FDA expands SOTYKTU label to active psoriatic arthritis with dual phase 3 RCT support
The US FDA recorded approval of an efficacy supplement for SOTYKTU on 6 March 2026, adding active psoriatic arthritis in adults based on PsA-1 and PsA-2 randomised trial evidence with significant week-16 ACR response improvements versus placebo.
MHRA updates trial-record archiving guidance ahead of April 2026 UK clinical-trial regime shift
The MHRA updated UK guidance on 19 March 2026 for archiving and retention of clinical-trial records, setting explicit operational expectations for Regulation 31A compliance before amended trial regulations come into force on 28 April 2026.
Genomic HTA is hitting a methods bottleneck and teams now need living evidence operations
New March 2026 evidence indicates that genomic science is outpacing HTA method standardisation, creating avoidable delays in reimbursement and policy decisions unless teams adopt living evidence governance with explicit economic and implementation traceability.
PBAC first-time non-recommendation and deferral disclosures create a new market access intelligence layer
Australia’s 20 March 2026 publication of PBAC first-time non-recommendation and deferral Public Summary Documents offers a practical signal set for earlier evidence triage, stronger economic alignment, and lower avoidable reimbursement delay.
G-BA’s March closure wave and new NMA quality data point to a stricter comparator-governance era
A dense 19 March 2026 closure wave in Germany’s AMNOG workflow, together with new meta-research on network meta-analysis quality published on 20 March, signals a higher bar for comparator governance, assumption traceability, and decision-grade uncertainty handling.
PBAC DUSC utilisation refresh creates a stronger evidence feedback loop for reimbursement resubmissions
PBS updates published on 20 March 2026 refreshed DUSC utilisation analysis access, creating a practical trigger for market access teams to re-baseline assumptions, tighten evidence traceability, and align comparative evidence with budget-impact and cost-effectiveness updates.
IQWiG A25-154 flags sex-specific added-benefit divergence for adjuvant nivolumab in urothelial carcinoma
IQWiG dossier assessment A25-154, published 16 March 2026, reassesses adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma and reports a sex-specific benefit pattern based on direct randomized evidence from CheckMate 274.
PBAC's equitable-access GLP-1 framework: a managed-rollout playbook for obesity market access
PBAC's March 2026 update on equitable GLP-1 obesity access defines a phased submission and evidence model centred on priority cohorts, managed rollout, and real-world value calibration.
IQWiG reports added benefit not proven for lisocabtagene maraleucel in relapsed or refractory mantle cell lymphoma
On 16 March 2026, IQWiG completed project A25-153 for lisocabtagene maraleucel in relapsed or refractory mantle cell lymphoma and reported added benefit not proven, citing absence of direct comparator-aligned evidence and methodological limitations of unanchored MAIC analyses built from single-arm sources.
NCPE sets a conditional reimbursement path for perioperative pembrolizumab in resectable NSCLC
On 10 March 2026, the National Centre for Pharmacoeconomics recommended perioperative pembrolizumab in resectable high-risk NSCLC be considered for reimbursement if cost-effectiveness improves, citing strong direct trial evidence versus chemotherapy and uncertain indirect comparative estimates versus nivolumab-based care.
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