~14K untapped pool 3× larger than current persistent base
Launch Year · The Next Prize
Iqirvo · PBC · US Value & Access Landscape
The expansion zone sits before the share war: ~14K eligible PBC patients untreated.¹²
Live · May 29, 2026
Ipsen V&A has won the 18K share war — CVS preferred, ESI Livdelzi excluded (eff. 7/1/26), EASL 2026 fatigue + ALP 1–1.67× ULN RWE + ELFINITY data deployed, ACG 2025 CEA shows elafibranor dominant.¹⁰¹¹ But the ~14K under-treated pool¹² is 3× larger than Iqirvo's current ~4.5K persistent base.Expansion is the natural next prize.
Ipsen
Iqirvo
elafibranor · PPAR α/δ · 80 mg PO QD
WAC / yr$139,430 −$14K vs. L
Net price (ICER)$125,487 −$13K vs. L
SP network6 SPs intentional Ocaliva mirror
ACG 2025 CEADominant −$250K/QALY
PBM preferredCVS + ESI 2 of 3
Fatigue (EASL '26)67% vs 31% new claim
Pruritus (ELFINITY)RWE relief parity recall
FY 2025 sales~$115M global trailing
ConfirmatoryELATIVE · ELFIDENCE · ELFINITY
ApprovalFDA accelerated · Jun 10, 2024
vs.
Gilead
Livdelzi
seladelpar · PPAR δ-selective · 10 mg PO QD
WAC / yr$153,373
Net price (ICER)$138,036
SP network3 SPs → 4 w/ Walgreens 7/1/26
ACG 2025 CEADominated
PBM preferredExcluded · ESI 7/1/26
Fatigue claimNo equivalent data
Pruritus (RCT)WI-NRS · ESI 5-D stat-sig
FY 2025 sales$345M ~50% 2L share
ConfirmatoryRESPONSE → AFFIRM outcomes
ApprovalFDA accelerated · Aug 14, 2024
Read the cascade below as one continuous access funnel. Every drop is a patient lost from the pool — and every drop has a Marigolds AI lever. The biggest single drop (~12.7K, between bars 6 and 7) is the competitive share war you've already half-won. The earlier drops (~14K total, bars 1–6) are the expansion zone — where the next round of access work compounds.
Access Cascade · 2L-Eligible Pool → Iqirvo Persistent · Every Drop Has a Reason
−5K
no spec
−3K
wait/see
−2K
unfam
−2K
decomp
−2K
declined
−12.7K
→ Livdelzi + Ocaliva
−0.8K
PA churn
~32K
Eligible pool
↕
~27K
Specialist-managed
↕
~24K
Actively monitored
↕
~22K
PPAR-considered
↕
~20K
Indication-eligible
↕
~18K
2L Rx written
↕
~5.3K
Iqirvo Rx
↕
~4.5K
Iqirvo persistent
↕
Expansion Zone · −14K total (~12K Iqirvo-addressable)
Cumulative dropouts across bars 1→6 · Marigolds AI levers in 4 of 5 drops
Share War · −12.7K
→ Livdelzi + Ocaliva
Doc · −0.8K
PA churn
~32K · 2L-Eligible Pool · the addressable universe
~106K diagnosed × ~85% UDCA-treated × ~30% inadequate response (HepComm 2025³ · CGH 2020⁴)Payer trigger: ALP >1.67× ULN after ≥12 mo UDCA · or documented UDCA intoleranceOf this pool, only ~18K are on any 2L therapy today. The other ~14K¹² sit in the expansion zone — addressable through a different set of access levers than the share war.Sensitivity range 6K–22K depending on inadequate-response rate (25–40%) and sales-to-patient conversion. See footnote 12 for full derivation.
~27K · Specialist-Managed · −5K to specialist access gap
~5K eligible patients are followed exclusively in primary care or community GI — never escalated to hepatologyillustrative breakdown~53% of PBC currently managed by hepatology/GI per published series · ~1,500–1,700 board-certified transplant hepatologists in USMarigolds AI lever: state-level hepatology activation map · AMC concentration overlays · telehealth referral pathways for low-density states (MT, WY, ND, AK, NM)
~24K · Actively Monitored · −3K to "watch-and-wait" clinical inertia
~3K eligible patients sit in the ALP 1.0–1.67× ULN "watch-and-wait" zone — historically deferred for 2LillustrativeEASL May 28, 2026 Health Verity RWE: 72% achieved ≥15% ALP reduction, mean ALP 174→131 U/L, 59% normalization at 6 months in this exact 1.0–1.67× ULN segment¹¹Marigolds AI lever: deploy this data to hepatology KOLs, AASLD writing group, and payer P&T to widen the treatable threshold
~22K · PPAR-Considered · −2K to provider unfamiliarity with new options
~2K eligible patients are with providers who haven't adopted PPAR agonists yet — default to fibrate off-label or watchful waitingillustrativeIqirvo and Livdelzi only launched June + August 2024. Ocaliva (gone Nov 2025) was the default 2L for 8 yearsMarigolds AI lever: track AASLD summer 2026 guideline update by state, KOL adoption signals, prescriber-level PPAR uptake from MMIT/IQVIA
~20K · Indication-Eligible · −2K to decompensated cirrhosis exclusion
~2K eligible patients have progressed to decompensated cirrhosis — outside Iqirvo + Livdelzi labelillustrativeIqirvo + Livdelzi: not recommended in decompensated cirrhosis (ascites, variceal bleed, encephalopathy)Marigolds AI lever: track GSK + Alphasigma IBAT inhibitor positioning for this excluded population. Decompensated patient pathway intel.
~18K · 2L Rx Written · −2K to patient affordability / declined
~2K indication-eligible patients decline 2L therapy at the bedsideillustrativeReasons: asymptomatic disease, specialty Tier 5 cost-share, copay concerns (especially Medicare without LIS), pill-burden objectionsMarigolds AI lever: state-level LIS eligibility mapping · IRA Part D smoothing patient-facing materials · affordability story by PBMThis is the bottom of the expansion zone. Closing dropouts 1–5 (specialist + watch-wait + provider + indication + affordability) would lift this number from ~18K toward ~32K.
~5.3K · Iqirvo Rx · −12.7K to competitive share (Livdelzi + ex-Ocaliva + other 2L)
~9.0K on Livdelzi (~50% share) · FY 2025 sales $345M · Q4 $150M (+42% QoQ)⁶~3.1K still on legacy Ocaliva at withdrawal · transitioning now via 6-SP channel⁵~0.6K on UDCA monotherapy holdouts / off-label fibrates / otherDefend & accelerate plays already secured: CVS Caremark Iqirvo-preferred since 7/1/25 · ESI step 4/15/26 + Livdelzi excluded 7/1/26 · 6-SP captures Ocaliva transition naturally · EASL 2026 fatigue (67% vs 31%) + ALP RWE + ELFINITY pruritus relief now deployable to UHC + Anthem open windows¹⁰¹¹This is the share war zone — and Ipsen is winning it. Closing the gap with Livdelzi (~9K) doubles Iqirvo to ~9–10K Rx.
~4.5K · Iqirvo Persistent at 6 mo · −0.8K to PA documentation friction
~0.8K Iqirvo scripts never fill or are abandoned in the PA cycleillustrativeProvider office staff (often <2 yrs school) submit complex medical info · concomitant UDCA documentation missed · 12-month UDCA duration disputes · ALP threshold timing · 40–60 eligible patients per clinic compounds the fatigueLong PA cycle → patient drops off → re-prescribed 6 months later or neverKorrie's #1 pain — solved by Marigolds AI's PA Documentation Assistant. Drafts payer-specific PA submissions pre-populated with Iqirvo + UDCA concomitancy language, ALP timing, hepatology attestation templates. Tracks denial reasons by payer in real time.~85% persistence at 6 mo · 2L PBC industry analogillustrative
~$1.4B
24-Month Addressable
Read the cascade in three zones. The −14K expansion zone is the cumulative drop across bars 1→6 — patients eligible but not on any 2L (~12K addressable by Marigolds AI; 2K decompensated, off-label). The −12.7K share war is between bars 6→7 — patients on Livdelzi or Ocaliva, not Iqirvo. Three levers stack:
Defend current
~$565M / yr
4.5K Iqirvo persistent × $125,487 ICER net
Accelerate share
+~$565M / yr
Close Livdelzi gap (5.3K → 9K) via PBM wins + EASL data
Expand pool
+~$263M / yr
50% of ~12K Iqirvo-addressable × 30% share = 1.8K new (excludes 2K decompensated)
Defend + Accelerate ≈ the share war ($1.1B). Expand ≈ the new opportunity ($263M baseline, more upside as AASLD shifts threshold). Net price per ICER 2025; patient projections illustrative.
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
2 of 7 · Where
Where the share war is being fought.
PBC patients · payers PBM coverage status Ocaliva transition cohort
v2 of this map adds MMIT/PolicyReporter for live PA criteria + Ipsen hub data on PA denial reasons by payer.
Commercial · Medical + Pharmacy Benefit
~46%
of 2L-eligible PBC · ~14.7K people · 2 of 3 big PBMs locked. CVS Caremark preferred (7/1/25). ESI Livdelzi excluded (7/1/26). UHC last battleground. Anthem & Aetna open windows.
2 WON · 1 BATTLEGROUND · 2 OPEN▼ View detail
Medicare · Part D Pharmacy Benefit
~42%
of 2L-eligible PBC · ~13.4K people · Specialty Tier 5 at all major sponsors. Iqirvo channel-favored at Humana CenterWell, UHC Optum, CVS SilverScript — all in 6-SP. VA monograph gap = federal opportunity.
CHANNEL-FAVORED · VA GAP▼ View detail
Medicaid · State PDLs
~12%
of 2L-eligible PBC · ~3.8K people · No state has put Iqirvo or Livdelzi on preferred status yet. TX reviewed Jan 2025 — both stayed non-preferred. CA, NY, FL, PA, TX P&T cycles in Q3–Q4 '26 are the catalyst. Whoever pre-positions first wins preferred.
OPEN FRONTIER · FIRST-MOVER WINS▼ View detail
Commercial · 2 of 3 big PBMs locked. Defend the wins, close UHC.
Per Ipsen V&A: Iqirvo is now preferred over Livdelzi at CVS Caremark (since 7/1/25, step-through) and Cigna/ESI (step 4/15/26 + Livdelzi excluded 7/1/26). The remaining work: UHC/OptumRx (last battleground), Anthem-Elevance and BCBS plans where templates are still being written, and 2027 NPF defense of existing wins.
Payer / PBM
Iqirvo policy
Livdelzi policy
Status
V&A lever
UnitedHealthcare ~27M commercial lives · OptumRx
PA required · step therapy program live · 12-mo UDCA + ALP threshold¹
PA required · same step therapy program · parity language
Last battleground
Only big-3 PBM not yet won. CVS + ESI precedent = strong wedge. EASL fatigue data + ALP <1.67× ULN RWE = new ammunition for 2027 NPF.
Aetna · CVS Health ~19M commercial lives · CVS Caremark
Preferred (sole source w/ step) since 7/1/25. CVS Specialty in 6-SP²
Non-preferred · step through Iqirvo required (effective 7/1/25)
Iqirvo preferred
Win secured. Defend through 2027 NPF cycle. Channel + CEA arguments held.
Cigna · Express Scripts ~17M commercial lives · ESI
Preferred · step starts 4/15/26. Accredo in 6-SP³
Excluded effective 7/1/26. ESI formulary exclusion list confirmed
Iqirvo win
2 of 3 big PBMs locked. Marigolds AI tracks competitor counter-moves + 2027 NPF defense.
No public PBC 2L policy yet. Open window before P&T template forms.
No public PBC 2L policy yet.
Window open
Pre-emptive P&T brief — highest-leverage move of Q3 '26
Humana ~5M commercial lives · CenterWell SP
CenterWell in Iqirvo 6-SP · Ocaliva withdrawal member alert published⁴
Not in CenterWell channel — out-of-network routing required
Iqirvo-favored
Channel advantage — Ocaliva transition members already inside Humana SP infrastructure
BCBS plans ~70M lives (ex-Anthem) · Premera, FEP, Florida Blue
Premera 5.01.615 + FEP 5.50.040 + Florida Blue MCG 09-J4000-93 · symmetric criteria⁵
Added to Premera template Jan 2025 — combo exclusion explicit
Symmetric
PolicyReporter daily monitoring · BCBS affiliates set state precedent · Florida, Texas, Pennsylvania first
Medicare Part D · ~42% of PBC patients · plan-by-plan
PBC's age skew (~9:1 female, median age 50s+) pushes ~42% of treated patients into Medicare. Iqirvo and Livdelzi both sit on specialty tier across the major Part D sponsors. Differences live in (a) which plans run Iqirvo through their captive SP, (b) which still use Ocaliva-era step language post-withdrawal, and (c) IRA Part D smoothing effects on patient affordability. Ipsen Cares cannot offset Part D cost-share — federal AKS.
Part D plan sponsor
Iqirvo position
Livdelzi position
Status
V&A lever
Humana ~5.8M MA-PD lives · CenterWell SP
Specialty Tier 5 · PA required · CenterWell Specialty in Iqirvo 6-SP network — in-channel⁷
Specialty Tier 5 · PA · Out-of-network SP routing to PantherX/Orsini
Iqirvo-favored
Channel advantage · Ocaliva withdrawal alert already published — Humana members in transition
UnitedHealthcare MA-PD ~9.4M MA lives · OptumRx
Specialty Tier 5 · PA + step therapy program active (commercial template applied)¹ · Optum Specialty in Iqirvo 6-SP
Caremark 2027 NPF window — channel-economics argument for preferred slot
Cigna HealthSpring MA-PD ~0.6M MA lives · ESI / Evernorth
Specialty Tier 5 · Cigna PA template published · Accredo in Iqirvo 6-SP · inherits ESI commercial step + exclusion logic³
Specialty Tier 5 · PA · Express Scripts/Accredo out-of-network · ESI excluding 7/1/26 (commercial) flows through
Iqirvo-favored
Channel advantage at the PBM level + ESI exclusion pressure · defend through 2027 NPF
WellCare / Centene ~1.3M MA-PD · Express Scripts
Specialty Tier 5 · PA · uses ESI/Express Scripts template · Accredo in Iqirvo 6-SP · inherits ESI commercial step + exclusion logic
Specialty Tier 5 · PA · Express Scripts/Accredo out-of-network · ESI excluding 7/1/26 (commercial) flows through
Iqirvo-favored
High LIS concentration + ESI channel advantage · IRA smoothing material here · dual-eligible carve-outs to track
Kaiser Permanente Senior Advantage ~1.9M MA · closed system
Specialty PA · Kaiser internal SP only · custom P&T⁸
Specialty PA · same Kaiser internal pathway
Closed P&T
Kaiser P&T is closed · CEA case + value-based contracting only durable lever
BCBS MA plans ~3.5M MA-PD · varies
Specialty Tier 5 · PA · most affiliates adopting Premera 5.01.615 / FEP 5.50.040 template⁵
Specialty Tier 5 · PA · same template, added Jan 2025
Symmetric
FEP Blue + state BCBS affiliates · CEA-based brief works across affiliates
VA / DoD ~9M veterans + 9.6M TRICARE
Not yet on VA Formulary · monograph pending
VA Monograph Jan 2025⁹ · drives VA Nat'l Formulary, cascades to TRICARE / CHAMPVA / IHS · reaches VHA Hepatology Field Advisory Committee
Livdelzi ahead
★ FEATURED MOVE — see S4 "+1 Federal Lever". Submit Iqirvo VA monograph submission packet Q3 '26. The most concrete white-space gap.
State Medicaid · ~12% of PBC patients · state-by-state PDL status
Most state P&T committees are mid-cycle on PBC 2L. Texas reviewed in Jan 2025 — neither drug flagged preferred yet. CA, NY, FL, PA P&T cycles run through Q3–Q4 '26. Preferred vs. non-preferred PDL designation determines supplemental rebate exposure and patient access friction. ~12K Medicaid PBC lives in play.
State Medicaid
Iqirvo PDL status
Livdelzi PDL status
Status
V&A lever
California Medi-Cal · ~14M lives · ~2,200 PBC est.
PA required · UDCA inadequate response OR intolerance · DUR Board has not yet designated PDL status
PA required · same DUR criteria pending
P&T pending
First-mover wins preferred — pre-position before next P&T cycle · largest single Medicaid · DHCS P&T Q3 '26 · pre-submit CEA + budget impact
PA · ODM Single Pharmacy Benefit Manager (Gainwell) standard 2L criteria · UDCA step
PA · same SPBM template
Symmetric PA
Single-PBM state · one negotiation gates ~1,200 lives
Oregon ~1.4M lives · illustrative
PA Criteria Oct 2025 · 6-mo auth · GI/hepatology consult · concomitant Iqirvo/Livdelzi/Ocaliva prohibited⁶
Same PA criteria · same 6-mo auth window
Symmetric PA
Most detailed public policy · template likely to spread to neighboring states
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
3 of 7 · Why
Three asymmetries.
Policy · Channel Evidence · where Iqirvo's value isn't compounding
Next Prize › Where › Why
Three Asymmetries · Each One a Lever You Already Have
You have the value case. It's not getting to the people writing the policies.
Same-PA-template trap
UHC, Cigna, Aetna, and most BCBS plans use one PA template for both PPARs — your CEA case can't compete inside a symmetric criteria document
▶
What the policies look like
"Iqirvo OR Livdelzi"
Symmetric language: UDCA inadequate response (ALP >1.67× ULN after ≥12 mo) OR intolerance · combination use excluded · 6-month auth · ALP renewal threshold. The two drugs are 1:1 substitutes inside the PA document.
≠
What you can argue
Preferred status, not parity
ACG 2025 CEA: elafibranor dominates seladelpar at –$250,415/QALY, $62,971 savings per patient over 5 years. ICER net price gap. WAC gap. The case for preferred-tier Iqirvo over parity-tier Livdelzi is ready to formally submit to payers — the CEA + net price differential are the wedge.
Lever · what Marigolds AI delivers
Payer-specific P&T brief built around ACG 2025 CEA + ICER net price + 5-yr budget impact ($40M/year savings if Iqirvo replaces Livdelzi at parity volume). Submitted to Anthem-Elevance and CarelonRx before the symmetric template is written.
Ocaliva transition policy drift
Every payer is rewriting language post-Ocaliva. Most are doing it without input — the rewrites lock in for the next 24 months
▶
Live signal · happening now
Premera updated Jan 2025 — others lagging
Premera 5.01.615 already updated combo-exclusion language to drop Ocaliva and keep Iqirvo/Livdelzi mutually exclusive. ~30 plans haven't updated yet. Each rewrite is an opportunity to shape language — or to inherit Gilead's framing.
→
What Marigolds AI tracks
Daily PolicyReporter delta
Every payer policy file change is captured the day it publishes. The team sees the diff before it cascades to other plans. Engagement window is measured in days — not quarters.
Medicaid PDL designation race
State P&T committees are deciding preferred status now — Texas reviewed in Jan 2025, neither preferred yet
▶
~12% of PBC patients
~12K Medicaid PBC lives
Medicaid PDL designation determines whether a drug needs supplemental rebate or not. Preferred = no rebate concession. Non-preferred = rebate or volume loss. The state decides in P&T meetings most V&A teams don't see until after the fact.
→
What Marigolds AI delivers
P&T calendar + state-specific briefs
Marigolds AI pulls every state's P&T meeting calendar, agenda, DUR Board membership, and historical voting record on analog 2L drugs from public Medicaid sites. Drafts submission briefs in each state's preferred format. The supplemental rebate decision and model are built from Ipsen's internal net price strategy. CA, NY, FL, TX, PA are the priority cycles.
PBM-captive specialty pharmacy access
Iqirvo dispenses through CVS Specialty, Optum, Accredo — the three biggest PBM-captive SPs. Livdelzi cannot
▶
Livdelzi · 2-SP LDD
PantherX + Orsini only
Niche rare-disease pharmacies · the rationale is hub-style high-touch service · the cost is that every Caremark, OptumRx, or ESI prescription routes out-of-network for the PBM. That creates friction in formulary design.
Every major PBM-captive SP is in-network for Iqirvo. The dispensing economics favor Iqirvo at every PBM that owns its own SP — and that's the entire top of the market.
Lever · what to do
Bring the channel story directly to OptumRx, CVS Caremark, and Express Scripts trade contracting. Preferred status for Iqirvo doesn't just save money on drug cost — it keeps the dispensing inside the PBM's owned channel. The economics compound.
PA documentation friction · the #1 pain Ipsen V&A flagged
Per Korrie Foley + Dan Keeley: payer coverage isn't the problem. The pain is provider-office staff submitting complex clinical documentation, getting denied, and losing patients in the cycle
▶
The friction loop
Office staff < 2 yrs school submit complex med info
40–60 eligible patients per clinic · UM criteria not universally applied across payers · concomitant UDCA documentation frequently missed · long PA cycle → patient drops off → re-prescribed 6 months later or never. "This is not unique to Iqirvo. That's where the stickiest points are." — Korrie Foley.
→
What Marigolds AI delivers
PA Documentation Assistant
Drafts payer-specific PA submissions pre-populated with Iqirvo + UDCA concomitancy language, ALP threshold timing, hepatology attestation templates. Tracks denial reasons by payer in real time. Feeds back into the field reimbursement team's playbook so the same denial doesn't happen twice.
Dan Keeley's ask · paraphrased
"Without full visibility into how Gilead navigates PA — can we get to the same level, or even better, on the normal PA process for our drug? If providers feel Iqirvo is the easier choice when they're clinically net-net neutral, that's a win." Marigolds AI's documentation tooling is built around this exact ask.
Hub + 6-SP architecture for transition cohort
Ipsen intentionally mirrored Ocaliva's SP network to capture transitions naturally. CureScript added 30 days post-Gilead launch for hospital systems
▶
What the ex-Ocaliva patient sees
SP they already know · no disruption
Patient on Ocaliva at CVS Specialty or Accredo. Hepatologist adds Iqirvo to UDCA — same SP fills the prescription. Same patient assistance program if commercial. Same clinical pharmacist. No onboarding friction.
→
What Livdelzi requires
SP transition · enrollment · re-onboarding
Livdelzi 3-SP network (Orsini, PantherX, + Walgreens 7/1/26) routes out-of-network at every PBM-captive SP — new hub enrollment, new patient assistance program, new clinical pharmacist. The friction is real and operational.
ACG 2025 cost-effectiveness analysis
Independent CEA in PSA: Iqirvo dominates Livdelzi. Published Oct 2025. Not yet in any payer dossier we can find
▶
The data
Elafibranor dominant · –$250K/QALY
5-yr Markov model · 1000-iteration PSA · Iqirvo cost-effective in 99.6% of simulations · $62,971 savings per patient · ~$40M annual budget impact if Iqirvo replaced Livdelzi at parity volume. Published ACG 2025 abstract S2750.
→
What to do with it
Payer-specific budget impact models
The CEA is published. The next step is a payer-specific budget impact model that converts the CEA into a tier-shift case for each P&T committee. UHC, Cigna, BCBS plans — each gets a tailored deck. Marigolds AI builds those.
Multi-symptom claim · Iqirvo now owns fatigue + ALP + pruritus relief
EASL May 28, 2026 late-breakers gave Iqirvo three new evidence layers Livdelzi can't match — fatigue (RCT post-hoc), ALP normalization in 1–1.67× ULN (RWE), pruritus relief (Phase IV ELFINITY)
▶
The old framing
"Livdelzi is the pruritus drug"
WI-NRS / ESI 5-D pruritus data drove prescribing through 2025. Iqirvo's PBC-40 itch domain improved but couldn't claim statistical significance — Ipsen's V&A team flagged this as the share-driver gap.
→
The new framing (May 28, 2026)
Iqirvo is the only 2L PBC drug with ALP + fatigue + pruritus claims
Per Ipsen May 28 PR: "the only second-line PBC treatment providing rapid and robust ALP reduction with fatigue improvement and pruritus relief." Three EASL late-breakers stack the case.
EASL 2026 late-breaker data · what just landedELATIVE post-hoc fatigue: 67% Iqirvo vs 31% placebo achieved clinically meaningful fatigue improvement at Wk 52 (p=0.020); improvements as early as Wk 4. Multiple dimensions: extreme exhaustion 62% vs 31%, "too tired to think clearly" 57% vs 31%, "too tired to bathe/shower" 55% vs 25%. Health Verity RWE in ALP 1–1.67× ULN: 72% achieved ≥15% ALP reduction; mean ALP 174 → 131 U/L; 59% ALP normalization at 6 months. First RWE in the under-1.67× ULN segment — directly challenges PA gates set above that threshold. ELFINITY Phase IV interim (month 3): 55% biochemical response; >50% of moderate-to-severe fatigue patients improved by month 3; clinically meaningful pruritus relief; no serious TEAEs.¹¹
Real next threats · GSK IBAT now, Zitus 2027
Not Mirum. The pressing competitive moves are GSK/Alphasigma's IBAT inhibitor (already approved for pruritus-associated PBC) and Zitus — another PPAR α/δ with the same MOA — entering early-to-mid 2027
▶
Near-term threat (now)
GSK + Alphasigma IBAT inhibitor
Already FDA-approved for pruritus-associated PBC. Adjacency, not direct 2L PPAR competition — but cuts into the symptom-relief narrative. AASLD summer 2026 update will define how it's positioned vs. Iqirvo's new EASL fatigue + pruritus claims.
→
2027 mechanistic threat
Zitus · same PPAR α/δ MOA · early-to-mid 2027
Direct mechanistic competitor — same dual PPAR alpha/delta as Iqirvo. Defends a 3-drug PPAR space and forces Iqirvo's EASL data advantage to compound before launch. Marigolds AI tracks Zitus pipeline + payer pre-positioning signals.
ELFIDENCE + AASLD summer 2026 — pre-position now
Ipsen Medical Affairs is working the AASLD guideline update this summer. Payers reset PA criteria at full approval. Marigolds AI maps both timelines onto the same engagement plan
▶
The catalysts
AASLD summer '26 + ELFIDENCE 2026
Per Ipsen V&A: Medical Affairs is actively working the AASLD update. ELFIDENCE confirmatory data drives full approval. Every payer revisits PA criteria at full approval.
→
Pre-position dossier
Map AASLD class-by-class · build post-conversion PA template
Marigolds AI maps the 2018 Lindor guidance class by class, identifies obsolete clauses post-Ocaliva, and tracks payer PA template revisions as guidelines publish — so V&A sees the diff the day it lands.
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
4 of 7 · What We Hand You
Four V&A tools.
Built for Ipsen Rare Disease BU Iqirvo-specific
Next Prize › Where › Why › What We Hand You
The Iqirvo Access Map · Four Components · Built for V&A + Payer + Commercial Ops
Four things Marigolds AI hands you.
The goal
~30% → ~45%
2L share by EOY 2026. Each point = ~180 patients.
The prize
~$380M / yr
Incremental at net price if 2L share climbs to ~45%. Illustrative.
Click any component to see what's inside — what decision it enables, who acts on it, and when.
01 · Value Asymmetry Tracker · Live
Decision enabled: where Iqirvo's value case is being heard — and where it's being treated as parity.
Side-by-side payer policy view for every commercial, Medicare, and Medicaid plan covering PBC 2L. For each plan: (a) Iqirvo PA criteria text, (b) Livdelzi PA criteria text, (c) preferred-status flag, (d) renewal-gating language, (e) SP routing, (f) any tier or rebate position your team has visibility into. Daily PolicyReporter delta surfaces every change the day it publishes.
Who acts on it: Korrie Foley (V&A Strategy) · Dan Keeley (Payers) · Jen English (Price & Value).
V&A StrategyPayer EngagementAlways On
02 · Share Recapture Playbook · Quarterly
Decision enabled: where to deploy resources to win 2L share — ranked by recoverable patient volume.
State-by-state and payer-by-payer view of where Iqirvo can credibly take share from Livdelzi this quarter. For each opportunity: (a) ex-Ocaliva transition cohort still up for grabs, (b) PBM-captive SP channel advantage, (c) Medicaid PDL preferred slot availability, (d) hepatologist KOL alignment status. Ranked by patient count + revenue at net price.
Who acts on it: Kyle Bailey (Commercial Ops / Rare Disease BU) · Korrie Foley · Pruthvi Shah (Data Strategy).
Commercial OpsField DeploymentQuarterly
03 · Net Price Position Monitor · Monthly
Decision enabled: where price & contracting strategy needs to flex — and where to hold the line.
Iqirvo gross-to-net trajectory tracked against Livdelzi disclosed metrics, ICER benchmarks, and CEA-implied value-based price. Tracks: WAC/net price gap, ICER 2025 net price benchmark drift, commercial vs. Medicare gross-to-net split, IRA Part D smoothing effects, supplemental rebate exposure across state Medicaid PDLs.
Who acts on it: Jen English (Head of US Price & Value Optimization) primary · Dan Keeley · Korrie Foley.
Price & ValueIRA / Part DMonthly
04 · Payer Brief Generator · On-Demand
Decision enabled: P&T-ready briefs built for the specific payer, not a generic AMCP dossier.
Per-payer P&T briefs built from your value evidence + the payer's own utilization patterns + ACG 2025 CEA + ICER 2025 net price benchmarks. Each brief is shaped to the payer's standard format and renewal calendar. Includes: budget impact model, tier-shift case, CEA pull-through, and pre-built exception language. Upload your existing value story and the brief is drafted in 48 hours.
Who acts on it: Dan Keeley (Sr. Director Payers) primary · field account team · Korrie Foley.
Payer EngagementP&T-ReadyOn-Demand
+1 · Federal LeverVA Monograph SubmissionQ3 '26 submission · 6–12 mo to publication
The most concrete federal gap in Iqirvo's positioning today.
Livdelzi has a VA Monograph published January 2025. Iqirvo doesn't. That document drives VA National Formulary decisions, reaches the captive VHA Hepatology Field Advisory Committee (concentrated 2L PBC prescribers post hep-C-eradication build-out), and cascades to TRICARE, CHAMPVA, IHS, and federal-aligned state Medicaid PDLs. VA covers ~9M veterans; PBC is enriched in this population. Federal sits in white space across most mid-cap pharma V&A workplans, and Iqirvo's PBM-win timing makes it the right moment to engage.
Marigolds AI delivers
VA Monograph submission packet
AMCP-format dossier · VA-population framing · EASL '26 fatigue + ALP 1–1.67× ULN RWE · no-boxed-warning narrative · 6-SP federal-friendly distribution. Drafted in 14 days from your existing value story.
Owners
Dan Keeley primary
Federal sits in payer team scope · Medical Affairs (Sandra Silvestri) for clinical content · Jen English for FSS Big-4 pricing implications
Federal cascade
VA → TRICARE → CHAMPVA → IHS
+ state Medicaid PDLs that reference federal benchmarks (OR, WA, NM) · ~9M VA + ~9.6M TRICARE lives
Why this is a fast win: 6–12 month submission-to-publication timeline lines up with ELFIDENCE confirmatory readout + AASLD summer '26 guideline update. Submit June '26 → monograph publishes early '27 → VA can revise at Iqirvo full-approval conversion. Low controversy, named deliverable, white space.Pre-engagement verification: confirm submission status with VA PBM Services to align timing.
Federal / PayerVA + DoD/TRICAREWhite-space moveQ3 '26 submit
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
5 of 7 · Live Query
The map is queryable.
Ask anything about Iqirvo, Livdelzi, and the PBC 2L share war
Policy Assistant · Live
Marigolds AI V&A Intelligence · Iqirvo / PBC
Ask it anything.
Marigolds AI V&A Assistant · IqirvoPowered by Marigolds AI Intelligence
Marigolds AI
I track the live access landscape for Iqirvo (elafibranor) — Ipsen's PPAR α/δ agonist for PBC. Updated May 29, 2026 with verified Ipsen V&A intel and the EASL 2026 late-breakers from May 28. I know: (a) Iqirvo is now preferred at CVS Caremark and Cigna/ESI (Livdelzi excluded 7/1/26) — 2 of 3 big PBMs locked; (b) the EASL fatigue, ALP 1–1.67× ULN RWE, and ELFINITY pruritus data; (c) the GSK IBAT and Zitus 2027 competitive threats per your team; (d) your #1 pain is PA documentation friction at provider offices, not coverage. Ask me anything.
Try these
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
6 of 7 · Engagement
How working with Marigolds AI looks for Ipsen.
Three phases One continuous map Iqirvo today · full approval tomorrow
Engagement Model · Three Phases
Per Drug · Per Brand · Continuous Through the Iqirvo Lifecycle
The access map doesn't stop at launch. Neither do we.
Iqirvo is already in market. The Ocaliva transition window is now. ELFIDENCE readout and full approval conversion are the catalysts of 2026–27. AASLD guideline update will land in between. Marigolds AI runs continuously across all three.
1
Recapture sprint
Now · Q2 '26 → Q4 '26
2
Full approval window
Q1 '27 → ELFIDENCE
3
Standing access
Post full approval · ongoing
Phase 1
Recapture sprint
Phase 2
Full approval window
Phase 3
Standing
Ipsen V&A does
Capture ex-Ocaliva cohort Push CEA to non-preferred payers Pre-empt symmetric PA templates Submit Anthem/Elevance brief Negotiate 2027 PBM contracts
Ipsen V&A does
Lead full approval conversion Reset PA criteria post-approval Engage AASLD guideline panel Reposition net price for FDA conversion + AASLD inclusion
Ipsen V&A does
Hold preferred-tier wins Defend net price against IRA negotiation pressure Track real-world outcomes Brief leadership quarterly
Marigolds AI delivers
Value Asymmetry Tracker Share Recapture Playbook (Q) Net Price Position Monitor Payer Brief Generator Ocaliva transition heatmap
Marigolds AI delivers
ELFIDENCE pre-position dossier AASLD guideline tracker Post-conversion PA template PBM 2027 contracting brief Full approval payer reset kit
Marigolds AI delivers
Standing access monitor IRA Part D negotiation prep Quarterly leadership brief Competitive entrant tracker (sub-indications, biosimilars)
Built for the Ipsen V&A + Payer + Commercial Ops team
Jen English (Price & Value), Dan Keeley (Payers), Korrie Foley (V&A Strategy), Pruthvi Shah (Data Strategy), Kyle Bailey (Commercial Ops, Rare Disease BU) — Marigolds AI can be deployed in 30 days across all four tools. The Ocaliva transition window is the catalyst — and it's closing.
Marigolds AI
Access Map
Iqirvo
elafibranor
PBC · 2L · PPAR α/δ · Ipsen
7 · Workspace
Your V&A workspace.
Upload your evidence. Ask anything. Download the brief.
Live Query › Intelligence Workspace
Session-aware · Multi-document · Exportable
Feed Marigolds AI your Iqirvo evidence. It compounds.
Upload your AMCP dossier, ICER response, P&T deck, contract term sheet, or competitive intelligence report. Ask questions that build on each other. At the end, synthesize everything into a downloadable executive brief.
⬆
Upload Document
AMCP dossier · Value story · P&T deck · Contract draft TXT or PDF text
Session documents
No documents uploaded yet
Step 1
Upload your evidence
AMCP dossier, value story, P&T deck, contract draft
Step 2
Ask building questions
Each answer compounds — Marigolds AI holds the full session context
Step 3
Download the output
Ask Marigolds AI to synthesize — get a formatted brief ready to share
Marigolds AI
This workspace remembers everything in your session. Upload your AMCP dossier, ICER response, P&T deck, or competitive analysis above, then ask questions that build on each other.