Carl Haakon's Podcast

Episode 31 — 15 June 2026 EMA's PRAC concludes valproate neurodevelopmental risk remains uncertain while EU JCA programme scales to 50 assessments in 2026. Emergency clinical trial guidance opens for consultation as oral GLP-1 approvals expand market access complexity. 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

Episode 30 — 14 June 2026 The EU JCA framework expands into medical devices this month while MHRA-NICE alignment delivers its first coordinated guidance. Europe's HTA infrastructure shows sustained momentum across multiple operational tracks. 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

Episode 29 — 13 June 2026 The UK's MHRA-NICE aligned pathway delivers first guidance this month with 27 early adopter companies, while the EU publishes its second JCA report on tovorafenib. These developments signal coordinated evolution in European HEOR infrastructure prioritizing accelerated patient access. 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

Episode 28 — 12 June 2026 The EU published its first joint clinical assessment report for tovorafenib, marking a milestone in HTA coordination. CHMP approval patterns show a pipeline increasingly skewed toward rare diseases and indication extensions over novel molecules. 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

Episode 27 — 10 June 2026 The EU published its first Joint Clinical Assessment report for tovorafenib while EMA approved oral semaglutide for weight management. JCA capacity constraints emerge as demand for scientific advice exceeds available slots. 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

Episode 26 — 09 June 2026 CHMP's May approvals reveal a structural shift toward rare disease development while the Critical Medicines Act introduces mandatory supply chain transparency requirements. AI maintains its dominance in HEOR methodology as NICE expands cardiovascular and digital health guidance. 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

Episode 25 — 08 June 2026 Medical device Joint Clinical Assessments begin in June 2026 as the EU HTA Regulation expands beyond oncology medicines. FDA approves first-in-class aldosterone synthase inhibitor baxdrostat while ISPOR signals a shift toward evidence judgment over 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

Episode 24 — 07 June 2026 NICE's revolutionary diabetes guideline makes SGLT-2 inhibitors first-line therapy while EU HTA regulation expands to high-risk medical devices. FDA accelerated approvals surge and EU clinical trial acceleration shows early progress toward 2030 targets. 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

Episode 23 — 06 June 2026 Marcus and Sara examine the CHMP's May session showing 42% orphan designation rates and debate whether oral semaglutide represents genuine innovation or market expansion. They clash over emergency regulatory collaboration priorities and disagree on JCA capacity constraints for specialty medicines. 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

Episode 22 — 05 June 2026 NICE approves third DMD treatment givinostat via Innovative Medicines Fund while CHMP's May output signals structural shift toward rare disease therapies. ISPOR 2026 highlights HEOR's expanding role in policy and value frameworks amid accelerating orphan designation trends. 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

Episode 21 — 04 June 2026 European Parliament and Council reach provisional agreement on Critical Medicines Act while EMA approves first RNA-based veterinary vaccine. ISPOR's latest trends report signals the shift from data production to evidence judgment as the new evaluation criterion. 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

Episode 20 — 03 June 2026 Multiple first-in-class therapies create new HEOR value demonstration challenges while industry increasingly funds academic research to support policy positions. EMA's annual report reveals optimization of medicines assessments and HTA regulation coordination progress. 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

Episode 19 — 02 June 2026 CHMP's May session approved eight medicines including oral semaglutide, signaling structural changes in European drug development. Medical device JCAs launch in June while AI tops ISPOR's 2026 trends report. 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

Episode 18 — 01 June 2026 Medical device JCAs begin this month as NICE refines implementation guidance and biosimilar value assessment approaches. The hosts disagree on whether NICE's procedural simplifications strengthen or weaken evidence standards. 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  GS1M3fTk8J53NF2ecagc

Episode 17 — 31 May 2026 EMA's CHMP approved eight medicines in May with heavy focus on rare diseases and specialty indications. NICE reveals implementation details for threshold increase while JCA capacity constraints intensify with only 17 scientific advice slots available. 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

Episode 16 — 30 May 2026 Medical device JCAs launch in June as NICE implements new prioritisation framework. Trump's MFN commitments clash with reality as pharma raises prices on over 350 products. 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

Episode 15 — 29 May 2026 The EU Critical Medicines Act positions EMA as central authority for supply chain assessments across 200+ substances. AI jumps to #1 in ISPOR trends while NICE advice cuts appraisal timelines by three months. 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

Episode 14 — 28 May 2026 NICE's first QALY valuation update in over a decade shows cancer medicines becoming more cost-effective while quality-of-life therapies face higher ICERs. Meanwhile, JCA expansion into medical devices and new NICE prioritisation frameworks signal tighter evidence requirements across the board. 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

Episode 13 — 27 May 2026 LSE expert challenges the new UK aligned drug approval pathway as industry-favoring while EU reports progress on 2030 clinical trial targets. NICE approves first HER2-targeted therapy for bile duct cancer as regulatory reforms reshape the clinical research landscape. 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

Episode 12 — 27 May 2026 The EU Critical Medicines Act's provisional agreement introduces supply chain resilience metrics into HTA frameworks, while NICE advances systematic technology adoption and new prioritisation criteria. EMA maintains strong approval rates as European HTA bodies expand beyond traditional pharmacoeconomic assessments. 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

Episode 11 — 27 May 2026 EMA's CHMP recommended eight medicines including first-ever PROS treatment while NICE raised cost-effectiveness thresholds to £25,000-35,000 per QALY. The EU's Joint Clinical Assessment framework expands into medical devices with five assessments planned for June 2026. 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

Episode 10 — 27 May 2026 EMA approves first oral GLP-1 for weight management while AI rises to top HEOR trend. NICE expands technology appraisals to digital health technologies and FDA raises real-world data standards. 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

Episode 9 — 27 May 2026 Marcus and Sara examine the NICE-MHRA aligned pathway's potential to accelerate UK medicine access by six months and debate whether 50 EU joint clinical assessments starting this year represents genuine coordination or administrative overhead. They disagree on US drug pricing policy effectiveness and discuss expanding international HTA collaboration benefits. 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

Episode 18 — 27 May 2026 NICE transforms guidance selection with unified prioritisation framework and EQ-5D-5L implementation while EMA shows regulatory momentum with eight May approvals. The episode examines operational impacts on evidence strategy and market access planning. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 8 — 26 May 2026 NICE confirms new £25,000-£35,000/QALY thresholds while EU reaches provisional agreement on Critical Medicines Act. Trump administration's MFN pricing projects $529 billion savings despite continued industry price increases. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 17 — 26 May 2026 EMA's CHMP delivered eight approvals including nerandomilast for pulmonary fibrosis while the Critical Medicines Act reached provisional political agreement. EU HTA capacity building expands with multilingual eLearning modules as joint clinical assessments scale to 35 oncology reviews despite persistent bottlenecks. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 16 — 26 May 2026 The EU's Critical Medicines Act provisional agreement combines regulatory tools with industrial policy to strengthen medicine supply resilience across 200+ active substances. HTACG scales joint clinical assessments while NICE operationalizes new thresholds amid evolving digital health technology frameworks. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 15 — 25 May 2026 HTACG publishes crucial data transparency principles distinguishing commercially confidential information for joint clinical assessments. NICE launches unified prioritisation framework with eight principles from public dialogue, while EMA approves challenging orphan medicines and EFPIA raises MFN pricing access concerns. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 14 — 24 May 2026 The EU reaches provisional agreement on the Critical Medicines Act while EMA advances key approvals including nerandomilast for pulmonary fibrosis. HTACG clarifies JCA data transparency requirements and NICE expands semaglutide access for cardiovascular risk reduction. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 13 — 20 May 2026 Political agreement on the EU Critical Medicines Act strengthens supply chain preparedness while IQWiG advances multiple JCA oncology assessments. NICE approves zanidatamab for rare biliary tract cancer as real-world evidence research emerges from ISPOR 2026. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 12 — 20 May 2026 EMA welcomes Critical Medicines Act agreement while NICE confirms new cost-effectiveness thresholds up to £35,000/QALY. EU JCA capacity issues persist with 55 assessments planned but only 17 scientific advice slots available. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 11 — 18 May 2026 Marcus and Sara analyze the EU's Critical Medicines Act provisional agreement and its supply chain resilience implications. They examine NICE's operational MHRA-aligned pathway with 27 early adopters and debate the strategic value of expanding digital health technology appraisals. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

Episode 10 — 14 May 2026NICE approves givinostat (Duvyzat) for NHS use in England — the third treatment recommended for Duchenne muscular dystrophy, benefiting around 530 people. Evidence suggests it may delay loss of walking ability by around five years compared with established care. Marcus and Sara examine what this approval reveals about NICE's approach to rare disease evidence under uncertainty, and the HTA implications for the broader ATMPs pipeline.Plus: EU Critical Medicines Act progress, HTACG capacity building across member states, and ISPOR 2026 in Philadelphia this week.Hosted by Marcus and Sara.Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.Full transcript and sources at outcomes-analytica.no/podcast

Episode 8 — 12 May 2026 Marcus and Sara examine how major conferences like ISPOR create strategic timing challenges for evidence generation and HTA submissions. They debate whether the industry over-indexes on conference cycles at the expense of continuous evidence development. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. outcomes-analytica.no

Episode 7 — 11 May 2026 This episode addresses the challenge of maintaining strategic momentum when major HEOR news is scarce. Marcus and Sara discuss how evidence teams can use quiet periods productively while avoiding the temptation to manufacture urgency around minor developments. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. outcomes-analytica.no

Episode 6 — 11 May 2026 Marcus and Sara examine the Trump administration's voluntary MFN pricing agreements with major pharma companies and discuss the HTA implications of WhiteSwell's DELTA-HF heart failure trial results. They debate the challenges of evidence strategy when major policy developments move at inconsistent paces. Hosted by Marcus and Sara. Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape. outcomes-analytica.no

Five developments shaping HEOR and market access this week.The EU Joint Clinical Assessment at sixteen months — structural tensions unresolved, thirteen PICOs in a single assessment, and why the first published reports are the real test of whether national HTA bodies actually use the output.Boehringer's survodutide Phase III posted 16.6% mean weight loss versus placebo. The clinical signal is strong. The HTA road is not — European payers reimburse cardiovascular outcomes, not weight loss numbers, and the comparator is semaglutide.ISPOR 2026 opens in Philadelphia this week. AI moves to number one on the trends report. Value-based healthcare enters the top three for the first time.Big pharma quietly restructuring internal HEOR functions. The independence of the evidence function is what gives it credibility in front of an HTA committee.Norway's New Methods framework updated its process for medical technologies, effective 1 May 2026.Hosted by Marcus and Sara. outcomes-analytica.no