Podcast
AI Access Brief Podcast
Hosted by Carl Haakon · EN
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.
17episodes
Episodes
Newest firstAll episodes
DMD Access Breakthrough and CHMP Pipeline Shift
4d ago00:04:41Tap to summarizeEpisode 22 — 05 June 2026 NICE approves third DMD treatment givinostat via Innovative Medicines Fund while CHMP's May output signals structural shift toward rare disease therapies. ISPOR 2026 highlights HEOR's expanding role in policy and value frameworks amid accelerating orphan designation trends. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →RNA Breakthroughs, Critical Medicines Act, and Evidence Judgment Era
5d ago00:05:41Tap to summarizeEpisode 21 — 04 June 2026 European Parliament and Council reach provisional agreement on Critical Medicines Act while EMA approves first RNA-based veterinary vaccine. ISPOR's latest trends report signals the shift from data production to evidence judgment as the new evaluation criterion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →First-in-Class HEOR Challenges and Regulatory Framework Shifts
6d ago00:05:08Tap to summarizeEpisode 20 — 03 June 2026 Multiple first-in-class therapies create new HEOR value demonstration challenges while industry increasingly funds academic research to support policy positions. EMA's annual report reveals optimization of medicines assessments and HTA regulation coordination progress. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →CHMP Approvals Signal Shift, JCA Device Rollout Begins
1w ago00:04:39Tap to summarizeEpisode 19 — 02 June 2026 CHMP's May session approved eight medicines including oral semaglutide, signaling structural changes in European drug development. Medical device JCAs launch in June while AI tops ISPOR's 2026 trends report. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →Medical Device JCAs Launch and NICE Methodology Shifts
1w ago00:05:14Tap to summarizeEpisode 18 — 01 June 2026 Medical device JCAs begin this month as NICE refines implementation guidance and biosimilar value assessment approaches. The hosts disagree on whether NICE's procedural simplifications strengthen or weaken evidence standards. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast GS1M3fTk8J53NF2ecagc
Transcribe →CHMP Rare Disease Pipeline and NICE Threshold Implementation
1w ago00:05:09Tap to summarizeEpisode 17 — 31 May 2026 EMA's CHMP approved eight medicines in May with heavy focus on rare diseases and specialty indications. NICE reveals implementation details for threshold increase while JCA capacity constraints intensify with only 17 scientific advice slots available. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →Device JCAs Launch, NICE Prioritisation, and MFN Reality Check
1w ago00:06:19Tap to summarizeEpisode 16 — 30 May 2026 Medical device JCAs launch in June as NICE implements new prioritisation framework. Trump's MFN commitments clash with reality as pharma raises prices on over 350 products. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →Critical Medicines Act, AI Tops HEOR Trends, NICE Advice ROI
2w ago00:06:19Tap to summarizeEpisode 15 — 29 May 2026 The EU Critical Medicines Act positions EMA as central authority for supply chain assessments across 200+ substances. AI jumps to #1 in ISPOR trends while NICE advice cuts appraisal timelines by three months. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →EQ-5D-5L Update Reshapes Cancer Economics
2w ago00:05:34Tap to summarizeEpisode 14 — 28 May 2026 NICE's first QALY valuation update in over a decade shows cancer medicines becoming more cost-effective while quality-of-life therapies face higher ICERs. Meanwhile, JCA expansion into medical devices and new NICE prioritisation frameworks signal tighter evidence requirements across the board. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
Transcribe →MHRA-NICE Pathway Under Fire, Clinical Trial Targets Hit
2w ago00:04:59Tap to summarizeEpisode 13 — 27 May 2026 LSE expert challenges the new UK aligned drug approval pathway as industry-favoring while EU reports progress on 2030 clinical trial targets. NICE approves first HER2-targeted therapy for bile duct cancer as regulatory reforms reshape the clinical research landscape. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast
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