Pharmacoeconomics of Certolizumab Pegol: A Systematic Literature Review

VA L U E I N H E A LT H

PMS38 A Cost Per Responder Analysis of Secukinumab Vs. Adalimumab Based on a Matching-Adjusted Indirect Comparison of Efficacy Data for the Treatment of Ankylosing Spondylitis at 52 Weeks from the Irish Payer Perspective Gunda P1, Nikoglou E2, Jugl SM3, Murphy A4 1Novartis Healthcare Private Limited, Hyderabad, India, 2Product Lifecycle Services - NBS, Novartis Global Service Center Dublin, Dublin, Ireland, 3Novartis Pharma AG, Basel, Switzerland, 4Novartis Ireland Ltd, Dublin, Ireland

Objectives: The objective of this analysis was to estimate and compare the long-term cost per responder (CPR) in Ireland based on the Assessment of Spondyloarthritis International Society (ASAS) outcomes following 52 weeks of treatment for ankylosing spondylitis (AS) with the fully human anti-IL-17A antibody Secukinumab 150mg (SEC) relative to the anti-TNF antibody Adalimumab (ADA).  Methods: CPR for each treatment was calculated by dividing the drug acquisition cost for the course of treatment with the corresponding response rates from a previously reported matching-adjusted indirect comparison (MAIC) based on MEASURE 2 and ATLAS RCTs. Drug costs were estimated based on cost to the national Irish payer (including VAT, rebates and wholesaler margins) and the number of doses required for 52 weeks. Other cost domains like administration or high-tech patient care fees were not included as this was considered to be equal for both treatments.  Results: Previous MAIC analysis showed that ASAS 20/40 response rates, which are key outcomes to determine symptomatic improvement in AS, were higher for SEC vs. ADA. ASAS 20/40 response rates were 81% and 65%; and 62% and 47% for SEC and ADA, respectively. CPR for ASAS 20/40 were EUR 13,856 and EUR 25,793; and EUR 18,013 and EUR 35,861 for SEC and ADA, respectively. SEC dominated ADA in terms of CPR, as the response rates were higher and the overall drug acquisition cost for 52 weeks was lower for SEC as compared to ADA. Sensitivity analyses confirmed the robustness of the main analysis. Results were based on list-prices as of May 2017.  Conclusions: The 52 weeks CPR for ASAS 20/40 response rates were lower for SEC compared to ADA in AS patients. Furthermore, with higher outcomes at lower costs, these findings suggest dominance of SEC over ADA. More AS patients could be treated more effectively with SEC versus ADA in Ireland. PMS39 Pharmacoeconomics of Certolizumab Pegol: A Systematic Literature Review Rubio-Terrés C1, Rubio-Rodrígues D1, Grau S2, Blanco R3, Sanchez JD4, Ferro B4 del Mar, Barcelona, Spain, 3Hospital Universitario Marqués de Valdecilla, Santander, Spain, 4UCB Pharma, Madrid, Spain

1Health Value, Madrid, Spain, 2Hospital

Objectives: Primary: To review the published evidence on the cost-effectiveness, cost-utility, cost-benefit and cost-minimization of certolizumab pegol (CZP) treatment for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) in comparison with the other biological disease-modifying antirheumatic drugs (bDMARDs). Secondary: To perform a quality assessment of the economic analyses in these indications.  Methods: A systematic literature search was conducted, without date or language restrictions, in PubMed and EMBASE databases. Internet searches were also made to identify possible gray literature. Main study characteristics, methods and outcomes were extracted and critically assessed. The quality of health economic studies was assessed by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), the Quality Assessment of Economic Evaluation in Health Care (QAEEHC) and the Quality of Health Economic Studies (QHES) checklists.  Results: The search identified 13 full-text pharmacoeconomic analyses: 11 in RA and 2 in axSpA. No studies were identified in the PsA indication. According to the economic analyses published in these articles, the high variability of the results and the design of the available studies prevent reliable conclusions from being drawn about the cost-effectiveness of CZP in comparison with other bDMARDs for the treatment of RA and axSpA. Of the 13 identified studies, only 3 (all related to RA) were classified as high quality in all three checklists. According to these, CZP+methotrexate (MTX) would be a cost-effective (dominant) treatment versus adalimumab, golimumab and infliximab (all add-on to MTX) in the US and Spain. In addition, a clinical risk-sharing agreement with CZP would generate considerable savings in all patients, compared to an alternative strategy in Spain.  Conclusions: Given the evidence, it was not possible to conclude which bDMARD is the most cost-effective treatment option. However, the high-quality studies indicated that CZP would be a cost-effective treatment in RA compared to other bDMARDs in the US and Spain. PMS40 Modelling the Societal Impact of Secukinumab in Patients with Psoriatic Arthritis in Germany Himmler S1, Mueller M1, Ostwald D1, Alten R2 1WifOR GmbH, Darmstadt, Germany, 2Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany

Objectives: Psoriatic arthritis (PsA) is associated with serious activity and work productivity impairment. For the first time in this disease area, this study estimates to what extent a novel medication, secukinumab, can reduce these societal and economic effects.  Methods: A Markov and a population model based on German PsA patients were used to simulate the progression of PsA under secukinumab versus the non-bioligic standard of care (methotrexate, sulfasalazine, leflunomide). Disease severity was measured via the Health Assessment Questionnaire-Disability Index (HAQ-DI) for the population of PsA patients predicted to receive secukinumab from 2017 to 2030, accounting for treatment discontinuation and disease progression. The relationship between HAQ-DI and the Work Productivity and Impairment Questionnaire in PsA patients was employed to determine the relative productivity benefit through the usage of secukinumab. Time-use survey and estimates of PsA-specific employment data were utilized to calculate the total amount of productive and active time gained, which will potentially be used for paid and unpaid work activities. Paid work was valued according to industry specific wages and

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unpaid work was valued according to the proxy good approach. Further economic effects induced by productivity increases were also taken into account.  Results: The usage of secukinumab decreases work and productivity impairment in the target population by over 13 percentage points, compared to the non-biologic standard of care, generating 30.6 million active and productive hours until 2030. These correspond to gross value added effects in the German economy of EUR 2.64 billion.  Conclusions: This study shows that the usage of biologics like secukinumab could lead to substantial reductions of functional limitations associated with PsA compared to the non-biologic standard of care, corresponding to significant societal and economic effects. In addition, the importance of including unpaid work in calculating the societal impact of a medication was demonstrated. PMS41 Tocilizumab after A First-Line with Anti-Tnf in Rheumatoid Arthritis: A Cost-Consequence Analysis in the Italian Setting Iannazzo S1, Benucci M2, Favalli EG3 Health Economics Consulting, Torino, Italy, 2Rheumatology Unit Hospital, Florence, Italy, 3Gaetano Pini Institute, Milan, Italy

1SIHS

Objectives: Clinical evidences showed that switching to a different mechanism of action in rheumatoid arthritis (RA) patients not responding or intolerant to a first anti-TNFa is effective. Objective of this study was the assessment of the cost-effectiveness profile of different treatment strategies after a first antiTNFa.  Methods: The study was conducted through the development of a Markov model in the perspective of the Italian healthcare system with a 3-year time horizon. The effectiveness was measured in terms of days gained in Low Disease Activity (LDA; DAS28-ESR <  3.2) or in remission (DAS28-ESR <  2.6). The model simulated the response to treatments, based on the findings of the Rotation Or Change (ROC) trial, the probability of discontinuation and switch to a 3rd-line biologic, and transition to death. Time on treatment curves for 2nd-line biologics derived from published Italian real-word data. Rituximab was assumed as 3rd-line biologic for all comparators. Costs were estimated based on published sources and Italian prices and tariffs: drugs, co-medications, administration, routine management (linked to disease severity).  Results: The switch to tocilizumab after the failure of a first anti-TNFa was more effective than a second anti-TNFa, in terms of days in remission (224 vs. 114 days) and of days in LDA (345 vs 193 days). The cost-effectiveness ratio with tocilizumab iv was Euro 174/day in remission and Euro 113/day in LDA. With tocilizumab sc the ratio was Euro 181/day in remission and Euro 117/day in LDA. The same ratios for the anti-TNFa treatments ranged from Euro 233 to Euro 320 per day in remission and from Euro 138 to Euro 190 per day in LDA (minimum was infliximab biosimilar; maximum was certolizumab).  Conclusions: The switch to a different mechanism of action after the failure of a first anti-TNFa is an effective and cost-effective strategy in RA. PMS42 Secukinumab Vs Adalimumab for the Treatment of Psoriasic Arthritis: a Cost Per Responder Analysis at 48 Weeks from a Peruvian Perspective for Public and Private Health Schemes Patino A, Karpf E Novartis Colombia, Bogota, Colombia

Objectives: The objective of this analysis was to compare the cost per responder based on the American College of Rheumatology (ACR) outcomes following 48 weeks of psoriatic arthritis (PsA) treatment with secukinumab (anti-IL-17 antibody) relative to adalimumab (anti-TNF antibody) from a third payer perspective.  Methods: The cost per responder for each treatment was estimated by dividing the drug acquisition cost with its response rate. Drug costs were estimated in US dollars (USD) from public sources: SEACE and DIGEMID for public and private health schemes, respectively. Response rates were estimated from a previous matching-adjusted indirect comparison (MAIC) based on the data from FUTURE2 and ADEPT clinical trials of secukinumab and adalimumab, respectively. MAIC analysis matched age, weight, race and gender distribution, PASI score, HAQ-DI score, and proportions of patients using methotrexate, with psoriasis ≥ 3% BSA, presence of dactylitis, enthesitis, and TNF-naive at baseline.  Results: ACR response rates were higher for secukinumab (150mg and 300mg) compared to adalimumab at 48 weeks in biologic-naive patients. Public scheme costs per ACR20 responder were USD14.088, USD30.509 and USD29.702, costs per ACR50 responder were USD19.632, USD36.527 and USD38.252, and costs per ACR70 responder were USD34.663, USD52.296 and USD56.103 for secukinumab 150mg, 300mg and adalimumab respectively. Private scheme costs per ACR20 responder were USD17.570, USD38.050 and USD58.302, costs per ACR50 responder were USD24.484, USD45.555 and USD75.085, and costs per ACR70 responder were USD43.231, USD65.221 and USD110.125 for secukinumab 150mg, 300mg and adalimumab respectively. Sensitivity analyses for ACR response and cost per responder showed similar results, confirming the validity of the main analysis.  Conclusions: ACR response rates were higher for secukinumab compared to adalimumab. Cost per responder for ACR outcomes at 48 weeks were lower for secukinumab (150mg and 300mg) versus adalimumab, indicating that it is more efficient to treat PsA patients with secukinumab versus adalimumab in the Peruvian context. PMS43 Cost-Effectiveness Analysis of Secukinumab in Ankylosing Spondylitis: A Canadian Perspective Chiva-Razavi S1, Jain M2, Graham CN3, Miles L3, Nikoglou E4, Gunda P5 1Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Healthcare Pvt. Ltd., Hyderabad, India, 3RTI Health Solutions, Research Triangle Park, NC, USA, 4Product Lifecycle Services - NBS, Novartis Global Service Center Dublin, Dublin, Ireland, 5Novartis Healthcare Private Limited, Hyderabad, India

Objectives: To evaluate the cost-effectiveness of Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, versus currently licensed biologic therapies in patients with Ankylosing Spondylitis (AS)