PREPARING FOR JOINT CLINICAL ASSESSMENT: COMPARING HTA COMPARATORS, CLINICAL PRACTICE, AND REAL-WORLD FIRST-LINE NSCLC TREATMENT IN THE EU4 + UK
Author(s)
Ramandeep Kaur, PhD.1, Divya Pushkarna, B. Tech1, Mir-Masoud Pourrahmat, BSc1, Jean-Paul Collet, MD, PhD1, Mir Sohail Fazeli, MD, PhD1, Massoud Toussi, MD, PhD, MBA2.
1Evidinno Outcomes Research Inc., Vancouver, BC, Canada, 2United BioSource LLC., Paris, France.
1Evidinno Outcomes Research Inc., Vancouver, BC, Canada, 2United BioSource LLC., Paris, France.
OBJECTIVES: The EU HTA Regulation introduces Joint Clinical Assessments to harmonize relative effectiveness evaluation across Europe, with comparator selection intended to reflect clinically relevant alternatives. This study assessed alignment between HTA-defined comparators, clinical practice guidelines, and real-world (RW) standards of care (SoC) across EU4+UK in advanced NSCLC, focusing on biomarker-defined subgroups.
METHODS: HTA appraisals (2021-2026) from NICE, G‑BA, HAS, AIFA, and AEMPS for first-line advanced NSCLC were reviewed. Alignment analysis was focused on commonly reported biomarker subgroups. Clinical practice recommendations were obtained from national and ESMO-aligned guidelines. RW-treatment patterns were derived from published observational studies reflecting RW SoC, defined as most frequently used regimen. Alignment with HTA, RW and guideline comparators was qualitatively classified as aligned, partially aligned, limited, or not aligned.
RESULTS: Forty-eight HTA appraisals were identified and comparators were extracted. Of these, 18 appraisals met the subpopulation criteria: PD‑L1 ≥50%, EGFR-mutated, and ALK-positive populations. Comparator patterns varied by subgroup: EGFR converged, ALK diverged moderately, PD‑L1 ≥50% highly heterogeneous (immunotherapy versus chemotherapy). Triangulation with clinical practice guidelines showed consistent recommendation of targeted therapies in EGFR/ALK and IO monotherapy in PD‑L1 ≥50%, aligning with RW-treatment patterns. Alignment with HTA comparators remained lowest in PD‑L1 ≥50% (16.6-33.3%; 2/6 aligned, 1/6 partially aligned), moderate-high in ALK (75%;3/4 aligned), high in EGFR (100%; 8/8 aligned), where treatment pathways are more consistent and dominated by targeted therapies. Cross-country variation observed, with higher alignment in UK/Italy (100%; UK:4/4; Italy:3/3), followed by Germany (80%;4/5), Spain (50%;1/2) and France (25%;1/4). Misalignment was driven by chemotherapy-based comparators and incomplete representation of combination regimens.
CONCLUSIONS: HTA-defined comparators only partially reflect RW practice in EU+UK NSCLC, with greatest misalignment in PD‑L1 ≥50% and higher alignment in EGFR and ALK. These findings highlight variation in comparators across Europe and suggest that incorporating RW-treatment patterns during PICO-scoping may improve relevance of EU-JCA assessments.
METHODS: HTA appraisals (2021-2026) from NICE, G‑BA, HAS, AIFA, and AEMPS for first-line advanced NSCLC were reviewed. Alignment analysis was focused on commonly reported biomarker subgroups. Clinical practice recommendations were obtained from national and ESMO-aligned guidelines. RW-treatment patterns were derived from published observational studies reflecting RW SoC, defined as most frequently used regimen. Alignment with HTA, RW and guideline comparators was qualitatively classified as aligned, partially aligned, limited, or not aligned.
RESULTS: Forty-eight HTA appraisals were identified and comparators were extracted. Of these, 18 appraisals met the subpopulation criteria: PD‑L1 ≥50%, EGFR-mutated, and ALK-positive populations. Comparator patterns varied by subgroup: EGFR converged, ALK diverged moderately, PD‑L1 ≥50% highly heterogeneous (immunotherapy versus chemotherapy). Triangulation with clinical practice guidelines showed consistent recommendation of targeted therapies in EGFR/ALK and IO monotherapy in PD‑L1 ≥50%, aligning with RW-treatment patterns. Alignment with HTA comparators remained lowest in PD‑L1 ≥50% (16.6-33.3%; 2/6 aligned, 1/6 partially aligned), moderate-high in ALK (75%;3/4 aligned), high in EGFR (100%; 8/8 aligned), where treatment pathways are more consistent and dominated by targeted therapies. Cross-country variation observed, with higher alignment in UK/Italy (100%; UK:4/4; Italy:3/3), followed by Germany (80%;4/5), Spain (50%;1/2) and France (25%;1/4). Misalignment was driven by chemotherapy-based comparators and incomplete representation of combination regimens.
CONCLUSIONS: HTA-defined comparators only partially reflect RW practice in EU+UK NSCLC, with greatest misalignment in PD‑L1 ≥50% and higher alignment in EGFR and ALK. These findings highlight variation in comparators across Europe and suggest that incorporating RW-treatment patterns during PICO-scoping may improve relevance of EU-JCA assessments.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA103
Topic
Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Oncology