Cost per responder for methotrexate versus other therapies in patients with moderate-to-severe plaque psoriasis in Italy
DOI:
https://doi.org/10.33393/grhta.2022.2474Keywords:
Cost per responder, csDMARDs, Methotrexate, Plaque psoriasisAbstract
Objective: Conventional synthetic disease modifying antirheumatic drugs (csDMARDs) were recommended in 2019 as first line therapy from Italian Medicines Agency (AIFA) for the treatment of moderate to severe psoriasis. Updated local guidelines recommended methotrexate (MTX) as the drug of first choice. Nevertheless, MTX is reported by AIFA to be underused. Since no study evaluated jointly the first-line efficacy and costs of the most widely used biologic drugs (adalimumab, etanercept, secukinumab and ustekinumab) and methotrexate in Italy, a cost per responder (CPR) analysis was performed.
Methods: A CPR model was developed based on efficacy data from a published Cochrane network meta-analysis.Drug costs included in the model were estimated based on average regional tender prices. The primary analysisassessed the CPR of both Psoriasis Area and Severity Index (PASI) 90 at weeks 12 and 52. A secondary analysis was conducted considering PASI 75. For methotrexate, both an average dosage of 13.4 mg, estimated by an expertpanel, and a dosage of 15 mg reported in European guidelines were considered.
Results: At weeks 12 and 52, the costs per responder PASI 90 were lower for methotrexate 13.4 mg compared to the most widely used biologics in Italy, € 566.71 and € 2,455.72 respectively. Methotrexate also showed a lowest CPR both at 12 and 52 weeks, € 529.95 and € 2,296.47 respectively, in the secondary analysis.
Conclusions: The analysis showed a lower cost per responder for methotrexate than for adalimumab, etanercept,secukinumab and ustekinumab. For healthcare budget holders, this means using the saved resources to treat more patients.
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References
Damiani G, Bragazzi NL, Karimkhani Aksut C, et al. The Global, Regional, and National Burden of Psoriasis: Results and Insights From the Global Burden of Disease 2019 Study. Front Med (Lausanne). 2021;8:743180. https://doi.org/10.3389/fmed.2021.743180 PMID:34977058 DOI: https://doi.org/10.3389/fmed.2021.743180
Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harb Perspect Med. 2014 Aug 1;4(8):a015354.https://pubmed.ncbi.nlm.nih.gov/25085957/ https://doi.org/10.1101/cshperspect.a015354 DOI: https://doi.org/10.1101/cshperspect.a015354
Augustin M, Krüger K, Radtke MA, Schwippl I, Reich K. Disease severity, quality of life and health care in plaque-type psoriasis: a multicenter cross-sectional study in Germany. Dermatology. 2008;216(4):366-72. https://pubmed.ncbi.nlm.nih.gov/18319601/ https://doi.org/10.1159/000119415 DOI: https://doi.org/10.1159/000119415
Augustin M, Reich K, Glaeske G, Schaefer I, Radtke M. Co-morbidity and age-related prevalence of psoriasis: analysis of health insurance data in Germany. Acta Derm Venereol. 2010;90(2):147-151. https://doi.org/10.2340/00015555-0770 PMID:20169297 DOI: https://doi.org/10.2340/00015555-0770
Prignano F, Rogai V, Cavallucci E, Bitossi A, Hammen V, Cantini F. Epidemiology of Psoriasis and Psoriatic Arthritis in Italy-a Systematic Review. Curr Rheumatol Rep. 2018 May 30;20(7):43. https://doi.org/10.1007/s11926-018-0753-1 https://doi.org/10.1007/s11926-018-0753-1 DOI: https://doi.org/10.1007/s11926-018-0753-1
Perrone V, Losi S, Maiorino A, Antonelli S, Giovannitti M, Giacomini E, Sangiorgi D, Degli Esposti L. Treatment Patterns and Pharmacoutilization in Patients Affected by Psoriasis: An Observational Study in an Italian Real-World Setting. Drugs Real World Outcomes. 2022 Jun;9(2):243-251. https://doi.org/10.1007/s40801-021-00290-3 PMID:35041194 DOI: https://doi.org/10.1007/s40801-021-00290-3
Blauvelt A, Griffiths CEM, Lebwohl M, et al. Reaching complete or near-complete resolution of psoriasis: benefit and risk considerations. Br J Dermatol. 2017;177(2):587-590. https://doi.org/10.1111/bjd.15463 PMID:28301048 DOI: https://doi.org/10.1111/bjd.15463
Farahnik B, Beroukhim K, Zhu TH, et al. Ixekizumab for the Treatment of Psoriasis: A Review of Phase III Trials. Dermatol Ther (Heidelb). 2016;6(1):25-37. https://doi.org/10.1007/s13555-016-0102-0 PMID:26910853 DOI: https://doi.org/10.1007/s13555-016-0102-0
Thaçi D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. https://doi.org/10.1016/j.jaad.2015.05.013 PMID:26092291 DOI: https://doi.org/10.1016/j.jaad.2015.05.013
Gazzetta Ufficiale della Repubblica Italiana. Serie Generale n. 129 del 20-5–2020. Online https://www.gazzettaufficiale.it/eli/gu/2020/05/20/129/sg/pdf (Accessed July 2022)
Nast A, Smith C, Spuls PI, et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol. 2020;34(11):2461-2498. https://doi.org/10.1111/jdv.16915 PMID:33349983 DOI: https://doi.org/10.1111/jdv.16915
Gruppo di lavoro multidisciplinare sui Farmaci Biotecnologici in Dermatologia Regione Emilia-Romagna . Linee guida terapeutiche /1 Trattamento sistemico della psoriasi cronica a placche moderata-grave con particolare riferimento ai farmaci biotecnologici. Novembre 2021. Online https://salute.regione.emilia-romagna.it/ssr/strumenti-e-informazioni/ptr/elaborati/94-linee-guida-psoriasi (Accessed July 2022)
Corazza, V., Cusano, F., De Pità, O., Rossi, L., & Virno, G. G. Methotrexate in the therapeutic pathway of patients with psoriasis. Analysis of clinical practice data and comparison with guidelines. Dermatology Reports. 2021;14(1). https://doi.org/10.4081/dr.2022.9454 PMID 35371426 DOI: https://doi.org/10.4081/dr.2022.9454
AIFA. Osservatorio Nazionale sull’impiego dei Medicinali. L’uso dei farmaci in Italia. Rapporto Nazionale 2015. Roma. 2016. Online https://www.aifa.gov.it/sites/default/files/Rapporto_OsMed_2015__AIFA.pdf (Accessed July 2022)
Sbidian E, Chaimani A, Garcia-Doval I, Doney L, Dressler C, Hua C, Hughes C, Naldi L, Afach S, Le Cleach L. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2022 May 23;5(5):CD011535. https://doi.org/10.1002/14651858.cd011535.pub5 PMID: 35603936 DOI: https://doi.org/10.1002/14651858.CD011535.pub5
Reich K, Sorbe C, Griese L, Reich JLK, Augustin M. The value of subcutaneous vs. oral methotrexate: real-world data from the German psoriasis registry PsoBest. Br J Dermatol. 2021 Apr;184(4):765-767. https://doi.org/10.1111/bjd.19690 PMID:33220078 DOI: https://doi.org/10.1111/bjd.19690
Leonardi CL, See K, Burge R, Sun Z, Zhang Y, Mallbris L, Garrelts A, Warren RB. Number Needed to Treat Network Meta-Analysis to Compare Biologic Drugs for Moderate-to-Severe Psoriasis. Adv Ther. 2022 May;39(5):2256-2269. https://doi.org/10.1007/s12325-022-02065-w PMID:35316500 DOI: https://doi.org/10.1007/s12325-022-02065-w
Gisondi P, Altomare G, Ayala F, et al. Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2017 May;31(5):774-790. https://doi.org/10.1111/jdv.14114 PMID:28244153 DOI: https://doi.org/10.1111/jdv.14114
Gisondi P, Loconsole F, Raimondo P, Ravasio R. Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy. Glob Reg Health Technol Assess. 2021;8(1):120-123. https://doi.org/10.33393/grhta.2021.2258 DOI: https://doi.org/10.33393/grhta.2021.2258
Ravasio R, Antonelli S, Maiorino A et al. Cost per responder for ixekizumab and other biologic drugs approved for the treatment of moderate-to-severe plaque psoriasis in Italy. Glob Reg Health Technol Assess. 2019;6(1). https://doi.org/10.1177/2284240318822289 DOI: https://doi.org/10.1177/2284240318822289
Attwa EM, Elkot RA, Abdelshafey AS, Hafez AR. Subcutaneous methotrexate versus oral form for the treatment and prophylaxis of chronic plaque psoriasis. Dermatol Ther. 2019 Sep;32(5):e13051. https://doi.org/10.1111/dth.13051 PMID:31381231 DOI: https://doi.org/10.1111/dth.13051
Dogra S, Singh N, Kumar S, Narang T, Handa S. Comparison of overall efficacy and safety of oral versus subcutaneous methotrexate in severe psoriasis. Dermatol Ther. 2022 Aug;35(8):e15656. https://doi.org/10.1111/dth.15656 PMID: 35730664 DOI: https://doi.org/10.1111/dth.15656
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Accepted 2022-10-11
Published 2022-11-10
