Dawnzera (donidalorsen) — prophylaxis of hereditary angioedema (HAE)
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This policy governs prior-authorization, coverage criteria, dosing, and administrative requirements for Dawnzera (donidalorsen) used as prophylaxis of hereditary angioedema (HAE) for patients age ≥12, for Medical Mutual - Ohio members when billed under the medical or pharmacy benefit.
No material clinical or coverage changes in this revision.
Coverage criteria for Dawnzera (donidalorsen)
HAE Prophylaxis — Initial and Continuation Therapy
Approve Dawnzera for 1 year if the patient meets ONE of the following (A or B):
A) Initial therapy
- i-ii diagnostic and age: i. Patient is ≥ 12 years of age; AND ii. Patient has HAE type I or II confirmed by: a) low functional C1-INH (< 50% of normal) at baseline; AND b) low serum C4 at baseline
HAE with normal C1-INH (type III) does NOT satisfy this requirement.
- iii prescriber: iii. Medication prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders
Initial approval requires prescription by or consultation with a specialist.
- iv prior therapies: iv. Patient has tried two other therapies for prophylaxis of HAE (examples: Andembry, Cinryze, Haegarda, Oladeyo, Takhzyro)
B) Patient currently receiving Dawnzera
- i diagnosis: i. Patient has diagnosis of HAE type I or II (HAE type III does NOT satisfy)
- ii response: ii. According to the prescriber, the patient has had a favorable clinical response since initiating Dawnzera prophylactic therapy (e.g., decreased attack frequency, severity, or duration)
- iii prescriber: iii. Medication 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 currently receiving therapy but has not previously received approval, review under Initial Therapy criteria.
The policy advises against concomitant long-term use of Dawnzera with other hereditary angioedema (HAE) prophylactic therapies because combination long-term prophylactic therapy has not been studied and therefore is not recommended. Short-term or procedural prophylaxis and on-demand treatments for acute HAE attacks (for example, intravenous C1 esterase inhibitor) remain acceptable as clinically indicated.
Use of Dawnzera for indications not listed in the policy’s Recommended Authorization Criteria is not recommended and may be considered not medically necessary. Coverage decisions are limited to the circumstances described in the criteria and will be updated only as new published data become available.
Coding and clinical thresholds
Provider requirements, prior authorization, and documentation
Prior authorization required for medical benefit
Prior authorization is required when Dawnzera is billed under the medical benefit using unclassified drug/biologic/antineoplastic HCPCS codes J3490, J3590, or J9999; requests meeting policy criteria may be authorized by a nurse reviewer, otherwise routed to a physician reviewer.
Prior trials required before initial therapy
Initial therapy approval requires documented prior trials of two other therapies for HAE prophylaxis (examples provided in the policy include Andembry, Cinryze, Haegarda, Oladeyo, and Takhzyro).
- Two prior prophylactic therapies must have been tried before initiating Dawnzera
- Examples listed: Andembry, Cinryze, Haegarda, Oladeyo, Takhzyro
- Requirement does not apply if patient is currently receiving Dawnzera
Required documentation to support medical necessity
Providers must provide documentation supporting the diagnosis and baseline laboratory values, records of prior therapies tried, and evidence of clinical response for renewals; the Company may request patient records, test results, and provider credentials.
- Diagnosis documentation: confirmation of HAE type I or II with baseline C1‑INH functional level and baseline serum C4
- Record of prior prophylactic therapies tried (for initial therapy)
- For continuation, documentation of favorable clinical response since initiating Dawnzera
Denial risks for lack of medical necessity or documentation
The Company may deny reimbursement or require write-off if the drug or services are determined not medically necessary, investigational/experimental, not within benefit scope, or if requested documentation is not provided; claims with HCPCS J3490, J3590, J9999 will pend and may be denied as not medically necessary.
Background on Dawnzera (donidalorsen)
Dawnzera (donidalorsen) is a prekallikrein‑directed antisense oligonucleotide indicated for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 12 years and older. It is intended for long‑term prophylaxis to reduce the frequency, severity, or duration of HAE attacks and should be prescribed or managed by a clinician experienced in HAE care.
Definitions and diagnostic thresholds
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