G-BA finds no added benefit for ixekizumab in paediatric enthesitis-associated arthritis after comparator-relevance review.
On 19 March 2026, G-BA concluded that added benefit is not proven for ixekizumab in paediatric enthesitis-associated arthritis after reviewing comparator relevance and the available evidence package.
What NICE TA1142 Reveals About Biomarker-Stratified Evidence Standards and Stopping-Rule Design for First-in-Class Biologics.
NICE published final guidance TA1142 on 26 March 2026, recommending dupilumab as add-on maintenance treatment for uncontrolled COPD in adults with blood eosinophils of 300 cells per microlitre or more. The decision is notable for approving a first-in-class biologic in a chronic non-oncology indication where no prior biological benchmark existed. The committee accepted a stopping rule based on exacerbation counts, rejected biomarker change as a surrogate, and required cost-effectiveness…
NICE's New EQ-5D-5L Value Set: What It Means for QALY Utility Measurement and Cost-Effectiveness Submissions.
NICE has announced it will adopt a newly published EQ-5D-5L value set, replacing the three-level tariff derived from data collected in the early 1990s. A consultation on implementation is expected to open in April 2026. This article explains the methodological difference between the 3L and 5L value sets, why the transition matters for quality-adjusted life-year (QALY) calculations, and the concrete steps evidence teams should take to future-proof cost-effectiveness analyses ahead of the change.
HAS France NMA Acceptability Framework: A Cross-Agency Evidence Planning Playbook.
France's Haute Autorité de Santé (HAS) publishes explicit validity conditions for indirect treatment comparison (ITC) evidence that diverge from the binary RCT-only stance historically associated with German AMNOG. Understanding these conditions — and how they intersect with IQWiG and NICE methodology — is one of the highest-leverage planning activities a global evidence team can perform. This playbook maps the HAS acceptability framework for network meta-analysis (NMA) evidence, compares it…
Bridging HAS and IQWiG Evidence Standards: A Cross-Border Network Meta-Analysis Planning Playbook.
France and Germany impose distinct but reconcilable methodological requirements on indirect treatment comparison evidence. This playbook maps the divergences between HAS and IQWiG and provides an actionable architecture for building a single NMA and MAIC evidence package that satisfies both national agencies — reducing submission rework and eliminating cross-dossier inconsistency risk.
FDA expands SOGROYA pediatric scope via three efficacy supplements across growth-disorder cohorts.
The FDA recorded three efficacy-supplement approvals on 27 February 2026 for SOGROYA, extending pediatric indications to short stature born small for gestational age, Noonan syndrome, and idiopathic short stature with phase 3 basket-study evidence anchored on annualized height velocity.
EMA update-cadence triage: a PIP and PSUSA evidence-maintenance playbook for HTA teams.
Between 17 and 20 March 2026, EMA recorded dense waves of new and updated content across medicine, paediatric investigation plan, and pharmacovigilance pages. This playbook shows how evidence teams can operationalize that cadence as a structured monitoring and re-baselining workflow before submission risk accumulates.
MHRA's patient-information modernisation and device advice refresh set a new evidence-operations baseline.
MHRA updates published between 12 and 18 March 2026 indicate a tighter operational cadence for patient information and medical device regulatory advice. This playbook translates those signals into concrete evidence-governance actions for HTA and market access teams.
EMA Management Board ePI roadmap turns product-information governance into an HTA evidence operations priority.
EMA Management Board updates on 13 March 2026 position electronic product information and implementation governance as immediate evidence-operations triggers. This playbook shows how decision teams can operationalise change detection, ITC assumption control, and auditable rerun logic.
PBAC updates December intracycle outcomes with blinatumomab listing amendments for newly diagnosed Ph-positive precursor B-cell ALL.
In an outcomes page updated on 13 March 2026, PBAC confirmed recommended PBS listing amendments for blinatumomab in newly diagnosed Philadelphia chromosome-positive precursor B-cell acute lymphoblastic leukaemia, with evidence lineage centred on the phase 2 single-arm D-ALBA programme.
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