CurrentViva Health PlanPolicy IC-0808

Dawnzera (donidalorsen) for hereditary angioedema prophylaxis

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This policy governs prior authorization, dosing, renewal, and billing requirements for subcutaneous Dawnzera in members seeking prophylaxis to prevent hereditary angioedema attacks. It applies to Viva Health Plan providers and requires specialist involvement, diagnostic confirmation, and documentation of clinical need.

Policy Summary

PayerViva Health Plan

PolicyDawnzera (donidalorsen) for hereditary angioedema prophylaxis

Policy CodePolicy IC-0808

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming HAE diagnosis, medical necessity, and the required prior HAE therapy response or trial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

80 mg/4 weeksMaximum routine dose

12+Minimum age

Every 8 weeksReduced-frequency option

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CurrentViva Health PlanPolicy IC-0808

Dawnzera (donidalorsen) for hereditary angioedema prophylaxis

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0808 alerts

Get alerted when Policy IC-0808 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyDawnzera (donidalorsen) for hereditary angioedema prophylaxis

Policy CodePolicy IC-0808

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming HAE diagnosis, medical necessity, and the required prior HAE therapy response or trial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

80 mg/4 weeksMaximum routine dose

12+Minimum age

Every 8 weeksReduced-frequency option

Covered diagnosis codes

Coverage Criteria

Initial Therapy

Covered when all applicable criteria are met.

Initial approval: The member is at least 12 years of age and meets all universal, clinical-history, diagnostic, medical-necessity, and prior-treatment criteria for hereditary angioedema prophylaxis.Age ≥ 12 years

All applicable criteria must be satisfied.

Continuation Therapy

Renewal may be approved when all criteria are met.

Continuation therapy: The member continues to meet applicable initial criteria, has no unacceptable toxicity, has experienced clinical benefit, and is assessed for reduced-frequency dosing every 8 weeks when clinically appropriate.Renewal every 12 months (365 days)

Every-8-week dosing is assessed for clinical appropriateness; it is not mandatory.

Concurrent prophylaxis exclusion: Dawnzera must not be used in combination with another agent indicated for the prophylaxis of hereditary angioedema (HAE) attacks. An exception applies when Cinryze is requested for short-term prophylaxis only.

Billing and Diagnosis Coding

HCPCS Code(s)HCPCS

J3490

Unclassified drugs

HCPCS Code(s)HCPCS

C9399

Unclassified drugs or biologicals (For hospital outpatient use only)

NDC(s)NDC

71860-0103-xx

Dawnzera 80 mg/0.8 mL single-dose autoinjector

Covered Diagnosis CodesICD-10Covered

D84.1

Defects in the complement system

High-dose antihistamine trial

Trial duration4 weeks

MedicationSecond-generation H1 antagonist

Required doseFour times the standard dose

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization is valid for 12 months (365 days) for members age 12 years or older who meet the applicable approval criteria. Renewal authorization may be granted every 12 months (365 days) thereafter.

Member must be at least 12 years of age.
Initial authorization period: 365 days.
Renewal interval: every 365 days.

Prior Authorization

Utilization Management Applies

Prior authorization is a utilization-management requirement for Dawnzera. The NQTL applies comparably, and not more stringently, to mental health/substance use disorder and medical/surgical medical-benefit prescription drugs; indication and drug cost were considered in applying PA, while safety and efficacy and misuse/abuse were not identified as PA priorities.

Indication: consider for prior authorization.
Cost of drug: consider for prior authorization.

Policy Background

Dawnzera (donidalorsen) is reviewed for long-term prophylaxis to prevent hereditary angioedema attacks in members who are at least 12 years of age. Coverage applies to qualifying HAE associated with C1-inhibitor deficiency or HAE with normal C1-inhibitor findings, when the policy’s diagnostic, clinical, medical-necessity, and prior-treatment requirements are met.

Definitions

HAE-C1-INH

DefinitionHereditary angioedema due to C1 inhibitor deficiency, Type 1 or 2

Antigenic confirmationCurrent or historical C1-INH antigenic level below the laboratory lower limit of normal

Functional confirmationCurrent or historical C1-INH functional level below the laboratory lower limit of normal

Genetic confirmationGenetic testing confirms pathogenic mutation(s) in SERPING1

HAE-nC1-INH

DefinitionHereditary angioedema with normal C1 inhibitor

Required laboratory finding

Initial Therapy Criteria

Initial Therapy

Initial approval requires age 12 or older and satisfaction of all universal criteria plus one qualifying HAE prophylaxis pathway with confirmed diagnosis and appropriate prior-treatment history.

Initial approval

Age and universal criteria: The member is at least 12 years of age; the medication is prescribed by or in consultation with a specialist in allergy, immunology, hematology, pulmonology, or medical genetics; the medication will not be used with another agent indicated for HAE prophylaxis, except Cinryze when requested for short-term prophylaxis only; and the provider confirms counseling to avoid possible HAE medication triggers such as estrogen-containing medications and ACE inhibitors.Age ≥ 12 years
All universal criteria are required.
Clinical history and medical necessity: The member has a qualifying history of recurrent swelling of mucous membranes, skin surface, or subcutaneous tissue; recurrent abdominal attacks with severe abdominal pain, nausea, vomiting, or diarrhea; upper-airway edema; prodromal signs or symptoms preceding angioedema attacks; or a positive family history of HAE. Other causes of angioedema have been ruled out, and the provider has determined that long-term prophylactic HAE treatment is necessary based on disease activity, quality of life, availability of health care resources, and/or inadequate control with appropriate acute HAE attack therapy.

Continuation Criteria

Renewal

Renewal may be approved when all continuation criteria are met.

Renewal criteria

Continued eligibility: The member continues to meet the universal and other applicable indication-specific criteria identified for initial approval.
Safety and clinical benefit
- No unacceptable toxicity: The member has no unacceptable toxicity from the drug, including severe hypersensitivity reactions such as anaphylaxis.
- Clinical benefit: The member has experienced clinical benefit from therapy, such as reduced attack severity or frequency or shortened attack duration.

Step Therapy

Step	Requirement
1	Demonstrate either a prior beneficial response to a therapy indicated for the treatment of acute hereditary angioedema attacks, or inadequate response or intolerance to an adequate trial of another prophylactic hereditary angioedema therapy, such as tranexamic acid, aminocaproic acid, danazol, and/or progestin therapy specific to females.

Quantity Limits

Dawnzera (donidalorsen)

Maximum routine dose80 mg per dose

Dosing intervalEvery 4 weeks

Interval in days28 days

Policy Summary

PayerViva Health Plan

PolicyDawnzera (donidalorsen) for hereditary angioedema prophylaxis

Policy CodePolicy IC-0808

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming HAE diagnosis, medical necessity, and the required prior HAE therapy response or trial.

SourceLink

On This Page

Safety and efficacy: prior authorization not a priority.

Potential for misuse/abuse: prior authorization not a priority.

Step Therapy

Prior HAE Therapy Response or Trial

Document that the member has demonstrated one acceptable prior-therapy pathway before initiating Dawnzera.

Prior beneficial response to a therapy indicated for treatment of acute HAE attacks; OR
Inadequate response or intolerance to an adequate trial of another prophylactic HAE therapy, such as tranexamic acid or aminocaproic acid, danazol, and/or progestin therapy when specific to females.

Documentation Required

Specialist and Trigger Counseling Documentation

The prescriber must be, or consult with, an appropriate specialist and must document counseling regarding avoidance of possible medication triggers for HAE attacks.

Prescriber specialty: allergy, immunology, hematology, pulmonology, or medical genetics.
Document counseling to avoid possible triggers, including estrogen-containing medications and ACE inhibitors.

Documentation Required

HAE Diagnosis and Medical Necessity Documentation

Document the member’s HAE history, exclusion of alternative causes, clinical need for long-term prophylaxis, and laboratory or genetic evidence confirming the diagnosis.

History of recurrent mucous-membrane, skin, or subcutaneous swelling; recurrent abdominal attacks with severe abdominal pain, nausea, vomiting, or diarrhea; upper-airway edema; prodromal symptoms; or a positive family history of HAE.
Rule out other causes of angioedema, including drug-induced angioedema, mast-cell-mediated angioedema, and acquired angioedema due to C1-INH deficiency.
Document that long-term prophylactic HAE treatment is necessary based on disease activity, quality of life, available health care resources, and/or inadequate control with appropriate acute HAE attack therapy.
For HAE-C1-INH type 1 or 2: provide current or historical C1-INH antigenic or functional level below the laboratory lower limit of normal, or genetic confirmation of pathogenic SERPING1 mutation(s).
For HAE-nC1-INH: document a normal C1-INH level and either a known HAE-causing mutation in F12, ANGPT1, PLG, KNG1, MYOF, or HS3ST6, or recurrent angioedema without hives refractory to a 4-week trial of high-dose antihistamines (a second-generation H1 antagonist at four times the standard dose).

Documentation Required

Renewal Documentation Required

For renewal, document that the member continues to meet the universal and applicable indication-specific criteria, has no unacceptable toxicity, and continues to benefit clinically from Dawnzera.

Document continued satisfaction of the universal and relevant indication-specific criteria from the initial approval requirements.
Document absence of unacceptable toxicity, including severe hypersensitivity reactions such as anaphylaxis.
Document clinical benefit, such as reduced attack severity or frequency and/or shortened attack duration.
Assess whether a reduced-frequency dosing regimen of every 8 weeks is clinically appropriate.

Denial Risk

Concurrent HAE Prophylaxis

Dawnzera must not be used in combination with another agent indicated for prophylaxis of HAE attacks.

Combination prophylaxis may result in denial.
Exception: combination therapy with Cinryze is allowable when Cinryze is requested for short-term prophylaxis only.

Denial Risk

Unconfirmed Diagnosis or Insufficient Clinical Need

Coverage may be denied when the HAE diagnosis is not confirmed, alternative causes have not been ruled out, or documentation does not establish the clinical need for long-term prophylactic treatment.

Insufficient diagnostic evidence includes failure to document the required HAE-C1-INH or HAE-nC1-INH laboratory, genetic, or clinical criteria.
Insufficient medical necessity includes failure to document disease activity, quality-of-life impact, available health care resources, and/or inadequate control with appropriate acute HAE attack therapy.
A diagnosis of recurrent angioedema without hives under the HAE-nC1-INH pathway requires failure of a 4-week trial of high-dose antihistamines.

Denial Risk

Toxicity or Lack of Benefit

Renewal may be denied when the member experiences unacceptable toxicity or does not demonstrate continued clinical benefit from therapy.

Unacceptable toxicity includes severe hypersensitivity reactions, including anaphylaxis.
Inadequate benefit includes failure to reduce attack severity or frequency or shorten attack duration.

Current or historical C1-INH level is normal, as defined by the laboratory performing the test

Genetic confirmation pathwayKnown HAE-causing mutation(s) in F12, ANGPT1, PLG, KNG1, MYOF, or HS3ST6

Clinical confirmation pathwayRecurrent angioedema attacks without hives refractory to a 4-week trial of high-dose antihistamines at four times the standard dose

Non-quantitative treatment limitation (NQTL)

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review or prior authorization

Application to this policyThe utilization management NQTL applies comparably, and not more stringently, to MH/SUD and medical/surgical Medical Benefit Prescription Drugs

Confirmed HAE diagnosis

HAE-C1-INH Type 1 or 2: The member has HAE due to C1 inhibitor deficiency, Type 1 or 2, confirmed by a current or historical C1-INH antigenic level below the laboratory lower limit of normal, a current or historical C1-INH functional level below the laboratory lower limit of normal, or genetic testing confirming pathogenic mutation(s) in SERPING1.C1-INH level below the laboratory lower limit of normal, or pathogenic SERPING1 mutation(s)
HAE-nC1-INH
- Normal C1-INH level: The member has a current or historical normal C1-INH level, as defined by the laboratory performing the test.
- Additional HAE-nC1-INH pathway
  - Known HAE-causing mutation: The member has a confirmed HAE-causing mutation in F12, ANGPT1, PLG, KNG1, MYOF, or HS3ST6.
  - Refractory recurrent attacks: The member has recurrent angioedema attacks without hives that are refractory to a 4-week trial of high-dose antihistamines, defined as a second-generation H1 antagonist at four times the standard dose.4 weeks at 4 times the standard dose

Prior HAE treatment response or trial

Prior beneficial response: The member has demonstrated a prior beneficial response to a therapy indicated for the treatment of acute HAE attacks.
Inadequate response or intolerance: The member has demonstrated inadequate response or intolerance to an adequate trial of another prophylactic HAE therapy, such as tranexamic acid, aminocaproic acid, danazol, and/or progestin therapy specific to females.

Dosing assessment: The provider assesses whether a reduced dosing frequency of every 8 weeks is clinically appropriate.Every 8 weeks if clinically appropriate

This is an assessment requirement, not a mandatory dose change.