CurrentCignaPolicy CNF790

Hereditary Angioedema – Kalbitor Drug Quantity Management Policy – Per Days - (CNF790)

Policy Summary

PayerCigna

PolicyHereditary Angioedema – Kalbitor Drug Quantity Management Policy – Per Days - (CNF790)

Policy CodePolicy CNF790

Change TypeQuantity limit override increased (revised)

Effective Date

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, approve a one-time override up to 12 additional vials when the patient requires additional doses for a subsequent HAE attack, with approval quantity calculated per channel and limited to once every 30 days.

SourceLink

POLICY UPDATE CHANGES

Override was updated to approve a one-time override for 12 additional vials if additional doses are required for a subsequent attack; previously criteria approved 6 additional vials.

Policy statement updated to note that 'one-time' approvals are provided for 30 days in duration.

Annual revisions with review dates 02/09/2024 and 02/19/2025 indicated; 02/02/2026 is the latest review date with no criteria changes noted.

12Max additional vials per override

12Retail max per 28 days

Home delivery max per 84 days

30 daysOverride frequency (once every)

Coverage Summary

Defines retail and home-delivery quantity limits and exception/override criteria for Kalbitor (ecallantide) for treatment of acute hereditary angioedema (HAE) attacks in patients ≥12 years. Kalbitor is indicated for the treatment of acute HAE attacks in patients ≥12 years. Standard quantity limits are set per dispensing channel and timeframe to manage use of the product, and exceptions are available when criteria are met.

Quantity limits and override thresholds

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

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

One-time override maximum additional quantity12 single-use vials (4 cartons)

Max additional vials per override12 vials

One-time approval duration / Override frequencyOne override may be approved once every 30 days (one-time approvals provided for 30 days)

Drug Quantity Limits — Standard

Drug Quantity Limits - Standard

Drug quantity limits applied per dispensing channel and timeframe:

ALL of the following

Package size = 3 single-use vials (10 mg/mL each) per carton.
Retail maximum: Retail Maximum Quantity per 28 Days = 4 cartons (12 single-use vials).
Home delivery maximum: Home Delivery Maximum Quantity per 84 Days = 12 cartons (36 single-use vials).
Quantity sufficiency statement: Quantity is sufficient to treat two acute HAE attacks in each 28-day period, assuming two doses in a 24-hour period to treat each attack.

Exceptions — One-time override for additional doses

Exceptions / One-time override for additional doses

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

ALL of the following

One-time override for additional doses: If the patient requires additional doses of Kalbitor to treat a subsequent attack of hereditary angioedema, approve a one-time override for the requested quantity, not to exceed 12 additional single-use vials (4 cartons of 3 vials each) at retail or home delivery.
Approval quantity calculation (choose based on channel)
- Retail calculation: At retail: approval quantity = number of vials the patient has received in the past 28 days plus 12 vials.

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Quantity limit enforcement and override

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria. Approve a one-time override of up to 12 additional single-use vials when the patient requires additional doses to treat a subsequent HAE attack. The override is limited to one approval once every 30 days. Calculate the approval quantity based on the dispensing channel (see channel-specific calculation).

One-time override maximum: up to 12 additional single-use vials (4 cartons).
Override frequency: ONE override may be approved ONCE every 30 days.
Channel-based calculation required (see billing_rule callout).

Billing Rule

Use appropriate dispensing channel calculation

Applicable Codes

NDC / product identifiersNDC

No codes listed

Clinical Evidence & Guidance

US HAE Medical Advisory Board guidelines (2020) recommend that all patients with laboratory confirmed HAE should have access to at least two standard doses of an approved on-demand medication for treatment of acute attacks.

Kalbitor prescribing information (Takeda, Dec 2020) states Kalbitor is indicated for the treatment of acute HAE attacks in patients ≥12 years.

The prescribing information recommends a dose of 30 mg SC administered as three 10 mg injections, with an additional 30 mg that may be given within 24 hours if the attack persists.

Background

Indication: Kalbitor is indicated for the treatment of acute HAE attacks in patients ≥ 12 years.

Recommended dosing: 30 mg SC administered as three 10 mg injections; if the attack persists, an additional 30 mg may be given within 24 hours.

Policy intent: This Drug Quantity Management program implements quantity management to promote the safe, effective, and economic use of Kalbitor, with specified retail and home-delivery limits and defined one-time override criteria.

Revision History

02/09/2024annual_review

Policy statement updated to note that 'one-time' approvals are provided for 30 days in duration.

02/19/2025annual_review

Annual revision noted; no criteria changes.

02/02/2026annual_reviewLatest

Latest annual review date recorded; no criteria changes noted.

Policy Summary

PayerCigna

PolicyHereditary Angioedema – Kalbitor Drug Quantity Management Policy – Per Days - (CNF790)

Policy CodePolicy CNF790

Change TypeQuantity limit override increased (revised)

Effective Date

Next Review Date

SourceLink

On This Page

Home delivery calculation:

At home delivery: approval quantity = number of vials the patient has received in the past 84 days plus 12 vials.

Override frequency: ONE override may be approved ONCE every 30 days.

Operational definitions

CartonPackage containing three single-use vials (each vial 10 mg ecallantide).

One-time overrideA single approval to exceed standard quantity limits for additional doses needed for a subsequent HAE attack, limited to up to 12 additional single-use vials and may be approved once every 30 days.

When approving an override, use the dispensing channel to calculate the approval quantity. At retail: approval quantity = the number of vials the patient has received in the past 28 days plus 12 vials. At home delivery: approval quantity = the number of vials the patient has received in the past 84 days plus 12 vials.

Retail calculation: vials received in past 28 days + 12.
Home delivery calculation: vials received in past 84 days + 12.

Documentation Required

Medical necessity for exceptions

To support a one-time override, document that the additional doses are required to treat a subsequent hereditary angioedema attack. Exceptions that do not meet this criterion are considered not medically necessary and should not be approved.

Document clinical need showing additional doses are for a subsequent HAE attack.
Other exception requests are considered not medically necessary.

02/09/2024material_change

Override updated to approve a one-time override for up to 12 additional single-use vials (4 cartons) when additional Kalbitor doses are required for a subsequent HAE attack (previously allowed 6 vials); approval quantity calculations clarified by dispensing channel and limited to one override per 30 days.