Loon Waters™ · Value simulation · Neurosymbolic Loon AI®

Forecast HTA reimbursement decisions and conditions before you file.

Loon Waters™ connects clinical evidence to coverage decisions. Monte Carlo Committee Simulation models how HTA and payer committees deliberate — anticipating outcomes, conditions, and coverage requirements while your strategy can still change.

See the evidence

Evidence that lands.

95.2%SensitivityDetecting “Reimburse with conditions” — Monte Carlo Committee Simulation, medRxiv 2026 97.6%Precision“Reimburse with conditions” predictions — medRxiv, 2026 96.4%F1 scoreHarmonic mean of sensitivity and precision — medRxiv, 2026 96.8%High-confidence accuracyStratified by Strength of Mandate — validated on temporally separated data

Committee outcomes stay a blind spot until the hearing.By then it is too late to fix the submission.

Approved therapies wait 2–5 years for reimbursement, and biopharma loses an estimated $33.5 billion annually to the delays. Risk is typically identified late — post-submission, pre-hearing — when options for course correction are limited.

Loon Waters™ replaces opinion-based advisory with a structured, objective pressure-test: Monte Carlo simulation of how HTA committees will deliberate on your dossier, while your strategy can still change.

The platform

From clinical evidence to committee decision

Loon Waters™

Value simulation, reimbursement and conditions forecasting

Connects clinical evidence to downstream value and coverage decisions. Monte Carlo Committee Simulation models how payer committees deliberate — anticipating outcomes, conditions, restrictions, and coverage requirements before filing.

Forecast specific reimbursement conditions before committee review
Stress-test value dossiers and submission strategies across jurisdictions simultaneously
Quantify how evidence, price, and ICER changes affect HTA deliberations

95.2% sensitivity97.6% precision96.4% F1

Capabilities

Reimbursement & conditions forecastingForecast recommendations and the specific conditions attached to them — before committee review, for every jurisdiction in scope.

Value dossier development & optimisationPrepare, assess, and continuously update value dossiers — quantifying how evidence, price, and ICER changes shift deliberations.

Joint Clinical Assessments (JCA)EU JCA readiness — eligibility criteria and evidence strategy stress-tested for every PICO before they land in the dossier.

HTA submission supportRun mock submissions and scenario analyses across jurisdictions to optimise launch sequencing and de-risk filing.

Committee-decision simulationPersona-modelled committees deliberate your dossier across thousands of runs — objection mapping, decision drivers, and evidence gaps.

How it works

A structured simulation of HTA committee deliberation

Advanced Monte Carlo simulation and sampling with the proprietary Loon AI® engine, interpreted with ex-HTA insider expertise. Not generative commentary. Not a black-box score.

InputWhat we ingest

Clinical evidence package
Economic parameters
Target population & positioning

SimulationWhat we run

Committee persona modelling
Objection probability mapping
Recommendation & conditions

OutputWhat you receive

Risk band: low, moderate, or high
Vulnerability heatmap & objection themes
Evidence gaps & mitigation options

Iterate before you file. Run scenario analyses to assess how strategic adjustments shift predicted outcomes and condition profiles — before submission.

Deliverables

01Executive intelligence briefAt-a-glance risk summary with key insights — calibrated for committee, executive, and access-team review.

02Objection mapping & decision-space analysisQuantified areas of concern with detailed root-cause tracing — and the levers available to address them.

03Predicted reimbursement conditionsConfidence scores, rationale, and likelihood for each condition — so teams know where to focus.

Optional add-ons:In-depth Q&A debriefScenario analysesObjection handling

Calibrated confidence

The only AI that knows when it is uncertain

Every Loon Waters™ prediction carries a calibrated confidence score. The system distinguishes high-confidence predictions from uncertain ones — so access teams know which findings to act on and where expert judgement should focus.

Stratified by Strength of Mandate, high-confidence predictions reached 96.8% accuracy — so strategic effort lands on the submissions and conditions where risk is real.

Committee persona modellingPanellists modelled on historical decision behaviour deliberate and vote independently across thousands of runs

Mathematical guardrailsNeurosymbolic architecture ensures reliability and full decision transparency

Five assessment pillarsClinical narrative strength, comparator alignment, economic credibility, precedent consistency, framing vulnerability

Services

AI-enabled services for HEOR, HTA & market access

Alongside the platform, Loon's team of drug reimbursement experts, epidemiologists, and HEOR scientists delivers full value-engineering engagements — as SaaS, tech-enabled services, or fully traditional service, whichever fits your workflow.

EU JCAs support & PICOs executionRapid support for every PICO in scope — evidence requirements anticipated, eligibility criteria stress-tested, and submission strategy validated before they land in the dossier.

Market access intel & committee predictionsForecast reimbursement recommendations and conditions, simulate HTA committee deliberations, and get in-depth therapeutic area analysis to optimize launch sequence.

Reimbursement & HTA submission strategyStreamline global HTA submissions with AI-driven insights — reducing time to market, minimizing conditions, and maximizing reimbursement success.

Value dossier: optimization & simsPrepare, assess, optimize, and continuously update your HTA value dossiers to maximize your drug reimbursement potential in each jurisdiction of interest.

Scientific validation

Peer-reviewed. Independently benchmarked.

medRxiv · 2026 · Pre-print · The Loon Waters™ validation studyMonte Carlo Committee Simulation with Large Language Models for predicting drug reimbursement recommendations and conditionsJanoudi et al. · doi.org/10.64898/2026.03.02.26347434

Enables the shift from reactive to proactive market access: anticipating specific reimbursement conditions before committee review, with calibrated confidence that identifies which predictions to trust. Validated on temporally separated data the models could not have memorised.

95.2% sensitivity97.6% precision96.4% F196.8% high-confidence accuracy

Loon AI® platform validation

Pediatric Academic Societies · 2026 · PresentedCan agentic AI replicate a Cochrane neonatal systematic review?Independently benchmarked by the BC Neonatal Cochrane group across 1,865 records: 98.9% workload reduction, 94.1% study concordance, 100% data extraction truthfulness.Mitra, Fisher-Huise, et al. · 2026.pas-meeting.org Value in Health (ISPOR) · 2025 · Peer-reviewedValidating Loon Lens 1.0 for autonomous abstract screening and confidence-guided human-in-the-loop workflows98.9% sensitivity and 95.2% specificity in full AI-only mode across 3,796 citations — rising to 99.0% sensitivity, 99.0% accuracy, and 99.1% specificity with confidence-guided review of ~5% of records, exceeding dual-human screening without pre-labelled training data.Janoudi G, et al. · doi.org/10.1016/j.jval.2025.09.008

Loon at ISPOR · Short courseApplied Generative AI for HEOR: Advanced ArchitecturesLoon leads ISPOR's advanced short course on generative AI architectures for HEOR.

Loon at ISPOR · Issue panel, 2025AI Agents and Guardrails in HEORInvited panellist alongside ICER and Bristol Myers Squibb, in a standing-room-only session on the trustworthiness of agentic AI.

Loon at ISPOR · Posters & papersPeer-reviewed contributions across the programmeIncluding autonomous data extraction from clinical study reports, benchmarked against Canada's Drug Agency reports.

All publications

Who uses Loon Waters™

Built for every team that owns drug access and commercialisation decisions

Pharmaceutical sponsorsStrengthen HTA submissions, refine pricing strategy, and maximise commercialisation by stress-testing dossiers and forecasting committee conditions and outcomes before filing.

HTA bodies & payersModel committee deliberations, stress-test policy changes, and simulate cross-jurisdictional alignment to inform consistent, evidence-based coverage decisions.

CROs & consultanciesHelp pharmaceutical clients sharpen submission strategies with quantified payer scenarios, jurisdiction-specific risk maps, and evidence-driven recommendations.

Access & HEOR teamsShift from reactive to predictive reimbursement strategy — anticipate conditions, model objections, and de-risk every payer interaction.

Security & compliance:No training on client dataZero-day retention with all LLM providersGDPR & PIPEDA compliantFAIR & RAISE audit trailsConfigurable data residencyCompliant with ISPOR ELEVATE-AI, NICE & CDA-AMC position statements

Team