CurrentColorado Rocky Mountain Health PlansPolicy N/A

Dawnzera (donidalorsen) prior authorization for hereditary angioedema prophylaxis

Defines prior authorization and medical necessity criteria for Dawnzera (donidalorsen) for prophylaxis of hereditary angioedema (HAE) in patients ≥12 years, applicable to Colorado Rocky Mountain Health Plans members covered under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDawnzera (donidalorsen) prior authorization for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNew policy

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior therapy failures (Andembry, Haegarda, Takhzyro), and prescriber specialty for a 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

New prior authorization/medical necessity program for Dawnzera (donidalorsen).

12 monthsauthorization duration

≥12minimum age

3required prior agents failed

2prescriber specialties

typically excluded

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Coverage Criteria for Dawnzera (donidalorsen)

Initial Authorization

Approved when ALL of the following are met:

Diagnosis
- C1-INH deficiency/dysfunction: C1-INH antigenic level below the lower limit of normal OR C1-INH functional level below the lower limit of normal
  laboratory confirmation required
- HAE with normal C1-INH: One of: confirmed pathogenic variant in factor XII, angiopoietin1, plasminogen-1, kininogen-1, myoferlin, or HS3ST6; recurring angioedema refractory to high-dose antihistamines with confirmed family history; recurring angioedema refractory to high-dose antihistamines with de-novo/unknown mutation
  genetic testing or documented clinical history
Treatment intent and combination: Prescribed for the prophylaxis of HAE attacks AND not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro)
Prescriber must attest patient would clinically benefit from prophylaxis
Prior therapy failures: History of failure to all of the following with documented dates and reasons: Andembry (garadacimab); Haegarda (C1 esterase inhibitor, human); Takhzyro (lanadelumab)
Document date of trial and reason for therapeutic failure
Prescriber: Prescribed by an immunologist or allergist
Authorization issued for 12 months when criteria met

Dawnzera must not be used in combination with other products indicated for prophylaxis against hereditary angioedema (HAE) attacks. Examples of prohibited concomitant prophylactic agents include Andembry, Cinryze, Haegarda, Orladeyo, and Takhzyro. In general, Dawnzera is typically excluded from coverage, and coverage may only be considered where required by the member's benefit plan or applicable law.

Requests for Dawnzera will not meet criteria when the medication is used without documented prior failures of required prophylactic agents, without diagnostic confirmation of HAE, or when prescribed by a clinician outside the authorized specialties. Specifically, approval requires a documented history of failure to Andembry (garadacimab), Haegarda (C1 esterase inhibitor, human), and Takhzyro (lanadelumab), and the drug must be prescribed by an immunologist or allergist. Because Dawnzera is generally excluded from coverage, absence of these required elements places the request at high risk for denial.

Coding and Identifiers

Minimum age

Minimum age for Dawnzera12 years (patients 12 years of age and older)

Indication age groupPediatric and adult patients 12 years and older

Age requirement applies toInitial authorization and reauthorization

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required; approval is granted for 12 months when all initial authorization criteria are met, including diagnosis confirmation.

Initial Authorization: Approval issued for 12 months when ALL initial criteria are met.
Diagnosis confirmation required (see documentation requirements).

Step Therapy

Step Therapy Requirement

Step therapy requirement: patient must have a documented history of therapeutic failure to Andembry, Haegarda, and Takhzyro prior to approval. Include dates of trials and reason for therapeutic failure for each agent.

Required failed therapies: Andembry (garadacimab), Haegarda (C1 esterase inhibitor, human), Takhzyro (lanadelumab).
Document trial dates and specific reasons for failure for each medication.

Definitions

HAE with C1‑INH deficiency/dysfunction — diagnostic criteria

Diagnostic criterionC1-INH antigenic level below the lower limit of normal

Alternative diagnostic criterionC1-INH functional level below the lower limit of normal

HAE type describedC1-INH deficiency or dysfunction (Type I or II HAE)

HAE with normal C1‑INH — diagnostic pathways

Core diagnostic requirementRecurring angioedema attacks with normal C1‑INH levels

Genetic confirmation optionConfirmed pathogenic variant(s) in genes such as factor XII, angiopoietin1, plasminogen‑1, kininogen‑1, myoferlin, or HS3ST6

Background

Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 12 years and older. The policy establishes prior authorization and medical necessity requirements for its use in preventing HAE attacks, including diagnostic confirmation, prophylactic intent, and documentation of prior therapy failures.

Revision History

2026-01P&T approval

Program for prior authorization/medical necessity for Dawnzera (donidalorsen) was created and approved by P&T.

2026-04-01Effective dateLatest

Dawnzera prior authorization/medical necessity program became effective for Colorado Rocky Mountain Health Plans members.