US gMG payer policy is converging on an FcRn-to-C5 step-edit — and efgartigimod's cycle dosing makes annual cost a moving target payers manage per cycle.
Commercial plans are building a three-tier access staircase in generalised myasthenia gravis. Tier one is traditional therapy — pyridostigmine plus at least one immunosuppressant (azathioprine, mycophenolate, or prednisone). Failure of that regimen opens tier two, the FcRn antagonists efgartigimod and rozanolixizumab, which carry broad generalised-MG labels with no serology restriction. Tier three is the C5 complement inhibitors, which require AChR-antibody positivity and, at many plans, prior failure or intolerance of an FcRn agent. ICER's 2021 review, which assessed eculizumab and efgartigimod in the anti-AChR-antibody-positive population, set efgartigimod's value-based price benchmark at $18,300–$28,400 a year and eculizumab's at $13,200–$19,400, far below their assumed prices (efgartigimod ~$418,400; eculizumab $470,200 WAC), both of which ICER judged 'low' long-term value for money.
Efgartigimod's cycle-dosing model is the distinctive payer-economics feature: four weekly infusions per cycle, with cycle frequency driven by clinical response. Annual cost therefore varies with the number of cycles a patient needs, with typical net annual cost reported near $225,000. Some plans also require prior authorisation and MG-ADL or QMG documentation at each cycle rather than annually, adding administrative burden. UCB's dual-asset position (rozanolixizumab on the FcRn tier, zilucoplan on the C5 tier) means UCB benefits from whichever sequence a payer imposes — a novel commercial architecture as the FcRn-to-C5 step-edit hardens plan by plan.
US gMG agent payer status — benefit routing, PA criteria and key risk
| Drug (Brand / INN) | Benefit Routing | PA Criteria (Commercial) | ICER 2021 Status | Key Payer Risk |
|---|---|---|---|---|
| Vyvgart Hytrulo (efgartigimod, SC) | Part B (SC, physician-administered) | Pyridostigmine + ≥1 immunosuppressant failure; generalised MG; no serology restriction | Priced ~$418K vs ICER value-based price $18–28K/yr ('low' value) | Cycle-dosing cost variability (~$225K/yr net); per-cycle PA burden |
| Rystiggo (rozanolixizumab, SC) | Part B (SC) | Same immunosuppressant-failure step-edit; AChR+ or MuSK+ | Not assessed in ICER 2021 review (approved 2023) | No standardised efgartigimod-vs-rozanolixizumab preference; both tier 2 specialty |
| Zilbrysq (zilucoplan, SC) | Part B (SC self-injection) | AChR-antibody positive required; IST failure; FcRn failure at many plans | Not assessed in ICER 2021 review (approved 2023) | AChR+ restriction limits population; FcRn step-edit precedes C5 |
| Soliris (eculizumab, IV) | Part B (IV infusion) | AChR+ refractory gMG; IST failure | ICER value-based price $13.2–19.4K/yr vs $470,200 WAC ('low' value) | Higher site-of-care cost; displacement by SC C5 self-injection |
| Ultomiris (ravulizumab, IV) | Part B (IV infusion) | AChR+ refractory gMG; IST failure | Not assessed in ICER 2021 review (approved 2022) | High Part B spend; long-acting IV vs SC C5 competition |
Sources: ICER 2021 — Eculizumab and Efgartigimod for the Treatment of Myasthenia Gravis: Final Evidence Report (Oct 20, 2021); FDA Drugs@FDA (label serology restrictions); efgartigimod net-price reporting in trade press 2023; commercial payer PA policy documents 2024.
What this assessment answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- ICER value-based price benchmarks for efgartigimod ($18,300–$28,400/yr) and eculizumab ($13,200–$19,400/yr)
- the gap between benchmark and launch/WAC price
- ICER as the gross-to-net negotiation anchor
Delivers
- The three-tier staircase (immunosuppression → FcRn → C5)
- immunosuppressant-failure documentation requirements
- AChR-antibody positivity and FcRn-failure gates for the C5 class
Delivers
- Per-cycle vs annual PA workflows
- how cycle count drives annual cost (typical net ~$225K)
- MG-ADL/QMG documentation at cycle renewal
- comparison with rozanolixizumab weekly dosing and C5 site-of-care costs
Custom assessment delivered in 72 hours.
Commission This AssessmentWhat's inside
- How pyridostigmine plus immunosuppressant failure opens access to Vyvgart and Rystiggo before C5 inhibitors are considered.
- Why Medicare Part B benefit routing shapes site-of-care costs across all five gMG specialty therapies reviewed.
- Why ICER priced efgartigimod's value at $18,300-$28,400 a year against a roughly $418,400 assumed launch price.
- How eculizumab's $13,200-$19,400 ICER benchmark compares to its $470,200 WAC, both rated 'low' long-term value.
- How the three-tier staircase moves patients from immunosuppression to FcRn antagonists to AChR-positive C5 inhibitors.
- Why zilucoplan's PA criteria require both AChR-antibody positivity and prior FcRn failure at many commercial plans.
- How four weekly infusions per cycle make efgartigimod's annual cost variable, averaging near $225,000 net.
- Why per-cycle MG-ADL or QMG documentation requirements add administrative burden beyond standard annual PA renewal.
- How PA criteria differ across Vyvgart Hytrulo, Rystiggo, Zilbrysq, Soliris, and Ultomiris in serology and step-edit requirements.
- Why no standardised preference exists between efgartigimod and rozanolixizumab despite both sitting on the FcRn tier.
- How UCB's rozanolixizumab and zilucoplan pairing captures share regardless of which FcRn-to-C5 sequence a payer sets.
- Why holding both an FcRn asset and a C5 asset shields UCB from step-edit sequencing risk entirely.
Included with every brief
How AXLRx builds this assessment
Prepared by MoatRx analysts.
Every AXLRx assessment is built from primary regulatory sources (FDA Drugs@FDA, ClinicalTrials.gov), peer-reviewed literature, and live payer and HTA documentation — not secondary summaries, market-research reports, or unverified estimates. Findings are independently verified before inclusion; if a figure cannot be sourced to a live record, it does not ship.
US Myasthenia Gravis Payer & HTA sources: the ICER 2021 Final Evidence Report on eculizumab and efgartigimod for generalised myasthenia gravis (value-based price benchmarks; published October 20, 2021), FDA Drugs@FDA labelling for serology-restricted indications, efgartigimod net-price reporting in trade press, and current commercial payer prior-authorisation coverage policies.
- Efgartigimod ($18,300–$28,400/yr) and eculizumab ($13,200–$19,400/yr) value-based price benchmarks verified against the ICER 2021 gMG Final Evidence Report (Oct 20, 2021)
- C5 inhibitor AChR-antibody-positive label restriction verified against FDA Drugs@FDA
- Efgartigimod cycle-dosing schedule verified against FDA label; typical annual net cost per trade-press reporting
- Step-edit and PA criteria verified against current commercial payer coverage policy documents
Frequently asked questions
Commission this assessment
AXLRx US Myasthenia Gravis Payer & HTA is built for market access, HEOR, and pricing teams navigating ICER positioning, the FcRn-to-C5 step-edit, and cycle-dosing economics in the US gMG market. Custom assessment in 72 hours.
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