Keywords
Rapid review; Biological Products; Evidence-Informed Policy.
How to Cite
Menezes Farinasso, C. ., Borges Silva, R. ., Ferreira Leite, B. ., Gomes Fernandes, D. ., Kagure Wachira, V. ., Aguiar de Lima, A., Fortunato Rêgo, D. ., Simões Camara Leão, L. ., & Giaretta Sachetti, C. . (2020). Rapid review to inform the National Policy on Biological Medicines in SUS. Boletim Do Instituto De Saúde - BIS, 20(2), 114–124. https://doi.org/10.52753/bis.2019.v20.34492
Abstract
Background: High costs with biological medicines threaten the sustai-nability of healthcare services. The objective of the present rapid re-view was to inform the discussion of the National Policy for Biological Medicines within the Brazilian Unified Health System (SUS), through the identification of barriers to the uptake of these medicines. Metho-dology: Rapid review of the data sources: Medline via PubMed, EM-BASE, Cochrane Library and Centre for Reviews and Dissemination. Results: Nine cross-sectional studies were included. For the users, the barriers were lack of knowledge about the treatment, the distance between residence and healthcare services, the long waiting periods for care and the passivity about the treatment decisions. For the he-alth professionals, the barriers were acceptability of treatment, inter-changeability and substitution and the perception of lack on clinical data of efficacy and safety. For the payers, the barriers were high cost of medicines, reimbursement and assistance problems. No barriers were found for healthcare system in the included studies, only regar-ding the private sector, which was the patent protection. Conclusion: It is essential that decision makers use scientific evidence in healthcare policies. There is a pressing need to identify solutions to the barriers to access biologic medicines identified in this rapid review.
References
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14. Rompas SG, T; Amanuel, S; Coutinho, V; Lai, Z; Anto-nini, P; Murphy, MF. Demonstrating Value for Biosimilars: A Conceptual Framework. Am Health Drug Benefits. 2015; 8(3):129-39.
15. Moorkens E, Jonker-Exler C, Huys I, Declerck P, Simo-ens S, Vulto AG. Overcoming barriers to the market access of biosimilars in the European union: The case of biosi-milar monoclonal antibodies. Frontiers in Pharmacology. 2016; 7.
16. Inotai AC, M; D, Vitezic; Francetic, I; Tesar, T; Bochenek, T; Lorenzovici, L; Dylst, P; Kalo, Z Policy Practices to Maximi-se Social Benefit from Biosimilars. Journal of Bioequivalen-ce & Bioavailability. 2017; 09(04).
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20. Ministério da Saúde (BR). Secretaria de Ciência, Tec-nologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. Diretrizes metodológicas : Sistema GRADE –Manual de graduação da qualidade da evidência e força de recomendação para tomada de decisão em saúde. Brasília (DF); 2014.
21. Inotai A, Prins CPJ, Csanádi M, Vitezic D, Codreanu C, Kaló Z. Is there a reason for concern or is it just hype?–a systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opinion on Biological Therapy. 2017; 17(8):915-26.
22. Inotai A, Csanadi M, Petrova G, Dimitrova M, Boche-nek T, Tesar T, York K, Fuksa L, Kostyuk A, Lorenzovici L, Omelyanovskiy V, Egyed K, Kalo Z. Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts. Biomed Res Int; 2018.
23. Laires PA, Mesquita R, Veloso L, Martins AP, Cernadas R, Fonseca JE. Patient’s access to healthcare and treat-ment in rheumatoid arthritis: the views of stakeholders in Portugal. BMC Musculoskelet Disord. 2013; 14:279.
24. Lammers P, Criscitiello C, Curigliano G, Jacobs I. Bar-riers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: a Physician Survey in the United States and Emerging Markets. Pharmaceuti-cals (Basel). 2014;7(9):943-53.
25. O’Callaghan J, Bermingham M, Leonard M, Hallinan F, Morris JM, Moore U, Griffin BT. Assessing awareness and attitudes of healthcare professionals on the use of biosi-milar medicines: A survey of physicians and pharmacists in Ireland. Regul Toxicol Pharmacol. 2017; 88:252-261.
26. Sandorff E, Pinheiro AV, Bruni DS, Halbert R, Azeve-do VF. Payer and physician evidence and discount require-ments for biosimilars in three Latin American countries. Ga-BI Journal. 2015; 4(1):11-6.
27. Sullivan E, Piercy J, Waller J, Black CM, Kachroo S. As-sessing gastroenterologist and patient acceptance of biosi-milars in ulcerative colitis and Crohn’s disease across Ger-many. PLoS One. 2017; 12(4).
28. Waller J, Sullivan E, Piercy J, Black CM, Kachroo S. Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloar-thritis and psoriatic arthritis across Germany. Patient Prefer Adherence. 2017; 11:519-530.
2. Fernandes GS SC, Lopes G, Chammas R, Gifoni MAC, Gil RA, Araujo DV. The use of biosimilar medicines in oncology- position statement of the Brazilian Society of Clinical Onco-logy (SBOC). Braz J Med Biol Res. 2018; 51(3).
3. Vieira, FS. Evolução do gasto com medicamentos do Sistema Único de Saúde no período de 2010 A 2016. Texto para discussão / Instituto de Pesquisa Econômica Aplica-da. Rio de Janeiro; 2018.
4. Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions: A Belgian case study. PharmacoEconomics. 2014; 32(7):681-91.
5. Hemmington A, Dalbeth N, Jarrett P, Fraser AG, Broom R, Browett P, et al. Medical specialists’ attitudes to prescribing biosimilars. Pharmacoepidemiology and Drug Safety. 2017; 26(5):570-7.
6. Presidência da República (BR). Lei nº 8.666, de 21 de junho de 1993, com alterações resultantes da Lei nº 8.883, de 08 de junho de 1994 e da Lei Nº 9.648, DE 27 DE MAIO DE 1998. Regulamenta o art. 37, inciso XXI, da Constitui-ção Federal, institui normas para licitações e contratos da Administração Pública e dá outras providências.
7. Azevedo VF, Meirelles Ede S, Kochen Jde A, Medeiros AC, Miszputen SJ, Teixeira FV, Damião AO, Kotze PG, Romiti R, Arnone M, Magalhães RF, Maia CP, de Carvalho AV. Re-commendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Stu-dy Group on Inflammatory Bowel Disease--Focus on clini-cal evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases. Autoimmun Rev. 2015; 14(9):769-73.
8. Torres P. Consenso brasileiro multi-institucional de pa-cientes sobre medicamentos biossimilares. Jornal Brasilei-ro de Economia da Saúde. 2017; 9(1):39-43.
9. Ministério da Saúde (BR). Gabinete do Ministro. Portaria nº 1.160, de 3 de maio de 2018. Brasília (DF); 2018.
10. Ministério da Saúde (BR). Grupo de Trabalho para dis-cussão e formulação da Política Nacional de Medicamentos Biológicos no âmbito do Sistema Único de Saúde (SUS). Re-gimento Interno.[internet] 2018. [acesso em 9 ago 2019]. Disponível em: http://portalarquivos2.saude.gov.br/ima-ges/pdf/2018/outubro/19/3-Regimento-GT-Biologicos.pdf.
11. Ministério da Saúde (BR). Secretaria-Executiva. Subse-cretaria de Assuntos Administrativos. Regimento Interno do Ministério da Saúde : Decreto nº 8.901, de 10 de novembro de 2016. Brasília (DF); 2017.
12. Oxman AD, Lavis JN, Lewin S, Fretheim A. SUPPORT To-ols for evidence-informed health Policymaking (STP) 1: What is evidence-informed policymaking? Health Res Policy Syst. 2009; 16(7).
13. Tricco AC, Langlois EV, Straus SE, editors. Rapid re-views to strengthen health policy and systems: a practical guide. Geneva: World Health Organization; 2017.
14. Rompas SG, T; Amanuel, S; Coutinho, V; Lai, Z; Anto-nini, P; Murphy, MF. Demonstrating Value for Biosimilars: A Conceptual Framework. Am Health Drug Benefits. 2015; 8(3):129-39.
15. Moorkens E, Jonker-Exler C, Huys I, Declerck P, Simo-ens S, Vulto AG. Overcoming barriers to the market access of biosimilars in the European union: The case of biosi-milar monoclonal antibodies. Frontiers in Pharmacology. 2016; 7.
16. Inotai AC, M; D, Vitezic; Francetic, I; Tesar, T; Bochenek, T; Lorenzovici, L; Dylst, P; Kalo, Z Policy Practices to Maximi-se Social Benefit from Biosimilars. Journal of Bioequivalen-ce & Bioavailability. 2017; 09(04).
17. Australian Government. Department of Health. Litera-ture Review of International Biosimilar Medicines: Update; 2017.
18. Rickwood SD, S. Searching for Terra Firma in the Biosi-milars and Non-original Biologics Market. IMS Health; 2013.
19. Prescribing and Research in Medicines Management (UK and Ireland) Annual Conference 2017. Pharmacoepide-miology and Drug Safety. 2017; 26.
20. Ministério da Saúde (BR). Secretaria de Ciência, Tec-nologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. Diretrizes metodológicas : Sistema GRADE –Manual de graduação da qualidade da evidência e força de recomendação para tomada de decisão em saúde. Brasília (DF); 2014.
21. Inotai A, Prins CPJ, Csanádi M, Vitezic D, Codreanu C, Kaló Z. Is there a reason for concern or is it just hype?–a systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opinion on Biological Therapy. 2017; 17(8):915-26.
22. Inotai A, Csanadi M, Petrova G, Dimitrova M, Boche-nek T, Tesar T, York K, Fuksa L, Kostyuk A, Lorenzovici L, Omelyanovskiy V, Egyed K, Kalo Z. Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts. Biomed Res Int; 2018.
23. Laires PA, Mesquita R, Veloso L, Martins AP, Cernadas R, Fonseca JE. Patient’s access to healthcare and treat-ment in rheumatoid arthritis: the views of stakeholders in Portugal. BMC Musculoskelet Disord. 2013; 14:279.
24. Lammers P, Criscitiello C, Curigliano G, Jacobs I. Bar-riers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: a Physician Survey in the United States and Emerging Markets. Pharmaceuti-cals (Basel). 2014;7(9):943-53.
25. O’Callaghan J, Bermingham M, Leonard M, Hallinan F, Morris JM, Moore U, Griffin BT. Assessing awareness and attitudes of healthcare professionals on the use of biosi-milar medicines: A survey of physicians and pharmacists in Ireland. Regul Toxicol Pharmacol. 2017; 88:252-261.
26. Sandorff E, Pinheiro AV, Bruni DS, Halbert R, Azeve-do VF. Payer and physician evidence and discount require-ments for biosimilars in three Latin American countries. Ga-BI Journal. 2015; 4(1):11-6.
27. Sullivan E, Piercy J, Waller J, Black CM, Kachroo S. As-sessing gastroenterologist and patient acceptance of biosi-milars in ulcerative colitis and Crohn’s disease across Ger-many. PLoS One. 2017; 12(4).
28. Waller J, Sullivan E, Piercy J, Black CM, Kachroo S. Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloar-thritis and psoriatic arthritis across Germany. Patient Prefer Adherence. 2017; 11:519-530.
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2019 Cecilia Menezes Farinasso, Roberta Borges Silva, Betânia Ferreira Leite, Dalila Gomes Fernandes, Virginia Kagure Wachira, Aurelina Aguiar de Lima, Daniela Fortunato Rêgo, Luciana Simões Camara Leão, Camile Giaretta Sachetti
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