CurrentCignaPolicy IP0761

Hereditary Angioedema - Dawnzera

Defines Cigna's coverage and prior authorization requirements for Dawnzera subcutaneous injection for prevention of hereditary angioedema (HAE) attacks in patients aged ≥12, including initial and continuation criteria and employer-plan specific preferred product requirements.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Dawnzera

Policy CodePolicy IP0761

Change TypeNew policy — material changes

Effective Dateas written

Next Review Date

Key ActionObtain prior authorization and document baseline C1‑INH functional level and serum C4 to support approval.

SourceLink

POLICY UPDATE CHANGES

Employer Plans preferred product requirements were added.

≥12minimum patient age for covered indication

80 mgapproved dosing per administration

q4wmaximum dosing frequency

1 yrinitial approval duration

IP0761coverage policy identifier

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Coverage Criteria for Dawnzera (donidalorsen)

FDA-Approved Indication

Approve Dawnzera for 1 year if the patient meets ONE of the following (A or B):

Main pathways: Either A) Initial therapy OR B) Currently receiving Dawnzera

A) Initial therapy: i. Patient is ≥ 12 years of age; AND ii. Patient has HAE type I or type II as confirmed by both: (a) functional C1-INH < 50% of normal at baseline [documentation required]; AND (b) lower than normal serum C4 at baseline [documentation required]; AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in HAE or related disorders; AND iv. Preferred product criteria for the product(s) as listed are met.

A diagnosis of HAE with normal C1-INH (HAE type III) does NOT satisfy this requirement.

B) Currently receiving Dawnzera: i. Patient has a diagnosis of HAE type I or type II [documentation required]; AND ii. According to the prescriber, the patient has had a favorable clinical response since initiating Dawnzera prophylactic therapy compared with baseline (examples: decreased attack frequency, severity, or duration); AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in HAE or related disorders.

If patient is currently receiving Dawnzera but has not previously received approval through the Coverage Review Department, review under Initial Therapy criteria.

Employer Plans

Employer Plans additional criteria

Employer Plans criteria: Either 1) Patient has tried BOTH Haegarda AND Takhzyro (both require prior authorization) OR 2) Patient is currently receiving Dawnzera.

Applies to Employer Plans as specified.

Concomitant long-term use of Dawnzera with other hereditary angioedema (HAE) prophylactic therapies is not recommended and is considered not medically necessary. The available data do not support combination therapy for ongoing prophylaxis; short-term (procedural) prophylaxis or use of other agents for on-demand treatment of acute HAE attacks is allowable as clinically indicated.

Dawnzera has not been studied in combination with other HAE prophylactic therapies, and therefore long-term combination use or use for indications other than HAE prophylaxis is considered not medically necessary. Examples of other HAE prophylactic therapies include Andembry, Cinryze, Haegarda, Orladeyo, and Takhzyro.

Coding and Laboratory Criteria

Considered Medically Necessary HCPCSHCPCSCovered

J3490

Unclassified Drugs

inv-06: C1-INH functional level

Laboratory thresholdFunctional C1-INH protein < 50% of normal at baseline as defined by laboratory reference values (documentation required)

PurposeRequired to confirm HAE type I or II for initial therapy eligibility

DocumentationBaseline laboratory report of C1-INH functional level must be submitted with prior authorization

inv-07: Serum C4 level

Laboratory thresholdSerum C4 level lower than normal at baseline as defined by laboratory reference values (documentation required)

Role in diagnosisMeasured together with C1-INH antigenic or functional level; low C4 plus low C1-INH supports HAE type I/II diagnosis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Dawnzera. Approval is recommended for patients who meet the policy's Criteria and Dosing for the listed indication. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing documented in this policy will be considered on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation and monitoring, Dawnzera must be prescribed by or in consultation with a physician who specializes in the condition being treated. A patient who previously met initial therapy criteria under the Coverage Review Department and is currently receiving Dawnzera only needs to meet continuation therapy criteria (i.e., currently receiving Dawnzera). If past criteria have not been met under the Coverage Review Department and the patient is currently receiving Dawnzera, initial therapy criteria must be met.

Prior authorization required for Dawnzera (donidalorsen)
Approvals recommended when patient meets policy Criteria and Dosing; extended approvals allowed if criteria continue to be met
Doses outside policy dosing considered case‑by‑case by clinician
Prescriber requirement: prescribed by or in consultation with a specialist in the condition being treated
Continuation vs initial therapy note: current recipients who previously met initial criteria need only meet continuation criteria; if initial criteria were not previously met, initial criteria apply

Definitions

inv-13: HAE type I/II — Definition

DefinitionHereditary angioedema due to C1-INH deficiency diagnosed by low C4 and low or dysfunctional C1-INH (functional C1-INH <50% of normal)

ExcludesHAE with normal C1-INH (HAE type III) does NOT satisfy this definition for coverage

Diagnostic testing recommendedMeasure serum C4, C1-INH antigenic level, and C1-INH functional level when HAE is suspected

Background

Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent hereditary angioedema (HAE) attacks in patients aged 12 years and older.