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AI Access Brief Podcast
AI Access Brief Podcast episodes
- Critical Medicines Act Agreement and EMA Pipeline MomentumEpisode 14 — 24 May 2026The EU reaches provisional agreement on the Critical Medicines Act while EMA advances key approvals including nerandomilast for pulmonary fibrosis. HTACG clarifies JCA data transparency requirements and NICE expands semaglutide access for cardiovascular risk reduction.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.Full transcript and sources at outcomes-analytica.no/podcast6 min
- Critical Medicines Act Agreement and JCA Operational MomentumEpisode 13 — 20 May 2026Political agreement on the EU Critical Medicines Act strengthens supply chain preparedness while IQWiG advances multiple JCA oncology assessments. NICE approves zanidatamab for rare biliary tract cancer as real-world evidence research emerges from ISPOR 2026.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.Full transcript and sources at outcomes-analytica.no/podcast6 min
- Critical Medicines Act, NICE Threshold Changes, EU JCA CapacityEpisode 12 — 20 May 2026EMA welcomes Critical Medicines Act agreement while NICE confirms new cost-effectiveness thresholds up to £35,000/QALY. EU JCA capacity issues persist with 55 assessments planned but only 17 scientific advice slots available.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.Full transcript and sources at outcomes-analytica.no/podcast5 min
- Critical Medicines Act Agreement and MHRA-NICE Pathway LaunchEpisode 11 — 18 May 2026Marcus and Sara analyze the EU's Critical Medicines Act provisional agreement and its supply chain resilience implications. They examine NICE's operational MHRA-aligned pathway with 27 early adopters and debate the strategic value of expanding digital health technology appraisals.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.Full transcript and sources at outcomes-analytica.no/podcast6 min
- NICE Approves Givinostat for DMD and EU Critical Medicines Act Progress
Episode 10 — 14 May 2026
NICE approves givinostat (Duvyzat) for NHS use in England — the third treatment recommended for Duchenne muscular dystrophy, benefiting around 530 people. Evidence suggests it may delay loss of walking ability by around five years compared with established care. Marcus and Sara examine what this approval reveals about NICE's approach to rare disease evidence under uncertainty, and the HTA implications for the broader ATMPs pipeline.
Plus: EU Critical Medicines Act progress, HTACG capacity building across member states, and ISPOR 2026 in Philadelphia this week.
Hosted by Marcus and Sara.
Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
Full transcript and sources at outcomes-analytica.no/podcast5 min - ISPOR Week: The Evidence Generation Timing GapEpisode 8 — 12 May 2026Marcus and Sara examine how major conferences like ISPOR create strategic timing challenges for evidence generation and HTA submissions. They debate whether the industry over-indexes on conference cycles at the expense of continuous evidence development.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.outcomes-analytica.no5 min
- When The News Slows: Strategy Through Quiet CyclesEpisode 7 — 11 May 2026This episode addresses the challenge of maintaining strategic momentum when major HEOR news is scarce. Marcus and Sara discuss how evidence teams can use quiet periods productively while avoiding the temptation to manufacture urgency around minor developments.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.outcomes-analytica.no3 min
- MFN Agreements, Heart Failure Evidence, and JCA TimelinesEpisode 6 — 11 May 2026Marcus and Sara examine the Trump administration's voluntary MFN pricing agreements with major pharma companies and discuss the HTA implications of WhiteSwell's DELTA-HF heart failure trial results. They debate the challenges of evidence strategy when major policy developments move at inconsistent paces.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.outcomes-analytica.no5 min
- JCA at Sixteen Months, Survodutide Phase III, and ISPOR 2026
Five developments shaping HEOR and market access this week.
The EU Joint Clinical Assessment at sixteen months — structural tensions unresolved, thirteen PICOs in a single assessment, and why the first published reports are the real test of whether national HTA bodies actually use the output.
Boehringer's survodutide Phase III posted 16.6% mean weight loss versus placebo. The clinical signal is strong. The HTA road is not — European payers reimburse cardiovascular outcomes, not weight loss numbers, and the comparator is semaglutide.
ISPOR 2026 opens in Philadelphia this week. AI moves to number one on the trends report. Value-based healthcare enters the top three for the first time.
Big pharma quietly restructuring internal HEOR functions. The independence of the evidence function is what gives it credibility in front of an HTA committee.
Norway's New Methods framework updated its process for medical technologies, effective 1 May 2026.
Hosted by Marcus and Sara. outcomes-analytica.no9 min
About AI Access Brief Podcast
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AI Generated Daily briefings on HEOR, HTA strategy and the evidence access landscape. For pharmaceutical and biotech professionals navigating regulatory-payer alignment, HTA submissions, and…
evidence strategy.