SHOULD ANTI-CGRP MONOCLONAL ANTIBODIES ALWAYS BE THE DRUG OF FIRST CHOICE FOR MIGRAINE PROPHYLAXIS IN BRAZIL? - A PHARMACOECONOMIC STUDY
DOI:
https://doi.org/10.48208/HeadacheMed.2024.34Palavras-chave:
Migraine Disorders, Calcitonin Gene-Related Peptide Receptor Antagonists, PharmacologyResumo
Efficacy (success of therapy under ideal conditions), efficiency (the relationship between the costs and outcomes of a specific intervention), and effectiveness (the balance between efficacy and efficiency in clinical practice) are measures used to evaluate health interventions. Thus, in private practice and the public health system, the knowledge of these pharmacoeconomic data should influence the appropriate treatment choice. Migraine prophylaxis falls within this context. Traditional medications are available in the public health system, while galcanezumab is not routinely available. The present study aims to analyze the efficacy and effectiveness of galcanezumab and traditional therapeutic alternatives (amitriptyline, divalproex sodium, and topiramate). Efficacy data were obtained from the relevant literature (PubMed) and cost values from the ABCFARMA magazine. The economic impact analysis considered the cost of living for an economically active adult in Brazil based on the Brazilian Institute of Geography and Statistics (Instituto Brasileiro de Geografia e Estatística, IBGE) and the Institute for Applied Economic Research (Instituto de Pesquisa Econômica Aplicada, IPEA). Efficacy: amitriptyline: 40%; divalproex sodium: 30%; topiramate: 31%; galcanezumab: 50%. Their annual costs were: amitriptyline R$ 240.00; sodium divalproate R$ 876.00; topiramate R$ 600.00; galcanezumab R$ 13,992.00. Efficiency: amitriptyline 200%; divalproex sodium 41.1%; topiramate 62%; galcanezumab 4%. Ultimately, effectiveness is amitriptyline 120%; divalproex sodium 35.7%; topiramate 46.5%; galcanezumab 27%. Galcanezumab is the most effective; however, in a broader analysis, where payers, availability, and patient conditions are considered, evaluating efficacy alone may not be feasible in practical contexts and, therefore, anti-CGRP antibodies will not always be the first-line medications in migraine prophylaxis.
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Burches E, Burches, M. Efficacy, Effectiveness and Efficiency in the Health Care: The Need for an Agreement to Clarify its Meaning. International Archives of Public Health and Community Medicine. 2020 Jan 25;4(1). DOI: 10.23937/2643-4512/1710035 DOI: https://doi.org/10.23937/2643-4512/1710035
Vila-Pueyo M, Gliga O, Gallardo VJ, Pozo-Rosich P. The Role of Glial Cells in Different Phases of Migraine: Lessons from Preclinical Studies. Int J Mol Sci. 2023 Aug 8;24(16):12553. DOI: 10.3390/ijms241612553 DOI: https://doi.org/10.3390/ijms241612553
Durham PL. Calcitonin Gene‐Related Peptide (CGRP) and Migraine. Headache: The Journal of Head and Face Pain. 2006 Jun 24;46(s1). DOI: 10.3390/ijms241612553 DOI: https://doi.org/10.1111/j.1526-4610.2006.00483.x
Lampl C, MaassenVanDenBrink A, Deligianni CI, Gil-Gouveia R, Jassal T, Sanchez-del-Rio M, et al. The comparative effectiveness of migraine preventive drugs: a systematic review and network meta-analysis. J Headache Pain. 2023 May 19;24(1):56. DOI: 10.1186/s10194-023-01594-1 DOI: https://doi.org/10.1186/s10194-023-01594-1
Schoenen J, Van Dycke A, Versijpt J, Paemeleire K. Ten open questions in migraine prophylaxis with monoclonal antibodies blocking the calcitonin-gene related peptide pathway: a narrative review. J Headache Pain. 2023 Aug 1;24(1):99. DOI: 10.1186/s10194-023-01637-7 DOI: https://doi.org/10.1186/s10194-023-01637-7
Diener HC, May A. New migraine drugs: A critical appraisal of the reason why the majority of migraine patients do not receive an adequate medication. Cephalalgia. 2024 Mar 23;44(3). DOI: 10.1177/03331024241228605 DOI: https://doi.org/10.1177/03331024241228605
Puledda F, Sacco S, Diener HC, Ashina M, Al-Khazali HM, Ashina S, et al. International Headache Society Global Practice Recommendations for Preventive Pharmacological Treatment of Migraine. Cephalalgia. 2024 Sep 11;44(9). DOI: 10.1177/03331024241269735 DOI: https://doi.org/10.1177/03331024241269735
Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine. Neurology. 2018 Dec 11;91(24). DOI: 10.1212/WNL.0000000000006640 DOI: https://doi.org/10.1212/WNL.0000000000006640
Gonçalves AL, Martini Ferreira A, Ribeiro RT, Zukerman E, Cipolla-Neto J, Peres MFP. Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention. J Neurol Neurosurg Psychiatry. 2016 Oct;87(10):1127–32. DOI: 10.1136/jnnp-2016-313458 DOI: https://doi.org/10.1136/jnnp-2016-313458
Freitag FG, Collins SD, Carlson HA, Goldstein J, Saper J, Silberstein S, et al. A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis. Neurology. 2002 Jun 11;58(11):1652–9. DOI: 10.1212/WNL.58.11.1652 DOI: https://doi.org/10.1212/WNL.58.11.1652
Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, et al. Erenumab versus topiramate for the prevention of migraine – a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. 2022 Feb 7;42(2):108–18. DOI: 10.1177/03331024211053571 DOI: https://doi.org/10.1177/03331024211053571
Marley J. Efficacy, effectiveness, efficiency. Aust Prescr. 2000 Dec 1;23(6):114–5. DOI: 10.18773/austprescr.2000.131 DOI: https://doi.org/10.18773/austprescr.2000.131
International Headache Society. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan 25;38(1):1–211. DOI: 10.1177/0333102417738202 DOI: https://doi.org/10.1177/0333102417738202
Sculpher M. Effectiveness, efficiency, and NICE. BMJ. 2001 Apr 21;322(7292):943–4. DOI: 10.1136/bmj.322.7292.943 DOI: https://doi.org/10.1136/bmj.322.7292.943
Wolinsky H. Effectiveness vs. Efficacy: What’s the Difference Anyway? [Internet]. [cited 2024 Aug 7]. Available from: https://www.globalhealth.northwestern.edu/centers/communicable-diseases/covaxcen/news/effectiveness-efficacy.html
Instituto de Pesquisa Econômica Aplicada. Desempenho do Mercado de Trabalho [Internet]. 2024 [cited 2024 Aug 7]. Available from: https://www.ipea.gov.br/cartadeconjuntura/wp-content/uploads/2024/06/240607_cc_63_nota_18.pdf
Abcfarma. CONSULTA DE PREÇOS. 2019.
de Negri F, Mello CER de, Mourthe ACL. Instituto de Pesquisa Econômica Aplicada. 2024 [cited 2024 Sep 26]. Aquisições de medicamentos pelo governo federal. Available from: https://www.ipea.gov.br/cts/pt/central-de-conteudo/artigos/artigos/370-evolucao-das-aquisicoes-de-medicamentos-pelo-governo-federal-nas-ultimas-duas-decadas
Kastner T. Você S/A. 2024 [cited 2024 Sep 26]. A disparidade de renda entre o 1% mais rico. Available from: https://vocesa.abril.com.br/sociedade/a-disparidade-de-renda-entre-o-1-mais-rico
Melhado EM, Santos PSF, Kaup AO, Costa ATNM da, Roesler CA de P, Piovesan ÉJ, et al. Consensus of the Brazilian Headache Society (SBCe) for the Prophylactic Treatment of Episodic Migraine: part I. Arq Neuropsiquiatr. 2022 Aug 17;80(08):845–61. DOI: 10.1055/s-0042-1756441 DOI: https://doi.org/10.1055/s-0042-1756441
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache: The Journal of Head and Face Pain. 2019 Jan 10;59(1):1–18. DOI: 10.1111/head.13456 DOI: https://doi.org/10.1111/head.13456
Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019 Dec 16;20(1):6. DOI: 10.1186/s10194-018-0955-y DOI: https://doi.org/10.1186/s10194-018-0955-y
Doctorovich ED, Martín Bertuzzi F, Goicochea MT, Miranda S, Figuerola M de L, Schubaroff PA, et al. Consenso sobre el uso de anticuerpos monoclonales en la migraña en Argentina. Rev Neurol. 2020;70(04):149. DOI: 10.33588/rn.7004.2019399 DOI: https://doi.org/10.33588/rn.7004.2019399
Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. J Headache Pain. 2022 Dec 11;23(1):67. DOI: 10.1186/s10194-022-01431-x DOI: https://doi.org/10.1186/s10194-022-01431-x
Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A. Calcitonin gene‐related peptide‐targeting therapies are a first‐line option for the prevention of migraine: An American Headache Society position statement update. Headache: The Journal of Head and Face Pain. 2024 Apr 11;64(4):333–41. DOI: 10.1111/head.14692 DOI: https://doi.org/10.1111/head.14692
Queiroz LP, Silva Junior AA. The Prevalence and Impact of Headache in B razil. Headache: The Journal of Head and Face Pain. 2015 Feb 6;55(S1):32–8. DOI: 10.1111/head.12511 DOI: https://doi.org/10.1111/head.12511
Rizzoli P. Preventive Pharmacotherapy in Migraine. Headache: The Journal of Head and Face Pain. 2014 Feb 21;54(2):364–9. DOI: 10.1111/head.12273 DOI: https://doi.org/10.1111/head.12273
Buse DC, Greisman JD, Baigi K, Lipton RB. Migraine Progression: A Systematic Review. Headache: The Journal of Head and Face Pain. 2019 Mar 27;59(3):306–38. DOI: 10.1111/head.14721 DOI: https://doi.org/10.1111/head.13459
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Copyright (c) 2024 Davy Henrique Sousa Pelliciari, Caio Ricco Alves Reis, Carlos Alberto Bordini (Author)
Este trabalho está licenciado sob uma licença Creative Commons Attribution 4.0 International License.
