CurrentColorado Rocky Mountain Health PlansPolicy N/A

Ruconest (C1 esterase inhibitor [recombinant]) prior authorization

Defines prior authorization criteria and coverage rules for Ruconest for treatment of acute hereditary angioedema (HAE) attacks for affected members; applies to pharmacy prior authorization/notification programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyRuconest (C1 esterase inhibitor [recombinant]) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing diagnosis of hereditary angioedema and that the request is for treatment of an acute HAE attack; approvals are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

acute HAEindication covered

laryngealnot established for

PA/Notifprogram type

Coverage Criteria for Ruconest

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Initial Therapy

Covered when ALL of the following are met:

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

Initial Authorization: Drug is being used for the treatment of acute HAE attacks

Initial Authorization: Drug is not used in combination with other products indicated for acute HAE attacks (e.g., Berinert, Firazyr, Kalbitor)

Authorization will be issued for 12 months if approved.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Approval will be granted when the member has a diagnosis of hereditary angioedema (HAE), the requested use is for treatment of an acute HAE attack, and the requested product will not be used in combination with other products indicated for acute HAE attacks.

Diagnosis: hereditary angioedema (HAE)
Indication: treatment of an acute HAE attack
Exclusion: not to be used in combination with other acute HAE products (e.g., Berinert, Firazyr, Kalbitor)
Authorization duration: up to 12 months (state mandates and member-specific benefit plans may apply)

Note

Automated Approval Option

Automated approval or reauthorization may be granted based on prior claim/medication history, diagnosis codes, and program rules. Use of automated processes varies by program/therapeutic class; supply limitations may apply.

Automated approval may consider prior claims, medication history, and ICD-10 diagnosis codes
Program-dependent; supply limits may apply

Documentation Required

Required Documentation

Documentation must support a diagnosis of hereditary angioedema and that the requested use is for treatment of an acute HAE attack. Include clinical notes describing the attack and rationale for the requested product.

Must document HAE diagnosis and details of the acute attack
Clinical rationale and prior treatment history (if applicable)

Denial Risk

Combination Therapy Exclusion

Requests for Ruconest used in combination with other products indicated for acute HAE attacks (for example, Berinert, Firazyr, Kalbitor) may be denied.

Combination therapy with other acute HAE agents is not covered

Denial Risk

Laryngeal Attack Effectiveness

Effectiveness of Ruconest for laryngeal HAE attacks has not been established; use for laryngeal attacks may not meet coverage criteria.

Laryngeal attacks: effectiveness not established — may not be covered

Definitions

Hereditary angioedema (HAE) — definition and relation to Ruconest indication

DefinitionHereditary angioedema (HAE) — a genetic condition characterized by recurrent episodes of angioedema; Ruconest is indicated for treatment of acute HAE attacks in adult and adolescent patients.

Ruconest indicationRuconest (C1 esterase inhibitor [recombinant]) is indicated for treatment of acute attacks in adult and adolescent patients with HAE.

Laryngeal attacksEffectiveness of Ruconest was not established for HAE patients with laryngeal attacks.

Re-authorization / Continuation Criteria

Re-authorization

Re-authorization/continuation rules

Continuation: Re-authorization may be based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic per UnitedHealthcare automated processes

Supply limitations may be in place; authorization duration is 12 months when issued.