PREVAIL succeeded. Here's how gefurulimab reaches the patients.
Access Map
PREVAIL met its primary endpoint.¹ MG-ADL −1.6 pts vs. placebo at week 26 (p<0.0001). The clinical case is made. The access map shows where the evidence wins. Click any bar to see details.
This map is built for gefurulimab. The same access intelligence can be built for Ultomiris, Strensiq, and any asset in your portfolio — we built gefurulimab first as your launch vehicle.
Clinical Funnel
Access Cascade · Marigold operates here
60K
Total MG
↕
42K
AChR+ gMG
↕
10K
Biologic-eligible
↕
6K
IST inadequate
↕
2.8K
Proj. Rx
↕
2,380
Hub enrolled
↕
2,190
Step met
↕
1,710
PA approved
↕
1,430
SP dispensed
↕
~1,176
On therapy
↕
Total MG Population · US
~60,000 diagnosed MG patients across all formsIncludes ocular, generalized, seronegative forms
Generalized MG · AChR-positive
~80% generalized MG · ~85% AChR antibody-positive−18K ocular · MuSK+ · seronegative — not eligible for gefurulimab
Moderate-to-Severe · Biologic-Eligible
MGFA Class II–IV · inadequate disease control−32K mild or stable on IST — not indicated
Inadequately Controlled on IST
Persistent symptoms despite steroids · azathioprine · MMF−4K controlled and stable on IST
Gefurulimab Prescribed · Projected Peak Year (Post-Approval)
Neurologist selects C5 complement inhibitor · AChR+ confirmed · illustrative projection at anticipated approval−3.2K lost to prescriber default · FcRn (Vyvgart Hytrulo SC · Rystiggo SC · Imaavy IV) · B-cell depletion (UPLIZNA) · existing SC C5 (Zilbrysq daily)Marigold maps prescriber default patterns to inform Alexion field team targeting — where the mechanism argument hasn't landed, and which payer criteria are reinforcing the default
Hub Enrolled & Benefits Verified · −420 not enrolled
IST failure documentation incomplete · ~85Only 1 prior failure on record · ~55≥0 vs ≥2 criteria gap · ~50 ⚡ pre-launch fix
Prior Authorization Approved · −480 PA denied · largest single drop
Criteria mismatch — IV C5 step required before SC · ~280SC C5 step (Zilbrysq) may also appear as payer requirement · emerging dynamicDocumentation incomplete at submission · ~140Benefit type mismatch (med vs. pharmacy benefit) · ~60 ⚡ pre-launch fix
Specialists 30/100K rural vs 263/100K urban — AAMC
Payer & Regulatory
Payer map AMA 2024 + Becker's 2024
Market share AMA report + Peterson-KFF
Step therapy NCSL + Aimed Alliance 2026
Payer Landscape · Commercial + Medicare
Commercial: step therapy required at UHC, Aetna, and Cigna. Medicare (59% of patients): Part D criteria not yet written.
Existing IV C5 policies are Part B medical benefit. Gefurulimab is SC self-administered — anticipated as Part D pharmacy benefit upon FDA approval. For Medicare patients, the cited IV policies do not apply. Click either channel to see the detail.
Medicare · Part D pharmacy benefit
59%
of gMG patients · ~1,770 people · no published Medicare-specific clinical criteria for SC C5 · Zilbrysq appears on some Part D formularies but excluded at ESI · copay assistance prohibited
Unmapped · Opportunity▾
Commercial · Medical + pharmacy benefit
41%
of gMG patients · UHC, Aetna, Cigna restrictive · Elevance window open · existing IV C5 criteria set the precedent
3 Restrictive · 1 Window▾
Medicare Detail · 59% of gMG patients · Part D · gefurulimab criteria not yet written⁴
Payer
Part D status
Patients
Risk
Lever
Medicare FFS Traditional · Part D PDPs · ~30% gMG
No published Medicare-specific clinical criteria for SC C5. Zilbrysq appears on some Part D formularies (Tier 5, PA required) but ESI 2026 excludes it in favor of Epysqli biosimilar — a warning for gefurulimab's trajectory. IV Part B policies do not govern SC Part D. Copay assistance prohibited — specialty tier is a cliff without LIS.
~900
Criteria Gap
Engage Part D sponsors before formulary submission · Vyvgart Hytrulo SC + Zilbrysq trajectory as analogs · LIS patient mapping
Medicare Advantage MA plans · Part D drug benefit · ~29% gMG
No published Medicare-specific clinical criteria for SC C5 gefurulimab. Each MA plan sets formulary criteria independently. IV Part B policies do not govern SC Part D. Zilbrysq's MA formulary position varies by plan — its ESI exclusion signals the cost-based access risk for a new SC C5 entrant.
~870
Criteria Gap
CMS MA prior auth oversight · CMS Formulary Reference File monitoring · MA P&T window open now · Zilbrysq coverage pattern as leading indicator
Commercial Detail · 41% of gMG patients · IV C5 criteria as precedent¹⁻³
Payer
IV C5 criteria (precedent)
Patients
Risk
Lever
UnitedHealthcare PBM: OptumRx
Path 1: ≥2 IST failures · ≥12 months · MGFA II–IV · MG-ADL ≥6 · OR Path 2: ≥1 IST failure + ≥4 PLEX/IVIG courses · ≥12 months · step therapy new entrants¹
~620
High
State step therapy laws (fully-insured) · CMS exception for MA · Safe Step Act pending ERISA
FcRn policy published Jul 2025 (CC-0207): MG-ADL ≥5 · 1 IST failure · AChR-Ab+ · MGFA II–IV — more permissive than UHC/Cigna. No C5/complement inhibitor policy written yet. The C5 page is blank — window open.
~300
Window
Pre-emptive P&T brief now — highest-leverage window
BCBS Plans PBM: varies by affiliate
Mixed. MN/TX trending restrictive. CA/NY more permissive. No national template yet.
~210
Mixed
State laws vary by affiliate · engage individually before template forms
Marigold
Access Map
3 of 6 · Why
Three Access Domains
Policy · Provider Patient · where the evidence gaps are
Gap › Where › Why
Access Loss Across Three Domains · Commercial + Medicare
Existing criteria reflect a different drug landscape. For 59% of patients, they haven't been written yet.
Route alignment
Existing criteria require IV C5 trial before SC gefurulimab — written before SC options existed
▶
Current criteria require
IV C5 → SC: not yet aligned
Existing criteria predate SC C5 options · written for IV administration · access equity question for rural, elderly, and severe patients not yet formally raised at P&T
≠
Access reality for some patients
Rural patients may not reach infusion centers
SC self-injection at home may represent a meaningfully different access profile · the evidence for this population has not yet been surfaced in P&T submissions
Live signal · happening now
ESI 2026 excludes Zilbrysq (SC daily C5) preferring Epysqli (biosimilar IV C5) — a patient prescribed SC self-injection is redirected to an infusion center for cost reasons. The P&T question is whether formulary design should account for a patient's ability to reach an infusion center.
Mechanism alignment
Formulary tier may require FcRn or B-cell trial even when a neurologist prescribes C5 for AChR+ confirmed disease
▶
Formulary tier can require
FcRn step before C5
Vyvgart preferred tier · gefurulimab non-preferred · formulary financial preference may not reflect mechanism-specific clinical reasoning for AChR+ confirmed disease
≠
The clinical consideration
C5 for confirmed AChR+ disease
When mechanism is deliberately chosen for confirmed AChR+ disease, the alignment between formulary tier and clinical rationale is a policy question worth raising
Part D formulary risk
Payers can exclude gefurulimab entirely — no criteria needed. Zilbrysq's ESI exclusion is the precedent
▶
The real risk
Formulary exclusion — no criteria required
ESI excluded Zilbrysq (SC C5) without writing clinical PA criteria — just a formulary exclusion preferring cheaper biosimilar IV C5. Payers can do the same to gefurulimab. The risk is not bad criteria — it is no coverage at all
→
The window
Engage before the exclusion decision
Part D plan sponsors are setting formularies now. Marigold tracks which plans cover the highest Medicare gMG concentration — so engagement happens before exclusion, not after the first denial wave
Prescriber default
Clinical habit and formulary preference both favor lower-friction agents over C5
▶
Two forces point the same direction
Habit + formulary favor FcRn
FcRn (Vyvgart) and B-cell (UPLIZNA) require no mechanism-specific diagnosis · broad labels, minimal friction · formulary preferred tier reinforces the pattern
≠
What precision targeting enables
Precision targeting at source
Educating prescribers is Alexion's clinical team's work — Marigold maps where the pattern is occurring, at what rate, and which formulary dynamics are reinforcing it
Prescriber navigation
Documentation gaps and PA variability lose patients even after the right drug is prescribed
▶
Where patients are lost after prescription
Documentation + routing gaps
Incomplete IST failure documentation · incorrect benefit type submission · variability in specialist experience navigating PA across payers
→
What Marigold provides
Prescriber intelligence · Exception Pack
Physician-level PA success patterns and pre-built exception documentation — see Component 04
Affordability cliff
Pharma copay assistance is prohibited in Medicare Part D — approved doesn't mean affordable
▶
Medicare Part D structure
Copay assistance prohibited in Part D
Patient on specialty tier faces significant out-of-pocket costs · copay support programs available commercially cannot be used for Medicare patients
≠
What protects patients
LIS protects qualifying patients
LIS eliminates specialty tier cost-sharing · Marigold maps LIS-eligible concentration by geography · non-LIS patients may face an affordability barrier even after coverage is approved
Geographic access equity
19% of gMG patients live in rural areas where infusion center access is limited
▶
The access reality
Rural patients face infusion barriers
19% of gMG patients live in rural areas · 30/100K specialist density rural vs 263/100K urban (AAMC) · SC self-injection at home removes the infusion center dependency entirely
→
What the data shows
Access gaps cluster geographically
Marigold maps rural concentration, Medicare density, and LIS eligibility by state · so evidence generation can be targeted where access barriers are highest
Marigold
Access Map
4 of 6 · What We Hand You
The Access Map · Four Components
Advisory + operational Pre-launch through post-launch
Gap › Where › Why › What We Hand You
The Access Map · Four Components · Advisory + Operational
Four things Marigold hands you.
The goal
~42% → higher
Access yield. Every point is ~28 patients reaching therapy.
The prize
~$98M recoverable
Per 10-point yield improvement at ~$350K/pt/yr. Illustrative.
The window
12–24 mo pre-launch
After approval, criteria calcify. Before approval, they're still being written.
Click any component to see what's inside — what decision it enables, who acts on it, and when.
01 · Gap Analysis · RWE Recommendations · Access Dossier
Decision enabled: Which criteria to shape, which to accept, which to challenge — before approval.
Drug-specific comparison of what your trial enrolled vs. what payers require — payer by payer, criterion by criterion. For each gap, a specific RWE study blueprint: patient cohort, data source, design, timeline, projected impact.
The Access Dossier is not a drug dossier. It's a mirror. It shows payers what their own criteria are producing for their own members — utilization, total cost of care, outcomes. Not "your criteria are wrong." But "here is what your criteria are costing your members — and here is what changes if criteria shift." Payers respond to that because it serves their interest, not Alexion's. Medicare layer: A separate Access Dossier for Part D plan sponsors timed to prevent the ESI/Zilbrysq exclusion pattern before formulary decisions are locked.
Who acts on it: HEOR team (evidence generation) · Market access (P&T engagement) · Part D plan sponsor engagement team.
HEORMarket AccessPre-Launch
02 · Access Yield Report · Monthly + Quarterly
Decision enabled: Where to deploy resources — ranked by recoverable patient volume.
Monthly waterfall per payer: prescribed → hub enrolled → step met → PA approved → dispensed → on therapy at 90 days. One headline number — access yield — with payer policy events overlaid so you know whether a yield drop is a criteria change, a field issue, or a formulary move. Medicare layer: Commercial and Medicare split. Same waterfall — completely different failure drivers and fixes. A commercial denial is a criteria mismatch. A Medicare failure may be formulary exclusion, cost-sharing cliff, or LIS gap. Leadership sees one number. Your team sees what drives it.
Who acts on it: Executive leadership (headline) · Access team (payer prioritization) · Hub and SP (operational triage).
CommercialMedicare SplitPost-Launch · Ongoing
03 · Policy Tracker · Always On · Automated
Decision enabled: When to act on a payer — before criteria harden or exclusions land.
Monitors commercial medical benefit policies across 47 plans — when language changes, which payers are copying which template, how fast restrictions are tightening. Detects the ESI/Zilbrysq pattern before it becomes the gefurulimab pattern. Medicare layer: CMS Formulary Reference File surveillance catches Part D formulary changes when filed — before field teams see a denial wave. MA plan prior authorization reporting tracked. Vyvgart Hytrulo SC and Zilbrysq monitored as the leading Part D analogs.
Who acts on it: HEOR team (policy surveillance, most relevant for office HEOR) · Market access (payer engagement timing) · Medical affairs (MSL deployment).
HEOR · Most relevant hereMedicare Part DAlways On
04 · Prescriber Navigation · Exception Pack
Decision enabled: Which neurologists need support and what documentation gets approvals.
Physician-level PA success rates and documentation patterns — which prescribers navigate successfully, which are losing patients at submission, and why. Exception Pack: payer-specific, pre-built exception documentation with criteria language and clinical checklist. The physician fills in the patient — not the framework. Medicare layer: Medicare Part D coverage determinations and appeals are entirely different from commercial PA. CMS mandates 72-hour standard and 24-hour expedited timelines. Exception Pack includes Medicare-specific forms and appeals language.
Who acts on it: Field access/reimbursement specialists (PA support) · MSLs (prescriber targeting) · Hub teams (exception submission).
Field AccessMedicare AppealsLaunch + Post-Launch
Marigold
Access Map
5 of 6 · Live Query
The map is queryable.
Ask anything about the access landscape for gefurulimab
Policy Assistant · Live
Marigold Policy Intelligence · Gefurulimab / gMG
Ask it anything.
Marigold Policy AssistantPowered by Marigold Intelligence
Marigold
I track the anticipated coverage landscape for gefurulimab — a pre-approval C5 complement inhibitor for AChR+ gMG that has completed Phase III. Built on publicly available payer policies for existing C5 inhibitors and PREVAIL trial data. Ask me what criteria gefurulimab will likely inherit at approval, how Cigna is likely to sequence biologics, or where the pre-launch shaping opportunity is.
Try these
Marigold
Access Map
6 of 6 · The Engagement
How working with Marigold looks.
Three phases One continuous map Per drug · per launch
Engagement Model · Three Phases
Per Drug · Per Launch · Continuous
The access map doesn't stop at launch. Neither do we.
Payer policies drift after approval. Marigold watches continuously so your HEOR team doesn't have to.
1
Pre-launch sprint
12–24 mo before approval
2
Launch window
0–6 mo post-approval
3
Standing access
6 mo+ · ongoing
Phase 1
Pre-launch
Phase 2
Launch
Phase 3
Standing
Alexion does
Shape payer criteria
Prioritize dossier gaps
Submit P&T briefs
Engage Medicare Part D
sponsors pre-formulary
Alexion does
Watch PA outcomes
Document denial patterns
Respond to payer drafts
File Medicare Part D
coverage determinations
We're looking for one or two launch teams to build this with. If you're preparing a 2027 asset, this is the conversation.
Marigold
Access Map
7 · Workspace
Your intelligence workspace.
Upload your evidence. Ask anything. Download the output.
Live Query › Intelligence Workspace
Session-aware · Multi-document · Exportable
Feed Marigold your evidence. It compounds.
Upload your value story, access dossier, or clinical package. Ask questions that build on each other. At the end, synthesize everything into a downloadable executive brief — grounded in your evidence against the payer landscape.
⬆
Upload Document
Value story · Dossier · Clinical brief TXT or PDF text
Session documents
No documents uploaded yet
Step 1
Upload your evidence
Value story, dossier, clinical package — one or many files
Step 2
Ask building questions
Each answer compounds — Marigold holds the full session context
Step 3
Download the output
Ask Marigold to synthesize — get a formatted brief ready to share
Marigold
This workspace remembers everything in your session. Upload your value story or access dossier above, then ask questions that build on each other. When you're ready, ask me to create an executive summary, and I'll synthesize the full session into a downloadable brief.