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STAGE 03 · HEALTH ECONOMICS

Which comparator anchors the value case?

⬢ ATLAS·economics & payer modeling·day 12 of ~21 · 47 of 78 scenarios

DECISION · ESCALATED TO CRO

Pick the comparator anchor for the cost-effectiveness model.

Both branches produce stable ICER bands across 47 sensitivity scenarios — they do not overlap. The choice is structural, not parametric. Marcus escalated per POL-CROSS-JURIS-V2 (cross-jurisdictional value decisions auto-escalate to CRO). Sensitivity scan resumes after sign-off.

OPTION A · PREDICATE-BASED

Reveal LINQ ICM as comparator

Same device family. Already reimbursed in PMDA C2 and KFDA. Comparator accepted across 6 of 7 jurisdictions without renegotiation. Caps value story to incremental gain.

ICER$18,200 / QALY

Sensitivity band$17.4k – $19.1k

Negotiation riskLOW

Claims postureNon-inferiority

Timeline impactNo delay

PMDAHSATGAKFDATFDANMPAFDA-ref

OPTION B · LIFETIME-MODEL

External loop recorder + standard care

Broader comparator. Captures full diagnostic-yield uplift. Stronger superiority claims and better positioning for next-gen LINQ extensions. Harder to defend across heterogeneous APAC payer formularies.

ICER$24,800 / QALY

Sensitivity band$23.1k – $26.4k

Negotiation riskMEDIUM

Claims postureSuperiority

Timeline impact+4–6 wk (PMDA + KFDA re-baseline)

PMDAHSATGAKFDATFDANMPAFDA-ref

CRO sign-off required

WORKFLOWATLAS's substages6 of 8 · day 12 of ~21

▶

W1

W2

W3

W4

W5

W6

W7

W8

Payer-input gathering

7 authorities

DONE

Predicate baseline lock

Reveal LINQ 12-yr · 4,217 events

DONE

Model v2.1 build

21 inputs · diff vs v2.0

DONE

Version + diff lock

sealed

DONE

Comparator scan

2 viable surfaced

DONE

Sensitivity scan

47 of 78 · paused

LIVE

Comparator gate

Sarah Chen · CRO sign-off

GATE

Value-claims pack seal

queued · blocked on gate

PENDING

Stage ThreadATLAS · GATE

03 HEOR · 12 events · escalated

ATLAS → GATE14 May · 10:14

Sensitivity scan paused at scenario 47/78. Both branches produce stable ICER bands across utility-weight perturbations of ±15%. Difference is structural, not parametric — cannot be resolved with more scans. Option A band $17.4k–$19.1k; Option B band $23.1k–$26.4k. Bands do not overlap. Per POL-HEOR-GATE-V1, structural comparator decisions are non-delegable to agent.

a8b1...3c45 · HUMAN GATE

M. YANG · HEOR14 May · 09:42

Cross-jurisdictional implications. Option B adds 4-6 weeks to PMDA + KFDA timelines if we re-baseline. CRO needs to balance speed-to-market against value-story strength. Routing to Sarah per POL-CROSS-JURIS-V2.

ATLAS14 May · 09:18

Model v2.1 locked and versioned. Inputs cross-validated against 02 EVID receipt chain. SAP-locked endpoint definitions, DSMB-cleared safety profile, predicate corpus all consistent. Diff vs v2.0: 3 utility weights updated, 1 discount rate harmonized to ISPOR APAC consensus.