Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

1 of 8 · The Opportunity

The category
you created.

First-ever PFIC drug
first IBAT inhibitor
the next prize: access

Category Creator · The Next Prize

Bylvay · PFIC + ALGS · US Value & Access Landscape

You built the category. The next prize is access.

Live · June 1, 2026

Bylvay invented the category — the first-ever PFIC drug (2021), the first IBAT inhibitor, with a lower list price and oral pellets dosable in the smallest infants.^⁵ Today, FY2025 puts Livmarli at $360M (US $244.7M, +69% YoY) alongside Bylvay ~$195M (€180M, +36%)^{¹ ²} in a two-horse PFIC + ALGS market.^³ The next prize sits in access execution — compressing time-to-approval, the ItchRO renewal cycle, and matching Mirum's MAP patient-services bar. The science is already yours. Click any metric to see the detail.

Livmarli entered PFIC in March 2024 — the franchise Bylvay created is now a two-horse race. These are pediatric patients: Medicaid/CHIP is the dominant payer, genetic confirmation gates the front door, and prescribing concentrates at a handful of pediatric liver centers. The center relationship and the PA gauntlet are where the next patient is won. The BOLD biliary-atresia readout (2026) is the catalyst that could open a third, far larger indication.

Ipsen

Bylvay

odevixibat · IBAT inhibitor · pellets / capsules QD

CategoryFirst PFIC drug 2021 · first IBAT

List price (AWP)Lower vs Livmarli

All-PFIC RWEPEDFIC 2 broad subtype data

FormulationPellets <19.5kg infant-ready

BOLD biliary atresiaReadout 2026 3rd indication

ALGS entry2023 2nd to market

FY2025 sales~$195M global +36% · trailing

TrialsPEDFIC 1/2 · ASSERT

ApprovalPFIC Jul 2021 · ALGS Jun 2023

vs.

Mirum

Livmarli

maralixibat · IBAT inhibitor · solution / tablet QD

CategoryFirst ALGS drug 2021

List price (AWP)Higher

BSEP-3 (severe)Limitation — both IBATs

FormulationSolution + tablet (Apr '25)

Patient servicesMAP 94% / 98% ≤$10 the weapon

PFIC entryMar 2024 fast follower

FY2025 sales$360M US +69%

TrialsICONIC · MARCH-PFIC

ApprovalALGS Sep 2021 · PFIC Mar 2024

PFIC + ALGS → Bylvay · the access cascade (each step a drop; bars are non-increasing)

Headline pool ~1,500 label-eligible · drug-addressable for revenue math excludes BSEP-3 severe-BSEP (neither IBAT is indicated). Strict subset cascade — each bar a subset of the one above.

Clinical context On Bylvay Persistent Marigolds AI lever

US PFIC+ALGS

~3,400

▾ −800Undiagnosed — the diagnostic odyssey before referral to pediatric hepatology

Diagnosed

~2,600

▾ −700Not yet gene/clinically confirmed — the PA front-door gate (CVS requires genetic results upfront)⟵ Marigolds AI: panel sequencing

Gene-confirmed

~1,900

▾ −400No qualifying cholestatic pruritus / below the ItchRO + bile-acid threshold payers require

Cholestatic itch

~1,500

▾ −400Eligible but untreated — the expansion pool; convert with access + center support⟵ Marigolds AI: expansion lever

On IBAT therapy

~1,100

▾ −620On Livmarli — Mirum's ALGS first-mover lead + PFIC fast-follow + the MAP access machine⟵ Marigolds AI: positioning + time-to-Tx

On Bylvay

~480

▾ −80Lost in PA / time-to-approval churn — denials, missed renewals, documentation gaps⟵ Marigolds AI: PA Documentation Assistant

Bylvay persistent

~400

Expansion zone · −400

addressable, untreated (cumulative)

Share war · −620

→ Livmarli (single drop)

Documentation · −80

PA / time-to-approval churn

Defend

~400 patients

Current Bylvay base. Hold against MAP + the 6-month renewal cycle. ≈ $135M at net.

Accelerate

+70–140 patients

Recapture toward ~50/50 of the ~1,100 on-IBAT pool — time-to-therapy + preferred-tier.

Expand

+48–112 patients

30–70% penetration of the ~400 untreated × ~40% Bylvay share of new starts.

Incremental ~120–250 patients → ~$35–95M / yr. Sensitivity at illustrative net price ($300–385K/yr, weight-based): Conservative ~$35M · Central ~$65M · Aggressive ~$95M. Revenue uses net price (not WAC); each input below. Ultra-rare N — patient figures Marigolds AI-modeled, net price launch-era/ICER-illustrative, not Ipsen-disclosed.^¹⁰

¹ Ipsen FY2025 results · Bylvay €180M, +36.3% · Feb 2026 ² Mirum FY2025 results · LIVMARLI $360M (US $244.7M, +69%) · Feb 2026 ³ Ipsen Q4 2025 earnings call · Livmarli PFIC competitive pressure · Feb 2026 ⁴ ALGS epidemiology · Orphanet · HCPLive ⁵ Bylvay oral pellets (<19.5 kg) / capsules & lower AWP vs Livmarli · dosing · NB: BOTH IBATs carry a BSEP-3 (severe BSEP) limitation of use · Bylvay LoU ⁶ PFIC overview · StatPearls ⁷ Mirum Access Plus 94% / 98% ≤$10 · livmarli.com · Ipsen Cares · ipsencares.com ⁸ Ipsen-Sponsored Cholestasis Panel (110-gene, Labcorp) · sponsoredtesting.com ⁹ Cigna/ESI IBAT coverage criteria (ItchRO ≥2, bile acid >3× ULN, 6-mo initial) ¹⁰ Bylvay BOLD biliary atresia Phase 3 · readout 2026 · enrollment complete
◆ Addressable-pool derivation (Marigolds AI; not a single citation — each input peer-reviewed or company-disclosed): ALGS ~2,500 US children (Orphanet ~3/100K) + PFIC <~1,000 (StatPearls ~1 in 50–100K births) → ~3,400 total; label-eligible ~1,500 (cholestatic pruritus, excl. BSEP-3); on-IBAT ~1,100 triangulated against Livmarli US net sales ($244.7M ÷ ~$385K) + Bylvay US share. Sensitivity on total: ~2,600 (low) – 3,400 (central) – 4,200 (high). Launch-era annual net ~$385K (weight-based) illustrative; figures not Ipsen-disclosed.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

2 of 8 · Where

Where the
patients
actually are.

PFIC + ALGS children
dominant carriers
Medicaid / CHIP density

Paradox › Where

PFIC + ALGS Patient Landscape · Center Concentration · Payer Mix

A few hundred children, mostly on Medicaid/CHIP.

verifiable public layers only

Access State of Play · June 1, 2026

~3,400US PFIC+ALGS

~55%Medicaid · CHIP

Open ○Medicaid frontier · first-mover

Lower $Price vs Livmarli

PelletsInfant formulation

BOLD '263rd-indication catalyst

Click a state

See PFIC+ALGS patients, on-IBAT estimate, Medicaid/CHIP %, and dominant carrier

▸Data Sources

Medicaid / CHIP · Pediatric

~55%

of PFIC+ALGS children · the dominant channel, and an open frontier. No state has put either IBAT on preferred status yet. The 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 ▾ Click to open

Commercial · Pharmacy Benefit

~40%

of PFIC+ALGS · symmetric "Bylvay OR Livmarli" PA templates. Cigna/ESI response-based renewal (ItchRO + bile acid) is the biggest sustained-access risk. UHC dropped the PFIC ItchRO gate Sept 2025.

SYMMETRIC PA · RENEWAL RISK ▾ Click to open

Patient Services & SP · The Real Battle

94%

Mirum's MAP cites ~94% approved & 98% ≤$10/fill — the competitive weapon. Ipsen Cares + the limited SP network must match it on navigation. This is where time-to-therapy is won or lost.

MIRUM MAP vs IPSEN CARES ▾ Click to open

Commercial · break the symmetric "Bylvay OR Livmarli" template.

Most commercial payers run one PA template for both IBAT inhibitors — genetic/clinical diagnosis, cholestasis evidence, baseline pruritus, ≥2 prior-therapy failures. What the symmetric template flattens into parity: Bylvay's lower list price, its pellet formulation for the smallest infants, and its category-creator breadth — the basis for a preferred-tier case. (The BSEP-3 severe-BSEP limitation applies to both IBATs, so genetic subtyping is a shared eligibility gate, not a wedge.) The other lever: defend against Cigna/ESI's response-based renewal.

Payer / PBM	Bylvay policy	Livmarli policy	Status	V&A lever
UnitedHealthcare PBM: OptumRx · ~27M commercial lives^⁹	PA · specialist + diagnosis + cholestasis + ≥2 prior failures · 12-mo auth^¹	PA · same criteria · removed PFIC ItchRO gate Sept 2025 · ALGS needs JAG1/NOTCH2	Symmetric	Largest commercial. Make the preferred-tier case on lower price + pellet formulation + PEDFIC breadth. Optum Specialty in Bylvay network.
Cigna · Express Scripts PBM: ESI · ~17M commercial lives^⁹	PA · ItchRO ≥2 baseline · bile acid >3× ULN · ≥2 systemic failures · 6-mo initial^²	Same combined IBAT guideline · renewal needs maintained ≥1-pt ItchRO drop + falling bile acids	Renewal risk	Most stringent. Response-based renewal is the #1 sustained-access risk — Marigolds AI tracks the ItchRO renewal clock per patient.
Aetna · CVS Health PBM: CVS Caremark · ~19M commercial lives^⁹	Policy 05.04.42 · genetic testing results required upfront · initial 6 mo, continuation 12 mo^³	Mirror policy · cannot combine with Bylvay	Genetic gate	Genetic-confirmation gate favors whoever speeds testing — push Ipsen-sponsored 110-gene panel at referral. CVS Specialty in network.
Anthem · Elevance PBM: CarelonRx · ~32M commercial lives^⁹	No standalone public IBAT policy surfaced. Open window before template hardens.	No standalone public IBAT policy surfaced.	Window open	Pre-emptive criteria brief positioning Bylvay on price + formulation breadth — shape the template before it's written.
BCBS · FEP FEP, Wellmark, affiliates · ~70M BCBS lives^⁹	FEP Bylvay 5.50.031 · Wellmark Bylvay policy · specialist + genetic/clinical dx^⁴	FEP Livmarli 5.50.032 · symmetric affiliate templates	Symmetric	PolicyReporter daily monitoring · FEP sets a federal-benchmark template affiliates copy · genetic differentiation brief

Medicaid / CHIP · ~55% of patients · open frontier, first-mover wins

Because PFIC and ALGS present in infancy and childhood, the majority of patients sit in Medicaid/CHIP — often via disability/medically-needy pathways. No state has placed either IBAT on preferred status yet, so the frame is first-mover, not catch-up. What Marigolds AI delivers here is honest and public: it pulls every state's P&T meeting calendar, agenda, DUR Board membership, and historical voting on analog rare-disease drugs from public Medicaid sites, and drafts submission briefs in each state's format. The supplemental-rebate decision and model stay with Ipsen's internal net-price strategy — that's not public, and we don't claim it. Pediatric payer-mix split is modeled (not publicly published).

State Medicaid	Bylvay PA / PDL	Livmarli PA / PDL	Status	V&A lever
Utah IBAT PA form · exemplar	PA · genetic confirm · weight/formulation rules · PFIC: 3 failed first-line therapies (≥4 wks each) · 6-mo initial^⁵	Same IBAT PA · ALGS JAG1/NOTCH2 in chart · formulation-by-indication rules	Strictest PA	Tougher than commercial. Pre-built documentation packet for the 3-failure requirement cuts denials and re-work.
California Medi-Cal · ~14M lives	PA · pediatric GI/hepatology · diagnosis + cholestasis · single statewide Medi-Cal Rx	PA · same DUR pathway	PDL pending	Largest Medicaid + multiple COE centers (UCSF, CHLA, Stanford). DHCS P&T pre-submission with budget impact.
Texas ~5.4M lives · Texas Children's COE	PA · vendor drug PDL · standard IBAT criteria · DURB review cycle	PA · same vendor drug template	Both non-preferred	Texas Children's drives volume — KOL + supplemental rebate negotiation for preferred status at next DURB
Ohio SPBM (Gainwell) · Cincinnati COE	PA · single PBM template · standard IBAT criteria · UDCA/prior-therapy step	PA · same SPBM template	Symmetric PA	Single-PBM state — one negotiation + Cincinnati Children's COE alignment gates the whole state
Pennsylvania CHOP COE · Highmark-aligned	PA · standard 2-failure IBAT criteria · PDL pending P&T	PA · same · review pending	PDL pending	CHOP is a national PFIC/ALGS referral hub — medical + V&A alignment here has outsized reach
Florida ~5.1M lives	PA · standard IBAT criteria · PDL not finalized	PA · same standard criteria	PDL pending	FL P&T cycle + managed-care plan variation — track per-MCO PA drift

Patient Services & SP · where the patient is actually won

With near-parity price and symmetric PA, the competition runs on navigation: how fast the hub gets a child approved and dispensed. Mirum has made its MAP program a marketing weapon. This is the axis Ipsen V&A flagged — "they navigate PA as well or better than us."

Service axis	Bylvay · Ipsen	Livmarli · Mirum	Status	V&A lever
Hub program	Ipsen Cares · Patient Access Manager (PAM) · copay support · PAP · patient educator (PEL)^⁶	Mirum Access Plus (MAP) · Navigator + Coordinator + MAP Mobile texting	Mirum ahead	Match MAP's outcomes transparency — instrument Ipsen Cares with a measured approval-rate + time-to-fill dashboard
Approval outcomes	Not publicly marketed as a stat	Markets ~94% approved · ~98% paying ≤$10/fill^⁶	Mirum ahead	Mirum's number is a sales tool at the center. Marigolds AI benchmarks Bylvay's real approval/time metrics to counter it.
SP network	Limited SP · Optum Frontier Therapies launch partner · Accredo / CVS Specialty / Optum Specialty in plan networks^⁷	Plan-dependent SPs · overnight ship post-approval	Parity	In-network at the PBM-captive SPs is fine — the gap is hub navigation speed, not dispensing reach
Genetic testing	Ipsen-Sponsored Cholestasis Panel · no-charge 110-gene (Labcorp/Invitae) + counseling^⁸	Mirum-sponsored no-cost cholestasis panel	Parity	Both free — but the panel that returns first opens the PA front door first. Push Ipsen panel at the referral point.
Expanded access	PAP for uninsured / hardship via Ipsen Cares	Expanded Access Program (EAP) via Clinigen for ALGS + PFIC	Parity	Close any bridge / interim-supply gap so no child goes untreated during the months-long PA
Time-to-therapy	Months — genetic results + serial labs + ItchRO + prior-failure docs	Same gauntlet — but MAP optimized to compress it	The battleground	Marigolds AI PA Documentation Assistant pre-populates payer-ready packets and tracks the clock — close the gap to MAP

¹ UHC/OptumRx Livmarli medical-necessity policy (ItchRO PFIC gate removed Sept 2025) · UHC PA ² Combined IBAT inhibitor coverage criteria (ItchRO ≥2, bile acid >3× ULN, 6-mo initial, response-based renewal) · policy ³ CVS Caremark / Wellmark Bylvay policy 05.04.42 (genetic results upfront) · policy PDF ⁴ FEP Blue Bylvay 5.50.031 · FEP policy ⁵ Utah Medicaid IBAT Inhibitors PA (Livmarli, Bylvay) · 3-failure PFIC rule, 6-mo initial · Apr 2026 ⁶ Mirum Access Plus 94% / 98% ≤$10 · MAP · Ipsen Cares · overview ⁷ Optum Frontier Therapies as Bylvay limited SP partner · 2021 ⁸ Ipsen-Sponsored Cholestasis Panel (110-gene, Labcorp) · sponsoredtesting.com ⁹ Commercial covered lives · UnitedHealth Group, Elevance, CVS Health/Aetna, Cigna, BCBSA 10-K / enrollment disclosures (2024–25); rounded · verify with current filings
Patient/payer-mix estimates: pediatric Medicaid/CHIP share modeled; exact PFIC/ALGS payer split not publicly published. Pre-engagement verification (V&A team to confirm): current per-state Medicaid PDL status for both IBATs, each state's P&T cycle dates, and whether any state has moved either drug to preferred — the open-frontier claim is based on standard state cadence and public PDLs as of June 2026.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

3 of 8 · Why

Three
asymmetries.

Policy · Channel
Evidence · where
the next round of
access work compounds

Paradox › Where › Why

Three Asymmetries · Each One a Lever You Already Have

The value case is yours. The next prize is mobilizing it.

The "Bylvay OR Livmarli" fungibility trap

Symmetric PA templates treat the two IBATs as 1:1 substitutes — flattening Bylvay's lower price, pellet formulation, and category-creator breadth into parity

▶

What the policies say

"Bylvay OR Livmarli"

Symmetric language: genetic/clinical diagnosis · cholestasis · baseline pruritus · ≥2 prior failures · cannot combine. The two IBATs read as interchangeable inside the PA document — the genetic subtype never enters the logic.

≠

What you can argue

Preferred status, not parity

Bylvay carries a lower WAC/AWP, is the category creator with the broadest all-PFIC-type real-world experience (PEDFIC 2), and offers oral pellets dosable in the smallest infants. That's a preferred-tier case the symmetric template erases. Note: the BSEP-3 severe-BSEP limitation of use applies to both IBATs — it's a shared eligibility gate, not a Bylvay-only segment.

Lever · what Marigolds AI delivers A payer criteria brief that makes the preferred-tier case — lower WAC, pellet formulation for infants, and PEDFIC all-PFIC-type breadth — rather than accepting parity. Submitted to Anthem/Elevance (open window) and into UHC/Cigna renewal cycles before the symmetric template hardens. (BSEP-3 is a shared limitation for both IBATs, so it's framed as an eligibility gate, not a wedge.)

The response-based renewal trap (Cigna/ESI)

6-month initial auths and renewals that require a maintained ItchRO drop + falling bile acids quietly disenroll patients — the biggest sustained-access risk

▶

The renewal bar

≥1-pt ItchRO drop + lower bile acids, every 6–12 mo

Cigna/ESI and several Medicaid programs grant only 6-month initial auths and demand documented, maintained response at renewal. A child whose ItchRO plateaus — or whose caregiver didn't capture the score — can lose coverage despite clinical benefit.

→

What Marigolds AI tracks

Per-patient renewal clock

Marigolds AI flags each renewal window before it closes, surfaces which ItchRO/bile-acid documentation the payer requires, and pushes the reauthorization packet to the field-reimbursement team in time. No patient lost to a missed renewal.

Medicaid PDL designation race · the dominant payer

~55% of patients are Medicaid/CHIP and state P&T committees set preferred status with stricter criteria — Utah requires 3 failed therapies for PFIC vs 2 commercial

▶

The dominant channel

Medicaid is biggest and hardest

Pediatric rare disease skews Medicaid/CHIP. Preferred PDL status = no supplemental rebate concession; non-preferred = rebate or access friction. State P&T meetings set this — and most V&A teams don't see them until after the fact.

→

What Marigolds AI delivers

State P&T calendar + COE-aligned briefs

Marigolds AI tracks each state's IBAT PA criteria + P&T calendar and pre-builds the documentation packet for the strict states (Utah-style 3-failure rule). Aligned to the pediatric COE — CA, TX, OH, PA — that drive the volume.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

4 of 8 · Time to Therapy

Where the
months go.

The approval gauntlet,
step by step — and
where Marigolds AI acts

Paradox › Where › Why › Time to Therapy

From Rx Written to First Fill · Where the Delay Lives · What Marigolds AI Removes

"Where does Marigolds AI actually come in?"

When the bottleneck moved from coverage to time-to-therapy, it moved from a contracting problem to an information problem — and that's the part Marigolds AI is built for. Most of the months-long delay is the right information not being in the right place at the right time. Here is the gauntlet, step by step, with each delay point tagged: Marigolds AI removes the information work, or it stays with your people. We don't staff your hub or call your centers — we make the people who do act with perfect payer knowledge and never miss a clock.

Marigolds AI removes it Marigolds AI cuts the loop Stays with your people

1

Genetic test ordered~1–3 wks

The office has to know this payer requires genetic confirmation upfront, pick the right cholestasis panel, and order it. Most delay here is simply not knowing — a free sponsored panel exists, and confirming the subtype early clears the PA gate sooner.

Marigolds AI removes this

2

Genetic result returns~2–4 wks

The lab assay itself takes time — that's physical turnaround Marigolds AI can't compress. But because Marigolds AI got the right panel ordered on day one, the clock started earlier instead of after a false start.

Stays with your people (lab)

3

PA packet assembled & submitted~1–3 wks + rework

The single biggest sink. Genetic report, serial bile acids, liver panel, fat-soluble vitamins, baseline ItchRO, and dated prior-failure records — each in this payer's exact format. One missing element is a denial. A human navigator has to remember every payer's rules.

Marigolds AI removes this

4

Payer review & decision~1–2 wks

Part of this is the payer's own clock. But a packet that's right the first time clears here instead of bouncing — so the lever is preventing the denial upstream, which is where most lost weeks are created.

Marigolds AI cuts the loop

5

Denial → peer-to-peer → appeal+2–6 wks / loop

Each loop adds weeks, and some families fall off entirely. The fix is knowing why this payer denies and the language that wins the appeal — and making sure the same denial never recurs.

Marigolds AI cuts the loop

6

Approval → SP dispense & onboarding~1 wk

Enrollment, shipment, and the family education that gets a child started belong to your hub and SP — the human, relationship part. Marigolds AI hands them a clean, approved case instead of a tangle.

Stays with your people (hub)

7

6-month renewalrecurring

A child can lose coverage at re-auth because nobody tracked the ItchRO + bile-acid response the payer demands, or the window quietly closed. Pure clock-and-documentation work — exactly what software should own.

Marigolds AI removes this

The honest line for the room

Of the weeks-to-months to first fill, the information-driven steps — ordering the right panel, assembling a right-first-time packet, preventing denials, and never missing a renewal — are Marigolds AI's. The lab assay and the human onboarding stay with your people. We're the intelligence layer under your hub and field team, not a replacement for them. That's where the AI comes in.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

5 of 8 · What We Hand You

Four
V&A tools.

Built for Ipsen
Rare Disease BU
Bylvay-specific

Paradox › Where › Why › What We Hand You

The Bylvay Access Map · Four Components · V&A + Payer + Patient Services

Four things Marigolds AI hands you.

The goal

Time-to-Tx ↓

Close the approval gap to Mirum MAP + defend the PFIC franchise.

The prize

~$385K / patient·yr

Small N, high value. Each recaptured child compounds. Illustrative.

The window

Now → BOLD '26

Defend PFIC, pre-position for the biliary-atresia readout.

Click any component to see what's inside — what decision it enables, who acts on it, and when.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

6 of 8 · Live Query

The map is
queryable.

Ask anything about
Bylvay, Livmarli,
and the IBAT access war

Policy Assistant · Live

Marigolds AI V&A Intelligence · Bylvay / PFIC + ALGS

Ask it anything.

Marigolds AI V&A Assistant · Bylvay Powered by Marigolds AI Intelligence

Marigolds AI I track the live access landscape for Bylvay (odevixibat) — Ipsen's IBAT inhibitor for cholestatic pruritus in PFIC and Alagille syndrome, vs Mirum's Livmarli (maralixibat). Updated June 1, 2026. I know: (a) Bylvay is the category creator (first PFIC drug, first IBAT) with a lower list price and pellet formulation for the smallest infants — though both IBATs share the BSEP-3 severe-BSEP limitation; (b) Livmarli is out-growing it on access execution + the MAP patient-services machine; (c) the months-long pediatric PA gauntlet — genetic confirmation, ItchRO renewal, Medicaid-heavy mix — is the real battleground; (d) BOLD biliary atresia reads out in 2026. Ask me anything.

Try these

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

7 of 8 · Engagement

How working
with Marigolds AI
looks for Ipsen.

Three phases
One continuous map
Bylvay today · biliary atresia tomorrow

Engagement Model · Three Phases

Per Drug · Per Brand · Continuous Through the Bylvay Lifecycle

The access map doesn't stop at launch. Neither do we.

Bylvay is in market across PFIC and ALGS, with Livmarli contesting the PFIC franchise now. The BOLD biliary-atresia readout in 2026 is the catalyst for a third, far larger indication. Marigolds AI runs continuously across all three phases.

1

Defend & recapture

Now · Q2 '26 → Q4 '26

2

BOLD window

2026 readout → launch

3

Standing access

Three indications · ongoing

Phase 1

Defend & recapture

Phase 2

BOLD window

Phase 3

Standing

Ipsen V&A does

Make the preferred-tier case (price/formulation)
Close time-to-therapy gap vs MAP
Pre-empt symmetric PA templates
Submit Anthem/Elevance brief
Win Medicaid PDL preferred status

Ipsen V&A does

Read out BOLD biliary atresia
Reset payer criteria for 3rd indication
Engage biliary-atresia COE hubs
Reposition price across
three pediatric indications

Ipsen V&A does

Hold access across PFIC/ALGS/BA
Defend net price vs IBAT
entrants (volixibat, others)
Track real-world outcomes
Brief leadership quarterly

Marigolds AI delivers

Genetic & Eligibility Tracker
Time-to-Therapy Playbook
Access Position Monitor
Payer Brief Generator
Preferred-tier value kit

Marigolds AI delivers

BOLD pre-position dossier
Biliary-atresia payer template
COE referral-hub map
Criteria-reset tracker
3rd-indication launch kit

Marigolds AI delivers

Standing access monitor
IBAT entrant tracker
Quarterly leadership brief
Renewal-clock automation
(across all three indications)

Built for the Ipsen V&A + Payer + Patient Services team

Jen English (Price & Value), Dan Keeley (Payers), Korrie Foley (V&A Strategy), Pruthvi Shah (Data Strategy), Mike Brown (Patient Services), Kyle Bailey (Commercial Ops, Rare Disease BU) — Marigolds AI can be deployed in 30 days across all four tools. The patient is won in the approval gauntlet — and BOLD is the catalyst that resets the whole frame.

Marigolds AI

Access Map

BylvayodevixibatPFIC + ALGS · IBAT · Ipsen

8 · 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 Bylvay evidence. It compounds.

Upload your AMCP dossier, value story, P&T deck, PA criteria comparison, or competitive intelligence on Mirum. 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 · PA comparison
TXT or PDF text

Session documents

No documents uploaded yet

Step 1

Upload your evidence

AMCP dossier, value story, P&T deck, PA comparison

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 Workspace · Bylvay · Session Memory On Multi-turn · Document-aware

Marigolds AI This workspace remembers everything in your session. Upload your AMCP dossier, value story, P&T deck, or Mirum competitive analysis above, then ask questions that build on each other.

Suggested workspace prompts