CurrentCignaPolicy N/A

Hemlibra (emicizumab-kxwh) prior authorization

Prior authorization form and requirements for Hemlibra (emicizumab-kxwh) requests submitted to Cigna Pharmacy Services; intended for prescribers requesting coverage for patients with Hemophilia A.

Policy Summary

PayerCigna

PolicyHemlibra (emicizumab-kxwh) prior authorization

Policy CodePolicy N/A

Change TypeInformational — form/requirements only

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for Hemlibra; submit the completed form via fax or online and attach supportive documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

(855) 840-1678fax number to send completed form

(800) 882-4462phone number for urgent requests

AccredoCigna's nationally preferred specialty pharmacy

Coverage Criteria for Hemlibra (emicizumab-kxwh)

Clinical information required for review

Authorization consideration when the following documented clinical information is provided

Primary diagnosis: Documented diagnosis of Hemophilia A (congenital factor VIII deficiency) or other specified diagnosis.

Form provides checkbox for Hemophilia A.

Inhibitor status or severity: Documentation of factor XIII inhibitors OR mild/moderate hemophilia (factor VIII level 1% to less than 40%) OR severe hemophilia (pre-treatment factor VIII level less than 1%).

Form asks to check the applicable box and attach lab results.

If mild/moderate Hemophilia A, bleeding history or joint disease: One or more CNS or other life-threatening bleeds OR 1+ large joint bleed in age ≤3 OR 2+ large joint bleeds OR presence of joint disease on exam and plain radiographs.

Required documentation requested on form; applies when mild/moderate is selected.

Policy Summary

PayerCigna

PolicyHemlibra (emicizumab-kxwh) prior authorization

Policy CodePolicy N/A

Change TypeInformational — form/requirements only

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for Hemlibra; submit the completed form via fax or online and attach supportive documentation.

SourceLink

On This Page

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Intended use: Is Hemlibra intended for routine prophylaxis to prevent or reduce the frequency of bleeding episodes? If not, specify the indication.

Form queries whether use is prophylactic and asks to specify if 'No'.

Authorization consideration is based on documented clinical information supplied on the Hemlibra prior authorization form. The form collects the primary diagnosis of Hemophilia A (congenital factor VIII deficiency), the patient’s inhibitor or severity status, details of bleeding history or joint disease when applicable, and whether the request is for routine prophylaxis to prevent or reduce bleeding frequency. Supporting documentation (chart notes, laboratory results, radiographs) must be attached to substantiate the answers provided on the form.

The form does not list any explicit conditions that are designated as not medically necessary. Review and adjudication rely on the presence of the required clinical documentation submitted with the request.

Drug and Clinical Coding

Drug identifierNDC

emicizumab-kxwh

Hemlibra (drug name)

Factor VIII level — severity ranges

Severe hemophiliaPre-treatment factor VIII level less than 1%

Mild hemophiliaFactor VIII level of 1% to less than 40%

Moderate hemophiliaFactor VIII level of 1% to less than 40%

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit the completed Cigna Hemlibra prior authorization form and include all required supportive documentation (chart notes, labs, test results) to substantiate the diagnosis and the answers on the form. Response time: standard prescription drug coverage requests are reviewed within 5 business days; if urgent, call to expedite.

Submit via fax or online at www.covermymeds.com/main/prior-authorization-forms/cigna/ or via SureScripts in your EHR
Standard response time: 5 business days; call to expedite urgent requests

Note

Mandatory Form Fields

Complete all asterisked patient and provider identifying fields on the form. Due to privacy regulations, Cigna will not respond via fax with the outcome unless all required (*) items are completed. Missing required fields may prevent a fax response.

Mandatory fields include physician name, DEA/NPI or TIN, patient name, Cigna ID, date of birth, and all other asterisked items.

Documentation Required

Supportive Documentation Required

This drug requires supportive documentation. Attach chart notes, laboratory tests, imaging or other relevant test results that substantiate the diagnosis and the clinical answers provided on the form. Failure to attach required supportive documentation may result in denial or delay of the request.

Document presence of one of: factor XIII inhibitors; mild or moderate hemophilia (factor VIII 1% to <40%); severe hemophilia (pre-treatment factor VIII <1%); or none of the above
If mild/moderate hemophilia is selected, provide documentation for qualifying bleeding history (e.g., CNS bleed, recurrent large joint bleeds, joint disease on exam/radiographs)

Step Therapy

Step therapy: no step therapy algorithms are specified on this form.

Note

Additional Provider Actions

Attach additional pertinent information where applicable (prior therapy, disease stage, performance status, and names/doses/administration schedule of any agents to be used concurrently). Prescriber attestation and signature are required on the form.

Include dose, quantity, duration, frequency, and patient weight on the form
Indicate whether this is a new start or continuation of therapy and, if continuation, whether there has been a good response to therapy

Background

Background: Hemlibra (emicizumab-kxwh) is requested for patients with Hemophilia A and the prior authorization form is intended to document disease severity, inhibitor status, bleeding history, and intended use (for example, routine prophylaxis). The form specifically asks for factor VIII level categories — severe (pre-treatment factor VIII level <1%) and mild or moderate (factor VIII level 1% to <40%) — and requests attachment of supporting chart notes, lab results, and radiographs to support the clinical information provided.

Definitions

pre-treatment factor VIII level less than 1% — Severe hemophilia

DefinitionPre-treatment factor VIII level less than 1% indicates severe hemophilia

Documentation requiredAttach lab and test results showing pre-treatment factor VIII level

Form checkboxForm includes a box to indicate 'severe hemophilia defined as pre-treatment factor VIII level less than 1%'

factor VIII level of 1% to less than 40% — Mild or moderate hemophilia

DefinitionFactor VIII level of 1% to less than 40% indicates mild or moderate hemophilia

Required supporting infoIf mild/moderate is selected, provide documentation of bleeding history or joint disease as specified on the form

Form checkboxForm includes a box to indicate 'mild or moderate hemophilia (defined as factor VIII level of 1% to less than 40%)'