Blue Cross Blue Shield - Iowa Cimzia Prior Auth | OpenPayer
CurrentBlue Cross Blue Shield - IowaPolicy 05.01.06
Cimzia (certolizumab pegol) — prior authorization and coverage criteria
Defines prior authorization, coverage criteria, and documentation requirements for Cimzia (prefilled syringes and lyophilized powder) for Wellmark/Blue Cross Blue Shield members; affects prescribers and pharmacy/medical benefit claim reviewers.
Policy Summary
PayerBlue Cross Blue Shield - Iowa
PolicyCimzia (certolizumab pegol) — prior authorization and coverage criteria
Policy CodePolicy 05.01.06
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionPrior authorization is required and initial approvals generally require documented trials of preferred products (commonly two) or documented exceptions such as current positive response or pregnancy/breastfeeding.
No material clinical or coverage changes in this revision.
7+FDA-approved indications listed
2Formulations addressed
>=2Preferred product trials required
12 monthsTypical authorization duration
3 kitsInitiation quantity limit
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J0717HCPCS billing code
Coverage Criteria
Ankylosing spondylitis initial approval
Ankylosing spondylitis — initial approval
Ankylosing spondylitis initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (Cosentyx, Enbrel, Adalimumab-aacf, Rinvoq, Simponi, Xeljanz/Xeljanz XR); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 8
Axial spondyloarthritis initial approval
Axial spondyloarthritis — initial approval
Axial spondyloarthritis initial criteria: One of: (a) inadequate response or intolerable adverse event with both preferred products (Cosentyx and Rinvoq); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
pJIA initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (adalimumab-aacf, Enbrel, Xeljanz/Xeljanz Oral solution); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 10
Psoriatic arthritis initial approval
Psoriatic arthritis — initial approval
Psoriatic arthritis initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (Cosentyx, Enbrel, Adalimumab-aacf, Otezla, Otulfi, Rinvoq, Simponi, Skyrizi, Tremfya, Xeljanz/Xeljanz XR); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 11
Rheumatoid arthritis initial approval
Rheumatoid arthritis — initial approval
Rheumatoid arthritis initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (Adalimumab-aacf, Enbrel, Rinvoq, Simponi, Xeljanz/Xeljanz XR); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 12
Crohn's disease initial approval
Crohn's disease — initial approval
Crohn's disease initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (Adalimumab-aacf, Entyvio, Otulfi, Rinvoq, Skyrizi, Tremfya); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 13
Plaque psoriasis initial approval
Plaque psoriasis — initial approval
Plaque psoriasis initial criteria: One of: (a) inadequate response or intolerable adverse event with at least TWO preferred products (Adalimumab-aacf, Enbrel, Cosentyx, Otezla, Otulfi, Skyrizi, Tremfya); (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 14
Lyophilized powder indication-specific criteria
Cimzia Lyophilized Powder — indication-specific initial approval when preferred IV/office-administered products are addressed
Ankylosing spondylitis (lyophilized) initial criteria: One of: (a) inadequate response or intolerable adverse event to each of Avsola, Inflectra, Simponi Aria; (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 15
pJIA (lyophilized) initial criteria: One of: (a) documented inadequate response or intolerable adverse event to Simponi Aria; (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
Initial approval — Moderately to severely active rheumatoid arthritis (RA)
RA initial approval pathway A2
Biomarker requirement: Member meets either positive testing for RF or anti-CCP OR has been tested for RF, anti-CCP, and CRP and/or ESR
see chunk 22
Methotrexate trial or intolerance: Member has either had inadequate response to at least a 3-month trial of methotrexate titrated to >=15 mg/week OR has intolerance/contraindication to methotrexate (see Appendix A)>=3 months
pJIA initial criteria: Authorization of 12 months may be granted for members >=2 years who have previously received a biologic/targeted synthetic drug indicated for active articular JIA OR meet any of the following: inadequate response to methotrexate or another csDMARD at adequate dose/duration; inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids plus at least one risk factor for poor outcome; presence of risk factors for disease severity and one of specified severity markers.
see chunk 23
Initial Therapy — Psoriatic arthritis
Initial approval — Psoriatic arthritis (PsA)
PsA initial criteria: Authorization of 12 months may be granted for adults who have previously received a biologic/targeted synthetic drug indicated for PsA OR when either: (a) mild-to-moderate disease with inadequate response to methotrexate/leflunomide/other csDMARD or intolerance/contraindication; or (b) severe disease.
AS/nr-axSpA initial criteria: Authorization of 12 months may be granted when member previously received an indicated biologic/targeted synthetic OR has inadequate response to at least two NSAIDs OR intolerance/contraindication to >=2 NSAIDs.
see chunk 25
Initial Therapy — Crohn's disease
Initial approval — Crohn's disease
Crohn's disease initial: Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease when criteria for clinical response or remission are met; non-formulary exception adds specific measures of response (abdominal pain, diarrhea, weight, hematocrit, mucosal appearance, CDAI).
see chunks 26 and 33
Initial Therapy — Plaque psoriasis
Initial approval — Moderate to severe plaque psoriasis (PsO)
Psoriasis initial criteria: Authorization of 12 months may be granted when any of the following: crucial body areas affected OR >=10% BSA OR >=3% BSA plus inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) or clinical reason to avoid those treatments.BSA >=10% or >=3% with additional criteria
Continuation criteria: Authorization of 12 months may be granted for members (including new members) using the requested medication who achieve or maintain a positive clinical response as defined per indication (examples include >=20% improvement in tender/swollen joint counts or symptom measures for RA; improvement or low disease activity markers for pJIA, PsA, AS/nr-axSpA; remission or positive response measures for Crohn's; reduction in BSA or symptom improvement for PsO).>=20% improvement for RA specified
see chunks 28-31, 34
Benefits and coverage for Cimzia are subject to the member’s specific plan and contract. Benefit determinations are based on the applicable contract language in effect at the time of service; exclusions, limitations, or exceptions may apply. This policy may not apply to Federal Employee Program (FEP) members — FEP benefits are determined by the Federal Employee Program and should be verified separately before making coverage decisions.
Prior to initiation, members must have documented tuberculosis screening. Obtain a documented negative TB test (tuberculin skin test, interferon-gamma release assay, or chest x-ray) within 12 months for patients naïve to biologic or targeted synthetic therapies. Do not administer Cimzia to members with active tuberculosis; if latent TB is detected, treatment must be started prior to initiation. Concomitant use of Cimzia with any other biologic or targeted synthetic drug for the same indication is not permitted.
When methotrexate or leflunomide is part of the treatment pathway, consider documented contraindications or clinical reasons to avoid these agents. Examples include: chronic liver disease or alcohol use disorder, breastfeeding or pregnancy (or planning pregnancy), blood dyscrasias, elevated transaminases, renal impairment, significant drug interactions, history of intolerance or hypersensitivity, interstitial pneumonitis, or other significant comorbidities that prohibit systemic therapy. Where such contraindications or clinical reasons exist, alternative treatment pathways and documentation should be considered in accordance with the appendices.
Cimzia is considered not medically necessary for members who do not meet the coverage criteria and requirements described in this policy, including screening, prior therapy trials, and required documentation.
Initial Therapy Requirements
Initial therapy requirements — general top-level options
Initial approval criteria generally require one of the following:
Initial approval common conditions: (a) inadequate response or intolerable adverse event to specified preferred products (number and specific agents vary by indication, commonly two); (b) currently receiving the requested non-preferred product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
Specific lists of preferred products differ by indication and are detailed per indication.
Initial Therapy — alternative pathways
Initial approval alternative pathways:
Preferred biologic failure or intolerance: For RA, Crohn's disease, and plaque psoriasis, initial approval applies when member has had inadequate response or intolerable adverse event to each of specified preferred biologic products listed per indication (e.g., Avsola, Inflectra, others depending on indication).
Continuation / Renewal Criteria
Continuation therapy requirements (general)
Continuation requests
Continuation documentation: Chart notes or medical record documentation supporting positive clinical response (and for psoriasis decreased BSA/improvement where applicable).n/a
Must meet Preferred Drug Plan Design and Criteria for Initial Approval/Continuation when applicable.
Continuation Therapy — Cimzia
Renewal/continuation criteria by indication
RA continuation: Maintain authorization for 12 months if member achieves or maintains >=20% improvement from baseline in tender joint count, swollen joint count, pain, or disability.>=20%
chunk 28
Step Therapy and Prior Trials
Requirement
Details
Step therapy requirement
Trials of two preferred products are required prior to approval of non-preferred Cimzia (prefilled syringes) for indications where preferred products are available; exceptions: member is currently receiving the requested non-preferred product through insurance with a positive therapeutic outcome, the member is pregnant or breastfeeding, or only one preferred product exists for the indication.
Requirement
Details
Prior therapy trials or documentation of intolerance/contraindication
Approval requires documentation of inadequate response or intolerable adverse events to the indicated prior therapies specified by indication (examples: failure of listed preferred biologics for RA, Crohn's disease, and plaque psoriasis; inadequate response to ≥2 NSAIDs for ankylosing spondylitis; inadequate response or intolerance to methotrexate/csDMARDs for arthritis indications). Where applicable, chart notes detailing outcomes, intolerable adverse events, contraindications, or exclusions to preferred products must be submitted.
Provider Actions, Documentation & Authorization
Prior Authorization
Prior Authorization Required
Prior Authorization Required: Prior authorization is required for Cimzia (certolizumab pegol). Approval duration and renewal: when criteria are met, initial and continuation approvals are generally authorized for 12 months.
Authorization duration: 12 months when approval criteria met for applicable indications (RA, pJIA, PsA, AS/nr-axSpA, Crohn's disease, moderate-to-severe plaque psoriasis).
Denial trigger: Missing required trials, documentation, positive TB testing without further evaluation, active TB, or concurrent use with another biologic/targeted synthetic for same indication may result in denial.
Documentation Required
Required Documentation
Documentation must be submitted to initiate and support the prior authorization review. Provide objective evidence of prior therapies, outcomes, and any contraindications or intolerances to preferred products.
Billing and Coding
Procedures/Billing codesHCPCS
J0717
Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
Body surface area (BSA) threshold for psoriasis indications
BSA threshold>= 10% of body surface area
Alternate BSA threshold>= 3% of body surface area PLUS either inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or clinical reason to avoid those treatments
Crucial body areasAny involvement of hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas may qualify regardless of BSA
Methotrexate adequate dose definition
Adequate methotrexate doseTitrated to at least 15 mg per week
Minimum trial durationAt least a 3-month trial at adequate dosing to be considered an inadequate response
Quantity Limits
Cimzia initiation quantity limits
Initiation quantity limit (first 28 days)3 maintenance kits (6 syringes/vials) OR 1 starter kit per first 28 days
Maintenance reporting unitKits may contain syringes or vials as specified (maintenance kits = 2 x 200 mg; starter kit details vary)
Measurement periodLimits applied per 28-day period
Cimzia maintenance quantity limits by indication
Plaque psoriasis maintenance2 kits (4 x 200 mg vials/syringes) per 28 days
Other indications maintenance1 kit (2 x 200 mg vials/syringes) per 28 days
Administration Site and Billing
Billing Rule
Office/infusion billing — use J0717 for supervised administration
When Cimzia is administered in an office or infusion center under direct physician supervision, report the administration using HCPCS code J0717.
J0717 is for injection of certolizumab pegol, 1 mg, and may be used when drug is administered under direct physician supervision (not for self‑administered doses).
Biosimilar / Reference Products
Note
Avsola listed as preferred comparator for lyophilized‑powder pathways
When evaluating requests for Cimzia lyophilized powder, Avsola is listed as a preferred alternative product for certain indications and must be addressed per the lyophilized‑powder criteria.
Lyophilized powder initial criteria list Avsola as a preferred product to trial or document failure/intolerance to, depending on the indication.
Note
Inflectra listed as preferred comparator for lyophilized‑powder pathways
When evaluating requests for Cimzia lyophilized powder, Inflectra is listed as a preferred alternative product for certain indications and must be addressed per the lyophilized‑powder criteria.
Lyophilized powder initial criteria list Inflectra as a preferred product to trial or document failure/intolerance to, depending on the indication.
PurposePreferred product lists are used to require trials of preferred agents before non-preferred Cimzia unless exceptions apply
Examples of contraindications to methotrexate or leflunomide
Liver diseaseClinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
Breastfeeding and pregnancy
Background
Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) inhibitor approved for multiple immune‑mediated inflammatory conditions, including Crohn’s disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis, ankylosing spondylitis/non‑radiographic axial spondyloarthritis, and moderate‑to‑severe plaque psoriasis. The policy is intended to ensure appropriate patient selection by requiring indication‑specific criteria, prior trials of preferred therapies where applicable, appropriate screening (for example, TB testing prior to biologic initiation), and documentation of therapeutic response for continuation.
Revision History
2026-05-29policy_effective_dateLatest
Policy revision effective — current policy effective date set to May 29, 2026 following April 2026 review/revision.
2026-04policy_revision
Policy was reviewed and revised in April 2026 (document notes 'Reviewed: April 2026' and 'Revised: April 2026').
Policy Summary
PayerBlue Cross Blue Shield - Iowa
PolicyCimzia (certolizumab pegol) — prior authorization and coverage criteria
Policy CodePolicy 05.01.06
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionPrior authorization is required and initial approvals generally require documented trials of preferred products (commonly two) or documented exceptions such as current positive response or pregnancy/breastfeeding.
One of: (a) inadequate response or intolerable adverse event to each of Avsola, Inflectra, Simponi Aria, Skyrizi; (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.
n/a
see chunk 17
Rheumatoid arthritis (lyophilized) initial criteria: One of: (a) inadequate response or intolerable adverse event to each of Avsola, Inflectra, Simponi Aria; (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 18
Crohn's disease (lyophilized) initial criteria: One of: (a) inadequate response or intolerable adverse event to each of Avsola, Entyvio, Inflectra, Skyrizi; (b) currently receiving the requested product through insurance with positive therapeutic outcome (samples and manufacturer assistance excluded); (c) currently pregnant or breastfeeding.n/a
see chunk 19
see chunks 18-20
Current therapy exception: Initial approval may be granted if member is currently receiving requested product through insurance and experiencing positive therapeutic outcome (samples and manufacturer assistance excluded).
see chunks 18-20
Pregnancy/breastfeeding: Initial approval may be granted if member is currently pregnant or breastfeeding.
see chunks 18-20
pJIA continuation: Maintain authorization for 12 months if member achieves low disease activity or improvement in joints with active arthritis, limitation of movement, or functional ability.
chunk 29
PsA continuation: Maintain authorization for 12 months if member achieves low disease activity or improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.
chunk 30
AS/nr-axSpA continuation: Maintain authorization for 12 months if member achieves low disease activity or improvement in functional status, spinal pain, inflammation, swollen/tender joints, or CRP.
chunk 31
PsO continuation: Maintain authorization for 12 months if member achieves reduction in BSA affected or improvement in signs/symptoms (itching, redness, scaling, etc.).
chunk 34
Required for initial requests: chart notes, medical record documentation, or claims history documenting prior medications tried and response (or clinical reason to avoid).
Laboratory results/biomarker testing when applicable (e.g., RF, anti-CCP, CRP, ESR).
For continuation requests: chart notes or medical record documentation supporting positive clinical response (e.g., reduced BSA, symptom improvement, low disease activity).
For plaque psoriasis: documentation of affected area(s) and body surface area (BSA) when applicable.
Step Therapy
Preferred Biologic Trial Requirement
Preferred Biologic Trial Requirement: For many indications the policy requires trials of the health plan's preferred products prior to approval of non-preferred Cimzia, unless clinical exceptions apply.
General rule: Use of two preferred products is typically required before non-preferred product use, unless all preferred products are contraindicated, member is already receiving the non-preferred product with positive outcome, or only one preferred product exists for the indication.
Specialized preferred list for provider-administered (lyophilized) context: Avsola, Inflectra, Entyvio, Ilumya, Stelara, Skyrizi, Simponi Aria.
Note
Consideration of Prior/Concurrent Therapies
Consideration of prior and concurrent therapies: Assess prior medication trials, adequate dosing and duration, and clinical reasons that preclude use of preferred agents. Document intolerances, contraindications, or lack of efficacy.
For RA: inadequate response to a 3-month trial of methotrexate at adequate dosing (≥15 mg/week) or intolerance/contraindication to methotrexate (see Appendix A).
For pJIA: inadequate response to methotrexate or another conventional synthetic DMARD (or NSAIDs/intra-articular steroids plus risk factors) as appropriate.
For PsA: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD, or intolerance/contraindication.
For AS/nr-axSpA: inadequate response to at least two NSAIDs or intolerance/contraindication to two or more NSAIDs.
For plaque psoriasis: prior phototherapy or systemic agents trialed or clinical reason to avoid them per Appendix B.
Concurrent therapy rule: do not use requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Denial Risk
Denial Triggers / Billing and Quantity Limits
Operational notes and denial risks: Missing required trials, absence of supporting documentation of outcomes or contraindications, or exceeding stated quantity limits may result in denial or not medically necessary determinations.
Quantity limits apply — initiation and maintenance kit limits differ by indication; requests exceeding limits may be denied.
TB screening: documented negative TB test within 12 months required for biologic/targeted synthetic–naïve persons; positive screens require further testing and active TB is a contraindication.
Clinical exception documentation: chart notes detailing outcomes of prior treatments, intolerable adverse events, contraindications, or exclusions to preferred products must be submitted where applicable.
Alternative pathwayIntolerance or contraindication to methotrexate documented (see Appendix A) may substitute for trial
Applicability
Maintenance limits apply after the initiation period and are indication-specific
Breastfeeding; pregnancy or currently planning pregnancy listed as contraindications
Hematologic abnormalitiesBlood dyscrasias such as thrombocytopenia, leukopenia, or significant anemia
Other examplesElevated liver transaminases; history of intolerance or hypersensitivity; interstitial pneumonitis or pulmonary fibrosis; myelodysplasia; renal impairment; significant drug interaction
Clinical reasons to avoid systemic agents (methotrexate, cyclosporine, acitretin)
Hepatic diseaseClinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
Breastfeeding and pregnancyBreastfeeding; pregnancy or planning pregnancy as reasons to avoid systemic agents
Significant comorbidity or interactionsDrug interactions or significant comorbidity (e.g., kidney disease, uncontrolled hypertension) that increase treatment-related toxicity
General toxicity riskCannot be used due to risk of treatment-related toxicity
Risk factors for articular juvenile idiopathic arthritis (JIA)
Rheumatoid factor (RF)Positive rheumatoid factor is a risk factor for articular JIA