UnitedHealthcare Cimzia medical benefit Coverage update

Coverage Criteria for Provider-Administered Cimzia (lyophilized)

Crohn's disease (CD) — Initial and continuation

Covered when ALL of the following are met

CD initial: Diagnosis of moderately to severely active Crohn's disease

chunk 4

Prior conventional therapy: History of failure to one conventional therapy (corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate) at maximally indicated doses unless contraindicated or intolerant

chunk 4

Prior targeted immunomodulator: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for Crohn's disease OR history of failure/contraindication/intolerance to one targeted immunomodulator (document drug, date, duration) OR patient is currently on Cimzia; prescriber attestation that patient/caregiver cannot self-administer is required

chunk 4, chunk 5

Additional conditions: Cimzia must be initiated and titrated per FDA-labeled dosing; patient must not be receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a gastroenterologist

chunk 5

Authorization length: Initial authorization issued for 12 months; continuation requires documentation of positive clinical response, continued prescriber attestation if applicable, and adherence to FDA dosing; continuation authorization issued for 12 months

chunk 6

Rheumatoid arthritis (RA) — Initial and continuation

Covered when ALL of the following are met

RA diagnosis: Diagnosis of moderately to severely active rheumatoid arthritis

chunk 6

Prior non-biologic DMARD: History of failure or intolerance to a 3-month trial of one non-biologic DMARD at maximally indicated doses (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) OR prior treatment with a systemic targeted immunomodulator for RA

chunk 6

Prior targeted immunomodulators: History of failure/contraindication/intolerance to two targeted immunomodulators (document drugs, dates, durations) OR patient currently on Cimzia; prescriber attestation that patient/caregiver cannot self-administer is required

chunk 7

Additional conditions:

Psoriatic arthritis (PsA) — Initial and continuation

Covered when ALL of the following are met

PsA diagnosis: Diagnosis of active psoriatic arthritis

chunk 8

Prior methotrexate: History of failure to a 3-month trial of methotrexate at the maximally indicated dose unless contraindicated OR prior treatment with a systemic targeted immunomodulator for PsA

chunk 8

Prior targeted immunomodulators: History of failure/contraindication/intolerance to two targeted immunomodulators (document drug, date, duration) OR patient is currently on Cimzia; prescriber attestation that patient/caregiver cannot self-administer is required

chunk 8, chunk 9

Additional conditions: Cimzia must be initiated and titrated per FDA-labeled dosing for PsA; patient must not be receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a rheumatologist or dermatologist

Ankylosing spondylitis (AS) / non-radiographic axial spondyloarthritis (nr-axSpA) — Initial and continuation

Covered when ALL of the following are met

AS/nr-axSpA diagnosis: Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis

chunk 11

Prior NSAIDs: History of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated OR prior treatment with a systemic targeted immunomodulator for AS/nr-axSpA

chunk 11

Prior targeted immunomodulator: History of failure/contraindication/intolerance to one targeted immunomodulator (document drug, date, duration) OR patient is currently on Cimzia; prescriber attestation required

chunk 11

Additional conditions:

Plaque psoriasis (PS) — Initial and continuation

Covered when ALL of the following are met

PS diagnosis: Diagnosis of moderate to severe plaque psoriasis

chunk 13

Disease severity or location: >=3% body surface area involvement or palmoplantar, facial, genital involvement, or severe scalp psoriasis

chunk 13

Prior topical and systemic therapy: History of failure to one topical therapy class AND failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated OR prior treatment with a systemic targeted immunomodulator for plaque psoriasis

chunk 13, chunk 14

Polyarticular juvenile idiopathic arthritis (PJIA) — Initial and continuation

Covered when ALL of the following are met

PJIA diagnosis: Diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA)

chunk 16, chunk 17

Prior targeted immunomodulators: History of failure/contraindication/intolerance to two targeted immunomodulators FDA-approved for PJIA (document drug, date, duration) OR patient currently on Cimzia; prescriber attestation that patient/caregiver cannot self-administer is required

chunk 17

Additional conditions: Cimzia must be initiated and titrated per FDA-labeled dosing for PJIA; patient must not be receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication; for continuation, patient must have previously received Cimzia injection and dosing per FDA label

chunk 17, chunk 18

Authorization limits

Covered when ALL of the following are met

Combination and duration requirements: Patient is not receiving Cimzia in combination with a systemic targeted immunomodulator (e.g., adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib) for treatment of the same condition; authorization is for no more than 12 months.

chunk 18

FDA-indicated uses (informational)

Covered when meeting FDA-indicated conditions (informational listing in this section):

FDA Indications: Use for the following FDA-labeled indications: Crohn's disease (adults with moderately to severely active disease with inadequate response to conventional therapy), rheumatoid arthritis (adults with moderately to severely active disease), psoriatic arthritis (adults with active disease), ankylosing spondylitis (adults with active disease), non-radiographic axial spondyloarthritis with objective signs of inflammation (adults), moderate-to-severe plaque psoriasis (adults candidates for systemic therapy or phototherapy), and active polyarticular juvenile idiopathic arthritis in patients >=2 years.

FDA indications listed in chunks 53 and 54

This policy applies to Cimzia lyophilized powder supplied for provider‑administered subcutaneous injection after reconstitution. The prefilled syringe formulation of Cimzia (self‑administered subcutaneous injection) is managed under the pharmacy benefit and is not governed by this medical benefit policy.

Cimzia must not be used concurrently with another systemic targeted immunomodulator for the same condition (examples include adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib). Requests for authorization should confirm the patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication.

Information on FDA‑approved indications is provided for reference only. FDA approval alone is not a basis for coverage; coverage decisions must follow the policy criteria and applicable plan terms.

Coverage determinations under this policy must be made in the context of each member’s benefit plan. Coverage must follow applicable federal, state, and contractual benefit plan requirements, and this policy is informational and does not override plan‑specific terms or legal obligations.

Initial Therapy Requirements

Initial therapy requirements

Initial therapy coverage requires specified prior therapy trials or prior targeted immunomodulator use and prescriber attestation regarding inability to self-administer.

Diagnosis-specific prior therapy: Each indication requires documentation of failure, contraindication, or intolerance to the specified conventional therapies and/or required number of targeted immunomodulator trials as listed per indication; include drug name, dates, and duration of each trial

chunk 4, chunk 6, chunk 8, chunk 11, chunk 13, chunk 16

Attestation: Prescriber attestation that the patient or caregiver cannot be trained or are physically unable to self-administer Cimzia (explanation required) must be submitted for initial therapy

chunk 5, chunk 7, chunk 9, chunk 12, chunk 15, chunk 17

Initial FDA-indicated therapy notes

Continuation / Renewal Requirements

Continuation therapy requirements

Continuation requires documented positive clinical response and ongoing inability to self-administer if still applicable.

Positive response: Documentation of positive clinical response is required for continuation

chunk 6, chunk 10

Attestation: Prescriber attestation that the patient or caregiver cannot be trained or are physically unable to self-administer Cimzia must be submitted for continuation when applicable

chunk 6, chunk 17

Dosing: Cimzia must be continued per FDA-labeled dosing for the specific indication

chunk 6, chunk 17

Step Therapy and Prior Treatment Requirements

Indication	Required number/type of prior targeted immunomodulator failures or prior targeted immunomodulator treatment
{"text":"Crohn's disease (CD)","status":""},{"text":"Patient has been previously treated with a systemic targeted immunomodulator FDA‑approved for Crohn's disease OR history of failure/contraindication/intolerance to one targeted immunomodulator (document drug, date, duration)","status":""}
{"text":"Rheumatoid arthritis (RA)","status":""},{"text":"History of failure/contraindication/intolerance to two targeted immunomodulators FDA‑approved for rheumatoid arthritis (document drugs, dates, durations) OR patient previously treated with a systemic targeted immunomodulator for RA","status":""}
{"text":"Psoriatic arthritis (PsA)","status":""},{"text":"History of failure/contraindication/intolerance to two targeted immunomodulators FDA‑approved for psoriatic arthritis (document drug, date, duration) OR patient currently on Cimzia","status":""}
{"text":"Ankylosing spondylitis (AS) / non‑radiographic axial spondyloarthritis (nr‑axSpA)","status":""},{"text":"History of failure/contraindication/intolerance to one targeted immunomodulator FDA‑approved for AS/nr‑axSpA (document drug, date, duration) OR patient previously treated with a systemic targeted immunomodulator for AS/nr‑axSpA","status":""}
{"text":"Plaque psoriasis (PS)","status":""},{"text":"History of failure/contraindication/intolerance to two targeted immunomodulators FDA‑approved for plaque psoriasis (document drug, date, duration) OR patient previously treated with a systemic targeted immunomodulator for PS","status":""}
{"text":"Polyarticular juvenile idiopathic arthritis (PJIA)","status":""},{"text":"History of failure/contraindication/intolerance to two targeted immunomodulators FDA‑approved for PJIA (document drug, date, duration) OR patient currently on Cimzia","status":""}

Situation	Policy guidance
{"text":"Concurrent systemic targeted immunomodulator in use for same indication","status":"not_covered"},{"text":"Do not authorize Cimzia when the patient is receiving another systemic targeted immunomodulator for treatment of the same condition (examples listed in policy: adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib, etc.). Authorization should not be issued while combination therapy is present.","status":""}
{"text":"Authorization duration when allowable","status":""},{"text":"Authorizations are limited to no more than 12 months; continuation requires documentation of positive clinical response and other continuation criteria per indication.","status":""}

Situation

Policy guidance

{"text":"Concurrent systemic targeted immunomodulator in use for same indication","status":"not_covered"},{"text":"Do not authorize Cimzia when the patient is receiving another systemic targeted immunomodulator for treatment of the same condition (examples listed in policy: adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib, etc.). Authorization should not be issued while combination therapy is present.","status":""}

{"text":"Authorization duration when allowable","status":""},{"text":"Authorizations are limited to no more than 12 months; continuation requires documentation of positive clinical response and other continuation criteria per indication.","status":""}

Coding — HCPCS and Diagnosis Codes

Applicable HCPCSHCPCS

J0717

Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

Example ICD-10 codes listedICD-10

K31.6	Fistula of stomach and duodenum.
K50.00	Crohn ' s disease of small intestine without complications

Covered/Applicable Codes (examples)mixed

J0717	Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
K31.6	Fistula of stomach and duodenum.
K50.00	Crohn ' s disease of small intestine without complications

Applicable ICD-10 Codes (continued list)ICD-10

K50.011	Crohn ' s disease of small intestine with rectal bleeding
K50.012	Crohn ' s disease of small intestine with intestinal obstruction
K50.013	Crohn ' s disease of small intestine with fistula
K50.014	Crohn ' s disease of small intestine with abscess
K50.018	Crohn ' s disease of small intestine with other complication
K50.019	Crohn ' s disease of small intestine with unspecified complications
K50.10	Crohn ' s disease of large intestine without complications
K50.111	Crohn ' s disease of large intestine with rectal bleeding
K50.112	Crohn ' s disease of large intestine with intestinal obstruction
K50.113	Crohn ' s disease of large intestine with fistula

1–10 of 36

1/4

Applicable ICD-10 CodesICD-10

M05.862
M05.869	Other rheumatoid arthritis with rheumatoid factor of unspecified knee
M05.871	Other rheumatoid arthritis with rheumatoid factor of right ankle and foot
M05.872	Other rheumatoid arthritis with rheumatoid factor of left ankle and foot
M05.879	Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot
M05.89	Other rheumatoid arthritis with rheumatoid factor of multiple sites
M05.9	Rheumatoid arthritis with rheumatoid factor, unspecified
M05.A	Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis
M06.00	Rheumatoid arthritis without rheumatoid factor, unspecified site
M06.011	Rheumatoid arthritis without rheumatoid factor, right shoulder

1–10 of 232

1/24

Age for pJIA indication

pJIA>= 2 years

Source clinical age criterionTreatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older (FDA-indicated)

Authorization implicationPolicy references pJIA FDA age threshold when assessing medical-benefit Cimzia requests

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cimzia (certolizumab pegol). Submit clinical documentation that supports the requested indication, prior treatment history, prescriber specialty/consultation (when required), and attestation regarding self‑administration training ability.

Prior authorization required before initiation of therapy
Include diagnosis, prior therapies (drug names, dates, durations), and prescriber attestation if patient/caregiver cannot self‑administer

Prior Authorization

Authorization Duration and Renewal

Initial and renewal authorizations are limited to a maximum of 12 months. Initial authorization typically issued for 12 months; continuation requires documentation of positive clinical response. Cimzia must be initiated and titrated per FDA‑labeled dosing for the specific indication.

Initial authorization: up to 12 months
Continuation/renewal: documentation of positive clinical response required; authorization up to 12 months

Site of Care and Administration

Billing Rule

Infusion/administration center guidance: provider‑administered lyophilized powder; use J0717

Cimzia lyophilized powder must be administered by a healthcare provider (medical benefit). When administered under direct physician supervision, HCPCS J0717 may be used on the claim; the self‑administered prefilled syringe is handled under the pharmacy benefit.

Administer lyophilized powder after reconstitution by a provider
Submit J0717 for provider‑administered injections (1 mg certolizumab pegol)

Note

Site‑of‑care considerations are plan‑dependent and may be managed by third‑party tools

Site‑of‑care coverage and administration setting decisions are subject to the member’s plan terms and may be influenced by third‑party tools; verify plan‑specific site‑of‑care rules before scheduling infusion or injection in a specific setting.

Definitions and Benefit Distinctions

Medical-benefit Cimzia

FormulationLyophilized powder for subcutaneous use after reconstitution by a healthcare provider

Benefit handlingGoverned by the medical benefit when administered by a provider

Administration requirementRequires reconstitution and provider administration (not self-administered)

Pharmacy-benefit Cimzia

FormulationPrefilled syringe for self-administered subcutaneous injection

Benefit handlingObtained under the pharmacy benefit (self-administered product)

Distinction

Background

Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker supplied in multiple formulations. This medical benefit policy governs the lyophilized powder formulation intended for reconstitution and administration by a healthcare provider. The policy covers medical‑benefit use across the FDA‑labeled inflammatory indications (e.g., Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis/nr‑axSpA, moderate‑to‑severe plaque psoriasis, and polyarticular juvenile idiopathic arthritis) when the documented clinical criteria and prior‑therapy requirements in this policy are met.

References and Revision History

References 1. Cimzia [package insert]. Smyrna, GA: UCB, Inc; September 2025. 2. Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. Arthritis Rheum. 2016;68(1):1-26. 3. MCG™ Care Guidelines. Ambulatory Care, 24th Edition. Certolizumab. 4. U.S. Food and Drug Administration. Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-tumor-necrosis-factor-tnf-blockers-marketed-remicade-enbrel-humiracimzia-and-simponi. Accessed July 1, 2013. 5. U.S. Food and Drug Administration. Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy. http://www.fda.gov/Drugs/DrugSafety/ucm278267.htm. Accessed July 1, 2013. 6. U.S. Food and Drug Administration. Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. http://www.fda.gov/Drugs/DrugSafety/ucm270849.htm. Accessed July 1, 2013. 7. Menter A, Strober BE, Kaplan DH, et al. Joint AAD‑NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019 Apr;80(4):1029-1072.

2026-04-01template_updateLatest

Template updated (policy history note).

OpenPayer

Cimzia (Certolizumab Pegol) — Medical Benefit Drug Policy (provider‑administered lyophilized powder)

Coverage Criteria for Provider-Administered Cimzia (lyophilized)

Initial Therapy Requirements

Continuation / Renewal Requirements

Step Therapy and Prior Treatment Requirements

Coding — HCPCS and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Site of Care and Administration

Definitions and Benefit Distinctions

Background

References and Revision History