CurrentCignaPolicy N/A

prior_authorization_form_ruconest

This document is a Cigna prior authorization request form to request coverage/authorization for Ruconest (recombinant C1 esterase inhibitor) including patient, prescriber, clinical and dispensing information to support approval for new starts or continuation of therapy for hereditary angioedema.

Policy Summary

PayerCigna

Policyprior_authorization_form_ruconest

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFor initial therapy, attach documentation showing low functional C1-INH (<50% of normal) and low serum C4 levels at baseline; include chart notes, lab results, or other patient-specific documents to avoid denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Medication covered via form

2Required baseline labs

3Administration settings listed

Ruconest Prior Authorization Form — At-a-Glance

This is a Cigna prior authorization request form to request coverage/authorization for Ruconest (recombinant C1 esterase inhibitor) for hereditary angioedema, to support both new starts and continuation of therapy.

Authorization required information and clinical conditions

Form collects required items to support a coverage decision; submissions must include the following when applicable:

ALL of the following

patient identifying info: Patient identifying information completed for all asterisked (*) items
Form will not respond via fax unless all asterisked items are completed.
medication request details: Medication requested specified (Ruconest 2100 unit vial) including J-code, directions, quantity, duration, and patient weight (kg)
start_or_continuation
- one of
  - New start
  - Continuation of therapy
obtained_where: Specify where medication will be obtained (Accredo Specialty Pharmacy, hospital outpatient, retail pharmacy, home health/home infusion vendor, physician's office stock, other)
dispensing_facility: Specify dispensing facility and/or doctor dispensing and administering medication (facility name, address, tax ID, state)
administration_setting: Specify administration setting (patient's home, physician's office, hospital outpatient, other) and indicate whether patient is candidate for redirection to a less intensive setting per plan rules
Per some Cigna plans, infusion must occur in the least intensive medically appropriate setting.
chronic_indicator: Indicate if medication is for chronic/long-term condition requiring lifetime therapy
diagnosis_selection: Diagnosis related to use must be selected: Hereditary Angioedema (HAE) due to C1 inhibitor (C1-INH) deficiency or other
hae_type_selection: Specify HAE type: type I or type II or other
Note that HAE with normal C1-INH (HAE type III) does NOT satisfy requirement.
indication_options
- prophylaxis: Prophylaxis of hereditary angioedema (HAE) attacks
- treatment_acute: Treatment of acute hereditary angioedema (HAE) attacks
- other_indication: Other (specify)
previous_ruconest_requirements: If treatment for acute attacks and previously treated with Ruconest: documentation to confirm diagnosis (chart notes, labs, claims, prescriptions) must be attached; must include patient-specific identifiers
prescriber_attest_response: If previously treated: prescriber must attest whether patient had favorable clinical response to Ruconest (examples provided)
specialist_involvement_previous: If previously treated: confirm medication is prescribed by or in consultation with an allergist/immunologist or physician specializing in HAE
initial_low_functional_c1inh: If initial therapy: documentation must show HAE type I or II confirmed by low functional C1-INH protein (<50% of normal per lab reference)< 50% of normal
Medical documentation must be attached.
initial_low_serum_c4: If initial therapy: documentation must show low serum C4 levels at baseline (per laboratory reference)Lower than normal per laboratory reference values
Medical documentation must be attached.
prescriber_specialist_initial: If initial therapy: medication must be prescribed by or in consultation with an allergist/immunologist
attestation_signature: Attestation and prescriber signature with date required

submission_instructions: Fax completed form to (855) 840-1678 or submit online via covermymeds.com or SureScripts; urgent requests require phone call to (800) 882-4462

What providers must do

Documentation Required

Attach diagnostic laboratory documentation for initial therapy

Attach medical documentation for initial therapy showing: • Functional C1‑INH protein below 50% of normal (per laboratory reference) • Low serum C4 at baseline (below lab normal). Include chart notes or laboratory results that contain patient identifying information (patient name or Cigna ID, DOB), test names, results and reference ranges. Examples of acceptable documents: chart visit notes, lab reports with reference ranges, medical test results. Failure to attach these patient‑specific documents may result in denial.

Functional C1‑INH < 50% of normal (per lab reference)
Low serum C4 at baseline (below laboratory normal)
Acceptable documents: chart notes, laboratory results, medical test results (must include patient identifiers)

Documentation Required

Attach prior treatment documentation for continuation

For continuation or if previously treated with Ruconest, attach documentation confirming the diagnosis and prior response. Acceptable documentation includes chart notes, laboratory results, claims records, and prescription receipts that include patient‑specific identifiers. If documentation confirming diagnosis and prior clinical response is not provided, the request could be denied.

Chart notes documenting diagnosis and clinical response
Lab results or medical test results
Claims records or prescription receipts (all must include patient identifiers)

Prior Authorization

Submit prior authorization request

Submit the completed prior authorization form by fax to 855-840-1678. You can also submit online via covermymeds.com or via SureScripts in your EHR. If this is an urgent request, call 800-882-4462 to expedite review.

Billing Rule

Specify dispensing and administration site and billing method

Indicate where the medication will be obtained and how it will be billed. Options include Accredo Specialty Pharmacy, hospital outpatient/retail pharmacy, home health/home infusion vendor, or physician's office stock (billing on a medical claim form). If dispensing from a facility, provide the facility name, address, state and tax ID number on the form.

Specify source: Accredo Specialty Pharmacy, Hospital Outpatient, Retail pharmacy, Home Health/Home Infusion vendor, or Physician's office stock
Provide facility name, address, state and Tax ID# if dispensing from a facility
Note: physician office stock is billed on a medical claim form

Documentation Required

Specialist involvement

The prescriber must be, or must consult with, an allergist/immunologist or a physician who specializes in HAE for initial therapy. The form also requires specialist involvement for certain continuation cases (as indicated in the prior treatment questions); documentation of consultation or specialist prescribing should be provided.

Prescriber is an allergist/immunologist or HAE specialist for initial therapy
For certain continuation/previously treated cases, prescribed by or in consultation with an allergist/immunologist or HAE specialist

OpenPayer

prior_authorization_form_ruconest

Ruconest Prior Authorization Form — At-a-Glance

Authorization required information and clinical conditions

Codes and billing placeholders

What providers must do

Definitions

Document history