Authors
Ryazhenov V. V.
Abstract
Introduction. Triple-negative breast cancer (TNBC) is diagnosed in approximately 12,700 Russian women annually, with aggressive disease course, high relapse risk within three years, and significant healthcare burden. Treatment of metastatic TNBC costs the mandatory health insurance system RUB 4.8–7.2 million per patient – substantially exceeding the cost of a neoadjuvant immunotherapy course – making relapse prevention a compelling economic priority. Aim. To conduct a comprehensive pharmacoeconomic evaluation of camrelizumab in neoadjuvant treatment of stage II–III TNBC in the Russian healthcare context, supporting its inclusion in state reimbursement programmes. Methods. Markov model with lifetime horizon; cost-effectiveness analysis, budget impact analysis, dominance analysis. Clinical data source: CamRelief trial (JAMA, 2025). Payer perspective: Russian OMS. Results. In the base case (neoadjuvant + adjuvant phases), ICER was RUB 2.14 million/QALY, below the willingness-to-pay threshold of RUB 4.10 million/QALY. In the priority scenario specifically endorsed by the Expert Council – neoadjuvant phase only, without subsequent adjuvant immunotherapy – per-patient costs fall to RUB 1.52 million and ICER decreases to RUB 666,100/QALY, 6.2-fold below the threshold and is unprecedented in immunotherapy in Russia. When accounting for prevented GDP losses (RUB 2.44 million/patient), this regimen achieves full social cost-neutrality. Prevention of metastatic progression yields additional cohort-level savings of ≥RUB 3.1–4.7 billion. Conclusion. Camrelizumab has been included in the Russian Essential Medicines List (ZHNVLP). Urgent next steps are integration into RUSSCO and Ministry of Health clinical guidelines and OMS reimbursement tariffs. The neoadjuvant monophase regimen represents the optimal balance of efficacy, safety, and state economic benefit.
Key words
triple-negative breast cancer, camrelizumab, pharmacoeconomics, cost-effectiveness analysis, budget impact analysis, health technology assessment, essential medicines list, neoadjuvant immunotherapy
DOI
References
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