CurrentCignaPolicy N/A

Dawnzera (donidalorsen) prior authorization for hereditary angioedema prophylaxis

Defines prior authorization requirements, coverage criteria, and documentation for Dawnzera (donidalorsen) as prophylaxis for hereditary angioedema (HAE) due to C1-INH deficiency for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDawnzera (donidalorsen) prior authorization for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeRevised diagnostic threshold wording

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionSubmit prior authorization with baseline documentation of functional C1‑INH and serum C4; approvals are provided for 1 year and require specialist prescription or consult.

SourceLink

POLICY UPDATE CHANGES

Changed the threshold wording for functional C1-INH protein levels from '(≤ 50% of normal)' to '(< 50% of normal)'.

≥12minimum patient age for approval

1 yearlength of approval

Not allowedconcomitant long-term prophylaxis

Requiredbaseline labs

Coverage Criteria for Dawnzera (donidalorsen)

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Initial and Continuation Therapy

Covered when ONE of the following is met for HAE due to C1-INH deficiency (approve Dawnzera for 1 year):

Overall: Either Initial therapy OR Currently receiving Dawnzera

Initial therapy: i. Patient is ≥ 12 years of age; AND ii. Patient has HAE type I or type II as confirmed by diagnostic criteria; AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Diagnostic criteria require BOTH: a) functional C1-INH protein < 50% of normal at baseline (per laboratory reference values) and b) lower-than-normal serum C4 at baseline (per laboratory reference values); documentation required.

Currently receiving Dawnzera (continuation): i. Patient has a diagnosis of HAE type I or type II; 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, decreased severity, or decreased duration); AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

If patient is receiving Dawnzera but has not previously received approval through the Coverage Review Department, review under Initial therapy criteria; documentation required.

Concomitant long‑term prophylactic use of Dawnzera with other hereditary angioedema (HAE) prophylactic therapies is considered not medically necessary. The policy states that Dawnzera has not been studied in combination with other prophylactic therapies for HAE and that combination therapy for long‑term prophylactic use is not recommended. Short‑term or procedural prophylaxis and on‑demand treatment with other agents (for example, C1 esterase inhibitor products) are permitted, but concurrent long‑term prophylaxis with Dawnzera and other HAE prophylactic agents is excluded.

Use of Dawnzera for any indication other than its FDA‑approved prophylactic use for hereditary angioedema, or in combination with other long‑term HAE prophylactic therapies, is considered not medically necessary. The policy explicitly lists concomitant use with other HAE prophylactic therapies among non‑covered conditions and notes that Dawnzera has not been studied in combination with those therapies; examples of other prophylactic agents include garadacimab, C1‑INH products, berotralstat, and lanadelumab.

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Dawnzera (donidalorsen) under the prescription benefit. Approvals are provided for 1 year. Because of the specialized skills required for evaluation, diagnosis, and monitoring, Dawnzera must be prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of hereditary angioedema (HAE) or related disorders. A patient currently receiving Dawnzera who previously met initial therapy criteria through the Coverage Review Department needs only meet continuation therapy criteria. If prior approval was not previously obtained through the Coverage Review Department for a patient currently receiving Dawnzera, the patient must meet the initial therapy criteria to be approved.

Approval duration: 1 year
Prescriber requirement: allergist/immunologist or HAE specialist (prescribed by or in consultation with)

Documentation Required

Documentation is required as noted in the clinical criteria. Acceptable documentation includes, but is not limited to, chart notes, laboratory records, and prescription claims records. All documentation must include patient-specific identifying information. For initial therapy approval, baseline laboratory documentation must include C1-INH functional level and serum C4 level with values and reference ranges. Diagnostic documentation must demonstrate HAE type I or II (HAE with normal C1-INH does NOT satisfy criteria). For continuation therapy, documentation of a diagnosis of HAE type I or II and that the patient is currently receiving Dawnzera is required.

Required documents: chart notes, laboratory records, prescription claims records
Baseline labs required for initial therapy: C1-INH functional level (<50% of normal per lab reference) and serum C4 level (below lab reference) [documentation required]
All documentation must include patient-identifying information

Step Therapy

Step Therapy / Sequencing

There is no explicit step-therapy sequence mandating prior use of other long-term prophylactic HAE therapies before Dawnzera. However, prescribers must be a specialist and should consider guideline-recommended first-line therapies (e.g., plasma-derived C1-INH products, lanadelumab, berotralstat) when determining appropriate treatment. Concomitant long-term prophylactic use of Dawnzera with other HAE prophylactic therapies is not recommended and is considered not medically necessary.

No formal step-therapy requiring prior trial of specific agents
Prescriber should consider guideline-recommended first-line therapies (plasma-derived C1-INH, lanadelumab, berotralstat)
Concomitant long-term prophylactic use with other HAE prophylactics is not allowed (not medically necessary)

Denial Risk

Denial Triggers

Triggers for denial include failure to submit prior authorization, lack of required documentation (including baseline C1-INH functional level and serum C4), prescribing by a non-specialist without documented consultation, and concomitant long-term prophylactic use with other HAE prophylactic therapies.

Missing or incomplete prior authorization request
Absence of required laboratory documentation (C1-INH functional level and C4) or chart evidence of HAE type I/II
Prescriber is not an allergist/immunologist or HAE specialist and no consultation is documented
Concomitant long-term prophylactic therapy with other HAE prophylactic agents

OpenPayer

Dawnzera (donidalorsen) prior authorization for hereditary angioedema prophylaxis

Coverage Criteria for Dawnzera (donidalorsen)

Laboratory Thresholds and Coding Details

Provider Requirements, Prior Authorization, and Denial Triggers

Background on Dawnzera and Hereditary Angioedema

Definitions and Disease Types