ModifiedUnitedHealthcarePolicy N/A

Cimzia (certolizumab) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and reauthorization criteria for Cimzia (certolizumab) for multiple labeled indications, and who may prescribe; applies to pharmacy benefit medical necessity determinations.

Policy Summary

PayerUnitedHealthcare

PolicyCimzia (certolizumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeMaterial: combination-therapy exclusion and pJIA added

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating diagnosis, required prior therapy trials or documented prior Cimzia use, and confirm patient is not receiving another targeted immunomodulator.

SourceLink

POLICY UPDATE CHANGES

Updated not receiving in combination language to targeted immunomodulator and updated examples.

Added coverage criteria for pediatric juvenile idiopathic arthritis (pJIA).

For Connecticut, Kentucky and Mississippi business only a 30-day trial will be required.

Removed prescriber requirement from reauthorization criteria (historical change noted).

12 monthsauthorization duration

multiplecovered diagnoses

specialistprescriber requirement

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requiredno concurrent targeted immunomodulator

30-day (CT/KY/MS)state-specific trial

annualreview frequency

Coverage and Clinical Criteria

Initial Authorization — Crohn's disease

Cimzia will be approved when ALL of the following are met:

Diagnosis of moderately to severely active Crohn's disease

Prior therapy: One of: (a) history of failure to one of the following conventional therapies at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (document drug, date, and duration of trial): corticosteroids (eg, prednisone, methylprednisolone, budesonide), azathioprine, 6-mercaptopurine, or methotrexate; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for Crohn's disease as documented by claims history or medical records (document drug, date, and duration of therapy); OR (c) patient is currently on Cimzia therapy as documented by claims history or medical records (document date and duration of therapy)

When claiming current Cimzia use, patients established solely via manufacturer samples or CIMplicity assistance must meet initial authorization criteria as new to therapy.

Concomitant therapy: Patient is not receiving Cimzia in combination with another targeted immunomodulator

Examples listed include Enbrel (etanercept), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Stelara (ustekinumab), Skyrizi (risankizumab).

Prescriber: Prescribed by or in consultation with a gastroenterologist

Initial Authorization — Rheumatoid arthritis

Cimzia will be approved when ALL of the following are met:

Diagnosis of moderately to severely active rheumatoid arthritis

Prior therapy: One of: (a) history of failure to a 3‑month trial of one non‑biologic DMARD (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (document date and duration of trial); OR (b) prior treatment with a targeted immunomodulator FDA‑approved for rheumatoid arthritis as documented by claims or medical records (document drug, date, and duration of therapy); OR (c) patient is currently on Cimzia therapy as documented by claims history or medical records (document date and duration of therapy)

Patients established via manufacturer sample or CIMplicity assistance must meet initial authorization criteria as new to therapy.

Concomitant therapy: Patient is not receiving Cimzia in combination with another targeted immunomodulator

Prescriber:

Initial Authorization — Psoriatic arthritis

Cimzia will be approved when ALL of the following are met:

Diagnosis of active psoriatic arthritis

Prior therapy: One of: (a) history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated or clinically significant adverse effects are experienced (document date and duration of trial); OR (b) prior treatment with a targeted immunomodulator FDA‑approved for psoriatic arthritis as documented by claims or medical records (document drug, date, and duration of therapy); OR (c) patient is currently on Cimzia therapy as documented by claims history or medical records (document date and duration of therapy)

Patients established via manufacturer sample or CIMplicity assistance must meet initial authorization criteria as new to therapy.

Concomitant therapy: Patient is not receiving Cimzia in combination with another targeted immunomodulator

Examples listed include Enbrel (etanercept), adalimumab, Simponi (golimumab), Orencia (abatacept), Stelara (ustekinumab), Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekizumab), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Otezla (apremilast).

Reauthorization (general across indications)

Reauthorization will be approved when ALL of the following are met:

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concomitant therapy: Patient is not receiving Cimzia in combination with another targeted immunomodulator

Authorization will be issued for 12 months upon approval.

Initial authorization — ankylosing spondylitis / non-radiographic axial spondyloarthritis