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
123 episodes
Profit Warnings & Scientific Advice
Episode 118 — 23 September 2026 HCA's profit warning signals systemic access challenges, while subcutaneous Leqembi and FTC-CVS settlement reshape insulin access dynamics. ICER expands early-phase scientific advice to de-risk development. Hosted...
HCA Warning, Leqembi Shift, Insulin PBM, ICER Advice
Episode 117 — 20 September 2026 Hospital system profit warnings signal access erosion; subcutaneous Alzheimer's delivery reshapes value narratives; FTC targets PBM insulin pricing; ICER expands early-phase evidence strategy. Hosted by Marcus and...
Supportive Care RWE, Cell Therapy Budget Impact, Patient-Centric HTA
Episode 116 — 19 September 2026 Examining RWE gaps in supportive care for rare diseases, budget impact challenges for cell/gene therapies, and patient-centric shifts in European HTA methodologies. Hosted by Marcus and Sara. Access Brief — Daily ...
HCA Warning, Leqembi, FTC, ICER Expansion
Episode 115 — 18 September 2026 HCA's profit warning signals US access challenges; subQ Leqembi, FTC insulin settlement, and ICER advice expansion highlight evolving market access dynamics. Hosted by Marcus and Sara. Access Brief — Daily briefin...
Star Ratings, Decentralized Trials, Gene Therapy Frameworks, RWE Guidance
Episode 114 — 17 September 2026 This week: CMS Medicare Advantage Star Ratings methodology shifts, FDA decentralized trials guidance, ICER's new gene therapy framework, and NICE's updated RWE guidance. Hosted by Marcus and Sara. Access Brief — D...
HTA Method Shifts & Pricing Trends
Episode 113 — 16 September 2026 Examining evolving HTA methodologies, adaptive pathways, and US operational challenges in drug pricing and evidence generation. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and t...
Access Erosion Signals & Value Frameworks
Episode 112 — 15 September 2026 Analyzing US healthcare access erosion signals, subcutaneous Alzheimer's therapy implications, insulin pricing competition impact, and early-phase HEOR strategy shifts. Hosted by Marcus and Sara. Access Brief — Da...
HTA Evolution & Access Pressures
Episode 111 — 14 September 2026 CMS Part D redesign operational hurdles, ICER's Alzheimer's evidence framework evolution, EMA's rare disease pathway expansion, and FDA gene therapy designation updates reshape evidence strategies. Hosted by Marcu...
HCA Warning, Leqembi Shift, PBM Scrutiny
Episode 110 — 13 September 2026 HCA's profit warning signals US healthcare access challenges; new Leqembi formulation and FTC insulin settlement reshape value arguments; ICER expands early scientific advice. Hosted by Marcus and Sara. Access Bri...
Global HTA Shifts & Digital Health
Episode 109 — 12 September 2026 Examining WHO's new health technology framework for resource-limited settings, Australia's TGA digital therapeutics updates, Canada's CADTH combination products pilot, and NICE's expanding global influence on HTA s...
HCA Warning & Leqembi Shift
Episode 108 — 11 September 2026 HCA's profit warning signals US hospital access erosion; subcutaneous Leqembi transforms Alzheimer's value assessments; FTC targets insulin pricing practices; ICER expands early-phase scientific advice. Hosted by ...
CMS Gene Therapy Coverage & RWE Integration
Episode 107 — 10 September 2026 CMS Part D gene therapy coverage shifts, FDA RWE guidance for post-marketing studies, NICE digital therapeutics framework updates, and EU Critical Medicines Act HTA timeline acceleration. Hosted by Marcus and Sara...
HTA Evolution & AI Governance
Episode 106 — 09 September 2026 Examining emerging HTA frameworks in Asia-Pacific, RWE barriers in Latin America, gene therapy value strategies, and digital therapeutics integration hurdles. Hosted by Marcus and Sara. Access Brief — Daily briefi...
Access Erosion & Value Signals
Episode 105 — 08 September 2026 HCA's profit warning signals access challenges; new Leqembi formulation and FTC settlement reshape pricing dynamics; ICER expands early-phase advice to align HEOR strategy. Hosted by Marcus and Sara. Access Brief ...
Profit Warnings & Insulin Pricing
Episode 104 — 07 September 2026 HCA's profit warning signals access erosion, subcutaneous Leqembi challenges cost-effectiveness, FTC insulin settlement reshapes PBMs, and ICER expands early-phase advice. Hosted by Marcus and Sara. Access Brief —...
Market Access Headlines: HCA, Leqembi, Insulin, ICER
Episode 103 — 06 September 2026 This week: HCA's profit warning signals US access erosion, subcutaneous Leqembi approval shifts Alzheimer's HEOR, FTC insulin settlement reshapes competition, and ICER expands early-phase scientific advice. Hosted...
Elections, AI, and Value Pricing
Episode 102 — 04 September 2026 Examining how US election outcomes may reshape drug pricing, AI's growing role in HTA evidence, oncology value-based pricing hurdles, and the evolving patient-centricity in HTA. Hosted by Marcus and Sara. Access B...
HTA in Fragile Settings
Episode 101 — 03 September 2026 Examining HTA methodologies in humanitarian crises, incorporating social determinants, blockchain for RWE security, and post-Brexit access challenges in Northern Ireland. Hosted by Marcus and Sara. Access Brief — ...
Patient Advocacy & HTA Evolution
Episode 100 — 02 September 2026 Examining the evolving role of patient advocacy in evidence generation, ESG integration into pricing, value demonstration challenges for first-in-class drugs, and HTA development in low-resource settings. Hosted b...
HCA Warning, Leqembi SubQ, FTC Insulin
Episode 99 — 01 September 2026 Examining HCA's profit warning, subcutaneous Leqembi's HEOR challenges, FTC insulin settlement implications, and ICER's scientific advice expansion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR...
Leqembi SubQ, HCA Access, FTC Insulin, ICER Advice
Episode 98 — 31 August 2026 Examining subcutaneous Leqembi’s access potential, HCA’s uninsured care surge, CVS insulin settlement dynamics, and ICER’s early-phase evidence shift. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR,...
HTA Method Shifts & RWE Expansion
Episode 97 — 30 August 2026 Examining evolving HTA methodologies across Asia-Pacific, RWE integration hurdles in Latin America, gene therapy HEOR strategies in Asia, and digital therapeutics' real-world utility. Hosted by Marcus and Sara. Access...
Accelerated Approvals & Value Models
Episode 96 — 29 August 2026 Examining FDA's real-world evidence guidance for accelerated approvals, CMS's Medicare Advantage Star Rating updates, NICE's threshold consultation for specialized tech, and EMA's adaptive licensing initiative for rare...
HCA Warning & Leqembi Approval
Episode 95 — 28 August 2026 HCA's profit warning signals US healthcare access stress; subQ Leqembi approval raises HEOR questions; FTC settlement reshapes insulin pricing dynamics; ICER expands scientific advice for novel therapies. Hosted by Ma...
FDA RWD Guidance & CMS Star Ratings
Episode 94 — 27 August 2026 Examining the FDA's new RWD guidance, CMS Star Ratings changes, NICE threshold consultation, and EMA's adaptive licensing initiative. A look at the implications for evidence generation and market access. Hosted by Mar...