Andembry (garadacimab) — Prior Authorization Guideline
Customize your policy alerts
Sign up for all careoregon policy alerts
Know when careoregon releases new policies or updates existing guidance.
Monitor payer policy activity
Prior authorization guideline for Andembry (garadacimab) for treatment of hereditary angioedema (HAE), covering initial and reauthorization clinical criteria and approval length. Applies to CareOregon-managed members requiring this specialty drug.
No material clinical or coverage changes in this revision.
Coverage Criteria for Andembry (garadacimab)
Initial Therapy
Covered when ALL of the following are met:
Approval length 6 months
Reauthorization
Covered when ONE of the following is met:
Approval length 6 months
Initial authorization
Initial authorization criteria and approval length
Approval length: 6 months
Provider Actions and Documentation Requirements
Prior authorization required for Andembry (garadacimab)
Prior authorization is required for Andembry (garadacimab). Initial approvals are for 6 months; reauthorization decisions follow the policy’s reauthorization criteria (attack-free >6 months OR ≥50% reduction in attacks with documented functional improvement).
- Initial approval length: 6 months
- Reauthorization requires meeting the specified reauthorization criteria in the policy
Confirm acute/abortive therapies are unsuitable or unavailable
Document that acute, abortive therapies are not an option for the member—specifically that treatment with agents such as Firazyr or Berinert is not an option—before approving Andembry.
- Policy requirement: “Treatment with acute, abortive therapy is not an option for this member (Firazyr, Berinert)”
Submit medical records to support reauthorization
For reauthorization, submit medical records (for example, chart notes) that confirm the member’s functional improvement when requesting continued coverage.
- Reauthorization pathway requires either attack-free >6 months OR ≥50% reduction in attacks plus submission of medical records confirming functional improvement
Provide complete diagnostic documentation for HAE or risk denial
Provide diagnostic documentation confirming HAE by C1‑INH antigenic or functional deficiency, OR documented normal C1‑INH levels plus genetic confirmation (variant in F12, ANGPT1, PLG, KNG1, MYOF, or HS3ST6) or evidence of recurring angioedema refractory to high‑dose antihistamines; lack of these records may result in denial.
- Acceptable diagnostic evidence: C1‑INH antigenic level below lower limit of normal OR C1‑INH functional level below lower limit of normal
- If C1‑INH levels are normal, provide genetic confirmation (listed genes) OR documentation of recurring angioedema refractory to high‑dose antihistamines
Key Definitions
Background
Hereditary angioedema (HAE) is a disorder characterized by recurrent angioedema attacks due to C1 inhibitor deficiency or dysfunction, or certain genetic variants. Severe attacks can involve the face, throat, or gastrointestinal tract and may significantly interrupt usual daily activity. Prophylactic therapy such as Andembry (garadacimab) is considered when attacks are severe, recurrent, or not adequately controlled with avoidance of triggers and available acute, short‑term symptomatic treatments.
Step Therapy Requirements
| Requirement | Documentation / Notes |
|---|---|
| Document that acute, abortive therapies are not an option for this member (examples: Firazyr, Berinert). | |
| Clinical rationale and supporting documentation that these therapies are unavailable, ineffective, or unsuitable (e.g., prior trial and failure, contraindication, intolerance, lack of access) must be included in the prior authorization request. |
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.