EFFECT OF PRICE REGULATION POLICY AND OTHER SYSTEMIC FACTORS ON THE AVAILABILITY OF CANCER MEDICINES IN THE REPUBLIC OF MOLDOVA: A 15-YEAR ANALYSIS (2011-2026)
Author(s)
Elena Chitan, MPH, PharmD1, Adrian Cojocaru, Pharmacist student2, Constantin Nedelea, Pharmacist3, Liliana Dogotari, PhD4, Valentina Buliga, PhD4, Stela Adauji, Habilitated doctor of pharmacy4.
1Assistant, Department of Social Pharmacy "Vasile Procopisin", Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 2Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 3Medicine and Medical Devices Agency, Chisinau, Moldova, Republic of, 4Vasile Procopisin Department of Social Pharmacy, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of.
1Assistant, Department of Social Pharmacy "Vasile Procopisin", Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 2Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 3Medicine and Medical Devices Agency, Chisinau, Moldova, Republic of, 4Vasile Procopisin Department of Social Pharmacy, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of.
OBJECTIVES: Equitable access to oncology medicines remains a systemic challenge. In the Republic of Moldova, cancer is a leading cause of mortality, yet access to oncology medicines is constrained by systemic barriers. This study analysed national pricing and regulatory mechanisms and the 2011-2026 evolution of antineoplastic medicine availability in relation to price regulation and other systemic factors.
METHODS: A retrospective descriptive-analytical mixed policy study triangulated documentary evidence, national legislation, essential medicines lists, the State Register of Medicines, the National Catalogue of Manufacturer Prices (2011-2026), and centralized procurement outcomes for oncology and immunosuppressive medicines (2022-2026).
RESULTS: Catalogue-listed INNs contracted from 80 in 2011 to 40 in 2021, corresponding to a 50% reduction, followed by partial recovery to 57 in 2025. Registered manufacturers decreased from 158 to 75, representing a 52.5% decline over the study period, with a statistically significant downward trend (Mann-Kendall Z=−3.80, p<0.001) and a compound annual change of −5.18%. Of 87 analyzed INNs, 35 (40.2%) disappeared from the market, and more than thirty depended on a single manufacturer, indicating high supply vulnerability. Only two INNs, methotrexate and zoledronic acid, met strict stability criteria, while declining trends outnumbered increasing trends by 6.3:1. After 2021, 14 new ATC subgroups emerged, including targeted therapies, immune-checkpoint inhibitors, and monoclonal antibodies. This increased Shannon diversity from 3.136 to 3.471, but diversification occurred alongside the disappearance of supportive therapeutic classes, including erythropoietins. Alignment of the national essential medicines list with WHO-referenced oncology priorities reached 90.0%; however, market authorization covered only 57.5%, leaving 26 listed INNs unauthorized. Centralized procurement performance also deteriorated, with success declining from 88.1% in 2022 to 68.1% in 2026.
CONCLUSIONS: Cancer medicine availability followed a biphasic trajectory: classical generics contracted, while modern therapies emerged thinly. Price regulation alone cannot secure sustainable availability; Moldova needs integrated value-based governance linking HTA, managed entry agreements, procurement-risk monitoring, and financing.
METHODS: A retrospective descriptive-analytical mixed policy study triangulated documentary evidence, national legislation, essential medicines lists, the State Register of Medicines, the National Catalogue of Manufacturer Prices (2011-2026), and centralized procurement outcomes for oncology and immunosuppressive medicines (2022-2026).
RESULTS: Catalogue-listed INNs contracted from 80 in 2011 to 40 in 2021, corresponding to a 50% reduction, followed by partial recovery to 57 in 2025. Registered manufacturers decreased from 158 to 75, representing a 52.5% decline over the study period, with a statistically significant downward trend (Mann-Kendall Z=−3.80, p<0.001) and a compound annual change of −5.18%. Of 87 analyzed INNs, 35 (40.2%) disappeared from the market, and more than thirty depended on a single manufacturer, indicating high supply vulnerability. Only two INNs, methotrexate and zoledronic acid, met strict stability criteria, while declining trends outnumbered increasing trends by 6.3:1. After 2021, 14 new ATC subgroups emerged, including targeted therapies, immune-checkpoint inhibitors, and monoclonal antibodies. This increased Shannon diversity from 3.136 to 3.471, but diversification occurred alongside the disappearance of supportive therapeutic classes, including erythropoietins. Alignment of the national essential medicines list with WHO-referenced oncology priorities reached 90.0%; however, market authorization covered only 57.5%, leaving 26 listed INNs unauthorized. Centralized procurement performance also deteriorated, with success declining from 88.1% in 2022 to 68.1% in 2026.
CONCLUSIONS: Cancer medicine availability followed a biphasic trajectory: classical generics contracted, while modern therapies emerged thinly. Price regulation alone cannot secure sustainable availability; Moldova needs integrated value-based governance linking HTA, managed entry agreements, procurement-risk monitoring, and financing.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR182
Topic
Health Policy & Regulatory, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology