Cigna Cimzia Prior Auth Policy Update

Indication-specific Coverage Criteria

inv-01: Ankylosing Spondylitis — Covered when ONE of the following is met

Covered when ONE of the following is met:

Ankylosing Spondylitis - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers such as CRP or ESR); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

inv-02: Crohn's Disease — Covered when ONE of the following is met

Covered when ONE of the following is met:

Crohn's Disease - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers such as fecal lactoferrin or fecal calprotectin, serum markers such as CRP, imaging studies [MRE, CTE], endoscopic assessment, and/or reduced corticosteroid dose); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

inv-03: Juvenile Idiopathic Arthritis (JIA) — Covered when ONE of the following is met

Covered when ONE of the following is met:

JIA - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is > 2 years of age; AND ii. Patient meets ONE of: a) Patient has tried one other systemic medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID; a previous trial of one biologic other than the requested drug counts; biosimilars do not count); OR b) Patient will be starting therapy concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) Patient has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide; OR d) Patient has aggressive disease as determined by the prescriber; AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers such as CRP or ESR, and/or reduced corticosteroid dose); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved limitation of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, improved function or activities of daily living).

inv-04: Non-radiographic Axial Spondyloarthritis — Covered when ONE of the following is met

Covered when ONE of the following is met:

Non-radiographic Axial Spondyloarthritis - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient has objective signs of inflammation defined as at least ONE of: a) C-reactive protein (CRP) elevated beyond the upper limit of normal for the reporting laboratory; OR b) Sacroiliitis reported on magnetic resonance imaging (MRI); AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

inv-05: Plaque Psoriasis — Covered when ONE of the following is met

Covered when ONE of the following is met:

Plaque Psoriasis - Initial or Ongoing: A) Initial Therapy: Approve for 3 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: a) Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples include methotrexate, cyclosporine, or acitretin; a 3-month trial of PUVA also counts); OR b) Patient has a contraindication to methotrexate; AND iii. Medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 3 months; AND ii. Patient experienced a beneficial clinical response defined as improvement from baseline in at least one of: estimated body surface area affected by psoriasis, erythema, induration/thickness, and/or scale; AND iii. Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).

inv-06: Psoriatic Arthritis — Covered when ONE of the following is met

Covered when ONE of the following is met:

Psoriatic Arthritis - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples of validated measures include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and/or serum markers such as CRP or ESR); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).

inv-07: Rheumatoid Arthritis — Covered when ONE of the following is met

Covered when ONE of the following is met:

Rheumatoid Arthritis - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless exception applies (a prior 3-month trial of at least one biologic other than the requested drug); AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI, CDAI); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).

inv-08: Initial and Continuing Therapy — Rheumatoid Arthritis (Rheumatoid Arthritis — Covered when ONE of the following is met)

Rheumatoid Arthritis — Covered when ONE of the following is met

Rheumatoid Arthritis: initial or continuing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient has tried ONE conventional synthetic DMARD for at least 3 months (exceptions if patient already had a 3-month trial of at least one biologic other than the requested drug; biosimilars do not count); AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) Experienced a beneficial clinical response when assessed by at least one objective measure; OR b) Experienced improvement in at least one symptom such as decreased joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).

inv-09: Initial and Continuing Therapy — Spondyloarthritis (other subtypes) — Covered when ONE of the following is met

Spondyloarthritis, Other Subtypes — Covered when ONE of the following is met

Spondyloarthritis other subtypes: initial or continuing: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Arthritis primarily involves peripheral joints (knees, ankles, elbows, wrists, hands, and/or feet); AND iii. Patient has tried at least ONE conventional synthetic DMARD (examples include methotrexate, leflunomide, sulfasalazine); AND iv. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS, CRP, ESR); OR b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function).

Coverage determinations are ultimately governed by the terms of the member's applicable benefit plan document and any applicable laws or regulations. While this policy defines clinical criteria for Cimzia (certolizumab pegol), those criteria do not override a customer's specific benefit plan exclusions or limits. If the benefit plan contains a specific exclusion or more restrictive language related to a requested service or diagnosis, the benefit plan controls and the request should be evaluated in that context. Claims for services that lack a covered diagnosis or procedure code under the applicable coverage policy will be denied as not covered.

Requests for Cimzia in combination with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition are considered not medically necessary and are excluded from coverage. This policy therefore does not support concurrent administration of Cimzia plus another biologic or plus a targeted synthetic oral small molecule used to treat inflammatory diseases. Note: this exclusion does not apply to conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine), which may be used in combination with Cimzia when clinically appropriate.

Combination therapy with Cimzia and another biologic or a targeted synthetic oral small molecule is specifically disallowed because of a higher potential for adverse events and a lack of controlled clinical evidence demonstrating additive benefit. When evaluating requests, reviewers should confirm that the requested regimen does not include a second biologic or a targeted synthetic oral small molecule; concomitant use of conventional synthetic DMARDs is permitted and is not considered a combination biologic/targeted‑synthetic regimen.

Prior Authorization, Documentation & Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cimzia for prescription benefit coverage. Initial and continuation requests must include supporting documentation as noted below. All approvals are provided for the durations specified in the FDA‑approved and supportive‑evidence criteria (1 month = 30 days). Initial approval requires the drug be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required for all indications listed in the policy.
Initial approvals measured in months — 1 month = 30 days.
Prescriber requirement: prescribed by or in consultation with a specialist in the treated condition (e.g., rheumatologist, gastroenterologist, dermatologist)

Documentation Required

Initial and Continuation Therapy Criteria

Initial therapy and continuation (currently receiving) requests are reviewed under separate criteria. Initial therapy approvals are typically shorter (3–6 months depending on indication); continuation requests require evidence the patient has been established on therapy for the minimum duration specified (commonly ≥3 or ≥6 months) and demonstrate benefit.

Definitions and Objective Measures

Objective signs of inflammation — examples

Elevated C-reactive protein (CRP)CRP above the laboratory reference range (e.g., 'elevated CRP' as an objective sign of inflammation)

Sacroiliitis on MRIImaging evidence of sacroiliitis reported on magnetic resonance imaging (specific to non-radiographic axial spondyloarthritis)

Other objective inflammatory markersSerum markers such as erythrocyte sedimentation rate (ESR) indicating inflammation

Objective measures of disease activity — examples

DAS28, CDAI, SDAIValidated composite measures for rheumatoid arthritis (examples cited include DAS28-ESR/CRP, CDAI, SDAI)

PAS-II, RAPID-3Standardized patient-reported or composite indices used to assess disease activity in rheumatoid arthritis (examples listed: PAS-II, RAPID-3)

Policy Background

Cimzia (certolizumab pegol) is a tumor necrosis factor inhibitor (TNFi) indicated for multiple inflammatory conditions including ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, non‑radiographic axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. TNFis are commonly recommended in specialty guidelines as a biologic treatment option for these conditions. Cimzia may be used as monotherapy or in combination with conventional synthetic DMARDs when appropriate and supported by the indication-specific coverage criteria.

Policy Changes & Effective Dates

2024-10-02additionLatest

Juvenile Idiopathic Arthritis was added as a newly approved condition to the policy.

2024-09-11revision

Multiple indications (Ankylosing Spondylitis, Non‑Radiographic Axial Spondyloarthritis, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis other subtypes) had age ≥18 requirement added for initial approvals and clarifications to traditional systemic therapy examples for plaque psoriasis; Conditions Not Covered language for concurrent use with biologic or targeted synthetic oral small molecule drugs was revised.

2024-03-27revision

OpenPayer

Inflammatory Conditions - Cimzia Prior Authorization Policy

Indication-specific Coverage Criteria

Prior Authorization, Documentation & Step Therapy

Definitions and Objective Measures

Policy Background

Policy Changes & Effective Dates