Assessing the value contribution of bimekizumab for the treatment of moderate-to-severe psoriasis using a multidisciplinary reflective multi-criteria decision analysis

References

• Bray N, Wolf P. Allocation of biologics: health economics and clinical decision making in plaque psoriasis. Br J Dermatol. 2018;178(5):997–998.
   PubMed Web of Science ®Google Scholar
• Angelis A, Lange A, Kanavos P. Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries. Eur J Health Econ. 2018;19(1):123–152.
   PubMed Web of Science ®Google Scholar
• Drake JI, de Hart JCT, Monleón C, et al. Utilization of multiple-criteria decision analysis (MCDA) to support healthcare decision-making. J Mark Access Health Policy. [cited 2017 Nov 21]. Available from 2017 Nov 21] 2017;5(1):1360545. Internet: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5645903/
   PubMedGoogle Scholar
• Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet. 2021;397(10281):1301–1315.
   PubMed Web of Science ®Google Scholar
• 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. [cited 2022 Mar 17]. Available from 2022 Mar 17] 2021;8. Internet: https://www.frontiersin.org/article/10.3389/fmed.2021.743180
   Web of Science ®Google Scholar
• Boehncke W-H, Schön MP. Psoriasis. Lancet. 2015;386(9997):983–994.
   PubMed Web of Science ®Google Scholar
• Carrascosa J, Pujol R, Daudén E, et al. A prospective evaluation of the cost of psoriasis in Spain (EPIDERMA project: phase II). J Eur Acad Dermatol Venereol. 2006;20(7):840–845.
   PubMed Web of Science ®Google Scholar
• Acción Psoriasis. Encuesta NEXT sobre necesidades actuales y expectativas de futuro en psoriasis en España. Informe de resultados 2019 [Internet]. 2020 [cited 2021 Apr 29]. Available from: https://www.accionpsoriasis.org/recursos/publicaciones/otras-publicaciones.html
   Google Scholar
• Reid C, Griffiths CEM. Psoriasis and treatment: past, present and future aspects. Acta Derm Venereol. 2020;100(3):adv00032.
   PubMedGoogle Scholar
• Kerkhof PCM, Reich K, Kavanaugh A, et al. Physician perspectives in the management of psoriasis and psoriatic arthritis: results from the population‐based multinational assessment of psoriasis and psoriatic arthritis survey. J Eur Acad Dermatol Venereol. 2015;29(10):2002–2010.
   PubMed Web of Science ®Google Scholar
• Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis. Cochrane Database Syst Rev. [Internet]. 2021 [cited 2021 Apr 20]; Available from]. [];4.: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011535.pub4/full
   PubMedGoogle Scholar
• Armstrong AW, Soliman AM, Betts KA, et al. Comparative efficacy and relative ranking of biologics and oral therapies for moderate-to-severe plaque psoriasis: a network meta-analysis. Dermatol Ther. 2021;11(3):885–905.
   PubMed Web of Science ®Google Scholar
• Egeberg A, Andersen YMF, Halling-Overgaard A-S, et al. Systematic review on rapidity of onset of action for interleukin-17 and interleukin-23 inhibitors for psoriasis. J Eur Acad Dermatol Venereol JEADV. 2020;34(1):39–46.
   PubMed Web of Science ®Google Scholar
• Lin P-T, Wang S-H, Chi -C-C. Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence. Sci Rep. 2018;8(1):16068.
   PubMedGoogle Scholar
• Tsai Y-C, Tsai T-F. Switching biologics in psoriasis - practical guidance and evidence to support. Expert Rev Clin Pharmacol. 2020;13(5):493–503.
   PubMed Web of Science ®Google Scholar
• Usha M, Abrar Q, Raquel L. The economic burden of switching biologics in psoriasis: a real-world analysis in the US population. J Am Acad Dermatol. 2014;70:AB191.
   Web of Science ®Google Scholar
• Conti A, Damiani G, Ruggeri R, et al. Switching infliximab in psoriatic patients during COVID −19 pandemics: a real-life retrospective study comparing intra-versus interclass switching strategies. Dermatol Ther. 2021;34(5):e15088.
   PubMed Web of Science ®Google Scholar
• Damiani G, Odorici G, Pacifico A, et al. Secukinumab loss of efficacy is perfectly counteracted by the introduction of combination therapy (rescue therapy): data from a multicenter real-life study in a cohort of Italian psoriatic patients that avoided secukinumab switching. Pharmaceuticals. 2022;15(1):95.
   Web of Science ®Google Scholar
• Damiani G, Conic RRZ, Pigatto PDM, et al. Predicting secukinumab fast-responder profile in psoriatic patients: advanced application of artificial-neural-networks (ANNs). J Drugs Dermatol JDD. 2020;19(12):1241–1246.
   PubMed Web of Science ®Google Scholar
• Monks G, Rivera-Oyola R, Lebwohl M. The psoriasis decision tree. J Clin Aesthetic Dermatol. 2021;14:14–22.
   PubMedGoogle Scholar
• Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based multinational assessment of psoriasis and psoriatic arthritis survey. J Am Acad Dermatol. 2014;70(5):871–881.e30.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA). Bimzelx. summary of product characteristics. 2021. Available from: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf [cited 2021 Jun 23]
   Google Scholar
• Badia X, de la Cueva P, Moreda FR, et al. Application of multi-criteria decision analysis (MCDA) to determine the value of treatments for the moderate to severe plaque psoriasis in Spain. Value Health. 2017;20(9):A564.
   Web of Science ®Google Scholar
• Zozaya N, Martínez-Galdeano L, Alcalá B, et al. Determining the value of two biologic drugs for chronic inflammatory skin diseases: results of a multi-criteria decision analysis. BioDrugs Clin Immunother Biopharm Gene Ther. 2018;32:281–291.
   Google Scholar
• Goetghebeur MM, Cellier MS. Can reflective multicriteria be the new paradigm for healthcare decision-making? The EVIDEM journey. Cost Eff Resour Alloc CE. [Internet]. 2018 cited 2020 Sep 23;16. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6225552/
   PubMed Web of Science ®Google Scholar
• Zozaya N, Oliva Moreno J, HIdalgo-Vega A. Multi-criteria decision analysis in healthcare. Its isefulness and limitations for decision making . [Internet]. Weber Foundation; 2018. Available from: https://weber.org.es/wp-content/uploads/2021/03/libro_admc_17_x_24_ingles_digital.pdf [cited 2020 Sep 24]
   Google Scholar
• Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet Lond Engl. 2021;397(10273):475–486.
   PubMed Web of Science ®Google Scholar
• Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–141.
   PubMed Web of Science ®Google Scholar
• Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet Lond Engl. 2021;397(10273):487–498.
   PubMed Web of Science ®Google Scholar
• Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142–152.
   PubMed Web of Science ®Google Scholar
• Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet Lond Engl. 2015;386(9993):541–551.
   PubMed Web of Science ®Google Scholar
• Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–661.
   PubMed Web of Science ®Google Scholar
• Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet Lond Engl. 2020;395(10222):427–440.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov (NIH U.S. National Library of Medicine). A phase 3, multicenter, randomized, double-blind, placebo-controlled, active reference (Adalimumab) study evaluating the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE OPTIMAL) [internet]. clinicaltrials.gov; 2021 [cited 2021 Dec 13]. Report No.: NCT03895203. Available from: https://clinicaltrials.gov/ct2/show/NCT03895203
   Google Scholar
• Bayón Yusta J, Gutiérrez Iglesias A, Galnares-Cordero L, et al. Proyecto metodológico. Síntesis de información relevante de apoyo a los MCDA (análisis de decisión multicriterio) para la toma de decisiones [Internet]. Ministerio de Sanidad, Servicios Sociales e Igualdad. Servicio de Tecnologías Sanitarias del País Vasco; 2019 [cited 2019 Apr 26]. Available from 2019 Apr 26: http://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052312&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf
   Google Scholar
• Marsh K, Lanitis T, Neasham D, et al. Assessing the value of healthcare interventions using multi-criteria decision analysis: a review of the literature. PharmacoEconomics. 2014;32(4):345–365.
   PubMed Web of Science ®Google Scholar
• Gilabert-Perramon A, Lens C, Betolaza JI, et al. Multi-criteria decision analysis (MCDA): common tools for different needs supporting healthcare decision making in Spain. Value Health. 2016;19(7):A489–90.
   Web of Science ®Google Scholar
• Guarga L, Badia X, Obach M, et al. Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan health service (CatSalut). Orphanet J Rare Dis. 2019;14(1):157.
   PubMedGoogle Scholar
• Hsu JC, Lin J-Y, Lin P-C, et al. Comprehensive value assessment of drugs using a multi-criteria decision analysis: an example of targeted therapies for metastatic colorectal cancer treatment. PloS One. 2019;14(12):e0225938.
   PubMed Web of Science ®Google Scholar
• Wagner M, Samaha D, Khoury H, et al. Development of a framework based on reflective MCDA to support patient-clinician shared decision-making: the case of the management of gastroenteropancreatic neuroendocrine tumors (GEP-NET) in the United States. Adv Ther. 2018;35(1):81–99.
   PubMed Web of Science ®Google Scholar
• Camps C, Badia X, García-Campelo R, et al. Development of a multicriteria decision analysis framework for evaluating and positioning oncologic treatments in clinical practice. JCO Oncol Pract. 2020;16(3):e298–e305.
   PubMedGoogle Scholar
• Garau M, Hampson G, Devlin N, et al. Applying a multicriteria decision analysis (MCDA) approach to elicit stakeholders’ preferences in Italy: the case of obinutuzumab for rituximab-refractory indolent non-Hodgkin lymphoma (iNHL). PharmacoEconomics Open. 2017;2(2):153–163.
   Web of Science ®Google Scholar
• Kolasa K, Zwolinski KM, Zah V, et al. Revealed preferences towards the appraisal of orphan drugs in Poland - multi criteria decision analysis. Orphanet J Rare Dis. [Internet]. 2018 [cited 2020 Jul 23];13. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5922020/
   PubMed Web of Science ®Google Scholar
• Zozaya N, Galindo J, Alcalá B, et al. El análisis de decisión multi-criterio como herramienta para la toma de decisiones en medicamentos huérfanos: una revisión de la literatura. IX Congreso Internacional de Medicamentos Huérfanos y Enfermedades Raras, Sevilla; 2019. [cited 2021 Oct 21]. Available from: www.farmaceuticosdesevilla.es
   Google Scholar
• Schey C, Krabbe PFM, Postma MJ, et al. Multi-criteria decision analysis (MCDA): testing a proposed MCDA framework for orphan drugs. Orphanet J Rare Dis. 2017;12(1):10.
   PubMedGoogle Scholar
• Wagner M, Khoury H, Bennetts L, et al. Appraising the holistic value of Lenvatinib for radio-iodine refractory differentiated thyroid cancer: a multi-country study applying pragmatic MCDA. BMC Cancer. Internet]. 2017;17(1). Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393009/ [cited 2020 Sep 14]
   Google Scholar