Life-Years Lost Due to Regulatory and Reimbursement Delays: A Study of Oncology Drugs Across England, Scotland, and France, 2022-2024
Author(s)
Diego Civitelli1, Panagiotis Therianos, BSc, MSc2, Jennifer Gill, BSc, MSc, PhD3, Panos Kanavos, BSc, MSc, PhD4.
1Research Officer, LSE, London, United Kingdom, 2Medical Technology Research Group at the LSE, London, United Kingdom, 3London School of Economics, London, United Kingdom, 4London School of Economics and Political Science, London, United Kingdom.
1Research Officer, LSE, London, United Kingdom, 2Medical Technology Research Group at the LSE, London, United Kingdom, 3London School of Economics, London, United Kingdom, 4London School of Economics and Political Science, London, United Kingdom.
OBJECTIVES: Innovative oncology drugs that improve survival outcomes often take years to reach patients due to lengthy regulatory and Health Technology Appraisal (HTA) assessments. This study investigates the Overall Survival (OS), Progression-Free Survival (PFS), Disease-Free Survival (DFS) and Event-Free Survival (EFS) years-lost as a result of such delays.
METHODS: All newly reimbursed drugs for prostate, breast and lung cancer in England, Scotland and France in 2022-2024 were included. Data on Marketing Authorization (MA) pathways, early-access schemes, HTA outcomes and respective dates were collected. Pivotal clinical trial results publication in peer-reviewed journals was used as a proxy for proof of efficacy (PoE). Magnitude of added clinical benefit was retrieved from clinical trials for each drug. The potential number of patients eligible for each drug in each country per year was estimated based on national epidemiological data. We multiplied the added clinical benefit by the number of eligible patients and time from PoE to MA and MA to HTA for each drug-indication pair.
RESULTS: The sample includes 23 agency-drug-indication triplets (7 approved in England, 8 in Scotland and 8 in France). Preliminary results indicate the average time from PoE to MA was 237, 275 and 338 days in England, Scotland and France, respectively. The average time from MA to HTA was 537, 650 and 33 days respectively. The total average delay from PoE to HTA decision was 774, 950 and 371 days respectively. 25062, 1787 and 43845 life-years were lost due to delays from PoE to MA. 21471, 4630 and 16682 life-years were lost because of delays from MA to HTA decision in England, Scotland and France, respectively. Full results will include the additional parameters outlined above.
CONCLUSIONS: Regulatory and reimbursement delays harm patients by limiting timely access to effective medicines. Regulators and HTAs should explore ways to further accelerate review processes.
METHODS: All newly reimbursed drugs for prostate, breast and lung cancer in England, Scotland and France in 2022-2024 were included. Data on Marketing Authorization (MA) pathways, early-access schemes, HTA outcomes and respective dates were collected. Pivotal clinical trial results publication in peer-reviewed journals was used as a proxy for proof of efficacy (PoE). Magnitude of added clinical benefit was retrieved from clinical trials for each drug. The potential number of patients eligible for each drug in each country per year was estimated based on national epidemiological data. We multiplied the added clinical benefit by the number of eligible patients and time from PoE to MA and MA to HTA for each drug-indication pair.
RESULTS: The sample includes 23 agency-drug-indication triplets (7 approved in England, 8 in Scotland and 8 in France). Preliminary results indicate the average time from PoE to MA was 237, 275 and 338 days in England, Scotland and France, respectively. The average time from MA to HTA was 537, 650 and 33 days respectively. The total average delay from PoE to HTA decision was 774, 950 and 371 days respectively. 25062, 1787 and 43845 life-years were lost due to delays from PoE to MA. 21471, 4630 and 16682 life-years were lost because of delays from MA to HTA decision in England, Scotland and France, respectively. Full results will include the additional parameters outlined above.
CONCLUSIONS: Regulatory and reimbursement delays harm patients by limiting timely access to effective medicines. Regulators and HTAs should explore ways to further accelerate review processes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA222
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Oncology