Sebetralstat (Ekterly) — Coverage Criteria
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Defines medical necessity and prior authorization criteria for Ekterly (sebetralstat) when used to treat acute hereditary angioedema (HAE) in patients age 12 and older for QualChoice lines of business.
Initial approval duration extended from 6 months to 12 months for a chronic condition.
Criteria updated to align with FDA labeling and to add step therapy bypass for Illinois HIM per IL HB 5395.
HCPCS code J8499 was added to the policy coding section.
Drug is now FDA approved - criteria updated per FDA labeling; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.
Coverage Criteria
inv-01: Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Based on policy initial approval criteria
inv-02: Continuation Therapy — Continued therapy covered when ALL of the following are met
Continued therapy covered when ALL of the following are met
Based on policy continued therapy criteria
Non‑FDA approved indications that are not specifically addressed by this clinical policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies. See the Health Plan off‑label policies CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), and CP.PMN.53 (Medicaid) for the required evidentiary standards and documentation.
All coverage determinations under this clinical policy are subject to the Health Plan’s terms, conditions, exclusions, and limitations specified in member coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance). Coverage decisions also must comply with applicable state and federal laws and Health Plan administrative policies and procedures. This clinical policy does not guarantee payment and the Health Plan reserves the right to change, amend, or withdraw the policy as allowed by contract and law.
When a state Medicaid program’s coverage provisions conflict with the provisions of this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that govern the member’s benefits.
Use of Ekterly (sebetralstat) for non‑FDA approved indications without adequate supporting evidence is not authorized per the Health Plan’s off‑label use policies. Requests for coverage of off‑label uses must include documentation that meets the evidentiary requirements referenced in the applicable off‑label policies (see CP.CPA.09, HIM.PA.154, and CP.PMN.53). Absent that documentation, such requests may be denied as not medically necessary.
Initial Therapy Criteria
inv-21: Initial Therapy — Initial therapy criteria for Ekterly
Initial therapy criteria for Ekterly
Reflects FDA‑aligned dosing and policy step therapy requirements
inv-22: Initial approval duration — Initial approval duration for a chronic condition was extended during review
Initial approval duration for a chronic condition was extended during review.
Change recorded in 2Q 2026 annual review
Continuation Therapy Criteria
inv-23: Continued Therapy — Continued therapy criteria
Continued therapy criteria
Based on policy continued therapy criteria
Step Therapy Requirements
| Step | Requirement | Applies to |
|---|---|---|
| 1 | Failure of icatibant (Firazyr®) is required prior to approval of Ekterly (sebetralstat) unless contraindicated or clinically significant adverse effects are experienced | Members age ≥ 18 years |
| 2 | Step therapy requirement does not apply when an Illinois Health Insurance Marketplace (HIM) request qualifies for the statutory bypass per IL HB 5395 (effective 1/1/2026) | Illinois HIM requests |
| Bypass | Authority / Law | Effective |
|---|---|---|
| Illinois HIM step therapy bypass | Illinois HB 5395 — statutory bypass for Health Insurance Marketplace step therapy requirements | 1/1/2026 (per policy note) |
| Policy note referencing bypass | Policy states: 'For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395' | As stated in policy CP.PHAR.723 |
Coding and Dose Limits
| J8499 | Prescription drug, oral, non chemotherapeutic, nos |
| J8499 | Prescription drug, oral, non chemotherapeutic, nos |
Provider Actions and Prior Authorization
Prior authorization required for Ekterly when criteria met
Ekterly (sebetralstat) requires prior authorization and is medically necessary only when all policy criteria are met, including confirmed HAE diagnosis, prescriber specialty/consultation, age criteria, use for acute HAE attacks, step therapy requirements where applicable, no concurrent use with other FDA‑approved acute HAE products, and dosing limits. HCPCS J8499 is referenced in the policy for claims.
- Diagnosis: history of recurrent angioedema plus low C4 and low C1‑INH antigenic or functional level
- Prescribed by or in consultation with a hematologist, allergist, or immunologist
- Age ≥ 12 years and prescribed for acute HAE attacks
- Not used in combination with another FDA‑approved product for acute HAE attacks
- Dose limits: 600 mg per dose; up to 2 doses (1,200 mg) in 24 hours
HCPCS J8499 referenced for Ekterly
The policy lists HCPCS code J8499 (Prescription drug, oral, non chemotherapeutic, nos) for informational coding purposes; prior authorization requirements in this clinical policy apply to claims for Ekterly.
- HCPCS: J8499 — Prescription drug, oral, non chemotherapeutic, nos
Step therapy: prior failure of icatibant for adults
For members age ≥ 18 years, the policy requires failure of icatibant (Firazyr) prior to approval of Ekterly unless the drug is contraindicated or clinically significant adverse effects occurred.
- Step therapy applies to adults (≥18 years): documented failure of icatibant is required unless contraindicated or adverse effects are present
- Prior authorization may be required for icatibant
Illinois HIM step therapy bypass (IL HB 5395)
Step therapy requirements do not apply for Illinois Health Insurance Marketplace (HIM) requests as of 1/1/2026 per Illinois HB 5395 — a statutory bypass is provided.
- IL HIM statutory bypass: step therapy requirements waived effective 1/1/2026 per IL HB 5395
Submit clinical documentation to support approval criteria
Submit supporting clinical documentation with the prior authorization request to show the member meets all approval criteria.
- Examples: office chart notes, laboratory results, consultation notes demonstrating HAE diagnosis and prior treatments
Check current coding guidance before claim submission
Providers should confirm current professional coding guidance before submitting claims; the policy’s code list is informational and may not reflect the most current coding rules.
- Reference up‑to‑date coding manuals and payer billing instructions prior to claim submission
Denial risk if documentation missing or off‑label criteria not met
Requests lacking required documentation or seeking non‑FDA indications without compliance with applicable off‑label policies may be denied.
- Missing chart notes, labs, or other evidence of meeting policy criteria can trigger denial
- Non‑FDA indications require sufficient documentation per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or may be considered not medically necessary
Coding listed in policy does not guarantee coverage
Inclusion or exclusion of codes in this policy does not guarantee coverage; providers must reference current coding guidance and payer requirements when submitting claims.
- Policy coding is informational only; verification with up‑to‑date coding sources is required
Background
Hereditary angioedema (HAE) is a genetic disorder characterized by recurrent episodes of localized, non‑pitting angioedema. HAE types I and II are associated with low complement C4 levels and either low C1‑inhibitor (C1‑INH) antigenic level or low C1‑INH functional activity, which are used to support diagnosis. Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor approved for treatment of acute HAE attacks in patients aged 12 years and older. Clinical trial enrollment excluded patients with HAE with normal C1‑INH (HAE‑nl‑C1INH), and there is insufficient evidence to support sebetralstat use in that subgroup.
Definitions
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