CurrentCommunity-CarePolicy N/A

Benlysta IV

Defines medical-necessity criteria for initial and continuation approval of intravenous belimumab (Benlysta) for systemic lupus erythematosus and active lupus nephritis, quantity limits, authorization periods, and applicable HCPCS code(s).

Policy Summary

PayerCommunity-Care

PolicyBenlysta IV

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting specialist prescriber/consult, required serologic markers or low complement, failure/intolerance to two listed agents for SLE, absence of severe active CNS lupus, prohibition on combination biologics (and voclosporin for lupus nephritis), and patient weight for dosing.

SourceLink

POLICY UPDATE CHANGES

No material changes

2Covered Indications

1Applicable HCPCS code

6 mo / 1 yrAuthorization Periods (initial/continuation)

Coverage Summary

Scope: This policy defines medical-necessity criteria for initial and continuation approval of intravenous belimumab (Benlysta) for systemic lupus erythematosus (active, autoantibody-positive) and active lupus nephritis. It specifies that belimumab is prescribed by or in consultation with appropriate specialists, requires serologic evidence or specified markers, and requires prior failure/intolerance/contraindication to required therapies for SLE. Quantity limits: none. Authorization periods: initial 6 months, continuation 1 year. Applicable HCPCS code(s): J0490 (Injection, belimumab, 10 mg). Coverage stance: covered_with_criteria. Status: CURRENT.

Initial Therapy — Systemic lupus erythematosus

Initial Approval — Systemic lupus erythematosus

Covered when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, a rheumatologist or dermatologist
Diagnosis of active, autoantibody-positive, systemic lupus erythematosus in a patient receiving standard therapy
ONE of
- Anti-double stranded DNA (anti-dsDNA) positive
- Low complement (C3 or C4) proteins
- Positive for anti-smith antibodies
At least 2 of the following
- hydroxychloroquine
- methotrexate
- azathioprine
- mycophenolate mofetil
- chronic corticosteroid treatment at ≥ 7.5 mg of prednisone daily, or equivalent≥ 7.5 mg prednisone daily or equivalent
Does not have severe active central nervous system (CNS) lupus
Will not be given in combination with other biologics

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Initial Therapy — Active lupus nephritis

Initial Approval — Active lupus nephritis

Covered when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, a rheumatologist or nephrologist
Diagnosis of active lupus nephritis in a patient receiving standard therapy
Does not have severe active central nervous system (CNS) lupus
Will not be given in combination with other biologics or voclosporin

Continuation of Therapy — All indications

Continued coverage when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, a rheumatologist, nephrologist, or dermatologist
ONE of
- Active, autoantibody-positive, systemic lupus erythematosus
- Active lupus nephritis
Documentation of disease stabilization or improvement on belimumab (Benlysta)
Does not have severe active central nervous system (CNS) lupus
Will not be given in combination with other biologics
If prescribed for active lupus nephritis, will not be given in combination with voclosporin

Authorization periods: Initial coverage is allowed for 6 months. Continuation coverage is allowed for 1 year if continuation criteria are met. A patient weight is required to support dosing and approval.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Approval requires documentation that the prescriber is an appropriate specialist (rheumatologist, dermatologist, or nephrologist as applicable) or that they consulted one; the diagnosis meets active disease criteria for systemic lupus erythematosus or active lupus nephritis; supporting serologic evidence such as anti-dsDNA positivity, low complement (C3 or C4), or anti-Smith antibodies; documentation of failure, intolerance, or contraindication to two listed agents for SLE (hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, or chronic corticosteroid treatment ≥ 7.5 mg prednisone daily or equivalent); absence of severe active central nervous system (CNS) lupus; and that belimumab will not be given in combination with other biologics (and will not be given with voclosporin when prescribed for lupus nephritis).

J0490

Documentation Required

Weight required for approval

A patient weight is required to support dosing and is necessary for approval.

Billing Rule

Authorization periods

Initial authorization is allowed for 6 months. If continued, authorization periods are allowed for 1 year per the policy.

Background

Background: Belimumab (Benlysta) is an intravenous biologic indicated for active, autoantibody-positive systemic lupus erythematosus and for active lupus nephritis when added to standard therapy. The policy requires prescribing by or consultation with a specialist (rheumatologist, nephrologist, or dermatologist as applicable), demonstration of serologic evidence (for example anti-dsDNA, low complement, or anti-Smith), and prior failure, intolerance, or contraindication to required therapies for SLE before approval. Safety considerations include exclusion of patients with severe active CNS lupus and prohibition on combining belimumab with other biologic agents (and with voclosporin when used for lupus nephritis).

Policy Summary

PayerCommunity-Care

PolicyBenlysta IV

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Benlysta IV

Coverage Summary

Initial Therapy — Systemic lupus erythematosus

Initial Therapy — Active lupus nephritis

Continuation of Therapy — All indications

Exclusions / Not Allowed

Applicable Codes

Provider Actions / Prior Authorization

Background

Revision History