INSTITUTIONAL IMPLEMENTATION OF ESMO-MCBS VALUE ASSESSMENT IN ONCOLOGY FORMULARY MANAGEMENT: A TERTIARY HEALTHCARE SYSTEM STUDY
Author(s)
Mansour Khan, BSc Pharmacy1, Laila Abu Esba2.
1MNGHA, Riyadh, Saudi Arabia, 2Physician, KSA, Riyadh, Saudi Arabia.
1MNGHA, Riyadh, Saudi Arabia, 2Physician, KSA, Riyadh, Saudi Arabia.
OBJECTIVES: Background: The increasing volume of oncology drug approvals has placed substantial demands on institutional formulary decision-making processes. Many newly approved therapies demonstrate modest improvements in survival or quality of life, highlighting the need for structured approaches to prioritize evaluation and resource allocation. The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) provides a standardized framework for assessing anticipated clinical benefit; however, its operational impact on institutional workflows remains unclear.
METHODS:
Methods: A retrospective cohort study of 54 oncology drug-indication pairs undergoing institutional formulary evaluation and 32 oncology therapies submitted through the non-formulary (NF) pathway at the Ministry of National Guard Health Affairs (MNGHA), a large government-funded healthcare system in Saudi Arabia, between January 2023 and December 2025 was conducted. Therapies were scored using ESMO-MCBS and categorized by clinical-benefit level (scores ≥3 or grade A-B vs scores ≤2 or grade C). Approval outcomes, time to formulary decision, and projected annual acquisition costs of rejected therapies were assessed. Time to decision was analyzed using Kaplan-Meier methodology with log-rank testing.
RESULTS:
Results: Approval rates were highest for high benefit therapies (ESMO MCBS ≥4/A; 91.7%), lower for intermediate benefit therapies (69.6%), and lowest for low benefit therapies. Kaplan-Meier analysis demonstrated significantly shorter time to formulary decision among therapies with higher clinical benefit (log-rank p = 0.019). Rejection of low-benefit therapies was associated with an estimated annual cost avoidance of approximately 60.4 million SAR, with therapies scoring ≤2 accounting for 73.5% of projected savings.
CONCLUSIONS: Conclusions: Structured magnitude-of-benefit frameworks may support more efficient allocation of evaluative resources and optimize institutional oncology formulary decision-making.
METHODS:
Methods: A retrospective cohort study of 54 oncology drug-indication pairs undergoing institutional formulary evaluation and 32 oncology therapies submitted through the non-formulary (NF) pathway at the Ministry of National Guard Health Affairs (MNGHA), a large government-funded healthcare system in Saudi Arabia, between January 2023 and December 2025 was conducted. Therapies were scored using ESMO-MCBS and categorized by clinical-benefit level (scores ≥3 or grade A-B vs scores ≤2 or grade C). Approval outcomes, time to formulary decision, and projected annual acquisition costs of rejected therapies were assessed. Time to decision was analyzed using Kaplan-Meier methodology with log-rank testing.
RESULTS:
Results: Approval rates were highest for high benefit therapies (ESMO MCBS ≥4/A; 91.7%), lower for intermediate benefit therapies (69.6%), and lowest for low benefit therapies. Kaplan-Meier analysis demonstrated significantly shorter time to formulary decision among therapies with higher clinical benefit (log-rank p = 0.019). Rejection of low-benefit therapies was associated with an estimated annual cost avoidance of approximately 60.4 million SAR, with therapies scoring ≤2 accounting for 73.5% of projected savings.
CONCLUSIONS: Conclusions: Structured magnitude-of-benefit frameworks may support more efficient allocation of evaluative resources and optimize institutional oncology formulary decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR131
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Organizational Practices
Topic Subcategory
Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Rare & Orphan Diseases