CurrentUnitedHealthcarePolicy N/A

Cinryze (C1 esterase inhibitor, human) prior authorization

Defines UnitedHealthcare prior authorization and notification requirements for Cinryze for routine prophylaxis of hereditary angioedema (HAE) for covered members; applies to providers requesting pharmacy benefit coverage.

Policy Summary

PayerUnitedHealthcare

PolicyCinryze (C1 esterase inhibitor, human) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateMar 1, 2026

Key ActionObtain prior authorization for Cinryze; approvals are issued for 12 months for patients age 6 and older when used for routine prophylaxis and not concurrently with other prophylactic HAE products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

>=6min age

Prior Authprogram type

2026 P 1018-14program number

Coverage Criteria for Cinryze (C1 esterase inhibitor, human)

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Initial and re-authorization criteria

Cinryze will be approved based on ALL of the following criteria:

Main approval criteria: 1) Diagnosis of hereditary angioedema (HAE); 2) Use is for prophylaxis against HAE attacks; 3) Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Andembry, Dawnzera, Haegarda, Orladeyo, Takhzyro).

Approval issued for 12 months.

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cinryze. Approvals are issued for 12 months. State mandates, federal requirements, and member benefit plan coverage may affect authorization.

Prior authorization required
Authorization period: 12 months

Step Therapy

Step Therapy / Concurrent Product Restriction

Concurrent use of Cinryze with other products indicated for prophylaxis against HAE attacks is not allowed. Examples include Andembry, Dawnzera, Haegarda, Orladeyo, and Takhzyro.

Do not combine with prophylactic HAE agents (Andembry, Dawnzera, Haegarda, Orladeyo, Takhzyro)

Documentation Required

Supporting Documentation

Decisions may be supported by prior claim/medication history, diagnosis codes (ICD-10), claim logic, and medical necessity documentation. Automated approval and re-approval processes may be used depending on program/therapeutic class. Medical necessity and supply limits may apply.

Previous claim/medication history
Relevant ICD-10 diagnosis codes
Claim logic and prior authorization history
Medical necessity documentation / supply limits

Denial Risk

Denial Triggers

Common reasons for denial include lack of a documented HAE diagnosis, use for indications other than prophylaxis, and concurrent use with other prophylactic HAE agents.

No documented diagnosis of hereditary angioedema (HAE)
Request is for non‑prophylaxis use
Concurrent use with other prophylactic HAE products

Re-authorization / Continuation Criteria

Re-authorization

Re-authorization conditions: Authorization will be issued for 12 months. UnitedHealthcare may approve re-authorization based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Medical necessity and supply limits may apply.

State mandates and member-specific benefit plan coverage may affect approval.

Step Therapy and Concurrency Rules

Restriction	Details
Concurrent prophylactic HAE agents	Use of Cinryze in combination with other products indicated for prophylaxis against HAE attacks (examples: Andembry, Dawnzera, Haegarda, Orladeyo, Takhzyro) is disallowed.
Sequential step therapy	No sequential step therapy requirements specified in the policy; restriction applies only to concurrent prophylactic use.

Site of Care / Benefit Application

Note

Site of care not specified — pharmacy benefit prior authorization typical

Site of care is not specified in this policy; coverage processing is consistent with pharmacy‑benefit prior authorization. State mandates and the member's specific benefit plan may affect coverage or site‑of‑care requirements.

Typical processing: pharmacy benefit prior authorization
State mandates and member benefit plans may alter coverage or requirements

Background

Cinryze is a plasma-derived C1 esterase inhibitor (human) indicated for routine prophylaxis to reduce angioedema attacks in adults, adolescents and pediatric patients 6 years of age and older. The policy addresses prophylactic use (not acute treatment) and references the Cinryze package insert as the primary clinical reference.