CurrentUnitedHealthcarePolicy N/A

Ekterly (sebetralstat) prior authorization for acute hereditary angioedema

Defines prior authorization and medical necessity criteria for coverage of Ekterly (sebetralstat) for treatment of acute hereditary angioedema (HAE) in patients aged 12 years and older for UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyEkterly (sebetralstat) prior authorization for acute hereditary angioedema

Policy CodePolicy N/A

Change TypeNew prior authorization programage-based step therapy added

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis and age‑specific trials/failures; authorization granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Ekterly (sebetralstat) was established.

Criteria were added requiring trial, failure, or contraindication to other HAE products based on patient age.

Ekterly must not be used in combination with other acute HAE treatments.

12 monthsauthorization duration

>=12 yrslabeled age

1new programs

NCapplicable state

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Coverage Criteria for Ekterly (sebetralstat)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization

Diagnosis of hereditary angioedema (HAE) confirmed by either: (1) C1-INH deficiency/dysfunction documented by C1-INH antigenic level below the lower limit of normal OR C1-INH functional level below the lower limit of normal; OR (2) HAE with normal C1-INH and either confirmed pathogenic variant in a relevant gene (factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, HS3ST6) OR recurrent angioedema attacks refractory to high-dose antihistamines with family history OR recurrent angioedema attacks refractory to high-dose antihistamines with de-novo mutation (HAEunknown).
Indication and concomitant use: Prescribed for the acute treatment of HAE attacks AND not used in combination with other products indicated for the acute treatment of HAE attacks (e.g., Berinert, Firazyr, icatibant, Kalbitor, Ruconest, Sajazir).
Age-specific step therapy: Either: (A) Patient <18 years AND submission of medical records documenting history of failure, contraindication, or intolerance to one of: Berinert OR Ruconest; OR (B) Patient >=18 years AND submission of medical records documenting history of failure, contraindication, or intolerance to both: (i) one of Berinert OR Ruconest AND (ii) icatibant (Firazyr).
Prescribed by an immunologist or allergist is required.

Some UnitedHealthcare plans have specific exclusions that affect coverage for acute hereditary angioedema (HAE) treatments. Ekterly and brand Firazyr are noted as therapies that are typically excluded under certain plan designs. Whether an exclusion applies, and any required prior trials or documentation of failure, intolerance, or contraindication to alternative therapies, depends on the member’s specific plan benefits and medical policy provisions. Providers should verify benefit design and plan-specific requirements before submitting an authorization request.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required; approved for 12 months when criteria met

Prior authorization is required for Ekterly and will be issued for 12 months when all clinical criteria are met, including a confirmed HAE diagnosis, use for acute HAE attacks, no concurrent use with other acute HAE products, age-specific trial requirements, and prescription by an immunologist or allergist.

Authorization will be issued for 12 months when initial criteria are met.

Step Therapy

Age-based trial requirements for alternative HAE therapies

Age-based step therapy is required: for patients under 18, medical records must document failure, contraindication, or intolerance to one C1‑INH product (Berinert or Ruconest); for patients 18 and older, records must document failure, contraindication, or intolerance to both a C1‑INH product (Berinert or Ruconest) and icatibant.

Patient <18: failure/contraindication/intolerance to one of Berinert or Ruconest.
Patient ≥18: failure/contraindication/intolerance to both (1) Berinert or Ruconest and (2) icatibant.

Background

Ekterly (sebetralstat) is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients aged >= 12 years. Coverage determinations and prior authorization requirements for Ekterly follow the policy’s clinical criteria, but plan-level exclusions may affect access.

Definitions

C1‑INH deficiency/dysfunction (Type I/II HAE)

DefinitionC1-INH deficiency or dysfunction (Type I/II HAE) is documented by laboratory evidence of C1‑INH levels below the lower limit of normal.

Diagnostic evidence — antigenicC1‑INH antigenic level below the lower limit of normal (per laboratory standard).

Diagnostic evidence — functionalC1‑INH functional level below the lower limit of normal (per laboratory standard).

Clinical contextMeets the program’s diagnosis requirement for initial authorization when either antigenic or functional C1‑INH is below the lab’s lower limit of normal.

HAE with normal C1‑INH

DefinitionHAE with normal C1‑INH is diagnosed when C1‑INH levels are normal but other confirmatory criteria are present.

Policy Summary

PayerUnitedHealthcare

PolicyEkterly (sebetralstat) prior authorization for acute hereditary angioedema

Policy CodePolicy N/A

Change TypeNew prior authorization programage-based step therapy added

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis and age‑specific trials/failures; authorization granted for 12 months when criteria are met.

SourceLink

On This Page

Documentation Required

Required documentation to support prior authorization

Submit medical records documenting the HAE diagnosis and, depending on patient age, the required history of failure, contraindication, or intolerance to specified alternative HAE therapies; documentation must also show the medication is prescribed for acute HAE and the prescriber is an immunologist or allergist.

Documentation of HAE diagnosis (C1‑INH antigenic or functional level below LLN, or criteria for HAE with normal C1‑INH).
For patients <18: records showing failure/contraindication/intolerance to Berinert or Ruconest.
For patients ≥18: records showing failure/contraindication/intolerance to Berinert or Ruconest and to icatibant.
Prescriber specialty: immunologist or allergist.

Denial Risk

Denial risks: concurrent acute HAE therapy or plan exclusions

Requests may be denied if Ekterly is used in combination with other products indicated for acute HAE treatment or if plan-specific exclusions apply (Ekterly and brand Firazyr are typically excluded by some plans).

Do not prescribe in combination with Berinert, Firazyr, icatibant, Kalbitor, Ruconest, or Sajazir; concurrent use is a denial trigger.
Verify member's plan for exclusions — Ekterly and brand Firazyr may be excluded depending on plan specifics.

Genetic confirmationPresence of pathogenic variant(s) in one of the listed genes: factor XII, angiopoietin‑1, plasminogen‑1, kininogen‑1, myoferlin, or HS3ST6.

Clinical confirmation — family historyRecurrent angioedema attacks refractory to high‑dose antihistamines with a confirmed family history of angioedema.

Clinical confirmation — de‑novoRecurrent angioedema attacks refractory to high‑dose antihistamines with no family history (de‑novo mutation; HAEunknown).