HTA · HEOR · Market Access

Every HTA decision is a
reverse-engineered study protocol.
Nobody has read them all at once.

Verum mines published HTA decisions across EU agencies, extracts the PICO specifications they actually accepted, and shows you — before you lock the protocol — what evidence satisfies all your target markets simultaneously.

Interactive demo · Pembrolizumab NSCLC · Real HTA data

550+
IPTs published by AEMPS
125
New Spanish IPTs in 2024
2,500+
EU HTA decisions publicly available
0
Structured as a queryable database
100
Days from JCA scope to dossier deadline
The problem

The evidence exists.
The intelligence doesn't.

Pharma companies run the trials. They have the data. The problem is that AEMPS, NICE, G-BA, and HAS each ask a slightly different question about that same evidence — and each question changes depending on what they've accepted for similar drugs before. Nobody has structured that institutional memory.

01
Wrong comparator, wrong country
G-BA uses platinum-pemetrexed as the standard of care for non-squamous NSCLC. AEMPS and NICE accept platinum-based chemotherapy. A single-arm trial comparing against one SoC will fail AMNOG assessment regardless of OS results.
02
Biomarker fragmentation
AEMPS accepted PD-L1 CPS ≥ 10. NICE and G-BA require TPS ≥ 50%. Different assays, different thresholds, different eligible populations. Without both pre-specified in Phase III, you cannot satisfy all three markets.
03
100 days after JCA scope
Since January 2025, oncology products must complete a Joint Clinical Assessment. The EU scope document — defining what evidence is needed — arrives only 100 days before the dossier deadline. Preparation must start years earlier.
How it works

Three steps from
decision to intelligence

01
📄
Mine decisions
Every published HTA decision — Spanish IPTs, NICE STAs, G-BA dossiers, HAS decisions — is ingested and parsed. LLM extraction pulls the implicit PICO from each document, always linked to the source paragraph.
02
Structure evidence
Extractions are validated by a human reviewer before being committed to the database. Every EvidenceUnit is versioned, auditable, and traceable — not a summarisation, a structured data object with a complete audit trail.
03
Map divergences
Cross-country PICO matrix showing where agencies align and where they diverge — for population, biomarker, comparator, endpoint, and study design. Including JCA consolidated scope as European reference layer.
04
Recommend action
Strategic recommendations calibrated to your stage — Phase II→III study design, pre-launch sequencing, dossier preparation, new indication planning, or competitive intelligence. The analysis tells you what to do next.
Who it's for

Five moments where
this changes the decision

🔬 Phase II → III
Lock the right protocol
Which comparator satisfies all target markets? Which endpoints must be co-powered? Which biomarker thresholds need dual assays? Answer these before the protocol is frozen — not after the trial is running.
HEOR · Clinical Development
🚀 Pre-launch
Sequence markets by evidence
Where does current evidence give you immediate access? Where do you have gaps that block submission? Launch where you can, generate evidence for where you can't. Stop guessing at market size in countries you haven't modelled.
Market Access · HEOR
📋 Dossier preparation
Write what each agency expects
AEMPS, NICE, and G-BA each have a decade of precedents that define what they find convincing. The same evidence package submitted to all three is the most common avoidable cause of restriction or rejection.
Regulatory Affairs · HEOR
↗ New indication
Reuse before you commission
Which evidence from the parent indication carries over? Which comparators have been accepted for adjacent indications? Before committing to a new Phase III, know what the database already answers.
Clinical Development · HEOR
📡 Market intelligence
Track agency signals continuously
Every competitor HTA decision reveals the current state of what agencies accept. Monitor PICO shifts, comparator drift, and JCA delta vs. national decisions as the corpus updates. Know before your competitor does.
Market Access · Strategy
The corpus

Public, structured,
never aggregated before

Every document Verum mines is publicly available. AEMPS publishes every IPT. NICE publishes every STA. G-BA and HAS publish their decisions. The EU Commission publishes every JCA scope document.

The information has always been there. Nobody has extracted it, structured it, and made it queryable across countries and indications — until now.

550+
AEMPS IPTs total
125
New IPTs in 2024
60
Oncology IPTs in 2024
2,500+
EU decisions available

A note on what this is — and isn't

Verum is a validated concept with a working prototype seeded with real HTA data for PD-1/PD-L1 inhibitors in NSCLC. It is not a production product and has no paying customers yet.

The architecture is designed. The data model is built. The gap that Verum fills is real — no platform structures and cross-references EU HTA PICO specifications at scale. This prototype exists to validate whether that problem is urgent enough to build for.

Concept in validation · May 2026 · Not for commercial use

See it in action.
Two minutes, real data.

The prototype shows the full four-step workflow with real decisions from AEMPS, NICE, and G-BA for pembrolizumab in NSCLC.