CurrentCignaPolicy v031526

Prior authorization form and clinical checklist for Uplizna (inebilizumab-cdon)

This document is Cigna's prior authorization form and clinical checklist used to request coverage and administration details for Uplizna (inebilizumab-cdon) for specified indications (IgG4‑RD, neuromyelitis optica spectrum disorder, generalized myasthenia gravis) and other indications. It governs providers submitting requests to Cigna Pharmacy Services for members covered under Cigna plans.

Policy Summary

PayerCigna

PolicyPrior authorization form and clinical checklist for Uplizna (inebilizumab-cdon)

Policy CodePolicy v031526

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete and submit the prior authorization form with required diagnostic documentation and prior-therapy details.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary indicated diagnoses listed on form

5administration settings options provided

5specialist types referenced

5documentation examples required

Coverage Criteria for Uplizna (inebilizumab-cdon)

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Indication-specific initial and continuation therapy criteria

Coverage consideration follows indication-specific criteria; requests must meet ALL applicable items for the chosen indication.

IgG4-RD initial therapy: ALL of the following must be met: (1) Diagnosis of immunoglobulin G4-related disease with history of involvement of at least one organ; (2) Confirmation by imaging of at least one organ OR elevated IgG4 levels OR biopsy of an involved organ with histopathologic features and, if biopsy performed, immunostaining confirming IgG-positive cells (documentation attached); (3) Patient has received or is currently receiving a systemic corticosteroid OR has inadequate efficacy, contraindication, or significant intolerance to systemic corticosteroid; (4) Medication is prescribed by or in consultation with an appropriate specialist (endocrinologist, gastroenterologist, immunologist, nephrologist, neurologist, pulmonologist, rheumatologist, or physician who specializes in treating immune-mediated disorders).

IgG4-RD continuation therapy: ALL of the following must be met: (1) Patient is currently receiving Uplizna; (2) Prescriber documents the patient has derived clinical benefit from Uplizna (examples include reduction in corticosteroid dose, reduction in number of disease flares, increased duration of flare-free period, or absence of disease activity); (3) Medication is prescribed by or in consultation with an appropriate specialist as listed for initial therapy; (4) Required supporting documentation is attached when indicated.

NMOSD initial therapy: ALL of the following must be met: (1) Diagnosis of neuromyelitis optica spectrum disorder confirmed by blood serum test positive for anti–aquaporin-4 (AQP4) antibody (documentation attached); (2) Medication is prescribed by or in consultation with a neurologist; (3) Required documentation is attached as indicated on the form.

NMOSD continuation therapy: ALL of the following must be met: (1) Patient is currently receiving Uplizna; (2) Diagnosis of AQP4-antibody–positive disease has been confirmed (documentation on file); (3) Prescriber documents clinical benefit from Uplizna (examples include reduction in relapse rate, reduction in symptoms such as pain or motor impairment, or slowing of symptom progression); (4) Prescribed by or in consultation with a neurologist.

Generalized Myasthenia Gravis (MG) initial therapy: ALL of the following must be met: (1) Documented antibody status: anti-acetylcholine receptor (AChR) antibody positive OR, if AChR negative, anti–muscle-specific tyrosine kinase (MuSK) antibody positive (documentation attached); (2) Myasthenia Gravis Foundation of America (MGFA) class II–IV; (3) MG–Activities of Daily Living (MG-ADL) total score greater than or equal to 6; (4) Patient has received or is currently receiving pyridostigmine OR has inadequate efficacy, contraindication, or significant intolerance to pyridostigmine; (5) Evidence of unresolved generalized MG symptoms (examples: difficulty swallowing, difficulty breathing, functional disability such as double vision, impaired mobility); (6) Medication is prescribed by or in consultation with a neurologist; (7) Required documentation is attached as indicated.

MG continuation therapy: ALL of the following must be met: (1) Patient is currently receiving Uplizna; (2) Prescriber documents continued clinical benefit from Uplizna (examples include reductions in exacerbations; improvements in speech, swallowing, mobility, or respiratory function); (3) Medication is prescribed by or in consultation with a neurologist; (4) Required documentation is attached when indicated.

Concomitant therapy exclusion check: Prescriber must attest whether Uplizna will be used in combination with a rituximab product, a complement inhibitor, a neonatal Fc receptor blocker, or Enspryng (satralizumab); combination use is queried on the form and may affect coverage decisions or require additional review.

The form requires the prescriber to attest whether Uplizna will be used in combination with a rituximab product, a Complement Inhibitor, a Neonatal Fc Receptor Blocker, or Enspryng (satralizumab). Examples of specified agents are provided for clarity (e.g., eculizumab, ravulizumab, zilucoplan as complement inhibitors; nipocalimab, rozanolixizumab, efgartigimod and formulations as neonatal Fc receptor blockers). Combination use is explicitly queried and may affect coverage decisions or require additional review.

Prescribers must sign an attestation that the information on the form is accurate; failure to disclose concomitant use when asked could lead to further review or denial of the request.

The form makes clear that requests lacking required confirmatory documentation may be considered incomplete or not medically necessary. For IgG4‑RD, documentation must show organ involvement and be attached: this may be imaging (CT, MRI, or PET), elevated IgG4 levels, or biopsy with histopathologic features and immunostaining demonstrating IgG‑positive cells. For NMOSD and MG, laboratory confirmation is required (AQP4 antibody testing for NMOSD; anti‑AChR or anti‑MuSK antibody testing for MG).

The form also requires documentation of prior therapy trials when specified (for example, use of a systemic corticosteroid for IgG4‑RD or pyridostigmine for MG) or documentation of inadequate efficacy, contraindication, or intolerance. The instructions state that medical documentation specific to the responses must be attached (chart notes, lab results, pathology reports, etc.), and that requests may be denied if such supporting documentation is not provided.

Prior Authorization Submission & Documentation Requirements

Prior Authorization

Prior Authorization Submission Requirements

Prior authorization is required for this request. Complete the prior authorization form with all patient identifiers and the requested medication details. Include diagnosis selection, the specific medication requested (e.g., Uplizna 100 mg/10 mL vial), dose, quantity, frequency, duration of therapy, directions for use, and urgency (standard or urgent). Identify where the medication will be obtained and where it will be administered (Accredo Specialty Pharmacy option noted as Cigna's nationally preferred specialty pharmacy).

Provide patient identifiers and clinical diagnosis selection
Specify medication requested (e.g., Uplizna 100 mg/10 mL vial), dose, quantity, frequency, duration, directions for use
Select urgency: Standard or Urgent (attestation required for urgent)
Indicate source: Accredo Specialty Pharmacy, Hospital Outpatient, Retail, Other, Home Health/Home Infusion, Physician office stock
Indicate administration site: Patient's Home, Physician's Office, Hospital Outpatient, Other

Documentation Required

Required Supporting Documentation — Attach to Prior Authorization

Requests must include supporting, patient-specific documentation as indicated by the clinical scenario. Attach relevant chart notes, imaging reports, laboratory results, pathology reports, and test results that confirm the diagnosis and clinical status. Failure to attach required documentation may lead to denial.

For IgG4‑RD: attach imaging (CT, MRI, or PET) of at least one involved organ OR elevated serum IgG4 levels, and when applicable histopathology or biopsy reports with immunostaining for IgG-positive cells
For neuromyelitis optica spectrum disorder: attach serum anti‑AQP4 antibody test results
For generalized myasthenia gravis (MG): attach antibody testing (anti‑AChR or anti‑MuSK), MG‑ADL score documentation, MGFA class documentation, and relevant clinical notes
All documentation must include patient-specific identifying information (name, DOB, medical record or claim identifiers)

Denial Risk

Prior Therapy Requirements and Denial Risk

Requests lacking required prior therapy documentation or necessary supporting records are at risk for denial. Document prior use, inadequate response, contraindication, or intolerance to required first‑line therapies where applicable.

IgG4‑RD initial therapy: document receipt of systemic corticosteroid therapy OR documentation of inadequate efficacy, contraindication, or significant intolerance to systemic corticosteroids
MG initial therapy: document prior or current use of pyridostigmine OR documentation of inadequate efficacy, contraindication, or significant intolerance to pyridostigmine; include MG‑ADL and MGFA class to support severity
If prior therapy requirements or supporting clinical documentation are not provided, the request may be denied

Condition Definitions and Diagnostic Criteria

inv-10: IgG4‑Related Disease (IgG4‑RD) — definition and diagnostic confirmations

DefinitionImmunoglobulin G4‑related disease (IgG4‑RD) — listed on the form as Immunoglobulin G4‑Related Disease (also referred to as IgG4‑related systemic disease, hyper‑IgG4 disease, IgG4‑related autoimmune disease, IgG4‑associated disease, IgG4‑related sclerosing disease, or IgG4‑syndrome)

Examples of involved organsAorta, bile ducts, kidneys, lacrimal glands, orbits, pachymeninges, pancreas, retroperitoneum, major salivary glands (submandibular, parotid, sublingual), thyroid gland (Riedel's thyroiditis)

Diagnostic confirmation — imagingImaging of at least one organ or area (CT, MRI, or PET) with documentation attached

Diagnostic confirmation — laboratoryElevated serum IgG4 levels with supporting documentation attached

Diagnostic confirmation — histopathology/biopsyBiopsy of at least one involved organ demonstrating characteristic histopathologic features (for example, dense lymphocytic infiltrate; obliterative phlebitis; storiform fibrosis) and, when performed, immunostaining confirming presence of IgG‑positive cells

inv-11: Myasthenia gravis (MG) initial therapy criteria

Required antibody confirmationDocumented anti‑acetylcholine receptor (AChR) antibody positive OR anti‑MuSK antibody positive if AChR is negative (medical documentation must be attached)

MGFA class requirementMyasthenia Gravis Foundation of America (MGFA) clinical classification II–IV must be met

MG‑ADL thresholdMyasthenia Gravis Activities of Daily Living (MG‑ADL) total score greater than or equal to 6

Prior therapy requirementReceived or currently receiving pyridostigmine OR documented inadequate efficacy, contraindication, or significant intolerance to pyridostigmine

Evidence of generalized MG symptomsDocumentation of unresolved generalized myasthenia gravis symptoms (examples: difficulty swallowing, difficulty breathing, or functional disability such as double vision, impaired mobility, or discontinuation of physical activity)

inv-12: Neuromyelitis optica spectrum disorder (NMOSD) — confirmation and continuation documentation

Required serologic confirmationDiagnosis confirmed by blood serum test positive for anti‑aquaporin‑4 (AQP4) antibody (documentation required)

Prescriber specialtyPrescribed by or in consultation with a neurologist (form queries neurologist involvement)

Documentation when currently treatedIf currently receiving Uplizna, prescriber must document that the patient has derived clinical benefit (examples: reduction in relapse rate, reduction in symptoms such as pain/fatigue/motor dysfunction, or slowing of progression)

OpenPayer

Prior authorization form and clinical checklist for Uplizna (inebilizumab-cdon)

Coverage Criteria for Uplizna (inebilizumab-cdon)

Requested Drug Product and Codes

Prior Authorization Submission & Documentation Requirements

Condition Definitions and Diagnostic Criteria

Background