Lanadelumab prices near $450,000 a year and berotralstat near $95,000; ICER's fair-value benchmark for berotralstat lands almost exactly on its own list price, leaving three 2025 entrants with no anchor of their own.
US HAE prophylaxis pricing splits along the same route-of-administration line that defines the competitive class. Lanadelumab (Takhzyro), the subcutaneous anti-kallikrein antibody with roughly 45% prophylaxis share, carries a WAC near $450,000 per patient per year. Berotralstat (Orladeyo), the oral once-daily kallikrein inhibitor with roughly 20% share, prices near $95,000. ICER assessed both agents, first in a 2018 Final Evidence Report and again in a 2021 real-world-evidence update, and set value-based fair-value benchmarks below list price in each case. Berotralstat's benchmark sits almost exactly at its own $95,000 list price, the tightest list-to-benchmark gap in the class; lanadelumab's benchmark sits further below its roughly $450,000 list, a wider gap payers already use as a rebate-negotiation lever.
Three 2025 entrants, garadacimab (Andembry), donidalorsen (Dawnzera) and the first oral on-demand agent sebetralstat (Ekterly), launched without a dedicated ICER review. Each must argue its value position against the existing lanadelumab/berotralstat benchmark set, and payers already apply specialty-tier prior authorization identically across the class regardless of ICER coverage: diagnosis confirmation via C4 and C1-INH testing, an allergist or immunologist prescriber, and documented failure of prior therapy. Benefit routing then splits the class again. Subcutaneous and intravenous agents run through the medical benefit; oral berotralstat runs through the pharmacy benefit, an asymmetry that shapes patient out-of-pocket cost independent of list price, and that any new entrant's GTN model has to route correctly from day one.
US HAE pricing — the ICER list-to-benchmark gap by agent
| Agent | US WAC/yr | ICER Fair-Value Benchmark | Benefit Route |
|---|---|---|---|
| Takhzyro (lanadelumab) | ~$450,000 | Below list (2018/2021 ICER) | Medical |
| Orladeyo (berotralstat) | ~$95,000 | Near list — tightest gap in class (2021 ICER) | Pharmacy |
| Andembry / Dawnzera / Ekterly (2025 entrants) | Not ICER-benchmarked | No dedicated review; argued vs existing set | Medical (Andembry/Dawnzera) · Pharmacy (Ekterly) |
Sources: ICER 2018 Final Evidence Report on HAE prophylaxis; ICER 2021 real-world-evidence update; FDA Drugs@FDA and FDA Orphan Drug database; Prime Therapeutics HAE cost-of-care analyses; US commercial payer specialty-pharmacy coverage policies.
What this model answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- ICER 2018 and 2021 fair-value benchmarks by agent
- the list-to-benchmark gap as a negotiation lever
- benchmark-setting methodology specific to HAE prophylaxis
Delivers
- Garadacimab, donidalorsen and sebetralstat's positioning against the lanadelumab/berotralstat benchmark
- the argument structure payers will expect
- scenario pricing ahead of a future ICER review
Delivers
- Benefit-routing map by agent
- OOP asymmetry mechanics
- GTN waterfall construction for a new entrant depending on route
Custom model delivered in 72 hours.
Commission This ModelWhat's inside
- Why the ICER list-to-benchmark gap, not list price alone, decides the pricing conversation
- Pressure-tested against the lanadelumab/berotralstat precedent before the model is built out
- Lanadelumab, garadacimab and donidalorsen WAC positioning
- Berotralstat and sebetralstat's oral-tier pricing logic
- Benchmark methodology and the list-to-benchmark gap by agent
- Where the 2025 entrants sit without a dedicated review
- Route-of-administration determines benefit channel and OOP exposure
- GTN waterfall construction by benefit type
- Diagnosis-confirmation and prior-therapy-failure criteria common across the class
- Where the list-to-benchmark gap is used in rebate negotiation
- Conservative, base and aggressive pricing scenarios against the existing benchmark set
- Sensitivity to a future dedicated ICER review
- The open pricing questions your team must close before launch price 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 and HTA sources (FDA, ICER) and live payer policy documentation, not secondary summaries. Findings are independently verified before inclusion.
US HAE pricing sources: the ICER 2018 Final Evidence Report and 2021 real-world-evidence update, FDA Drugs@FDA and the FDA Orphan Drug database, Prime Therapeutics HAE cost-of-care analyses, and current US commercial payer specialty-pharmacy coverage policies.
- Lanadelumab and berotralstat WAC figures verified against Prime Therapeutics / ICER published cost analyses
- ICER fair-value benchmark methodology and list-to-benchmark gap verified against the ICER 2018 Final Evidence Report and 2021 real-world-evidence update
- Benefit-routing split (medical vs pharmacy) and specialty-tier PA criteria verified against current US commercial payer coverage policy documents
Frequently asked questions
Commission this model
AXLRx delivers US HAE pricing strategy models built for pricing and market access teams navigating the ICER benchmark gap and the medical-versus-pharmacy benefit split. Custom model in 72 hours.
Specify your indication, payer segment, and comparator scope.
AXLRx analyst confirms pricing mechanism assumptions and benchmark scope before building.
Research-verified pricing model in 72 hours with optional analyst readout.