CLOSING THE LOOP IN HOSPITAL-BASED HTA: FROM ASSESSMENT TO REAL-WORLD OUTCOMES OF ADJUVANT OSIMERTINIB
Author(s)
Ana Soares, PharmD1, Maria Lourenço, PharmD2, Armando Alcobia, PharmD2.
1Pharmacist, Hosp Garcia de Orta, Almada, Portugal, 2ULS Almada-Seixal, Almada, Portugal.
1Pharmacist, Hosp Garcia de Orta, Almada, Portugal, 2ULS Almada-Seixal, Almada, Portugal.
OBJECTIVES: To demonstrate how hospital pharmacists contribute to a continuous Health Technology Assessment (HTA) cycle by integrating assessment, decision-making, and evaluation of real-world outcomes using adjuvant osimertinib as a case study.
METHODS: Osimertinib was evaluated through a structured hospital-based (HB)-HTA framework based on evidence from the ADAURA trial and approved. A retrospective analysis of patients treated with adjuvant osimertinib in clinical practice was conducted, including treatment duration, safety, and pharmaceutical interventions. Outcomes were analyzed to assess alignment with initial HTA expectations.
RESULTS: A structured HB-HTA assessment of adjuvant osimertinib was conducted based on clinical evidence from the ADAURA trial, incorporating clinical benefit, safety, and cost considerations, and supporting its adoption with defined treatment duration (3 years) and patient selection criteria. Following HB-HTA-based adoption, 9 patients received adjuvant osimertinib after tumor resection. Mean treatment duration was 18,1 months [3,1-28,4 months], with all patients remaining on therapy at the time of analysis, without disease progression. Adverse events were common but manageable, with 55.5% of patients requiring dose adjustments, while 44.5% reported no adverse events. Dose modifications were more frequent in clinical practice compared to those reported in the ADAURA trial (approximately 9-12%), reflecting the complexity of real-world patients. Pharmaceutical care was provided to all patients, with medication review identifying potential drug interactions in over half of cases. In this context, pharmacist-led follow-up supports treatment optimization and may facilitate continued therapy despite higher rates of dose adjustment.
CONCLUSIONS: Hospital pharmacists play a central role in “closing the loop” of HTA by linking initial evaluation to real-world implementation and outcome monitoring. In the case of adjuvant osimertinib, real-world use aligned with expectations derived from the HTA process and clinical trial framework. This continuous evaluation cycle supports optimized use of high-impact therapies and reinforces the value of integrating HTA into routine clinical practice.
METHODS: Osimertinib was evaluated through a structured hospital-based (HB)-HTA framework based on evidence from the ADAURA trial and approved. A retrospective analysis of patients treated with adjuvant osimertinib in clinical practice was conducted, including treatment duration, safety, and pharmaceutical interventions. Outcomes were analyzed to assess alignment with initial HTA expectations.
RESULTS: A structured HB-HTA assessment of adjuvant osimertinib was conducted based on clinical evidence from the ADAURA trial, incorporating clinical benefit, safety, and cost considerations, and supporting its adoption with defined treatment duration (3 years) and patient selection criteria. Following HB-HTA-based adoption, 9 patients received adjuvant osimertinib after tumor resection. Mean treatment duration was 18,1 months [3,1-28,4 months], with all patients remaining on therapy at the time of analysis, without disease progression. Adverse events were common but manageable, with 55.5% of patients requiring dose adjustments, while 44.5% reported no adverse events. Dose modifications were more frequent in clinical practice compared to those reported in the ADAURA trial (approximately 9-12%), reflecting the complexity of real-world patients. Pharmaceutical care was provided to all patients, with medication review identifying potential drug interactions in over half of cases. In this context, pharmacist-led follow-up supports treatment optimization and may facilitate continued therapy despite higher rates of dose adjustment.
CONCLUSIONS: Hospital pharmacists play a central role in “closing the loop” of HTA by linking initial evaluation to real-world implementation and outcome monitoring. In the case of adjuvant osimertinib, real-world use aligned with expectations derived from the HTA process and clinical trial framework. This continuous evaluation cycle supports optimized use of high-impact therapies and reinforces the value of integrating HTA into routine clinical practice.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA258
Topic
Clinical Outcomes, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology