CurrentUnitedHealthcarePolicy N/A

Dawnzera (donidalorsen) prior authorization

Defines prior authorization and reauthorization criteria for Dawnzera (donidalorsen) for prevention of hereditary angioedema (HAE) attacks in patients age 12 and older; applies to UnitedHealthcare benefit plans where this clinical pharmacy program is in effect.

Policy Summary

PayerUnitedHealthcare

PolicyDawnzera (donidalorsen) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documenting diagnosis of hereditary angioedema, use for prophylaxis, and that Dawnzera will not be used with other HAE prophylactic products.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Dawnzera (donidalorsen) created and effective 4/1/2026.

Prior AuthorizationProgram type

>=12Minimum approved patient age

12 moAuthorization duration

ProphylaxisIndication type covered

ExcludedTypical coverage status

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Coverage Criteria for Dawnzera (donidalorsen)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization for Dawnzera: Member has a diagnosis of hereditary angioedema (HAE)

Medication is prescribed for prophylaxis against HAE attacks

Dawnzera is not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro)

Reauthorization

Covered when ALL of the following are met

Reauthorization for Dawnzera: Documentation of positive clinical response to Dawnzera therapy

Authorization will be issued for 12 months.

Dawnzera is not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro)

Dawnzera (donidalorsen) is typically excluded from coverage; however, review and coverage determinations may be required or permitted by applicable state mandates, federal regulatory requirements, or the member-specific benefit plan. Other policies and utilization management programs may also apply and could further restrict access or impose additional requirements.

Initial Therapy Requirements

Initial Therapy

Initial authorization requirements

Initial therapy: Diagnosis of hereditary angioedema (HAE)

Therapy is prescribed for prophylaxis against HAE attacks

Not used in combination with other products indicated for HAE prophylaxis (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro)

Reauthorization / Continuation Criteria

Reauthorization

Continuation/Reauthorization: Documentation of positive clinical response to Dawnzera therapy

Authorization duration: 12 months.

Dawnzera is not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro)

Coding and Authorization Duration

No codes listedmixed

No codes listed

inv-05: Authorization duration

Authorization duration12 months

Effective period noteAuthorization will be issued for 12 months; state mandates and member benefit plans may affect coverage.

Program interactionOther policies and utilization management programs may apply and could modify authorization duration.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required — diagnosis, prophylaxis, and combination-use rules

Prior authorization is required for Dawnzera. Initial approval requires documentation that the member has a diagnosis of hereditary angioedema (HAE), the medication is being used for prophylaxis against HAE attacks, and Dawnzera is not being used in combination with other products indicated for HAE prophylaxis (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro). Authorization will be issued for 12 months.

Diagnosis of hereditary angioedema (HAE) is required
Use must be for prophylaxis against HAE attacks
Not to be used in combination with other HAE prophylactic products
Authorization duration: 12 months

Step Therapy

Program automation and supply limits

Some program workflows may use automated approval or reapproval based on prior claim/medication history, diagnosis codes, and claim logic. Supply limits may also be applied per program.

Key Definitions

inv-11: Prophylaxis definition

DefinitionProphylaxis against HAE attacks: ongoing preventive therapy to reduce frequency or severity of hereditary angioedema episodes.

Intended useDawnzera is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

Combination therapy restrictionNot to be used in combination with other products indicated for HAE prophylaxis (e.g., Andembry, Cinryze, Haegarda, Orladeyo, Takhzyro).

Age groupApplicable to adult and pediatric patients 12 years of age and older when used for prophylaxis.

Background

Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent hereditary angioedema (HAE) attacks in patients aged 12 years and older. It is intended for routine preventive use and should not be combined with other products indicated for HAE prophylaxis.

When authorized, prior authorization is required and approvals are issued for 12 months; plan-level rules, state mandates, and federal requirements may affect coverage and program requirements.

Revision History and Policy Changes

1/2026P&T approval

Program established with P&T approval for Dawnzera (donidalorsen).

2026-04-01Effective dateLatest

New prior authorization program for Dawnzera (donidalorsen) became effective.