were extracted from Swedish registries including the National Patient Register and the Social Security Agency register. Productivity loss was measured as the sum of days with sick insurance benefits multiplied with the proportion of the patient’s working time covered by a benefit. The main diagnosis registered at surgery was used in the analysis. Patients were followed for two years before and two years after surgery and were only included if in working age (19–64 years). Results: 18,315 patients who underwent surgery for lumbar disc herniation, and 11,511 patients who underwent surgery for spinal stenosis were identified for inclusion. In patients operated for disc herniation, productivity loss gradually increased during the year leading up to surgery, peaking at the first month post-surgery at almost full time work absence (25.3 days/month), and then gradually decreased. Mean days of productivity loss per month two years and year one before surgery was 5.2 and 9.4 days respectively, and 11.4 year one and 6.8 days year two post-surgery. Patients operated for spinal stenosis had a similar trajectory in productivity loss in relation to surgery, with a peak at the first month post-op (27.5 days/month). In this group, mean productivity loss/month was 12.0 year two and 15.4 year one pre-op, and 17.3 year one and 12.5 year two post-surgery. Conclusions: Productivity loss after lumbar surgery returned to a level similar to the level two years before surgery. The trajectory was similar across the diagnosis groups, although the loss in spinal stenosis patients was higher over the four year time period.
Garcia Perlaza J1, Arocho R2 1AMGEN, Bogotá, Colombia, 2Amgen, Inc., Barcelona, Spain
Objectives: Postmenopausal osteoporosis (PMO) is a disease that reduces the bone density and bone quality increasing the risk of fractures that causes disability. As such, PMO places a significant burden on health care resources. Our objective is to assess the cost utility of Denosumab vs intravenous (IV) bisphosphonates when used for the treatment of women with PMO from the perspective of Colombian health system. Methods: A lifetimeMarkov model with 8 health states was developed to assess the cost-utility of denosumab 60 mg SQ every 6 months versus zolendronate 5mg IV every 12 months and ibandronate 150mg IV every 3 months in women > 72 years with a T-score > -2.5. Efficacy, resource use and treatment patterns were obtained from the literature. Direct medical cost included drug administration, hospitalization, outpatient costs, diagnostic tests, and treatment of adverse events. For all procedures, Social Security tariff (ISS+30%) were applied; and SISMED 2015 prices for drugs costs. Costs and benefits are discounted 5% per year. A probabilistic sensitivity analysis was performed for efficacy, safety, persistence, utilities and long-term care variables Results: In the base case scenario, the estimated total cost of PMO treatment was 13,695,881$COP, 13,561,562$COP, 14,248,093$COP for denosumab, zolendronate, and ibandronate IV respectively. While the estimated QALY’s gain were 7.479 for denosumab, 7.466 for zolendronate, and 7.43 for ibandronate. The estimated denosumab incremental cost-effectiveness ratio (ICER) vs zolendronate was 9,650,071$COP/QALY. Denosumab was dominant vs ibandronate. Sensitivity analyses confirmed the robustness of these findings. Conclusions: Denosumab use in the treatment of PMO in Colombia is likely to be a cost-effective alternative to zolendronate IV with an ICER less than 1 GDP per capita. Denosumab is also likely to be a cost-saving alternative to ibandronate IV. PMS60 Cost-Utility Analysis Of Injecting A “Dexamethasone Ropivacaine” Mixture Subcutaneously In The Management of Traumatic Bone Surgeries of The Forefoot Dalifard B1, Chauvet P2, Nebout J1, Dos Remedios C1, Robillard B3, Tilleul P4 Rochelle Hospital, la rochelle, France, 2Nantes Hospital University, nantes, France, 3Jules Verne Clinic, Nantes, France, 4Hospital Pitie-Salpetriere, Paris, France
1La
Objectives: According to the National Health Authority [NHA], “ambulatory surgery remains underdeveloped in France: about 40% of surgical interventions vs 80% in the US”. In this context, the team of the orthopaedic department of Hospital Group [GH] of La Rochelle has developed a peri-scar intra-operative injection protocol of ropivacaine and dexamethasone. This injection with analgesic aim seeks a faster and less painful post-operative support of traumatic bone surgeries of the forefoot. Using before and after cost-utility analysis, this work proposes to determine the most efficient strategy from hospital perspective, by linking consumption of resources and control of post-operative pain as main clinical outcome. Methods: Our work is an observational study with two arms (before any treatment vs periscar intra-operative injection of ropivacaine and dexamethasone protocol) without randomization groups. Comparative statistical analysis has done. The assessment of post-operative pain has been extracted from the patient records. The utility values were extracted from a pain/utility value mapping from the literature. Costs are derived from the readjusted NSCMC (National Study of Common Methodology Costs) scale. Results: After 28 months of collection, the control group consisted of 51 patients and the study population of 30 patients. Implementation of the new protocol means a significant reduction in pain (Mann-Whitney-Wilcoxon test and Fisher exact test) and, in parallel, an increase in the utility score of 0.025 units in the population treated by post-operative injection. The decrease in costs is € 59.5. This represents around € 430,000 saved by QALY gained. The studied strategy is therefore dominant: less costly and more efficient. Conclusions: The protocol appears dominant in clinical and economical terms. PMS61 Productivity Loss In Patients Diagnosed With Spinal Stenosis And Lumbar Disc Herniation Jonsson E1, Olafsson G1, Fritzell P2, Hägg O3, Borgström F1 Research, Stockholm, Sweden, 2Capio St Göran Hospital, Stockholm, Sweden, 3Spine Center Göteborg, Gothenburg, Sweden 1Quantify
PMS62 The Association Between Disability And Early Exit From Work In Osteoarthritis Laires PA1, Canhão H2, Rodrigues A2, Eusébio M2, Gouveia M3, Branco JC2 de Medicina da Universidade de Lisboa, Lisbon Academic Medical Center, Lisbon, Portugal, Lisbon, Portugal, 2Sociedade Portuguesa de Reumatologia, Lisbon, Portugal, 3Católica Lisbon School of Business and Economics, Lisbon, Portugal
1Faculdade
Objectives: To describe the association between physical disability and early exit from work in patients with clinically confirmed knee osteoarthritis (OA). Methods: We analyzed data from the population-based EpiReumaPt study (Sep2011-Dec2013). 10,661 inhabitants were surveyed to capture all cases of rheumatic diseases within a representative sample of the population. We analyzed all participants aged 50-64, near the official retirement age and all knee OA cases were clinically validated, according to the ACR classification criteria. Disability was measured according with the Health Assessment Questionnaire (HAQ) with score of 0-3, 0 meaning no loss of physical function and 3 full disability. The association of disability and early exit from work was tested using individual level logistic regression. Results: The Portuguese population aged between 50 and 64 who were out of paid work (51.8%) had a knee OA prevalence of 18.6% (women: 26.0%; men: 11.5%) and worst average HAQ score compared with those employed (0.47 vs. 0.28, respectively. p= 0.0002). knee OA patients with higher levels of disability, measured by HAQ (scores ≥ 2) are at the greatest risk of early exit from work (80.7% vs. 67.4% for all knee OA population and 51.2% for those with HAQ scores ≥ 2 but without knee OA). We estimated an almost linear relationship between levels of disability and the probability of early exit from work, with its y-intercept increasing with the presence of knee OA. This association was independent from other relevant factors, such as age, comorbidities, education and household income (OR: 1.50; CI: 1.04-2.16; p= 0.03). Conclusions: We observed an overall significant association between physical disability and premature withdrawal from employment. In particular, knee OA patients with higher levels of disability were at the highest risk of leaving the labor market. Decision makers should prioritize investments in policies targeting patients with disabling OA.
PMS63 Economic Burden of Ankylosing Spondylitis In Europe. A Systematic Review of The Literature Blanch C1, Comellas M2, Prada C2, Lizan L2 Pharmaceuticals, Barcelona, Spain, 2Outcomes 10, Universitat Jaume I, Castellon, Spain
1Novartis
Objectives: To appraise the literature referred to direct and indirect costs of ankylosing spondylitis (AS) in Europe. Methods: A systematic review of the literature was performed. Electronic databases [MedLine/PubMed, Cochrane Library, ISI Wok, DARE, NHSEED, HTA] and Google Scholar were searched to identify publications regarding direct and indirect costs of AS in Europe. Bibliographic references were hand searched. European studies published in English or Spanish until May 2015 were selected. Editorials, letters, commentaries, opinion papers, congress proceedings and studies related to specific treatments were excluded. Costs were updated to € ,2015. Results: Ten studies were reviewed (n= 2 systematic reviews, n= 1 costeffectiveness, n= 5 cross-sectional and n= 2 retrospective observational studies). Half of them (n= 5) evaluated AS cost from patient perspective. The main component of the the cost from societal perspective was the indirect cost (53.4%-62%). AS severity increased 2 times the direct cost and 4 times the indirect cost. The total cost increased 18.4 times from BASFI= 1 to BASFI= 10, and 1.6 times form BASDAI= 1 to BASDAI= 10. Absenteeism rates varied from 11% to 16%, and presentism from 19% to 33%. Disease activity (OR= 3,24; OR= 3,97) and depression (OR= 3,22; OR= 5,69) were predictors of absenteeism and presentism, while anxiety (OR= 3,90) and patients’ age (OR= 1,04 per year) were associated with presentism. Conclusions: Although costs estimations related to AS varied across European countries, the results showed that economic burden of AS in Europe is substantial, being the indirect cost due to productivity loss the main components of total cost. Worse physical function and higher disease activity were the main determinants of total costs. Disease activity and depression were associated with absenteeism and presentism.
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fractures, and it helps to restore the bone marrow density to normal levels. We assessed the cost-effectiveness of drug therapy to prevent osteoporotic fractures in postmenopausal women with osteopenia in Korea. Methods: A Markov cohort simulation was conducted for lifetime with a hypothetical cohort of postmenopausal women with osteopenia and without prior fractures. They were assumed to receive calcium/vitamin D supplements only (control arm) or drug therapy (i.e., raloxifene or risedronate) along with calcium/vitamin D (treatment arm) for 5 years. The Markov model includes fracture-specific and non-fracture specific health states (i.e. breast cancer and venous thromboembolism), and all-cause death. Published literature was used to determine the model parameters. Local data were used to estimate the baseline incidence rates of fracture in those with osteopenia and the costs associated with each health state. Results: From a societal perspective, the estimated incremental cost-effectiveness ratios (ICERs) for the base cases that had T-scores near the threshold of osteoporosis (i.e., -2.0 ~ -2.4) and began drug therapy at the age of 55, 60, or 65 years were $16,472, $6,741, and -$13,982 per quality-adjusted life year (QALY) gained, respectively. Sensitivity analyses for medication compliance, risk of death following vertebral fracture, and relaxing definition of osteopenia resulted in ICERs reached to $24,227 per QALY gained. Conclusions: ICERs for the base case and sensitivity analyses remained within the World Health Organization’s willingness-to-pay threshold, which is less than per-capita gross domestic product in Korea (about $25,700). Thus, we conclude that drug therapy for osteopenia would be a cost-effective intervention, and recommend that the Korean National Health Insurance consider expanding its coverage to include drug therapy for osteopenia. PMS54 Cost-Effectiveness Analysis of Once-Yearly Injection of Zoledronic Acid For The Treatment of Osteoporosis In Japan Moriwaki K1, Mouri M2, Hagino H3 1Kobe Pharmaceutical University, Kobe, Japan, 2Kanagawa Academy of Science and Technology, Kawasaki, Japan, 3Tottori University, Yonago, Japan
Objectives: The purpose of this study was to estimate the cost-effectiveness of once-yearly injection of zoledronate for the treatment of osteoporosis in Japan. Methods: A patient-level state transition model was developed to predict the outcome of patients with osteoporosis who have experienced a previous vertebral fracture. Efficacy of zoledronate was derived from the HORIZON-Pivotal Fracture Trial. Lifetime costs and quality-adjusted life years (QALYs) were estimated in the patients who received zoledronate plus basic treatment and those who received basic treatment alone. The incremental cost-effectiveness ratio (ICER) of zoledronate therapy compared to basic treatment alone was calculated. Results: For the patients 70 years with T-score of -2.0, -2.5, and -3.0, the ICER of zoledronate compared to basic treatment alone was estimated to be $57,721, $32,362, and $13,905 per QALY, respectively. Applying a societal willingness to pay (WTP) of $50,000 per QALY, the probability that zoledronate therapy become cost-effectiveness compared to basic treatment alone was estimated to be 30.6%, 88.5%, and 100% for patients with T-score of -2.0, -2.5, and -3.0, respectively. According to the results of scenario analyses, the ICERs of zoledronate in patients with T-score of -2.0 who had an additional clinical risk factor ranged from $18,752 to $39,439 per QALY and were below an equivalent WTP. Conclusions: Zoledronate for the treatment of osteoporosis in Japanese women with T-score of less than -2.5 who have experienced a previous vertebral fracture was cost-effective compared to basic treatment alone. In addition, for the patients with T-score of -2.0 who had an additional risk factor, zoledronate could also be cost-effective. These findings would aid clinical decision makings in the management of osteoporosis in Japan.
PMS55 Direct Costs, Work Productivity Loss, And Effectiveness of Treatment Of Rheumatoid Arthritis (RA) Patients Through A TreatTo-Target (T2T) Approach: A Real-World Administrative Database Analysis Princic N1, Chu B2, Skup M3, Kalabic J4, Garg V5 Health Analytics, Cambridge, MA, USA, 2Truven Health Analytics, Santa Barbara, CA, USA, 3AbbVie Inc., North Chicago, IL, USA, 4AbbVie Deutschland GmbH & Co, Ludwigshafen, Germany, 5AbbVie Inc, North Chicago, IL, USA
1Truven
Objectives: To compare direct healthcare costs, work productivity loss, and treatment effectiveness for RA patients treated with T2T compared to usual care in real-world. Methods: Patients ≥ 18 years old diagnosed with RA during January 2005-2014 were identified in MarketScan® U.S. claims databases. The index event was first use of a biologic and/or non-biologic disease-modifying antirheumatic drug > 6 months following diagnosis. Patients were continuously enrolled 6-months pre- and ≥ 12-months (baseline year) after index. A subset linked to the Health and Productivity Management database were identified for assessing work productivity loss. Patients were categorized as being treated with T2T if they had > 3 visits to a rheumatologist and achieved low disease activity (LDA) during the baseline year. LDA was estimated using a claims-based algorithm1. Healthcare costs, work productivity loss, and treatment effectiveness were measured over five post-baseline years among patients with T2T in their first year compared to a matched cohort with usual care. Results: Of 80,509 eligible patients, 10.4% (N= 8,333) were treated per T2T and 13.5% were followed for five years post-baseline. Over five years, compared to usual care, patients with T2T incurred $14,758 less in direct healthcare costs, had a significantly lower proportion of short-term disability claims (26.2% vs. 15.8%; p< 0.001), and significantly lower work hours lost/ month (mean 4.6 [SD= 12.5] vs. mean 2.2 [SD= 7.9]; p< 0.001). During each of the 5 post-baseline years, 43-45% of T2T patients achieved LDA which was significantly higher (p< 0.001) than for patients with usual care (28-32%). Cumulative time in LDA over five years was 1,220 days for the T2T cohort versus 1,087 days for the usual care cohort (p< 0.001). Conclusions: This analysis demonstrates that T2T is a cost-effective treatment strategy for RA
patients compared to usual care in a large national payer database. 1Curtis et al. Arthritis Res Ther, 2011, 13(5), R155 PMS56 Cost And Cost Per Responder In Spain of Adalimumab, Methotrexate And Apremilast In The Treatment of Methotrexate-Naïve Patients With Psoriatic Arthritis Morell A1, Ramírez E1, Llorente I1, García-Vicuña R1, Blasco AJ2 1Hospital Universitario de la Princesa, Madrid, Spain, 2Independent Researcher, Madrid, Spain
Objectives: A recently published study has evaluated the relative efficacy of adalimumab, apremilast and methotrexate, and their incremental cost per responder (CPR) in the treatment of methotrexate-naïve patients with psoriatic arthritis (PsA) in the United States of America. To the best of our knowledge, the CPRs of these treatments have not been estimated in Spain. This research aims to compare the cost and the CPRs of adalimumab, apremilast and methotrexate in methotrexatenaïve patients with PsA in Spain. Methods: The efficacy of the treatments (NNT for achieve a ≥ 20% improvement in American College of Rheumatology component scores, ACR20) was obtained from a Bayesian network meta-analysis of 3 phase 3 randomized controlled trials (RCT) previously published. The official Spanish prices were considered to calculate the drug costs. Drug costs (in terms of 2016 euros) for 16 weeks were determined based on the dosing regimens of the RCT, and annual costs based on the dosing regimens recommended in the summary of products characteristics. The incremental costs per ACR20 responder were estimated for each of the therapies. Results: The NNTs relative to placebo were 2.63 for adalimumab, 6.69 for apremilast, and 8.31 for methotrexate. The 16 week costs were € 3,628 for adalimumab, € 2,597 for apremilast, and € 5 for methotrexate. The 16 week incremental costs per ACR20 responder were € 9,542 for adalimumab, € 17,377 for apremilast, and € 38 for methotrexate. The annual costs are € 11,791 for adalimumab, € 8,430 for apremilast, and € 9.5-19 for methotrexate. In clinical practice, these costs may be different because of price changes (e.g., price negotiations with pharmaceutical companies) and changes in the dosing regimens used (e.g., dose tapering). Conclusions: According the official Spanish prices, the most efficient treatment (in terms of incremental cost per ACR20 responder) for methotrexate-naïve patients with PsA was methotrexate because of its low price, followed by adalimumab. PMS57 A Cost-Effectiveness Analysis of Biosimilar Infliximab (Inflectra ®) For The Treatment of Ankylosing Spondylitis In Nine European Countries Rencz F, Brodszky V, Péntek M, Gulacsi L, Baji P Corvinus University of Budapest, Budapest, Hungary
Objectives: Biosimilar infliximab (Inflectra®) has been approved by the European Medicines Agency for the treatment of severe active ankylosing spondylitis (AS) in adult patients since 2013. Currently in most European countries, the price of biosimilars is considerably lower compared to the reference product. We aim to compare cost-effectiveness of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab and biosimilar infliximab for the treatment of AS in nine European countries (Belgium, France, Germany, Hungary, Italy, the Netherlands, Spain, Sweden and the UK). Methods: A probabilistic Markov model was developed to compare the cost-effectiveness of selected biological treatment sequences to standard care or to other biological sequences in AS patients who have responded inadequately to conventional therapy. Model outcomes were based on the reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. The model included costs of drugs, monitoring, administration and hospitalisation from third-party payer perspective. A five-year time horizon was adopted, and both costs and benefits were discounted at country-specific discount rates. Results: The incremental cost-utility ratios (ICUR) of biosimilar infliximab versus standard care were as follows: € 34,977/QALY (Belgium), € 41,948/QALY (France), € 55,309/QALY (Germany), € 28,191/QALY (Hungary), € 33,454/QALY (Italy), € 34,437/QALY (the Netherlands), € 37,361/QALY (Spain), € 51,431/QALY (Sweden) and € 47,880/QALY (the UK). Compared to standard care, the originator infliximab was dominated by the biosimilar infliximab in all countries. The inclusion of additional biologicals to the treatment sequence resulted in higher cost-utility ratios. ICURs of biosimilar infliximab-etanercept-adalimumab sequence ranged from € 40,672/ QALY to € 79,678/QALY and between € 42,329/QALY and € 84,412/QALY for the biosimilar infliximab-certolizumab pegol-golimumab sequence. The results were the most sensitive to changes in the perspective of the analysis, utility weights and time horizon (10-year). Conclusions: Biosimilar infliximab is a cost-effective alternative to the originator product for the treatment of adults with severe active AS that may increase the affordability of, and thus the access to biological treatments in Europe.
PMS58 A Cost-Effectiveness Analysis of Biosimilar Infliximab (Inflectra®) For The Treatment of Psoriatic Arthritis In Nine European Countries Rencz F, Brodszky V, Péntek M, Gulacsi L, Baji P Corvinus University of Budapest, Budapest, Hungary
Objectives: Biosimilar infliximab (Inflectra®) has been approved by the European Medicines Agency for the treatment of active and progressive psoriatic arthritis (PsA) in adult patients since 2013. Currently in most European countries, the price of biosimilars is considerably lower compared to the reference product. We aim to compare cost-effectiveness of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab, ustekinumab and biosimilar infliximab for the treatment of PsA in nine European countries: Belgium, France, Germany, Hungary, Italy, the Netherlands, Spain, Sweden and the UK. Methods: The analysis was based on a probabilistic Markov model of selected biological treatment sequences
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
compared to the standard care or to other biological sequences in patients with PsA with inadequate response to previous disease-modifying antirheumatic drug therapy. Transition probabilities between health states were derived from randomized controlled trials. The model included costs of drugs, monitoring, administration and hospitalisation from third-party payer perspective. A five-year time horizon was adopted, and both costs and benefits were discounted at country-specific discount rates. Results: The incremental cost-utility ratios (ICUR) of biosimilar infliximab-standard care treatment sequence versus standard care were as follows: € 50,103/QALY (Belgium), € 60,141/QALY (France), € 79,730/QALY (Germany), € 40,897/ QALY (Hungary), € 48,059/QALY (Italy), € 49,212/QALY (the Netherlands), € 53,602/QALY (Spain), € 74,773/QALY (Sweden) and € 68,697/QALY (the UK). Compared to standard care, the originator infliximab was dominated by biosimilar infliximab in all countries. The inclusion of additional biologicals to the treatment sequence resulted in higher cost-utility ratios. ICURs of biosimilar infliximab-secukinumab-etanercept sequence ranged from € 54,946/QALY to € 104,113/QALY and between € 67,487/QALY and € 121,203/QALY for the biosimilar infliximab-ustekinumab-certolizumab pegol sequence. The results were the most sensitive to changes in the perspective of the analysis, utility weights and time horizon (10-year). Conclusions: Biosimilar infliximab is a cost-effective alternative to the originator product for the treatment of adults with PsA that may increase the affordability of, and thus the access to biological treatments in Europe. PMS59 Cost-Utility of Denosumab For The Treatment of Postmenopausal Osteoporosis In Colombia
A541
Objectives: To evaluate the trajectory of productivity loss in patients diagnosed with lumbar disc herniation or spinal stenosis before and after surgery. Methods: Patients who underwent surgery for spinal stenosis or lumbar disc herniation during 2000–2012 were identified from the national spine surgery register “Swespine”. Additional data were extracted from Swedish registries including the National Patient Register and the Social Security Agency register. Productivity loss was measured as the sum of days with sick insurance benefits multiplied with the proportion of the patient’s working time covered by a benefit. The main diagnosis registered at surgery was used in the analysis. Patients were followed for two years before and two years after surgery and were only included if in working age (19–64 years). Results: 18,315 patients who underwent surgery for lumbar disc herniation, and 11,511 patients who underwent surgery for spinal stenosis were identified for inclusion. In patients operated for disc herniation, productivity loss gradually increased during the year leading up to surgery, peaking at the first month post-surgery at almost full time work absence (25.3 days/month), and then gradually decreased. Mean days of productivity loss per month two years and year one before surgery was 5.2 and 9.4 days respectively, and 11.4 year one and 6.8 days year two post-surgery. Patients operated for spinal stenosis had a similar trajectory in productivity loss in relation to surgery, with a peak at the first month post-op (27.5 days/month). In this group, mean productivity loss/month was 12.0 year two and 15.4 year one pre-op, and 17.3 year one and 12.5 year two post-surgery. Conclusions: Productivity loss after lumbar surgery returned to a level similar to the level two years before surgery. The trajectory was similar across the diagnosis groups, although the loss in spinal stenosis patients was higher over the four year time period.
Garcia Perlaza J1, Arocho R2 1AMGEN, Bogotá, Colombia, 2Amgen, Inc., Barcelona, Spain
Objectives: Postmenopausal osteoporosis (PMO) is a disease that reduces the bone density and bone quality increasing the risk of fractures that causes disability. As such, PMO places a significant burden on health care resources. Our objective is to assess the cost utility of Denosumab vs intravenous (IV) bisphosphonates when used for the treatment of women with PMO from the perspective of Colombian health system. Methods: A lifetimeMarkov model with 8 health states was developed to assess the cost-utility of denosumab 60 mg SQ every 6 months versus zolendronate 5mg IV every 12 months and ibandronate 150mg IV every 3 months in women > 72 years with a T-score > -2.5. Efficacy, resource use and treatment patterns were obtained from the literature. Direct medical cost included drug administration, hospitalization, outpatient costs, diagnostic tests, and treatment of adverse events. For all procedures, Social Security tariff (ISS+30%) were applied; and SISMED 2015 prices for drugs costs. Costs and benefits are discounted 5% per year. A probabilistic sensitivity analysis was performed for efficacy, safety, persistence, utilities and long-term care variables Results: In the base case scenario, the estimated total cost of PMO treatment was 13,695,881$COP, 13,561,562$COP, 14,248,093$COP for denosumab, zolendronate, and ibandronate IV respectively. While the estimated QALY’s gain were 7.479 for denosumab, 7.466 for zolendronate, and 7.43 for ibandronate. The estimated denosumab incremental cost-effectiveness ratio (ICER) vs zolendronate was 9,650,071$COP/QALY. Denosumab was dominant vs ibandronate. Sensitivity analyses confirmed the robustness of these findings. Conclusions: Denosumab use in the treatment of PMO in Colombia is likely to be a cost-effective alternative to zolendronate IV with an ICER less than 1 GDP per capita. Denosumab is also likely to be a cost-saving alternative to ibandronate IV. PMS60 Cost-Utility Analysis Of Injecting A “Dexamethasone Ropivacaine” Mixture Subcutaneously In The Management of Traumatic Bone Surgeries of The Forefoot Dalifard B1, Chauvet P2, Nebout J1, Dos Remedios C1, Robillard B3, Tilleul P4 Rochelle Hospital, la rochelle, France, 2Nantes Hospital University, nantes, France, 3Jules Verne Clinic, Nantes, France, 4Hospital Pitie-Salpetriere, Paris, France
1La
Objectives: According to the National Health Authority [NHA], “ambulatory surgery remains underdeveloped in France: about 40% of surgical interventions vs 80% in the US”. In this context, the team of the orthopaedic department of Hospital Group [GH] of La Rochelle has developed a peri-scar intra-operative injection protocol of ropivacaine and dexamethasone. This injection with analgesic aim seeks a faster and less painful post-operative support of traumatic bone surgeries of the forefoot. Using before and after cost-utility analysis, this work proposes to determine the most efficient strategy from hospital perspective, by linking consumption of resources and control of post-operative pain as main clinical outcome. Methods: Our work is an observational study with two arms (before any treatment vs periscar intra-operative injection of ropivacaine and dexamethasone protocol) without randomization groups. Comparative statistical analysis has done. The assessment of post-operative pain has been extracted from the patient records. The utility values were extracted from a pain/utility value mapping from the literature. Costs are derived from the readjusted NSCMC (National Study of Common Methodology Costs) scale. Results: After 28 months of collection, the control group consisted of 51 patients and the study population of 30 patients. Implementation of the new protocol means a significant reduction in pain (Mann-Whitney-Wilcoxon test and Fisher exact test) and, in parallel, an increase in the utility score of 0.025 units in the population treated by post-operative injection. The decrease in costs is € 59.5. This represents around € 430,000 saved by QALY gained. The studied strategy is therefore dominant: less costly and more efficient. Conclusions: The protocol appears dominant in clinical and economical terms. PMS61 Productivity Loss In Patients Diagnosed With Spinal Stenosis And Lumbar Disc Herniation Jonsson E1, Olafsson G1, Fritzell P2, Hägg O3, Borgström F1 Research, Stockholm, Sweden, 2Capio St Göran Hospital, Stockholm, Sweden, 3Spine Center Göteborg, Gothenburg, Sweden 1Quantify
PMS62 The Association Between Disability And Early Exit From Work In Osteoarthritis Laires PA1, Canhão H2, Rodrigues A2, Eusébio M2, Gouveia M3, Branco JC2 de Medicina da Universidade de Lisboa, Lisbon Academic Medical Center, Lisbon, Portugal, Lisbon, Portugal, 2Sociedade Portuguesa de Reumatologia, Lisbon, Portugal, 3Católica Lisbon School of Business and Economics, Lisbon, Portugal
1Faculdade
Objectives: To describe the association between physical disability and early exit from work in patients with clinically confirmed knee osteoarthritis (OA). Methods: We analyzed data from the population-based EpiReumaPt study (Sep2011-Dec2013). 10,661 inhabitants were surveyed to capture all cases of rheumatic diseases within a representative sample of the population. We analyzed all participants aged 50-64, near the official retirement age and all knee OA cases were clinically validated, according to the ACR classification criteria. Disability was measured according with the Health Assessment Questionnaire (HAQ) with score of 0-3, 0 meaning no loss of physical function and 3 full disability. The association of disability and early exit from work was tested using individual level logistic regression. Results: The Portuguese population aged between 50 and 64 who were out of paid work (51.8%) had a knee OA prevalence of 18.6% (women: 26.0%; men: 11.5%) and worst average HAQ score compared with those employed (0.47 vs. 0.28, respectively. p= 0.0002). knee OA patients with higher levels of disability, measured by HAQ (scores ≥ 2) are at the greatest risk of early exit from work (80.7% vs. 67.4% for all knee OA population and 51.2% for those with HAQ scores ≥ 2 but without knee OA). We estimated an almost linear relationship between levels of disability and the probability of early exit from work, with its y-intercept increasing with the presence of knee OA. This association was independent from other relevant factors, such as age, comorbidities, education and household income (OR: 1.50; CI: 1.04-2.16; p= 0.03). Conclusions: We observed an overall significant association between physical disability and premature withdrawal from employment. In particular, knee OA patients with higher levels of disability were at the highest risk of leaving the labor market. Decision makers should prioritize investments in policies targeting patients with disabling OA.
PMS63 Economic Burden of Ankylosing Spondylitis In Europe. A Systematic Review of The Literature Blanch C1, Comellas M2, Prada C2, Lizan L2 Pharmaceuticals, Barcelona, Spain, 2Outcomes 10, Universitat Jaume I, Castellon, Spain
1Novartis
Objectives: To appraise the literature referred to direct and indirect costs of ankylosing spondylitis (AS) in Europe. Methods: A systematic review of the literature was performed. Electronic databases [MedLine/PubMed, Cochrane Library, ISI Wok, DARE, NHSEED, HTA] and Google Scholar were searched to identify publications regarding direct and indirect costs of AS in Europe. Bibliographic references were hand searched. European studies published in English or Spanish until May 2015 were selected. Editorials, letters, commentaries, opinion papers, congress proceedings and studies related to specific treatments were excluded. Costs were updated to € ,2015. Results: Ten studies were reviewed (n= 2 systematic reviews, n= 1 costeffectiveness, n= 5 cross-sectional and n= 2 retrospective observational studies). Half of them (n= 5) evaluated AS cost from patient perspective. The main component of the the cost from societal perspective was the indirect cost (53.4%-62%). AS severity increased 2 times the direct cost and 4 times the indirect cost. The total cost increased 18.4 times from BASFI= 1 to BASFI= 10, and 1.6 times form BASDAI= 1 to BASDAI= 10. Absenteeism rates varied from 11% to 16%, and presentism from 19% to 33%. Disease activity (OR= 3,24; OR= 3,97) and depression (OR= 3,22; OR= 5,69) were predictors of absenteeism and presentism, while anxiety (OR= 3,90) and patients’ age (OR= 1,04 per year) were associated with presentism. Conclusions: Although costs estimations related to AS varied across European countries, the results showed that economic burden of AS in Europe is substantial, being the indirect cost due to productivity loss the main components of total cost. Worse physical function and higher disease activity were the main determinants of total costs. Disease activity and depression were associated with absenteeism and presentism.