FIVE YEARS OF THE FIFARMA W.A.I.T. INDICATOR: A LONGITUDINAL ANALYSIS OF ONCOLOGY AND ORPHAN DRUG ACCESS IN LATIN AMERICA (2022-2026)
Author(s)
Diego F. Guarin, MPH, MSc, MD1, Carmen S. Lay Ma2, Francisca Rodriguez, MSc3, OSCAR COURTNEY, BSc4.
1ISPOR, Weston, FL, USA, 2FIFARMA, Frisco, TX, USA, 3cif chile, santiago, Chile, 4IQVIA, Mexico, Mexico.
1ISPOR, Weston, FL, USA, 2FIFARMA, Frisco, TX, USA, 3cif chile, santiago, Chile, 4IQVIA, Mexico, Mexico.
OBJECTIVES: The FIFARMA W.A.I.T. Indicator has monitored access to innovative medicines across Latin America since 2022. This study evaluated five-year trends (2022-2026) in regulatory approval and public availability timelines for oncology and orphan medicines to assess whether recent regulatory reliance initiatives have translated into faster patient access.
METHODS: A retrospective longitudinal analysis was conducted using aggregated data from five consecutive editions (2022-2026) of the FIFARMA W.A.I.T. Indicator, developed in collaboration with FIFARMA and IQVIA. FDA or EMA approved oncology and orphan medicines were tracked across ten Latin American countries. Outcomes included rates of availability and time to availability, defined as the interval between first global authorization and public reimbursement or broad public-sector access. Annual trends in regulatory and post-approval timelines were assessed descriptively.
RESULTS: Longitudinal trends reveal that despite increased regulatory tracking, the average time to availability for oncology and orphan therapies has remained steadily risen to a striking 68 months, showing no statistically significant improvement from the 2022 baseline year-on-year. As a critical structural shift in regulatory reliance frameworks occurred in some countries, stabilizing or decreasing times to approval, the reimbursement gap widened. By 2026, health technology assessment (HTA) and pricing gridlocks now account for over 50% of the total time to availability in many countries
CONCLUSIONS: Five years of data prove that measuring the bottleneck is no longer enough. While regulatory reliance successfully accelerates local approvals, it shifts the barrier towards the reimbursement phase. To turn the tide and begin to reverse the trend that has now surpassed 6 yrs, LATAM health systems must urgently transition from traditional HTA to specialized access pathways, such as European-style orphan funds and managed entry risk-sharing agreements.
METHODS: A retrospective longitudinal analysis was conducted using aggregated data from five consecutive editions (2022-2026) of the FIFARMA W.A.I.T. Indicator, developed in collaboration with FIFARMA and IQVIA. FDA or EMA approved oncology and orphan medicines were tracked across ten Latin American countries. Outcomes included rates of availability and time to availability, defined as the interval between first global authorization and public reimbursement or broad public-sector access. Annual trends in regulatory and post-approval timelines were assessed descriptively.
RESULTS: Longitudinal trends reveal that despite increased regulatory tracking, the average time to availability for oncology and orphan therapies has remained steadily risen to a striking 68 months, showing no statistically significant improvement from the 2022 baseline year-on-year. As a critical structural shift in regulatory reliance frameworks occurred in some countries, stabilizing or decreasing times to approval, the reimbursement gap widened. By 2026, health technology assessment (HTA) and pricing gridlocks now account for over 50% of the total time to availability in many countries
CONCLUSIONS: Five years of data prove that measuring the bottleneck is no longer enough. While regulatory reliance successfully accelerates local approvals, it shifts the barrier towards the reimbursement phase. To turn the tide and begin to reverse the trend that has now surpassed 6 yrs, LATAM health systems must urgently transition from traditional HTA to specialized access pathways, such as European-style orphan funds and managed entry risk-sharing agreements.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR136
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Study Approaches
Topic Subcategory
Health Disparities & Equity, Reimbursement & Access Policy
Disease
Oncology, Rare & Orphan Diseases