Key takeaways
- 3 NICE technology appraisals recommending HAE prophylaxis (TA606 lanadelumab, TA738 berotralstat, TA1101 garadacimab), each with a confidential PAS
- £133,121 Berotralstat's published annualised list price under NICE TA738, before its own confidential discount
- £20,625 Garadacimab's list price per pre-filled pen under NICE TA1101, the only fully transparent list figure in the class
- £20-30K Per-QALY threshold NICE applied to all three positive appraisals, the standard technology appraisal bar
Three NICE technology appraisals gate UK HAE pricing, each behind a confidential PAS discount; garadacimab's £20,625-per-pen list is the only fully transparent price point in the class.
NICE has issued three positive technology appraisals for HAE prophylaxis in England, and every one carries a confidential simple-discount Patient Access Scheme, so published list prices understate the real net cost NHS England actually pays. Lanadelumab (Takhzyro), recommended under TA606 in October 2019, carries a PAS discount estimated at 50 to 60 percent off UK list price, bringing net NHS cost to roughly £180,000 to £200,000 a year per patient. Berotralstat (Orladeyo), recommended under TA738 in October 2021 for patients with two or more attacks a month, lists at approximately £133,121 a year before its own confidential discount. Garadacimab (Andembry), the newest entrant under TA1101 published October 2025, prices at £20,625 per pre-filled pen, the only fully transparent list figure across the three NICE-recommended agents, since its appraisal is recent enough that a public discount narrative has not yet obscured the base price.
Two MHRA-licensed agents sit earlier in the pricing conversation entirely. Donidalorsen (Dawnzera) has an open NICE draft guidance consultation and no confirmed final price; sebetralstat (Ekterly), the first oral on-demand agent, has favourable draft guidance and an EAMS bridge from March 2025 but likewise no NICE-confirmed net cost. Every one of NICE's three positive appraisals worked within the ordinary £20,000 to £30,000 per QALY threshold, the standard technology appraisal bar rather than the more permissive highly specialised technology route. Any new entrant's pricing model has to clear that same threshold on its own health-economic case, not inherit a more generous rare-disease allowance.
UK HAE pricing — three NICE-recommended agents and two still in appraisal
| Agent | NICE Status | List Price | Estimated Net Cost / QALY Threshold |
|---|---|---|---|
| Takhzyro (lanadelumab) | TA606 (Oct 2019), confidential PAS | List undisclosed publicly at drug level | Est. net £180,000-£200,000/yr; £20-30K/QALY threshold cleared |
| Orladeyo (berotralstat) | TA738 (Oct 2021), confidential PAS, 3-month stop rule | ~£133,121/yr before discount | Net cost undisclosed; same £20-30K/QALY threshold |
| Andembry (garadacimab) | TA1101 (Oct 2025), confidential PAS | £20,625/pre-filled pen | Only fully transparent list price in the class |
| Dawnzera (donidalorsen) / Ekterly (sebetralstat) | Draft guidance stage, no final decision | Not yet confirmed | Pending NICE final appraisal |
Sources: NICE TA606 Final Appraisal Determination (lanadelumab), 2019; NICE TA738 Final Appraisal Determination (berotralstat), 2021; NICE TA1101 (garadacimab), published 8 October 2025; NICE in-development project pages for donidalorsen and sebetralstat; UK HAE Alliance real-world outcomes survey, 2022-2023.
What this model answers
Every section answers a named commercial question your team is asking, scoped to your asset.
- How does a confidential PAS discount change the real net cost of TA606 lanadelumab and TA738 berotralstat, and what does that mean for a new entrant's pricing model? • PAS discount mechanics under TA606 and TA738 • the estimated net-cost range each produces • how to model an undisclosed discount for a comparator
- Why is garadacimab's £20,625 per-pen list price the only fully transparent figure in the class, and what does TA1101 tell us about NICE's current pricing bar? • TA1101 appraisal detail and per-pen pricing structure • the £20-30K/QALY threshold applied • positioning implications for a new entrant's list price
- What pricing precedent applies to donidalorsen and sebetralstat while their NICE appraisals remain open, and what should a comparator agent assume? • Donidalorsen and sebetralstat's current appraisal status • EAMS bridge mechanics for sebetralstat • scenario pricing pending each drug's final NICE decision
What's inside
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1 · The Binding Constraint 2 pp
- Why the confidential PAS discount, not the published list price, decides real net cost
- Pressure-tested against the TA606/TA738/TA1101 precedent
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2 · Price Ladder — Three NICE-Recommended Agents 3 pp
- Lanadelumab, berotralstat and garadacimab list prices and estimated net cost
- Garadacimab's per-pen structure as the transparent reference point
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3 · PAS Discount Mechanics & QALY Threshold 3 pp
- How NICE's simple-discount PAS interacts with the £20-30K/QALY bar
- Estimating an undisclosed comparator discount
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4 · Agents Still in Appraisal — Donidalorsen & Sebetralstat 3 pp
- NICE draft guidance status and the EAMS bridge mechanism
- Scenario pricing pending final NICE decisions
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5 · NHS Acute-Therapy Cost Offset in the Economic Case 3 pp
- Berinert and Firazyr rescue-therapy cost as part of the prophylaxis value argument
- How the offset strengthens a new entrant's NICE submission
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6 · Launch Pricing Scenarios & Sensitivity 4 pp
- Conservative, base and aggressive PAS-adjusted pricing scenarios
- Sensitivity to NICE's QALY threshold and stop-rule design
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7 · Client Alignment Questions 2 pp
- The open pricing questions your team must close before the NICE submission is locked
- Structured for an internal pricing committee session
Appendix and source ledger included · 45-minute analyst readout included with delivery
Custom model delivered in 72 hours.
Assess this reportIncluded with every brief
Get Started
Commission this model
AXLRx delivers UK HAE pricing strategy models built for pricing and market access teams navigating NICE's PAS discount structure and the QALY threshold. Custom model in 72 hours.
- 1. Submit your requestSpecify your indication, comparator set, and the NICE pathway question you need answered.
- 2. Scoping callAXLRx analyst confirms PAS assumptions and QALY threshold scope before building.
- 3. DeliveryResearch-verified pricing model in 72 hours with optional analyst readout.
How AXLRx builds this model
Prepared by MoatRx analysts on the AXLRx commercial consulting engine.
Every AXLRx pricing model is built from NICE's published technology appraisal documentation and live NHS commissioning cost data, not secondary summaries. Findings are independently verified before inclusion.
UK HAE pricing sources: NICE TA606, TA738 and TA1101 Final Appraisal Determinations, NICE in-development project pages for donidalorsen and sebetralstat, and the UK HAE Alliance real-world outcomes survey 2022-2023.
- Berotralstat's £133,121 list price and garadacimab's £20,625 per-pen price verified against the live NICE TA738 and TA1101 guidance pages
- Lanadelumab's estimated net cost verified against NHS England commissioning cost data and the UK HAE Alliance real-world outcomes survey
- Donidalorsen and sebetralstat's appraisal status confirmed as draft guidance stage with no final decision, based on live NICE in-development project pages
Frequently asked questions
Deliverables What formats are included with every model?
Every commissioned Pricing Strategy Model includes an editable 6-sheet Excel model (Price Ladder, PAS Discount & QALY Sensitivity, Agents in Appraisal, Acute-Therapy Cost Offset, Launch Scenarios, Sources) and a PDF methodology brief, no PowerPoint deck. An optional 45-minute analyst readout call is included.
Sources How is the pricing evidence verified?
AXLRx builds from primary sources only: NICE technology appraisal documentation and NHS commissioning cost data. No secondary summaries or market research reports. Every list price and PAS estimate is independently verified before inclusion.
Customisation Can I model a specific comparator set or NICE pathway question?
Yes. The intake form captures your indication, target comparator set, and the specific NICE pathway question you need answered. A scoping call confirms scope before research starts. Commission via the intake form to start.