CurrentViva HealthPolicy IC-P0614

Saphnelo (anifrolumab-fnia) IV for systemic lupus erythematosus

Policy governing medical benefit coverage, dosing, and prior authorization criteria for intravenous Saphnelo (anifrolumab-fnia) for members with systemic lupus erythematosus (SLE) without active lupus nephritis; applies to Viva Health medical drug review processes.

Policy Summary

PayerViva Health

PolicySaphnelo (anifrolumab-fnia) IV for systemic lupus erythematosus

Policy CodePolicy IC-P0614

Change TypeNo material change

Effective DateSep 1, 2021

Next Review DateApr 7, 2025

Key ActionObtain prior authorization and document prior therapies (including trial or intolerance to belimumab and standard SLE therapies) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsLength of authorization

300 mgDose per administration

q4wDosing interval

J0491HCPCS code

M32.xCovered ICD-10 root

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Initial Therapy

Initial Approval Criteria: Target agent approved when ALL of the following are met

ALL of the following

Continuation of therapy
- Continuation - recent use: Patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; OR prescriber attests patient treated with the requested agent within the past 90 days and is at risk if therapy is changed
Initial use for active SLE without active LN
- FDA labeling/compendia and severity: Requested agent is FDA labeled or supported in compendia for SLE; AND patient has moderate to severe SLE
- Benlysta requirement: One of: inadequate response to belimumab (Benlysta) after ≥6 months; intolerance or hypersensitivity to belimumab; FDA labeled contraindication to belimumab; OR use of belimumab is not clinically appropriate
- Prior hydroxychloroquine and immunosuppressive/corticosteroid therapy: ONE of: inadequate response to hydroxychloroquine OR intolerance/hypersensitivity to hydroxychloroquine OR FDA labeled contraindication to hydroxychloroquine; AND ONE of: inadequate response to one corticosteroid OR one immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR intolerance/hypersensitivity to one corticosteroid or one immunosuppressive agent OR FDA labeled contraindication to ALL corticosteroids AND immunosuppressive agents
- Concurrent standard therapy and specialist: Patient is currently treated with and will continue standard SLE therapy (eg, corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) in combination with the requested agent; prescriber is a specialist or has consulted a specialist
- Safety and combination restrictions: Patient does NOT have severe active central nervous system (CNS) lupus or severe active lupus nephritis; patient will NOT be using the requested agent in combination with Lupkynis; patient will NOT be using the requested agent in combination with other immunomodulatory agents unless prescribing information allows and supportive evidence is provided; patient has no FDA labeled contraindications to the requested agent; requested dose/quantity is within FDA labeled dosing or supported in compendia

Other FDA or compendia supported indications

Continuation/Renewal Therapy

Renewal Criteria: Target agent approved when ALL of the following are met

ALL of the following

Diagnosis-specific renewal: Either patient has active SLE without active LN and will continue standard SLE therapy in combination with the agent OR patient has a diagnosis other than active SLE or active LN
Renewal safety and combination restrictions: Prescriber is a specialist or has consulted a specialist; patient does NOT have severe active CNS lupus; patient does NOT have severe active LN; patient will NOT be using the requested agent in combination with Lupkynis; ONE of the following regarding concomitant immunomodulatory agents: patient will NOT be using the requested agent with another immunomodulatory agent OR patient will be using it with another immunomodulatory agent AND the prescribing information does NOT limit such use AND there is support for the use of combination therapy (submit clinical trials, phase III studies, or guidelines); patient has no FDA labeled contraindications; requested dose/quantity is within FDA labeled dosing or supported in compendia

Compendia allowed: AHFS, or DrugDex 1 or 2a level of evidence

Saphnelo (anifrolumab-fnia) must not be used concomitantly with a broad set of immunomodulatory agents unless the product labeling allows and supportive evidence is provided. The policy explicitly lists multiple biologics, JAK inhibitors, TNF inhibitors, IL inhibitors, and other targeted immunomodulators as contraindicated as concomitant therapy (examples include: rituximab products, infliximab products, adalimumab products, etanercept, abatacept, baricitinib, tofacitinib, ustekinumab and multiple IL/IL‑related agents).

Medicare rules may supersede or modify coverage under this policy. Where applicable, providers and claims must comply with relevant Medicare guidance including the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15 §50 and any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs) or Local Coverage Articles (LCAs). The policy’s non‑Medicare guidance is intended for non‑Medicare determinations; providers should consult the CMS coverage search for NCD/LCD/LCA documents when treating Medicare Part B enrollees.

Use of Saphnelo is excluded for patients with severe active central nervous system (CNS) lupus or severe active lupus nephritis (LN). Continuation and renewal criteria both require that the patient does NOT have severe active CNS lupus and does NOT have severe active LN.

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J0491

Injection, anifrolumab-fnia 1 mg; 1 billable unit = 1 mg

NDCNDCCovered

00310-3040-xx

Saphnelo 300 mg/2 mL single-dose vial for injection

Covered ICD-10 CodesICD-10Covered

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
M32.14	Glomerular disease in systemic lupus erythematosus
M32.15	Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19	Other organ or system involvement in systemic lupus erythematosus
M32.8	Other forms of systemic lupus erythematosus
M32.9	Systemic lupus erythematosus, unspecified

Covered ICD-10 Diagnosis CodesICD-10Covered

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
M32.14	Glomerular disease in systemic lupus erythematosus
M32.15	Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19	Other organ or system involvement in systemic lupus erythematosus
M32.8	Other forms of systemic lupus erythematosus
M32.9	Systemic lupus erythematosus, unspecified

Medicare Part B Covered Diagnosis Codesmixed

No codes listed

CMS MAC Jurisdictionsmixed

CA, HI, NV, AS, GU, CNMI	Noridian Healthcare Solutions, LLC (Jurisdiction E (1))
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ	Noridian Healthcare Solutions, LLC (Jurisdiction F (2 & 3))
KS, NE, IA, MO	Wisconsin Physicians Service Insurance Corp (WPS) (Jurisdiction 5)
MN, WI, IL	National Government Services, Inc. (NGS) (Jurisdiction 6)
LA, AR, MS, TX, OK, CO, NM	Novitas Solutions, Inc. (Jurisdiction H (4 & 7))
MI, IN	Wisconsin Physicians Service Insurance Corp (WPS) (Jurisdiction 8)
FL, PR, VI	First Coast Service Options, Inc. (Jurisdiction N (9))
TN, GA, AL	Palmetto GBA (Jurisdiction J (10))
NC, SC, WV, VA	Palmetto GBA (Jurisdiction M (11))
DE, MD, PA, NJ, DC	Novitas Solutions, Inc. (Jurisdiction L (12))

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Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation requests. Initial approvals follow the policy's multi-step criteria, including documentation of prior therapies and meeting diagnostic and concomitant-therapy requirements. Requests lacking required documentation may be denied.

Prior authorization required for initial and renewal requests per policy criteria.
Initial approvals require demonstration of prior therapy trials or valid reasons for not using preferred agents.
Continuation requests require prior treatment with the requested agent within the past 90 days (samples not acceptable) or prescriber attestation of prior use and risk if therapy changed.

Documentation Required

Documentation of Prior Therapies Required

Providers must document the patient's prior therapies, responses, or reasons for intolerance/contraindication. This includes prior use or documented inadequate response to belimumab (Benlysta), hydroxychloroquine, and at least one corticosteroid or immunosuppressive agent (e.g., azathioprine, methotrexate, mycophenolate, cyclophosphamide) when applicable.

Document trial and inadequate response to belimumab (Benlysta) after at least 6 months when applicable, or document intolerance/contraindication.
Document trial and inadequate response to hydroxychloroquine or intolerance/contraindication.
Document trial and inadequate response to one corticosteroid or immunosuppressive agent (or intolerance/contraindication), or document contraindication to all listed agents.

Documentation Required

Diagnosis Linkage Required

The prescriber must link the request to an appropriate ICD-10 diagnosis code supporting active systemic lupus erythematosus (SLE) without active lupus nephritis when applicable. Use one of the covered ICD-10 codes from Appendix 1 when billing.

Ensure documentation supports the selected ICD-10 code and clinical presentation (active SLE without active LN where required).

Step Therapy

Step Therapy / Preferred Prior Agents

Step therapy: the policy prefers prior use of belimumab (Benlysta) and other standard SLE therapies before approving target agents. Exceptions are allowed only for documented intolerance, hypersensitivity, FDA-labeled contraindication, or clinical support that Benlysta is not appropriate.

Preferred trial of Belimumab (Benlysta) prior to approval unless inadequate response after ≥6 months, intolerance, contraindication, or other documented clinical rationale.
Patient must continue standard SLE background therapy (e.g., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) in combination with the requested agent per policy.
Requests lacking documentation of step-therapy trials or a valid reason for exemption may be denied.

Note

Medicare Coverage and Compliance

Medicare Part B enrollees must comply with applicable CMS policies, NCDs, LCDs, and LCAs. Claims inconsistent with applicable Medicare coverage determinations may be denied or require additional compliance.

Medicare Part B coverage follows Medicare Benefit Policy Manual (Pub.100-02) Chapter 15 §50 and any applicable NCD/LCD/LCA.
Local Coverage Articles or Contractor guidance may apply for payment and benefit eligibility; providers should verify applicable MAC jurisdiction rules.

Definitions and Eligibility Terms

Standard SLE therapy — policy definition

Included agentsCorticosteroids; hydroxychloroquine; azathioprine; methotrexate; mycophenolate; cyclophosphamide

Role in policyRequired to be continued in combination with the requested agent for active SLE without active lupus nephritis

Examples of corticosteroids/immunosuppressives listedSpecifically names azathioprine, methotrexate, mycophenolate, cyclophosphamide as immunosuppressive options

Continuation of therapy eligibility

DefinitionPatient treated with the requested agent (starting on samples not approvable) within the past 90 days; OR prescriber attests patient treated with the requested agent within past 90 days and is at risk if therapy changed

SamplesStarting therapy on samples is not approvable for continuation eligibility

Alternative continuation pathIf not recently treated, continuation may still be permitted when full initial criteria (FDA/compendia support, disease severity, prior therapies) are met

Covered diagnosis — M32.10

ICD-10 codeM32.10

DescriptionSystemic lupus erythematosus organ or system involvement unspecified

Use in policyListed as a covered diagnosis code for SLE in Appendix 1

Covered diagnosis — M32.11

ICD-10 codeM32.11

DescriptionEndocarditis in systemic lupus erythematosus

Use in policyIncluded in Appendix 1 list of covered SLE diagnosis codes

Covered diagnosis — M32.12

ICD-10 codeM32.12

DescriptionPericarditis in systemic lupus erythematosus

Use in policyIncluded in Appendix 1 list of covered SLE diagnosis codes

OpenPayer

Saphnelo (anifrolumab-fnia) IV for systemic lupus erythematosus

Coverage Criteria for Saphnelo (anifrolumab-fnia)

Billing and Diagnosis Codes

Provider Requirements and Prior Authorization

Definitions and Eligibility Terms

Background

Revision History