No UK gMG biologic has ever cleared NICE at any price. Two consecutive appraisals ended without a positive recommendation, so a future entrant's price ladder has to be modelled from the IVIg cost-offset up, not from a cleared precedent down.
Eculizumab's NICE appraisal for refractory myasthenia gravis was terminated in June 2020 after the manufacturer withdrew without submitting a cost-effectiveness dossier; no cost-per-QALY figure was ever modelled or published for the drug in this indication. Efgartigimod's appraisal concluded differently but with the same result: NICE's final guidance, published 4 June 2025, does not recommend the drug for NHS use, citing gaps and uncertainties in the cost-effectiveness evidence rather than a specific quantified ICER breach, despite a 68% MG-ADL responder rate in the ADAPT trial. Rozanolixizumab's NICE appraisal has not yet been initiated, leaving it as the FcRn class's one still-open bid. A new entrant's pricing strategy therefore starts from a genuinely blank precedent rather than a benchmark to beat.
The strongest unused lever for a future submission is the NHS IVIg cost offset: an estimated £40-60 million a year is spent on immunoglobulin for gMG across roughly 4,000 patients, with supply constrained under the NHS-wide IVIg prioritisation programme. Modelling that offset against a target WAC of £80-120,000 a year, with a 45-55% patient access scheme discount, implies an effective NHS price of £40,000-78,000 a year, crediting an IVIg cost-offset of £5,000-10,000 per patient per year plus subcutaneous administration savings of £3,000-5,000 per patient per year versus IV. Subcutaneous formulation is not optional for a competitive submission on these numbers.
UK gMG pricing — from zero precedent to a modelled NHS-acceptable price
| Agent / Scenario | NICE Status | Reference Mechanism | Estimated NHS-Acceptable Price |
|---|---|---|---|
| Eculizumab | Appraisal terminated 2020; no ICER ever modelled | Manufacturer withdrew before evidence submission | No NICE-cleared price exists; Individual Funding Request access only |
| Efgartigimod | Not recommended, June 2025 | Cost-effectiveness evidence judged too uncertain at the submitted price | Would need a resubmission at a materially lower net price or a managed-access proposal |
| Future entrant (modelled) | Not yet appraised | Target WAC £80-120K/yr, 45-55% PAS | Effective NHS price £40-78K/yr, crediting IVIg and SC-administration offsets |
Sources: NICE eculizumab MG termination decision document; NICE efgartigimod final guidance (not recommended, June 2025); ADAPT trial MG-ADL data; NHS England IVIg demand and prioritisation programme documentation.
What this model answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- The two termination mechanisms compared
- why efgartigimod's evidence-uncertainty rejection is the more informative precedent for a future submission
- rozanolixizumab's still-open bid as the class's remaining test case
Delivers
- Target WAC £80-120K/yr and PAS 45-55% modelling
- the £40-78K effective-price range this implies
- SC-versus-IV administration-cost offset mechanics
Delivers
- £40-60M/yr NHS IVIg spend across ~4,000 patients
- the IVIg prioritisation programme's supply-constraint context
- the offset argument structure a submission should lead with
Custom model delivered in 72 hours.
Commission This ModelWhat's inside
- Why no UK gMG biologic has ever cleared NICE at any price, and what that means for a first-mover pricing strategy
- Pressure-tested against both prior appraisal outcomes before the rest of the model is built out
- How a WAC and PAS combination must translate into an NHS-acceptable ICER
- Where the evidence-uncertainty rejection differs from a cost-per-QALY failure
- Eculizumab's manufacturer withdrawal before any evidence was submitted
- Efgartigimod's evidence-uncertainty rejection despite a 68% MG-ADL responder rate
- The FcRn class's one still-untested appraisal
- What a positive rozanolixizumab outcome would set as the class's first price precedent
- The £40-60M/yr NHS IVIg spend as the strongest unused pricing lever
- GTN waterfall components decomposed against the IVIg-offset and SC-administration savings
- £80-120K/yr target WAC and 45-55% PAS scenario grid
- The £40-78K/yr effective-price range this implies
- Resubmission-versus-new-entrant sequencing options
- Conservative, base, and aggressive revenue scenarios tied to a first positive NICE outcome
- The open pricing questions your team must close before a NICE submission is locked
- Structured for an internal pricing committee session
Included with every brief
How AXLRx builds this model
Prepared by MoatRx analysts.
Every AXLRx pricing model is built from primary regulatory sources, published NICE appraisal and guidance documents, and NHS commissioning data, not secondary summaries. Findings are independently verified before inclusion.
UK myasthenia gravis pricing sources: NICE's eculizumab termination decision document, NICE's efgartigimod final guidance, ADAPT trial evidence, and NHS England IVIg demand-management programme data.
- Eculizumab's appraisal-termination rationale and efgartigimod's rejection rationale verified against the published NICE decision documents
- NHS IVIg spend and patient-count figures verified against NHS England IVIg demand-management programme documentation
- Target WAC and PAS modelling cross-checked against the effective-price ranges implied by comparable NICE rare-disease appraisals
Frequently asked questions
Commission this model
AXLRx delivers myasthenia gravis pricing strategy models built for market access and pricing teams navigating the UK's zero-precedent NICE landscape. Custom model in 72 hours.
Specify your asset, prior NICE history if any, and target WAC/PAS range.
AXLRx analyst confirms pricing mechanism assumptions and IVIg-offset scope before building.
Research-verified pricing model in 72 hours with optional analyst readout.