CurrentNeighborhood Health Plan of Rhode IslandPolicy 2005-A

Certolizumab pegol (Cimzia) — Coverage Criteria and Prior Authorization

Defines prior authorization, documentation, prescriber specialty, and coverage criteria for Cimzia (certolizumab pegol) across FDA-approved and select compendial indications for patients of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCertolizumab pegol (Cimzia) — Coverage Criteria and Prior Authorization

Policy CodePolicy 2005-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes documenting prior therapies and required labs or TB testing as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7FDA-approved indications listed

12 monthstypical authorization duration

≥2 yrsminimum age for pJIA

Prohibitedno concomitant biologic

12 moTB screening required

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Coverage criteria by indication

Rheumatoid Arthritis (Initial)

Covered when ALL of the following are met for adult RA:

RA overall

Biomarker requirement: Member meets either: (1) positive test for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP); OR (2) has been tested for ALL of RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
From policy: testing positive or having testing of all listed biomarkers
Prior therapy requirement: Member meets ONE of the following prior-therapy paths: (A) Failed to achieve low disease activity after a 3-month trial of methotrexate (MTX) monotherapy at a maximum titrated dose of ≥15 mg/week AND one of: inadequate response to MTX plus at least one other conventional synthetic drug after a 3-month trial at max tolerated doses; OR intolerable adverse event to hydroxychloroquine or sulfasalazine; OR documented contraindication to hydroxychloroquine and sulfasalazine; OR moderate-to-high disease activity; (B) Unable to tolerate 3-month MTX trial at ≥15 mg/week AND after MTX intolerance has had inadequate response to MTX combined with at least one other conventional synthetic drug after 3 months at max tolerated doses; (C) Stopped MTX and had documented inadequate response to another conventional synthetic drug (eg, leflunomide, hydroxychloroquine, sulfasalazine) alone or in combination after a 3-month trial at max tolerated doses; (D) Documented intolerable adverse event or contraindication to MTX and inadequate response to another conventional synthetic drug after 3 months at max tolerated doses3-month trial durations; MTX >=15 mg/week where applicable
Detailed nested prior therapy logic per policy

Polyarticular Juvenile Idiopathic Arthritis (Initial)

Covered when ANY of the following criteria are met for pJIA (members ≥2 years):

pJIA criteria group: Member meets ANY of the following: (1) inadequate response to methotrexate or another conventional synthetic drug (eg, leflunomide, sulfasalazine, hydroxychloroquine) administered at an adequate dose and duration; OR (2) inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids plus one or more risk factors for poor outcome (eg, involvement of ankle, wrist, hip, sacroiliac joint, temporomandibular joint; erosive disease or enthesitis; delay in diagnosis; elevated inflammatory markers; symmetric disease); OR (3) has risk factors for disease severity (see Appendix B) and meets one of: high-risk joint involvement (eg, cervical spine, wrist, hip), high disease activity, or is judged at high risk for disabling joint disease

Authorization of 12 months may be granted when criteria met

Psoriatic Arthritis (Initial)

Covered when ONE of the following is met for adult PsA:

PsA criteria group: Member meets ONE of the following: (1) mild-to-moderate disease with inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (eg, sulfasalazine) administered at an adequate dose and duration; OR (2) intolerance or contraindication to methotrexate or leflunomide (or another conventional synthetic drug); OR (3) enthesitis or predominantly axial disease; OR (4) severe disease

Authorization of 12 months may be granted when criteria met

Polyarticular Juvenile Idiopathic Arthritis (pJIA) — Initial authorization (members ≥2 years with prior biologic) or when criteria met

Authorization of 12 months may be granted for members 2 years of age or older for moderately to severely active pJIA when ANY of the following are met:

pJIA initial criteria: Member has had an inadequate response to methotrexate or another conventional synthetic drug administered at an adequate dose and duration

Examples of conventional drugs: leflunomide, sulfasalazine, hydroxychloroquine

pJIA alternative pathway: Member has had an inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids and has one or more risk factors for poor outcome (eg, involvement of ankle, wrist, hip, sacroiliac joint, TMJ; erosive disease or enthesitis; delay in diagnosis; elevated inflammatory markers; symmetric disease)

pJIA high-risk features: Member has risk factors for disease severity and meets one of: high-risk joints involved (eg, cervical spine, wrist, hip), high disease activity, or is judged at high risk for disabling joint disease

See Appendix B for risk factors

Psoriatic Arthritis (PsA) — Initial authorization

Authorization of 12 months may be granted for adult members for active PsA when EITHER of the following is met:

PsA mild-moderate pathway: Member has mild to moderate disease and inadequate response to methotrexate, leflunomide, or another conventional synthetic drug administered at an adequate dose and duration

Examples include sulfasalazine

PsA intolerance pathway: Member has intolerance or contraindication to methotrexate or leflunomide (or another conventional synthetic drug)

See Appendix A

PsA specific manifestations: Member has enthesitis or predominantly axial disease

PsA severe disease: Member has severe disease

Ankylosing Spondylitis / nr-axSpA — Initial authorization

Authorization of 12 months may be granted for adult members for active AS or nr-axSpA when EITHER of the following is met:

AS insufficient NSAID response: Member has had an inadequate response to at least two NSAIDs

AS NSAID intolerance: Member has an intolerance or contraindication to two or more NSAIDs

Plaque Psoriasis — Initial authorization

Authorization of 12 months may be granted for adult members for moderate to severe plaque psoriasis when ANY of the following are met:

PsO crucial areas: Crucial body areas affected (eg, hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

PsO BSA10: At least 10% body surface area (BSA) affected

PsO BSA3_plus: At least 3% BSA affected AND either inadequate response or intolerance to phototherapy (eg, UVB, PUVA) or to methotrexate, cyclosporine, or acitretin; OR a clinical reason to avoid those pharmacologic treatments

See Appendix A for clinical reasons to avoid

Immune Checkpoint Inhibitor-Related Toxicity — Initial authorization

Authorization of 12 months may be granted for treatment when member has moderate or severe immunotherapy-related inflammatory arthritis and EITHER of the following is met:

ICI inadequate steroids/CS: Member has had an inadequate response to corticosteroids or a conventional synthetic drug (eg, methotrexate, sulfasalazine, leflunomide, hydroxychloroquine)

ICI intolerance: Member has an intolerance or contraindication to corticosteroids and a conventional synthetic drug

Rheumatoid Arthritis (RA) — Continuation/maintenance authorization

Authorization of 12 months may be granted for adult members using the requested medication for moderately to severely active RA who achieve or maintain a positive clinical response.

RA response requirement: Positive clinical response evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability>=20% improvement

Applies to reauthorization and maintenance

pJIA — Continuation/maintenance authorization

Authorization of 12 months may be granted for members ≥2 years using the medication for moderately to severely active pJIA who achieve or maintain a positive clinical response.

pJIA response metrics: Improvement from baseline in number of joints with active arthritis, number of joints with limitation of movement, or functional ability

Psoriatic Arthritis (PsA) — Continuation/maintenance authorization

Authorization of 12 months may be granted for adult members using the medication for PsA who achieve or maintain a positive clinical response.

PsA response metrics: Improvement from baseline in number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or C-reactive protein (CRP)

AS / nr-axSpA — Continuation/maintenance authorization

Authorization of 12 months may be granted for adult members using the medication for AS or nr-axSpA who achieve or maintain a positive clinical response.

AS response metrics: Improvement from baseline in functional status, total spinal pain, inflammation (eg, morning stiffness), swollen/tender joints, or C-reactive protein (CRP)

Crohn's Disease — Continuation/maintenance authorization

Authorization of 12 months may be granted for members using the medication for moderately to severely active Crohn's disease who achieve or maintain remission or a positive clinical response.

CD response metrics: Improvement from baseline in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (eg, CDAI); OR maintenance of remission

Plaque Psoriasis — Continuation/maintenance authorization

Authorization of 12 months may be granted for adult members using the medication for moderate to severe plaque psoriasis who achieve or maintain a positive clinical response.

PsO response metrics: Reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms from baseline (eg, itching, redness, flaking, scaling, burning, cracking, pain)

Immune Checkpoint Inhibitor-Related Toxicity — Continuation/maintenance authorization

Authorization of 12 months may be granted for members using the medication for immunotherapy-related inflammatory arthritis who achieve or maintain a positive clinical response.

ICI maintenance: Achievement or maintenance of low disease activity or improvement in signs and symptoms

Other universal requirements

Applies to all indications

TB screening: Documented negative tuberculosis (TB) test (TST or IGRA) within 12 months for biologic/targeted synthetic-naïve persons; if positive, further evaluation to exclude active disease (eg, chest x-ray) and treatment of latent TB prior to initiation

Do not administer if active TB

No concomitant biologic: Requested medication cannot be used concomitantly with any other biologic or targeted synthetic drug for the same indication

Concomitant use will trigger denial

Age minimum for pJIA: Member is 2 years of age or older for pJIA indications>= 2 years

Applies to initial and continuation pJIA coverage

The indications listed in this policy — including FDA-approved and compendial uses — are considered a covered benefit only when all approval criteria are met and the member has no exclusions to the prescribed therapy. Prior authorization is required and, when criteria are satisfied for a given indication, an authorization of 12 months may be granted. Approval is contingent on submission of required documentation (for example, medical records or chart notes demonstrating prior therapies and clinical response) and compliance with the universal requirements specified in this policy.

Do not administer the requested medication to members with active tuberculosis infection. For members naïve to biologic or targeted synthetic drugs, documentation of a negative tuberculosis test (TST or IGRA) within 12 months of initiating therapy is required. If TB screening is positive, additional evaluation (e.g., chest x-ray) to exclude active disease and documentation of appropriate latent TB treatment prior to initiation are required.

Coding and measurement rules

Plaque Psoriasis BSA

BSA ≥10%At least 10% body surface area affected

BSA ≥3% with treatment failureAt least 3% BSA affected AND inadequate response or intolerance to phototherapy or methotrexate, cyclosporine, or acitretin

BSA ≥3% with clinical contraindicationAt least 3% BSA affected AND clinical reason to avoid methotrexate, cyclosporine, or acitretin (see Appendix A)

Plaque Psoriasis response metrics

Reduction in BSAReduction in body surface area affected from baseline

Improvement in signs/symptomsImprovement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

Low disease activityAchievement or maintenance of low disease activity demonstrated by clinical assessment

Prescriber requirements and actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the indications listed in this policy; when criteria are met a typical authorization length of 12 months may be granted across the listed indications.

Typical authorization length: 12 months when criteria are met (applies across listed indications such as RA, pJIA, PsA, AS/nr-axSpA, Crohn's disease, plaque psoriasis, immune checkpoint inhibitor–related toxicity).
Prior authorization required before initiation of therapy.

Note

Prior Authorization Not Specified in Segment (Informational)

Some source segments note that prior authorization is not specified in that particular segment; include this as informational context but do not override the policy-wide prior authorization requirement above.

If a source subsection does not explicitly restate prior authorization, the overall PA requirement remains in effect under this policy.

Documentation Required

Concomitant Therapy Prohibition

The requested medication must not be used concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Concomitant use with another biologic or targeted synthetic agent for the same indication is prohibited.

Note

No Denial Triggers Specified in This Segment (Informational)

No specific denial triggers are enumerated in this document segment beyond the usual failure to meet clinical criteria or documentation requirements; include as informational.

Absence of explicit denial triggers in this segment — denials will be based on not meeting medical necessity criteria or missing required documentation.

Documentation Required

TB Screening and Follow-up Required

For all indications, documentation of TB screening is required for biologic- or targeted-synthetic–naïve persons: a documented negative TB test (TST or IGRA) within 12 months prior to initiating therapy is required. If TB testing is positive, further evaluation to rule out active TB (e.g., chest x-ray) is required; do not start therapy for active TB. If latent TB is identified, TB treatment must be started before initiating the requested medication.

Acceptable tests: Tuberculin skin test (TST) or interferon-gamma release assay (IGRA).
Negative test must be within 12 months for biologic- or targeted-synthetic–naïve persons.
If positive: obtain confirmatory testing (e.g., chest x-ray) to exclude active TB; treat latent TB prior to therapy; do not administer therapy for active TB.

Step Therapy

No Universal Step Therapy Requirement Specified (See Indication Criteria)

No step therapy requirements are described in this segment as a universal policy exception; however, many specific indications do require prior trials of conventional therapies (see indication-specific criteria).

This segment does not state a single step-therapy algorithm that applies to all indications (informational).
Refer to indication-specific criteria for required conventional therapy trials (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, NSAIDs, phototherapy).

Background and drug information

Certolizumab pegol (Cimzia) is a tumor necrosis factor (TNF) inhibitor indicated for multiple inflammatory conditions. This policy covers FDA-approved and certain compendial indications for Cimzia — including inflammatory rheumatologic diseases, Crohn’s disease, and plaque psoriasis — subject to the indication-specific clinical criteria and the policy’s universal requirements (for example, TB screening and prohibition on concomitant use with another biologic or targeted synthetic for the same indication). Authorization length is generally 12 months when criteria are met.

Definitions and clinical terms

Biomarker testing

Rheumatoid factor (RF)Testing for rheumatoid factor (RF)

Anti-CCPTesting for anti-cyclic citrullinated peptide (anti-CCP) antibodies

CRP (and/or ESR)Testing for C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)

Risk factors for pJIA

Rheumatoid factor positivePositive rheumatoid factor (RF)

Anti-CCP positivePositive anti-cyclic citrullinated peptide (anti-CCP) antibodies

Pre-existing joint damageEvidence of pre-existing joint damage

Clinical reasons to avoid conventional systemic agents

Chronic liver disease / alcohol use disorderClinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease

Pregnancy / breastfeedingPregnancy or currently planning pregnancy, or breastfeeding

Drug interactions / comorbidityDrug interactions, significant comorbidity (e.g., liver or kidney disease, blood dyscrasias), hypersensitivity, or prior intolerance/adverse event

Risk factors for polyarticular juvenile idiopathic arthritis

RF positivePositive rheumatoid factor (RF)