ModifiedEmblemHealthPolicy N/A

Cimzia (certolizumab pegol) subcutaneous therapy — Coverage Criteria

Medical policy governing prior authorization, renewal, dosing limits, and coverage criteria for Cimzia (certolizumab pegol) for specified inflammatory and autoimmune indications for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyCimzia (certolizumab pegol) subcutaneous therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — clinical criteria and authorization period revised

Effective Date

Next Review DateMar 22, 2024

Key ActionSubmit clinical documentation demonstrating the member meets indication-specific prior therapy and disease activity criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Annual Review: Length of Authorization updated from 12 months to 6 months.

Psoriatic Arthritis initial criteria modified: removed requirement for TWO NSAID trials for certain presentations and replaced with 4-week trial of ONE for axial/enthesitis/dactylitis presentations; other wording adjustments to DMARD trial durations and percent BSA for plaque psoriasis.

Annual Review: Removed PI link, added dosing chart.

6 monthsauthorization length

400 mg wk0/2/4loading regimen

200 mg q2w or 400 mg q4wmaintenance options

J0717

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.

Investigationalexclusions

Coverage and Medical Necessity Criteria

General Initial Approval Criteria

Covered when ALL of the following general criteria are met:

General prerequisites: 1. Patient has been evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment; AND 2. Patient has been evaluated and screened for hepatitis B virus (HBV) prior to initiating treatment; AND 3. Patient does not have an active infection, including clinically important localized infections; AND 4. Therapy must not be administered concurrently with live vaccines; AND 5. Patient is not on concurrent treatment with another TNF-inhibitor, biologic response modifier, or specified nonbiologic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib); AND 6. Patient is aged 18 years or older; AND 7. Physician has assessed baseline disease severity using an objective measure/tool.

Initial RA

Rheumatoid Arthritis — covered when ALL of the following are met:

RA criteria: i. Documented moderate to severe active rheumatoid arthritis; AND ii. Patient has had at least a 3-month trial and failed previous therapy with ONE oral disease-modifying antirheumatic drug (DMARD) (e.g., methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, or leflunomide); AND iii. Prescribed in combination with methotrexate unless methotrexate is contraindicated.

Initial Crohn's Disease

Crohn's Disease — covered when ALL of the following are met:

CD criteria: i. Documented moderate to severe active Crohn's disease; AND ii. Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate).

Initial Psoriatic Arthritis

Psoriatic Arthritis — covered when ALL of the following are met:

PsA criteria: i. Documented moderate to severe active psoriatic arthritis; AND ii. For patients with predominantly axial disease or active enthesitis: an adequate trial and failure of at least a 4-week trial of ONE NSAID unless contraindicated; OR for patients with peripheral arthritis and/or dactylitis: trial and failure of at least a 3-month trial of ONE oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine).4 week trial of one NSAID; 3 month trial of one DMARD

Revision history removed prior requirement for TWO NSAID trials for certain presentations and adjusted peripheral arthritis DMARD wording (see revision notes).

Initial Ankylosing Spondylitis

Ankylosing Spondylitis — covered when ALL of the following are met:

AS criteria: i. Documented active ankylosing spondylitis; AND ii. Adequate trial and failure of at least TWO NSAIDs over a total of 4 weeks unless contraindicated.Two NSAIDs over 4 weeks

Non-radiographic axial spondyloarthritis was separated into its own indication in the revision history.

Initial Non-radiographic Axial Spondyloarthritis

Non-radiographic Axial Spondyloarthritis — covered when ALL of the following are met:

nraxSpA criteria: i. Objective signs of inflammation (e.g., elevated CRP and/or sacroiliitis on MRI); AND ii. Absence of definitive radiographic structural damage on the sacroiliac joints; AND iii. Active disease defined by BASDAI ≥4 and spinal pain ≥4 on a 0–10 NRS; AND iv. Adequate trial and failure of at least TWO NSAIDs unless contraindicated.BASDAI ≥4; spinal pain ≥4

nr-axSpA was added as a separate indication with distinct initial and renewal criteria per revision history.

Initial Plaque Psoriasis

Plaque Psoriasis — covered when ALL of the following are met:

Plaque psoriasis criteria: i. Moderate to severe plaque psoriasis for at least 6 months with at least ONE of: involvement of at least 3% of body surface area (BSA), OR PASI score ≥10, OR incapacitating location or serious emotional consequences due to plaque location or intractable pruritus; AND ii. Inadequate response to, or not a candidate for, a minimum 4-week trial of topical agents; AND iii. Inadequate response to, or not a candidate for, a minimum 3-month trial of at least ONE non-biologic systemic agent (e.g., methotrexate); AND iv. Inadequate response to, or not a candidate for, a minimum 3-month trial of phototherapy; AND v. Note: Patients with body weight ≤90 kg should initiate at the lower dosing regimen of 200 mg every other week plus loading doses.BSA ≥3% or PASI ≥10 or incapacitating location

Revision history changed BSA threshold from 10% to 3% and shortened topical trial minimum to 4 weeks.

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

Renewal general: 1. Patient continues to meet the initial criteria identified in Section I; AND 2. Absence of unacceptable toxicity from the drug (examples: severe hypersensitivity, serious infection, cardiotoxicity/heart failure, lupus-like syndrome, demyelinating disease, cytopenias, malignancy, Hepatitis B reactivation); AND 3. Patient is receiving ongoing monitoring for TB or other active infections; AND 4. Evidence of disease-specific clinical response as defined per indication (e.g., RA: improvement in tender/swollen joint counts, CRP reduction, patient global assessment or DAS28 improvement ≥1.2 or ACR20 ≥20%; CD: improvement in signs/symptoms or CDAI/Harvey-Bradshaw; PsA: improvement per PsARC [≥2 of 4 criteria including tenderness/swelling]; AS/nr-axSpA: ASDAS ≥1.1 improvement or BASDAI ≥2 improvement; Plaque psoriasis: clinical improvement such as total BSA involvement ≤1% or PASI75 or PASI50 plus a four-point DLQI reduction).e.g., DAS28 ≥1.2 improvement; ASDAS ≥1.1; BASDAI ≥2; BSA ≤1% or PASI75/PASI50 + DLQI -4

Renewal requires documented objective response and absence of unacceptable toxicity.

Plaque Psoriasis: Response and Dose Escalation

Covered when ALL of the following are met

Plaque Psoriasis Response Criteria

Response measures
- Clinical signs improvement: Improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or amount of surface area involvementtotal BSA involvement ≤ 1%
- Disease activity scoring tool improvement: Improvement on a disease activity scoring tool e.g. PASI 75 or PASI 50 AND a four-point reduction in DLQI from when treatment startedPASI 75 or PASI 50 plus DLQI -4
Dose escalation prerequisites

Revised initial and renewal criteria highlights

Revisions to initial and renewal clinical criteria for multiple dermatologic and rheumatologic indications were made; highlights below reflect explicit changes from the revision history.

Psoriatic Arthritis - initial criteria edits: Removed 'and/or dactylitis' and removed the 'TWO' NSAID trial requirement for predominantly axial disease or active enthesitis/dactylitis; replaced the 'TWO' NSAID requirement with a 4-week trial of ONE NSAID.4 week trial of one NSAID

Chunk 44 documents wording changes.

Psoriatic Arthritis - peripheral arthritis: Added 'and/or dactylitis' to peripheral arthritis DMARD trial wording and replaced prior 'TWO' trial language with a 3-month trial of ONE oral DMARD.3 month trial of one DMARD

Chunk 44.

Plaque Psoriasis - severity threshold: Initial criteria BSA involvement changed from >=10% to >=3%; added 'serious emotional consequences' and 'intractable pruritus' as qualifying features; topical trial minimum reduced from 3 months to 4 weeks.

Cimzia (certolizumab pegol) is considered investigational when used for any indication that is not specifically listed in this policy. Requests for off‑label uses that fall outside the enumerated covered indications will be reviewed as investigational and may be denied.

Any request to use Cimzia for an indication not expressly included in the policy should be treated as investigational. Providers must document that the requested indication appears in this policy; absence of a listed indication supports investigational status and potential denial.

Revision history shows that Non‑radiographic Axial Spondyloarthritis (nr‑axSpA) was removed from some Ankylosing Spondylitis language and then added back as a separate indication with its own initial and renewal criteria. When assessing requests, reviewers should use the updated, separate nr‑axSpA indication and criteria rather than the prior combined wording.

Edits in the annual revision alter initial and renewal requirements across several indications; as a result, documentation previously acceptable under older criteria may no longer meet the revised standards. Providers should be aware that insufficient or out‑of‑date documentation consistent with the new wording may increase the risk of denial.

Procedure, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J0717

Injection, certolizumab pegol, 1 mg; 1 billable unit = 1 mg

Applicable NDCsNDCCovered

50474-0700-xx	Cimzia 400 mg Kit - powder for injection; Single Dose Vial
50474-0710-xx	Cimzia 200 mg prefilled syringe and Starter Kit; Single Dose

Covered ICD-10 DiagnosesICD-10Covered

K50.00	Crohn's disease of small intestine without complications
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

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Requirements for Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. The treating clinician must submit clinical evidence that the member meets preauthorization criteria. Without submitted documentation, EmblemHealth cannot properly review the request and may deny authorization.

Provider must submit supporting clinical records at time of request (see required clinical documentation bullets).
Lack of documentation may result in denial.

Billing Rule

Procedure and Product Identification

Use HCPCS code J0717 (Injection, certolizumab pegol, 1 mg) on authorization and claims submissions. Include applicable NDCs on requests when available to aid product identification.

Clinical Definitions and Response Metrics

Non-radiographic axial spondyloarthritis (nraxSpA) criteria

Objective inflammation requirementElevation of C‑reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI

Radiographic exclusionAbsence of definitive radiographic structural damage of the sacroiliac joints (i.e., no radiographic sacroiliitis)

Disease activity and pain thresholdsBASDAI ≥4 and spinal pain ≥4 on a 0–10 NRS

Prior therapy requirementAdequate trial and failure of at least TWO NSAIDs unless contraindicated

PASI 75 / PASI 50 — definitions and use

PASI 75 definitionPercent reduction in Psoriasis Area and Severity Index — 75% reduction from treatment start (PASI 75)

Background and Scope

Certolizumab pegol is a TNF‑inhibitor indicated for multiple immune‑mediated inflammatory diseases. Baseline safety screening is required prior to initiation, including documentation of screening for latent tuberculosis and hepatitis BJ0717) and may reference the listed NDCs for product selection.

Policy Revision History

2024-03-22Annual review - operational updateLatest

Length of authorization changed from 12 months to 6 months and PI link removed with dosing chart added.

2022-04-06Revision - indication and criteria changes

Added Non-radiographic Axial Spondyloarthritis as a separate indication with initial and renewal criteria and specified disease response measures (e.g., ASDAS/BASDAI/ASAS40); transferred policy to new template.

2021-10-04

Policy Summary

PayerEmblemHealth

PolicyCimzia (certolizumab pegol) subcutaneous therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — clinical criteria and authorization period revised

Effective Date

Next Review DateMar 22, 2024

Key ActionSubmit clinical documentation demonstrating the member meets indication-specific prior therapy and disease activity criteria when requesting prior authorization.

SourceLink

On This Page

Initial response: Patient has shown an initial response to therapy

Loading doses administered: Received the three loading doses at the dose and interval specified

Maintenance dose administered: Received a minimum of one maintenance dose at the dose and interval specified

Response timing and loss: Responded to therapy (by treatment week 6) with subsequent loss of response

Plaque psoriasis monitoring note: Dose escalation up to the maximum dose and frequency may be considered only upon clinical review when the above response measures and prerequisites are documented.

BSA >=3% or significant impact

Ankylosing spondylitis / nr-axSpA: Non-radiographic axial spondyloarthritis was added as a separate indication with initial and renewal criteria; renewal measures include improvements in total back pain, physical function, CRP reduction, ASDAS/BASDAI metrics, ASQoL, or ASAS40 responses.e.g., ASDAS improvement >=1.1 or BASDAI improvement >=2 or ASAS40

Chunk 46 provides example measures.

HCPCS: J0717
NDCs: 50474-0700-xx (Cimzia 400 mg kit), 50474-0710-xx (Cimzia 200 mg prefilled syringe)

Prior Authorization

Prior Authorization and Criteria Updates

Policy criteria and prior authorization requirements are updated periodically. Notable recent operational updates include shortening the authorization period and multiple indication-specific criteria revisions. Review submitted clinical documentation against the current criteria at time of request.

Annual review updates to initial and renewal criteria.
Length of authorization changed from 12 months to 6 months (effective 08/18/2023 revision).
PsA step-therapy and Plaque Psoriasis thresholds were revised in recent updates.

Documentation Required

Documentation Submission Required

The treating clinician must submit clinical evidence that the member meets all stated criteria. Failure to provide the requested clinical information may result in denial of the request.

Submit clinical notes, prior therapy documentation, baseline disease severity measures, and response assessments.
Include documentation of screening for latent TB and hepatitis B prior to therapy initiation.

Denial Risk

Investigational Uses

Use of Cimzia for any indication not listed in the policy is considered investigational and may be denied.

Requests for non-listed indications will be evaluated as investigational.

Note

Authorization Period Changed

Operational change: the standard length of authorization was updated to 6 months (previously 12 months). Authorized duration may affect renewal submissions and required documentation for continuation.

Length of authorization: 6 months.

Documentation Required

Clinical Evidence Submission

Treating clinician must document and submit objective baseline disease severity and subsequent response measures. Clinical evidence should directly support the indication-specific criteria being requested.

Documentation must include baseline objective measures (e.g., PASI, BSA, DLQI for plaque psoriasis; BASDAI, ASDAS, CRP for axial disease; clinical disease activity for RA, Crohn's, PsA).
Document screening for latent TB and HBV prior to initiation and absence of active infection.

Documentation Required

Required Clinical Documentation

Provide baseline disease activity and response documentation as specified per indication. Include objective scoring tools and documentation of prior therapies tried, duration and reason for discontinuation.

Plaque psoriasis: baseline BSA, PASI, DLQI and documentation of prior topical, systemic, and phototherapy trials and responses.
PsA: documentation of peripheral vs axial disease, prior NSAID or DMARD trials per updated step therapy guidance.
RA: documentation of moderate to severe disease and trial of ≥3 months of one oral DMARD; note methotrexate combination unless contraindicated.
Crohn's Disease: documentation of moderate to severe disease and failure/contraindication to ≥3 month trial of corticosteroids or immunomodulators.

Documentation Required

Documentation Expectations

Provider documentation should clearly demonstrate how each applicable criterion is met. Expect reviewers to assess objective measures, prior therapy history, screening results, and evidence of response or loss of response when applicable.

For dose escalation in psoriasis, document initial response, completion of loading doses, at least one maintenance dose, and subsequent loss of response by week 6.
Include dates, doses, durations and clinical rationale for prior therapy failures or contraindications.

Step Therapy

Indication-specific Prior Therapy Requirements

Indication-specific prior therapy (step therapy) requirements must be met as listed in the initial criteria for each indication. Recent revisions modified PsA step requirements in some presentations.

RA: ≥3 month trial and failure of one oral DMARD prior to approval; combination with methotrexate unless contraindicated.
Crohn's: ≥3 month failure/contraindication to corticosteroids or immunomodulators.
PsA: For axial disease or enthesitis (and/or dactylitis as noted in revisions), a 4-week trial of one NSAID (unless contraindicated) is acceptable in many presentations replacing the previous TWO-NSAID requirement; for peripheral arthritis/dactylitis, a 3-month trial of one oral DMARD required.
Ankylosing spondylitis and nr-axSpA: NSAID trial requirements remain as specified for each indication.

Step Therapy

Step Therapy Revisions for PsA

Psoriatic Arthritis (PsA) step therapy was revised: the previous requirement for two NSAID trials in certain presentations was removed and replaced with a shorter single 4-week NSAID trial in many axial/enthesitis presentations; other PsA presentations retain a single 3-month DMARD trial requirement.

Axial disease or active enthesitis: adequate trial and failure of a 4-week trial of ONE NSAID (unless contraindicated) now meets the step requirement in many cases.
Peripheral arthritis/dactylitis: continue to require a 3-month trial of ONE oral DMARD.

PASI 50 definitionPercent reduction in Psoriasis Area and Severity Index — 50% reduction from treatment start (PASI 50)

Use in response assessmentPASI 75 or PASI 50 (with DLQI improvement) is used as a disease activity scoring tool to document clinical response for renewal or dose escalation

DLQI — measure and referenced response threshold

DLQI measureDermatology Life Quality Index (DLQI) — patient‑reported measure of dermatology‑related quality of life

Response thresholdA four‑point (≥4) reduction in DLQI from baseline is referenced as part of psoriasis response assessment

Combined use with PASIDLQI reduction is used in conjunction with PASI 50 (or PASI 75) to define therapeutic response

Non-radiographic axial spondyloarthritis (nr-axSpA) — definition and coding note

DefinitionNon‑radiographic axial spondyloarthritis (nr‑axSpA) — axial spondyloarthritis without definitive radiographic sacroiliitis

ICD‑10 codes addedSpecific ICD‑10 codes M45.A0 through M45.AB denote non‑radiographic axial spondyloarthritis (e.g., M45.A0 = Non‑radiographic axial spondyloarthritis of unspecified sites)

Policy change notenr‑axSpA was added as a separate indication with its own initial and renewal criteria during the revision; it was previously removed from combined AS wording and later reintroduced as distinct indication

Revision - coding update

Added 10 new ICD-10 codes for Non-radiographic axial spondyloarthritis and related structural changes to indications.

2019-07-22Revision - new indication added

Added new indication 'Axial spondyloarthritis, nonradiographic' and applicable diagnosis codes (M46.81 - M46.89).

Criteria wording update

Psoriatic Arthritis initial criteria: replaced requirement for TWO NSAID trials with a 4-week trial of ONE NSAID for axial/enthesitis/dactylitis presentations; adjusted peripheral arthritis DMARD trial language; and Plaque Psoriasis initial BSA threshold updated from 10% to 3% with topical trial minimum reduced from 3 months to 4 weeks.