WHEN EVIDENCE MOVES FASTER THAN GUIDELINES: MAINTAINING SYNCHRONIZATION ACROSS REGULATORY, CLINICAL, AND HTA MILESTONES IN BREAST CANCER (BC)
Author(s)
Stacy Grieve, PhD1, Anna Forsythe, MBA, MSc, PharmD1, Peter Kaufman, MD2.
1Oncoscope, Miami, FL, USA, 2The University of Vermont, Miami, FL, USA.
1Oncoscope, Miami, FL, USA, 2The University of Vermont, Miami, FL, USA.
OBJECTIVES: In rapidly evolving oncology indications, regulatory approvals, guideline updates, conference presentations, and HTA assessments occur on different timelines. Traditional SLRs are updated periodically and may fail to capture pivotal evidence changes when they occur, creating evidence synchronization challenges for market access and HTA planning. This study evaluated whether a Real-Time AI-Assisted Living SLR (REAL-SLR) can maintain alignment between evolving evidence and key decision-making milestones in BC.
METHODS: A PRISMA-aligned, continuously-updated REAL-SLR was established in BC using a protocol-driven search strategy. Evidence from interventional clinical trials, regulatory approvals, clinical guidelines, and HTA reviews were systematically identified and structured. A year-in-review of studies of antibody-drug conjugates (ADCs) published from January 1, 2025 to June 16, 2026 was conducted. Evidence capture and update timelines were compared with a traditional SLR approach.
RESULTS: During the study period, the REAL-SLR captured 690 interventional trials, 5 regulatory approvals, 4 guideline updates, and 1 new HTA review. Among 104 ADC studies identified, 81 were conducted in metastatic (m)BC and 23 in early-stage disease. Three of five regulatory approvals involved ADCs. In mBC, 20 phase 2/3 randomized controlled trials were identified, including 19 reporting congress data and 9 presenting new results at ASCO 2026 or ESMO-Breast 2026. In early-stage BC, two regulatory approvals for trastuzumab deruxtecan for the neoadjuvant and adjuvant setting occurred within a one-week period, whereas incorporation into US treatment guidelines lagged by approximately one month. During this interval, additional subgroup, safety, QOL and efficacy results became available. Compared with traditional SLRs, REAL-SLR identified relevant evidence changes 6-12 months earlier, reduced incorporation time for conference data by 75% and eliminated 3-5 custom SLR updates during development.
CONCLUSIONS: In BC, evolving evidence and decision-making milestones frequently occur on asynchronous timelines. REAL-SLR may reduce evidence synchronization risk, improve HTA and market access preparedness, and support timely evidence generation and reimbursement decision-making.
METHODS: A PRISMA-aligned, continuously-updated REAL-SLR was established in BC using a protocol-driven search strategy. Evidence from interventional clinical trials, regulatory approvals, clinical guidelines, and HTA reviews were systematically identified and structured. A year-in-review of studies of antibody-drug conjugates (ADCs) published from January 1, 2025 to June 16, 2026 was conducted. Evidence capture and update timelines were compared with a traditional SLR approach.
RESULTS: During the study period, the REAL-SLR captured 690 interventional trials, 5 regulatory approvals, 4 guideline updates, and 1 new HTA review. Among 104 ADC studies identified, 81 were conducted in metastatic (m)BC and 23 in early-stage disease. Three of five regulatory approvals involved ADCs. In mBC, 20 phase 2/3 randomized controlled trials were identified, including 19 reporting congress data and 9 presenting new results at ASCO 2026 or ESMO-Breast 2026. In early-stage BC, two regulatory approvals for trastuzumab deruxtecan for the neoadjuvant and adjuvant setting occurred within a one-week period, whereas incorporation into US treatment guidelines lagged by approximately one month. During this interval, additional subgroup, safety, QOL and efficacy results became available. Compared with traditional SLRs, REAL-SLR identified relevant evidence changes 6-12 months earlier, reduced incorporation time for conference data by 75% and eliminated 3-5 custom SLR updates during development.
CONCLUSIONS: In BC, evolving evidence and decision-making milestones frequently occur on asynchronous timelines. REAL-SLR may reduce evidence synchronization risk, improve HTA and market access preparedness, and support timely evidence generation and reimbursement decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA338
Topic
Health Technology Assessment, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Systems & Structure
Disease
Oncology