AI Access Brief Podcast
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.
Episodes
32 episodes
CHMP Pipeline Shift and Critical Medicines Act Mandates
Episode 26 — 09 June 2026 CHMP's May approvals reveal a structural shift toward rare disease development while the Critical Medicines Act introduces mandatory supply chain transparency requirements. AI maintains its dominance in HEOR methodology ...
Medical Device JCAs Launch and Novel Mechanism Approvals
Episode 25 — 08 June 2026 Medical device Joint Clinical Assessments begin in June 2026 as the EU HTA Regulation expands beyond oncology medicines. FDA approves first-in-class aldosterone synthase inhibitor baxdrostat while ISPOR signals a shift t...
NICE Diabetes Revolution, EU Device JCAs, Clinical Trial Acceleration
Episode 24 — 07 June 2026 NICE's revolutionary diabetes guideline makes SGLT-2 inhibitors first-line therapy while EU HTA regulation expands to high-risk medical devices. FDA accelerated approvals surge and EU clinical trial acceleration shows ea...
Orphan Dominance and Oral Semaglutide Market Shifts
Episode 23 — 06 June 2026 Marcus and Sara examine the CHMP's May session showing 42% orphan designation rates and debate whether oral semaglutide represents genuine innovation or market expansion. They clash over emergency regulatory collaboratio...
DMD Access Breakthrough and CHMP Pipeline Shift
Episode 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 f...
RNA Breakthroughs, Critical Medicines Act, and Evidence Judgment Era
Episode 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...
First-in-Class HEOR Challenges and Regulatory Framework Shifts
Episode 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 asse...
CHMP Approvals Signal Shift, JCA Device Rollout Begins
Episode 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 M...
Medical Device JCAs Launch and NICE Methodology Shifts
Episode 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 sta...
CHMP Rare Disease Pipeline and NICE Threshold Implementation
Episode 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 scie...
Device JCAs Launch, NICE Prioritisation, and MFN Reality Check
Episode 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...
Critical Medicines Act, AI Tops HEOR Trends, NICE Advice ROI
Episode 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 M...
EQ-5D-5L Update Reshapes Cancer Economics
Episode 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 priorit...
MHRA-NICE Pathway Under Fire, Clinical Trial Targets Hit
Episode 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 re...
Critical Medicines Act and NICE Technology Priorities
Episode 12 — 27 May 2026 The EU Critical Medicines Act's provisional agreement introduces supply chain resilience metrics into HTA frameworks, while NICE advances systematic technology adoption and new prioritisation criteria. EMA maintains stron...
CHMP Pipeline Surge, NICE Threshold Jump, JCA Device Push
Episode 11 — 27 May 2026 EMA's CHMP recommended eight medicines including first-ever PROS treatment while NICE raised cost-effectiveness thresholds to £25,000-35,000 per QALY. The EU's Joint Clinical Assessment framework expands into medical devi...
Oral GLP-1s, AI Dominance, and Digital Health Parity
Episode 10 — 27 May 2026 EMA approves first oral GLP-1 for weight management while AI rises to top HEOR trend. NICE expands technology appraisals to digital health technologies and FDA raises real-world data standards. Hosted by Marcus and Sara....
UK Alignment Acceleration and EU JCA Implementation
Episode 9 — 27 May 2026 Marcus and Sara examine the NICE-MHRA aligned pathway's potential to accelerate UK medicine access by six months and debate whether 50 EU joint clinical assessments starting this year represents genuine coordination or adm...
NICE Unified Prioritisation and EMA Regulatory Momentum
Episode 18 — 27 May 2026 NICE transforms guidance selection with unified prioritisation framework and EQ-5D-5L implementation while EMA shows regulatory momentum with eight May approvals. The episode examines operational impacts on evidence strat...
NICE Threshold Shift, Critical Medicines Act, and MFN Reality Check
Episode 8 — 26 May 2026 NICE confirms new £25,000-£35,000/QALY thresholds while EU reaches provisional agreement on Critical Medicines Act. Trump administration's MFN pricing projects $529 billion savings despite continued industry price increase...
CHMP Momentum, Critical Medicines Act, HTA Capacity Scaling
Episode 17 — 26 May 2026 EMA's CHMP delivered eight approvals including nerandomilast for pulmonary fibrosis while the Critical Medicines Act reached provisional political agreement. EU HTA capacity building expands with multilingual eLearning mo...
Critical Medicines Act Shapes EU HTA Landscape
Episode 16 — 26 May 2026 The EU's Critical Medicines Act provisional agreement combines regulatory tools with industrial policy to strengthen medicine supply resilience across 200+ active substances. HTACG scales joint clinical assessments while ...
HTACG Data Transparency and NICE Prioritisation Overhaul
Episode 15 — 25 May 2026 HTACG publishes crucial data transparency principles distinguishing commercially confidential information for joint clinical assessments. NICE launches unified prioritisation framework with eight principles from public di...
Critical Medicines Act Agreement and EMA Pipeline Momentum
Episode 14 — 24 May 2026 The 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 semag...
Critical Medicines Act Agreement and JCA Operational Momentum
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 evid...