AI Access Brief Podcast

40 Episodes
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By: Carl Haakon

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.Β 

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Access Erosion & Value Signals
#122
Today at 5:00 AM

Episode 122 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


FDA RWE Guidance & CMS Star Ratings
#121
Yesterday at 5:00 AM

Episode 121 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Methodological Shifts & Pricing Pressures
#120
Last Friday at 5:00 AM

Episode 120 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi SubQ, FTC CVS, ICER Advice
#119
Last Thursday at 5:00 AM

Episode 119 β€” 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. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Profit Warnings & Scientific Advice
#118
Last Wednesday at 5:00 AM

Episode 118 β€” 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 by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi Shift, Insulin PBM, ICER Advice
#117
09/20/2026

Episode 117 β€” 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 Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Supportive Care RWE, Cell Therapy Budget Impact, Patient-Centric HTA
#116
09/19/2026

Episode 116 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi, FTC, ICER Expansion
#115
09/18/2026

Episode 115 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Star Ratings, Decentralized Trials, Gene Therapy Frameworks, RWE Guidance
#114
09/17/2026

Episode 114 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Method Shifts & Pricing Trends
#113
09/16/2026

Episode 113 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Access Erosion Signals & Value Frameworks
#112
09/15/2026

Episode 112 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Evolution & Access Pressures
#111
09/14/2026

Episode 111 β€” 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 Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi Shift, PBM Scrutiny
#110
09/13/2026

Episode 110 β€” 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 Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Global HTA Shifts & Digital Health
#109
09/12/2026

Episode 109 β€” 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 standards. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning & Leqembi Shift
#108
09/11/2026

Episode 108 β€” 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 Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


CMS Gene Therapy Coverage & RWE Integration
#107
09/10/2026

Episode 107 β€” 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. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Evolution & AI Governance
#106
09/09/2026

Episode 106 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Access Erosion & Value Signals
#105
09/08/2026

Episode 105 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Profit Warnings & Insulin Pricing
#104
09/07/2026

Episode 104 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Market Access Headlines: HCA, Leqembi, Insulin, ICER
#103
09/06/2026

Episode 103 β€” 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 by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Elections, AI, and Value Pricing
#102
09/04/2026

Episode 102 β€” 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 Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA in Fragile Settings
#101
09/03/2026

Episode 101 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Patient Advocacy & HTA Evolution
#100
09/02/2026

Episode 100 β€” 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 by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi SubQ, FTC Insulin
#99
09/01/2026

Episode 99 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Leqembi SubQ, HCA Access, FTC Insulin, ICER Advice
#98
08/31/2026

Episode 98 β€” 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 β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Method Shifts & RWE Expansion
#97
08/30/2026

Episode 97 β€” 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 Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Accelerated Approvals & Value Models
#96
08/29/2026

Episode 96 β€” 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 diseases. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning & Leqembi Approval
#95
08/28/2026

Episode 95 β€” 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 Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


FDA RWD Guidance & CMS Star Ratings
#94
08/27/2026

Episode 94 β€” 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 Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


US Healthcare Access & Pricing Shifts
#93
08/25/2026

Episode 93 β€” 25 August 2026 Examining US healthcare access pressures, novel Alzheimer's treatment implications, insulin pricing precedent, and early-stage HTA alignment. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Evolution & Digital Health
#92
08/24/2026

Episode 92 β€” 24 August 2026 Examining operational hurdles in CMS Part D redesign, ICER's approach to ultra-orphan therapies, FDA decentralized trials guidance, and NICE's RWE integration. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


FDA Accelerations, CMS Models, NICE RWE
#91
08/23/2026

Episode 91 β€” 23 August 2026 Examining FDA's accelerated approvals in neurodegeneration, CMS's oncology payment models, NICE's RWE framework evolution, and emerging HTA methodologies in Asia-Pacific. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


US Access Signals & Global Shifts
#90
08/22/2026

Episode 90 β€” 22 August 2026 Profit warnings signal US access challenges, new Alzheimer's formulations reshape HEOR strategies, insulin pricing settlements reveal systemic flaws, and ICER expands evidence frameworks. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Profit Warnings & Pricing Pressures
#89
08/21/2026

Episode 89 β€” 21 August 2026 Analyzing HCA's profit warning signaling US healthcare access pressures, SubQ Leqembi's approval impact on HEOR strategies, FTC insulin pricing settlement implications, and ICER's expanded scientific advice program. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Method Shifts & RWE Integration
#88
08/20/2026

Episode 88 β€” 20 August 2026 Examining evolving regulatory frameworks for real-world evidence, Medicare payment system changes, digital health HTA integration, and emerging sustainability metrics in value assessments. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, SubQ Leqembi, FTC Insulin, ICER Advice
#87
08/19/2026

Episode 87 β€” 19 August 2026 HCA profit warning signals US healthcare access challenges; subQ Leqembi approval transforms Alzheimer's HEOR landscape; FTC insulin settlement reshapes PBM practices; ICER expands scientific advice services. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HTA Digital Shifts & Pricing Pressures
#86
08/18/2026

Episode 86 β€” 18 August 2026 Examining digital health HTA hurdles, emerging market pricing dynamics, blockchain for RWE, and sustainability metrics in value frameworks. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi, Insulin, ICER
#85
08/16/2026

Episode 85 β€” 16 August 2026 HCA's profit warning signals US healthcare access pressures; subcutaneous Leqembi, FTC insulin settlement, and ICER expansion reshape value strategies. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


Gene Therapy Access & RWE Guidance
#84
08/15/2026

Episode 84 β€” 15 August 2026 Examining CMS Part D gene therapy coverage, FDA RWE guidance, NICE digital health HTA, and EU Critical Medicines Act impact on HTA timelines. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast


HCA Warning, Leqembi, Insulin, ICER
#83
08/13/2026

Episode 83 β€” 13 August 2026 US hospital chain HCA's profit warning signals systemic access challenges; subQ Leqembi approval reshapes Alzheimer's HEOR; FTC insulin settlement impacts PBMs; ICER expands scientific advice scope. Hosted by Marcus and Sara. Access Brief β€” Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast