Background: the Department of Science and Technology from the Brazilian Ministry of Health has a key role in providing evidence to inform decision-making. Thus, the Center of Evidence (NEv) from this Department performed a series of studies in order to support the discussion regarding the formulation of the National Policy for Biologic Medicines.
Objectives: the aim of this process was to provide methodological assistance to the Brazilian Working Group for the National Policy for Biologic Medicines.
Methods: the evidence team from the NEv followed three main steps to conduct this project. First, we performed the study 'Barriers to access biologic products: a rapid review', following the main methods of a traditional systematic review. After that, we conducted a Rapid Review for Policy to inform the working group regarding the interchangeability of biologic products motivated solely by economic factors, which was based on the SUPPORT tools for evidence-informed health policymaking. The third product was the conduct of a Policy Dialog as well as its synthesis.
Results: the rapid review was an important study to inform the prioritization of health problems and the description of the problem within the Working Group. It synthesized the main barriers of access according to the following perspectives: patient, clinician, payer and the health system. After several meetings and two surveys (public and private), the problem we prioritized was the interchangeability of biologic medicines motivated solely by economic factors. Thus, the rapid evidence synthesis was a key product that identified four political options that could help confront the prioritized problem: 1) evidence production regarding interchangeability; 2) implementation of a pharmacovigilance system for biologic medicines; 3) appreciation of clinical efficacy and safety on the interchangeability practice; and 4) educational strategies for health practitioners regarding the interchangeability of biologic medicines. As a final point, the Policy Dialog was crucial to support the discussion of the working group participants regarding the main barriers and factors associated with the possibility of implementation of the options identified.
Conclusions: the first experience of the NEv with supporting the development of a health policy was of great importance to the Brazilian Ministry of Health, reinforcing the need to inform decision-making using scientific evidence and standardized methodologies.
Patient or healthcare consumer involvement: the Policy Dialog included representatives of patients' associations, which was an important step to consider experiences and needs of different stakeholders regarding the use of biologic medicines.