AI Access Brief

EP 21

04 June 2026

RNA Breakthroughs, Critical Medicines Act, and Evidence Judgment Era

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.

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Critical Medicines Act political agreementEMA RNA technology approvalsISPOR evidence judgment shiftEU JCA medical device expansion

EP 16

03 June 2026

First-in-Class HEOR Challenges and Regulatory Framework Shifts

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.

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Baxdrostat approval and novel mechanism valueRevolution Medicines KRAS breakthroughGenentech academic research solicitationEMA 2025 annual report HTA implementation

EP 15

02 June 2026

CHMP Approvals Signal Shift, JCA Device Rollout Begins

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.

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CHMP May approvals and development shiftMedical device JCAs launchAI dominates ISPOR trendsOral semaglutide market implications

EP 14

01 June 2026

Medical Device JCAs Launch and NICE Methodology Shifts

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.

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EU medical device JCA rolloutNICE tranexamic acid guidance updateEMA Critical Medicines Act responseNICE natalizumab MS decision rationale

EP 13

31 May 2026

CHMP Rare Disease Pipeline and NICE Threshold Implementation

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.

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CHMP May approvals rare disease focusNICE threshold transition proceduresJCA capacity constraints scientific adviceISPOR evidence judgment shift

EP 12

30 May 2026

Device JCAs Launch, NICE Prioritisation, and MFN Reality Check

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.

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Medical device JCAs starting JuneNICE prioritisation board implementationMFN pricing disconnect realityFDA accelerated approvals May

EP 11

29 May 2026

Critical Medicines Act, AI Tops HEOR Trends, NICE Advice ROI

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.

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EU Critical Medicines Act operational frameworkAI dominance in ISPOR 2026 trendsNICE scientific advice timeline analysisMHRA-NICE aligned pathway rollout

EP 10

28 May 2026

EQ-5D-5L Update Reshapes Cancer Economics

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.

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NICE EQ-5D-5L consultationCHMP rare disease approvalsJCA device expansionNICE prioritisation framework

EP 09

27 May 2026

MHRA-NICE Pathway Under Fire, Clinical Trial Targets Hit

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.

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MHRA-NICE aligned pathway criticismEU clinical trial target progressUK clinical trials regulatory reformNICE zanidatamab approval

EP 08

27 May 2026

Critical Medicines Act and NICE Technology Priorities

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 strong approval rates as European HTA bodies expand beyond traditional pharmacoeconomic assessments.

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EU Critical Medicines Act HTA implicationsNICE liver preservation technology guidanceEMA CHMP approval ratesNICE prioritisation framework launch

EP 07

27 May 2026

NICE Unified Prioritisation and EMA Regulatory Momentum

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 strategy and market access planning.

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NICE prioritisation board launchEQ-5D-5L value set consultationEMA CHMP May approvalsNICE Biosimilar Taskforce operations

EP 06

26 May 2026

CHMP Momentum, Critical Medicines Act, HTA Capacity Scaling

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 modules as joint clinical assessments scale to 35 oncology reviews despite persistent bottlenecks.

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EMA CHMP May approvals and regulatory momentumCritical Medicines Act provisional political agreementHTAR capacity building programme expansionEU JCA scaling and persistent capacity constraints

EP 05

25 May 2026

HTACG Data Transparency and NICE Prioritisation Overhaul

HTACG publishes crucial data transparency principles distinguishing commercially confidential information for joint clinical assessments. NICE launches unified prioritisation framework with eight principles from public dialogue, while EMA approves challenging orphan medicines and EFPIA raises MFN pricing access concerns.

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HTACG data transparency principlesNICE unified prioritisation frameworkEMA CHMP orphan approvalsEFPIA MFN pricing concerns

EP 04

24 May 2026

Critical Medicines Act Agreement and EMA Pipeline Momentum

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 semaglutide access for cardiovascular risk reduction.

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EU Critical Medicines Act political agreementEMA nerandomilast pulmonary fibrosis approvalHTACG data transparency principlesNICE semaglutide cardiovascular expansion

EP 03

18 May 2026

Critical Medicines Act Agreement and MHRA-NICE Pathway Launch

The EU Critical Medicines Act reaches political agreement, reshaping how Europe approaches drug supply security and evidence requirements. The MHRA-NICE aligned pathway goes live — Marcus and Sara examine what both mean for evidence strategy teams.

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EU Critical Medicines ActMHRA-NICE pathwayHTA reform

EP 02

14 May 2026

NICE Approves Givinostat for DMD and EU Critical Medicines Progress

NICE approves givinostat for Duchenne muscular dystrophy — the third DMD treatment through the system, benefiting around 530 people in England. Evidence suggests it may delay loss of walking ability by around five years versus established care.

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NICE rare diseaseDMD givinostatATMP evidence

EP 01

09 May 2026

Digital HTA Expansion and Biosimilar Strategy Shifts

HTA digital expansion and biosimilar strategy developments in the European market access landscape.

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