Neighborhood Health Plan Cimzia Coverage Update

Coverage Criteria for Cimzia (certolizumab pegol)

Initial Therapy

Covered when ALL of the following are met (universal criteria plus indication-specific criteria):

Universal requirements: Patient is at least 18 years of age; patient has been evaluated and screened for hepatitis B virus (HBV) prior to initiating treatment; physician has assessed baseline disease severity using an objective measure/tool; patient has been evaluated and screened for latent tuberculosis (TB) prior to initiating treatment and will receive ongoing TB monitoring during treatment; patient does not have an active infection (including clinically important localized infections); patient will not receive live vaccines during therapy; patient is not on concurrent treatment with an injectable biologic response modifier (including TNF-inhibitors and IL-inhibitors) or specified oral non-biologic agents.

MMP members who received this medication within the past 365 days are not subject to Step Therapy Requirements

Indication-specific: Rheumatoid Arthritis: Documented moderate to severe active rheumatoid arthritis; at least a 3-month trial and failure of ONE oral DMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide); may be used as single agent or with non-biologic DMARDs; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Indication-specific: Crohn's Disease: Documented moderate to severe active Crohn's disease; inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab or infliximab IV at maximum tolerated doses; and inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab at maximum tolerated doses.

Indication-specific: Psoriatic Arthritis: Documented moderate to severe active psoriatic arthritis; for predominantly axial disease, trial and failure of at least a 4-week trial of ONE NSAID unless contraindicated; for peripheral arthritis/dactylitis/enthesitis, trial and failure of at least a 3-month trial of ONE oral DMARD; may be used as single agent or with non-biologic DMARDs; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab and to at least a 6-month trial of ustekinumab at maximum tolerated doses.

Indication-specific: Ankylosing Spondylitis: Prescribed by or in consultation with a rheumatology specialist; documented active disease; adequate trial and failure of at least TWO NSAIDs over 4 weeks total unless contraindicated; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Indication-specific: Non-radiographic Axial Spondyloarthritis: Objective signs of inflammation (e.g., elevated CRP and/or sacroiliitis on MRI without definitive radiographic structural damage) and documented active disease; adequate trial and failure of at least TWO NSAIDs unless contraindicated; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Indication-specific: Plaque Psoriasis: Moderate to severe plaque psoriasis for at least 6 months with at least one of: BSA ≥ 3%, PASI ≥ 10, or incapacitation/serious emotional consequences due to plaque location; failed a 4-week trial of topical therapy, a 3-month trial of at least ONE nonbiologic systemic agent, and a 3-month trial of phototherapy; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab and to at least a 6-month trial of ustekinumab. Note: patients with body weight ≤ 90 kg should initiate at 200 mg every other week plus loading doses.

Renewal / Continuation Therapy

Coverage renewal provided when ALL of the following are met:

General renewal: Patient continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity from the drug (examples: severe hypersensitivity reactions, serious infection, heart failure, lupus-like syndrome, demyelinating disease, cytopenias, development of malignancies, Hepatitis B reactivation).

RA renewal response: Objective disease response such as improvement in tender and swollen joint counts, reduction in C-reactive protein, improved patient global assessment, or improvement on a disease activity scoring tool (e.g., DAS28 improvement ≥1.2 or ≥20% improvement ACR20).

CD renewal response: Objective disease response including improvement in endoscopic activity, stool frequency, abdominal pain, weight, hematocrit, extra-intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroids, or improvement on a disease activity scoring tool (e.g., CDAI or Harvey-Bradshaw Index).

PsA renewal response:

Coverage — indication and dosing conditions

Covered when disease-specific response criteria and dosing conditions are met

General: Therapy must be judged by documented improvement in signs and symptoms compared to baseline using indication-appropriate measures (examples: Psoriatic Arthritis — PsARC; Ankylosing Spondylitis — ASDAS/BASDAI; Non-radiographic axSpA — ASDAS/BASDAI/ASAS40; Plaque Psoriasis — PASI/DLQI/BSA).

Examples of acceptable response metrics are listed in policy renewal criteria.

Dosing requirements: Loading dose 400 mg subcutaneously at weeks 0, 2, and 4 is required for most indications followed by maintenance dosing as indicated: commonly 200 mg subcutaneously every other week (or 400 mg every 4 weeks); Crohn's disease maintenance is 400 mg subcutaneously every 4 weeks. Plaque psoriasis has an alternate dosing pathway for patients ≤90 kg. Management of immunotherapy-related toxicity may be a single dose up to 400 mg and may not be renewed.

See Dosage/Administration for indication-specific schedules.

Plaque Psoriasis — Dose escalation criteria

Plaque psoriasis dose escalation conditions (special criteria)

Plaque psoriasis escalation: Dose escalation up to the maximum dose and frequency may be approved on a case-by-case basis only if all of the following are met: patient showed an initial response to therapy; patient received the three loading doses at the dose and interval specified; patient received at least one maintenance dose at the dose and interval specified; patient responded by treatment week 6 but subsequently lost response.

Dose escalation considered only after documented initial response and completion of loading/maintenance doses.

General coverage criteria

Covered when consistent with FDA-approved labeling and the plan's P&T-adopted clinical criteria

General coverage conditions: Use must be consistent with FDA-approved labeling and relevant clinical literature; prescriber must submit supporting clinical information for individual consideration and Neighborhood will give individual consideration to each request. Coverage criteria were adopted by the P&T Committee to ensure medically accepted indications and encourage cost-effective options first where appropriate.

Detailed stepwise or additional criteria align with FDA labeling and cited clinical literature.

The policy prohibits concurrent treatment with another injectable biologic response modifier (including TNF‑inhibitors and IL‑inhibitors) or certain oral non‑biologic immunomodulatory agents. This universal requirement is part of initial-therapy criteria and must be met before approving Cimzia.

Use of Cimzia for management of immunotherapy‑related toxicity is limited to a single administration and may not be renewed. The dosing section notes an allowance of up to a 400 mg single dose for this purpose, but continuation beyond that single dose is not permitted.

Medicare Part B coverage is subject to applicable CMS policy: where National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) exist they supersede the plan criteria and must be followed. The document also states that Medicare Part B Covered Diagnosis Codes are listed as N/A in this policy and that Neighborhood will give individual consideration when NCD/LCD guidance is absent.

The policy lists examples of contraindications or limitations relevant to phototherapy in plaque psoriasis that should be considered when planning treatment. Examples include xeroderma pigmentosum, other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne syndrome, Bloom syndrome, Rothmund‑Thomson syndrome with UVB), genetic disorders increasing skin cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism with UVB), pregnancy or lactation for PUVA, lupus erythematosus, prior photosensitivity diseases or history of melanoma/non‑melanoma skin cancer, immunosuppression in organ transplant patients (UVB), photosensitizing medications (PUVA), and severe liver, renal, or cardiac disease (PUVA). These examples inform contraindication assessment for phototherapy options when considering biologic therapy for psoriasis.

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Requests for Cimzia that are inconsistent with FDA‑approved labeling, relevant clinical literature, or the plan’s P&T‑adopted clinical coverage criteria may be considered not medically necessary and may be denied. Providers should supply documentation demonstrating that the requested use aligns with labeling or the plan’s criteria; lack of such concordance increases the risk of denial.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet indication-specific trials and universal criteria (age ≥18, HBV and latent TB screening prior to initiation, no active infection, avoid live vaccines during therapy, and no concurrent disallowed biologic or specified oral agents).

Prior authorization required for all indications listed unless member received the medication within the past 365 days (exempt from step therapy).
Universal criteria include: age ≥18; hepatitis B virus (HBV) screening prior to treatment; latent TB screening prior to treatment and ongoing TB monitoring; absence of active infection; no live vaccines during therapy; and no concurrent treatment with listed injectable biologics or specified oral non-biologic agents.

Billing Rule

Prior Authorization and Billing/Coding

Prior authorization must be obtained and billing should reference the appropriate HCPCS code and covered diagnosis codes from Appendix 1 when applicable.

Use HCPCS J0717 for certolizumab pegol (1 mg = 1 billable unit).
Providers should code authorizations and claims using Appendix 1 ICD-10 codes that correspond to the covered diagnoses.
Medicare-specific billing notes: J0717 may be used for Medicare when administered under direct physician supervision; do not use when self-administered.

Documentation Required

Documentation Required and Individual Consideration

Providers must submit documentation that supports the applicable indication and required baseline assessments. Neighborhood will consider prescriber-submitted clinical information on a case-by-case basis.

Required documentation: patient age; HBV screening results prior to treatment; latent TB screening prior to treatment; objective baseline disease severity assessment (e.g., PASI, DAS28, CDAI, ASDAS, BASDAI); baseline laboratory tests as relevant to the indication.
Prescribers should include prior therapy history, dates and outcomes of trials (e.g., adalimumab, infliximab, ustekinumab, oral DMARDs, NSAIDs, phototherapy), and objective measures of response.
Neighborhood will give individual consideration to clinical information submitted by the prescriber when reviewing requests.

Denial Risk

Denial Risk and Triggers

Requests may be denied if required screenings or documentation are missing, if there is active infection, if the request is for a non-concordant indication, or if concurrent disallowed therapies are being used.

Triggers for denial include: lack of HBV or latent TB screening prior to initiation, evidence of active infection, missing objective baseline disease severity assessment, or concurrent use of prohibited injectable biologics or specified oral agents.
Requests for indications not consistent with FDA labeling, relevant clinical literature, or the plan's clinical criteria may be denied.
Management of immunotherapy-related toxicity requests may not be renewed.

Step Therapy

Step Therapy Requirements

Step therapy criteria apply for many indications; prior trials and failures of specified therapies are required before approval unless contraindicated or intolerant.

RA: ≥3 months trial and failure of ONE oral DMARD (e.g., methotrexate) and inadequate response/intolerance to adalimumab at max tolerated doses.
CD: inadequate response/intolerance/contraindication to ≥3 months adalimumab or infliximab IV and to ≥6 months ustekinumab.
PsA/AS/nr-axSpA: required NSAID or DMARD trials as specified (examples above) and inadequate response/intolerance to adalimumab at max tolerated doses.
PsO: failure of topical (≥4 weeks), nonbiologic systemic (≥3 months), phototherapy (≥3 months), inadequate response/intolerance to adalimumab (≥3 months) and ustekinumab (≥6 months).
Members who received the medication within the past 365 days are not subject to step therapy requirements.

Prior Authorization

Dose Escalation Conditions for Plaque Psoriasis

Dose escalation for plaque psoriasis may be considered up to the maximum dose on a case-by-case basis after documented initial response and completion of loading and at least one maintenance dose.

Dose escalation conditions: demonstrated initial response to therapy; receipt of three loading doses at the specified intervals; receipt of a minimum of one maintenance dose; response by treatment week 6 with subsequent loss of response.
Note on dosing: patients ≤90 kg should initiate therapy at the lower regimen (200 mg every other week after loading).

Billing Rule

Use Appendix 1 Codes

Use Appendix 1 ICD-10 codes when submitting authorizations and claims to ensure alignment with covered diagnoses.

Appendix 1 lists covered ICD-10 codes for Crohn's disease, plaque psoriasis, psoriatic arthropathy, rheumatoid arthritis and related codes — providers should select the most specific applicable code from Appendix 1.
Failure to use appropriate Appendix 1 codes may delay processing.

Definitions and Response Criteria Examples

nr-axSpA objective signs of inflammation definition (CRP and/or MRI sacroiliitis)

DefinitionObjective signs of inflammation: elevation of C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI

Radiographic exclusionFindings occur without definitive radiographic evidence of structural damage on sacroiliac joints

Context of useRequired as part of nr-axSpA eligibility in addition to documented active disease and prior NSAID trial failure

Psoriatic Arthritis response (example) — improvement in tender/swollen joints or disease activity measures

Primary response metricImprovement in number of tender and swollen joint counts compared to baseline

PsARC criterionImprovement in at least 2 of 4 Psoriatic Arthritis Response Criteria (PsARC), one of which must be joint tenderness or swelling, with no worsening in any criterion

Alternate measuresImprovement on a disease activity scoring tool may also indicate response

Ankylosing Spondylitis response (example) — improvement in pain, function, stiffness, or ASDAS ≥1.1

Clinical domainsImprovement in total back pain, physical function, or morning stiffness

ASDAS thresholdASDAS improvement ≥ 1.1 qualifies as a response

BASDAI thresholdAlternatively, an improvement of ≥ 2 on BASDAI may indicate response

Non-radiographic axial spondyloarthritis response (example) — improvements such as ASDAS ≥1.1 or BASDAI ≥2

ASDAS responseAn improvement of ≥ 1.1 on ASDAS (or ASDAS-MI) is an acceptable response for nr-axSpA

BASDAI responseAn improvement of ≥ 2 on BASDAI may also be used to document response

Other acceptable outcomesASAS40 response, reduction in CRP, or improvements in back pain/function are additional examples of response metrics

Plaque psoriasis response (example) — improvements in redness/thickness/scaliness, BSA or PASI reductions (PASI75 or PASI50 + DLQI)

Skin sign improvementsReduction in redness, thickness, scaliness, and/or body surface area (e.g., total BSA ≤ 1%)

PASI/DLQI thresholdsPASI 75 (75% reduction) OR PASI 50 (50% reduction) plus a 4-point reduction in DLQI are acceptable measures of response

Dose-escalation contextDose escalation may be considered case-by-case after initial response, completion of three loading doses, at least one maintenance dose, and documented early response with later loss of effect

Covered diagnosis codes (examples) — example ICD-10 codes such as M06.89, M06.9 and M45.* variants

Example covered codesM06.89 (Other specified rheumatoid arthritis, multiple sites); M06.9 (Rheumatoid arthritis, unspecified)

nr-axSpA codesM45.AB, M45.A1, M45.A2, M45.A3, M45.A4, M45.A5, M45.A6, M45.A7, M45.A8, M45.A0 (Non-radiographic axial spondyloarthritis variants)

Policy appendix useAppendix 1 provides these example ICD-10 codes to be used for authorizations and claims

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

L40.0	Psoriasis vulgaris
M45.A0	Non-radiographic axial spondyloarthritis of unspecified sites in spine
K50.00	Crohn's disease of small intestine without complications

OpenPayer

Cimzia (certolizumab pegol) (Subcutaneous) — Coverage Criteria

Coverage Criteria for Cimzia (certolizumab pegol)

Coding — Units, HCPCS, NDC, and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Background — Drug and Policy Context

Definitions and Response Criteria Examples

Policy Revision History