Access Map · Restricted Preview
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Access Map
2 of 5 · Access Cascade
The Cascade
7.5M → 21K
Where patients are lost
in the access system
Envudeucitinib · Plaque Psoriasis · US Access Landscape

ONWARD succeeded.
Now the access map.

Live
ONWARD1/2: PASI 75 Wk16 — 76.5% / 70.4% vs placebo (p<0.0001). NDA planned H2 2026.
▶ Clinical Detail · Envudeucitinib Oral TYK2 · ONWARD1/2 · PASI 90 ~56% Wk16
Envudeucitinib is NOT FDA-approved. NDA H2 2026. All payer analysis uses Sotyktu (BMS) criteria as the direct proxy.
Mechanism
Allosteric TYK2 inhibitor · JH2
Route / Dose
Oral · 40 mg BID
Trials
ONWARD1 (912) · 2 (862)
PASI 75 · Wk16
76.5% / 70.4% vs 18.7% / 13.7%
PASI 90 · Wk16→24
59.9% / 53.1% → 68.0% / 62.1%
Safety
Positioned to avoid JAK class BBW · nasopharyngitis · headache
7.5M
US Adults with Plaque PsO
Armstrong 2021 · 3.0%
~1.7M
Mod-Severe Biologic-Eligible
72.5%
Commercially Insured
Commercial is the battlefield

The access cascade

Click any bar for detail · illustrative
Clinical Funnel
Access Cascade · Marigold operates here
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7.5M
Total PsO
1.7M
Mod-Severe
~200K
Oral Address.
~50K
TYK2 Class Rx
~42.5K
Hub Enrolled
~39K
Step Met
~30K
PA Approved
~25K
Dispensed
~21K
On Therapy
Total US Plaque Psoriasis · 7.5M adults
Armstrong 2021 NHANES · 3.0% prevalenceNPF cites >8M with 2024 growthBimodal onset: 20–30 yrs and 50–60 yrs
Moderate-to-Severe · ~1.7M biologic-eligible
BSA ≥3–10% or DLQI-inclusive · range 1.5–2.0M~5.8M mild or controlled on topicals~59% of mod-severe received NO treatment in prior year
Oral Addressable · ~200K
Prefer oral route, injection-averse, or would switch from injectableOtezla ~34K pts ($2.27B at ~$67K) validates oral demandIcotrokinra (oral IL-23, J&J Mar 2026) expanding oral-eligible poolDerms rank TYK2 near bottom on efficacy (Recon Strategy Dec 2025)
TYK2 Class Rx at Maturity · ~50K · illustrative
Sotyktu Wall St peak ~$1.9B → ~54K pts at $35K netAlumis disclosed ZERO pricing — all modeling illustrativeLeerink bear: $832M (~24K pts) — class ceiling riskSkyrizi ramp benchmark: $355M yr1 → $17.6B 2025
Hub Enrolled · ~42.5K · −7.5K not enrolled
~85% hub enrollment · specialty oral benchmark~15% prescriber bypasses hub to retail/specialty pharmacyHub design = Alumis decision — no existing infrastructure launch design
Step Therapy Met · ~39K · −3.5K step barrier
Sotyktu-step: 50–75% probability · ~1.5K lost headline riskBiosimilar adalimumab gate · Cordavis/Quallent/Nuvaila · ~1KMTX documentation incomplete · ~1K pre-launch fix67% of commercial lives in ERISA self-funded — state ST laws don't reach them
PA Approved · ~30K · −9K denied · largest single drop
Elevance NON-FORMULARY — 14 states, ~47M members · ~3KMedicare Part D exclusion — 8/10 plans · ~2KDocumentation incomplete / criteria mismatch · ~2.5KCopay maximizer exhaust · ~1.5K pre-launch fix
Dispensed · ~25K · −5K not filled
~70% abandon when OOP >$250 (IQVIA) · ~2.5KMaximizers (47% commercial lives) capture copay card · ~1.5KPharmacy logistics / mail-order friction · ~1K
~42%
Access Yield
~29K of ~50K never reach therapy · ~$1.0B/yr at risk · 10-pt yield lift ≈ ~5K patients ≈ ~$175M recoverable/yr◆
Access Map
1 of 5 · Payer Landscape
Envudeucitinib
Oral TYK2 · 40 mg BID
Alumis Inc.
Pre-NDA · 2027
Envudeucitinib · Plaque Psoriasis · US Access Landscape

The clinical data got envu here.
The payer landscape decides what happens next.

Built on verified Sotyktu payer criteria (the direct proxy for what envu inherits at approval), ONWARD data, and the competitive landscape as of April 2026.

National
7.5MTotal PsO
1.7MBiologic-Elig.
72.5%Commercial
5 / 7Payers Pref.
1Non-Formulary
Click a state
See PsO patients, payer, Sotyktu status
Payer Criteria · Sotyktu as Envudeucitinib Proxy

Five payers preferred. One wall. One dead zone.

UHC / OptumRx
Preferred · Tier 2
Step removed Oct 2024. Most permissive.
Aetna / CVS
ACSF Preferred
Three paths. No topical gate. PrudentRx active.
Cigna / ESI
NPF Preferred
Lightest criteria. 3-mo initial auth.
Elevance / Anthem
NON-FORMULARY
14 states · 47M members. The wall.
Medicare Part D
8/10 Excluded
Multi-year build. Not launch-year.
Highest-leverage insight: If BMS — with $291M Sotyktu revenue and full commercial infrastructure — cannot get Sotyktu listed at Elevance, Alumis with zero commercial presence faces a structural lockout across 14 states. Elevance is the #1 pre-launch engagement target.
Click for payer-by-payer criteria detail:
Commercial Criteria Detail
5 payers · PA requirements · step therapy · auth durations
▾
Medicare Part D Detail
8/10 excluded · IRA impact · pricing inversion
▾
Commercial Detail · Sotyktu PA Criteria · Envudeucitinib Proxy
Payer (PBM)Sotyktu PA CriteriaRiskEnvu Implication
UnitedHealthcare
OptumRx		 P 2297-6 (eff 1/17/2026). Tier 2 PREFERRED. BSA ≥3% or critical site. MTX ≥3mo at max dose OR prior Otezla/biologic. Removed "step through preferred" Oct 2024. No biologic step. 12-mo auth. Window Most permissive. Step removal Oct 2024 is strongest precedent for envu access. Pre-position for Tier 2 parity before P&T review.
Aetna / CVS
CVS Caremark		 SGM 5600-A. ACSF Preferred 2025+2026. Three paths: prior biologic/Otezla, crucial body area (no BSA min), ≥10% BSA alone, ≥3% BSA + systemic failure. No topical gate. 12-mo auth. Moderate ACSF excludes Humira, Cosentyx, Enbrel, Taltz. Envu ACSF preferred = #1 commercial target. PrudentRx copay maximizer active.
Cigna
Express Scripts		 IP0671 (eff 11/01/2025). ESI NPF Preferred. No BSA threshold. 3mo any systemic or prior biologic/Otezla. 3-month initial auth (not 12). Renewal: 1 year. Moderate Lightest criteria, shortest initial auth — early re-auth burden. SaveOnSP maximizer active via Accredo. Quallent private-label biosim preferred.
Elevance / Anthem
CarelonRx		 NON-FORMULARY. "Medications NOT on Drug List" on CarelonRx Guided + Advanced. Preferred alts: Cosentyx, Skyrizi, Tremfya, Otezla. Requires formulary-exception PA — structurally harder. High 14-state Anthem footprint · ~47M members. If BMS can't get Sotyktu listed with $291M revenue, Alumis faces worse. Highest-leverage pre-launch target.
OptumRx
(standalone PBM)		 Tier 2 PA/SP/QL on Premium + Select. Executes UHC P 2297-6 for UHC commercial. Copay Accumulator + Variable Copay active. Moderate Nuvaila private-label biosimilar (Optum subsidiary) preferred step. Bimzelx reinstated Tier 3 2026.
Medicare Part D Detail · Sotyktu Non-Formulary on 8 of 10 Major 2026 Plans
PlanSotyktu StatusKey MetricEnvu Implication
AARP / Humana / Wellcare / Kaiser / Cigna HS / Anthem MediBlue NON-FORMULARY
8 of 10 major plans		 Plan sponsors bear 60% catastrophic (up from 15%) Drives formulary tightening. #1 reason for exclusion. Part D Access Dossiers must be submitted before 2028 formulary review cycle.
SilverScript / Aetna Tier 4/5 · PA+QL 25–50% coinsurance · $2,100 OOP cap Where covered: 1–2 fills hit catastrophic → $0 rest of year. LIS patients: $12.65/fill (~$152/yr).
IRA MFP dynamic Pricing inversion Stelara MFP $4,695/30d < Sotyktu WAC $6,828/30d Cheaper branded biologics on Part D undercut oral TYK2 pricing. Medicare = multi-year exception-pathway build, not launch-year win.
1 UHC P 2297-6 (eff 1/17/2026) · 2 Aetna/CVS SGM 5600-A · ACSF 2026 · 3 Cigna IP0671 (eff 11/01/2025) · 4 CarelonRx Guided + Advanced Drug Lists · 5 CMS IRA Part D Redesign
Access Map
3 of 5 · Competitive
The Triangle
Icotrokinra · Sotyktu
Zasocitinib · Where
envu sits
Competitive Positioning · Envudeucitinib

The efficacy gap isn't there.
The commercial gap is.

Icotrokinra's PASI 90 came in at ~50–55% — comparable to envu's ~56%. The threat isn't clinical superiority. It's J&J's infrastructure, IL-23 mechanism perception, and 12–18 months of market lead.

Envudeucitinib
~56%
TYK2 · Oral BID · PASI 90 Wk16
Icotrokinra
~50–55%
IL-23R · Oral QD · J&J infrastructure
Sotyktu
~36%
TYK2 · Oral QD · 3y head start
Zasocitinib
Ph3+
TYK2 · Oral QD · Takeda
Click to drill into each threat:
▶ Full Efficacy Table 5 oral competitors · PASI 90 Wk16 · access implications
Oral Competitors · PASI 90 at Week 16
DrugMechanismRoutePASI 90 Wk16Access Implication
Envudeucitinib
Alumis · Pre-NDA		 TYK2 (allosteric) Oral BID ~56%
59.9% / 53.1%		 No commercial infrastructure. No payer contracts. No hub. Must build everything.
Icotrokinra
J&J · ICOTYDE · Approved		 Oral IL-23R peptide Oral QD ~50–55%
ICONIC-LEAD / ADV		 J&J full infrastructure. IL-23 mechanism trust. 12–18 mo market lead by envu launch.
Sotyktu
BMS · Approved Sep 2022		 TYK2 (allosteric) Oral QD ~36%
POETYK PSO-1/2		 $291M 2025 rev. Deepening rebates. Step-therapy gatekeeper. DTC $950/mo.
Zasocitinib
Takeda/Nimbus · Ph3+		 TYK2 (allosteric) Oral QD Ph3 positive · TBD Third TYK2. QD dosing. $4B deal. Takeda commercial muscle.
Otezla
Amgen · Generic Feb 2028		 PDE4 Oral BID Not reported Generic = potential new mandatory step gate before any TYK2.
▶ Icotrokinra · Commercial Threat J&J infrastructure · IL-23 trust · 12–18mo lead
The efficacy gap didn't materialize — PASI 90 ~50–55% vs envu ~56%. But the commercial gap is real: J&J has full infrastructure, payer contracts, and IL-23 is the mechanism dermatologists trust most. By envu launch, icotrokinra will have 12–18 months of real-world data and established formulary positions.
PAYER QUESTION AT FORMULARY REVIEW
"Why add a second oral TYK2 when we already have an oral IL-23?" The answer is clinical differentiation — but it must be pre-built into payer materials, not argued at the PA desk.
▶ Zasocitinib · Class-Crowding Threat Third TYK2 · QD dosing · Takeda muscle · $4B deal
Phase 3 positive (Dec 2025). Third TYK2. QD dosing vs envu BID. $4B upfront deal = Takeda conviction. Three TYK2s in class forces payers to set step order. Sotyktu is first-mover. Zasocitinib has Takeda's muscle.
THE STRUCTURAL RISK
Envu is third in a TYK2 class of three, with the least commercial infrastructure and the only BID dosing. Step-therapy ordering becomes a three-way negotiation.
▶ Safety Profile Comparison ONWARD1/2 · no BBW · no lipid signal vs Sotyktu
ONWARD1/2 safety profile: no new safety signals · no major CV events · no TB reactivation · no clinically relevant hematologic or metabolic lab abnormalities · no lipid signal of the kind observed in deucravacitinib. Most common AEs: nasopharyngitis, URI, headache, acne. 52-week Phase 2 OLE discontinuation rate: 3.7%.
THE PAYER ANGLE
Selective allosteric TYK2 design avoids JAK1/2/3 blockade — class-wide JAK BBW does not apply. No required TB screening. Clean dossier. The access variable isn't P&T approval (everyone in this class is safe enough) — it's PA monitoring language: which plans require lipid or hepatic monitoring, which adds administrative burden.
The access strategy implication Envu's efficacy is competitive with icotrokinra — not inferior. The differentiation is TYK2 mechanism specificity, safety profile (positioned to avoid JAK BBW), and patients who need an alternative to IL-23. The access strategy must be built around payer-by-payer positioning against both icotrokinra (mechanism perception) and Sotyktu (step-therapy gatekeeper) — before formulary decisions lock. That's a criteria-level intelligence problem, not a clinical data problem.
Access Map
4 of 5 · Sequencing
The Step Ladder
2, 3, 4 doors —
or the wall.
Payer by payer.
Sequencing · Plaque Psoriasis Step Therapy · Envudeucitinib

Clinical evidence decides
if the drug works.
Sequencing decides if patients reach it.

Live
Envu faces 2–4 mandatory steps before access at preferred payers · Elevance blocks the ladder entirely across 14 states, ~47M members · post-IL-23 sequencing evidence gap compounds the risk at every ladder.
The sequencing insight: The number of doors a plaque psoriasis patient must fail through before envu is not a clinical question — it is written into step therapy language by each payer, and it varies by 2× across major plans. Each added door is a 3–6 month delay and a 20–30% patient-loss risk. The IL-23 sequencing evidence gap means envu is positioned after IL-23 failure by default, not as an alternative — which adds one more door.
DRUG CLASSES — Conv. systemic (MTX) PDE4 oral TNF (adalimumab biosimilar) IL-12/23 biosimilar IL-17 IL-23p19 TYK2 (Sotyktu · envu)
▶
UnitedHealthcare
OptumRx · P 2297-6 · Tier 2
2 doors to envu
Most permissive. Step removed Oct 2024 — strongest precedent for launch-year access.
S1
Methotrexate
Conv. systemic · 3mo at max dose
"MTX ≥3mo at max dose OR prior Otezla/biologic." OR condition — MTX can be skipped if any prior biologic.
↓
S2
Adalimumab biosimilar
Nuvaila (Optum private-label)
PBM economic preference — step removed from formal PA Oct 2024 but rebate economics still favor Nuvaila first. Not hard-coded as step.
↓
→
Envudeucitinib
TYK2 · Tier 2 parity target
UHC removed "step through preferred" Oct 2024 — strongest precedent for envu access at launch. No mandatory Sotyktu step if positioned correctly.
Most permissive ladder. 12-mo auth.
▶
Aetna / CVS
CVS Caremark · ACSF · SGM 5600-A
3 doors to envu
Sotyktu is an ACSF step. ACSF parity for envu = #1 pre-launch target.
S1
Conventional systemic
MTX · cyclosporine · acitretin
"≥10% BSA alone, or ≥3% BSA + systemic failure" — three entry paths reduce MTX strictness.
↓
S2
Adalimumab biosimilar
Cordavis (CVS private-label)
ACSF excludes brand Humira — Cordavis Hyrimoz is the preferred TNF. Economic gate before advanced therapy.
↓
S3
Sotyktu
TYK2 · ACSF preferred · 3y head start
The Sotyktu-step risk. BMS rebate lock-in on ACSF makes Sotyktu the default first TYK2. 50–75% probability Sotyktu is written as step before envu unless pre-empted.
↓
→
Envudeucitinib
TYK2 · ACSF parity = #1 target
ACSF parity is the single highest-value pre-launch formulary outcome. Alternative: step-behind Sotyktu for 3–6 months per patient.
ACSF excludes Humira, Cosentyx, Enbrel, Taltz.
▶
Cigna
Express Scripts · IP0671 · NPF
2 doors to envu
IL-23 biosimilar gate — the evidence gap from our brief lives here.
S1
3-month any systemic
Including apremilast / prior biologic
"3mo any systemic or prior biologic/Otezla." No BSA threshold — lightest clinical gate of the five.
↓
S2
Ustekinumab biosimilar IL-23 GATE
Quallent (Cigna private-label)
IL-12/23 biosimilar preferred via Quallent. This is the IL-23 sequencing gap in action — envu positioned after IL-12/23 failure by default, not as an alternative. The post-IL-23 outcome evidence gap documented in our brief makes this positioning hard to contest with current data.
↓
→
Envudeucitinib
TYK2 · NPF preferred target
NPF preferred but 3-month initial auth (not 12) creates early re-auth burden. SaveOnSP maximizer active via Accredo.
Shortest initial auth — re-auth risk.
▶
Elevance / Anthem
CarelonRx · 14 states · 47M lives
Blocked · TYK2 excluded
TYK2 class is non-formulary. Alumis pre-launch is the only leverage point.
A1
Skyrizi (IL-23p19)
Preferred alternative
CarelonRx Guided + Advanced list Skyrizi, Tremfya, Cosentyx, Otezla as preferred alternatives to TYK2 class entirely.
A2
Tremfya (IL-23p19)
Preferred alternative
The IL-23p19 class is the preferred destination at Elevance — TYK2 is categorically excluded from the formulary ladder.
A3
Cosentyx · Otezla
Preferred alternatives
IL-17 and PDE4 complete the preferred alternatives list.
✕
NON-FORMULARY
Sotyktu and envu both blocked. Formulary-exception PA only. 14 states · ~47M members.
If BMS can't crack it, Alumis pre-launch is the ONLY leverage point.
The sequencing strategy implication Three of four permissive payers route envu through Sotyktu or an IL-23 biosimilar before granting access. The 1–2 door difference between UHC (2) and Aetna (3) is worth 3–6 months of patient-reach delay per member — and the Aetna ACSF parity decision is the single highest-leverage pre-launch formulary moment. Elevance is a categorical exclusion: the TYK2 class is not on the ladder at all. Every added door compounds the post-IL-23 evidence gap documented in our sequencing brief — payers default to the most conservative interpretation where evidence is thin.
1 UHC P 2297-6 (eff 1/17/2026) · 2 Aetna/CVS SGM 5600-A · ACSF 2026 · 3 Cigna IP0671 (eff 11/01/2025) · 4 CarelonRx Guided + Advanced Drug Lists · 5 Private-label PBM biosimilars: Cordavis (CVS) · Quallent (Cigna) · Nuvaila (Optum)
Access Map
5 of 5 · Live Query
Ask anything.
Grounded in verified
payer policies.
Policy Intelligence · Envudeucitinib

Ask the access map.

Grounded in verified Sotyktu policies, ONWARD data, and PsO competitive intelligence.

Marigold Policy Intelligence
MarigoldI track the anticipated coverage landscape for envudeucitinib — a pre-NDA oral TYK2 inhibitor for moderate-to-severe plaque psoriasis. Built on verified Sotyktu payer policies and ONWARD1/2 data. Ask me about payer criteria, Sotyktu-step risk, biosimilar gates, or the pre-launch window.