Dawnzera (donidalorsen) coverage and prior authorization
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Governs prior authorization, coverage criteria, dosing, duration, and site-of-care restrictions for Dawnzera (donidalorsen) for prevention of hereditary angioedema (HAE) for applicable Medical Mutual - Ohio members.
No material clinical or coverage changes in this revision.
Coverage and Authorization Criteria
Recommended Authorization Criteria for HAE prophylaxis
Coverage is recommended for prophylaxis of HAE due to C1-INH deficiency in patients meeting diagnostic, prescriber, and response requirements.
ANY of the following
Initial therapy (A)
- Patient is ≥ 12 years of age
- Diagnosis of HAE type I or type II confirmed by: functional C1-INH <50% of normal at baseline
- Diagnosis confirmed by low serum C4 at baseline
- Medication prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders
Currently receiving Dawnzera (B)
- Patient has a diagnosis of HAE type I or type 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 attack severity, or decreased attack duration)
- Medication prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders
Initial Therapy Requirements
Initial approval is granted when ALL diagnostic and prescriber criteria are met and dosing conforms to medical benefit requirements.
ALL of the following
- Patient is ≥ 12 years of age
- HAE type I or II confirmed with low functional C1-INH (<50% of normal) and low serum C4 at baseline
- Medication prescribed by or in consultation with an allergist/immunologist or HAE specialist
- Recommended dosing (medical benefit): 80 mg subcutaneously every 4 weeks (80 mg every 8 weeks may be considered)
- Initial approval duration: 1 year
Continuation / Extended Approval
Continuation or renewal requires documented clinical benefit; approvals are issued for 1 year.
ALL of the following
- For patients currently receiving Dawnzera without prior approval through Coverage Review, evaluate under initial therapy criteria
- Prescriber must attest to favorable clinical response compared to baseline (examples: decreased attack frequency, severity, or duration)
- Extended approval duration: 1 year
Billing Codes and Coverage Status
Prior Authorization, Documentation, and Site-of-Care
Prior approval required for Dawnzera billed under medical benefit
Prior approval is required for Dawnzera when billed under the medical benefit using HCPCS J3490, J3590, or J9999. Prior approval requests that meet the policy criteria may be authorized by a nurse reviewer; requests that do not meet criteria will be forwarded to a qualified physician reviewer. Claims submitted with these HCPCS codes will pend with remark code M3M or M4M and be adjudicated per the Corporate Medical Policy.
Restrict medical-benefit administration to non-hospital facility-based locations
When Dawnzera is billed under the medical benefit, administration is restricted to non-hospital facility-based locations (for example: home infusion provider, provider's office, or free-standing ambulatory infusion center) unless the member meets site-of-care exception criteria.
- Site-of-care restriction applies to initial and renewal requests
- Exceptions permitted only if member meets the site-of-care exception criteria
Provide requested clinical documentation to support medical necessity
The Company may request additional documentation to support medical necessity and may deny reimbursement if the drug or services are not medically necessary, investigational, outside benefit scope, or if inappropriate/excessive billing is identified. Requested documentation may include patient records, test results, and provider credentials, and must be made available upon request.
- Documentation may include patient records, test results, and provider ordering/performing credentials
- Failure to provide requested documentation or determination of non-medical necessity may result in denial of reimbursement
Drug and Diagnostic Definitions
Dosing and Quantity
Administration Location Guidance
Site-of-care restriction for medical-benefit billing (non-hospital locations)
For billing Dawnzera under the medical benefit, administer the drug only in non-hospital facility-based settings (such as home infusion, provider office, or free-standing ambulatory infusion center) unless the member qualifies for a site-of-care exception.
- Applicable settings: home infusion provider, provider's office, free-standing ambulatory infusion center
- If member meets site-of-care exception criteria, alternative settings may be allowed
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