Payer-Native Pharmacovigilance

Drug safety signals
from your own
claims data.

The only pharmacovigilance platform built for payers. Real-time CNSS signal detection, ISPOR-compliant HEOR evidence, and AMCP Format 5.0 dossiers — generated in 60 seconds from your FHIR R4 endpoint.

Live drug safety signal feed — PayerSignal™ CNSS™ Engine
3,842 MEMBERS · GLP-1 CLASS · DEMO PLAN
semaglutidePANCREATITIS|CNSS 3.82MODERATE semaglutideGASTROPARESIS|CNSS 3.21MODERATE tirzepatidePANCREATITIS|CNSS 2.14LOW liraglutidePANCREATITIS|CNSS 1.88LOW semaglutideTHYROID NEOPLASM|CNSS 2.88MODERATE atorvastatinMYOPATHY|CNSS 1.24MONITOR dulaglutidePANCREATITIS|CNSS 1.62LOW metforminLACTIC ACIDOSIS|CNSS 0.84MONITOR semaglutidePANCREATITIS|CNSS 3.82MODERATE semaglutideGASTROPARESIS|CNSS 3.21MODERATE tirzepatidePANCREATITIS|CNSS 2.14LOW liraglutidePANCREATITIS|CNSS 1.88LOW semaglutideTHYROID NEOPLASM|CNSS 2.88MODERATE atorvastatinMYOPATHY|CNSS 1.24MONITOR dulaglutidePANCREATITIS|CNSS 1.62LOW metforminLACTIC ACIDOSIS|CNSS 0.84MONITOR
$1.59M
ANNUAL ADE BURDEN · SEMAGLUTIDE/PANCREATITIS
NNH 133
vs 250 PUBLISHED BENCHMARK · 47% HIGHER RISK
$478K
STEP THERAPY SAVINGS · 3-YEAR BIA
<60s
FULL HEOR ANALYSIS FROM FHIR ENDPOINT

Pharmacovigilance was built
for pharma. Not payers.

Every tool in this space — Certara, IQVIA, Evidera — was built to help drug manufacturers submit evidence to you. PayerSignal generates that evidence from your own data, independently.

01

Pharma submits. You accept.

Traditional pharmacovigilance tools generate HEOR models that pharma submits in AMCP dossiers. Payers receive the output. They don't own the analysis, the data, or the assumptions.

02

FAERS is population-level. Claims are yours.

FDA FAERS signals are real but they can't tell you that your semaglutide population has a pancreatitis NNH of 133 — 47% worse than the published benchmark. Only your claims data can.

03

P&T needs evidence in hours, not months.

A Certara HEOR model takes 6–12 months and costs $200K–$500K. Your P&T committee meets quarterly. PayerSignal generates NNH, BIA, and AMCP dossier in under 60 seconds.

From FHIR endpoint
to P&T committee memo.

Step 01

Connect your FHIR R4

Point PayerSignal at your FHIR R4 endpoint. OAuth2 client credentials, GCP Secret Manager. 15-minute IT integration.

15 minutes
Step 02

CNSS signal detection

PayerSignal extracts MedicationRequest + Condition resources, computes CNSS scores fused with FAERS PRR and literature signal strength.

2 minutes
Step 03

HEOR evidence layer

NNH with 95% CI, Monte Carlo PSA, budget impact analysis, ICER benchmark alignment, NICE TA comparison. ISPOR-compliant, JMCP-publishable.

60 seconds
Step 04

P&T action

AMCP Format 5.0 dossier, PA criteria update, step therapy protocol, natural language P&T memo — all generated by Claude Sonnet 4.

Instant

Four capabilities no competitor
combines in one platform.

◆ Signal Detection

CNSS™ — Composite National Safety Score

Three-source signal fusion: plan claims (CNSS), FDA FAERS (PRR + chi-squared), and PubMed literature signal count. Weighted 50/30/20. Computes in 2ms per drug-ADE pair.

13 active signals
2ms per query
PRR 3.84 semaglutide/pancreatitis
892 EU reports
⟳ Monte Carlo PSA

ISPOR-compliant probabilistic sensitivity analysis

10,000-iteration Monte Carlo simulation across all uncertain parameters. Gamma distributions for costs, Beta for rates, Normal for utilities. Tornado diagram, CEAC at 21 WTP thresholds, NMB at $50K/$100K/$150K. JMCP-publishable under your plan's name.

10,000 iterations
78.3% P(cost saving)
NNH 90–240 95% CI
10 tornado parameters
◎ ICER Benchmark

Align plan findings with ICER & NICE published HTAs

Semaglutide at $182K/QALY per ICER 2024 obesity report — above $150K threshold. Value-based price $9,930/yr vs WAC $12,048/yr. NICE TA875. Published NNH benchmarks from Prime Therapeutics. P&T committee minutes that cite independent third-party evidence.

$182K/QALY ICER semaglutide
$9,930/yr value-based price
NICE TA875 corroborated
17.6% above VBP
✦ NLQ Engine

Ask your formulary anything in plain English

Two-pass Claude Sonnet 4 architecture. Type "Which GLP-1 drugs have pancreatitis signals above MODERATE with EU corroboration?" and receive a P&T committee memo in 4 seconds. No SQL. No dashboards. No training required.

4s to P&T memo
0 SQL required
Claude Sonnet 4
58 live endpoints
◈ Formulary Tier + PA Context

PA safety check with live formulary intelligence

Without PayerSignal: "FLAG FOR REVIEW." With PayerSignal: "Semaglutide is T3-PA at UHG. Step therapy: metformin (90 days, HbA1c ≥7.0%) → dulaglutide (90 days) → requested drug. PA criteria: lipase/amylase at baseline. Bypass criteria: documented pancreatitis history, MEN2, medullary thyroid carcinoma."

That's an operationally deployable PA protocol generated in under 1 second. Updated from live FHIR MedicationKnowledge resources. 15 payers pre-seeded.

WITHOUT PAYERSIGNAL
FLAG_FOR_REVIEW — semaglutide pancreatitis signal detected
↓ PayerSignal enrichment
WITH PAYERSIGNAL
T3-PA · Step therapy required
Step 1: metformin ≥90 days
Step 2: dulaglutide ≥90 days
PA: HbA1c ≥7.0% · lipase at baseline
Bypass: prior pancreatitis · MEN2

Evidence that P&T
committees cite.

Every HEOR output from PayerSignal follows ISPOR Good Practices, AMCP Format 5.0, and Drummond et al. methodology. A P&T pharmacist can submit the PSA output as a study to JMCP under the plan's name.

That publication is the reference case that brings in the next 10 payers.

SEMAGLUTIDE · PANCREATITIS · 500K-MEMBER PLAN
$1.59M
ANNUAL ECONOMIC BURDEN
NNH 133
vs 250 PUBLISHED · 47% HIGHER
78.3%
P(COST SAVING) · MONTE CARLO
$4.2M
NMB AT $150K WTP
SPRINT S23 10,000 ITERATIONS
Monte Carlo PSA
Beta/Gamma/Normal distributions. CEAC at 21 WTP thresholds. Tornado diagram. Best/base/worst scenarios. Per ISPOR Good Practices (Briggs et al.).
SPRINT S24 ICER + NICE
HTA Benchmark Alignment
ICER $/QALY, value-based price, NICE technology appraisal numbers. Negotiation leverage statements. P&T committee citations with direct links to ICER and NICE reports.
SPRINT S25 CLAUDE SONNET 4
Natural Language Querying
Ask your formulary anything. Two-pass Claude NLQ → structured filter → narrative synthesis. P&T memo in 4 seconds. No SQL, no dashboards, no training.
SPRINT S26 FHIR R4 LIVE
Formulary Tier + PA Intelligence
Live formulary tier from FHIR MedicationKnowledge. Step therapy protocol. PA approval language auto-generated. 15 payers pre-seeded. Updates in real-time from Da Vinci Drug Formulary IG.
AMCP FORMAT 5.0 7 SECTIONS
AMCP Dossier Generator
Full 7-section AMCP Format 5.0 dossier generated in under 60 seconds. Clinical evidence, HEOR evidence, budget impact, comparative effectiveness, safety, appendices. Ready for P&T submission.

The only platform built
for the payer side of pharmacovigilance.

Capability
Certara / Evidera
MMIT / Norstella
PayerSignal™
Signal detection from payer claims
Pharma-side only
No signal detection
CNSS™ from FHIR claims
HEOR modeling (NNH, BIA, ICER)
6–12 months, $200K+
Not available
60 seconds, included
Monte Carlo PSA (ISPOR-compliant)
Manual Excel models
Not available
10,000 iterations live
ICER / NICE benchmark alignment
Pharma positioning only
Not available
Automated, with VBP
FHIR R4 real-time connectivity
SFTP data extracts
Formulary data only
15 payers, SMART OAuth2
PA safety check (<500ms)
Not a PA tool
Not available
Redis cache, <50ms
Natural language querying
Not available
Not available
Claude Sonnet 4, 4s
AMCP Format 5.0 dossier
Pharma submits TO payer
Not available
Generated in 60s
Multi-tenant SaaS / GCP Marketplace
Consulting engagement
SaaS, limited API
GCP Cloud Run, RLS
58
Live API endpoints, 0 stubs
15
Payer FHIR connectors pre-built
529
FAERS cases processed
<500ms
PA safety check SLA (p95)

Connects to your existing
infrastructure.

No new data warehouse. No SFTP extracts. Connect via FHIR R4 in 15 minutes. Deploy on GCP in one command.

GCP CLOUD RUN
FHIR R4
🔑
AUTH0
🗄
POSTGRESQL 15
REDIS
UHG FHIR
ANTHEM FHIR
CIGNA FHIR
AETNA FHIR
CMS BLUE BUTTON
BCBS PLANS
EVICORE PA
AVAILITY PA
CLAUDE SONNET 4
🔒
SECRET MANAGER

See your formulary's
real signal profile.

We'll connect to your FHIR R4 endpoint, run PayerSignal against your actual population, and show you your NNH, burden, and ICER benchmark in a live 30-minute session.

No data sharing required for the initial session · HIPAA-compliant · Runs against synthetic population if preferred