CurrentCignaPolicy N/A

Inflammatory Conditions - Cimzia (certolizumab pegol) Prior Authorization

Coverage and prior authorization criteria for Cimzia (certolizumab pegol) for multiple inflammatory conditions under Cigna health benefit plans; affects prescribers, pharmacists, and utilization reviewers.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Cimzia (certolizumab pegol) Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 19, 2025

Key ActionObtain prior authorization with documentation of required trials and specialist prescribing or consultation as specified for the indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7FDA-approved indications listed

6 monthsInitial approval (most indications)

1 yearRenewal duration (established patients)

YesPrescriber specialty required

Not allowedConcurrent biologic/tso

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Coverage and Medical Necessity Criteria

FDA-Approved Indications (Initial and Continued Therapy rules)

Covered when the indication-specific criteria below are met.

Ankylosing Spondylitis: Approve if ONE of: 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, or serum markers such as CRP/ESR); OR b) compared with baseline patient experienced improvement in at least one symptom (eg, decreased pain or stiffness, improved function).

Crohn's Disease: Approve if ONE of: A) Initial Therapy — Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient meets at least ONE of: a) has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR b) had ileocolonic resection to reduce recurrence; OR c) tried/using corticosteroids or tried one other conventional systemic therapy (examples) or has contraindication/intolerance; AND iii. 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 CRP, imaging such as MRE/CTE, endoscopy, or reduced corticosteroid dose); OR b) compared with baseline patient experienced improvement in at least one symptom (eg, decreased pain, fatigue, stool frequency, or blood in stool).

Juvenile Idiopathic Arthritis (JIA): Approve if ONE of: A) Initial Therapy — Approve for 6 months if ALL: i. Patient is > 2 years of age; AND ii. Patient meets at least ONE of: a) patient has tried one other systemic medication for JIA (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID) or a prior trial of one biologic other than the requested drug counts as a trial; OR b) patient will start therapy concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) patient has an absolute contraindication to methotrexate/sulfasalazine/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; OR b) compared with baseline patient experienced improvement in at least one symptom.

Non-radiographic Axial Spondyloarthritis: Approve if ONE of: A) Initial Therapy — Approve for 6 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Objective signs of inflammation are present (elevated CRP above lab-specific upper limit of normal OR sacroiliitis on 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 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; OR b) compared with baseline patient experienced improvement in at least one symptom.

Plaque Psoriasis: Approve if ONE of: A) Initial Therapy — Approve for 3 months if ALL: i. Patient is ≥ 18 years of age; AND ii. Patient meets at least ONE of: a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months (examples: methotrexate, cyclosporine, acitretin, or a 3-month PUVA trial) unless intolerant; 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 in skin measures (eg, % BSA, erythema, induration/thickness, scale) AND iii. Compared with baseline patient experienced improvement in at least one symptom (eg, decreased pain, itching, burning).

Psoriatic Arthritis: Approve if ONE of: A) Initial Therapy — Approve for 6 months if BOTH: 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 BOTH: 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 improvement in at least one symptom.

Rheumatoid Arthritis: Approve if ONE of: 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: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception: requirement may be waived if patient already had a 3-month trial of at least one biologic other than the requested drug; biosimilars of the requested biologic 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) compared with baseline experienced improvement in at least one symptom (eg, less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).

Initial and Continuation Therapy Criteria (RA and Spondyloarthritis subtypes)

Covered when ONE of the following is met (A or B) for each condition:

Rheumatoid Arthritis - A (Initial Therapy)

RA initial criteria list: i. Patient is ≥ 18 years of age; AND ii. Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception: if patient already had a 3-month trial of at least one biologic other than the requested drug, the DMARD trial may be waived; biosimilars of the requested biologic do not count; patients who have already tried a biologic are not required to 'step back' to a conventional DMARD; AND iii. Medication prescribed by or in consultation with a rheumatologist.

Rheumatoid Arthritis - B (Established Therapy)

RA continuation criteria list: i. Patient has been established on Cimzia for at least 6 months; AND ii. Patient meets at least ONE of the following: a) experienced a beneficial clinical response when assessed by at least one objective measure, OR b) compared with baseline experienced improvement in at least one symptom (eg, less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).

Spondyloarthritis, Other Subtypes - A (Initial Therapy)

Coverage determinations under this policy are subject to the member's specific benefit plan document. In the event of any conflict between this coverage policy and the customer's benefit plan, the customer's benefit plan document supersedes the policy. Review of individual requests should consider the applicable benefit plan terms, any laws or regulations, relevant collateral materials, and the specific clinical facts. Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable benefit plan will be denied as not covered; providers must use the most appropriate codes as of the submission date.

Concurrent use of Cimzia with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary. Combination therapy with multiple biologic or targeted synthetic oral agents is not recommended due to increased risk of adverse events and limited evidence of additive benefit. This exclusion does not prohibit the concomitant use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) with Cimzia.

Services billed for conditions or diagnoses that are not covered under this policy or that are not accompanied by covered diagnosis or procedure codes will be denied as not covered. When submitting claims, providers must ensure they use the most appropriate codes in effect on the date of service to avoid denials.

Administration of Cimzia in combination with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition is explicitly considered not medically necessary and may prompt denial of authorization or claims. The policy clarifies that this restriction does not apply to combination with conventional synthetic DMARDs.

Product Codes, Durations, and Objective Criteria

Covered productNDC | neutralCovered

Cimzia

certolizumab pegol subcutaneous injection (lyophilized powder or solution) — product name as covered

Minimum trial durations for initial approval (typical initial and renewal durations)

Typical initial approval durations3 months for plaque psoriasis; 6 months for ankylosing spondylitis, Crohn's disease, JIA, non‑radiographic axial spondyloarthritis, psoriatic arthritis, and rheumatoid arthritis (per indication-specific initial therapy rules).

Typical renewal/continuation duration1 year for patients currently receiving Cimzia who have been established on therapy for at least 6 months (3 months minimum for psoriasis continuation).

Minimum establishment period for continuationPatient must have been established on therapy for at least 6 months to be eligible for 1‑year renewal (psoriasis continuation requires ≥3 months).

Psoriasis initial trial exceptionInitial approval for plaque psoriasis may be 3 months when the patient meets traditional systemic agent trial requirements (3‑month trial) or exception criteria noted in policy.

Objective inflammation definition (nr-axial spondyloarthritis)

Defined objective inflammation (nr-axSpA)Either C-reactive protein (CRP) elevated beyond the upper limit of normal for the reporting laboratory, OR sacroiliitis reported on magnetic resonance imaging (MRI).

Purpose of definitionRequired for initial therapy approval of non‑radiographic axial spondyloarthritis (patient must have objective signs of inflammation).

Reference to age requirementInitial therapy criteria also require patient is ≥ 18 years of age and medication prescribed by or in consultation with a rheumatologist.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization and Prescriber Specialty

Prior authorization is required for Cimzia. Initial approvals require the drug be prescribed by or in consultation with a specialist who treats the condition (e.g., rheumatologist for RA, dermatologist for psoriasis, gastroenterologist for Crohn's). Approvals are provided for the durations specified in the FDA‑approved indication criteria (months are counted as 30 days).

Initial approvals: generally 6 months for initial therapy unless otherwise specified in indication-specific criteria.
Continuation (patients currently receiving Cimzia): generally 1 year when continuation criteria are met (patient established on therapy ≥ 6 months for most indications; some indications specify ≥ 3 months).

Documentation Required

Objective Response Documentation

Document objective evidence of clinical benefit when requesting continuation/renewal. Evidence may include standardized disease activity scores, laboratory markers, imaging, or clear clinician assessment of symptom improvement. If objective measures are not available, documentation of symptomatic improvement in pain, stiffness, function, or activities of daily living may be acceptable.

Examples of objective measures by condition: ASDAS, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, CRP, ESR for ankylosing spondylitis/spondyloarthritis.
CDAI, DAS28 (ESR or CRP), PAS-II, RAPID-3, SDAI for rheumatoid arthritis.
DAPSA, CPDAI, PsA DAS, LEI, SPARCC, MDA, PsAID-12, CRP, ESR for psoriatic arthritis.
PGA, MD global, JADAS/cJADAS, JSpADA, CRP, ESR for juvenile idiopathic arthritis.
For Crohn's disease: prior and current use of corticosteroids or conventional systemic agents and objective markers of response (e.g., symptom reduction, CRP).

Documentation Required

Disease Activity and Response Documentation

Document baseline disease activity and follow-up assessments to show response to therapy. Provide the baseline value(s) used prior to initiating Cimzia and at least one follow-up assessment demonstrating improvement when seeking continuation.

Include dates for baseline and follow-up measurements and the specific instrument or lab used (e.g., BASDAI decreased from X to Y on MM/DD/YYYY; CRP decreased from A mg/L to B mg/L).
If using symptom-based documentation, describe change from baseline in pain, stiffness, joint swelling, function, or corticosteroid dose reduction.
For continuation requests: show that the patient was established on therapy for the required minimum duration (typically ≥ 6 months for most indications; ≥ 3 months for some psoriasis criteria) and that clinical benefit was achieved during that period.

Step Therapy

Required Prior Trials of Conventional/Systemic Agents

Prior trials of conventional/systemic agents are required as a condition of initial approval for many indications. Document the agent(s) tried, dates of trial, duration (when specified), and reason for discontinuation (lack of efficacy, intolerance, or contraindication). Exceptions may apply if the patient previously had an adequate trial of a biologic other than the requested agent.

Rheumatoid arthritis and many spondyloarthritis subtypes: trial of ONE conventional synthetic DMARD for ≥ 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).
Psoriasis: trial of one traditional systemic agent (e.g., methotrexate, cyclosporine, acitretin) or 3-month PUVA trial; exception if prior adequate trial or intolerance to at least one biologic, Otezla, or Sotyktu.
Crohn's disease: trial of corticosteroids (or documented contraindication) or one other conventional systemic therapy (examples: azathioprine, 6‑mercaptopurine, methotrexate). Note that mesalamine does not count as a systemic agent for Crohn's.
Juvenile idiopathic arthritis: trial of one other systemic medication (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID); a prior trial of one biologic other than the requested drug also counts.
When an exception to step therapy is claimed (e.g., contraindication or prior biologic trial), provide documentation supporting the exception.

Drug 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 used as initial biologic therapy for many of these diseases; the policy applies prior authorization and criteria specific to each FDA-approved indication and requires specialist prescribing or consultation for initial therapy in several indications. Concurrent administration of Cimzia with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary (see exclusions).

Key Definitions and Measures

TNFi definition — class and Cimzia identification

Class definitionTumor necrosis factor inhibitor (TNFi): a class of biologic agents used to treat inflammatory conditions; Cimzia is a TNFi (certolizumab pegol).

Product identificationCimzia (certolizumab pegol) — subcutaneous injection (lyophilized powder or solution) — product named in policy as the covered agent.

Class role in therapyTNFis are commonly recommended as initial biologic therapy in specialty society guidelines for axial spondyloarthritis, Crohn's disease, and other inflammatory conditions.

Objective signs of inflammation (nr-axial spondyloarthritis)

Objective signs of inflammation (nr-axSpA)CRP elevated beyond the laboratory upper limit of normal OR sacroiliitis reported on MRI — at least one required for initial therapy approval.

Use in initial criteriaPresence of objective inflammation is a required element of the initial therapy pathway for non‑radiographic axial spondyloarthritis (with rheumatologist prescribing/consultation).

Verification methodsLaboratory report documenting CRP above normal range or MRI report documenting sacroiliitis are acceptable evidence.

Standardized disease activity measures — list of examples

Examples of standardized measures (psoriatic arthritis)DAPSA, CPDAI, PsA DAS, Minimal Disease Activity (MDA), PsAID-12.

Examples of standardized measures (axial and spondyloarthritis)ASDAS, SPARCC enthesitis score, Leeds Enthesitis Index (LEI), Leeds Dactylitis Instrument Score.

Examples of standardized measures (rheumatoid arthritis and general)Clinical Disease Activity Index (CDAI), DAS28 (ESR or CRP), SDAI, RAPID-3, Patient Activity Scale-II (PAS-II).

Laboratory markersSerum markers such as C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) may be used as objective measures of inflammation/response.