CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1503-1

Andembry® (garadacimab-gxii) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Prior authorization/notification policy for Andembry (garadacimab-gxii) for prophylaxis of hereditary angioedema (HAE) in patients aged 12 years and older under UnitedHealthcare Commercial Plans; defines approval criteria, authorization duration, and program notes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAndembry® (garadacimab-gxii) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1503-1

Change TypeNew program (added)

Effective DateJan 1, 2026

Next Review Date

Key ActionPrior authorization/notification is required for Andembry; approval will be issued for up to 12 months and is contingent on meeting all listed clinical criteria.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Andembry (garadacimab-gxii) established.

1Covered Indication (HAE prophylaxis)

12 monthsAuthorization Length

Coverage Summary

Background: Andembry is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Coverage stance: covered_with_criteria. Scope summary: Prior authorization/notification policy for Andembry (garadacimab-gxii) for prophylaxis of hereditary angioedema (HAE) in patients aged 12 years and older under UnitedHealthcare Commercial Plans; defines approval criteria, authorization duration, and program notes. Authorization duration threshold: 12 months. Effective date: 2026-01-01. Last review (P&T approval) date: 2025-11-01.

Initial Therapy Criteria

Initial Approval Criteria

Andembry will be approved based on ALL of the following:

Diagnosis of hereditary angioedema (HAE)
Intended use: Used for prophylaxis against HAE attacks
Combination therapy exclusion: Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro)
Examples provided in source

Unproven Uses / Exclusions

Combination Therapy Exclusion

Combination Therapy Exclusion: Use in combination with other products indicated for prophylaxis against HAE attacks (Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro) is excluded and may result in denial per provider actions.

See provider actions: Combination therapy exclusion (risk of denial).

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Andembry; approval will be issued for up to 12 months and is contingent on meeting all listed clinical criteria.

Documentation Required

Documentation of diagnosis and treatment intent

Provider must document diagnosis of hereditary angioedema (HAE) and that therapy is intended for prophylaxis; must document that Andembry will not be used in combination with other HAE prophylactic products.

Denial Risk

Combination therapy exclusion

Claims where Andembry is used in combination with other products indicated for HAE prophylaxis (e.g., Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro) risk denial.

Cinryze
Dawnzera
Haegarda
Orladeyo
Takhzyro

Billing Rule

State and plan-specific mandates apply

State mandates, federal regulatory requirements, and member-specific benefit plan coverage may impact coverage; other policies and utilization management programs (including supply limits and step therapy) may apply.

Background

Background: Andembry is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of HAE in adult and pediatric patients aged 12 years and older.

subject: Andembry (garadacimab-gxii) prophylaxis for hereditary angioedema

policy_number: 2025 P 1503-1