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 Donidalorsen (Dawnzera) has an open NICE draft guidance consultation and no confirmed final price; sebetralstat (Ekterly), the first oral on-demand agent, has favourable draft guidance and an EAMS bridge from March 2025 but likewise no NICE-confirmed net cost.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.
Delivers
- PAS discount mechanics under TA606 and TA738
- the estimated net-cost range each produces
- how to model an undisclosed discount for a comparator
Delivers
- TA1101 appraisal detail and per-pen pricing structure
- the £20-30K/QALY threshold applied
- positioning implications for a new entrant's list price
Delivers
- Donidalorsen and sebetralstat's current appraisal status
- EAMS bridge mechanics for sebetralstat
- scenario pricing pending each drug's final NICE decision
Custom model delivered in 72 hours.
Commission This ModelWhat's inside
- Why the confidential PAS discount, not the published list price, decides real net cost
- Pressure-tested against the TA606/TA738/TA1101 precedent
- Lanadelumab, berotralstat and garadacimab list prices and estimated net cost
- Garadacimab's per-pen structure as the transparent reference point
- How NICE's simple-discount PAS interacts with the £20-30K/QALY bar
- Estimating an undisclosed comparator discount
- NICE draft guidance status and the EAMS bridge mechanism
- Scenario pricing pending final NICE decisions
- Berinert and Firazyr rescue-therapy cost as part of the prophylaxis value argument
- How the offset strengthens a new entrant's NICE submission
- Conservative, base and aggressive PAS-adjusted pricing scenarios
- Sensitivity to NICE's QALY threshold and stop-rule design
- The open pricing questions your team must close before the 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 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
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.
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