CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0614

Saphnelo® (anifrolumab-fnia) Intravenous Therapy for Systemic Lupus Erythematosus

Customize your policy alerts

Sign up for security_health_plan_of_wisconsin_inc Policy SHP-P0614 alerts

Get alerted when Policy SHP-P0614 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Governs medical necessity, prior authorization, dosing, renewal, administration, and billing requirements for intravenous Saphnelo in systemic lupus erythematosus and other FDA-labeled or compendia-supported indications.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySaphnelo® (anifrolumab-fnia) Intravenous Therapy for Systemic Lupus Erythematosus

Policy CodePolicy SHP-P0614

Change TypeNo material change

Effective DateN/A

Last ReviewApr 7, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the plan's Medical Drug Review process before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

300 mg q4wMaximum dose

Active SLE without active LNPrimary indication

CNS lupus, active LNKey exclusions

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0614

Saphnelo® (anifrolumab-fnia) Intravenous Therapy for Systemic Lupus Erythematosus

Customize your policy alerts

Sign up for security_health_plan_of_wisconsin_inc Policy SHP-P0614 alerts

Get alerted when Policy SHP-P0614 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySaphnelo® (anifrolumab-fnia) Intravenous Therapy for Systemic Lupus Erythematosus

Policy CodePolicy SHP-P0614

Change TypeNo material change

Effective DateN/A

Last ReviewApr 7, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the plan's Medical Drug Review process before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

300 mg q4wMaximum dose

Active SLE without active LNPrimary indication

CNS lupus, active LNKey exclusions

9Covered diagnosis codes

Medical Necessity and Coverage Requirements

Initial Approval Criteria

Covered when all applicable requirements are met.

Initial approval

Continuation or new-start pathway
- Continuation pathway: All target agents are eligible for continuation, and the patient has been treated with the requested agent within the past 90 days; or the prescriber states that the patient was treated with the requested agent within the past 90 days and is at risk if therapy is changed. Starting therapy with samples is not approvable.Treatment within the past 90 days
- New-start pathway
  - Supported indication
    Active moderate-to-severe SLE without active lupus nephritis
    Benlysta subcutaneous requirement: The patient has tried and had an inadequate response to Benlysta subcutaneous after at least 6 months of therapy; or has an intolerance or hypersensitivity to Benlysta subcutaneous; or has an FDA-labeled contraindication to Benlysta subcutaneous; or there is support that Benlysta subcutaneous is not clinically appropriate.At least 6 months of therapy before determining inadequate response
    Hydroxychloroquine requirement: The patient has tried and had an inadequate response to hydroxychloroquine; or has an intolerance or hypersensitivity to hydroxychloroquine; or has an FDA-labeled contraindication to hydroxychloroquine.
    Corticosteroid or immunosuppressive-agent requirement: The patient has tried and had an inadequate response to one corticosteroid or immunosuppressive agent, specifically azathioprine, methotrexate, mycophenolate, or cyclophosphamide; or has an intolerance or hypersensitivity to one of these agents; or has an FDA-labeled contraindication to all listed corticosteroids and immunosuppressive agents.
    Other FDA-labeled indication: The patient has another FDA-labeled indication for the requested agent and route of administration, and the patient's age is within FDA labeling for the requested indication or supported for use at that age for the requested indication.
    Other compendia-supported indication: The patient has another indication supported in compendia for the requested agent and route of administration.AHFS or DrugDex level 1 or 2a evidence
  - Standard SLE therapy: For active SLE without active lupus nephritis, the patient is currently treated with standard SLE therapy and will continue that therapy in combination with the requested agent. Standard therapy includes corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, or cyclophosphamide.
  - Specialist involvement: The prescriber is a specialist in the area of the patient's diagnosis, such as a rheumatologist or nephrologist, or has consulted with such a specialist.
  - Disease exclusions: The patient does not have severe active central nervous system lupus or severe active lupus nephritis and will not use the requested agent in combination with Lupkynis.
  - Concomitant immunomodulatory therapy: The patient will not use the requested agent in combination with another immunomodulatory agent; or the patient will use combination therapy only when the prescribing information does not limit such use and supporting clinical trials, phase III studies, or guidelines are submitted.
  - Safety and dosing: The patient does not have an FDA-labeled contraindication to the requested agent, and the requested quantity or dose is within FDA-labeled dosing or compendia-supported dosing for the requested indication.

Renewal Criteria

Renewal is covered when all applicable requirements are met.

Renewal requirements

Renewal indication pathway
- Active SLE without active lupus nephritis: The patient has active systemic lupus erythematosus without active lupus nephritis, is currently treated with standard SLE therapy, and will continue standard SLE therapy in combination with the requested agent. Standard therapy includes corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, or cyclophosphamide.
- Other indication
  - Specialist involvement: The prescriber is a specialist in the area of the patient's diagnosis, such as a rheumatologist or nephrologist, or has consulted with such a specialist.
  - Disease exclusions:

Coverage is excluded for severe active central nervous system lupus, severe active lupus nephritis, and concomitant use of Saphnelo with Lupkynis.

Saphnelo is not to be used with the policy-listed immunomodulatory agents, including biologic therapies, JAK inhibitors, and other immunomodulators. An exception may apply only when the requested agent’s prescribing information does not limit the combination and submitted clinical trials, phase III studies, or guideline evidence supports combined use.

Use is not medically necessary when the requested indication lacks FDA-label or compendia support, required prior therapies or qualifying exceptions are not documented, the requested dose exceeds supported dosing, or an FDA-labeled contraindication is present. For active SLE without active lupus nephritis, documentation must support the required treatment history or an accepted intolerance, hypersensitivity, contraindication, or clinical-inappropriateness exception for Benlysta subcutaneous, hydroxychloroquine, and one corticosteroid or immunosuppressive agent.

Billing Codes and Treatment Parameters

Covered HCPCS CodeHCPCSCovered

J0491

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

Covered NDCNDCCovered

00310-3040-xx

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

Covered 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

Saphnelo Dosage and Billing Limits

Dose and frequency300 mg intravenously as an infusion every 4 weeks

Maximum billable units300 billable units (300 mg) per dose every 4 weeks

Step-Therapy Requirement

Benlysta subcutaneous trialThe patient must have tried and had an inadequate response to Benlysta subcutaneous after at least 6 months of therapy.

Continuation of Therapy

Continuation treatment historyThe patient has been treated with the requested agent within the past 90 days; treatment initiated with samples is not approvable.

Authorization, Documentation, and Denial Risks

Prior Authorization

Medical Drug Review Authorization

Prior authorization through the plan’s Medical Drug Review process is required. Initial approval is provided for 12 months and may be renewed when renewal criteria are met.

Patients not previously approved through Medical Drug Review require an initial evaluation review.

Billing Rule

Dose and Frequency Limit

Do not request or bill above the policy dose and frequency limit.

Maximum: 300 billable units (300 mg) intravenously every 4 weeks.
For SLE, administer 300 mg every 4 weeks as an intravenous infusion.

Therapy and Policy Context

Saphnelo (anifrolumab-fnia) is an intravenous therapy used primarily for active systemic lupus erythematosus. The policy focuses on moderate-to-severe active SLE without active lupus nephritis, requires continuation of standard SLE therapy, and addresses authorization, dosing, safety, specialist involvement, and permitted combination therapy.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySaphnelo® (anifrolumab-fnia) Intravenous Therapy for Systemic Lupus Erythematosus

Policy CodePolicy SHP-P0614

Change TypeNo material change

Effective DateN/A

Last ReviewApr 7, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the plan's Medical Drug Review process before treatment.

SourceLink

On This Page

The patient does not have severe active central nervous system lupus or severe active lupus nephritis and will not use the requested agent in combination with Lupkynis.

Concomitant immunomodulatory therapy: The patient will not use the requested agent in combination with another immunomodulatory agent; or the patient will use combination therapy only when the prescribing information does not limit such use and supporting clinical trials, phase III studies, or guidelines are submitted.

Safety and dosing: The patient does not have an FDA-labeled contraindication to the requested agent, and the requested quantity or dose is within FDA-labeled dosing or compendia-supported dosing for the requested indication.

Step Therapy

Benlysta and Hydroxychloroquine Requirements

For active moderate-to-severe SLE without active lupus nephritis, document the required treatment history for both Benlysta subcutaneous and hydroxychloroquine, unless an applicable intolerance, hypersensitivity, contraindication, or clinical-inappropriateness exception applies.

Benlysta subcutaneous: inadequate response after at least 6 months, intolerance or hypersensitivity, an FDA-labeled contraindication, or support that use is not clinically appropriate.
Hydroxychloroquine: inadequate response, intolerance or hypersensitivity, or an FDA-labeled contraindication.

Step Therapy

Corticosteroid or Immunosuppressive Therapy

Document that the patient has tried and had an inadequate response to one qualifying corticosteroid or immunosuppressive agent, or has an applicable intolerance, hypersensitivity, or contraindication.

Qualifying immunosuppressive agents include azathioprine, methotrexate, mycophenolate, and cyclophosphamide.
An FDA-labeled contraindication must apply to all corticosteroids and immunosuppressive agents listed in the policy.

Documentation Required

Initial Clinical Documentation

Submit initial clinical documentation establishing the diagnosis, severity, indication, route, treatment history, and response or exception supporting the request.

Document active SLE without active lupus nephritis, when that is the requested indication, and moderate-to-severe disease.
Identify the requested agent, indication, intravenous route, and FDA-labeled or compendia-supported basis.
Provide treatment history and inadequate response, intolerance, hypersensitivity, contraindication, or clinical-inappropriateness documentation for required prior therapies.
For another FDA-labeled or compendia-supported indication, document the indication, route, age support when applicable, and supporting source.

Documentation Required

Lupus Treatment and Safety Documentation

For SLE requests, document concurrent standard therapy, specialist involvement, and the required safety and exclusion attestations.

The patient is currently treated with standard SLE therapy: corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, or cyclophosphamide.
The prescriber is a specialist in the diagnosis area, such as a rheumatologist or nephrologist, or has consulted with one.
The patient does not have severe active CNS lupus or severe active lupus nephritis, will not use Lupkynis concomitantly, and has no FDA-labeled contraindication to the requested agent.

Documentation Required

Combination Therapy Evidence

If another immunomodulatory agent will be used, submit documentation that combination therapy is permitted and clinically supported.

The requested agent’s prescribing information must not limit use with another immunomodulatory agent.
Submit clinical trials, phase III studies, or guideline support for the combination.
Otherwise, document that the requested agent will not be used with another immunomodulatory agent.

Prior Authorization

Continuation and Renewal Documentation

Renewal requires prior plan approval through Medical Drug Review, documented clinical benefit, and current documentation supporting the applicable indication and treatment conditions.

Document prior approval for the requested agent and clinical benefit since the prior authorization.
For active SLE without active lupus nephritis, document current standard SLE therapy and planned continuation in combination with the requested agent.
For other indications, document the applicable diagnosis, specialist involvement, safety exclusions, combination-therapy support, and dose support.

Denial Risk

Unverifiable Continuation or Sample-Only Use

Samples alone do not establish approvable continuation of therapy.

Document treatment with the requested agent within the past 90 days; starting on samples is not approvable.
A prescriber statement that the patient used the agent within the past 90 days and is at risk if therapy changes may also support continuation, but sample-only use remains insufficient.

Denial Risk

Failure to Meet SLE Treatment History

Requests are not approvable when the required SLE indication, severity, or prior-treatment history is unsupported.

Active SLE must be documented without active lupus nephritis, and disease must be moderate to severe.
Required Benlysta subcutaneous and hydroxychloroquine treatment history or an allowed exception must be documented.
The required corticosteroid or immunosuppressive treatment history or applicable exception must be documented.

Denial Risk

No Concomitant Standard SLE Therapy

For active SLE without active lupus nephritis, requests are not approvable unless the patient is currently receiving standard SLE therapy and will continue it with the requested agent.

Standard therapy includes corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, or cyclophosphamide.
Document both current treatment and planned continuation in combination with the requested agent.

Denial Risk

Excluded Lupus Manifestations or Lupkynis Combination

Do not approve requests involving excluded lupus manifestations or concomitant Lupkynis use.

The patient must not have severe active central nervous system lupus.
The patient must not have severe active lupus nephritis.
The requested agent must not be used in combination with Lupkynis.

Denial Risk

Unsupported Immunomodulatory Combination

Combination use with another immunomodulatory agent requires both prescribing-information permission and submitted clinical support; otherwise, the request is not approvable.

Submit clinical trials, phase III studies, or guideline support for the combination.
The requested agent’s prescribing information must not limit use with another immunomodulatory agent.
Apply the policy’s contraindicated-concomitant-agent list.

Denial Risk

Contraindication or Unsupported Dose

The patient must not have an FDA-labeled contraindication to the requested agent, and the requested dose must be FDA-labeled or supported in compendia for the requested indication.

Compendia allowed by the policy: AHFS or DrugDex level 1 or 2a evidence.
Requests with a contraindication or unsupported dose are not approvable.

Denial Risk

Contraindicated Concomitant Agents

Do not use the requested agent concomitantly with the agents listed below. Combination requests involving these agents are not approvable under the policy’s contraindicated-concomitant-therapy rule.

Abrilada (adalimumab-afzb); Actemra (tocilizumab); Adalimumab; Adbry (tralokinumab-ldrm); Amjevita (adalimumab-atto); Arcalyst (rilonacept); Avsola (infliximab-axxq); Benlysta (belimumab); Bimzelx (bimekizumab-bkzx); Cibinqo (abrocitinib); Cimzia (certolizumab); Cinqair (reslizumab); Cosentyx (secukinumab); Cyltezo (adalimumab-adbm); Dupixent (dupilumab); Ebglyss (lebrikizumab-lbkz).
Enbrel (etanercept); Entyvio (vedolizumab); Fasenra (benralizumab); Hadlima (adalimumab-bwwd); Hulio (adalimumab-fkjp); Humira (adalimumab); Hyrimoz (adalimumab-adaz); Idacio (adalimumab-aacf); Ilaris (canakinumab); Ilumya (tildrakizumab-asmn); Imuldosa (ustekinumab-srlf); Inflectra (infliximab-dyyb); Infliximab; Kevzara (sarilumab); Kineret (anakinra); Leqselvi (deuruxolitinib); Litfulo (ritlecitinib); Nemluvio (nemolizumab-ilto); Nucala (mepolizumab); Olumiant (baricitinib); Omvoh (mirikizumab-mrkz); Opzelura (ruxolitinib); Orencia (abatacept); Otezla (apremilast); Otulfi (ustekinumab-aauz); Pyzchiva (ustekinumab-ttwe); Remicade (infliximab); Renflexis (infliximab-abda); Riabni (rituximab-arrx); Rinvoq (upadacitinib); Rituxan (rituximab); Rituxan Hycela (rituximab/hyaluronidase human); Ruxience (rituximab-pvvr).
Saphnelo (anifrolumab-fnia); Selarsdi (ustekinumab-aekn); Siliq (brodalumab); Simlandi (adalimumab-ryvk); Simponi (golimumab); Simponi ARIA (golimumab); Skyrizi (risankizumab-rzaa); Sotyktu (deucravacitinib); Spevigo (spesolimab-sbzo); subcutaneous injection Stelara (ustekinumab); Steqeyma (ustekinumab-stba); Taltz (ixekizumab); Tezspire (tezepelumab-ekko); Tofidence (tocilizumab-bavi); Tremfya (guselkumab); Truxima (rituximab-abbs); Tyenne (tocilizumab-aazg); Tysabri (natalizumab); Ustekinumab; Velsipity (etrasimod); Wezlana (ustekinumab-auub); Xeljanz (tofacitinib).
Xeljanz XR (tofacitinib extended release); Xolair (omalizumab); Yesintek (ustekinumab-kfce); Yuflyma (adalimumab-aaty); Yusimry (adalimumab-aqvh); Zeposia (ozanimod); Zymfentra (infliximab-dyyb).

Denial Risk

Renewal Without Prior Approval or Benefit

A renewal request without prior Medical Drug Review approval or documented clinical benefit is not approvable.

Patients not previously approved require initial evaluation review.
Document clinical benefit with the requested agent and the applicable renewal criteria.