sierra health and life Cimzia Coverage Update

Coverage Criteria for Cimzia (certolizumab pegol)

Crohn's disease (CD)

Covered when ALL of the following are met

CD initial therapy: Diagnosis of moderately to severely active Crohn's disease; patient has had an inadequate response to conventional therapies (e.g., anti-inflammatory drugs, corticosteroids, or oral immunosuppressive agents) OR prior treatment with a targeted immunomodulator FDA‑approved for Crohn's disease OR patient is currently on Cimzia; Cimzia is initiated and titrated according to US FDA labeled dosing for Crohn's disease; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); prescribed by or in consultation with a gastroenterologist; initial authorization will be issued for 12 months

CD continuation: Documentation of positive clinical response; Cimzia is initiated and titrated according to US FDA labeled dosing for Crohn's disease; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization will be issued for 12 months

Rheumatoid arthritis (RA)

Covered when ALL of the following are met

RA initial therapy: Diagnosis of moderately to severely active rheumatoid arthritis; history of failure or intolerance to a 3‑month trial of one non‑biologic DMARD at maximally indicated doses unless contraindicated OR prior treatment with a targeted immunomodulator FDA‑approved for RA OR patient is currently on Cimzia; Cimzia is initiated and titrated according to US FDA labeled dosing for RA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); prescribed by or in consultation with a rheumatologist; initial authorization will be issued for 12 months

RA continuation: Documentation of positive clinical response; Cimzia is initiated and titrated according to US FDA labeled dosing for RA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization will be issued for 12 months

Psoriatic arthritis (PsA)

Covered when ALL of the following are met

PsA initial therapy: Diagnosis of active psoriatic arthritis; history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated OR prior treatment with a targeted immunomodulator FDA‑approved for PsA OR patient is currently on Cimzia; Cimzia is initiated and titrated according to US FDA labeled dosing for PsA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); prescribed by or in consultation with a rheumatologist or dermatologist; initial authorization will be issued for 12 months

PsA continuation: Documentation of positive clinical response; Cimzia is initiated and titrated according to US FDA labeled dosing for PsA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization will be issued for 12 months

Ankylosing spondylitis (AS) and non‑radiographic axial spondyloarthritis (nr‑axSpA)

Covered when ALL of the following are met

AS/nr-axSpA initial therapy: Diagnosis of active ankylosing spondylitis or non‑radiographic axial spondyloarthritis; history of failure to two NSAIDs at maximally indicated doses each used for at least 4 weeks unless contraindicated OR prior treatment with a targeted immunomodulator FDA‑approved for AS/nr‑axSpA OR patient is currently on Cimzia; Cimzia is initiated and titrated according to US FDA labeled dosing for AS or nr‑axSpA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); prescribed by or in consultation with a rheumatologist; initial authorization will be issued for 12 months

AS/nr-axSpA continuation: Documentation of positive clinical response; Cimzia is initiated and titrated according to US FDA labeled dosing for AS or nr‑axSpA; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization will be issued for 12 months

Plaque psoriasis (PS)

Covered when ALL of the following are met

PS initial therapy: Diagnosis of moderate to severe plaque psoriasis; greater than or equal to 3% body surface area involvement or involvement of palmoplantar, facial, genital areas, or severe scalp psoriasis; history of failure to one listed topical therapy unless contraindicated AND history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated OR prior treatment with a targeted immunomodulator FDA‑approved for plaque psoriasis OR patient is currently on Cimzia; Cimzia is initiated and titrated according to US FDA labeled dosing for plaque psoriasis; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); prescribed by or in consultation with a dermatologist; initial authorization will be issued for 12 months

PS continuation: Documentation of positive clinical response; Cimzia is initiated and titrated according to US FDA labeled dosing for plaque psoriasis; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization will be issued for 12 months

Plaque Psoriasis

Cimzia is medically necessary for plaque psoriasis when ALL of the following are met

Diagnosis of moderate to severe plaque psoriasis

Severity or location: Greater than or equal to 3% body surface area involvement, palmoplantar, facial, genital involvement, or severe scalp psoriasis>=3% BSA or specific site involvement

Topical therapy failure: History of failure to one of the listed topical therapies unless contraindicated or clinically significant adverse effects (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar)

Methotrexate trial: History of failure to a 3 month trial of methotrexate at the maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Cimzia is proven for treatment of active polyarticular juvenile idiopathic arthritis when ALL of the following are met

Diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA)

Dosing: Cimzia is initiated and titrated according to US FDA labeled dosing for polyarticular juvenile idiopathic arthritis

Combination therapy exclusion: Patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed)

Prescriber: Prescribed by or in consultation with a rheumatologist (for initial therapy)

Authorization length:

FDA‑approved Indications

Covered when FDA‑approved indication is met

FDA-approved indications: Cimzia is indicated for any of: reducing signs and symptoms of moderately to severely active Crohn's disease in adults with inadequate response to conventional therapy; treatment of adults with moderately to severely active rheumatoid arthritis; treatment of adult patients with active psoriatic arthritis; treatment of adults with active ankylosing spondylitis; treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation; treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

From Proven indications list

Coverage aligned to indications and guideline-informed agent selection

Covered when treatment corresponds to FDA-labeled indications and clinical guidance supports use:

FDA-indications: Member has one of the FDA‑labeled indications for certolizumab pegol: moderately to severely active Crohn's disease with inadequate response to conventional therapy; moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; active non‑radiographic axial spondyloarthritis with objective signs of inflammation; moderate‑to‑severe plaque psoriasis (candidates for systemic therapy/phototherapy); active polyarticular juvenile idiopathic arthritis in patients ≥2 years.

FDA indications listed in document

Guideline-preference: Guideline considerations: for Crohn's disease, professional guidance suggests infliximab, adalimumab, or ustekinumab may be preferred over certolizumab for biologic‑naïve patients and certolizumab evidence may be lower quality; for ankylosing spondylitis/axSpA, TNF inhibitors are recommended as first‑line biologic therapy and agent choice should consider extra‑articular disease and patient preference.

Professional society guidance may affect agent selection

Response assessment: Assess definitive response generally at 12–16 weeks for most TNF inhibitors (except infliximab assessed earlier at 8–10 weeks); lack of response by guideline timeframes supports changing therapy.

General coverage governance

Policy guidance and applicability

Benefit-document precedence: Member specific benefit plan document governs coverage decisions; in the event of a conflict, the member specific benefit plan governs; check member documents and applicable federal or state mandates before applying this policy.

Operational requirement to consult member plan

Use of Cimzia in combination with another targeted immunomodulator is explicitly prohibited across the listed indications. The policy requires that patients not be concurrently receiving Cimzia with other targeted immunomodulators (examples listed in the criteria include agents such as Enbrel [etanercept], Simponi [golimumab], Orencia [abatacept], adalimumab, Xeljanz [tofacitinib], Olumiant [baricitinib], Rinvoq [upadacitinib], Stelara [ustekinumab], Skyrizi [risankizumab], and others). This combination‑use exclusion applies to both initial and continuation authorization determinations and is repeated in each indication-specific section.

For all indications covered by this policy, requests will be denied if the patient is receiving Cimzia concurrently with another targeted immunomodulator. Each indication’s initial and continuation criteria specifically state that the patient must not be receiving Cimzia in combination with a targeted immunomodulator and list multiple examples of such agents; confirm that the member is not on agents like etanercept, golimumab, abatacept, adalimumab, tofacitinib, baricitinib, upadacitinib, ustekinumab, risankizumab, among others, before approving authorization.

Experimental, investigational, or otherwise unproven uses of Cimzia may be excluded from coverage under the member’s benefit. Where a member’s Certificate of Coverage or an applicable state mandate expressly permits coverage for such uses, those provisions take precedence and should be followed. Providers must consult the member‑specific benefit plan and any relevant federal or state mandates when requesting coverage for off‑label or investigational indications.

This policy may exclude experimental, investigational, or unproven uses of Cimzia unless the member’s Certificate of Coverage specifically allows such coverage or a state mandate requires it. Always check the member‑specific benefit document prior to rendering a coverage decision for off‑label or investigational requests.

FDA approval and the drug’s prescribing information are provided for informational purposes only. FDA approval alone is not a basis for coverage; coverage determinations require that the request meet the policy’s clinical criteria and any applicable member plan terms or mandates.

Professional society guidance indicates limited or low‑quality evidence for certolizumab’s efficacy in certain Crohn’s disease scenarios. Notably, guideline statements suggest that certolizumab pegol may be less effective for induction of perianal fistula remission; alternative agents (e.g., adalimumab, ustekinumab, vedolizumab) are generally preferred for fistula induction. Consider guideline recommendations when evaluating requests for perianal fistula indications.

Although Cimzia is labeled by the FDA for multiple inflammatory conditions, coverage still requires that the request satisfy this policy’s clinical criteria and the member’s plan terms. FDA approval is informational only; coverage depends on meeting plan requirements and supporting clinical documentation such as diagnosis, prior therapy history, dosing per FDA label, and absence of contraindicated combination therapy.

Applicable Billing and Diagnosis Codes

Applicable CPT/HCPCS Codesmixed

96372	Therapeutic, prophylactic or diagnostic injection; subcutaneous or intramuscular
96401	Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic
J0717	Injection, certolizumab pegol, 1 mg

Applicable ICD-10 Codes (partial list)ICD-10

K31.6	Fistula of stomach and duodenum
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

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Applicable ICD-10 Diagnosis CodesICD-10

M05.631	Rheumatoid arthritis of right wrist with involvement of other organs and systems.
M05.632	Rheumatoid arthritis of left wrist with involvement of other organs and systems.
M05.639	Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems.
M05.641	Rheumatoid arthritis of right hand with involvement of other organs and systems.
M05.642	Rheumatoid arthritis of left hand with involvement of other organs and systems.
M05.649	Rheumatoid arthritis of unspecified hand with involvement of other organs and systems.
M05.651	Rheumatoid arthritis of right hip with involvement of other organs and systems.
M05.652	Rheumatoid arthritis of left hip with involvement of other organs and systems.
M05.659	Rheumatoid arthritis of unspecified hip with involvement of other organs and systems.
M05.661	Rheumatoid arthritis of right knee with involvement of other organs and systems.

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Updated ICD-10 CodesICD-10

M05.A

Added to applicable ICD-10 diagnosis codes list per annual edits

Body surface area (BSA) involvement for psoriasis — criterion values

BSA threshold>= 3% body surface area involvement

Special site involvementPalmoplantar, facial, genital involvement qualifies regardless of % BSA

Severe scalp psoriasisClassified as qualifying even if total BSA <3%

Age for juvenile indication

Minimum age for PJIA indication>= 2 years

Indication contextActive polyarticular juvenile idiopathic arthritis (pJIA)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization requirement — initial and continuation authorization periods and benefit routing

Prior authorization is required for Cimzia for the diagnoses listed in the ICD-10 code groups in this policy. Requests must include documentation of the diagnosis and supporting clinical information (see documentation callout). Initial and continuation approvals are typically issued for up to 12 months when criteria are met. Requests may be reviewed under the pharmacy benefit for self-administered subcutaneous Cimzia (certolizumab pegol) unless the member's benefit plan specifies medical benefit routing; for certain UnitedHealthcare of California plans with delegated provider groups, prior authorization review and benefit routing may be conducted by the delegated group and the agent may be obtained under the medical benefit.

Prior authorization required for listed ICD-10 diagnoses (see Applicable Codes section).
Initial and continuation authorizations generally issued for 12 months when criteria met.
Self-administered subcutaneous Cimzia is normally obtained under the pharmacy benefit unless member plan states otherwise; delegated reviews may result in medical benefit routing.
Member-specific benefit plan governs in case of conflict with this policy.

Initial Therapy Criteria

Initial therapy

Initial therapy — covered when diagnosis, prior treatment history and dosing per FDA label requirements are met

General initial rules: Diagnosis per FDA‑labeled indication; initiation and titration per US FDA labeled dosing for the requested indication; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); documentation of prior failure or intolerance to specified conventional therapies per indication is required unless contraindicated; prescriber specialty documentation required for some indications (e.g., gastroenterologist for Crohn's, rheumatologist for RA/AS, dermatologist for psoriasis); initial authorization will be issued for 12 months.

Indication‑specific prior therapy: Follow indication‑specific prior treatment requirements: CD — inadequate response to conventional therapies OR prior targeted immunomodulator OR current Cimzia; RA — failure/intolerance to a 3‑month trial of one non‑biologic DMARD OR prior targeted immunomodulator OR current Cimzia; PsA — failure to a 3‑month trial of methotrexate OR prior targeted immunomodulator OR current Cimzia; AS/nr‑axSpA — failure to two NSAIDs each for ≥4 weeks OR prior targeted immunomodulator OR current Cimzia; PS — topical failures plus 3‑month methotrexate trial unless substituted by prior targeted immunomodulator or current Cimzia.

Continuation of Therapy Requirements

Continuation therapy

Continuation therapy — covered when documentation shows ongoing benefit and other criteria maintained

Continuation for indications: Documentation of positive clinical response; continued dosing per US FDA labeled dosing for the indication; patient is not receiving Cimzia in combination with a targeted immunomodulator (examples listed); authorization typically issued for 12 months

Continuation of Therapy

Continuation of Therapy — continuation criteria for covered indications

Positive response: Documentation of positive clinical response

Dosing: Cimzia is dosed according to US FDA labeled dosing for the indication

Step Therapy and Prior Treatment Requirements

Step	Requirement
1	Must document prior trial and failure or intolerance to specified conventional or prior targeted therapies unless contraindicated; requirement varies by indication (examples: corticosteroids/oral immunosuppressives for Crohn's disease; a 3‑month trial of a non‑biologic DMARD for RA; 3‑month methotrexate trial for PsA/PS; two NSAIDs for AS/nr‑axSpA).

Step	Psoriasis-specific requirement
1	For plaque psoriasis initial therapy: documented diagnosis of moderate‑to‑severe plaque psoriasis (≥3% BSA or palmoplantar/facial/genital/severe scalp involvement), failure of at least one listed topical therapy, AND failure of a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; alternatively, prior treatment with an FDA‑approved targeted immunomodulator for psoriasis or current use of Cimzia may substitute for the methotrexate requirement.

Step

Psoriasis-specific requirement

For plaque psoriasis initial therapy: documented diagnosis of moderate‑to‑severe plaque psoriasis (≥3% BSA or palmoplantar/facial/genital/severe scalp involvement), failure of at least one listed topical therapy, AND failure of a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; alternatively, prior treatment with an FDA‑approved targeted immunomodulator for psoriasis or current use of Cimzia may substitute for the methotrexate requirement.

Step	Plan-dependent requirement
1	May require trial/failure of conventional therapy or other agents as defined by the member's benefit plan (e.g., inadequate response to conventional therapy for Crohn's disease); consult the member specific benefit plan for any additional step therapy mandates or state-required coverage rules.

Step	Guideline-informed sequencing
1	Consider alternative biologic classes or switching to another TNF inhibitor per guideline-recommended sequencing (examples: guidelines may favor infliximab, adalimumab, or ustekinumab over certolizumab for biologic‑naïve Crohn's disease; for ankylosing spondylitis, start with TNFi and if failure occurs consider switching to another TNFi or to an IL‑17 inhibitor).

Step	Administrative tools / plan process
1	UnitedHealthcare may use external tools (for example, InterQual® criteria) to assist in administering benefits; follow any step therapy processes and prior authorization requirements specified by the member's benefit plan. Confirm benefit routing (pharmacy vs medical) per member plan.

Site of Care and Benefit Routing

Billing Rule

Site of care and benefit routing for self‑administered Cimzia

Self‑administered subcutaneous Cimzia is generally obtained under the pharmacy benefit; provider‑administered formulations or exceptions per the member plan are subject to the medical‑benefit prior authorization process.

Site of care settings include office, infusion center, or home; confirm benefit routing and billing per the member plan.

Billing Rule

Infusion center coverage may vary by plan — consult member benefits

Site‑of‑care or coverage differences (e.g., infusion center vs pharmacy) may vary by member benefit specifications; consult the member's plan for any site‑specific coverage requirements.

Background on Cimzia and Clinical Context

Cimzia (certolizumab pegol) is a recombinant, PEGylated humanized antibody Fab' fragment that selectively neutralizes tumor necrosis factor alpha (TNF‑α). It is FDA‑labeled for multiple inflammatory conditions including moderately to severely active Crohn’s disease (after inadequate response to conventional therapy), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and non‑radiographic axial spondyloarthritis, moderate‑to‑severe plaque psoriasis (candidates for systemic therapy or phototherapy), and active polyarticular juvenile idiopathic arthritis in patients aged ≥ 2 years. The policy distinguishes medical‑benefit prior authorization and coverage rules for provider‑administered use while noting that self‑administered subcutaneous formulations are generally obtained under the pharmacy benefit unless the member’s plan specifies otherwise.

Definitions and Clinical Measures

Moderate to severe plaque psoriasis — BSA threshold and special site definitions

BSA threshold for moderate‑severe plaque psoriasis>= 3% BSA involvement

Special site definitionsPalmoplantar, facial, genital involvement qualify regardless of % BSA

Severe scalp psoriasisConsidered qualifying disease location even if total BSA is below threshold

Certolizumab pegol (Cimzia) — agent description

Agent class and structureRecombinant, humanized antibody Fab' fragment (PEGylated) selective for TNFα

MechanismBinds and neutralizes TNFα; lacks Fc region so does not fix complement or cause ADCC in vitro

OpenPayer

Cimzia (certolizumab pegol) — Medical Benefit Drug Coverage Criteria

Coverage Criteria for Cimzia (certolizumab pegol)

Applicable Billing and Diagnosis Codes

Provider Requirements, Prior Authorization, and Documentation

Initial Therapy Criteria

Continuation of Therapy Requirements

Step Therapy and Prior Treatment Requirements

Site of Care and Benefit Routing

Background on Cimzia and Clinical Context

Definitions and Clinical Measures