https://doi.org/10.4081/reumatismo.2021.1329
Assessment of patients affected by rheumatoid arthritis eligible for biotechnological agents and evaluation of their healthcare resource utilization and related costs
Submitted: 1 August 2020
Accepted: 15 February 2021
Published: 19 April 2021
Accepted: 15 February 2021
Abstract Views: 3549
PDF: 500
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Objective. To provide estimates of patients with rheumatoid arthritis (RA) eligible for biotechnological therapy and to evaluate their healthcare costs. Method. An observational analysis was performed based on data-linkage between administrative databases of selected Italian Regional/Local healthcare departments. Data were then re-proportioned to the Italian population. Patients with RA diagnosis defined by discharge diagnosis and/or exemption code during 01/01/2013- 31/12/2017 were included. The criteria applied to evaluate the elegibility for biotechnological therapy were: 1) methotrexate (MTX)-treatment failure ≥6 months and start of a different conventional-synthetic diseasemodifying antirheumatic drugs (csDMARD); 2) corticosteroid ≥6 months with dosage ≥7.5 mg/die; 3) MTX-contraindication (therapy or hospitalization for renal damage/interstizial lung disease/hepatic failure). Mean annual costs per patient included drugs, hospitalizations, outpatient services. Results. Data re-proportioned to the Italian population estimated 318,328 RA patients: 43,361 with, 274,967 without biotechnological agents. Among the latter, 26,487(9.6%) patients met ≥1 criteria applied for eligibility: 1,896 had MTX-treatment failure and started another csDMARD; 15,833 received corticosteroid ≥7.5 mg/die; 7,788 had MTX-contraindication. Regarding patients fulfilling two criteria, 107 had MTX-treatment failure followed by another csDMARDs and corticosteroid ≥7.5 mg/die, 53 were treated with another csDMARDs after MTX-treatment failure and also presented MTX-contraindication, 810 had corticosteroid ≥7.5 mg/die and MTX-contraindication. Mean total annual costs for patients estimated eligible for biotechnological therapy was € 3,132, of which € 177 related to drugs indicated for RA and € 2,955 related to other direct costs. Conclusions. According to our estimates, around 10% RA patients not currently treated with biotechnological agents are eligible for such therapies, highlighting a trend of under-use in clinical practice for RA management.
Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016; 388: 2023-38.
DOI: https://doi.org/10.1016/S0140-6736(16)30173-8
Cross M, Smith E, Hoy D, et al. The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014; 73: 1316-22.
DOI: https://doi.org/10.1136/annrheumdis-2013-204627
Pahwa R, Singh A, Jialal I. Chronic Inflammation. In: StatPearls (Internet). Treasure Island (FL): StatPearls Publishing; 2020 (cited 2020 Feb 12). Available from: http://www.ncbi.nlm.nih.gov/books/NBK493173/
WHO. Chronic rheumatic conditions (Internet). WHO. (cited 2020 Feb 12). Available from: http://www.who.int/chp/topics/rheumatic/en/
Rossini M, Rossi E, Bernardi D, et al. Prevalence and incidence of rheumatoid arthritis in Italy. Rheumatol Int. 2014; 34: 659-64.
DOI: https://doi.org/10.1007/s00296-014-2974-6
Benucci M, Rogai V, Atzeni F, et al. Costs associated with rheumatoid arthritis in Italy: past, present, and future. CEOR. 2016; 33.
DOI: https://doi.org/10.2147/CEOR.S91006
Guo Q, Wang Y, Xu D, et al. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res (Internet). 2018 Apr 27 (cited 2019 Sep 2); 6. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5920070/
DOI: https://doi.org/10.1038/s41413-018-0016-9
Köhler BM, Günther J, Kaudewitz D, Lorenz H-M. Current therapeutic options in the treatment of rheumatoid arthritis. J Clin Med. 2019; 8(7).
DOI: https://doi.org/10.3390/jcm8070938
Silvagni E, Di Battista M, Bonifacio AF, et al. One year in review 2019: novelties in the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2019; 37: 519-34.
Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020; annrheumdis-2019-216655.
Favalli EG, Matucci-Cerinic M, Szekanecz Z. The Giants (biologicals) against the Pigmies (small molecules), pros and cons of two different approaches to the disease modifying treatment in rheumatoid arthritis. Autoimmun Rev. 2020; 19: 102421.
DOI: https://doi.org/10.1016/j.autrev.2019.102421
Harrold LR, Patel PA, Griffith J, et al. Assessing disease severity in bio-naïve patients with RA on treatment with csDMARDs: insights from the Corrona Registry. Clin Rheumatol. 2020; 39: 391-400.
DOI: https://doi.org/10.1007/s10067-019-04727-7
Wei W, Knapp K, Wang L, et al. Treatment persistence and clinical outcomes of tumor necrosis factor inhibitor cycling or switching to a new mechanism of action therapy: real-world observational study of rheumatoid arthritis patients in the United States with Prior tumor necrosis factor inhibitor therapy. Adv Ther. 2017; 34: 1936-52.
DOI: https://doi.org/10.1007/s12325-017-0578-8
Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017; 76: 960-77.
DOI: https://doi.org/10.1136/annrheumdis-2016-210715
Agenzia Italiana del Farmaco (AIFA). Guideline for the classification and conduction of the observational studies on medicines. (Internet) 2010. Available from: https://www.agenziafarmaco.gov.it/ricclin/sites/default/files/files_ wysiwyg/files/CIRCULARS/Circular%2031st%20May%202010.pdf
Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement. PLoS Med. 2015; 12: e1001885.
DOI: https://doi.org/10.1371/journal.pmed.1001885
Carrara G, Scirè CA, Zambon A, et al. A validation study of a new classification algorithm to identify rheumatoid arthritis using administrative health databases: case-control and cohort diagnostic accuracy studies. Results from the RECord linkage On Rheumatic Diseases study of the Italian Society for Rheumatology. BMJ Open. 2015; 5: e006029.
DOI: https://doi.org/10.1136/bmjopen-2014-006029
Silvagni E, Bortoluzzi A, Carrara G, et al. Comparative effectiveness of first-line biological monotherapy use in rheumatoid arthritis: a retrospective analysis of the RECord-linkage On Rheumatic Diseases study on health care administrative databases. BMJ Open. 2018; 8: e021447.
DOI: https://doi.org/10.1136/bmjopen-2017-021447
Iannazzo S, Furneri G, Demma F, et al. The burden of rheumatic diseases: an analysis of an italian administrative database. Rheumatol Ther. 2016; 3: 167-77.
DOI: https://doi.org/10.1007/s40744-016-0034-2
Curtis JR, Singh JA. The use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011; 33: 679-707.
DOI: https://doi.org/10.1016/j.clinthera.2011.05.044
Nam JL, Winthrop KL, van Vollenhoven RF, et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010; 69: 976-86.
DOI: https://doi.org/10.1136/ard.2009.126573
Chen Y-F, Jobanputra P, Barton P, et al. A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness. Health Technol Assess. 2006; 10: iii–iv, xi–xiii, 1–229.
DOI: https://doi.org/10.3310/hta10420
Miltenburger C, Günther OH, Justo N, et al. A Survey of barriers to treatment access in rheumatoid arthritis (Internet). 2009 (cited 2020 Feb 14) p. 29. Available from: http://www.comparatorreports.se/RA%20Barrier%20Report_FINAL_050110.pdf
Federfarma. Farmaci biologici, in Italia poco utilizzati. I dati della Sir (Internet). (cited 2020 Feb 14). Available from: https://federfarma.it/Edicola/FiloDiretto/VediNotizia.aspx?id=19547
Malattie autoimmuni: un esercito di 200mila pazienti senza accesso ai biologici (Internet). Italian Biosimilars Group. (cited 2020 Feb 13). Available from: http://www.italianbiosimilarsgroup.it/it/area-stampa/in-primo-piano/158-malattie-autoimmuni-un-esercito-di-200mila-pazienti-senza-accesso-ai-biologici.html
Lucioni C, Mazzi S, Caporali R. Budget impact analysis of infliximab biosimilar: the Italian scenery. Global Region Health Technol Assess. 2015; 2: GRHTA.5000194.
DOI: https://doi.org/10.5301/GRHTA.5000194
D’Ambrosio G. Primo Rapporto Sociale sull’Artrite reumatoide in Italia SIR-ANMAR-Censis (Internet). Anmar Italia ONLUS. (cited 2020 Feb 13). Available from: http://www.anmar-italia.it/news-doc/anmar-istituzioni/202-primo-rapporto-sociale-sullartrite-reumatoide-in-italia-sir-anmar-censis
Fedele D, Marra A, Carletti R, Scanavacca P. Cost-effectiveness analysis of drugs biological in rheumatoid arthritis. Giorn Ital Farmacoecon Farmacoutil. 2015; 7: 44-52.
Gulácsi L, Brodszky V, Baji P, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Exp Rev Clin Immunol. 2015; 11: 43-52.
DOI: https://doi.org/10.1586/1744666X.2015.1090313
Vermeer M, Kuper HH, Bernelot Moens HJ, et al. Adherence to a treat-to-target strategy in early rheumatoid arthritis: results of the DREAM remission induction cohort. Arthritis Res Ther. 2012; 14: R254.
DOI: https://doi.org/10.1186/ar4099
Morsley K, Kilner T, Steuer A. Biologics prescribing for rheumatoid arthritis in older patients: a single-center retrospective cross-sectional study. Rheumatol Ther. 2015; 2: 165-72.
DOI: https://doi.org/10.1007/s40744-015-0021-z
Tatangelo M, Tomlinson G, Paterson JM, et al. Association of patient, prescriber, and region with the initiation of first prescription of biologic disease-modifying antirheumatic drug among older patients with rheumatoid arthritis and identical health insurance coverage. JAMA Netw Open. 2019; 2: e1917053-e1917053.
DOI: https://doi.org/10.1001/jamanetworkopen.2019.17053
Kalkan A, Husberg M, Hallert E, et al. Physician preferences and variations in prescription of biologic drugs for rheumatoid arthritis: a register-based study of 4,010 patients in Sweden. Arthritis Care Res. 2015; 67: 1679-85.
DOI: https://doi.org/10.1002/acr.22640
Taylor PC, Moore A, Vasilescu R, et al. A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective. Rheumatol Int. 2016; 36: 685-95.
DOI: https://doi.org/10.1007/s00296-015-3415-x
How to Cite
Degli Esposti, L., Perrone, V., Sangiorgi, D., & Sinigaglia, L. (2021). Assessment of patients affected by rheumatoid arthritis eligible for biotechnological agents and evaluation of their healthcare resource utilization and related costs. Reumatismo, 73(1), 5–14. https://doi.org/10.4081/reumatismo.2021.1329
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
Similar Articles
- R. Restuccia, D. Ruggieri, L. Magaudda, R. Talotta, The preventive and therapeutic role of physical activity in knee osteoarthritis , Reumatismo: Vol. 74 No. 1 (2022)
You may also start an advanced similarity search for this article.
