https://doi.org/10.4081/reumatismo.2023.1627
Janus kinase inhibitors: between prescription authorization and reimbursability
Submitted: 31 July 2023
Accepted: 11 September 2023
Published: 19 December 2023
Accepted: 11 September 2023
Abstract Views: 1055
PDF: 228
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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
Following the restrictions on the reimbursability of Janus kinase inhibitors introduced by the Italian Medicines Agency, the Italian Society of Rheumatology has drafted this document to shed light on the clinical conditions and reimbursability criteria set out in the prescription forms.
European Medicines Agency. Janus kinase inhibitors (JAKi); 2023. Available from: https://www.ema.europa.eu/en/medicines/human/referrals/janus-kinase-inhibitors-jaki.
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med 2022; 386: 316-26.
DOI: https://doi.org/10.1056/NEJMoa2109927
Salinas CA, Louder A, Polinski J, Zhang TC, Bower H, Phillips S, et al. Evaluation of VTE, MACE, and serious infections among patients with RA treated with baricitinib compared to TNFi: a multi-database study of patients in routine care using disease registries and claims databases. Rheumatol Ther 2023; 10: 201-23.
DOI: https://doi.org/10.1007/s40744-022-00505-1
Avina-Zubieta JA, Thomas J, Sadatsafavi M, Lehman AJ, Lacaille D. Risk of incident cardiovascular events in patients with rheumatoid arthritis: a meta-analysis of observational studies. Ann Rheum Dis 2012; 71: 1524-9.
DOI: https://doi.org/10.1136/annrheumdis-2011-200726
Li L, Lu N, Avina-Galindo AM, Zheng Y, Lacaille D, Esdaile JM, et al. The risk and trend of pulmonary embolism and deep vein thrombosis in rheumatoid arthritis: a general population-based study. Rheumatology (Oxford) 2021; 60: 188-95.
DOI: https://doi.org/10.1093/rheumatology/keaa262
Omair MA, Alkhelb SA, Ezzat SE, Boudal AM, Bedaiwi MK, Almaghlouth I. Venous thromboembolism in rheumatoid arthritis: the added effect of disease activity to traditional risk factors. Open Access Rheumatol 2022; 14: 231-42.
DOI: https://doi.org/10.2147/OARRR.S284757
Simon TA, Thompson A, Gandhi KK, Hochberg MC, Suissa S. Incidence of malignancy in adult patients with rheumatoid arthritis: a meta-analysis. Arthritis Res Ther 2015; 17: 212.
DOI: https://doi.org/10.1186/s13075-015-0728-9
Italian Medicines Agency. Aggiornamento della scheda di prescrizione cartacea dei farmaci JAKi (baricitinib, filgotinib, tofacitinib, upadacitinib) per l'artrite reumatoide. Determina n. DG/195/2023. In: Official Journal, 99, 28/04/2023. Available from: https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-04-28&atto.codiceRedazionale=23A02492&elenco30giorni=false. [In Italian].
Italian Medicines Agency . Aggiornamento della scheda di prescrizione cartacea dei farmaci JAKi (tofacitinib, upadacitinib) nel trattamento dell'artrite psoriasica. Determina n. DG/194/2023. In: Official Journal, 99, 28/04/2023. Available from: https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-04-28&atto.codiceRedazionale=23A02491&elenco30giorni=false. [In Italian].
Italian Medicines Agency . Aggiornamento della scheda di prescrizione cartacea dei farmaci JAKi (upadacitinib) nel trattamento della spondilite anchilosante. Determina n. DG/196/2023. In: Official Journal, 99, 28/04/2023. https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-04-28&atto.codiceRedazionale=23A02493&elenco30giorni=false. [In Italian].
Roubille C, Richer V, Starnino T, McCourt C, McFarlane A, Fleming P, et al. The effects of tumour necrosis factor inhibitors, methotrexate, non-steroidal anti-inflammatory drugs and corticosteroids on cardiovascular events in rheumatoid arthritis, psoriasis and psoriatic arthritis: a systematic review and meta-analysis. Ann Rheum Dis 2015; 74: 480-9.
DOI: https://doi.org/10.1136/annrheumdis-2014-206624
Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis 2023; 82: 3-18.
DOI: https://doi.org/10.1136/ard-2022-223356corr1
Gossec L, Baraliakos X, Kerschbaumer A, de Wit M, McInnes I, Dougados M, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis 2020; 79: 700-12.
DOI: https://doi.org/10.1136/annrheumdis-2020-217163
Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis 2023; 82: 19-34.
DOI: https://doi.org/10.1136/ard-2022-223296
Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, et al, EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis 2017; 76: 17-28.
DOI: https://doi.org/10.1136/annrheumdis-2016-209775
Istituto Superiore di Sanità. Il progetto. Available from: https://www.cuore.iss.it/altro/cuore.
Istituto Superiore di Sanità. Calcolo del punteggio individuale. Available from: https://www.cuore.iss.it/valutazione/calc-rischio.
Cacciapaglia F, Spinelli FR, Erre GL, Gremese E, Manfredi A, Piga M, et al. Italian recommendations for the assessment of cardiovascular risk in rheumatoid arthritis: a position paper of the Cardiovascular Obesity and Rheumatic DISease (CORDIS) Study Group of the Italian Society of Rheumatology. Clin Exp Rheumatol 2023; 41: 1784-91.
DOI: https://doi.org/10.55563/clinexprheumatol/hyaki6
SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J 2021; 42: 2439-54.
DOI: https://doi.org/10.1093/eurheartj/ehab309
SCORE2-OP working group and ESC Cardiovascular risk collaboration. SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions. Eur Heart J 2021; 42: 2455-67.
DOI: https://doi.org/10.1093/eurheartj/ehab312
Previtali E, Bucciarelli P, Passamonti SM, Martinelli I. Risk factors for venous and arterial thrombosis. Blood Transfus 2011; 9: 120-38.
Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, et al. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost 2010; 8: 2450-7.
DOI: https://doi.org/10.1111/j.1538-7836.2010.04044.x
How to Cite
Spinelli, F., Conti, F., Caporali, R., Iannone, F., Cacciapaglia, F., & Steering Committee of the Italian Society of Rheumatology, on behalf of the. (2023). Janus kinase inhibitors: between prescription authorization and reimbursability. Reumatismo, 75(4). https://doi.org/10.4081/reumatismo.2023.1627
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