ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cimzia

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This policy governs NC Medicaid outpatient pharmacy prior approval for Cimzia, a systemic immunomodulator used for specified inflammatory diseases. It establishes diagnosis-specific clinical criteria, preferred-drug step therapy, safety screening, concurrent biologic restrictions, and authorization duration.

Policy Summary

PayerNorth Carolina Medicaid

PolicyCimzia (certolizumab pegol) coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateFebruary 26, 2019

Next Review DateN/A

Key ActionPrior approval is required for Cimzia; approval may be granted for up to 12 months when applicable diagnosis-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

Non-radiographic axial spondyloarthritis was added as an approved diagnosis for Cimzia.

The policy document was separated out by individual agents.

6covered diagnosis categories

12 monthsmaximum approval duration

1injectable immunomodulator allowed at a time

Jan 2, 2025

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ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cimzia

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Sign up for all North Carolina Medicaid policy alerts

Know when North Carolina Medicaid releases new policies or updates existing guidance.

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Policy Summary

PayerNorth Carolina Medicaid

PolicyCimzia (certolizumab pegol) coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateFebruary 26, 2019

Next Review DateN/A

Key ActionPrior approval is required for Cimzia; approval may be granted for up to 12 months when applicable diagnosis-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

Non-radiographic axial spondyloarthritis was added as an approved diagnosis for Cimzia.

The policy document was separated out by individual agents.

6covered diagnosis categories

12 monthsmaximum approval duration

1injectable immunomodulator allowed at a time

Jan 2, 2025

Diagnosis-Specific Coverage Criteria

Ankylosing spondylitis

Covered for ankylosing spondylitis when all required conditions are met.

NSAID response or disease severity: Beneficiary has inadequate symptom relief from treatment with at least two NSAIDs, is unable to receive NSAIDs because of contraindications, or has clinical evidence of severe or rapidly progressing disease.At least two NSAIDs
Preferred-product requirement: There is a trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try these agents.
Applies to non-preferred medications.

Adult Crohn's disease

Covered for adult Crohn's disease when all required conditions are met.

Preferred-product requirement: There is a trial and failure of Humira, or a clinical reason the beneficiary cannot try Humira.
Applies to non-preferred medications.

Adult plaque psoriasis

Covered for adult moderate-to-severe chronic plaque psoriasis when all required conditions are met.

Disease extent: Body surface area involvement is at least 3%, or involvement of the palms, soles, head and neck, or genitalia causes disruption in normal daily activities and/or employment.BSA >= 3%
Prior treatment or contraindication: Beneficiary failed to respond to or was unable to tolerate phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine, or has contraindications to these treatments.Phototherapy plus one specified medication
Preferred-product requirement: There is a trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try these agents.
Applies to non-preferred medications.

Psoriatic arthritis

Covered for psoriatic arthritis when all required conditions are met.

Age requirement: Beneficiary is 18 years of age or older, or is 2 years of age or older when the product is Simponi Aria.18 years; 2 years for Simponi Aria
Preferred-product requirement: There is a trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try these agents.
Applies to non-preferred medications.

Rheumatoid arthritis

Covered for rheumatoid arthritis when all required conditions are met.

Prior treatment or disease severity: Beneficiary has therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug, is unable to receive methotrexate or a disease-modifying antirheumatic drug because of contraindications or intolerabilities, or has clinical evidence of severe or rapidly progressing disease.At least one DMARD when applicable
Examples include leflunomide, hydroxychloroquine, minocycline, and sulfasalazine.
Preferred-product requirement: There is a trial and failure of Enbrel or Humira, or a clinical reason the beneficiary cannot try either agent.
Applies to non-preferred medications.

Non-radiographic axial spondyloarthritis

Covered for non-radiographic axial spondyloarthritis when all required conditions are met.

Preferred-product requirement: There is a trial and failure of Cosentyx.
Applies to non-preferred medications.

Coverage of more than one injectable immunomodulator at a time is excluded. Coverage is limited to one injectable immunomodulator at a time.

Initial Therapy Requirements

Initial therapy requirements

Initial coverage requires the applicable diagnosis-specific clinical criteria, safety screening, treatment history, and preferred-product trial or documented clinical exception.

Initial Cimzia authorization: The beneficiary meets the criteria for one of the covered diagnoses; is not receiving another injectable biologic immunomodulator; completes the required latent tuberculosis and hepatitis B evaluation; meets the diagnosis-specific prior-treatment or severity criteria; and meets applicable preferred-product step-therapy requirements.

Approval may be granted for up to 12 months.

Preferred-Product Step Therapy

Condition	Preferred agent(s)	Step-therapy requirement
Ankylosing spondylitis
Cosentyx, Enbrel, or Humira
For non-preferred medications, document a trial and failure of one of these agents, or a clinical reason the beneficiary cannot try them.

Condition	Preferred agent	Step-therapy requirement
Adult Crohn's disease
Humira
For non-preferred medications, document a trial and failure of Humira, or a clinical reason the beneficiary cannot try Humira.

Condition	Preferred agent(s)	Step-therapy requirement
Adult plaque psoriasis or psoriatic arthritis
Cosentyx, Enbrel, or Humira
For non-preferred medications, document a trial and failure of one of these agents, or a clinical reason the beneficiary cannot try them.

Condition	Preferred agent(s)	Step-therapy requirement
Rheumatoid arthritis
Enbrel or Humira
For non-preferred medications, document a trial and failure of Enbrel or Humira, or a clinical reason the beneficiary cannot try either agent.

Condition	Preferred agent	Step-therapy requirement
Non-radiographic axial spondyloarthritis
Cosentyx
For non-preferred medications, document a trial and failure of Cosentyx.

Authorization and Documentation Requirements

Prior Authorization

Prior Approval Required

Prior approval is required for Cimzia. When the applicable clinical and documentation criteria are met, approval may be granted for up to 12 months.

Submit a prior approval request before dispensing or administering Cimzia.
Approval duration: up to 12 months.

Step Therapy

Preferred-Product Requirement

For non-preferred medications, document a trial and failure of the specified preferred agent(s), or provide a clinical reason the beneficiary cannot try them.

Preferred therapy varies by diagnosis; see the indication-specific requirements below.
Document the trial, failure, contraindication, or intolerance in the request.

Medication and Clinical Context

Cimzia (certolizumab pegol) is a tumor necrosis factor inhibitor used to treat chronic inflammatory conditions, including inflammatory arthritis, axial spondyloarthritis, Crohn’s disease, and plaque psoriasis.

Clinical Definitions

Definition

TermAnkylosing spondylitis

DefinitionA chronic inflammatory arthritis affecting the spine and sacroiliac joints.

Definition

TermNon-radiographic axial spondyloarthritis

DefinitionAxial spondyloarthritis without definitive radiographic evidence of sacroiliitis.

Policy Summary

PayerNorth Carolina Medicaid

PolicyCimzia (certolizumab pegol) coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateFebruary 26, 2019

Next Review DateN/A

Key ActionPrior approval is required for Cimzia; approval may be granted for up to 12 months when applicable diagnosis-specific criteria are met.

SourceLink

On This Page

Step Therapy

Ankylosing Spondylitis Preferred Therapy

For ankylosing spondylitis, document a trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try one of these preferred agents.

Submit the applicable preferred-product history or clinical exception.

Step Therapy

Crohn’s Disease Preferred Therapy

For adult Crohn’s disease, document a trial and failure of Humira, or a clinical reason the beneficiary cannot try Humira.

Submit the applicable preferred-product history or clinical exception.

Step Therapy

Psoriasis and Psoriatic Arthritis Preferred Therapy

For plaque psoriasis and psoriatic arthritis, document a trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try the applicable preferred agent.

Submit the applicable preferred-product history or clinical exception.
For psoriasis, also document failure or inability to tolerate phototherapy and one of the specified systemic therapies when required.

Step Therapy

Rheumatoid Arthritis Preferred Therapy

For rheumatoid arthritis, document a trial and failure of Enbrel or Humira, or a clinical reason the beneficiary cannot try either preferred agent.

Submit the applicable preferred-product history or clinical exception.

Step Therapy

Axial Spondyloarthritis Preferred Therapy

For non-radiographic axial spondyloarthritis, document a trial and failure of Cosentyx, or a clinical reason the beneficiary cannot try Cosentyx.

Submit the applicable preferred-product history or clinical exception.

Documentation Required

Clinical Documentation Required

Include documentation supporting the qualifying diagnosis and required disease severity or treatment response. Also document that the beneficiary is not receiving another injectable biologic immunomodulator and provide the required safety-screening and treatment-history information.

Qualifying diagnosis and indication-specific severity requirements.
Disease response or failure, contraindication, intolerance, or rapidly progressing disease, as applicable.
Latent tuberculosis screening and hepatitis B surface antigen (Hep B SAG) and core antibody testing when required.
Current injectable biologic immunomodulator status.

Documentation Required

Siliq REMS Documentation

When Siliq is requested or used, document appropriate registration of the beneficiary, provider, and pharmacy in the Siliq Risk Evaluation and Mitigation Strategy (REMS) program.

Provide Siliq REMS registration documentation when applicable.

Prior Authorization

EPSDT Prior Approval

For beneficiaries under 21, prior approval remains required whenever the service, product, or procedure requires prior approval. Age under 21 does not eliminate the prior approval requirement.

Apply the same prior approval process when the requested service, product, or procedure requires it.

Denial Risk

Denial Risk: Clinical and Step-Therapy Requirements

Requests may be denied when clinical or step-therapy requirements are not met. Denial risks include concurrent use of another injectable biologic immunomodulator, missing required safety screening, or failure to document the applicable diagnosis, treatment response, contraindication, or preferred-product requirement.

Do not request coverage while the beneficiary is receiving another injectable biologic immunomodulator.
Include latent tuberculosis screening and hepatitis B testing when required.
Document all indication-specific clinical and preferred-product requirements.

Denial Risk

Denial Risk: Siliq REMS Registration

Requests involving Siliq may be denied if the beneficiary, provider, and pharmacy are not appropriately registered in the Siliq REMS program.

Verify and document all required Siliq REMS registrations before submitting the request.

Billing Rule

One Injectable Immunomodulator at a Time

Coverage is limited to one injectable immunomodulator at a time. Document that the beneficiary is not currently receiving another injectable biologic immunomodulator.

Concurrent injectable immunomodulator therapy is not covered under this requirement.