Carl Haakon

AI Access Brief Podcast

Business EN ↓ 58 episodes

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.

Author

Carl Haakon

Episodes

Critical Medicines Act Agreement and JCA Operational Momentum 20.05.2026 5:23

Episode 13 — 20 May 2026 Political 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 acce...

Critical Medicines Act, NICE Threshold Changes, EU JCA Capacity 20.05.2026 4:56

Episode 12 — 20 May 2026 EMA 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...

NICE Approves Givinostat for DMD and EU Critical Medicines Act Progress 18.05.2026 4:50

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 unc...

Critical Medicines Act Agreement and MHRA-NICE Pathway Launch 18.05.2026 5:46

Episode 11 — 18 May 2026 Marcus 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, HT...

ISPOR Week: The Evidence Generation Timing Gap 12.05.2026 4:15

Episode 8 — 12 May 2026 Marcus 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 lan...

MFN Agreements, Heart Failure Evidence, and JCA Timelines 11.05.2026 4:29

Episode 6 — 11 May 2026 Marcus 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 — Dail...

When The News Slows: Strategy Through Quiet Cycles 11.05.2026 2:27

Episode 7 — 11 May 2026 This 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 acce...

JCA at Sixteen Months, Survodutide Phase III, and ISPOR 2026 11.05.2026 8:14

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...