Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis

IVAMA-BRUMMELL, Adriana M.; Marciniuk, Fernanda Ledo; Wagner, Anita K.; Osório-de-Castro, Claudia Garcia Serpa; Vogler, Sabine; Mossialos, Elías; Andrade, Carla Lourenço Tavares de; Naci, Huseyin

doi:10.1016/j.lana.2023.100506

Cited by 4 publications

(3 citation statements)

References 24 publications

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“…This case study also raises an important question for low- and middle-income countries whose regulatory agencies may be facing similar pressures to approve drugs with limited evidence of clinical benefit which are highly priced and take limited resources away from other uses. We caution against other regulatory agencies’ benchmarking their approvals on FDA or EMA approvals of drugs with uncertain clinical efficacy (Ivama-Brummell et al, 2023 ).…”

Section: Discussionmentioning

confidence: 96%

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Shahzad,

Naci,

Esselen

et al. 2024

Journal of Pharmaceutical Policy and Practice

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Section: Discussionmentioning

confidence: 96%

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Shahzad,

Naci,

Esselen

et al. 2024

Journal of Pharmaceutical Policy and Practice

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“…We applaud this signal of preferential approval by Chinese regulatory authorities of cancer drug indications with evidence of clinical benefit, a finding similar to that of study of cancer drug approvals in Brazil. 46 …”

Section: Discussionmentioning

confidence: 99%

Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001–2020

Wei,

Zhang,

et al. 2024

The Lancet Regional Health - Western Pacific

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“…Care should be used by industry and other sellers of oncology drugs to maintain the proposed increased access after market share is obtained, especially in public hospitals in low- and middle-income countries . On the regulatory side, expedited approvals in high-income countries, such as the US, can lead to more rapid approvals and access in low- and middle-income countries, such as Brazil, although it is unclear whether this strategy results in achieving cost-effective pricing . In addition, value-based pricing is an alternative model used by payers that industry might adapt to inform global pricing strategies that minimize financial toxicity and increase global access to oncology drugs …”

Section: Discussionmentioning

confidence: 99%

International Cost-Effectiveness Analysis of Durvalumab in Stage III Non–Small Cell Lung Cancer

Kareff,

Han,

Haaland

et al. 2024

JAMA Netw Open

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ImportanceStandard of care for unresectable locally advanced non–small cell lung cancer (NSCLC) involves definitive chemoradiotherapy followed by maintenance therapy with durvalumab. However, the cost of durvalumab has been cited as a barrier to its use in various health systems.ObjectiveTo evaluate the cost-effectiveness of durvalumab vs placebo as maintenance therapy in patients with unresectable stage III NSCLC from 4 international payer perspectives (US, Brazil, Singapore, and Spain).Design, Setting, and ParticipantsIn this economic evaluation, a Markov model was designed to compare the lifetime cost-effectiveness of maintenance durvalumab for unresectable stage III NSCLC with that of placebo, using 5-year outcomes data from the PACIFIC randomized placebo-controlled trial. Individual patient data were extracted from the PACIFIC, KEYNOTE-189, ADAURA, ALEX, and REVEL randomized clinical trials to develop a decision-analytic model to determine the cost-effectiveness of durvalumab compared with placebo maintenance therapy over a 10-year time horizon. Direct costs, adverse events, and patient characteristics were based on country-specific payer perspectives and demographic characteristics. The study was conducted from June 1, 2022, through December 27, 2023.Main Outcomes and MeasuresLife-years, quality-adjusted life years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs) were estimated at country-specific willingness-to-pay thresholds ([data reported in US$] US: $150 000 per QALY; Brazil: $22 251 per QALY; Singapore: $55 288 per QALY, and Spain: $107 069 per QALY). One-way and probabilistic sensitivity analyses were performed to account for parameters of uncertainty. A cost-threshold analysis was also performed.ResultsThe US base-case model found that treatment with durvalumab was associated with an increased cost of $114 394 and improved effectiveness of 0.50 QALYs compared with placebo, leading to an ICER of $228 788 per QALY. Incremental cost-effectiveness ratios, according to base-case models, were $141 146 for Brazil, $153 461 for Singapore, and $125 193 for Spain. Durvalumab price adjustments to the PACIFIC data improved cost-effectiveness in Singapore, with an ICER of $45 164. The model was most sensitive to the utility of durvalumab.Conclusions and RelevanceIn this cost-effectiveness analysis of durvalumab as maintenance therapy for unresectable stage III NSCLC, the therapy was found to be cost-prohibitive from the perspective of various international payers according to country-specific willingness-to-pay thresholds per QALY. The findings of the study suggest that discounted durvalumab acquisition costs, as possible in Singapore, might improve cost-effectiveness globally.

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Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis

Cited by 4 publications

References 24 publications

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001–2020

International Cost-Effectiveness Analysis of Durvalumab in Stage III Non–Small Cell Lung Cancer

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