CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cimzia

Policy governing coverage, dosing, quantity limits, approval and renewal criteria, diagnosis codes, and billing codes for Cimzia for Medicaid, Commercial, and Medicare-Medicaid members (medication on medical benefit for Medicaid effective 6/1/2024).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCimzia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review Date

Key ActionCoverage requires meeting the initial approval criteria including prior trials of specified agents and documentation of screening for HBV and latent TB and baseline objective disease severity assessment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

6Indications listed (RA, CD, PsA, AS, nr-axSpA, PsO)

J0717Primary HCPCS code

2Formulations

~150ICD-10 covered diagnosis codes listed (approx.)

N/AMedicare Part B covered diagnosis codes

Coverage Summary

Scope: This policy governs coverage, dosing, quantity limits, approval and renewal criteria, diagnosis codes, and billing codes for Cimzia (certolizumab pegol) for Medicaid, Commercial, and Medicare-Medicaid members; medication is on the medical benefit for Medicaid effective 6/1/2024.

Coverage stance: Cimzia is covered with criteria — approval requires meeting universal screening and safety checks (HBV and latent TB screening, no active infection, no live vaccines, no concurrent biologic therapy), age and disease-severity documentation, and indication-specific prior-therapy requirements.

Indications summary: Cimzia is a TNF inhibitor with demonstrated efficacy in multiple inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), plaque psoriasis (PsO), and Crohn's disease (CD) and is approved/used to induce and maintain clinical response and improve disease activity and patient-reported outcomes.

Initial Approval Criteria

Coverage is provided when ALL of the following universal and indication-specific criteria are met:

Renewal Criteria

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

Renewal Requirements

Continued eligibility: Patient continues to meet the universal and indication-specific relevant criteria
Toxicity: Absence of unacceptable toxicity from the drug (examples: severe hypersensitivity, serious infection, heart failure, lupus-like syndrome, demyelinating disease, cytopenias, malignancy, Hepatitis B reactivation)
Indication-specific response
- Rheumatoid Arthritis response: Rheumatoid Arthritis: improvement in signs/symptoms vs baseline (e.g., DAS28 improvement ≥1.2 or ≥20% ACR20)
- Crohn's Disease response: Crohn's Disease: improvement in signs/symptoms vs baseline (e.g., improvement in CDAI or Harvey-Bradshaw Index, endoscopic activity, stool frequency, weight, etc.)
- Psoriatic Arthritis response: Psoriatic Arthritis: improvement in signs/symptoms vs baseline (e.g., improvement in at least 2 of 4 PsARC, one must be joint tenderness/swelling, with no worsening in any of the 4)
- Ankylosing Spondylitis response: Ankylosing Spondylitis: improvement in signs/symptoms (e.g., ASDAS improvement ≥1.1 or BASDAI improvement ≥2)

Continuation & Toxicity Management

Management of Immunotherapy-Related Toxicity

Non-renewal: Management of immunotherapy-related toxicity: may not be renewed
Dose note: Dose for management of immunotherapy-related toxicity: up to 400 mg subcutaneously x 1 dose

General coverage rationale

Neighborhood reviewed Cimzia and adopted clinical coverage criteria to ensure use per FDA labeling and relevant literature. For INTEGRITY members, NCD/LCD criteria supersede plan criteria when present.

Plan rationale

Alignment:

Provider Actions & Billing Rules

Prior Authorization

Prior authorization requirement

Coverage requires prior authorization. Providers must meet the initial approval criteria including documented prior trials of specified agents and documentation of HBV and latent TB screening and baseline objective disease severity assessment.

J0717

Documentation Required

Baseline and ongoing screening

Providers must document hepatitis B virus (HBV) screening prior to initiation and latent tuberculosis (TB) screening prior to initiation with ongoing TB monitoring during treatment. These screenings are required as part of baseline and ongoing monitoring obligations.

HBV screening prior to initiating treatment

Applicable Codes

HCPCS Billing CodeHCPCSCovered

J0717

Injection, certolizumab pegol, 1 mg; 1 billable unit = 1 mg. Code may be used for Medicare when drug is administered under direct supervision of a physician; not to be used when drug is self-administered

NDCs (drug identifiers)NDC

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

Covered Diagnosis Codes (ICD-10) - Crohn's diseaseICD-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

1–10 of 28

1/3

Covered Diagnosis Codes (ICD-10) - Psoriasis / Psoriatic arthritis / Rheumatoid arthritis / SpondyloarthritisICD-10Covered

L40.0	Psoriasis vulgaris
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.59	Other psoriatic arthropathy
M05.10	Rheumatoid lung disease with rheumatoid arthritis of unspecified site
M05.111	Rheumatoid lung disease with rheumatoid arthritis of right shoulder
M05.112	Rheumatoid lung disease with rheumatoid arthritis of left shoulder
M05.119	Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder

1–10 of 32

1/4

Medicare Part B Covered Diagnosis Codes (NCD/LCD applicability)ICD-10

No codes listed

Surface definition

Billable unit1 mg certolizumab pegol = 1 billable unit (J0717)

Clinical Evidence & References

Background: Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) inhibitor indicated across several inflammatory diseases. Clinical trial evidence and the product label support efficacy in reducing disease activity, improving joint and skin symptoms, and inducing and maintaining remission in Crohn's disease. Dosing varies by indication with loading and maintenance schedules described in the label.

Guidelines and labeling: The policy references the Cimzia package insert and multiple guideline sources (ACR, EULAR, AGA, AAD/NPF, ASAS-EULAR and others) to align coverage with FDA-approved labeling and relevant clinical literature and P&T recommendations.

Key evidence and sources:

Cimzia [package insert], UCB, Inc; January 2023 (product labeling and dosing).

PRECISE 1 and PRECISE 2 (Sandborn WJ et al., NEJM 2007; Schreiber S et al., NEJM 2007) — pivotal induction and maintenance trials for Crohn's disease.

Keystone E et al., phase III randomized trial (Arthritis Rheum. 2008) — certolizumab plus methotrexate in rheumatoid arthritis.

CIMPASI-1 and CIMPASI-2; CIMPACT — randomized phase III psoriasis trials with long-term efficacy data for plaque psoriasis (Gordon KB/Warren RB et al.).

Response Thresholds & Assessment Metrics

Quick reference thresholds

PASI (psoriasis) threshold>= 10 PASI or >=3% BSA for moderate-severe disease

BSA (psoriasis) threshold>= 3% of body surface area (BSA)

DAS28 (RA) renewal threshold>= 1.2 point improvement in DAS28

ACR response (RA) renewal threshold>= 20% improvement (ACR20)

ASDAS (AS/axial SpA) renewal threshold>= 1.1 improvement in ASDAS

BASDAI (AS) renewal threshold>= 2 improvement in BASDAI

Plaque Psoriasis renewal response

Background

Contextual background: Cimzia is a subcutaneous TNF inhibitor approved for RA, PsA, AS, nr-axSpA, PsO, and Crohn's disease with indication-specific loading and maintenance regimens described in the label (e.g., loading 400 mg at weeks 0, 2, 4 and maintenance dosing that varies by indication: 200 mg every other week or 400 mg every 4 weeks for RA/PsA/AS/nr-axSpA; 400 mg every 4 weeks for Crohn's; 400 mg every other week for PsO).

Policy implementation: Neighborhood reviewed Cimzia and adopted coverage criteria to ensure use consistent with FDA labeling and guideline literature; for Medicaid the medication moved to the medical benefit effective 6/1/2024.

Revision History

2020-01-01effective

Policy effective date per document header: Effective Date: 01/01/2020.

2025-01-22last_reviewLatest

Most recent review date listed: 01/22/2025. Status: CURRENT.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCimzia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review Date

SourceLink

On This Page

Non-radiographic Axial SpA response: Non-radiographic Axial SpA: improvement in signs/symptoms (e.g., ASDAS ≥1.1 improvement, ASDAS-MI, ASDAS ≥2 improvement, BASDAI ≥2, ASAS40, etc.)

Plaque Psoriasis response: Plaque Psoriasis: improvement in signs/symptoms (e.g., PASI75 or PASI50 plus DLQI 4-point reduction) and criteria for dose escalation described (initial response, received 3 loading doses, received minimum one maintenance dose, responded by week 6 with subsequent loss of response)

Coverage aligned with FDA approved labeling and/or relevant clinical literature

Purpose: Plan criteria intended to ensure medically accepted indication and cost-effective options are used first if applicable

Individual consideration given to each request based on prescriber-submitted information

NCD/LCD precedence note: For INTEGRITY (Medicare-Medicaid Plan) members, apply NCD/LCD criteria when available

If NCD/LCD exist, they take precedence

Latent TB screening prior to initiating treatment and ongoing TB monitoring during treatment

Documentation Required

Specialist prescribing requirement for AS

Ankylosing spondylitis (AS) prescriptions must be written by, or in consultation with, a rheumatology specialist.

Must be prescribed by, or in consultation with, a specialist in rheumatology

Billing Rule

Quantity limits (NDC unit)

Quantity limits by NDC unit: Loading — 6 vials (200 mg powder) or 6 prefilled syringes (200 mg) in the first 29 days; Maintenance — 2 vials or 2 syringes (200 mg) every 14 days.

50474-0700-xx
50474-0710-xx
Loading: 6 vials (200 mg) or 6 syringes (200 mg) first 29 days
Maintenance: 2 vials (200 mg) or 2 syringes (200 mg) every 14 days

Billing Rule

Max units per dosing interval (HCPCS)

Maximum units per dosing interval (HCPCS J0717): Plaque psoriasis — 400 billable units every other week. All other indications — loading 400 billable units on weeks 0, 2, and 4; maintenance 400 billable units every 4 weeks. Note: RA/PsA/AS/nr-axSpA maintenance may alternatively be 200 mg every other week (200 units every other week) or 400 mg every 4 weeks.

J0717 billing: 1 billable unit = 1 mg
Plaque Psoriasis: 400 units every other week
Other indications: loading 400 units weeks 0,2,4; maintenance 400 units every 4 weeks
RA/PsA/AS/nr-axSpA maintenance option: 200 mg every other week = 200 units every other week (or 400 mg every 4 weeks)

Denial Risk

Concurrent biologic use prohibited

Claims may be denied if the patient is receiving concurrent treatment with another injectable biologic response modifier or specified oral targeted agents; concurrent biologic use is prohibited per universal criteria.

Concurrent injectable biologic response modifiers (e.g., adalimumab, etanercept, infliximab, secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab, etc.) are prohibited
Concurrent oral targeted agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib, etc.) are prohibited

Documentation Required

Use of FDA labeling and clinical evidence

Prescribers must submit documentation that Cimzia use aligns with FDA-approved indications and relevant clinical literature; the plan will give individual consideration based on prescriber-submitted information.

Submit prescriber documentation demonstrating alignment with FDA labeling and relevant literature
Plan will consider requests individually based on submitted information

Prior Authorization

NCD/LCD precedence for INTEGRITY members

For INTEGRITY (Medicare‑Medicaid Plan) members, applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) take precedence and must be followed; NCD/LCD criteria supersede plan criteria when present.

If an NCD or LCD exists for the requested use, it supersedes plan criteria for INTEGRITY members
Medicare coverage requirements must be followed where applicable

PASI75 OR PASI50 plus 4-point DLQI reduction