Donidalorsen (Dawnzera) for hereditary angioedema prophylaxis
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Covers medical necessity and prior authorization criteria for donidalorsen (Dawnzera) used for prevention of hereditary angioedema (HAE) attacks in members age 12 and older across specified QualChoice lines of business.
Drug is now FDA approved - criteria updated per FDA labeling; revised initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition.
Per September SDC, added redirection to one of the following: Haegarda, Takhzyro, or Orladeyo.
2Q 2026 annual review: no significant changes; references reviewed and updated.
Coverage Criteria
inv-01: Initial Therapy - Hereditary Angioedema
Covered when ALL of the following are met:
See Appendix D for lab reference ranges.
For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
inv-02: Continued Therapy - Hereditary Angioedema
Covered when ALL of the following are met:
Non–FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies. Refer to CP.CPA.09 for commercial off‑label requests, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid when submitting supporting evidence.
A history of a serious hypersensitivity reaction, including anaphylaxis, to donidalorsen or to any excipient in the Dawnzera formulation is a contraindication to therapy and precludes coverage.
For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the applicable state Medicaid manual for any specific coverage rules or exceptions.
Requests for use of donidalorsen for non‑FDA approved indications that are not addressed in this policy will be considered only if adequate supporting documentation of efficacy and safety is provided in accordance with the referenced off‑label use policies. Without such evidence, these requests will be handled per the off‑label policies and may be denied.
Initial Therapy
inv-23: Initial therapy — initial approval criteria for HAE prophylaxis
Initial approval criteria for HAE prophylaxis:
Continued Therapy / Renewal Criteria
inv-25: Continued therapy — criteria for continued coverage for HAE prophylaxis
Criteria for continued coverage for HAE prophylaxis:
Refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B.
inv-26: Continuation/approval duration — policy revision notes include change to initial approval duration for maintenance therapy
Policy revision notes regarding approval duration:
This change aligns criteria with FDA labeling and was recorded in reviews/revisions.
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Must trial and fail one preferred alternative prior to donidalorsen | Preferred alternatives include Haegarda, Takhzyro, or Orladeyo; step therapy may be waived for Illinois HIM requests per IL HB 5395 effective 1/1/2026 |
| Redirect To | Rationale / When Applied | Source Note |
|---|---|---|
| Haegarda | Considered as a preferred alternative therapy to try prior to donidalorsen; trial required unless contraindicated or intolerant | Appendix B lists Haegarda dosing; September SDC added redirection to Haegarda |
| Takhzyro | Considered as a preferred alternative therapy to try prior to donidalorsen; trial required unless contraindicated or intolerant | Appendix B lists Takhzyro dosing options; September SDC added redirection to Takhzyro |
| Orladeyo | Considered as a preferred alternative therapy to try prior to donidalorsen; trial required unless contraindicated or intolerant | Appendix B lists Orladeyo dosing; September SDC added redirection to Orladeyo |
Coding
Provider Actions / Prior Authorization
Prior authorization required; approval when initial criteria met
Prior authorization is required. Approval is granted when all initial criteria for HAE are met, including diagnosis confirmation (history of recurrent angioedema plus low C4 and low C1‑INH antigenic or functional level), prescriber specialty (allergist, hematologist, or immunologist), age ≥ 12 years, prophylaxis intent and severity criteria, prior‑therapy/step requirements, no combination with another FDA‑approved long‑term HAE prophylaxis, and dosing ≤ 80 mg every 4 weeks.
Step therapy: trial and failure of one preferred alternative required
Members must fail at least one preferred alternative (Haegarda, Takhzyro, or Orladeyo) before donidalorsen will be approved unless contraindicated or clinically significant adverse effects occur; Illinois HIM requests are exempt from step therapy per IL HB 5395 effective 1/1/2026.
Redirection to alternative HAE therapies (Haegarda, Takhzyro, Orladeyo)
Policy language added redirection to alternative HAE agents; providers should consider Haegarda, Takhzyro, or Orladeyo as alternatives and may be directed to these agents per the September SDC.
- Redirection added: Haegarda, Takhzyro, Orladeyo
Required supporting documentation: office notes, labs, clinical information
Providers must submit supporting documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.
- Include office notes documenting history of recurrent angioedema
- Include relevant laboratory results confirming low C4 and low C1‑INH antigenic or functional levels
- Include documentation of prior therapies and responses
Diagnostic lab evidence required: low C4 and low C1‑INH levels
Provide laboratory documentation confirming diagnosis: evidence of recurrent angioedema plus low C4 and low C1‑INH antigenic or functional levels. Reference laboratory example ranges are provided (e.g., C4 ~10–57 mg/dL depending on lab; C1‑INH functional abnormal <41% per listed labs).
- C4 examples: 10–57 mg/dL (lab dependent)
- C1‑INH functional abnormal: <41% (lab‑specific reference ranges provided)
Supporting references: Dawnzera PI and HAE guideline/lab sources
Policy references the Dawnzera (donidalorsen) Prescribing Information and multiple HAE guideline and laboratory sources; include these references with submissions when available.
- Dawnzera Prescribing Information (accessed Feb 6, 2026)
- WAO/EAACI HAE guideline update and other listed HAE references
- Mayo Clinic, Quest, and LabCorp laboratory references
Off‑label/non‑covered indications: will be denied without off‑label policy documentation
Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies referenced in the policy.
- Off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM/ICHRA), CP.PMN.53 (Medicaid)
Combination therapy exclusion: donidalorsen cannot be combined with other long‑term HAE prophylaxis
Requests where donidalorsen would be used in combination with another FDA‑approved long‑term prophylaxis product for HAE (examples listed: Takhzyro, Cinryze, Haegarda, Orladeyo, Andembry) will be denied.
Coding and coverage disclaimer: codes are informational only
Inclusion or exclusion of the codes listed in this policy does not guarantee coverage; providers must reference up‑to‑date professional coding guidance prior to claim submission and follow plan prior authorization requirements.
Quantity Limits & Product Strengths
Site of Care
Self‑administered subcutaneous autoinjector (home use)
Dawnzera is supplied as a self‑administered subcutaneous autoinjector (single‑dose autoinjector: 80 mg/0.8 mL); the product presentation supports home self‑administration.
- Available single‑dose autoinjector strength: 80 mg/0.8 mL.
No explicit office site‑of‑care restriction stated
The extracted policy portion does not state any explicit site‑of‑care restriction for administration in an office setting.
Background
Donidalorsen (Dawnzera) is a prekallikrein‑directed antisense oligonucleotide approved for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. Coverage and use are subject to the policy’s contraindications (including a history of serious hypersensitivity to the product or its excipients) and to state‑specific Medicaid provisions where applicable.
Definitions
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