CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0083R

Cimzia (certolizumab pegol) — Medical Benefit Drug Policy (lyophilized powder for provider-administered SC)

Medical benefit coverage and authorization criteria for Cimzia (certolizumab pegol) supplied as lyophilized powder for provider-administered subcutaneous injection; prefilling syringe self-administered product is managed under the pharmacy benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCimzia (certolizumab pegol) — Medical Benefit Drug Policy (lyophilized powder for provider-administered SC)

Policy CodePolicy CS2026D0083R

Change TypeTemplate update

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis, prior therapy trials (drug/date/duration), prescriber attestation that patient/caregiver cannot self-administer, and applicable ICD-10 and procedure codes (e.g., J0717) to support medical-benefit Cimzia requests.

SourceLink

POLICY UPDATE CHANGES

Template update noted in Policy History/Revision Information dated 04/01/2026.

7FDA-indicated clinical conditions listed

12Typical authorization period (months)

J0717HCPCS code

ProhibitedCombination therapy

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Cimzia (certolizumab pegol)

Authorization conditions

Covered when ALL of the following are met

Combination therapy: Patient is not receiving Cimzia in combination with a systemic targeted immunomodulator (examples listed) for treatment of the same condition.

Combination agents enumerated in text

Authorization duration: Authorization is for no more than 12 months.<=12 months

FDA Indications

Covered when INDICATION is an FDA-listed condition and clinical context supports use

FDA-indicated conditions: Use for one of the following FDA-indicated conditions: Crohn's disease (adult moderately to severely active with inadequate response to conventional therapy), rheumatoid arthritis (adult moderately to severely active), psoriatic arthritis (adult active), ankylosing spondylitis (adult active), non-radiographic axial spondyloarthritis with objective inflammation (adult), moderate-to-severe plaque psoriasis (adult candidates for systemic therapy or phototherapy), polyarticular juvenile idiopathic arthritis (patients ≥2 years)

From FDA indications

Clinical background

Clinical rationale supporting use

Mechanism and clinical effect: Certolizumab pegol neutralizes TNFα, reducing downstream inflammatory mediators (e.g., IL‑1, prostaglandins) and CRP; elevated TNFα is implicated in Crohn's disease and rheumatoid arthritis pathology

Background summary

The prefilled syringe (self‑administered) formulation of Cimzia is excluded from the medical benefit. Medical‑benefit coverage and prior authorization in this policy apply to the lyophilized powder for subcutaneous use reconstituted and administered by a healthcare provider; requests for the self‑administered prefilled syringe should be managed through the pharmacy benefit.

Cimzia must not be prescribed or authorized in combination with another systemic targeted immunomodulator for the same condition. Examples of prohibited concurrent agents include adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, and tofacitinib. Additionally, authorizations are limited to a maximum of 12 months, and combination‑therapy requests may be denied.

The policy includes FDA‑labeled indications for Cimzia for informational purposes. FDA approval and the listed indications (for Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, moderate‑to‑severe plaque psoriasis, and polyarticular juvenile idiopathic arthritis) are provided to describe approved uses and clinical context.

FDA approval alone is not the sole basis for coverage decisions. Coverage determinations must reference applicable federal, state, or contractual benefit plan requirements, which may differ from this policy; in the event of conflict, plan‑specific requirements govern. This policy is informational and does not replace those plan terms.

Initial Therapy Requirements

Initial therapy — initial approval considerations

Initial approval considerations

Initial use should align with an FDA-indicated diagnosis; for Crohn's disease initial approval is for reducing signs/symptoms and maintaining response in adults with moderately to severely active disease after inadequate response to conventional therapy

From indications

Continuation and Maintenance Therapy

Maintenance use — continuation/maintenance therapy

Continuation/maintenance therapy

Maintenance indication: Cimzia is indicated for maintaining clinical response in adult Crohn's disease after induction response

From proven indications

Step Therapy and Prior Treatments

Indication	Required prior therapy trials / documentation
Crohn's disease
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis / non-radiographic axial spondyloarthritis
Plaque psoriasis
Polyarticular juvenile idiopathic arthritis (PJIA)

Coverage rule	Notes
Do not administer Cimzia concurrently with another systemic targeted immunomodulator for the same indication.
Requests for Cimzia in combination with another systemic targeted immunomodulator (examples listed) may be denied.

Context	Requirement
Requires history of inadequate response to conventional therapy (corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate) OR prior treatment with a systemic targeted immunomodulator for Crohn's disease.
Policy references that trial and failure or intolerance of conventional therapy may be required prior to Cimzia for certain indications; specifics vary by indication and are listed in the criteria sections.

Billing and Diagnosis Codes

Age indicationsPediatric and adult age indications per FDA label (e.g., JIA from age 2 and older)

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for provider‑administered Cimzia (certolizumab pegol) lyophilized powder when billed to the medical benefit. Refer to the payer's full Medical Benefit Drug Policy and the member's federal, state, or contractual benefit plan for plan‑specific requirements and any third‑party utilization criteria (e.g., InterQual). FDA approval alone does not guarantee coverage; benefit plan terms govern in case of conflict.

Medical‑benefit administration: J0717 (Injection, certolizumab pegol, 1 mg) — use when drug is administered under direct physician supervision (not for self‑administered product) [chunk 19]
Diagnosis codes: submit an applicable ICD‑10 code from the policy’s listed diagnoses (e.g., K50.00 for Crohn's disease; rheumatoid arthritis and related ICD‑10 codes listed in policy) to support medical necessity [chunks 19, 36–38]
Authorization length: initial and continuation authorizations are typically issued for up to 12 months per indication unless otherwise specified in the policy [chunks 6, 10, 17, 18]
Combination therapy: do NOT co‑administer Cimzia with another systemic targeted immunomodulator for the same indication; requests to combine therapies may be denied [chunks 5, 6, 7, 9, 16, 18]
Prior therapy requirements: document failure, contraindication, or intolerance to required conventional therapies and/or prior targeted immunomodulators as specified for each indication (include drug name, dates, and duration of trial) [chunks 4, 5, 7, 13, 17]

Administration Setting and Site of Care Notes

Billing Rule

Medical‑benefit billing: use J0717 for provider‑administered Cimzia

When Cimzia lyophilized powder is administered by a healthcare provider it is billed as a medical benefit; use HCPCS code J0717 for certolizumab pegol (injection, 1 mg).

Note

Site‑of‑care guidance not specified in excerpt

The excerpt does not specify a required site of care; consult the full policy or the Cimzia package insert for guidance on administration setting.

Clinical Background

Cimzia (certolizumab pegol) is a PEGylated Fab fragment that targets and neutralizes tumor necrosis factor alpha (TNFα). As an anti‑TNF biologic, it reduces downstream inflammatory mediators and clinical markers such as CRP. Cimzia has multiple FDA‑approved indications including adult Crohn's disease (for reducing signs and symptoms and maintaining response after inadequate response to conventional therapy), adult rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis with objective inflammation, moderate‑to‑severe plaque psoriasis (candidates for systemic therapy or phototherapy), and active polyarticular juvenile idiopathic arthritis in patients aged 2 years and older. This policy applies specifically to the medical‑benefit presentation (lyophilized powder for provider‑administered subcutaneous injection).

Definitions and Drug Description

J0717 — HCPCS code definition

HCPCS codeJ0717

Code descriptionInjection, 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)

Use contextIntended for medical-benefit administration of the lyophilized provider-administered formulation (prefilled syringe is pharmacy benefit)

Certolizumab pegol (Cimzia) — mechanism

Molecular typePEGylated Fab fragment that binds and selectively neutralizes TNFα

Fc region noteDoes not contain an Fc region and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro