Nivolumab and pembrolizumab in the treatment of metastatic melanoma: a retrospective budget impact analysis from theAbstract
Objective To estimate the budget impact of using nivolumab and pembrolizumab in the treatment of metastatic melanoma in Brazil.
Methods This was a retrospective budget impact analysis using data from the Outpatient Information System of the Brazilian National Health System. Chemotherapy authorizations issued between 2019 and 2022 were analyzed. The main measures were the number of procedures, reimbursed amounts, and the percentage variation in expenditures over the study period.
Results The total number of chemotherapy authorizations ranged from 10,799 in the first year to 8,328 in the fourth year. Between the third and fourth year, the increase in the value of procedures resulted in a 5.96-fold rise in total expenditure, following a period of relative stability in previous years. In the last year, 1,148 authorizations for pembrolizumab and 173 for nivolumab were recorded. Only 15.8% of the authorizations included one of these two drugs. The budget impact generated by the increase in the value of procedures amounted to BRL 37,170,493.01. Considering a market share of 15.0% in the first year and its evolution to 80.0% in five years, the incremental budget impact estimated for this period would be BRL 564,233,633.28 with the expanded use of nivolumab and pembrolizumab.
Conclusion The increase in reimbursement value, associated with the low adoption of the new immunobiologicals, produced a substantial extra expenditure with drugs prescribed before the incorporation of new technologies, which may represent a burden on the Brazilian health system.
Keywords
Melanoma; Immunotherapy; Medical Oncology; Brazil; Analysis of the Budgetary Impact of Therapeutic Advances
Resumo
Objetivo Estimar o impacto orçamentário no uso do nivolumabe e do pembrolizumabe no tratamento de melanoma metastático no Brasil.
Métodos Análise retrospectiva de impacto orçamentário com dados do Sistema de Informações Ambulatoriais do Sistema Único de Saúde. As autorizações de quimioterapia emitidas entre 2019 e 2022 foram analisadas. As principais medidas foram o número de procedimentos, os valores reembolsados e a variação percentual dos gastos ao longo do período.
Resultados O número total de autorizações de quimioterapia variou de 10.799 no primeiro ano para 8.328 no quarto ano. Entre o terceiro e o quarto ano, a elevação do valor dos procedimentos resultou em incremento de 5,96 vezes no gasto total, após um período de relativa estabilidade nos anos anteriores. No último ano, foram registradas 1.148 autorizações com pembrolizumabe e 173 com nivolumabe. Apenas 15,8% das autorizações utilizaram algum dos dois medicamentos. O impacto orçamentário produzido com o aumento no valor dos procedimentos foi de R$ 37.170.493,01. Considerando uma participação de mercado, no primeiro ano, de 15,0% e a sua evolução para 80,0% em cinco anos, o impacto incremental estimado nesse período seria de R$ 564.233.633,28 com o uso ampliado do nivolumabe e do pembrolizumabe.
Conclusão O aumento no valor de reembolso, associado à baixa adoção dos novos imunobiológicos utilizados, produziu um gasto extra importante com medicamentos prescritos antes da incorporação das novas tecnologias, o que pode representar um prejuízo ao sistema de saúde brasileiro.
Palavras-chave
Melanoma; Imunoterapia; Oncologia; Brasil; Análise de Impacto Orçamentário de Avanços Terapêuticos
Resumen
Objetivo Estimar el impacto presupuestario del uso de nivolumab y pembrolizumab en el tratamiento del melanoma metastásico en Brasil.
Métodos Se trató de un análisis retrospectivo de impacto presupuestario utilizando datos del Sistema de Información Ambulatoria del Sistema Nacional de Salud de Brasil. Se analizaron las autorizaciones de quimioterapia emitidas entre 2019 y 2022. Las principales medidas fueron el número de procedimientos, los montos reembolsados y la variación porcentual de los gastos durante el período de estudio.
Resultados El número total de autorizaciones de quimioterapia varió de 10.799 en el primer año a 8.328 en el cuarto año. Entre el tercer y el cuarto año, el aumento en el valor de los procedimientos resultó en un incremento de 5,96 veces en el gasto total, tras un período de relativa estabilidad en los años anteriores. En el último año se registraron 1.148 autorizaciones para pembrolizumab y 173 para nivolumab. Solo el 15,8% de las autorizaciones incluyeron uno de estos dos fármacos. El impacto presupuestario generado por el aumento en el valor de los procedimientos ascendió a BRL 37.170.493,01. Considerando una participación de mercado del 15,0% en el primer año y su evolución hasta el 80,0% en cinco años, el impacto presupuestario incremental estimado para este período sería de BRL 564.233.633,28 con el uso ampliado de nivolumab y pembrolizumab.
Conclusión El aumento en el valor del reembolso, asociado a la baja adopción de los nuevos inmunobiológicos, produjo un gasto adicional sustancial con medicamentos prescritos antes de la incorporación de nuevas tecnologías, lo que puede representar una carga para el sistema de salud brasileño.
Palabras clave
Melanoma; Inmunoterapia; Oncología Médica; Brasil; Análisis de Impacto Presupuestario de Avances Terapéuticos
This research used public domain anonymized databases.
Introduction
Cutaneous melanoma is a highly lethal skin neoplasm owing to its marked potential for distant dissemination (1,2). Although its incidence is lower compared to other types of skin neoplasms, it has significant mortality rates, with 1,923 deaths recorded in 2020 and an estimated 8,980 new cases for each year of the three-year period from 2023 to 2025 (3).
Surgical wide excision is the primary therapeutic recommendation for this condition and should be performed immediately after diagnostic confirmation (1,2).
Immunotherapy revolutionized metastatic melanoma treatment by significantly improving overall patient survival in real-world settings (4-6). Among the therapeutic alternatives available, nivolumab and pembrolizumab stand out.
Several studies have shown that the use of nivolumab and pembrolizumab in patients with metastatic melanoma results in a significant increase in overall survival and progression-free survival, compared to conventional chemotherapy regimens previously available (7-10). These clinical benefits were decisive for the recommendation to incorporate these technologies into the Brazilian National Health System (SUS), even considering the budget impact associated with their use (11).
Funding for cancer therapies within the Brazilian healthcare system is decentralized, with predefined values established in the Management System of the Table of Procedures, Medications, Orthoses, Prostheses, and Special Materials. Financial reimbursement for services is provided by the Ministry of Health through the authorization of high-complexity procedures, according to the type and staging of the neoplasm (12,13).
The objective of this study was to estimate the budget impact of nivolumab and pembrolizumab in the treatment of metastatic melanoma in Brazil, as well as to assess the diffusion of these drugs in oncology treatment centers and the financial effects resulting from the significant increase in the reimbursement value of procedures.
Methods
Study Design
A retrospective budget impact analysis was conducted in Brazil, considering the national (14) and international (15) methodological guidelines.
Target population and subgroups
The population of interest consisted of individuals with advanced metastatic melanoma. No subgroups were defined, since the unit of analysis corresponded to the aggregate record of procedure authorizations.
Setting and location
The study was conducted within the SUS context and used national records of high-complexity outpatient chemotherapy extracted from the Brazilian Outpatient Information System of SUS between March 2019 and February 2023.
Study perspective
The study adopted the perspective of SUS as the entity responsible for financing Brazilian public health services.
Comparators
No comparators were considered, as the objective was exclusively to estimate the costs associated with the use of the medications over the study period.
Time horizon
The time horizon included four retrospective years, from March 2019 to February 2023. These were defined based on the demand for the incorporation of immunobiologicals by the Brazilian National Commission for the Incorporation of Technologies, considering Ordinance No. 23, dated August 4, 2020 (16), plus 180 days in accordance with Law No. 12,401/2011, up to one year after the adjustment in the reimbursement value by SUS through Ordinance No. 638, dated March 28, 2022 (17). It was hypothesized that this measure could stimulate the adoption of these medications by centers and high-complexity oncology care units across the country. This period was organized into four consecutive annual cycles, each corresponding to the interval from March of one year to February of the following year. Furthermore, a five-year prospective projection, based on observed trends, was included.
Discount rate
Since this was a retrospective analysis with a short-term projection, no discount rate was applied.
Resource and cost estimates
Costs were estimated based on the average price in Brazilian Reais (BRL) recorded in the Health Price Database per unit of medication, multiplied by the standard dosage per patient and the number of authorizations identified each year. No opportunity cost adjustments were made.
Currency, price date, and conversion
All values were expressed in 2022 Brazilian Reais (BRL). No foreign currency conversion was performed.
Analysis strategies
Procedure volumes were obtained from high-complexity procedure authorizations. To identify the medications, two free-text fields in the database were analyzed, corresponding to the primary prescription and the confirmation of the information. Terms were standardized and categorized as representing nivolumab or pembrolizumab.
The dynamics of budget impact were assessed through the annual sum of reimbursed amounts and correspondence with the average price of each immunotherapy, according to data from the Health Price Database.
Annual market share of the drugs in total authorizations was calculated descriptively.
To estimate the budget impact of incorporating nivolumab and pembrolizumab into the health system, regardless of authorization reimbursement and considering the prices mentioned in the Health Price Database, a simulation was conducted assuming constant monthly treatment costs over the years, as well as the proportion of prescriptions between the two drugs. This assumption was based on the retrospective stability observed in the volume of authorizations during the study period, with this constancy being adopted as a parameter for the prospective horizon.
The prospective budget impact scenario was constructed based on an exploratory hypothesis of progressive adoption, estimating market share growth up to 80.0% by the end of the projection horizon, rather than by direct statistical extrapolation of historical trends.
The database used in the analysis can be accessed at: https://data.mendeley.com/preview/fc5mjrypp8?a=c429543b-2d8a-4466-9952-5766d23fcaed (18).
Results
The analysis of chemotherapy records identified a variety of terminologies associated with the prescription of nivolumab and pembrolizumab, which were subsequently grouped for standardization (Table 1). Over the four years, the number of authorizations for metastatic melanoma chemotherapy remained relatively stable, with a slight reduction during this time, but accompanied by a significant increase in the amounts paid (Table 2).
Annual number of authorizations for high-complexity procedures for metastatic melanoma chemotherapy, with use of nivolumab, pembrolizumab, and other medications, in addition to average total expenditures. Brazil, 2019-2022
Terms recorded in prescription fields for identification of nivolumab and pembrolizumab in authorizations for high-complexity outpatient chemotherapy procedures. Brazil, 2019-2022
The total expenditure from the third to the fourth year increased by 5.96-fold, similar to the increase in the average cost per authorization, which was 5.86-fold. During the same period, when the authorization value rose to BRL 7,500.00, the use of immunobiologicals increased by 4.40-fold for pembrolizumab and 2.00-fold for nivolumab (Figure 1).
Annual trend in the number of chemotherapy authorizations with nivolumab and pembrolizumab in the Brazilian National Health System. Brazil, 2019-2022
Of the total 8,328 authorizations in the final year, only 1,321 (15.9%) utilized these medications. There remains 85.0% of the market share available for the full adoption of the new therapies.
The Health Price Bank indicated an average cost of BRL 13,202.00 per 100-milligram vial of pembrolizumab. Considering the label-based posology of two milligrams per kilogram of body weight and a patient weighing between 65 and 70 kilograms, the use of two vials of pembrolizumab per month was estimated, which would represent a monthly cost per authorization of BRL 26,404.00. For nivolumab, with a posology of three milligrams per kilogram and a patient weighing between 65 and 70 kilograms, the use of two vials every two weeks was considered, which would represent a monthly cost per authorization of BRL 28,628.96, since each 100-milligram vial was listed at BRL 7,157.49 in the Bank.
In 2022, expenditures for 1,148 pembrolizumab authorizations amounted to approximately BRL 30,311,792.00, while 173 nivolumab authorizations amounted to BRL 4,952,810.08, totaling an expenditure of BRL 35,264,602.08. This amount corresponded to 78.0% of the total federal funds transferred via high-complexity procedure authorizations in the fourth year (BRL 45,058,083.00), even though only 15.9% of authorizations included these immunobiologicals.
When examining the total value of high-complexity procedure authorizations that did not include prescribed biologicals, the sum reached BRL 37,910,901.57 in the fourth year, in addition to BRL 9,532,473.53 for the first year, BRL 9,507,878.16 for the second year, and BRL 7,241,162.95 for the third year, resulting in an average of BRL 8,760,504.88 for these three years. Thus, considering the total spent on non-study medications (biological) in the fourth year and the average of the first three years of the study, an increase of BRL 29,150,396.68 was observed in expenditures to utilize the same medications as before the incorporation.
Of the total 7,007 authorizations for high-complexity procedures involving other medications in the fourth year, which cost BRL 37,910,901.57, the average cost per authorization was BRL 5,410.43. In previous years, average values of BRL 901.67 for the first year, BRL 1,016.89 for the second year, and BRL 922.79 for the third year were observed, resulting in an average of BRL 947.12. Therefore, there was a 471.3% increase in the average value per authorization for other medications, amounting to an additional BRL 4,463.32 per authorization.
Given the increase in the standard authorization value from BRL 1,080.00 to BRL 7,500.00, the total number of high-complexity procedure authorizations in the fourth year was multiplied by the average cost of previous years (BRL 947.12), resulting in BRL 7,887,590.08. This would be the approximate expected expenditure had the authorization value not changed. Subtracting this from the BRL 45,058,083.00 actually spent, a budget impact of BRL 37,170,493.01 is observed for this fourth year.
Based on the previously calculated market share of 15.9%, the initial estimated expenditure of BRL 35,264,602.08, and considering the prices from the Health Price Bank, it was projected that this value would represent a 15.0% market share in the first simulation year. For subsequent years, the market share was estimated to gradually increase from 15.0% in the first year to 80.0% in the fifth year, with a cumulative budget impact exceeding BRL 560 million by the end of the analyzed period (Table 3).
Projected expenditures on nivolumab and pembrolizumab for the treatment of metastatic melanoma in the Brazilian National Health System, including market share and cumulative values. Brazil, 2023-2027
Discussion
This study showed that, despite the incorporation of the immunotherapies nivolumab and pembrolizumab and the significant increase in reimbursement for the treatment of metastatic melanoma by the Brazilian health system, the dissemination of these technologies was limited. It was observed that the increase in the amount authorized for high-complexity procedures resulted in greater use of nivolumab and pembrolizumab; however, adherence to treatment with these therapies still accounted for only a small proportion of all treatments. As a consequence, a large share of the additional resources was allocated to covering the cost of previously used drugs, of comparatively lower effectiveness, increasing overall expenditure without a corresponding expansion in the use of the new therapies.
This finding suggests a mismatch between the availability of funding and the effective clinical adoption of these therapies in oncology centers across the country, which may negatively affect the quality of oncological care offered to patients with metastatic melanoma.
The results must be interpreted with caution, since this study has important limitations. The data were obtained from administrative records in public databases, subject to reporting errors and to the lack of standardization in drug nomenclature, which required manual interpretation and standardization of the terms. In addition, stability in the volume of authorizations and in market prices was assumed over the simulated years, which may not reflect the fundamental dynamics of acquisition and prescription of immunotherapies. Such assumptions may lead to over- or underestimation of the calculated budgetary impact.
Although the scenario appeared favorable for health facilities to standardize these drugs, with expanded federal reimbursement and additional resources available, the data showed that the degree of dissemination of these technologies remained restricted during the first two years after their incorporation, accounting for less than 16.0% of all authorizations. These findings, together with other results presented in this study, indicate the need to review the financing method and the organization of oncological care in Brazil. The strategies adopted so far do not appear to be effective in ensuring access to pharmacological treatment for cancer patients. This behavior reinforces the understanding that institutional, regional, and operational barriers may restrict the adoption of new therapies, even in the presence of financial incentives.
The Brazilian National Policy for Cancer Prevention and Control establishes that hospitals authorized in oncology, whether public or private, are responsible for acquiring, standardizing, and providing medications, according to institutional protocols and Ministry of Health guidelines (19). Although federal funding is transferred through authorizations for high-complexity procedures, the results suggest that this decentralized management model may contribute to regional variations in the effective incorporation of new therapies, as observed in the limited market share of nivolumab and pembrolizumab.
The increase in reimbursement, which did not result in proportional growth in the use of immunobiologicals, generated an additional expenditure of BRL 29,150,396.68 on less effective drugs that were already prescribed before the incorporation of new technologies. These findings cast doubt on the efficacy of this funding model for cancer care and underscore the financial consequences of non-incorporation in healthcare units.
It is also relevant to consider, as an additional reflection, whether the drugs previously used and still prescribed after the reimbursement increase remain aligned with the current therapeutic guidelines for the cases in which they were indicated. It cannot be ruled out that the new reimbursement ceiling may have indirectly created incentives for maintaining older therapies, which were perceived to offer higher margins for healthcare services, even when more effective alternatives were available. Although this aspect was not explored in depth in this study, it represents an important opportunity for future research.
In a decentralized health system built upon a federation, the data raises the suspicion of heterogeneity in the standardization of incorporated drugs among different high-complexity oncology centers and oncology care units, and consequently, of regional differences in the provision of oncological care for patients. It should be noted that the average price of nivolumab and pembrolizumab did not change over the years, as shown by the Health Price Database.
The recommendation report of the Brazilian National Commission for the Incorporation of Technologies proposed the incorporation of the drugs, provided that the monthly cost of treatment was reduced to BRL 12,000.00 for pembrolizumab and BRL 11,000.00 for nivolumab, which the data show did not occur. In addition, the reimbursement adjustment reached only BRL 7,500.00 and not the values recommended in the Commission’s report. These two facts may explain the low adherence to the standardization of these treatments by oncology centers in the country.
The integration of methods that combine economic evaluation with implementation aspects could help identify and overcome barriers limiting the adoption of these technologies. Some methods, such as cost-effectiveness analysis of the policy and implementation value assessment, are widely recommended, as they provide a more comprehensive evaluation that aligns financing with the practical needs of oncology centers (20).
The low dissemination of immunobiologicals observed is consistent with previous experiences in the public health system, such as in the case of bortezomib for multiple myeloma, whose incorporation did not achieve broad adoption, even after significant price reduction and increased reimbursement (21). At the 122nd meeting of the National Commission for the Incorporation of Technologies, data on the incorporation and budgetary impact of bortezomib for multiple myeloma, introduced in September 2020, were presented (21). The purchase price of the drug was significantly reduced during this period, with the ampoule decreasing from BRL 732.29 to BRL 207.41, while the authorization value after incorporation rose to BRL 5,224.65 to cover a monthly treatment that, at this ampoule price, costs on average BRL 1,659.28.
In the context of the Brazilian health system, the integration of economic evaluation methods with implementation-oriented approaches, such as cost-effectiveness analysis and implementation value assessment, may provide alternatives for addressing challenges in the adoption of immunobiologicals. When costs and clinical benefits are considered alongside the factors that shape the incorporation and effective use of these therapies, these approaches can promote a fairer and more effective adoption of such technologies. Previous studies indicate that decentralization in the acquisition of oncological drugs, the absence of updated clinical guidelines, and weak monitoring of incorporation hinder the alignment between policy and practice (22,23).
This study highlights that, although the reimbursement increase promoted some degree of dissemination of immunotherapies for metastatic melanoma treatment, adherence to these treatments is still insufficient. Within the Brazilian health system, such a scenario results in inefficiency, as a substantial share of treatments continue to be reimbursed at higher rates despite the ongoing use of older, less effective therapies. Integrating implementation methods with economic analysis may provide better alignment between financing and the real needs of treatment centers, favoring more efficient resource use and promoting greater equity in access to innovative oncological treatments.
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Peer Review Administrator
Izabela Fulone (https://orcid.org/0000-0002-3211-6951)
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Peer Reviewers
Osmar Cardoso (https://orcid.org/0000-0001-6093-7629),
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Roberto Carlos Lyra da Silva (https://orcid.org/0000-0001-9416-9525),
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Bernadette Cunha Waldvogel (https://orcid.org/0000-0001-5267-7361)
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Data availability
The database used in the research is available at https://data.mendeley.com/preview/fc5mjrypp8?a=c429543b-2d8a-4466-9952-5766d23fcaed.
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Use of generative artificial intelligence
Not used.
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Edited by
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Editor-in-Chief
Jorge Otávio Maia Barreto (https://orcid.org/0000-0002-7648-0472)
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Scientific Editor
Everton Nunes da Silva (https://orcid.org/0000-0001-8747-4185)
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Associate Editor
Letícia Xander Russo (https://orcid.org/0000-0001-9592-8212)
Data availability
The database used in the research is available at https://data.mendeley.com/preview/fc5mjrypp8?a=c429543b-2d8a-4466-9952-5766d23fcaed.
Publication Dates
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Publication in this collection
08 Dec 2025 -
Date of issue
2026
History
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Received
8 Apr 2025 -
Accepted
19 Aug 2025
