Currentmedical mutual - ohioPolicy N/A

Dawnzera (donidalorsen) — prophylaxis of hereditary angioedema (HAE)

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.

Policy Summary

Payermedical mutual - ohio

PolicyDawnzera (donidalorsen) — prophylaxis of hereditary angioedema (HAE)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateNov 20, 2025

Next Review DateMar 19, 2026

Key ActionSubmit prior authorization with documentation of diagnosis, baseline C1‑INH function and serum C4, prior prophylactic therapies tried, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12min age

80 mgdose

1 yrapproval duration

J3490/J3590/J9999medical benefit codes

Coverage criteria for Dawnzera (donidalorsen)

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HAE Prophylaxis — Initial and Continuation Therapy

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

A or B: A) Initial therapy OR B) Currently receiving Dawnzera

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.

Coding and clinical thresholds

Prior-authorization required HCPCS codes when Dawnzera is billed under medical benefitHCPCSCovered

J3490	Unclassified drugs
J3590	Unclassified biologics
J9999	Unclassified antineoplastics

C1‑INH functional level — threshold value for diagnosis

Threshold for functional C1-INH< 50% of normal (functional C1-INH protein at baseline)

ContextRequired as part of diagnostic confirmation for HAE type I or II when seeking Dawnzera for prophylaxis

Laboratory referenceMeasured against laboratory reference values at baseline as specified by the testing laboratory

Age relevanceApplied when patient is ≥ 12 years of age per initial therapy criteria

Role in prior authorizationDocumentation of baseline C1-INH functional level is required for approval of initial therapy

Provider requirements, prior authorization, and documentation

Prior Authorization

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.

Applies when Dawnzera is billed under the medical benefit
HCPCS codes: J3490, J3590, J9999
Nurse reviewer may authorize if submitted documentation meets policy; otherwise forwarded to physician reviewer

Step Therapy

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

Documentation Required

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 Risk

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.

Claims with HCPCS J3490, J3590, J9999 will pend with remark codes and may be denied
A participating provider may be required to write off charges denied as not medically necessary
Additional documentation must be made available upon request to avoid denial

Definitions and diagnostic thresholds

HAE type I or II — diagnostic definition

Diagnostic definition for HAE type I or IIHereditary angioedema due to C1‑INH deficiency confirmed by low functional C1‑INH protein (<50% of normal) at baseline AND low serum C4 levels at baseline.

ExclusionHAE with normal C1‑INH (also known as HAE type III) does NOT satisfy this requirement.

Age requirementApplies for patients aged ≥ 12 years when used for initial therapy of HAE prophylaxis.

Documentation neededBaseline laboratory results (functional C1‑INH and serum C4) must be provided to support diagnosis for prior authorization.

Use in continuationFor patients currently receiving Dawnzera, a confirmed diagnosis of HAE type I or II is required for continuation approval.