CurrentAvMedPolicy Pub. 100-2

Cimzia (certolizumab) IV prior authorization / step-edit

This form governs prior authorization and step-therapy requirements for AvMed-covered outpatient (medical/IV) administration of Cimzia (certolizumab) and applies to providers requesting coverage for members in North Carolina.

Policy Summary

PayerAvMed

PolicyCimzia (certolizumab) IV prior authorization / step-edit

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with prescriber signature and supporting clinical documentation including prior DMARD trial evidence and required labs/notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1DMARD trial required (minimum)

3 moMinimum DMARD duration

2 yrsMin age for polyarticular JIA

60 daysNSAID trial timeframe

Coverage Criteria

(untitled)

Approval requires ALL checked criteria to be met for the selected diagnosis. To support each checked item, provide complete documentation (lab results, diagnostics, and chart notes); incomplete documentation may delay or result in denial of authorization.

ALL of the following

Patient history and drug information provided: drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code (if applicable), weight and date weight obtained.
Request type indicated: Standard Review (non-urgent) or Urgent Review with justification that lack of treatment would seriously jeopardize life/health or member's ability to regain maximum function.
- Methotrexate

Policy Summary

PayerAvMed

PolicyCimzia (certolizumab) IV prior authorization / step-edit

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with prescriber signature and supporting clinical documentation including prior DMARD trial evidence and required labs/notes.

SourceLink

On This Page

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Diagnosis-specific requirements

Crohn's Disease
- Prescribed by or in consultation with a Gastroenterologist.
- Diagnosed with Crohn's disease.
- Failure of budesonide or high-dose (40-60 mg) prednisone steroids.
- Member tried and failed at least one DMARD for ≥ 3 months (refer to PART A).
Rheumatologic indications (Rheumatoid Arthritis, Psoriatic Arthritis)
- Prescribed by or in consultation with a Rheumatologist.
- Diagnosis of the applicable rheumatologic condition (must be checked).
- Member tried and failed at least one DMARD for ≥ 3 months (refer to PART A).
Axial Spondyloarthritis / Ankylosing Spondylitis
- Prescribed by or in consultation with a Rheumatologist.
- Diagnosis of the applicable axial spondyloarthritis condition (must be checked).
- Member tried and failed at least one DMARD for ≥ 3 months (refer to PART A).
Plaque Psoriasis
- Prescribed by or in consultation with a Dermatologist.
- Diagnosed with moderate-to-severe chronic plaque psoriasis.
- Trial and failure of at least one of either Phototherapy or an alternative systemic therapy for ≥ 3 months. Phototherapy options: UV light therapy, NB UV-B, PUVA. Alternative systemic therapy options: oral medications including acitretin, methotrexate, cyclosporine.
- Trial and failure of two (2) NSAIDs within the last 60 days when applicable.
Polyarticular Juvenile Idiopathic Arthritis
- Prescribed by or in consultation with a Rheumatologist.
- Diagnosed with active polyarticular juvenile idiopathic arthritis.
- Patient is ≥ 2 years of age and weighs ≥ 10 kg.
- Member has tried and failed at least ONE of the following DMARD therapies for ≥ 3 months: cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine, tacrolimus, or has trialed appropriate NSAIDs or oral corticosteroids as indicated.

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J0717

Injection, certolizumab pegol, 1 mg (Cimzia) - billed as Cimzia Lyophilized IV

inv-05: Minimum DMARD trial duration

Minimum prior DMARD trial duration>= 3 months (member must have trial and failure of at least ONE DMARD for at least THREE months; refer to Part A and check each DMARD tried)

DMARDs listed on formmethotrexate; sulfasalazine; azathioprine; leflunomide; auranofin; hydroxychloroquine; other (check box)

Documentation required to support prior DMARDProvide chart notes, lab results, or diagnostics for each checked DMARD therapy tried

inv-06: NSAID trial timeframe

NSAID trial requirementTrial and failure of two (2) NSAIDs within the last 60 days

Applies to diagnosisRequired for ankylosing/axial spondyloarthritis and related axial indications as specified on the form

Documentation to submitProvide chart notes or other documentation demonstrating trials of two NSAIDs within the 60‑day timeframe

inv-07: Minimum age for polyarticular JIA

Minimum age for polyarticular JIA>= 2 years

Minimum weight for polyarticular JIA>= 10 kg

Additional requirementPrescribed by or in consultation with a Rheumatologist

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cimzia (certolizumab) Lyophilized IV billed as J0717 prior to administration. The prescribing physician must sign and clearly print their name on the prior authorization/step-edit request form (preprinted stamps are not valid). Fax completed forms to 1-877-535-1391. For Medicare members, applicable Medicare Coverage Manual (Pub. 100-2) rules, NCDs and LCDs apply.

Drug Requested: Cimzia (certolizumab) Lyophilized IV — J0717 (Medical)
Fax: 1-877-535-1391

Documentation Required

Incomplete Documentation or Form — Delay or Denial Risk

Authorization may be delayed or denied if the request form or documentation is incomplete, incorrect, or illegible. To avoid delays, provide complete supporting documentation with the request, including drug name/form/strength, dosing schedule, length of therapy, diagnosis with ICD code, weight (if applicable) and date weight obtained, relevant lab results, diagnostics, and chart notes. The form must indicate the review type (e.g., Standard Review) when applicable.

Ensure prescriber signature and printed name present (stamps not valid)
Include documentation of prior therapies (e.g., DMARDs, NSAIDs, phototherapy) and duration of trials

Background

Cimzia (certolizumab) is an anti-TNF biologic indicated for multiple inflammatory conditions, including Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis/axial spondyloarthritis, plaque psoriasis, and polyarticular juvenile idiopathic arthritis. The prior authorization form requires specialist involvement appropriate to the diagnosis (for example, rheumatologist, gastroenterologist, or dermatologist) and documentation of prior therapy failures — including a trial and failure of at least one DMARD for a minimum of 3 months for most indications and, for axial disease, trial and failure of two NSAIDs within the last 60 days. Approval is granted only when all checked criteria for the selected diagnosis are met and supporting documentation is provided.

OpenPayer

Cimzia (certolizumab) IV prior authorization / step-edit

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions and Requirements

Background

Definitions