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.
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 FcRn prescriber default · Vyvgart · Rystiggo · Imaavy
Hub Enrolled & Benefits Verified · −420 not enrolled
~42% access yield · illustrative · specialty biologic analog~1,624 patients lost across cascadeRecoverable with pre-launch evidence moves
~42%
Access Yield
~1,624 of 2,800 projected prescribed patients never reach therapy · $1.5B+ revenue at risk · illustrative · specialty biologic analog◆
Marigold
Access Map
2 of 6 · Where
Payer Risk
Medicare · Commercial 59% of gMG patients on Medicare
Gap › Where
Payer Landscape · Commercial + Medicare
UHC, Aetna, and Cigna require step therapy for commercial patients. Medicare — 59% of your population — is unmapped.
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 · Part D policies not yet written · copay assistance prohibited · SC C5 has no Medicare precedent
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 · policies unmapped⁴
Payer
Part D status
Patients
Risk
Lever
Medicare FFS Traditional · Part D PDPs · ~30% gMG
No SC C5 Part D policy. First SC C5 in Medicare Part D for gMG. Copay assistance prohibited — specialty tier is a cliff without LIS.
~900
Unmapped
Engage Part D sponsors before formulary submission · Vyvgart Hytrulo SC analog · LIS patient mapping
Medicare Advantage MA plans · Part D drug benefit · ~29% gMG
Part D formulary decisions pending. Each MA plan sets criteria independently. Cited IV Part B policies do not govern SC Part D.
~870
Unmapped
CMS MA prior auth oversight · CMS Formulary Reference File monitoring · MA P&T window open now
Commercial Detail · 41% of gMG patients · IV C5 criteria as precedent¹⁻³
Payer
IV C5 criteria (precedent)
Patients
Risk
Lever
UnitedHealthcare PBM: OptumRx
≥2 IST failures · ≥12 months · MGFA II–IV · MG-ADL ≥6 · step therapy new entrants¹
~620
High
State step therapy laws (fully-insured) · CMS exception for MA · Safe Step Act pending ERISA
Five Access Problems · Commercial A–C · Medicare D–E
The criteria were written for a different drug. For 59% of patients, they haven't been written at all.
Commercial · Access Equity
Payer step therapy requires
IV Ultomiris failure before SC gefurulimab
Infusion center every 8 weeks · treats IV and SC C5 as clinically interchangeable
≠
Reality for access-limited patients
Rural · elderly · severe patients cannot reach infusion centers
Weekly SC at home · IV and SC are not interchangeable for this population
Commercial · Prescriber Behavior
Prescriber default — lower friction agents
FcRn or B-cell depletion first — easier to prescribe, less diagnostic precision required
Vyvgart (FcRn) — weekly SC, broad label, minimal diagnostic specificity · UPLIZNA (B-cell) — twice-yearly IV after loading, established from NMOSD, both AChR+ and MuSK+ · Neither requires mechanism-specific reasoning to prescribe
≠
The clinical case for C5 in AChR+ confirmed disease
C5 blocks complement activation directly at the nerve-muscle junction
FcRn broadly reduces IgG — non-specific · B-cell depletion works upstream, systemic · C5 is the mechanism-matched choice when AChR+ and complement-mediated disease is confirmed. Mechanism matters when it is known.
C5 for AChR+ confirmed complement-mediated disease
Mechanism chosen deliberately · payer-mandated FcRn trial is not step therapy — it is practicing medicine
Medicare · Part D · Policy Vacuum
Medicare Part D status
No SC C5 Part D policy exists for gMG
First SC C5 in Medicare Part D · cited IV Part B policies do not apply · whoever writes criteria first sets the precedent for ~1,770 patients
→
The opportunity
The page is blank. Engage now before it gets written wrong.
Part D plan sponsors setting formularies now · Vyvgart Hytrulo SC is the closest analog · Marigold tracking which plans cover highest gMG Medicare concentration
Medicare · Part D · Cost-Sharing Cliff
Medicare Part D rule
Pharma copay assistance is prohibited in Medicare Part D
Patient on specialty tier faces thousands out-of-pocket · copay programs Alexion deploys commercially are illegal in Medicare
≠
What protects patients
LIS (Low Income Subsidy) — only for those who qualify
LIS eliminates specialty tier cost-sharing · Marigold maps LIS-eligible concentration by geography · non-LIS Medicare patients hit affordability cliff even after coverage approval
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.
Click any component to see what's inside — including what's new for the Medicare Part D environment.
01 · Policy Tracker · Always On · Automated
Commercial + Medicare Part D policy surveillance
Monitors commercial medical benefit policies across 47 plans — when language changes, which payers are copying UHC's framework, how fast criteria are hardening. Medicare layer: CMS Formulary Reference File surveillance detects Part D formulary changes when filed — faster than field feedback. MA plan prior authorization data (CMS-mandated reporting). Vyvgart Hytrulo SC tracked as the closest Part D analog for gefurulimab precedent.
CommercialMedicare Part DAlways On
02 · Gap Analysis · RWE Recommendations · Access Dossier
Drug-specific comparison of what your trial enrolled vs. what payers require — payer by payer, criterion by criterion. For each gap, the specific RWE study that closes it: patient cohort, data source, design, timeline, projected access yield impact. The Access Dossier packages this into a P&T-ready document — not a drug dossier, an access argument showing payers what their own criteria are producing. Medicare layer: A separate Medicare Access Dossier for Part D plan sponsors — not "your criteria are wrong" but "here is the framework you should adopt before you write anything."
Commercial P&TMedicare Part D SponsorPre-Launch
03 · Prescriber Navigation · Exception Pack
PA success by physician. Exception documentation pre-built.
Physician-level PA success rates, documentation patterns, and where patients are lost by prescriber. Exception Pack: payer-specific, pre-built medical exception documentation — criteria language, clinical checklist, physician fills in patient details only. Medicare layer: Medicare Part D coverage determination and appeals process is entirely different from commercial PA. The Exception Pack includes Medicare-specific coverage determination forms and CMS appeals language with mandated timelines — 72 hours standard, 24 hours expedited.
Commercial PAMedicare Part D AppealsLaunch + Post-Launch
04 · Access Yield Report · Monthly + Quarterly
One number per payer. Commercial and Medicare split.
Monthly one-pager per payer: prescribed → enrolled → approved → dispensed → on therapy at 90 days. One headline number — access yield — with payer policy events overlaid. Medicare layer: Report splits commercial vs. Medicare access yield separately. A commercial denial is a criteria mismatch. A Medicare access failure may be a formulary exclusion, a cost-sharing cliff, or an LIS gap. Same waterfall number — completely different fix. Leadership sees one number. Your team sees what drives it.
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-BLA 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
6–12 mo before BLA
2
Launch window
0–6 mo post-approval
3
Standing access
6 mo+ · ongoing
Phase 1
Pre-launch
Phase 2
Launch
Phase 3
Standing
You do
Shape payer criteria
Prioritize dossier gaps
Submit P&T briefs
Engage Medicare Part D
sponsors pre-formulary
You do
Watch PA outcomes
Document denial patterns
Respond to payer drafts
File Medicare Part D
coverage determinations