Monitoramento da Incorporação dos medicamentos para melanoma metastático e impacto orçamentário pós incorporação

Abstract

Introduction: Cutaneous melanoma is a neoplasm that develops from the uncontrolled proliferation of melanocytes (1). Although it is not among the most common malignant tumors, melanoma is considered the most aggressive type of skin cancer due to its great potential for distant spread and consequent high lethality. In August 2020, an ordinance was published incorporating nivolumab and pembrolizumab for this indication. The two immunobiologicals promise significant survival gains in these patients whose standard treatment until then resulted in extremely early deaths. In March 2022, an ordinance was published by SAES that increased the APAC reimbursement value for chemotherapy for malignant melanoma from R$1,800 to R$7,500. This study aims to assess the budgetary impact of this measure as well as the advancement of the use of these two drugs, as well as the use of alpha interferon for the treatment of this morbidity. Methods: To construct the analysis, it is possible to establish two time frames to consider the incorporation of technologies. The first is the date of publication of the incorporation ordinance and the second would be from the date of publication of the ordinance that increased the amount reimbursed by the SUS, assuming that such an act would induce the adoption of the drugs by the CACONs and UNACONs in the country. For each period unit (1 year), the APACS where the authorization date corresponded to the month of March of one year until the month of February of the following year were extracted from the DATASUS databases, starting with 2019, which was the year of assessment of the demand for immunobiological drugs at CONITEC. The unit of analysis was the number of APACs carried out with the drugs considering the date on which they were authorized. Furthermore, the dynamics of the impact were also measured by adding the value of the APACs per year and by matching the average price of each immunotherapeutic found in the health price database and its use over the years of the horizon, which was 4 years for the retrospective impact and 5 years for the prospective impact. To identify which drug was used in each APAC, two columns of variables from the Chemotherapy database were observed: ESQ1 and ESQ2, which are open-ended. The terms to be filled in were identified and translated as synonyms for the use of Nivolumab, Pembrolizumab and Alfa-Interferon. The market share generated a trend curve for the use of drugs over the years through the number of APACs containing the corresponding dispensing, and from there a market share was calculated for each of the prospective years. The budgetary impact was calculated based on the increase in the value of the APAC and through the proportion of increase in APACs with the drugs studied. The prices charged and computed in the Health Price Database were also used for analysis. An estimated budget impact was calculated for the next 5 years based on the incorporation already carried out so far with the proposal of a market share for the future. Results: The number of APACs until 2022 was stable. The increase in the total amount spent from the last to the penultimate year was 5.71 times, similar to the increase in the average cost per APAC (5.87 times). However, the increase in the use of immunotherapeutics in the last year was 3 times for Pembrolizumab and 1.75 times for Nivolumab. Alpha-interferon proved to be an obsolete treatment, being reduced in the last year to 3% of the number of APACs in relation to the previous year. Of the 8,242 APACs in the last year, only 962 (11.6%) used immunobiologicals. Considering the number of 806 APACs for pembrolizumab and nivolumab in the last year, and the prices sought in the BPS, approximately R$21,281,624 and R$4,466,117.76 were spent, respectively. Adding the two together, we have a total expense of R$25,717,741.76. The amount of R$44,563,911 spent via APAC in year 4 would represent 57.7% of the total spent on immunobiologicals, approximately, to serve only 11.6% of the total number of APACS. Considering the total spent on non-studied drugs (non-biologicals) in year 4 and the average of the first 3 years of the study, an increase of R$33,086,039.81 was observed to use the same drugs as before incorporation. This amount can be considered a loss to the system. There was then a 583% increase in the average value per APAC for other drugs from R$912.55 to R$4,414.06 per APAC. In terms of reimbursement expenses, we have a budgetary impact in the fourth year of R$35,720,879.18. Considering a market share of 10% in the first year and rising to 80% in the fifth year, we would have a budgetary impact in the total of 5 years of $604,366,931.36 considering the prices practiced in the BPS. Discussion and conclusions: The incorporation so far has been 10% of patients, and interferon alpha is in disuse. The increase in the value had the effect of increasing pembrolizumab by 3x and nivolumab by 1.57x, which has a higher monthly cost than the first. The increase in the value still produces losses to the system that can be reversed with the increase in market share.