Culinary Health Fund Cimzia Policy Update

Indication-specific Coverage Criteria

Ankylosing Spondylitis

Approve when meeting ONE of the following (A or B)

Ankylosing Spondylitis A or B: A) Initial Therapy — Approve for 6 months if ALL of: 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 of: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: ASDAS, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, or serum markers such as CRP or ESR); OR b) improvement in at least one symptom compared with baseline (eg decreased pain or stiffness, improved function or activities of daily living).

Crohn's Disease

Approve when meeting ONE of the following (A or B)

Crohn's Disease A or B: A) Initial Therapy — Approve for 6 months if ALL of: 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 of: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: fecal markers such as fecal lactoferrin or calprotectin, serum markers such as CRP, imaging studies [MRE/CTE], endoscopic assessment, or reduced corticosteroid dose); OR b) improvement in at least one symptom compared with baseline (eg decreased pain, fatigue, stool frequency, and/or blood in stool).

Juvenile Idiopathic Arthritis (JIA)

Approve when meeting ONE of the following (A or B)

JIA A or B: A) Initial Therapy — Approve for 6 months if ALL of: i. Patient is > 2 years of age; AND ii. Patient meets ONE of: a) tried one other systemic medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID); OR b) starting concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) absolute contraindication to methotrexate, sulfasalazine, or leflunomide; OR d) 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 of: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: MD global, PGA, PDA, JADAS, cJADAS, JSpADA, or serum markers such as CRP/ESR, or reduced corticosteroid dose); OR b) improvement in at least one symptom compared with baseline (eg less joint pain/tenderness, decreased duration of morning stiffness, improved function or activities of daily living).

Non-radiographic Axial Spondyloarthritis

Approve when meeting ONE of the following (A or B)

Non-radiographic Axial Spondyloarthritis A or B: A) Initial Therapy — Approve for 6 months if ALL of: 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 of: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: ASDAS or serum markers such as CRP/ESR); OR b) improvement in at least one symptom compared with baseline (eg decreased pain or stiffness, improved function or activities of daily living).

Plaque Psoriasis

Approve when meeting ONE of the following (A or B)

Plaque Psoriasis A or B: A) Initial Therapy — Approve for 3 months if ALL of: 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 (examples: methotrexate, cyclosporine, acitretin, or a 3-month trial of PUVA) unless intolerant; OR b) prescriber documents 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 of: 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, erythema, induration/thickness, and/or scale; AND iii. Compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain, itching, or burning).

Psoriatic Arthritis

Approve when meeting ONE of the following (A or B)

Psoriatic Arthritis A or B: 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) beneficial response by at least one objective measure (examples: DAPSA, CPDAI, PsA DAS, LEI, SPARCC, MDA, PsAID-12, or serum markers such as CRP/ESR); OR b) improvement in at least one symptom compared with baseline (eg less joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling).

Rheumatoid Arthritis

Approve when meeting ONE of the following (A or B)

Rheumatoid Arthritis A or B: A) Initial Therapy — Approve for 6 months if ALL of: 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) unless exception applies; 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. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI); OR b) improvement in at least one symptom compared with baseline (eg decreased joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling).

Rheumatoid Arthritis

Covered when ONE of the following is met

RA A or B: A) Initial Therapy: Approve for 6 months if ALL of (i, ii, iii) are met; OR B) Currently Receiving Cimzia: Approve for 1 year if BOTH (i and ii) are met.

RA A - Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient has tried ONE conventional synthetic DMARD for at least 3 months; AND iii. Medication is prescribed by or in consultation with a rheumatologist;

Exception: a previous 3-month trial of at least one biologic other than the requested drug may substitute for the conventional DMARD requirement; a biosimilar of the requested biologic does not count.

RA B - Currently Receiving Cimzia: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: (a) beneficial clinical response by objective measure OR (b) improvement in at least one symptom (eg decreased joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling).

If <6 months or restarting, review under Initial Therapy.

Spondyloarthritis, Other Subtypes

Covered when ONE of the following is met

Spondyloarthritis A or B: A) Initial Therapy: Approve for 6 months if ALL of (i-iv) are met; OR B) Currently Receiving Cimzia: Approve for 1 year if BOTH (i and ii) are met.

Spondyloarthritis A - Initial Therapy: i. Patient is ≥ 18 years of age; 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;

Spondyloarthritis B - Currently Receiving Cimzia: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: (a) beneficial clinical response by at least one objective measure (examples: ASDAS, CRP, ESR) OR (b) improvement in at least one symptom such as decreased pain or stiffness or improved function.

If <6 months or restarting, review under Initial Therapy.

Dosing

Approved dosing (ONE of the following regimens):

Dosing A: Initial Therapy dosing: 400 mg subcutaneously at Weeks 0, 2, and 4 (induction), then either: i. 400 mg subcutaneously not more frequently than once every 4 weeks; OR ii. 200 mg subcutaneously not more frequently than once every 2 weeks.

Dosing B: For Initial or Continuation: 400 mg subcutaneously not more frequently than once every 4 weeks.

Dosing C: For Initial or Continuation: 200 mg subcutaneously not more frequently than once every 2 weeks.

A biosimilar of the requested biologic does not count as a prior trial of the requested biologic for step-therapy requirements. For example, a prior trial of a biosimilar may not be used to satisfy the policy requirement that the patient previously tried the specific biologic agent requested. This distinction is explicitly noted in the plaque psoriasis criteria where exceptions and substitutions are described.

Coverage is not recommended when Cimzia is prescribed concurrently with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition. Requests for combination therapy with another biologic or a targeted synthetic oral small molecule should be denied unless the concurrent use is specifically listed in the Recommended Authorization Criteria.

Combination use of Cimzia with another biologic or a targeted synthetic oral small molecule drug is not recommended primarily because it is associated with a potentially higher rate of adverse events and because there is a lack of controlled clinical data supporting additive efficacy. The policy therefore disallows routine concurrent biologic or targeted synthetic oral small molecule therapy except where specific criteria explicitly permit it.

Prescriber Requirements & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Cimzia. Approval is provided only when the patient meets the documented criteria and dosing for the requested indication. Initial approval requires the medication to be prescribed by, or in consultation with, a physician who specializes in the condition being treated (e.g., rheumatologist for RA, ankylosing spondylitis, spondyloarthritis; dermatologist for psoriasis; pediatric rheumatologist for JIA where applicable). Requests for doses outside the established dosing documented in the policy will be considered on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist) and may be denied. Automation: None.

Prior authorization recommended for medical benefit coverage of Cimzia.
Initial prescriber requirement: must be prescribed by or in consultation with a specialist for the treated condition.

Documentation Required

Clinical Response Documentation Required for Continuation

For continuation/renewal approvals, documentation must show that the patient experienced a beneficial clinical response to Cimzia compared with baseline (prior to initiating therapy) as demonstrated by at least one objective measure OR improvement in at least one symptom (for example, decreased pain or stiffness, improved function or activities of daily living, or decreased swelling). Examples of objective measures referenced in the policy include disease‑specific validated scores such as ASDAS, BASDAI, BASFI, CDAI, DAS28 (ESR or CRP), RAPID‑3, SDAI, PAS‑II, ASQoL, and relevant serum markers (e.g., CRP, ESR). For pediatric indications, use age‑appropriate validated measures where available.

Dosing, Induction, and Activity Measures

Induction dosing — Initial dosing of 400 mg subcutaneously at Weeks 0, 2, and 4

Induction dosing400 mg subcutaneously at Weeks 0, 2, and 4.

Pediatric weight-based induction (JIA)For patients ≥40 kg: 400 mg initially and at Weeks 2 and 4; lower weight bands have proportionate dosing (eg, 200 mg or 100 mg schedules).

Psoriasis induction notePsoriasis maintenance differs (see maintenance dosing); induction remains 400 mg at Weeks 0, 2, and 4.

Maintenance dosing (adult) — 400 mg q4w or 200 mg q2w options referenced

Maintenance dosing option — q4w400 mg administered subcutaneously not more frequently than once every 4 weeks.

Maintenance dosing option — q2w200 mg administered subcutaneously not more frequently than once every 2 weeks.

Clinical Background

Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) inhibitor 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. It may be used as monotherapy or in combination with conventional synthetic DMARDs and has defined induction and maintenance dosing options (for example, induction of 400 mg subcutaneously at Weeks 0, 2, and 4, followed by maintenance regimens).

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Inflammatory Conditions - Cimzia Utilization Management Medical Policy

Indication-specific Coverage Criteria

Prescriber Requirements & Documentation

Dosing, Induction, and Activity Measures

Clinical Background