CurrentCignaPolicy N/A

Hereditary Angioedema - Ekterly Drug Quantity Management Policy - Per Days

Defines quantity limits, overrides, and criteria for coverage of Ekterly (sebetralstat 300 mg tablets) for treatment of acute hereditary angioedema (HAE) attacks in patients ≥12 years, including retail and home delivery maximums and one-time override rules.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Ekterly Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date07/16/2025

Key ActionApprove a one-time override for 16 additional tablets at retail or home delivery when the patient requires additional doses to treat a subsequent HAE attack; one override may be approved once every 30 days.

POLICY UPDATE CHANGES

New policy created for Ekterly drug quantity management with review date 07/16/2025.

16Retail max per 28 days

48Home delivery max per 84 days

16Override quantity

1Override frequency (per 30 days)

Coverage Summary

Ekterly (sebetralstat 300 mg tablets) quantity is managed for treatment of acute hereditary angioedema (HAE) attacks in patients aged ≥12 years. Retail and home delivery maximums are specified (Retail: 16 tablets per 28 days; Home delivery: 48 tablets per 84 days), and one-time overrides are available per policy when criteria are met.

Quantity Limit Exceptions / Overrides (Medically Necessary)

Exceptions to the quantity limits listed above are covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

Additional doses for subsequent HAE attack: Patient requires additional doses of Ekterly to treat a subsequent attack of hereditary angioedema (HAE).
If met, approve a one-time override for 16 additional tablets at retail or home delivery.
Retail approval quantity calculation: At retail, approval quantity = number of Ekterly tablets the patient has received in the past 28 days plus 16 tablets.
ONE override may be approved ONCE every 30 days.
Home delivery approval quantity calculation: At home delivery, approval quantity = number of Ekterly tablets the patient has received in the past 84 days plus 16 tablets.
ONE override may be approved ONCE every 30 days.

Prior Authorization

Quantity override / one-time approval

Approve a one-time override for 16 additional tablets at retail or home delivery when the patient requires additional doses to treat a subsequent HAE attack; one override may be approved once every 30 days.

Retail: approval quantity = number of Ekterly tablets the patient has received in the past 28 days plus 16 tablets.
Home delivery: approval quantity = number of Ekterly tablets the patient has received in the past 84 days plus 16 tablets.

Drug Quantity Management Rule / Point-of-Service Determination

If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the Criteria below. 'One-time' approvals are provided for 30 days in duration.

Point-of-service determination: Coverage determined by criteria when quantity management rule is not met at point of service.
One-time approval duration: One-time approvals are provided for 30 days.

Billing Rule

Supply calculation for dispensing

Retail maximum supply per 28 days is 16 tablets; home delivery maximum supply per 84 days is 48 tablets.

One-time overrides modify the approved quantity based on the number of tablets the patient previously received (retail: past 28 days; home delivery: past 84 days) plus 16 tablets.

Provider Actions & Documentation Requirements

Documentation Required

Indication required

Requests should indicate that Ekterly is for treatment of acute HAE attacks in patients ≥12 years of age; documentation of need for additional doses for a subsequent attack is required for overrides.

Indicate the patient is being treated for acute hereditary angioedema (HAE) and is ≥12 years of age.
Provide documentation supporting the need for additional Ekterly doses for a subsequent attack when requesting a one-time override.

Prior Authorization

Quantity override / one-time approval

One-time override of 16 tablets may be approved; frequency limit is one override once every 30 days. Retail and home delivery approval quantities are calculated by adding 16 tablets to the number of tablets the patient received in the prior 28 days (retail) or 84 days (home delivery).

Retail calculation: past 28 days received + 16 tablets.
Home delivery calculation: past 84 days received + 16 tablets.
Overrides are limited to one approval every 30 days.

Background

Ekterly is indicated for treatment of acute HAE attacks in patients ≥12 years of age. The recommended dosing is 600 mg (two 300 mg tablets) at attack onset, with an optional second 600 mg dose at least 3 hours later if needed; the maximum recommended dose is 1,200 mg (four 300 mg tablets) in any 24‑hour period. Ekterly is supplied as 300 mg tablets in packets of 4 tablets.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Ekterly Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date07/16/2025

On This Page

OpenPayer

Hereditary Angioedema - Ekterly Drug Quantity Management Policy - Per Days

Coverage Summary

Quantity Limit Exceptions / Overrides (Medically Necessary)

Drug Quantity Management Rule / Point-of-Service Determination

Provider Actions & Documentation Requirements

Applicable Product / Codes

Clinical Evidence & Guidance

Background

Definitions

Revision History