ModifiedAmeriHealth Caritas VIP CarePolicy MA08.140c

Anifrolumab-fnia (Saphnelo) Coverage Criteria

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Medical-benefit coverage of intravenous anifrolumab-fnia (Saphnelo) for adult Medicare Advantage members with moderate to severe systemic lupus erythematosus; pharmacy-benefit coverage is outside this policy.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyAnifrolumab-fnia (Saphnelo) Coverage Criteria

Policy CodePolicy MA08.140c

Change TypeModified

Effective DateSeptember 16, 2024

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionSubmit documentation confirming adult moderate to severe SLE, standard therapy, absence of excluded lupus manifestations, and objective improvement or stabilization for continuation.

SourceLink

POLICY UPDATE CHANGES

The policy added classification criteria for systemic lupus erythematosus and specified continuation-therapy criteria.

The policy removed HCPCS codes J3590 and C9086 from the coding table.

The policy added HCPCS code J0491 for anifrolumab-fnia injection, 1 mg.

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.140c

Anifrolumab-fnia (Saphnelo) Coverage Criteria

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Sign up for amerihealth_caritas_vip_care Policy MA08.140c alerts

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyAnifrolumab-fnia (Saphnelo) Coverage Criteria

Policy CodePolicy MA08.140c

Change TypeModified

Effective DateSeptember 16, 2024

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionSubmit documentation confirming adult moderate to severe SLE, standard therapy, absence of excluded lupus manifestations, and objective improvement or stabilization for continuation.

SourceLink

POLICY UPDATE CHANGES

The policy added classification criteria for systemic lupus erythematosus and specified continuation-therapy criteria.

The policy removed HCPCS codes J3590 and C9086 from the coding table.

The policy added HCPCS code J0491 for anifrolumab-fnia injection, 1 mg.

Coverage Criteria

Initial Therapy Criteria

Covered when all of the following are met:

Initial therapy: The individual is an adult with moderate to severe systemic lupus erythematosus (SLE), is receiving standard SLE therapy, and does not have severe active lupus nephritis or severe active central nervous system lupus.Adult; moderate to severe SLE

Standard therapy may include oral corticosteroids, antimalarials such as hydroxychloroquine or chloroquine, and/or immunosuppressants such as azathioprine, methotrexate, or mycophenolate mofetil/mycophenolic acid. It excludes other biologic agents, including B-cell-targeted therapies, and cyclophosphamide.

Continuation Therapy Criteria

Covered when all of the following are met:

Continuation therapy

Initial-therapy criteria: All initial-therapy criteria remain met.All initial criteria
Treatment response: There is documented improvement or stabilization in SLE disease activity attributable to anifrolumab treatment.Objective improvement or stabilization
Use an SLE-associated disease activity and severity scoring instrument, such as SLEDAI-2K, BILAG, or PGA. The same objective measurement scale is expected for baseline and response to treatment.

Experimental or Investigational Use

Not covered unless supported under the Company's off-label coverage policy:

Experimental or investigational use: Uses other than the covered SLE indication are considered experimental or investigational and are not covered unless the indication is supported as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.Any noncovered use

Severe active lupus nephritis and severe active central nervous system lupus are excluded from the covered indication. Anifrolumab has not been evaluated in these clinical situations and is not recommended for use when either is present.

Anifrolumab is not recommended in combination with biologic therapies, including B-cell-targeted therapies, because this combination has not been studied.

The safety and efficacy of anifrolumab in individuals younger than 18 years have not been established.

Anifrolumab is medically necessary only for the covered indication of adult moderate to severe systemic lupus erythematosus meeting the policy criteria, including receipt of standard therapy. Uses outside this indication are not medically necessary unless supported as an accepted off-label use under the Company's applicable policy.

Coding and Response Measures

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10

M32.0	Drug-induced systemic lupus erythematosus
M32.8	Other forms of systemic lupus erythematosus
M32.9	Systemic lupus erythematosus, unspecified
M32.10	Systemic lupus erythematosus, organ or system involvement unspecified
M32.11	Endocarditis in systemic lupus erythematosus
M32.12	Pericarditis in systemic lupus erythematosus
M32.13	Lung involvement in systemic lupus erythematosus
M32.19	Other organ or system involvement in systemic lupus erythematosus

HCPCS Level II Code Number(s)HCPCS

J0491

Injection, anifrolumab-fnia, 1 mg

Revenue Code Number(s)Revenue

N/A

SRI-4 SLEDAI-2K Response

MeasureSLEDAI-2K score

Required responseAt least a 4-point reduction from baseline

Assessment contextSRI-4 response criterion

SRI-4 BILAG Response

MeasureBILAG score

BILAG-A requirementNo new BILAG-A scores

Provider Documentation and Authorization

Prior Authorization

Clinical Authorization Criteria

Before authorization, document that the individual is an adult with moderate to severe systemic lupus erythematosus (SLE), is receiving qualifying standard therapy, and does not have severe active lupus nephritis or severe active central nervous system lupus. Anifrolumab-fnia (Saphnelo) is covered for initial therapy when all of these requirements are met.

Standard therapy includes, but is not limited to, oral corticosteroids; antimalarials such as hydroxychloroquine or chloroquine; and/or immunosuppressants such as azathioprine, methotrexate, or mycophenolate mofetil/mycophenolic acid.
Standard therapy excludes other biologic agents, including B-cell-targeted therapies, and cyclophosphamide.
Use is for intravenous anifrolumab-fnia (Saphnelo) treatment of adults with moderate to severe SLE. Severe active lupus nephritis and severe active central nervous system lupus are exclusions.

Step Therapy

Standard Therapy Requirement

Document use of a qualifying standard SLE therapy before or with anifrolumab-fnia (Saphnelo).

Clinical Background

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that may affect multiple organs, commonly including the skin and musculoskeletal system, with intermittent disease flares. Anifrolumab is intended for adults with moderate to severe SLE who are receiving standard therapy.

Clinical Definitions and Disease Measures

Moderate Systemic Lupus Erythematosus

Disease severitySignificant but non-organ-threatening disease

Representative manifestationsConstitutional, cutaneous, musculoskeletal, or hematologic disease

Classification contextSystemic lupus erythematosus disease severity classification

Severe Systemic Lupus Erythematosus

Disease severityOrgan-threatening manifestations

Representative organ involvementKidney and central nervous system involvement

Lupus nephritis manifestations

Anifrolumab Initial Therapy

Initial therapy is covered when all of the following are met:

Anifrolumab initial therapy: The individual is an adult with moderate to severe systemic lupus erythematosus (SLE), is receiving standard SLE therapy, and does not have severe active lupus nephritis or severe active central nervous system lupus.Adult; moderate to severe SLE

Anifrolumab Continuation Therapy

Continuation therapy is covered when all of the following criteria are met:

Anifrolumab continuation therapy

Initial-therapy criteria: All criteria under initial therapy continue to be met.All initial criteria
Documented response: There is documented improvement or stabilization in SLE disease activity attributable to anifrolumab treatment.Objective improvement or stabilization
Use an SLE-associated disease activity and severity scoring instrument, such as SLEDAI-2K, BILAG, or PGA. The same objective measurement scale is expected for baseline and response to treatment.

Step Therapy Requirement

Step	Requirement	Coverage
1	Member must be receiving standard SLE therapy before or with anifrolumab therapy. Standard therapy may include oral corticosteroids, antimalarials (such as hydroxychloroquine or chloroquine), and/or immunosuppressants (such as azathioprine, methotrexate, or mycophenolate mofetil/mycophenolic acid). Other biologic agents, including B-cell-targeted therapies, and cyclophosphamide are excluded from the standard-therapy definition.	Required

Dose and Quantity Limits

Quantity Limit

DrugAnifrolumab-fnia (Saphnelo)

Dose300 mg

RouteIntravenous infusion

FrequencyEvery 4 weeks

Site of Care Requirements

Billing Rule

Use the appropriate infusion setting

When services can be administered in various settings, the Company reserves the right to reimburse only services furnished in the most appropriate and cost-effective setting consistent with the member's medical needs and condition.

The determination may consider the member's current medical condition, required monitoring, and additional services that coincide with delivery.