HEALTH ECONOMICS PUBLISHED EVIDENCE FOR FDA-APPROVED DRUGS (2022-2023): AVAILABILITY, TIMING & DISSEMINATION PATHWAY
Author(s)
Kamilla Guliyeva, MSc1, Benjamin White, MSc1, Sandra Milev, MSc1, Anne Heyes, MBA2, Monique Martin, MBA, MSc, PharmD3;
1Red Nucleus, HEOR, Yardley, PA, USA, 2Red Nucleus, HEOR, London, United Kingdom, 3Red Nucleus, London, United Kingdom
1Red Nucleus, HEOR, Yardley, PA, USA, 2Red Nucleus, HEOR, London, United Kingdom, 3Red Nucleus, London, United Kingdom
OBJECTIVES: To characterize the availability, dissemination pathways, and timing of publicly available health economics (HE) publications for drugs approved by the U.S. Food and Drug Administration (FDA) in 2022-2023.
METHODS: FDA-approved drugs from 2022-2023 were identified, and targeted searches were conducted to capture publicly available HE publications relevant to the US context. Dissemination pathways were classified as abstract only, journal only, or both. Time from FDA approval to first HE publication was assessed using Kaplan-Meier methods. Analyses were stratified by year, disease area, study type, and annual list price quartile. Publications were limited to those appearing within 24 months of FDA approval.
RESULTS: Among 92 FDA-approved drugs, 48% had at least one public HE publication within 24 months. Dissemination pathways were abstract only (11%), journal only (18%), and both abstract and journal (18%). Median time to first HE publication was 9.0 months post-approval. Kaplan-Meier estimates indicated that 34% of drugs had an HE publication within 12 months and 48% within 24 months. Oncology products were most likely to have at least one HE publication (69%), compared with chronic disease (31%) and rare disease products (33%). Median time to first publication was 8.9 months for oncology, 8.2 months for chronic disease, and 11.6 months for rare disease. Among journal publications, cost-effectiveness/cost-utility analyses predominated (72%), followed by budget impact analyses (19%) and costing studies (11%). Drugs in the highest price quartile had the lowest proportion with HE evidence (39%) and the longest median time to first HE publication (13.0 months).
CONCLUSIONS: In the United States, publicly available HE evidence was absent within two years of FDA approval for about half of newly approved drugs; when available, it typically emerged months after approval, highlighting persistent gaps in timely, payer relevant HE evidence to support US coverage and reimbursement decisions.
METHODS: FDA-approved drugs from 2022-2023 were identified, and targeted searches were conducted to capture publicly available HE publications relevant to the US context. Dissemination pathways were classified as abstract only, journal only, or both. Time from FDA approval to first HE publication was assessed using Kaplan-Meier methods. Analyses were stratified by year, disease area, study type, and annual list price quartile. Publications were limited to those appearing within 24 months of FDA approval.
RESULTS: Among 92 FDA-approved drugs, 48% had at least one public HE publication within 24 months. Dissemination pathways were abstract only (11%), journal only (18%), and both abstract and journal (18%). Median time to first HE publication was 9.0 months post-approval. Kaplan-Meier estimates indicated that 34% of drugs had an HE publication within 12 months and 48% within 24 months. Oncology products were most likely to have at least one HE publication (69%), compared with chronic disease (31%) and rare disease products (33%). Median time to first publication was 8.9 months for oncology, 8.2 months for chronic disease, and 11.6 months for rare disease. Among journal publications, cost-effectiveness/cost-utility analyses predominated (72%), followed by budget impact analyses (19%) and costing studies (11%). Drugs in the highest price quartile had the lowest proportion with HE evidence (39%) and the longest median time to first HE publication (13.0 months).
CONCLUSIONS: In the United States, publicly available HE evidence was absent within two years of FDA approval for about half of newly approved drugs; when available, it typically emerged months after approval, highlighting persistent gaps in timely, payer relevant HE evidence to support US coverage and reimbursement decisions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE312
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas