1,969
Views
1
CrossRef citations to date
0
Altmetric
Rheumatology

A budget impact analysis for making treatment decisions based on anti-cyclic citrullinated peptide (anti-CCP) testing in rheumatoid arthritis

, , , &
Pages 624-630 | Received 13 Jan 2020, Accepted 17 Feb 2020, Published online: 19 May 2020

References

  • Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69(3):89–95.
  • Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS. 2010;5(6):463–466.
  • Oderda GM, Lawless GD, Wright GC, et al. The potential impact of monitoring disease activity biomarkers on rheumatoid arthritis outcomes and costs. Per Med. 2018;15(4):291–301.
  • Robinson WH, Mao R. Biomarkers to guide clinical therapeutics in rheumatology? Curr Opin Rheumatol. 2016;28(2):168–175.
  • Kurowska W, Kuca-Warnawin EH, Radzikowska A, et al. The role of anti-citrullinated protein antibodies (ACPA) in the pathogenesis of rheumatoid arthritis. Cent Eur J Immunol. 2017;42(4):390–398.
  • Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569–2581.
  • van der Helm-van Mil AH, Verpoort KN, Breedveld FC, et al. Antibodies to citrullinated proteins and differences in clinical progression of rheumatoid arthritis. Arthritis Res Ther. 2005;7(5):R949–58.
  • Ajeganova S, Humphreys JH, Verheul MK, et al. Anticitrullinated protein antibodies and rheumatoid factor are associated with increased mortality but with different causes of death in patients with rheumatoid arthritis: a longitudinal study in three European cohorts. Ann Rheum Dis. 2016;75(11):1924–1932.
  • Shafrin J, Tebeka MG, Price K, et al. The economic burden of ACPA-positive status among patients with rheumatoid arthritis. J Manag Care Spec Pharm. 2018;24(1):4–11.
  • Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1–26.
  • Dekkers JS, Bergstra SA, Chopra A, et al. Autoantibody status is not associated with early treatment response to first-line methotrexate in patients with early rheumatoid arthritis. Rheumatology (Oxford). 2019;58(1):149–153.
  • Jonsson MK, Hensvold AH, Hansson M, et al. The role of anti-citrullinated protein antibody reactivities in an inception cohort of patients with rheumatoid arthritis receiving treat-to-target therapy. Arthritis Res Ther. 2018;20(1):146.
  • van den Broek M, Dirven L, Klarenbeek NB, et al. The association of treatment response and joint damage with ACPA-status in recent-onset RA: a subanalysis of the 8-year follow-up of the BeSt study. Ann Rheum Dis. 2012;71(2):245–248.
  • Schiff M, Weinblatt ME, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73(1):86–94.
  • Harrold LR, Litman HJ, Connolly SE, et al. Effect of anticitrullinated protein antibody status on response to abatacept or antitumor necrosis factor-alpha therapy in patients with rheumatoid arthritis: a US national observational study. J Rheumatol. 2018;45(1):32–39.
  • Harrold LR, Litman HJ, Connolly SE, et al. Comparative effectiveness of abatacept versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis who are anti-CCP positive in the United States Corrona registry. Rheumatol Ther. 2019;6(2):217–230.
  • Bozec A, Luo Y, Engdahl C, et al. Abatacept blocks anti-citrullinated protein antibody and rheumatoid factor mediated cytokine production in human macrophages in IDO-dependent manner. Arthritis Res Ther. 2018;20(1):24.
  • Bapat B, Klink AJ, Kaufman J, et al. ACPA testing and resultant treatment patterns in patients with rheumatoid arthritis: findings from U.S. community rheumatology practices. ACR/ARP Annual Meeting; Nov 8–13; Atlanta, Georgia. 2019.
  • Hunter TM, Boytsov NN, Zhang X, et al. Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004-2014. Rheumatol Int. 2017;37(9):1551–1557.
  • Decision Resources Group. Pharmacor immune and inflammatory disease: rheumatoid arthritis; 2015. Available from: https://decisionresourcesgroup.com/report/246098-biopharma-rheumatoid-arthritis-2015/
  • National Committee for Quality Assurance. DMARD treatment rate: disease-modifying anti-rheumatic drug therapy for rheumatoid arthritis; 2016. Available from: http://www.ncqa.org/report-cards/health-plans/state-of-health-care-quality/2016-table-of-contents/dmards
  • Ferrufino CP, Munakata J, Wei W, et al. Budget impact analysis of sarilumab for the treatment of rheumatoid arthritis in patients with an inadequate response to conventional synthetic DMARD or TNF inhibitor therapies. Clinicoecon Outcomes Res. 2018;10:805–819.
  • Fryar CD, Kruszon-Moran D, Gu Q, et al. Mean body weight, height, waist circumference, and body mass index among adults: United States, 1999-2000 through 2015-2016. Natl Health Stat Report. 2018;(122):1–16.
  • BMS Internal Study. Real-world distribution of anti-cyclic citrullinated peptide concentrations from a US community rheumatology clinics chart review study. Internal data.
  • Bristol-Myers S. Symphony market share research. Internal data.
  • CMS Clinical Diagnostic Laboratory Fee Schedule 2019 [cited 2019 Mar 11]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html
  • CMS Physician Fee Schedule 2019 [cited 2019 Mar 11]. Available from: https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx
  • Micromedex® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA [cited 2019 Mar 11]. Available from: https://www.micromedexsolutions.com/
  • Alten R, Nüßlein HG, Mariette X, et al. Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naive: 6-month results from a real-world, international, prospective study. RMD Open. 2017;3(1):e000345.
  • Gottenberg JE, Courvoisier DS, Hernandez MV, et al. Brief report: association of rheumatoid factor and anti-citrullinated protein antibody positivity with better effectiveness of abatacept: results from the Pan-European registry analysis. Arthritis Rheumatol. 2016;68(6):1346–1352.
  • Gottenberg JE, Ravaud P, Cantagrel A, et al. Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept: data from the ‘Orencia and Rheumatoid Arthritis’ registry. Ann Rheum Dis. 2012;71(11):1815–1819.
  • Nüßlein HG, Alten R, Galeazzi M, et al. Efficacy and prognostic factors of treatment retention with intravenous abatacept for rheumatoid arthritis: 24-month results from an international, prospective, real-world study. Clin Exp Rheumatol. 2016;34(3):489–499.
  • Weijers L, Baerwald C, Mennini FS, et al. Cost per response for abatacept versus adalimumab in rheumatoid arthritis by ACPA subgroups in Germany, Italy, Spain, US and Canada. Rheumatol Int. 2017;37(7):1111–1123.
  • Neubauer AS, Minartz C, Herrmann KH, et al. Cost-effectiveness of early treatment of ACPA-positive rheumatoid arthritis patients with abatacept. Clin Exp Rheumatol. 2018;36(3):448–454.
  • Lindstrom TM, Robinson WH. Biomarkers for rheumatoid arthritis: making it personal. Scand J Clin Lab Invest Suppl. 2010;242:79–84.
  • Gu T, Mutebi A, Stolshek BS, et al. Cost of biologic treatment persistence or switching in rheumatoid arthritis. Am J Manag Care. 2018;24(8 Spec No):SP338–SP345.
  • Rendas-Baum R, Wallenstein GV, Koncz T, et al. Evaluating the efficacy of sequential biologic therapies for rheumatoid arthritis patients with an inadequate response to tumor necrosis factor-alpha inhibitors. Arthritis Res Ther. 2011;13(1):R25.
  • Vanderpoel J, Tkacz J, Brady BL, et al. Health care resource utilization and costs associated with switching biologics in rheumatoid arthritis. Clin Ther. 2019;41(6):1080–1089 e5.
  • Zhang J, Shan Y, Reed G, et al. Thresholds in disease activity for switching biologics in rheumatoid arthritis patients: experience from a large U.S. cohort. Arthritis Care Res. 2011;63(12):1672–1679.
  • US Food and Drug Administration. Center for Drug Evaluation and Research list of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date [cited 2010 Jan 29]. Available from: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf