Culinary Health Fund Cimzia Prior Auth Policy

Coverage Criteria for Cimzia (certolizumab pegol)

Ankylosing Spondylitis (Initial and continuation criteria and dosing)

Ankylosing Spondylitis — Covered when ONE of the following is met

Ankylosing Spondylitis: 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 B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH 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: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, CRP, ESR); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

Dosing options: see Approved Dosing Regimens block.

Crohn's Disease (Initial and continuation criteria and dosing)

Crohn's Disease — Covered when ONE of the following is met

Crohn's Disease: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: a) has tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR b) has tried one other conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate); OR c) has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) had ileocolonic resection to reduce chance of recurrence. Note: An exception to steroid/systemic trial requirement can be made if patient already tried at least one biologic other than the requested drug (a biosimilar does not count). AND iii. medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH i. established on therapy ≥ 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: fecal markers such as fecal lactoferrin or calprotectin; serum markers like CRP; imaging such as MRE/CTE; endoscopic assessment; and/or reduced steroid dose); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, blood in stool).

Mesalamine does not count as a systemic agent for Crohn's disease; biosimilars do not count as previous biologic trials.

Juvenile Idiopathic Arthritis (Initial and continuation criteria and dosing)

Juvenile Idiopathic Arthritis (JIA) — Covered when ONE of the following is met

JIA: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is > 2 years of age; AND ii. Patient meets ONE of: a) has tried one other systemic medication for JIA (examples: methotrexate, sulfasalazine, leflunomide, NSAID); OR b) will be starting therapy concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide; OR d) 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 BOTH i. established on therapy ≥ 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: Physician Global Assessment, PGA, PDA, JDAS, cJDAS, JSpADA, CRP, ESR, reduced steroid dose); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., improved limitation of motion, less joint pain/tenderness, decreased duration of morning stiffness or fatigue, improved function or activities of daily living).

Weight-based dosing schedules provided for maintenance (see dosing block).

Non-radiographic Axial Spondyloarthritis (Initial and continuation criteria and dosing)

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

Non-radiographic Axial Spondyloarthritis: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient has objective signs of inflammation defined as at least ONE of: a) CRP elevated beyond the upper limit of normal for the reporting laboratory; OR b) sacroiliitis reported 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 BOTH i. established on therapy ≥ 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 (e.g., decreased pain or stiffness, improved function or activities of daily living).

Examples of objective measures include ASDAS, BASDAI, CRP, etc.; dosing options in dosing block.

Plaque Psoriasis (Initial and continuation criteria and dosing)

Plaque Psoriasis — Covered when ONE of the following is met

Plaque Psoriasis: A) Initial Therapy: Approve for 3 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: a) has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; a 3-month PUVA trial also counts); OR b) prescriber documents a contraindication to methotrexate; AND iii. medication is prescribed by or in consultation with a dermatologist. Note: An exception to the trial requirement can be made if the patient already had a 3-month trial or intolerance to at least one biologic (other than requested drug), apremilast, or deucravacitinib; a biosimilar does not count. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i. established on requested drug ≥ 3 months; AND ii. experienced a beneficial clinical response (improvement in estimated BSA, erythema, induration/thickness, and/or scale); AND iii. compared with baseline, experienced improvement in at least one symptom (e.g., decreased pain, itching, burning).

Dosing for psoriasis: see dosing block; initial approval shorter (3 months).

Psoriatic Arthritis (Initial and continuation criteria and dosing)

Psoriatic Arthritis — Covered when ONE of the following is met

Psoriatic Arthritis: 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. established on requested drug ≥ 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: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, CRP, ESR); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, improved function, decreased soft tissue swelling).

Examples of standardized measures listed in policy.

Rheumatoid Arthritis (partial — initial criteria present)

Rheumatoid Arthritis — Covered when ONE of the following is met

Rheumatoid Arthritis (initial portion): A) Initial Therapy: Approve for 6 months if ALL of the following are met: 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). Note: An exception can be made if the patient already had a 3-month trial of at least one biologic other than the requested drug; a biosimilar does not count. Further continuation criteria and measures appear in subsequent sections of the policy.

Prescriber should be a rheumatologist or consultation with one; continuation criteria appear elsewhere.

Psoriatic Arthritis

Psoriatic arthritis — Covered when ONE of the following is met

Psoriatic Arthritis: Initial OR Continuing: A) Initial Therapy: Approve for 6 months if ALL of: i. Patient is ≥ 18 years; AND ii. medication prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Currently receiving Cimzia: Approve for 1 year if ALL of: i. established on drug ≥ 6 months; AND ii. patient meets at least ONE of: a) objective measure shows beneficial clinical response from baseline; OR b) improvement in at least one symptom vs baseline (e.g., less joint pain, morning stiffness, improved function, decreased soft tissue swelling).see text

Objective measures examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, CRP, ESR.

Approved Dosing Regimens

Dosing regimens allowed

Dosing options: A) Initial Therapy (induction): 400 mg subcutaneously at Weeks 0, 2, and 4 (approve) followed by ONE of: i. 400 mg SC every 4 weeks; OR ii. 200 mg SC every 2 weeks. OR B) For Initial or Continuation: 400 mg SC every 4 weeks. OR C) For Initial or Continuation: 200 mg SC every 2 weeks. Note: For JIA pediatric weight‑based maintenance dosing: 10–<20 kg: 100 mg at 0,2,4 weeks then 50 mg q2w; 20–<40 kg: 200 mg at 0,2,4 weeks then 100 mg q2w; ≥40 kg: 400 mg at 0,2,4 weeks then 200 mg q2w.

Dosing alternative: For plaque psoriasis, initial/continuation options include 400 mg SC every 2 weeks or 200 mg SC every 2 weeks per indication-specific language.

Rheumatoid Arthritis

Rheumatoid arthritis — Covered when ONE of the following is met

Rheumatoid Arthritis: Initial OR Continuing: A) Initial Therapy: Approve for 6 months if ALL of: i. Patient is ≥ 18 years; AND ii. patient has tried ONE conventional synthetic DMARD for ≥ 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) OR exception if patient already had a 3‑month trial of at least one biologic other than the requested drug (a biosimilar does 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 of: i. established on requested drug ≥ 6 months; AND ii. patient meets at least ONE of: a) beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28‑ESR/CRP, PAS‑II, RAPID‑3, SDAI); OR b) improvement in at least one symptom (decreased joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling).see text

Biologic prior trial exempts DMARD requirement; biosimilars do not count toward that biologic trial.

Other Spondyloarthritis Subtypes

Spondyloarthritis, other subtypes — Covered when ONE of the following is met

Other Spondyloarthritis: Initial OR Continuing: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years; AND ii. arthritis primarily in peripheral joints (knees, ankles, elbows, wrists, hands, and/or feet); AND iii. Patient has tried at least ONE conventional synthetic DMARD (examples: 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 of: i. established on requested drug ≥ 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: ASDAS, CRP, ESR); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).see text

Examples of other subtypes include undifferentiated arthritis and reactive arthritis (Reiter's disease).

For Crohn's disease prior-therapy requirements, a trial of mesalamine does not count as a systemic agent and therefore is not acceptable to satisfy the policy's prior-therapy requirement for initial approval.

Concurrent administration of Cimzia with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not recommended. Combination therapy may increase adverse events and lacks controlled data showing additional benefit; conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) may be continued with Cimzia.

Coverage is not recommended for uses or circumstances that are not specifically listed in the policy's Recommended Authorization Criteria. The criteria will be updated as new published data become available; requests for indications outside the listed criteria should not be approved absent supporting evidence described in the policy.

Definitions and Dosing Terms

Induction dosing

Standard induction regimen400 mg subcutaneously at Weeks 0, 2, and 4 (approved induction dosing)

Pediatric JIA weight-based inductionFor patients 10 kg to <20 kg: 100 mg at 0, 2, and 4 weeks; 20 to <40 kg: 200 mg at 0, 2, and 4 weeks; ≥40 kg: 400 mg at 0, 2, and 4 weeks

Induction purposeInitiates therapy prior to transition to maintenance dosing for indications such as Crohn's disease, AS, nr-axSpA, JIA, PsA, PsO, RA

Maintenance dosing

Primary maintenance optionsEither 400 mg subcutaneously once every 4 weeks (can be given as two 200 mg injections q4w) or 200 mg subcutaneously every 2 weeks

Psoriasis maintenanceFor plaque psoriasis maintenance dosing is 400 mg given every 2 weeks

Prescriber and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cimzia (certolizumab pegol). Requests should document indication, prior therapy (when applicable), and meet the clinical criteria and dosing outlined in this policy. Initial approvals require the medication to be prescribed by or in consultation with a specialist appropriate to the condition (e.g., rheumatologist, gastroenterologist, dermatologist, or pediatric rheumatologist as applicable).

Applies to all indications listed in the policy.
Automation: None.
Initial prescribing or documented specialist consultation required.

Denial Risk

Nonstandard Dosing Risk

Nonstandard dosing (any request for doses, dose intervals, or cumulative doses outside the regimens specified in the FDA-approved dosing and the Dosing sections of this policy) carries a higher risk of denial and will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Provide clinical justification and supportive documentation when requesting nonstandard dosing.

Product and Billing Codes

Neutral — Product Listing (NDC/HCPCS not explicitly listed)mixed

Adalimumab (Humira, biosimilars)	Subcutaneous TNF inhibitor — indications: AS, CD, JIA, PsO, PsA, RA, UC. NDC/HCPCS codes not specified in source.
Certolizumab pegol (Cimzia)	Subcutaneous TNF inhibitor — indications: AS, CD, JIA, nr-axSpA, PsO, PsA, RA. NDC/HCPCS codes not specified in source.
Etanercept (Enbrel, biosimilars)	Subcutaneous TNF inhibitor — indications: AS, JIA, PsO, PsA, RA. NDC/HCPCS codes not specified in source.
Infliximab (Remicade, biosimilars)	Intravenous TNF inhibitor — indications: AS, CD, PsO, PsA, RA, UC. NDC/HCPCS codes not specified in source.
Infliximab-dyyb (Zymfentra)	Subcutaneous infliximab formulation — indications: CD, UC. NDC/HCPCS codes not specified in source.
Golimumab (Simponi, Simponi Aria)	SC and IV TNF inhibitor — SC indications: AS, PsA, RA, UC; IV indications: AS, PJIA, PsA, RA. NDC/HCPCS codes not specified in source.
Tocilizumab (Actemra and biosimilars)	IV (and SC formulations) IL-6 receptor inhibitor — product listing present; NDC/HCPCS codes not specified in source.
Guselkumab (SC and IV)	IL-23 inhibitor — SC indications: CD, PsA, PsO, UC; IV formulation listed for CD, UC. NDC/HCPCS codes not specified in source.
Vedolizumab (Entyvio) IV and SC	Integrin receptor antagonist — indications: CD, UC. NDC/HCPCS codes not specified in source.
Apremilast (Otezla, Otezla XR)	Oral PDE4 inhibitor — indications: PsO, PsA. NDC/HCPCS codes not specified in source.

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Background

Background: Cimzia (certolizumab pegol) is a tumor necrosis factor inhibitor indicated for multiple inflammatory diseases including ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, non-radiographic axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Prior authorization is recommended for medical benefit coverage; dosing regimens, specialist prescribing requirements, and prior-therapy steps vary by indication. Concurrent use with another biologic or a targeted synthetic oral small molecule for an inflammatory condition is not recommended.

OpenPayer

Inflammatory Conditions - Cimzia Utilization Management Medical Policy

Coverage Criteria for Cimzia (certolizumab pegol)

Definitions and Dosing Terms

Prescriber and Authorization Requirements

Product and Billing Codes

Background