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Hereditary Angioedema - Ekterly
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This policy governs prior authorization and coverage criteria for Ekterly (sebetralstat tablets) for treatment of acute hereditary angioedema (HAE) attacks in members of Cigna-administered health plans.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ekterly (sebetralstat)
FDA-Approved Indication - Acute HAE attacks
Ekterly is considered medically necessary when the following are met:
HAE with normal C1-INH (HAE type III) does NOT satisfy this requirement.
If the patient is currently receiving the requested therapy but has not previously received approval through the Coverage Review Department, review under Initial Therapy criteria.
Plan-level product criteria
For certain plans, product-specific criteria apply (patient must meet one of the following):
A previous trial of any icatibant product counts toward this requirement.
Ekterly (sebetralstat) for any use other than the specified acute HAE treatment indication is not medically necessary. The policy explicitly lists non-covered uses and states that Ekterly for other indications outside the FDA-approved acute hereditary angioedema (HAE) attacks treatment is considered not medically necessary.
Use of Ekterly for prophylaxis of HAE attacks is considered not medically necessary. The policy notes that data are not available and Ekterly is not indicated for HAE prophylaxis, and requests for this use will not be covered.
Provider Actions, Authorization, and Documentation
Prior Authorization required; 1‑year approvals; specialist prescriber
Prior authorization is required for benefit coverage of Ekterly. All approvals are provided for up to 1 year when coverage criteria are met. Ekterly must be prescribed by or in consultation with an allergist/immunologist or a physician who specializes in HAE or related disorders.
Plan-level product criteria — Employer & Individual/Family
For Employer and Individual/Family plans, coverage requires the patient to meet one of the plan-specific options: age ≥12 and <18 years, prior treatment of an acute HAE attack with Ekterly, or trial of generic icatibant (Individual/Family plans also accept Sajazir).
- Employer plans: trial of generic icatibant satisfies requirement.
- Individual/Family plans: trial of generic icatibant or Sajazir satisfies requirement.
Required documentation to support request
Documentation must be provided as noted in the coverage criteria and may include chart notes, prescription claims/receipts, and other records; all documentation must include patient-identifying information.
- For initial therapy: baseline lab results documenting low functional C1‑INH (<50% of normal) and low serum C4 as defined by lab reference values.
- Diagnosis documentation confirming HAE type I or II.
- For continuation: documentation of prior favorable clinical response to Ekterly when applicable.
Denial triggers — no PA and non‑covered prophylaxis use
Requests submitted without prior authorization will be denied; use of Ekterly for prophylaxis of HAE attacks is considered not medically necessary and will be denied.
- A diagnosis of HAE with normal C1‑INH (HAE type III) does not meet criteria and will not satisfy coverage requirements.
- If a patient is on therapy but lacks prior approval through the Coverage Review Department, initial therapy criteria must be met for approval.
Background and Drug Information
Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor indicated for treatment of acute hereditary angioedema (HAE) attacks in patients meeting the FDA-approved criteria. Clinical guidelines recommend on-demand therapies for acute HAE attacks and include oral plasma kallikrein inhibitors among first-line options. Diagnostic confirmation for coverage requires HAE due to C1‑INH deficiency (HAE type I or II) with appropriate laboratory documentation; Ekterly is not indicated for prophylactic use and such use is not covered.
Definitions
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