Find policies, billing codes, payers, states, and providers
Saphnelo (anifrolumab-fnia) Injectable Medication Precertification Request / Coverage Criteria
Customize your policy alerts
Sign up for all Aetna policy alerts
Know when Aetna releases new policies or updates existing guidance.
Monitor payer policy activity
Precertification form and requirements for Saphnelo (anifrolumab-fnia) injectable therapy requests for Aetna members; used by providers to request start or continuation of therapy and supply required clinical, insurance, and administration information.
No material clinical or coverage changes in this revision.
Coverage Criteria for Saphnelo (anifrolumab-fnia)
Initiation Therapy
Covered when ALL of the following are met
Form asks providers to indicate presence of severe active CNS lupus and severe active lupus nephritis.
Form requires documentation of autoantibody status and current treatments (glucocorticoids, antimalarials, immunosuppressives).
Continuation Therapy
Covered when ALL of the following are met
Form includes checkbox asking whether patient has achieved or maintained a positive clinical response for continuation requests.
Continuation requests should include clinical documentation consistent with initiation requirements and ongoing management.
Administration setting considerations
Consider administration setting when ANY of the following apply
Form asks whether infusion is in an outpatient hospital setting.
Presence of serious or refractory infusion reactions may necessitate a higher-acuity setting.
Severe venous access problems are specifically queried on the form.
Form requests description of behavioral or cognitive impairments that affect infusion safety.
Form asks providers to indicate and describe cardiovascular, respiratory, renal, or other conditions relevant to setting selection.
The form specifically asks providers to indicate whether the patient has severe active central nervous system (CNS) lupus (examples listed include seizures attributed to CNS lupus, psychosis, organic brain syndrome, cerebritis, or CNS vasculitis requiring therapeutic intervention within 60 days before initiation) and whether the patient has severe active lupus nephritis. These documented findings are used to note disease severity and may affect the suitability of Saphnelo therapy for initiation.
Requests may be incomplete or may not meet medical necessity if they lack documentation of active systemic lupus erythematosus (SLE), documentation of relevant autoantibody positivity (e.g., ANA, anti-dsDNA, anti‑Sm, antiphospholipid antibodies, complement proteins) when available, or evidence that the patient is on a stable standard SLE treatment regimen (glucocorticoids, antimalarials, or immunosuppressives) unless clinically inappropriate. For continuation requests, the form requires documentation that the patient has achieved or maintained a positive clinical response (low disease activity or improvement in signs and symptoms) as attested by the provider.
Coding and Diagnosis Codes
| Administration code(s) (CPT) | Place provided for administration CPT codes to be recorded on form |
| Primary ICD Code | Primary ICD code field for diagnosis |
| Secondary ICD Code | Secondary ICD code field for diagnosis |
Required Provider Actions and Documentation
Prior Authorization Required — Contact Aetna Precertification Notification
Precertification is required. Contact Aetna Precertification Notification by phone or fax to submit the completed precertification form.
- Submit the two-page Saphnelo (anifrolumab-fnia) Injectable Medication Precertification Request form.
- Ensure all fields on both pages are complete and legible (patient demographics, insurance, prescriber, dispensing/provider, product, diagnosis, and clinical information).
- For Medicare Advantage Part B, use the Medicare request form and the dedicated contact information.
Baseline Therapy and Testing — Document autoantibodies and current stable SLE treatment
Before initiating therapy, document baseline testing and current stable SLE treatment.
- Document presence of relevant autoantibodies (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins).
- Document whether patient has severe active CNS lupus or severe active lupus nephritis (these are exclusions/considerations).
- Document that the patient is currently receiving a stable standard SLE regimen (identify agents: glucocorticoids, antimalarials, immunosuppressives) or indicate if not.
Required Documentation — Complete all fields on the 2-page precertification form and include supporting clinical data
Providers must complete and submit the full two-page precertification form with all required fields and supporting clinical documentation for review.
- Complete all patient demographics (name, DOB, contact, weight, height, allergies).
- Complete insurance information including Aetna Member ID, group number, and other coverage details.
- Provide full prescriber information (name, specialty, NPI, state license, contact).
- Provide dispensing/provider and place of administration details, including CPT administration codes if applicable.
- Specify product information: Saphnelo dose and frequency.
- Include primary and any secondary ICD-10 diagnosis codes.
- Complete required clinical information: indication (active SLE), prior adverse events, venous access or behavioral/medical stability considerations, and for continuation requests document clinical response (improvement or low disease activity).
- Attach supporting documentation of laboratory results (autoantibodies), and records demonstrating stable prior therapies where applicable.
- Sign and date the acknowledgement on the form.
Additional Information and Fraud Notice
The plan may request additional information or clarification as needed. Knowingly submitting materially false information may result in denial, criminal or civil penalties.
- Aetna may request further documentation to evaluate requests.
- Fraudulent or materially false information can lead to denial of coverage and legal consequences.
Background
This precertification form targets patients with systemic lupus erythematosus (SLE)
Definitions
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.