Aetna Avsola prior auth coverage

Coverage and Indication Criteria

Indication-specific coverage criteria

Coverage requires completion of indication-specific clinical questions and documentation; examples below reflect forms of required criteria for initiation/continuation by indication.

General requirements: Complete form fields (patient, insurance, prescriber), provide product/dose/frequency, document primary ICD code, provide TB screening within 6 months and results, and state whether concomitant biologics/targeted synthetics will be used.

Supported by chunks 0-7

Site-of-care justification: If infusion in outpatient hospital setting selected, document reason (severe adverse event, antibodies to infliximab, severe venous access issues, significant behavioral or medical instability) to justify hospital setting.

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Initial therapy higher-dose documentation: For initiation requests, indicate if the medication is requested at a higher dose or frequency, and confirm whether requested dosing is supported by manufacturer prescribing information or compendia/guidelines; attach supporting information if non-standard dosing is used.

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Pediatric dosing acknowledgement: For patients under 18 years: prescriber must acknowledge that doses above 5 mg/kg are higher and confirm appropriate monitoring will be performed.>5 mg/kg acknowledgement

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Indication-specific precertification criteria (form checklist)

Coverage assessment depends on meeting indication-specific items including diagnosis confirmation, specialist prescribing/consultation, prior therapy history (biologic or conventional), inadequate response or intolerance to prior therapies, and dosing.

Immune checkpoint inhibitor toxicity: Checklist requires dosing supported by compendia/guidelines; oncologist/hematologist prescribing or consultation; inadequate response/intolerance/contraindication to corticosteroids; presence of moderate or severe diarrhea or colitis.

See chunk 18

Immunotherapy arthritis (ICI): Checklist requires dosing supported by compendia/guidelines; severity assessment; oncologist/hematologist prescribing or consultation; inadequate response/intolerance/contraindication to corticosteroids.

See chunk 19

Plaque psoriasis: Diagnosis of moderate to severe plaque psoriasis; dermatologist prescribing/consultation; prior biologic or targeted synthetic use queried; involvement of crucial body areas and BSA percent requested; if BSA<10% requires inadequate response/intolerance to phototherapy or systemic agents or clinical reasons to avoid them.

Ulcerative colitis

Ulcerative colitis (UC) questions

UC coverage questions: Member has moderately to severely active ulcerative colitis; prescriber is or consulted a gastroenterologist

Uveitis

Uveitis coverage questions: Dose supported by compendia/literature or prescribing info; prescriber is or consulted an ophthalmologist or rheumatologist; prior biologic exposure documented; inadequate response/intolerance/contraindication to corticosteroids or immunosuppressive therapy documented

Acute graft versus host disease

aGVHD coverage questions: Prescriber is or consulted an oncologist/hematologist; inadequate response to systemic corticosteroids or intolerance/contraindication documented; requested quantity supported by compendia/guidelines when applicable

Ankylosing spondylitis / nr-axSpA

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

AS/nr-axSpA coverage questions: Specify AS or nr-axSpA; prescriber is or consulted a rheumatologist; document active disease; prior biologic/targeted synthetic use queried; document inadequate response with at least two NSAIDs or intolerance/contraindication to two NSAIDs; provide loading and maintenance dosing as requested.

Hidradenitis suppurativa

HS coverage questions: Diagnosis of severe, refractory HS; prescriber is or consulted a rheumatologist or dermatologist; prior biologic exposure queried; documentation of inadequate response after at least 90 days of oral antibiotics or intolerance/contraindication to oral antibiotics required; indicate clinical response measures if continuing therapy.90 days

Immune checkpoint inhibitor toxicity

ICI-toxicity coverage questions: Prescriber is or consulted an oncologist/hematologist; requested dosing supported by compendia/guidelines; document inadequate response to corticosteroids or intolerance/contraindication; assess severity and specific organ involvement (e.g., diarrhea/colitis, cardiac toxicity, immunotherapy arthritis).

Plaque psoriasis / Psoriatic arthritis

Plaque psoriasis and psoriatic arthritis

Psoriasis/PsA coverage questions: Diagnosis of moderate to severe plaque psoriasis or active PsA; prescriber is or consulted a dermatologist (or rheumatologist/dermatologist for PsA without co-existent plaque psoriasis); indicate loading and maintenance dosing where requested; document prior biologic or targeted synthetic exposure and clinical response (BSA reduction, joint counts, symptom improvement) for continuation requests.

Pyoderma gangrenosum

PG coverage questions: Prescriber is or consulted a dermatologist; dosing supported by compendia/guidelines; document prior biologic exposure queried; inadequate response or intolerance to corticosteroids or immunosuppressive therapy required or contraindication to these therapies; document achieved or maintained clinical response for continuation.

Reactive arthritis

Reactive arthritis coverage questions: Prescriber is or consulted a rheumatologist; dosing supported by compendia/guidelines; document prior biologic exposure queried; document inadequate response after at least 3 months to sulfasalazine 1000 mg twice daily or methotrexate >=15 mg/week or intolerance/contraindication to those agents; document clinical response for continuation.

Rheumatoid arthritis

RA coverage questions: Diagnosis of moderately to severely active RA; prescriber is or consulted a rheumatologist; indicate loading and maintenance dosing; document prior biologic/targeted synthetic exposure; confirm combination with methotrexate or leflunomide or provide clinical reason not to use them; document RF/anti-CCP testing and inflammatory markers; if increasing dose, document need for >3 mg/kg or dosing more frequent than every 8 weeks and ensure prescribed dose does not exceed 10 mg/kg; document clinical response/improvement.

Sarcoidosis

Sarcoidosis coverage questions: Prescriber is or consulted a dermatologist or pulmonologist; dosing supported by compendia/guidelines; document inadequate response or intolerance to corticosteroids or immunosuppressive therapy (e.g., azathioprine, methotrexate) or contraindications; document maintained positive clinical response for continuation.

Takayasu's arteritis

Takayasu's arteritis coverage questions: Diagnosis of refractory Takayasu's arteritis; prescriber is or consulted a rheumatologist; dosing supported by compendia/guidelines; document inadequate response or intolerance to corticosteroids or immunosuppressive therapy (e.g., methotrexate, azathioprine, mycophenolate) or contraindications; document maintained positive clinical response for continuation.

Attestation-based criteria for listed indications

Covered when ALL of the following are met (as attested on the form):

Sarcoidosis - specialist involvement: Requested drug must be prescribed by or in consultation with a dermatologist or pulmonologist (attestation Yes/No)

from sarcoidosis checklist

Sarcoidosis - clinical response: Patient has achieved or maintained a positive clinical response evidenced by low disease activity or improvement in signs and symptoms since starting treatment (attestation Yes/No)

from sarcoidosis checklist

Takayasu's arteritis - diagnosis: Patient diagnosed with refractory Takayasu's arteritis (attestation Yes/No)

from Takayasu's arteritis checklist

Takayasu's arteritis - specialist involvement:

The precertification form explicitly asks whether Avsola will be administered in combination with another biologic or targeted synthetic agent and requires the provider to document this. Concurrent use of another biologic/targeted agent must be indicated on the form and is a factor considered during authorization review.

For members enrolled in Medicare Advantage Part B, the form directs providers to use a separate Medicare Request Form rather than the standard Avsola precertification form; this instruction appears on the submission/contact information page.

Medicare Advantage Part B requests must be submitted using the Medicare-specific request form. The document reiterates that all fields must be completed and legible for precertification review; incomplete or illegible submissions — including failure to use the Medicare form for Part B members — may prevent review or be excluded from consideration.

Within the cited portions of the form there are no explicit exclusion statements listed; the form instead focuses on attestation, specialist consultation, and documentation of clinical response for certain diagnoses.

Initiation requests that propose dosing or frequency above what is supported by the manufacturer's prescribing information or recognized compendia must include supporting documentation. The form asks whether the medication is being requested for initiation at a higher dose or frequency and whether the requested quantity is supported by the manufacturer's labeling or compendia guidance; unsupported higher-dose initiation requires justification.

Several continuation/attestation fields require provider confirmation of specialist involvement and that the patient has achieved or maintained a positive clinical response. Failure to complete these attestation items or to provide required specialty consultation documentation for diagnoses such as sarcoidosis or Takayasu's arteritis could result in non-approval of the request.

Initial Therapy Requirements

Initial therapy requirements

Initial therapy requests must state whether loading doses are requested and whether dosing is within manufacturer or compendia-supported ranges; pediatric higher-dose acknowledgement required when applicable.

Initial dosing documentation: Is the medication requested for initiation at a higher dose or frequency (e.g., loading dose)? Is the requested quantity supported by the manufacturer's prescribing information or compendia/guidelines? Attach supporting information if using non-standard dosing.

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Initial dosing documentation

Initial dosing fields and requirements vary by indication; prescriber must provide loading and maintenance dosing where requested and confirm monitoring for pediatric higher doses.

Dosing documentation: Provider must indicate loading dose at weeks 0, 2 and 6 and maintenance dose/frequency for indications that request it (e.g., AS, PsA, RA, UC); for under-18 UC or CD patients, prescriber must acknowledge monitoring for doses >5 mg/kg and indicate if doses exceed 10 mg/kg induction or maintenance.

Continuation Therapy Requirements

Continuation therapy requirements

For continuation requests, provide date of last treatment and current dose/frequency; indicate whether therapy is a continuation.

Continuation request fields: Indicate continuation of therapy and date of last treatment; supply current dosing regimen and any relevant clinical monitoring documentation; confirm if patient is receiving drug via samples or manufacturer assistance.

Supported by chunks 0,5,38

Continuation therapy

Requirements for continuation requests

Continuation request nodes: Confirm current receipt of the drug (including via samples or manufacturer assistance), confirm requested quantity/dose is supported by manufacturer's prescribing information or compendia, indicate whether supporting documentation is attached, and confirm dose/frequency is supported for the diagnosis.

Prior Treatment and Step Requirements

Requirement	Details
Evidence of prior treatment or failure
Form asks whether patient has ever received or is currently receiving biologic or targeted synthetic agents and whether there was an inadequate response or intolerance for indications such as ankylosing spondylitis, Behçet's disease, Crohn's disease, and hidradenitis suppurativa; providers must document prior treatment or failure when indicated on the form.

Requirement	Details
Documentation of prior conventional therapy
Form requests documentation of inadequate response, intolerance, or contraindication to conventional synthetic therapies (e.g., methotrexate, leflunomide, sulfasalazine) with adequate dose and duration (for example ≥3 months for methotrexate or specified dosing for sulfasalazine) before approval for several indications such as psoriatic arthritis, reactive arthritis, and rheumatoid arthritis.

Requirement	Details
Document inadequate response, intolerance, or contraindication to prior therapies
For indications including uveitis, acute graft versus host disease, and immune checkpoint inhibitor toxicity the form asks whether the patient had an inadequate response to corticosteroids or immunosuppressive therapy, an intolerance, or a contraindication; providers must document these findings when present.

Requirement	Details
No specific step therapy steps described
For certain listed indications (e.g., sarcoidosis, Takayasu's arteritis) the form does not specify stepwise prior therapy sequences; it instead requires attestation of specialist involvement and that the patient has achieved or maintained a positive clinical response since starting the drug.

Diagnosis, Administration, and Dose-related Codes / Flags

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be provided by ordering site

Diagnosis codesICD-10

Primary ICD Code	Primary diagnosis ICD code to be entered
Secondary ICD Code	Secondary diagnosis ICD code to be entered
Other ICD Code	Additional ICD codes as applicable

Pediatric dosing threshold acknowledgment

Pediatric higher‑dose acknowledgmentFor patients under 18, prescriber must recognize that a dose above 5 mg/kg is a higher dose and confirm that appropriate monitoring will be done.

Applies to which indicationsSpecifically requested on the Crohn's disease checklist for patients <18 years of age.

Form response optionsYes/No checkbox on the precertification form to document prescriber acknowledgement and monitoring plan.

Maximum dose checks

Adult maximum dose checkForm asks whether the prescribed dose exceeds 10 mg/kg (Yes/No).

Rheumatoid arthritis specific checks

How to Request, Submit, and Documentation Requirements

Documentation Required

Required form completion and submission

Prior Authorization and Documentation Requirements — Providers must complete the Avsola precertification form in full and submit all required clinical information. All fields (demographics, insurance, prescriber info, product/dose/frequency, diagnosis, and indication-specific questions) must be completed and legible. Incomplete or illegible forms or missing clinical documentation may prevent precertification review or lead to denial.

All fields on the Avsola Injectable Medication Precertification Request form must be completed and legible for review.
For Medicare Advantage Part B members, use the Medicare request form (do not use the standard form).
Contact Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277.

Prior Authorization

Indication-specific prior authorization

Indication-specific prior authorization — the form includes indication-tailored questions and prior-therapy/step requirements that must be answered. Provide documentation of prior treatments, intolerances, contraindications, and responses where requested.

Administration Site and Justification

Billing Rule

Indicate site of administration and justify outpatient hospital use

Select the site of administration on the form (office, infusion center, outpatient hospital, or home). If the outpatient hospital setting is chosen, provide justification (medical instability, severe adverse event, antibodies to infliximab, severe venous access issues, or significant behavioral/physical/cognitive impairment).

Place of Administration options include: Self-administered, Physician's Office, Outpatient Infusion Center, Home Infusion
If outpatient hospital infusion selected, document the specific justification such as medical instability or severe infusion-related adverse event

Note

Infusion center — use standard precertification contact info

Infusion center administration is an available site option; use the standard precertification contact information on the form for submissions or questions.

Dose and Quantity Checks

Avsola (infliximab-axxq) dose and RA-specific checks

Dose exceedance check (all adults)Form asks whether the prescribed dose exceeds 10 mg/kg (Yes/No).

RA-specific dose/frequency checksFor rheumatoid arthritis the form specifically asks if a dose >3 mg/kg or dosing more frequent than every 8 weeks is required due to incomplete response.

Context of checkThese checks appear in adult dosing sections to document dose escalation or loss of response before approving higher/ more frequent dosing.

Product-specific Notes

Billing Rule

Specify Avsola product name, dose, and frequency

The precertification form is specific to Avsola; include the product name, requested dose, and frequency on the form when requesting authorization.

Request is for: Avsola (infliximab-axxq) — record dose and frequency
Form fields request loading and maintenance dosing where applicable

Note

Form specific to Avsola (infliximab-axxq)

The form is the precertification request specific to Avsola (infliximab-axxq), implying reference to infliximab as the biologic class; complete product-specific fields accordingly.

Form heading: Avsola (infliximab-axxq) Injectable Medication Precertification Request
Include product-specific dosing information to support authorization

Key Definitions and Screening

TB testing (screening methods and timing)

TB screening methodsForm queries TB testing within 6 months and lists PPD (tuberculin skin test), interferon‑release assay (IGRA), and chest x‑ray as options.

Test result optionsThe form requests TB test results be indicated as positive, negative, or unknown.

If positiveForm asks to indicate latent versus active TB and treatment status (treatment initiated, completed, or not initiated).

Definitions: inadequate response, intolerance, and contraindication

Inadequate responseThe form asks whether the patient has experienced an inadequate response to prior therapy (e.g., corticosteroids or conventional agents) as part of clinical justification.

Intolerance

Clinical Background

Avsola (infliximab-axxq) is an intravenous, monoclonal antibody biologic in the tumor necrosis factor (TNF) inhibitor class. The precertification form requests indication-specific dosing (e.g., induction doses at weeks 0, 2 and 6 and maintenance schedules), prior treatment history, specialist involvement, and safety screening such as Tuberculosis (TB) testing within 6 months prior to initiation. These features reflect typical use of infliximab products across multiple inflammatory and immune-mediated conditions.

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Avsola (infliximab-axxq) Injectable Medication Precertification Request — Coverage Criteria