Predicting PICOs for EU HTA: The Validated PICO Planner Approach Based on Retrospective Analysis
Author(s)
Shivani Shah, Masters in Pharmacy1, Richard Wenzel, PhD2, Chad Gibson, MSC3, Akanksha Dubey, Masters in Pharmacy4, Ria Aradhyya, MA in Economics4, Alan Crowther, BA5.
1Eversana, Mumbai, India, 2Eversana, Munich, Germany, 3Eversana, Yardley, PA, USA, 4Eversana, Pune, India, 5Eversana, Philadelphia, PA, USA.
1Eversana, Mumbai, India, 2Eversana, Munich, Germany, 3Eversana, Yardley, PA, USA, 4Eversana, Pune, India, 5Eversana, Philadelphia, PA, USA.
OBJECTIVES: The European Union Health Technology Assessment Regulation (EU HTAR) and Joint Clinical Assessment (JCA) aim to harmonize clinical evaluations while allowing national Health Technology Assessment (HTA) decisions. Each country defines its own Population, Intervention, Comparator, and Outcomes (PICO). This research evaluated how targeted literature reviews using HTA reports, clinical guidelines, and reimbursement decisions—combined with a structured “PICO planner” methodology —can anticipate national and EU-level PICO requirements.
METHODS: PICOs were developed independently based on secondary research—without knowledge of European Network for Health Technology Assessment (EUnetHTA) results—using a three-step consolidation process aligned with HTA Coordination Group (HTACG) Scoping Guidelines. Populations were derived from draft labels and HTA reports; comparators from HTA reports, clinical guidelines, and reimbursement decisions; and outcomes from HTA reports, guidelines, and trial protocols. Exercises were conducted for four products across oncology (Pluvicto and non-small cell lung cancer [NSCLC]), rare disease (Pombiliti), and type 2 diabetes (T2DM). The methodology—developed using the NSCLC and T2DM indications—was applied to generate PICOs for all 27 EU member states. Outputs for Pluvicto and Pombiliti were subsequently validated against EUnetHTA scoping exercise
RESULTS: A consistent methodological approach and three-step consolidation process effectively predicted PICOs for all four drugs, with steps unchanged across products. Validation against EUnetHTA exercises showed 100% accuracy for population and outcome prediction for Pluvicto and Pombiliti, and 93-100% accuracy for comparator identification, one off-label comparator not cited in HTA documents was missed
CONCLUSIONS: The findings demonstrate that a structured, data-driven approach to evidence collection and consolidation can predict PICOs. These predictions can be further supported through validation with country affiliates and systematic literature reviews. This approach fosters collaboration with HTA stakeholders, enhances evidence planning, accelerates reviews, and promotes equitable, value-based access—positioning secondary research as a strategic enabler of patient-centered innovation across Europe.
METHODS: PICOs were developed independently based on secondary research—without knowledge of European Network for Health Technology Assessment (EUnetHTA) results—using a three-step consolidation process aligned with HTA Coordination Group (HTACG) Scoping Guidelines. Populations were derived from draft labels and HTA reports; comparators from HTA reports, clinical guidelines, and reimbursement decisions; and outcomes from HTA reports, guidelines, and trial protocols. Exercises were conducted for four products across oncology (Pluvicto and non-small cell lung cancer [NSCLC]), rare disease (Pombiliti), and type 2 diabetes (T2DM). The methodology—developed using the NSCLC and T2DM indications—was applied to generate PICOs for all 27 EU member states. Outputs for Pluvicto and Pombiliti were subsequently validated against EUnetHTA scoping exercise
RESULTS: A consistent methodological approach and three-step consolidation process effectively predicted PICOs for all four drugs, with steps unchanged across products. Validation against EUnetHTA exercises showed 100% accuracy for population and outcome prediction for Pluvicto and Pombiliti, and 93-100% accuracy for comparator identification, one off-label comparator not cited in HTA documents was missed
CONCLUSIONS: The findings demonstrate that a structured, data-driven approach to evidence collection and consolidation can predict PICOs. These predictions can be further supported through validation with country affiliates and systematic literature reviews. This approach fosters collaboration with HTA stakeholders, enhances evidence planning, accelerates reviews, and promotes equitable, value-based access—positioning secondary research as a strategic enabler of patient-centered innovation across Europe.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA271
Topic
Health Technology Assessment, Organizational Practices, Patient-Centered Research
Topic Subcategory
Systems & Structure
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), Oncology, Rare & Orphan Diseases