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
140 episodes
US Market Access Shifts: Profit Warnings, New Approvals, and Policy Changes
Episode 135 — 10 October 2026 Episode 135 examines critical shifts in US market access, including HCA's profit warning signaling access challenges, subcutaneous Leqembi's impact on Alzheimer's treatment value, the FTC-CVS insulin settlement revea...
US Access Shifts: Leqembi, PBMs, and Early HEOR Strategy
Episode 134 — 09 October 2026 HCA's profit warning signals US healthcare access erosion; Leqembi's subQ approval and FTC-CVS insulin settlement reshape market dynamics, while ICER's early-phase advice expands HEOR evidence strategy. Hosted by Ma...
HTA Framework Evolution & Digital Guidance
Episode 133 — 08 October 2026 Examining emerging HTA frameworks in low-resource settings, digital therapeutic guidance updates, combination product assessment pilots, and global standard harmonization efforts. Hosted by Marcus and Sara. Access B...
EMA AI Paper, NICE RWE Pilot, CMS Value Model, ISPOR Digital Framework
Episode 132 — 07 October 2026 EMA's AI reflection paper, NICE's RWE pilot, CMS's new value model, and ISPOR's digital framework reshape evidence generation and value assessment. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, ...
Gene Therapy Value & HTA Evolution
Episode 131 — 06 October 2026 Examining the evolving value narrative for gene therapies, NICE's PRO framework shift, and CMS Part D coverage gap reforms impacting biologic access. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR...
FDA RWE Guidance & CMS Star Ratings
Episode 130 — 05 October 2026 Examining FDA's RWE guidance implications, CMS Star Ratings methodology shifts, NICE's digital health evolution, and EU oncology JCAs launch. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA st...
HCA Warning, Leqembi Shift, FTC Insulin, ICER Advice
Episode 129 — 04 October 2026 HCA's profit warning signals broader US access challenges; subcutaneous Leqembi transforms Alzheimer's treatment paradigms; FTC's insulin settlement targets PBM pricing opacity; ICER expands scientific advice to resh...
HCA Warning, Leqembi SubQ, FTC CVS, ICER Advice
Episode 128 — 03 October 2026 HCA's profit warning signals US access erosion; subcutaneous Leqembi reshapes Alzheimer's value; FTC-CVS insulin settlement exposes PBM practices; ICER expands early-phase scientific advice. Hosted by Marcus and Sar...
RWE Guidance, Star Ratings, Digital Therapeutics, EU HTA
Episode 127 — 02 October 2026 FDA releases new RWE guidance for rare diseases, CMS proposes 2027 Medicare Advantage changes, NICE updates digital therapeutics framework, and EU HTA begins oncology JCAs. Hosted by Marcus and Sara. Access Brief — ...
HTA Method Shifts & IRA Implications
Episode 126 — 01 October 2026 Examining evolving HTA frameworks across Asia-Pacific, IRA's influence on evidence generation, PRO integration challenges, and RWE adoption barriers. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR...
HCA Warning & Leqembi Access
Episode 125 — 30 September 2026 HCA's profit warning signals systemic access challenges in US healthcare, while subcutaneous Leqembi approval redefines Alzheimer's value frameworks. FTC-CVS insulin settlement and ICER's expanded scientific advice...
Access Erosion Signals & Leqembi Shift
Episode 124 — 29 September 2026 HCA's profit warning signals systemic access challenges; subcutaneous Leqembi transforms Alzheimer's value assessment; FTC settlement exposes PBM pricing practices; ICER expands early-phase scientific advice. Host...
CMS Rebate Shift & NICE Threshold
Episode 123 — 28 September 2026 CMS proposes Medicaid rebate reforms, ICER expands early-phase advice, FDA updates RWE guidance for accelerated approvals, and NICE consults on ultra-orphan cost-effectiveness thresholds. Hosted by Marcus and Sara...
Access Erosion & Value Signals
Episode 122 — 27 September 2026 Examining hospital profit warnings, subcutaneous Leqembi's impact, FTC insulin settlements, and ICER's early-phase scientific advice expansion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HT...
FDA RWE Guidance & CMS Star Ratings
Episode 121 — 26 September 2026 Examining FDA's RWE guidance, CMS Star Ratings changes, ICER's gene therapy framework, and NICE's RWE updates. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence acces...
HTA Methodological Shifts & Pricing Pressures
Episode 120 — 25 September 2026 Examining operational hurdles in CMS Part D redesign, EMA's adaptive licensing expansion, NICE's threshold consultation, and FDA's RWE guidance implications. Hosted by Marcus and Sara. Access Brief — Daily briefin...
HCA Warning, Leqembi SubQ, FTC CVS, ICER Advice
Episode 119 — 24 September 2026 HCA's profit warning signals US access erosion; subcutaneous Leqembi reshapes Alzheimer's value; FTC-CVS settlement exposes PBM practices; ICER expands early-phase scientific advice. Hosted by Marcus and Sara. Acc...
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...