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