CurrentCignaPolicy N/A

Hereditary Angioedema - Ekterly Drug Quantity Management Policy

Defines quantity limits, override rules, and coverage criteria for Ekterly (sebetralstat) used to treat acute hereditary angioedema attacks for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Ekterly Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review DateJul 16, 2025

Key ActionEnsure requests document covered diagnosis and prior dispensing when seeking a one-time 16-tablet override for additional HAE attack treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16Retail max (28d)

48Home delivery max (84d)

600 mgRecommended dose

1200 mg24h max

+16Override allowance

Coverage and Quantity Limits

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Ekterly quantity limits and one-time override

Covered when ALL of the following are met

Quantity limit adherence: Requested quantity does not exceed retail maximum of 16 tablets per 28 days or home delivery maximum of 48 tablets per 84 daysretail <= 16 tablets/28 days; home delivery <= 48 tablets/84 days

These are the default covered quantities; see override criteria for additional tablets.

One-time override for additional attack treatment: If the patient requires additional doses to treat a subsequent HAE attack, approve a one-time override for 16 additional tablets+16 tablets; ONE override may be approved ONCE every 30 days

At retail, approval = number of Ekterly tablets received in past 28 days plus 16; at home delivery, approval = number received in past 84 days plus 16.

Ekterly (sebetralstat) is subject to drug quantity limits: retail maximum = 16 tablets per 28 days and home delivery maximum = 48 tablets per 84 days. A one-time override of 16 additional tablets may be approved when the patient requires additional doses to treat a subsequent hereditary angioedema (HAE) attack; at retail the approval total equals the number of tablets dispensed in the prior 28 days plus 16, and for home delivery the approval total equals the number dispensed in the prior 84 days plus 16. The one-time override may be approved only once every 30 days.

Exceptions to the listed quantity limits that do not meet the specified one-time override criteria are considered not medically necessary and will not be approved.

Provider Actions, Billing, and Point-of-Service Rules

Documentation Required

Coding and documentation expectations

Providers must submit prior authorization or coverage requests with the appropriate diagnosis and procedure/drug codes and supporting clinical documentation to facilitate review. Requests should include the covered diagnosis code(s) that justify use of Ekterly and any relevant clinical notes, treatment history, dosing records, and frequency of attacks when applicable. Use the most appropriate and current codes as of the date of submission; claims submitted without covered code(s) under the applicable benefit plan will be denied as not covered.

Include diagnosis and procedure/NDC codes that support the requested service or drug.
Attach clinical documentation: history of hereditary angioedema (HAE), prior treatments, dosing and refill history, and rationale for exceeding quantity limits when applicable.
Use current coding as of the submission date; claims lacking covered codes will be denied.

Prior Authorization

Quantity limits and one-time override — retail and home delivery summary

Ekterly has Drug Quantity Management limits: retail maximum 16 tablets per 28 days and home delivery maximum 48 tablets per 84 days. A one-time override may be approved for 16 additional tablets when treating a subsequent HAE attack. At retail, set the approval quantity equal to the number of Ekterly tablets the patient received in the past 28 days plus 16 tablets; at home delivery, set approval to the number received in the past 84 days plus 16 tablets. ONE override may be approved ONCE every 30 days. One-time approvals are for 30 days in duration. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria in the policy.

Retail maximum: 16 tablets per 28 days.
Home delivery maximum: 48 tablets per 84 days.
One-time override: +16 tablets (retail or home delivery) for a subsequent HAE attack; approval quantity = prior-period dispensed tablets +16.
One-time override can be granted once every 30 days; approvals are 30 days in duration.

Denial Risk

Point-of-service quantity rule and potential denial

Coverage at point-of-service follows the Drug Quantity Management rule; if the requested quantity exceeds the rule and no criteria-based approval exists, the claim or request may be denied. When the Drug Quantity Management rule is not met at POS, adjudication will follow the policy criteria (including allowance of a one-time override where applicable).

If POS quantity limits are exceeded and criteria are not met, coverage may be denied.
Adjudication will use the policy criteria and any applicable one-time override rules.

Step Therapy

Step therapy

Step therapy is not applicable for this policy; quantity management rules are used instead to manage Ekterly utilization.

No step-therapy requirements; use Drug Quantity Management and one-time override criteria.

Drug and Dose Definitions

inv-09: Ekterly — definition / mechanism and indication (plasma kallikrein inhibitor for acute HAE attacks ≥12 yrs)

Mechanism / drug classPlasma kallikrein inhibitor.

IndicationTreatment of acute hereditary angioedema (HAE) attacks in patients ≥ 12 years of age.

Recommended single dose600 mg (two 300 mg tablets) at earliest recognition of an acute HAE attack.

Repeat dosing and timingA second 600 mg dose may be taken at least 3 hours after the first dose if response is inadequate or symptoms worsen or recur.

Maximum 24-hour doseMaximum recommended dosage is 1,200 mg (four 300 mg tablets) in any 24‑hour period.

inv-10: Dose packet — Ekterly supplied as 300 mg tablets in packets of 4 tablets

Tablet strength and packagingSupplied as 300 mg tablets in packets containing 4 tablets each.

Packet tablet countEach packet contains 4 tablets (total 1,200 mg per packet).

Dose equivalenceTwo 300 mg tablets = recommended 600 mg single dose; four 300 mg tablets = 1,200 mg maximum per 24 hours.

OpenPayer

Hereditary Angioedema - Ekterly Drug Quantity Management Policy

Coverage and Quantity Limits

Provider Actions, Billing, and Point-of-Service Rules

Background and Clinical Context

Drug and Dose Definitions