Ruconest (C1 esterase inhibitor, recombinant) Medication Precertification Request
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This document is Aetna's precertification request form and instructions for Ruconest (C1 esterase inhibitor, recombinant) used for acute hereditary angioedema (HAE) and related indications; it governs what information providers must submit to request authorization for start or continuation of therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria and Form Queries
Precertification clinical criteria (informational form fields)
Covered when the following documentation is provided on the precertification form and supports appropriate use:
See form fields on pages 1-2 of the precertification request form.
Form includes selectable checkboxes to document which diagnostic pathway applies.
For continuation requests, include documentation of reduction in severity/duration of attacks and rationale regarding prophylactic therapy consideration.
The precertification form asks whether Ruconest will be used in combination with any other medication for acute hereditary angioedema (HAE) attacks (for example, Berinert, Firazyr, Kalbitor). Providers must disclose concurrent use of other acute HAE therapies on the form; this information is collected to inform the review but the form itself does not state that combination therapy is an automatic coverage exclusion.
The plan may request additional information or clarification to evaluate a precertification request. If the requested supporting information is not provided or if a submission contains false or misleading information, the request may be denied and knowingly filing fraudulent information may result in criminal or civil penalties. Providers should respond promptly to any requests for clarification to avoid delays or adverse coverage determinations.
Administration and Diagnosis Codes
| Administration code(s) (CPT) | Administration CPT codes (specific codes to be provided by prescriber) |
| Primary ICD Code | Primary diagnosis ICD code (to be specified) |
| Secondary ICD Code | Secondary diagnosis ICD code (to be specified) |
| Other ICD Code | Other diagnosis ICD code (to be specified) |
Precertification and Submission Requirements
Obtain precertification and include start/last treatment date
Precertification is required for either start of treatment or continuation of Ruconest; the precertification form includes selectable fields to indicate Start of treatment with Start date or Continuation of therapy with Date of last treatment. For continuation requests, include documentation showing reduction in attack severity and/or duration or rationale for ongoing therapy.
- Check box for Start of treatment and provide Start date (form page 1).
- Or check box for Continuation of therapy and provide Date of last treatment (form page 1).
- Continuation requests must document reduction in severity and/or duration of acute attacks or provide rationale per continuation section.
Document trial of high‑dose antihistamine when applicable
When requesting Ruconest for HAE with normal C1-INH, the form asks whether angioedema was refractory to a trial of high‑dose antihistamine therapy (cetirizine 40 mg/day or equivalent) for at least one month as part of the diagnostic criteria.
- Indicate whether angioedema was refractory to high‑dose antihistamine (cetirizine 40 mg/day or equivalent) for ≥1 month.
Complete entire precertification form and include clinical documentation
Complete all fields on the two‑page precertification form, including patient, insurance, prescriber, dispensing/administration, product (Ruconest dose and frequency), diagnosis ICD codes, required clinical information (HAE type, laboratory or genetic confirmation, prior therapies), and a signature with date.
- Patient demographics and contact information (page 1).
- Prescriber information including specialty, NPI and signature (prescriber section).
- Dispensing/provider or administration setting and product dose/frequency.
- Diagnosis ICD codes and required clinical fields confirming HAE subtype and prior therapy history.
- Signature and date required on acknowledgement section.
Avoid incomplete or fraudulent submissions — plan may request clarification
The plan may request additional information or clarification to evaluate requests; knowingly filing materially false or fraudulent information is a crime and may lead to criminal and civil penalties.
- Be prepared to provide supplemental documentation if requested by the plan.
- Do not file requests with intent to defraud or conceal material information; fraudulent submissions are subject to penalties.
Drug Background
Ruconest (C1 esterase inhibitor, recombinant) is a treatment for acute hereditary angioedema (HAE) attacks. The two‑page precertification request form must be completed in full when requesting start or continuation of therapy, including documentation of diagnosis (HAE subtype and relevant laboratory or genetic confirmation), whether the prescriber specializes in HAE management, concurrent acute HAE therapies if any, and for continuation requests evidence of clinical benefit. The form requires a signature and date and includes Aetna precertification contact information for follow‑up.
HAE Diagnostic Definitions
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