CurrentCignaPolicy N/A

Hereditary Angioedema - Kalbitor Drug Quantity Management Policy - Per Days

Defines quantity limits and override criteria for Kalbitor (ecallantide SC) for treatment of acute hereditary angioedema attacks for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Kalbitor Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeRevised — material change

Effective Date

Next Review DateFeb 19, 2025

Key ActionApprove a one-time override of up to 12 additional single-use vials (one-time approval) when the patient requires additional doses to treat a subsequent HAE attack and criteria are met.

SourceLink

POLICY UPDATE CHANGES

Override quantity for additional doses was updated from 6 additional vials to 12 additional vials for treatment of a subsequent HAE attack.

One-time approvals are provided for 30 days in duration.

12Retail max (vials/28d)

36Home delivery max (vials/84d)

12One-time override (additional vials)

30dOne-time approval duration

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One-time override for subsequent attack

Approve a one-time override when ALL of the following are met:

Override for additional doses: Patient requires additional doses of Kalbitor to treat a subsequent attack of hereditary angioedemanot to exceed 12 additional single-use vials (4 cartons)

One override may be approved once every 30 days; approval quantity calculation differs by distribution channel (retail vs home delivery).

Approval quantity calculation

Approval quantity must be calculated as follows depending on distribution channel:

Retail calculation: Approval quantity = number of vials of Kalbitor the patient has received in the past 28 days + 12 vialsnot to exceed retail maximum when applicable (4 cartons / 12 vials per 28 days)

Home delivery calculation: Approval quantity = number of vials of Kalbitor the patient has received in the past 84 days + 12 vialsnot to exceed home delivery maximum when applicable (12 cartons / 36 vials per 84 days)

Any exception requests that fall outside the specified one-time override criteria and the required approval quantity calculations are considered not medically necessary. The policy limits exceptions to the criteria described for additional doses used to treat a subsequent hereditary angioedema attack; requests that do not meet those conditions should be denied.

Requests that would exceed the Drug Quantity Limits are considered not medically necessary unless they meet the specified one-time override criteria. The Drug Quantity Limits are enforced (retail maximum of 4 cartons / 12 single-use vials per 28 days; home delivery maximum of 12 cartons / 36 single-use vials per 84 days), and only a single one-time override meeting the criteria is allowed to exceed these limits.

Product Packaging and Quantity Limits (Coding)

Product packagingNDC

NDC not listed

Document lists product packaging (three 10 mg/mL single-use vials per carton) but no NDC provided in policy text.

inv-06: Retail maximum per 28 days

Retail maximum per 28 days4 cartons (12 single-use vials)

Per-noteQuantity sufficient to treat two acute HAE attacks in each 28-day period (assumes up to two doses within 24 hours per attack)

Override considerationOne-time override may add up to 12 additional single-use vials per criteria when applicable

inv-07: Home delivery maximum per 84 days

Home delivery maximum per 84 days12 cartons (36 single-use vials)

Per-noteThis equals 36 single-use vials (3 vials per carton)

Override considerationOne-time override may add up to 12 additional single-use vials per criteria when applicable

Provider Actions, Documentation, and Enforcement

Billing Rule

Quantity limit enforcement and override

Quantity limits apply as follows: Retail maximum = 4 cartons per 28 days (each carton contains three 10 mg single‑use vials; total 12 vials). Home delivery maximum = 12 cartons per 84 days (36 vials). These limits represent a quantity sufficient to treat two acute HAE attacks in each 28‑day period, assuming up to two doses per attack within 24 hours.

Retail Maximum: 4 cartons per 28 days (12 single‑use vials).
Home Delivery Maximum: 12 cartons per 84 days (36 single‑use vials).

Denial Risk

Quantity limit exceedance

Requests that exceed the Drug Quantity Limits and do not meet the one‑time override criteria will be considered not medically necessary and may be denied. Providers should ensure documentation supports medical necessity for amounts beyond the established limits before submitting a request.

Documentation Required

Dosing and administration documentation

Dosing must follow the product labeling: the recommended dose of Kalbitor is 30 mg administered subcutaneously as three separate 10 mg injections (3 mL total). If the attack persists, an additional 30 mg dose may be given within 24 hours. Kalbitor is supplied as cartons containing three 10 mg/mL single‑use vials (one vial per 10 mg injection). Providers must document administered doses, date/time of each injection, and any administration‑related adverse reactions.

Recommended dose: 30 mg SC as three 10 mg injections.
Additional dose: one additional 30 mg dose may be given within 24 hours if attack persists.
Product supply: cartons contain three 10 mg/mL single‑use vials.

Prior Authorization

Quantity limit enforcement and one‑time override criteria

One‑time overrides: If a patient requires additional doses to treat a subsequent HAE attack, a one‑time override may be approved for up to 12 additional single‑use vials (equivalent to 4 cartons) at retail or home delivery. Calculate approval quantity as: at retail, the number of vials received in the past 28 days plus 12 vials; at home delivery, the number of vials received in the past 84 days plus 12 vials. Only one override may be approved once every 30 days. Approvals provided under this criteria are time‑limited as specified.

One‑time override limit: up to 12 additional single‑use vials (4 cartons).
Retail calculation: prior 28‑day vials + 12 vials.
Home delivery calculation: prior 84‑day vials + 12 vials.
Frequency: ONE override may be approved ONCE every 30 days.

Background

Kalbitor (ecallantide) is a plasma kallikrein inhibitor indicated for the treatment of acute hereditary angioedema (HAE) attacks in patients aged ≥ 12 years. The recommended dose is 30 mg administered subcutaneously as three 10 mg injections; if the attack persists, an additional 30 mg may be given within 24 hours. The product is supplied as cartons containing three 10 mg single-use vials and carries a risk of serious hypersensitivity reactions, including anaphylaxis, so administration should occur where appropriate medical support is available to manage these reactions.

Quantity Limits

inv-14: Kalbitor (ecallantide SC injection)

Quantity limit (retail)4 cartons (12 single-use vials)

Package sizeEach carton contains three 10 mg single-use vials

DrugKalbitor (ecallantide SC injection)

inv-15: Kalbitor (ecallantide SC injection)

Quantity limit (home delivery)12 cartons (36 single-use vials)

Package sizeEach carton contains three 10 mg single-use vials

DrugKalbitor (ecallantide SC injection)

inv-16: Kalbitor (ecallantide SC injection)

One-time override maximumUp to 12 additional single-use vials (4 cartons of 3 vials each)

Frequency/durationOne override may be approved once every 30 days; one-time approvals are provided for 30 days in duration

Application by channelAt retail, approval = vials received in past 28 days + 12 vials; at home delivery, approval = vials received in past 84 days + 12 vials