Tratamento da artrite reumatoide no sistema público de saúde brasileiro: persistência, perfil de utilização de medicamentos e gastos.

Abstract

Introduction: Rheumatoid Arthritis (RA) is one of the most prevalent chronic inflammatory diseases in the world and its worldwide prevalence is estimated at 0.5% - 1%. The main symptoms of the disease are pain, swelling, numbness, and deformities, which can subsequently lead to the destruction of cartilage and joints through bone erosion. Treatment aims to improve functional capacity and quality of life and prevent and control joint and extra-articular injuries. The evaluation of the implementation of incorporated technologies, in terms of use, effectiveness, and safety by the Clinical Protocol and Therapeutic Guidelines (PCDT) contributes to the sustainability of the SUS and improved equity and access to medicines. Objective: The objective of this study was to analyze the profile of use, expenses, and persistence with biological disease-modifying drugs (MMCDbio) and synthetic target-specific drugs (MMCDsae) used to treat Rheumatoid Arthritis (RA) in the SUS from 2017 to 2021. Method: Prospective non-concurrent cohort of RA patients who started at least one MMCDbio or MMCDase between January 2017 and December 2021, registered in the SABEIS/DATASUS database. This database allows the removal of administrative data containing the consolidation of drug dispensations that are part of the scope of the Clinical Protocols and Therapeutic Guidelines (PCDT) per patient; contains the following information: the region and year of dispensation, sociodemographic information of the patients such as age, sex, body mass index (BMI), geographic region of Brazil and which the patient lives in, the code of the medicine dispensed, the number of patients who used each medication and the total amount spent per year. Patient characteristics were verified using descriptive statistics of categorical and continuous variables; for continuous variables, medians and interquartile ranges (IQRs) were used. In the analysis of expenses, all APACs generated (n=195163) for patients (n=95466) who used these medications during the studied period were considered. A valuation study was carried out on ten medicines for each year of the evaluated period; the average unit values were estimated by the weighted average of the values of public purchases registered in the Health Price Bank and active search with the Ministry of Health. The total expenditure per medicine was obtained by the amount approved in APAC's multiplied by the weighted average price. The expenditure on each medication was evaluated based on the number of APACs registered in the system for each year analyzed; the average and total expenses per period were calculated. Monetary values were converted in reference to December 2021 to dollars adjusted by Purchasing Power Parity. The budgetary impact resulting from the incorporation of the drugs abatacept, tofacitinib, and baricitinib into the SUS was analyzed by comparing real-world data and the data described in the reports on the incorporation of these drugs. Result: Between 2017 and 2021, 95,466 patients were evaluated. The majority were women, aged between 45 and 64 years old, living in the Southeast region. A total of 33,270 patients were eligible for the persistence analysis evaluation. The average overall persistence time was 11 months. People using tofacitinib, living in the South region and over 65 years of age showed better performance in terms of persistence when compared to all other therapeutic strategies. To analyze the usage profile and costs, a total of 195,163 APACs were evaluated. The most consumed medicines were adalimumab, etanercept, and golimumab, but there was a rapid increase in the consumption of tofacitinib. The difference between the values projected in the incorporation reports varied significantly those found in the real world. Global persistence was assessed and stratified by gender, age group, BMI, region of residence, CID-10, therapeutic class, and medication. From the baseline (n=95466) patients were excluded: under 18 years of age (n=228); experienced (n=40239); with less than two dispensing records (n=12516); using rituximab (n=3782); with less than one year of follow-up (n=5431). The total treatment time for each patient was established as the duration in months from the moment the first medication was dispensed (cohort entry) until discontinuation or change (when there was no other dispensation within 90 days of the last registration), or censoring. Persistence was calculated as the ratio between the proportion of patients who persisted with treatment in relation to the total number of patients followed up over the analyzed period. Multivariate logistic regression was used to verify the correlation between sociodemographic variables and loss of persistence. The treatment time until its interruption was demonstrated by Kaplan-Meier curves and differences were measured by the long-rank method. The median persistence time for each medication was calculated. Univariate Cox analysis estimated the discontinuation Hazard Ratio. Pearson's chi-square test and Kruskal-Wallis test for variance were used in statistical analysis. In this study, statistical significance was defined when the p-value was less than 0.05. The IBM SPSS Statistics software, version 26, was used for the analyses. Conclusion: Changes were observed in the usage and expenditure profile of MMCDbio and MMCDase. Distortions were found between theoretical models for assessing budgetary impact when compared to real-world data. The group of drugs with the best performance among the most used groups was the disease-modifying, synthetic, janus kinase inhibitor drug class (MMCD-S-JAK), as it showed greater persistence in relation to other therapeutic options. It is worth noting that it is a class of medications used orally, which increases the convenience of administration.