CurrentAetnaPolicy N/A

Soliris (eculizumab) precertification request form — coverage criteria

Precertification form and clinical information checklist for Aetna coverage review of Soliris (eculizumab) for multiple labeled indications; intended for providers requesting start or continuation of therapy.

Policy Summary

PayerAetna

PolicySoliris (eculizumab) precertification request form — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form with required patient, prescriber, diagnosis and indication-specific documentation to request start or continuation of Soliris.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indications listed

2form pages

3continuation examples

2contact methods

Indication-specific and General Coverage Criteria

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Generalized myasthenia gravis (gMG) — required documentation for precertification

Generalized myasthenia gravis — required documentation for precertification

gMG diagnostic and treatment history: Is the requested drug being used for an anti-acetylcholine receptor (AchR) antibody–positive patient? Provide MGFA clinical classification and MG-ADL. Has the patient had inadequate response to at least two immunosuppressive therapies and to chronic IVIG?document prior therapies and responses

Form requests documentation of prior therapy failures before approval consideration

Neuromyelitis optica spectrum disorder (NMOSD) — required documentation for precertification

Neuromyelitis optica spectrum disorder — required documentation for precertification

NMOSD diagnostic criteria: Is the patient anti-aquaporin-4 (AQP4) antibody positive? Does the patient exhibit at least one core clinical characteristic (select from acute myelitis; acute brainstem syndrome; area postrema syndrome; optic neuritis; symptomatic cerebral syndrome with NMOSD-typical brain lesions; symptomatic diencephalic syndrome with NMOSD-typical lesions)? Will the patient receive the requested drug concomitantly with other biologics?document AQP4 status and core clinical characteristic(s)

Form asks about concomitant biologic use

Paroxysmal nocturnal hemoglobinuria (PNH) — required documentation for precertification

Paroxysmal nocturnal hemoglobinuria — required documentation for precertification

PNH diagnostic criteria: Was the diagnosis confirmed by detecting a deficiency of GPI-anchored proteins (GPI-APs)? Indicate how diagnosis was established (e.g., quantification of PNH cells or GPI-AP–deficient polymorphonuclear cells) and provide percent PNH cells. Was flow cytometry used?percent PNH cells as provided

Flow cytometry/quantification required to document PNH diagnosis

Continuation therapy — For continuation requests evidence of response required

For continuation requests — evidence of response required

Continuation response: Is there evidence of clinical or laboratory response for the relevant indication (examples: aHUS — normalization of LDH and platelet counts; gMG — improvement in MG-ADL or QMG; NMOSD — reduction in relapses; PNH — improvement in hemoglobin and normalization of LDH)?documented improvement or absence of unacceptable toxicity

Continuation requires documented positive response or absence of unacceptable toxicity

The precertification form captures the place of administration and specifically asks whether the infusion is being requested in an outpatient hospital setting. If hospital outpatient administration is selected, the form requires documentation of the reason the hospital setting is needed, such as severe adverse event history not responsive to conventional interventions, severe adverse events (for example anaphylaxis, myocardial infarction, thromboembolism, seizures) during or immediately after prior infusions, severe venous access issues requiring interventions only available in the hospital, significant behavioral or cognitive impairment with no available caregiver, or medical instability (cardiovascular, respiratory, renal or other) that cannot be safely managed in an alternate setting. Contact information for Aetna Precertification Notification (phone and fax) is provided on the form for submission.

For continuation requests the form asks whether there is evidence of unacceptable toxicity or disease progression while on the current regimen. If such toxicity or progression is present, continuation approval may not be granted unless the issue is addressed and documented per the clinical information requested on the form.

Billing and Diagnostic Codes

Administration CPT codesCPT

Administration code(s) (CPT)

Administration code(s) to be provided on form

Diagnosis ICD codesICD-10

Primary ICD Code	Primary ICD code to be specified
Secondary ICD Code	Secondary ICD code to be specified
Other ICD Code	Other ICD code to be specified

Laboratory percentage values — required fields

ADAMTS13 levelProvide ADAMTS13 level as a percentage (ADAMTS 13 level: %)

PNH cells — percent PNH cellsIndicate percentage of PNH cells by quantification (Please indicate the percentage of PNH cells: %)

PNH cells — GPI‑AP deficient PMNsIf quantified on polymorphonuclear cells, indicate percentage of GPI‑anchored protein deficient PMNs (Please indicate the percentage of GPI‑anchored protein deficient poly‑morphonuclear cells: %)

PNH diagnostic confirmation

PNH diagnostic confirmation methodConfirm diagnosis by detecting deficiency of GPI‑anchored proteins (GPI‑APs)

How diagnosis was establishedIdentify method used (e.g., quantification of PNH cells)

Flow cytometryIndicate whether flow cytometry was used to demonstrate GPI‑anchored protein deficiency (Yes/No)

What Providers Must Do to Request Precertification

Prior Authorization

Precertification Required

Precertification required — use the Soliris (eculizumab) Injectable Medication Precertification Request form for both start and continuation of therapy. Contact Aetna Precertification Notification if assistance is needed: Phone 1-866-752-7021; FAX 1-888-267-3277. For Medicare Advantage Part B: Phone 1-866-503-0857; FAX 1-844-268-7263.

Start of treatment or continuation must be indicated on the form
Include dates for start or last treatment

Prior Authorization

Prior Therapy Documentation (gMG)

For generalized myasthenia gravis (gMG) requests, include documentation that the patient is anti-acetylcholine receptor (AchR) antibody positive when applicable, the Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-ADL score, and documentation that the patient had an inadequate response to at least two immunosuppressive therapies and to chronic IVIG when applicable.

Document AchR antibody status
Provide MGFA clinical class and MG-ADL score
Document inadequate response to ≥2 immunosuppressive therapies (e.g., azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus, rituximab)
Document inadequate response to chronic IVIG if applicable

Documentation Required

Required Documentation

Completed patient, prescriber, dispensing/provider, product, diagnosis and indication‑specific clinical information must be provided. The form includes required sections: patient demographics and contact information; prescriber name, credentials, specialty, NPI and state license; product dosing (loading and maintenance dose/frequency); primary and any secondary ICD codes; and indication‑specific clinical fields for aHUS, gMG, NMOSD, and PNH.

Patient information: name, DOB, contact, weight, height, allergies
Prescriber information: name, credentials (MD/DO/NP/PA), address, phone, fax, state license, NPI, DEA, specialty
Product information: specify Soliris, loading and maintenance dose and frequencies
Diagnosis information: primary ICD code (and any secondary/other codes)
Indication-specific clinical documentation: aHUS (Shiga toxin testing, ADAMTS13 level), gMG (AchR status, MGFA class, MG-ADL, prior therapies), NMOSD (AQP4 antibody status, core clinical characteristics), PNH (flow cytometry/quantification of PNH cells)

Denial Risk

Incomplete Documentation Risk

Incomplete clinical information may prevent precertification review. All required fields on the two‑page form must be completed and legible. For continuation requests include documentation of response to therapy (e.g., lab or clinical improvement) or evidence of unacceptable toxicity or disease progression.

All required clinical information must be completed in entirety and legible
For continuation: document positive response (aHUS, gMG, NMOSD, PNH) or unacceptable toxicity/disease progression
Form must be signed and dated in the acknowledgement section

Requirements for New Therapy Requests

Initial therapy — requests must indicate start date and specify loading and maintenance dosing/frequency on form

Initial therapy requests must indicate start date and specify loading and maintenance dosing/frequency on form.

Initial request elements: Provide whether this is start of treatment and the start date. Specify product (Soliris), loading dose and frequency, and maintenance dose and frequency. Include indication-specific diagnostic documentation as required on the form.dosing and diagnostic info provided

Start of treatment checkbox and start date required on the form

Requirements for Continuing Therapy

Continuation therapy evidence — continuation requests must document response and absence of unacceptable toxicity

Continuation requests must document response and absence of unacceptable toxicity.

Continuation documentation: For continuation requests indicate whether there is evidence of unacceptable toxicity or disease progression. Document positive response measures per indication (examples: aHUS — normalization of LDH and platelet counts; gMG — improvement in MG-ADL or QMG; NMOSD — reduction in relapses; PNH — improvement in hemoglobin and normalization of LDH).documented response and absence of unacceptable toxicity

Incomplete clinical information may prevent precertification review; all required clinical information must be completed in its entirety

Place of Administration

Note

Document place of administration and justify hospital outpatient requests

Indicate the place of administration on the form (self‑administered, physician's office, outpatient infusion center, home infusion center) and provide supporting documentation if outpatient hospital setting is requested.

Select one place of administration checkbox and provide center/agency name and phone where requested.
If requesting an outpatient hospital setting, complete the form fields documenting reasons (severe adverse event history, severe venous access issues, medical instability, behavioral/caregiver issues) as required.

Diagnostic and Disease Definitions

Distinguishing aHUS from Shiga‑toxin HUS

Shiga toxin as causeForm asks whether the disease is caused by Shiga toxin (Yes/No)

Testing for Shiga toxinDocument whether tests were completed to confirm the absence of Shiga toxin (Yes/No)

ADAMTS13 measurement requestProvide ADAMTS13 level (%) to support differentiation of aHUS from Shiga‑toxin HUS

Drug and Indication Background

Soliris (eculizumab) is indicated for multiple rare complement-mediated disorders. The precertification checklist collects disease-specific diagnostic confirmation and baseline/response measures for each indication—for example, the form requests ADAMTS13 and Shiga-toxin assessment to help distinguish aHUS, anti-AQP4 antibody status and core clinical characteristics for NMOSD, flow cytometry or percent PNH cells to confirm PNH, and antibody status plus functional scores (eg, MG-ADL, MGFA class) and prior treatment history for gMG. The form differentiates start versus continuation of therapy and requires evidence of clinical or laboratory response on continuation (examples provided by indication).