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.Β
Access Erosion & Value Signals
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Episode 98 β 31 August 2026 Examining subcutaneous Leqembiβs access potential, HCAβs uninsured care surge, CVS insulin settlement dynamics, and ICERβs 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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