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Carl Haakon

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. 

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Auteur

Carl Haakon

Catégorie

Business

Dernier épisode

15 nov. 2026

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Épisodes

Gene Therapy Value Frameworks 15.11.2026

Episode 168 — 15 November 2026 Examining evolving value frameworks for gene therapies, focusing on evidence requirements, threshold adjustments, and payment model innovations. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

HCA Access Crisis & Leqembi Implications 14.11.2026

Episode 167 — 14 November 2026 Examining HCA's profit warning as a signal of access erosion, subcutaneous Leqembi's implications, FTC's insulin settlement impact, and ICER's early-phase advice expansion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

HCA Warning, Leqembi SubQ, Insulin Settlement, ICER Advice 12.11.2026

Episode 166 — 12 November 2026 HCA's profit warning signals US access erosion; subcutaneous Leqembi reshapes Alzheimer's value narrative; FTC-CVS insulin settlement exposes PBM practices; ICER early-phase advice aims to de-risk development. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at out...

Access Erosion & Evidence Shifts 11.11.2026

Episode 165 — 11 November 2026 Examining systemic access pressures from hospital operators, new Alzheimer's evidence demands, PBM pricing transparency, and proactive HEOR strategies. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

FDA RWE Guidance & PBM Pricing Shifts 10.11.2026

Episode 164 — 10 November 2026 FDA updates RWE standards for post-marketing studies, FTC cracks down on PBM insulin pricing, ICER expands early-phase advice, and HCA's profit warning signals systemic access challenges. Hosted by Marcus and Sara. Access Brief — 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 08.11.2026

Episode 163 — 08 November 2026 HCA's profit warning signals US access erosion; subcutaneous Leqembi reshapes Alzheimer's value narrative; FTC-CVS insulin settlement exposes PBM practices; ICER early-phase advice aims to de-risk development. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at out...

RWE, PBMs, and Value Advice 07.11.2026

Episode 162 — 07 November 2026 This week, we cover the FDA's draft guidance on real-world evidence, the FTC's settlement with CVS Caremark, ICER's expansion of early-phase scientific advice, and NICE's updated guidance on real-world evidence for technology appraisals. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landsca...

VBID Models, Surrogate Endpoints, DCT Guidance 06.11.2026

Episode 161 — 06 November 2026 CMS launches VBID model for chronic conditions, NICE revises surrogate endpoint frameworks, and FDA releases DCT guidance for oncology drugs. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

HTA Methodology Shifts & RWE Integration 05.11.2026

Episode 160 — 05 November 2026 Examining evolving HTA methodologies, RWE integration challenges, and operational hurdles in US/EU access frameworks. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

FDA RWE Guidance & PBM Insulin Settlement 04.11.2026

Episode 159 — 04 November 2026 Examining new FDA guidance on RWE for post-marketing studies, FTC's landmark insulin pricing settlement with CVS, CMS Star Rating changes, and ICER's expanded early-phase scientific advice program. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analyt...

ESG in Pricing & RWE Evolution 03.11.2026

Episode 158 — 03 November 2026 Examining how ESG metrics reshape drug pricing, RWE's expanding role in HTA, and the impact of AI on evidence generation. Hosted by Marcus and Sara. Access Brief — 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 02.11.2026

Episode 157 — 02 November 2026 HCA signals access erosion in US healthcare; new subcutaneous Leqembi approved; FTC settles with CVS Caremark over insulin pricing; ICER expands scientific advice to pre-Phase 3. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

FDA RWE Guidance & Value Framework Updates 01.11.2026

Episode 156 — 01 November 2026 This episode examines FDA's new RWE guidance, CMS Star Rating changes, NICE's digital therapeutics framework, and the first wave of EU oncology JCAs. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

FDA RWE Guidance & CMS Value Models 31.10.2026

Episode 155 — 31 October 2026 Examining FDA's RWE guidance for post-marketing studies, CMS's new hospital value model, ISPOR's digital therapeutics framework, and EMA's AI reflection paper. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Access Brief 154: HCA, Leqembi, FTC & ICER 30.10.2026

Episode 154 — 30 October 2026 Examining HCA's profit warning as an access erosion signal, subcutaneous Leqembi's HEOR implications, FTC-CVS insulin settlement impact on PBMs, and ICER's early-phase scientific advice expansion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-ana...

CMS Star Ratings, NICE Digital Health, EU Oncology JCAs 29.10.2026

Episode 153 — 29 October 2026 CMS overhauls Star Ratings methodology, NICE advances digital health assessment, EU launches oncology JCAs, and FDA expands RWE use for rare diseases. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

US Access Erosion & Pricing Signals 28.10.2026

Episode 152 — 28 October 2026 Examining HCA's profit warning as a bellwether for US healthcare access erosion, analyzing subcutaneous Leqembi's HEOR implications, and dissecting the FTC-CVS insulin settlement's impact on PBM practices. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at out...

Leqembi SubQ, FTC Insulin, ICER Advice, HCA Warning 27.10.2026

Episode 151 — 27 October 2026 FDA approves subcutaneous Leqembi; FTC settles insulin pricing case; ICER expands early-phase advice; HCA profit warning flags US access challenges. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

US Healthcare Access & Value Shifts 26.10.2026

Episode 150 — 26 October 2026 Examining US healthcare access erosion, Alzheimer's treatment evolution, PBM pricing practices, and early-phase evidence strategy reshaping. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

HTA Evidence Evolution & IRA Impact 25.10.2026

Episode 149 — 25 October 2026 Examining evolving HTA evidence frameworks, IRA implications for evidence strategies, patient-centered endpoint integration, and gene therapy cost-effectiveness hurdles. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Access Erosion Signals & New Pathways 24.10.2026

Episode 148 — 24 October 2026 Examining systemic access challenges, novel Alzheimer's administration shifts, PBM reform implications, and early HEOR integration in development. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

HTA Frameworks & Pricing Pressures 23.10.2026

Episode 147 — 23 October 2026 Examining operational hurdles in CMS Part D redesign, evolving FDA RWE guidance, NICE's RWE framework updates, and the first wave of oncology JCAs under EU HTA. Hosted by Marcus and Sara. Access Brief — 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, ICER Advice 22.10.2026

Episode 146 — 22 October 2026 HCA's profit warning signals US healthcare access erosion; subcutaneous Leqembi approval transforms Alzheimer's value evidence; FTC-CVS insulin settlement exposes PBM pricing practices; ICER expands early-phase scientific advice to align development with HTA needs. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the eviden...

HTA Evolution & Market Access 21.10.2026

Episode 145 — 21 October 2026 Examining evolving HTA frameworks across emerging markets and digital health evidence integration challenges. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Profit Warning, Leqembi, Insulin, ICER 20.10.2026

Episode 144 — 20 October 2026 Examining HCA's access crisis, subcutaneous Leqembi's value shift, insulin pricing reforms, and ICER's evidence strategy evolution. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

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