CurrentCareSourcePolicy N/A

Hereditary Angioedema - Kalbitor Utilization Management Medical Policy

Defines prior authorization recommendations, diagnostic and prescriber criteria, dosing limits, continuation and exclusion conditions for medical-benefit coverage of Kalbitor for treatment of acute hereditary angioedema (HAE) due to C1-INH deficiency in patients ≥ 12 years.

Policy Summary

PayerCareSource

PolicyHereditary Angioedema - Kalbitor Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdded continuation allowancewording clarifications

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document baseline functional C1‑INH and serum C4 and ensure prescription by or in consultation with an allergist/immunologist or HAE specialist.

SourceLink

POLICY UPDATE CHANGES

Added that a person who previously met initial therapy criteria under the Coverage Review Department and has treated previous HAE attacks with Kalbitor is only required to meet continuation criteria.

Deleted '[Type I or Type II]' from the indication heading and added wording clarifications regarding diagnosis language (e.g., added 'type' before II).

1Covered Indication (acute HAE attacks due to C1-INH deficiency)

1 yearTypical approval duration

≥12Minimum patient age per indication

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Coverage Summary

Scope: Prior authorization is recommended for Kalbitor (ecallantide) for the treatment of acute hereditary angioedema (HAE) attacks due to C1‑INH deficiency in patients aged ≥12 years. Coverage is covered_with_criteria. Typical approvals are provided for 1 year when criteria are met. Dosing is limited to a maximum of 30 mg per injection administered subcutaneously, no more frequently than twice daily.

Initial Therapy Criteria and Continuation Criteria

Dosing Limits

ALL of the following

Maximum dose of 30 mg per injection administered subcutaneously no more frequently than twice daily30 mg per injection; ≤2 times/day

Exclusions / Not Recommended

Provider Actions / Administrative Requirements

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical-benefit coverage of Kalbitor. Approvals are provided for the duration noted (1 year). Extended approvals are allowed if the patient continues to meet the Criteria and Dosing (continuation criteria).

Documentation Required

Diagnostic documentation required

Documentation of baseline laboratory results is required for initial therapy: functional C1‑INH protein level and serum C4 at baseline per laboratory reference values. Chart notes, laboratory records, and prescription claims records may be requested as supporting documentation.

Documentation Required

Prescriber specialty requirement

The medication must be prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.

Applicable Codes

NDC / HCPCS / CPT codesmixed

No codes listed

Clinical Evidence and Guidelines

Evidence references: Takeda Kalbitor prescribing information (December 2023); US HAEA Medical Advisory Board Guidelines, 2020 (J Allergy Clin Immunol Pract 2021); WAO/EAACI HAE guideline update 2021 (Allergy 2022). These sources support the indication and guideline recommendations cited in this policy.

Safety note: Serious hypersensitivity reactions, including anaphylaxis, have occurred with Kalbitor; it should only be administered by healthcare professionals able to manage anaphylaxis. Guidelines recommend on‑demand treatment of all HAE attacks and that patients have access to at least two doses of on‑demand medication.

Background & Definitions

Background summary: Kalbitor (ecallantide) is a plasma kallikrein inhibitor indicated for treatment of acute HAE attacks in patients ≥12 years. Serious hypersensitivity reactions including anaphylaxis have been reported; administration should be by healthcare professionals with the ability to manage anaphylaxis. Per the policy scope, prior authorization is recommended with diagnostic, prescriber, and dosing criteria, typical approvals of 1 year, and dosing limited to 30 mg per injection subcutaneously, no more frequently than twice daily.

Term	Definition
HAE type I/II	Hereditary angioedema due to C1-INH deficiency; type I/II differentiated by antigenic and functional C1-INH levels.
Favorable clinical response	Decrease in duration of HAE attacks, quick onset of symptom relief, complete resolution of symptoms, or decrease in attack frequency or severity.

Revision History

10/09/2024material_changeLatest

Policy Statement updated to allow a patient who previously met initial therapy criteria under the Coverage Review Department and has treated prior HAE attacks with Kalbitor to meet only continuation criteria; if past criteria were not met under the Coverage Review Department and the patient has treated previous HAE attacks with Kalbitor, initial therapy criteria must be met.

09/20/2023clarification

Wording and diagnostic clarifications made: deleted '[Type I or Type II]' from the indication heading and added wording edits including adding the word 'type' before II when referring to diagnosis of HAE types; note added under continuation criteria that patients previously approved through another entity must meet initial therapy criteria through the Coverage Review Department.