EMA weekly PIP and PSUSA cadence is now an evidence-maintenance signal, not admin noise
EMA updates from 3 to 10 March 2026 show dense PIP and PSUSA activity. For evidence teams, this is a practical trigger to run weekly lifecycle triage, versioned ITC assumption tracking, and audit-ready refresh workflows.
CEE HTA bodies like Poland's AOTMiT face a dual challenge: aligning domestic benefit-assessment methodology with EU JCA evidence standards for ITC & NMA while preserving reimbursement integrity. A practical playbook for market-access teams.
https://www.mattheneus.com/editorial/aotmit-poland-itc-nma-eu-jca-evidence-standards-cee-market-access-playbook-2026-03-27#HTA #NMA #EvidenceSynthesis #RegulatoryAffairs
AOTMiT and the EU JCA Era: How Central and Eastern European HTA Bodies Are Operationalising ITC and NMA Evidence Standards
As EU JCA joint clinical assessments move from pilot to routine in 2025–2026, Central and Eastern European HTA bodies face a dual challenge: satisfying the HTA Coordination Group's evidence expectations for indirect treatment comparisons (ITC) and network meta-analysis (NMA) while maintaining the integrity of domestic reimbursement processes.
Publication bias is systematically under-tested in NMA dossiers — a scoping review of 22 critical appraisal instruments confirms no standardised decision rules exist. Comparison-adjusted funnel plots should be mandatory in HTA submissions:
https://www.mattheneus.com/editorial/fallback-canary-publication-bias-nma-comparison-adjusted-funnel-plot-playbook-2026-03-28 #HTA #NMA #EvidenceSynthesis #RegulatoryAffairs
Publication Bias in Network Meta-Analysis: Why Comparison-Adjusted Funnel Plots Should Be Standard in HTA Submissions
A scoping review of 22 NMA critical appraisal instruments (Mondragon et al., J Clin Epidemiol, 2026) confirms that publication bias lacks standardised decision rules across all major tools. Comparison-adjusted funnel plots and selection model diagnostics are often absent from HTA submissions even as NICE and EU JCA assessors flag the omission. This playbook covers the three-layer protocol that should be standard in any NMA dossier.
Validating the GRADE Dominant First-Order Loop Shortcut in Network Meta-Analysis: What the Evidence Says
A 2026 Journal of Clinical Epidemiology case study tested the GRADE dominant first-order loop shortcut for network meta-analysis certainty ratings across 103 indirect comparisons and found discordant ratings in only 6% of cases, with few decision-relevant downgrades.
CADTH Reimbursement Reviews: ITC and NMA Evidence Standards for Canadian Market Access
Canada’s CADTH Reimbursement Review (CRR) process imposes distinct indirect treatment comparison (ITC) and network meta-analysis (NMA) evidence standards that differ materially from EMA, NICE, and G-BA requirements. This playbook decodes CADTH’s pharmacoeconomic guidelines, the expert review committee’s approach to unanchored matching-adjusted indirect comparisons, and the evidence-synthesis quality thresholds that determine whether a reimbursement recommendation is positive, conditional, or...
IQWiG A25-156: Added Benefit Not Proven for Iptacopan in Paroxysmal Nocturnal Haemoglobinuria
IQWiG's March 2026 A25-156 assessment concluded no added benefit proven for iptacopan in PNH due to comparator misalignment in the submitted evidence. The AMNOG decision reflects evidence-design constraints, not absence of clinical effect.
Sweden's TLV Opens Consultation on New Regulations Governing Medicine Subsidy and Pricing Applications
On 20 March 2026, Tandvards- och lakemedelsformansverket (TLV), Sweden's Dental and Pharmaceutical Benefits Agency, opened a public consultation on proposed new regulations for medicine subsidy and pricing applications — with changes to application requirements for new medicines and a new simplified procedure for established substances. The deadline for comments is 10 April 2026, with the regulations proposed to enter into force on 1 July 2026.
Non-Proportional Hazards in Network Meta-Analysis: A Five-Step Governance Protocol for Time-to-Event HTA Submissions
The proportional hazards (PH) assumption underpins the standard hazard ratio approach to network meta-analysis (NMA) of time-to-event outcomes. When that assumption fails — as increasingly observed in oncology with immunotherapy and combination regimens — evidence teams must switch to non-PH NMA methods or risk producing biased comparative effectiveness estimates. This playbook sets out a five-step governance protocol covering PH diagnostics, model selection, sensitivity analysis, result...
Sweden's TLV Grants Limited Reimbursement for Avapritinib (Ayvakyt) in GIST and Systemic Mastocytosis
Sweden's TLV granted limited reimbursement for avapritinib (Ayvakyt) in GIST and systemic mastocytosis on 24 March 2026, effective April 2026. The decision reinforces Nordic HTA willingness to accept single-arm trial evidence in high-need rare oncology and illustrates the indirect treatment comparison and health economic modelling demands for sponsors pursuing further European submissions.
G-BA Approves LDCT Lung Cancer Screening for German Statutory Health Insurance from April 2026
Germany's G-BA confirmed on 13 March 2026 that LDCT lung cancer screening will become a statutory GKV benefit from 1 April 2026 for smokers and ex-smokers aged 50-75 with a 20 pack-year history. The decision translates landmark NELSON and NLST trial evidence into population care and sets a precedent for European HTA agencies still deliberating on programme introduction.
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