Prior Authorization Required

Prior authorization is required for Cimzia. Initial authorizations are typically issued for 12 months. Requests for continuation/renewal also require prior authorization and, when approved, authorizations are generally issued for 12 months.

• Initial authorization duration: 12 months (unless otherwise specified).
• Continuation/renewal authorization duration: 12 months (documentation of ongoing response required).

Authorization Duration and Renewal Requirements

Authorization renewal requires documentation of a positive clinical response to Cimzia. Renewal requests must include clinical notes or other objective information demonstrating treatment benefit since the prior authorization period.

• Include objective evidence of improvement (e.g., disease activity scores, clinician assessment, decrease in steroid use, improved signs/symptoms).
• Lack of documentation of positive clinical response may result in denial or reduced authorization duration.

Prior Authorization Requirements

All prior authorization requests must document that the patient meets the coverage criteria for the requested indication. This includes the specific diagnosis, required prior trials or intolerances, dosing per FDA labeling, absence of contraindicated concurrent systemic targeted immunomodulators for the same indication, and any required prescriber attestations or specialist involvement.

• Document prior treatment history (agents, doses, durations, and reason for discontinuation: lack of response, intolerance, or contraindication).
• Confirm Cimzia dosing and titration per FDA labeling for the indicated condition.
• If request is for combination therapy with another systemic targeted immunomodulator for the same indication, state that combination therapy is NOT allowed.

Use Listed ICD-10 Diagnosis Code

Use the applicable ICD-10-CM diagnosis code(s) that correspond specifically to the patient’s diagnosed site and subclass. Missing or incorrect diagnosis coding may result in nonpayment or denial of the request.

• Select one of the listed ICD-10 codes from the policy's coding section that matches the diagnosed condition and anatomic site.
• Ensure codes are current and specific (site, laterality, and complication codes where applicable).

Denial Triggers

Failure to provide required information may trigger denial. Common denial triggers include missing prescriber attestation when required, absence of documentation of prior therapies or trial durations, lack of specialist consultation when indicated, use of non‑covered combination systemic targeted immunomodulators for the same indication, and failure to document positive response for continuation requests.

• Missing prescriber attestation (explanation why patient/caregiver cannot self‑administer) may result in denial.
• Requesting Cimzia in combination with another systemic targeted immunomodulator for the same indication may result in denial.
• Insufficient prior-treatment documentation or missing objective response data for renewals may result in denial.

Prescriber Attestation and Specialty Involvement

Certain indications require a prescriber attestation that the patient or caregiver cannot be trained or is physically unable to administer Cimzia for self-administration. When required, the attestation must include an explanation and, for some indications, the request must be prescribed by or in consultation with a specialist (gastroenterologist, rheumatologist, or dermatologist as specified by indication).

• Submit a written prescriber attestation explaining why the patient or caregiver cannot self-administer when applicable.
• Indication-specific specialist requirement examples: Crohn's disease – gastroenterologist; PsA, AS, nr-axSpA, PJIA – rheumatologist; Plaque psoriasis – dermatologist or consultation with dermatologist.
• Failure to include required attestation or specialist consultation documentation may result in denial.

Code-Specific Documentation Guidance

Code-specific documentation must align the selected ICD-10-CM diagnosis code with the clinical diagnosis and site. Provide medical record evidence supporting the coded diagnosis (e.g., physical exam findings, imaging reports, lab results) to avoid coding-related denials.

• Ensure the ICD-10 code selected matches the diagnosed condition and anatomic site/subclass.
• Attach supporting documentation (notes, test results) that corroborate the diagnosis code.

Required Prior Trials for Initial Therapy

Initial therapy requests must document required prior trials unless the patient meets an alternative pathway (e.g., prior systemic targeted immunomodulator exposure or current use of Cimzia). Examples: Crohn's disease requires inadequate response to conventional therapies; RA requires failure/intolerance to a 3‑month trial of a non-biologic DMARD or prior biologic; PsA and psoriatic conditions require methotrexate trial or prior systemic targeted immunomodulator as specified.

• Provide dates, agents, doses, and reasons for discontinuation of prior therapies.
• If prior trials were not completed due to contraindication or adverse effects, include clinical rationale.
• If patient previously received an FDA‑approved systemic targeted immunomodulator for the indication, include details of that therapy.

Step Requirements for Plaque Psoriasis

For plaque psoriasis, step requirements include failure of topical therapy and a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated or intolerant. Alternatively, prior treatment with an FDA‑approved systemic targeted immunomodulator for plaque psoriasis is an acceptable pathway.

• Document failure of topical agents (examples listed in policy) and the methotrexate 3‑month trial with dose and response.
• If methotrexate is contraindicated or not tolerated, provide supporting clinical rationale and documentation.

Step Therapy Note

Step therapy note: when documenting prior therapies, include examples and lists of systemic targeted immunomodulators relevant to each indication. Requests for combination therapy with another systemic targeted immunomodulator for the same indication will not meet criteria.

• Examples of systemic targeted immunomodulators (non-exhaustive) appear in the policy per indication — reference the policy lists when documenting prior biologic exposure.
• Concurrent use of Cimzia plus another systemic targeted immunomodulator for the same indication is not permitted and will be a basis for denial.