💳 Module 01 · Payer Landscape

Global Payer Landscape Mapper

US commercial, Medicare, Medicaid + EU5 + Japan payer coverage analysis. Formulary positioning, prior authorization landscape, and competitive access benchmarking.

US Payer Coverage

82%

commercial lives

▲ +6 pp YoY

Tier Position

T3

avg formulary tier

PA in 78%

Gross-to-Net

42%

rebate/discount

▲ +4 pp

Time to Reimbursement

8.4

months avg (EU5)

🇺🇸 US Payer Coverage — Top 15 Payers (ASC-301)

Payer	Type	Covered Lives (M)	Coverage Status	Tier	PA Required	Step Edits	GtN%
UnitedHealthcare	Commercial	49.2	Covered	T3	Yes	None	38%
Anthem (Elevance)	Commercial	47.8	Covered	T3	Yes	Failed 1L SoC	42%
Aetna (CVS)	Commercial	38.4	Covered	T3	Yes	None	44%
Cigna	Commercial	18.5	Covered	T3	Yes	Failed 1L SoC	40%
Humana	Commercial + MA	22.4	PA-restricted	T4	Yes	2 fails required	46%
Medicare Part B	Federal	63.8	Covered	—	No	None	22%
Medicaid (National)	Federal+State	93.5	PA-restricted	T4	Yes	State-dependent	56%
Kaiser Permanente	Integrated	12.6	Restricted	T5	Yes	P&T review	35%
BCBS Federal	Commercial	5.6	Covered	T3	Yes	None	36%
Centene/WellCare	Medicaid+MA	26.7	PA-restricted	T4	Yes	State-dependent	52%
Molina Healthcare	Medicaid	5.1	Restricted	T5	Yes	2 fails required	58%
Express Scripts (Cigna)	PBM	85.0	Restricted	T4	Yes	Step edit applied	45%
CVS Caremark	PBM	92.0	Covered	T3	Yes	None	41%
OptumRx (UHG)	PBM	66.0	Covered	T3	Yes	None	39%
Tricare (DoD)	Federal	9.6	Covered	T3	No	None	28%

🌍 Global Coverage Comparison (EU5 + JP)

📈 Access Ramp Trajectory

⚡ Payer Strategy Insight

US commercial access is solid at 82% covered lives; key gap is Medicaid restriction (PA + 2 step edits in 60% of states). Three priority moves:

Outcomes-based contract (OBC): Pilot with Cigna and Aetna — clinical outcome (OS at 24 months) triggers rebate refund. Demonstrates value to ICER and CMS.
Medicaid supplemental rebates: Negotiate state-level supplemental rebates in 6 priority states (CA, TX, NY, FL, IL, PA) to reduce step-edit burden.
IRA exposure assessment: ASC-301 is small-molecule, eligible for Medicare Drug Price Negotiation starting 2028. Model 25-40% price cut scenario impact on 5-year NPV.

📐 Module 02 · Health Economics

HEOR Study Designer

Cost-effectiveness analysis (CEA), budget impact analysis (BIA), cost-utility analysis (CUA), and indirect treatment comparison (ITC/NMA) study design.

🎛️ Study Parameters

Study Type

Perspective

Comparator

Time Horizon (years)15

Discount Rate (%)3.0

Outcome Measure

ICER vs SoC

$84,200

per QALY

▲ Below threshold

Incremental QALYs

3.84

over 15 years

Incremental Cost

$323K

per patient

NMB @ $150K WTP

$253K

net monetary benefit

📊 Cost-Effectiveness Plane

Probabilistic sensitivity analysis: 1,000 simulations of incremental cost vs incremental QALYs. Dashed line is $150K/QALY willingness-to-pay threshold.

🌊 Cost Breakdown

📉 Tornado — Sensitivity

⚡ HEOR Strategic Insight

Base case ICER of $84,200/QALY is below the US payer-typical $150K threshold and within ICER's "high value" range. Probabilistic sensitivity analysis shows 78% probability of being cost-effective at $150K WTP.

Key driver: Overall survival benefit dominates the cost-effectiveness — a 1-month change in incremental OS shifts ICER by ±$18,000.
Vulnerability: Long-term extrapolation assumption (10-15 year tail) drives 32% of total QALY gain. Recommend conservative tail in payer-facing model and detailed in academic publication.
NICE adaptation: If adapting for UK NICE submission, expect £30,000/QALY threshold. Base case £58,000/QALY will fail; need patient access scheme of ~50% to clear bar.

📂 Module 03 · Value Dossier

Global Value Dossier (GVD) & AMCP eDossier Builder

Structured value story development covering unmet need, clinical evidence, economic evidence, and patient-reported outcomes. AMCP Format 4.0-compliant eDossier sections.

GVD Completion

78%

14 / 18 sections

Value Pillars

5

defined

Evidence Gaps

3

requires HEOR study

AMCP Sections

12/12

Format 4.0 covered

🏛️ Value Story Pillars — ASC-301

Pillar	Headline	Evidence Strength	Gap
1. Unmet Need	Limited treatment options after 1L progression	Strong	None
2. Clinical Benefit	OS HR 0.68 vs SoC, PFS 8.4 vs 5.2 months	Strong	None
3. Quality of Life	EORTC-QLQ-C30 +12.4 vs SoC at week 24	Moderate	PRO long-term
4. Economic Value	ICER $84K/QALY vs SoC	Strong	Real-world cost-effectiveness
5. System Value	Reduced hospitalization (-32%) and inpatient days	Moderate	RWE confirmation

📋 AMCP Format 4.0 Compliance

Section	Required Content	Status
1.0 Executive Summary	≤2 pp summary of value	Complete
2.0 Product Information	Indication, MOA, dosing, PK	Complete
3.0 Disease & Population	Epidemiology, burden, unmet need	Complete
4.0 Clinical Evidence	Pivotal + supportive trials	Complete
5.0 Comparative Effectiveness	SLR + NMA / ITC	In review
6.0 Economic Model	BIA + CEA results	Complete
7.0 Patient Perspectives	PRO + patient burden	In review
8.0 Real-World Evidence	RWE study results	Drafting
9.0 References & Appendices	Citation database	Complete

⚡ Value Dossier Strategic Brief

GVD is 78% complete with strong evidence on Pillars 1, 2, and 4. Three critical gaps to close before launch:

Quality-of-life long-term data (Pillar 3): Open-label extension study reading out Q2 2027. Recommend interim PRO publication at ASCO 2027 to strengthen payer narrative.
Real-world cost-effectiveness (Pillar 4): Plan IQVIA Komodo claims-linked study to validate trial-based ICER in real-world setting. 12-month timeline to first publication.
System value evidence (Pillar 5): Hospitalization data from trial is suggestive; need RWE confirmation via Optum or Flatiron data partnership. Position for value-based contract negotiations with major commercial payers.

⚖️ Module 04 · HTA Strategy

HTA Pathway Scorer (NICE / G-BA / AMNOG / HAS / PBAC)

Health Technology Assessment pathway prediction across major HTA bodies. Probability of positive recommendation, expected pricing constraints, and adaptive submission strategy.

HTA Bodies Modeled

7

major jurisdictions

Avg P(Positive)

68%

across HTAs

Expected Price Cut

22%

vs US net price

Time to Reimbursement

14

months avg

🌍 HTA Body Assessment

HTA Body	Country	P(Positive)	Expected Outcome	Time to Decision	Pricing Constraint	Strategy
NICE	🇬🇧 UK	52	Conditional w/ PAS	9 mo	50% PAS discount required	Patient Access Scheme
G-BA / IQWiG	🇩🇪 Germany	78	"Considerable" added benefit	6 mo	15-25% price negotiation	Direct negotiation
HAS / CEPS	🇫🇷 France	72	ASMR III-IV	12 mo	22-30% price discount	SMR strategy
AIFA	🇮🇹 Italy	62	Innovativeness fund eligible	10 mo	MEA (PbR or risk-sharing)	MEA contract
Spanish DGCYP	🇪🇸 Spain	58	Conditional reimbursement	14 mo	Regional access variation	National + regional
CDA-AMC	🇨🇦 Canada	71	Conditional positive	15 mo	pCPA negotiation 30-40%	pCPA early engagement
PBAC	🇦🇺 Australia	64	Restricted listing	11 mo	Special pricing arrangement	PBAC submission Q2

📊 HTA Outcome Probability

💰 Net Price Trajectory (Index US=100)

⚡ HTA Strategic Brief

G-BA (Germany) and HAS (France) are the strongest pillars — submit first to anchor international reference pricing favorably. NICE (UK) requires preparation: base case fails the £30K/QALY threshold; Patient Access Scheme of ~50% discount needed for positive recommendation.

Sequencing strategy: Germany Q3 2026 → France Q4 2026 → Italy + Spain Q1 2027 → UK Q2 2027 (after evidence package strengthening). Avoid UK-first to prevent low-anchor reference pricing.
Risk-sharing in Italy: MEA contract (payment by result) creates 18-month bridge while AIFA finalizes innovativeness fund eligibility.
EUnetHTA JCA preparation: EU Joint Clinical Assessment becomes mandatory 2026 for oncology. Pre-emptive Scientific Advice with EUnetHTA recommended Q2 2026.

🌐 Module 05 · Real-World Evidence

RWE Data Source Matcher & IRA Pricing Strategy

Real-world data source selection across claims, EHR, registries, and tokenized datasets. Medicare Drug Price Negotiation (IRA) impact modeling and value-based contract design.

RWE Studies Active

6

across portfolio

Data Source Partners

8

claims + EHR + registries

IRA-Eligible Assets

3

small molecules

▲ 2028 selection

5-Yr IRA Revenue Risk

$2.1B

at 40% MFP cut

🗄️ RWE Data Source Matcher

Data Source	Type	Coverage	Strengths	Use Case Fit	Annual Cost
IQVIA PharMetrics Plus	Claims (Comm + MA)	235M lives	Longitudinal claims, comm + MA	BIA, RWE comparative effectiveness	$450K
Komodo Healthcare Map	Integrated Claims + EHR	320M lives	Closed claims linkage	Real-world treatment patterns	$680K
Optum Clinformatics	Claims + lab	75M lives	Lab + claims linkage	Surrogate endpoint validation	$520K
Flatiron Oncology	EHR (Oncology)	3.5M oncology pts	Curated oncology EHR	External control arm, RWE	$780K
Truveta	EHR Network	120M pts	Real-time EHR, multi-system	Safety surveillance, RWE	$420K
TriNetX	EHR Federation	280M pts	Global EHR network, fast feasibility	Trial feasibility + RWE	$380K
Aetion Evidence Platform	Tokenized + analytical	N/A (platform)	FDA-grade RWE analytics	Regulatory RWE submissions	$550K
Medicare LDS / CMS	Federal Claims	63M lives	Federal claims, IRA-relevant	Medicare cost-effectiveness	$25K

📉 IRA Medicare Drug Price Negotiation Impact

Modeled NPV impact across 4 IRA scenarios for ASC-301 (small molecule, eligible 2028).

🤝 Value-Based Contract Design

VBC Type	Trigger Metric	Rebate %
Outcomes-based (OS)	24-mo OS < 65%	15%
Outcomes-based (PFS)	Median PFS < 7 mo	10%
Annuity/Installment	Spread over 60 months	N/A
Indication-specific	Earlier-line failure	8%
Adherence-based	<80% adherence	12%

⚡ RWE & IRA Strategic Brief

ASC-301 is a small-molecule small-molecule oncology asset and falls within the IRA Medicare Drug Price Negotiation 9-year post-approval window starting 2028. Two-pronged strategy required:

RWE program: Lock data partnership with Flatiron (oncology EHR) + Komodo (claims linkage) by Q3 2026. Use combined cohort for external control arm support, post-marketing OS validation, and IRA pre-negotiation evidence package.
IRA negotiation preparation: CMS evaluates "comparable therapeutic alternatives," clinical benefit, and unmet need. Build defensible value case using G-BA + NICE-style HTA evidence package. Pre-emptive submission to ICER for independent value assessment.
VBC pivot: Outcomes-based contracts with top-5 commercial payers create non-IRA revenue protection and demonstrate confidence in efficacy claims. Target Cigna and Aetna as first pilots — both have published OBC frameworks.

Expected impact: Combined RWE + VBC + IRA preparation reduces NPV erosion from 40% (worst case) to 18% (base case) under MFP scenarios.