Sign up for all North Carolina Medicaid policy alerts
Know when North Carolina Medicaid releases new policies or updates existing guidance.
Monitor payer policy activity
Receive email alerts as soon as relevant payer policies are published or updated.
This policy governs North Carolina Medicaid prior approval for Enbrel, a systemic immunomodulator and anti-inflammatory tumor necrosis factor inhibitor. It applies to eligible NC Medicaid beneficiaries and establishes diagnosis-specific clinical criteria, screening requirements, treatment history requirements, and duration limits.
Policy Summary
PayerNorth Carolina Medicaid
PolicyEnbrel outpatient pharmacy prior approval
Policy CodePolicy N/A
Change TypeAdministrative revisionno material clinical or coverage change
Effective DateAugust 15, 2014
Next Review DateN/A
Key ActionSubmit prior approval only when the beneficiary meets the clinical criteria for a covered indication.
The criteria were separated into individual-agent criteria documents.
6covered clinical indication groups
12 monthsmaximum approval duration
1injectable immunomodulator permitted at a time
Enbreldrug covered by the policy
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.
Systemic immunomodulatortherapeutic category
Outpatient pharmacyservice setting
Covered Indications and General Requirements
Plaque Psoriasis — Pediatric
Covered for pediatric plaque psoriasis when all of the following criteria are met.
Pediatric plaque psoriasis
Diagnosis and treatment candidacy: Beneficiary has plaque psoriasis and is a candidate for systemic therapy or phototherapy.
No concurrent biologic: Beneficiary is not receiving another injectable biologic immunomodulator.
Safety screening: Beneficiary has been considered and screened for latent tuberculosis infection and has been tested with Hepatitis B surface antigen and core antibody.
Methotrexate response or intolerance: Beneficiary has experienced therapeutic failure or an inadequate response to methotrexate, or has a contraindication or intolerance to methotrexate.
Disease extent
BSA involvement: Beneficiary has body surface area involvement of at least 3%.at least 3% BSA
Special-site involvement: Beneficiary has involvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment.
Plaque Psoriasis — Adult
Covered for adult plaque psoriasis when all of the following criteria are met.
Adult plaque psoriasis
Diagnosis and age: Beneficiary has a documented definitive diagnosis of moderate-to-severe chronic plaque psoriasis and is 18 years of age or older.18 years of age or older
No concurrent biologic: Beneficiary is not receiving another injectable biologic immunomodulator.
Safety screening: Beneficiary has been considered and screened for latent tuberculosis infection and has been tested with Hepatitis B surface antigen and core antibody.
Tuberculosis and hepatitis B requirements are not required for Otezla.
Disease extent
Psoriatic Arthritis
Covered for psoriatic arthritis when all of the following criteria are met.
Psoriatic arthritis
Diagnosis: Beneficiary has a documented definitive diagnosis of psoriatic arthritis.
Age: Beneficiary is 18 years of age or older for Enbrel.18 years of age or older for Enbrel
The policy states 2 years of age or older for Simponi Aria.
No concurrent biologic: Beneficiary is not receiving another injectable biologic immunomodulator.
Safety screening:
For beneficiaries under 21 years of age, EPSDT requires coverage of medically necessary services, products, or procedures to correct or ameliorate an identified defect, illness, or condition, subject to EPSDT limitations. EPSDT does not require coverage of services that are unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment.
Initial Enbrel Therapy
Diagnosis-Specific Prior Treatment Requirements
Step
Requirement
1
Ankylosing spondylitis: inadequate symptom relief from at least two NSAIDs, inability to receive NSAIDs because of contraindications, or clinical evidence of severe or rapidly progressing disease.
Step
Requirement
1
Polyarticular juvenile idiopathic arthritis: inadequate response to one systemic corticosteroid, methotrexate, leflunomide, or sulfasalazine; inability to take these therapies because of contraindications; or the enthesitis-related arthritis subtype.
Step
Requirement
1
Pediatric plaque psoriasis: therapeutic failure or inadequate response to methotrexate, or a contraindication or intolerance to methotrexate.
Step
Requirement
1
Adult plaque psoriasis: failure or inability to tolerate phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine, or contraindications to these treatments. Non-preferred medications also require trial and failure of Cosentyx, Enbrel, or Humira, or a clinical reason the beneficiary cannot try them.
Step
Requirement
1
Psoriatic arthritis: documented inadequate response or inability to take methotrexate.
Step
Requirement
1
Rheumatoid arthritis: therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug; inability to receive these therapies because of contraindications or intolerability; or clinical evidence of severe or rapidly progressing disease.
The beneficiary must be enrolled in North Carolina Medicaid on the date of service. Confirm that the beneficiary's eligibility category does not impose service restrictions that would make the beneficiary ineligible, and obtain prior approval whenever required; being under age 21 does not eliminate the prior approval requirement.
Verify active Medicaid enrollment on the date of service.
Review eligibility-category service restrictions.
Prior approval remains required for services, products, or procedures subject to prior approval, including EPSDT cases.
Prior Authorization
Covered Indication Required
Prior approval requires documentation that the beneficiary meets the criteria for a covered indication. Covered indications include ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, adult plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Ankylosing spondylitis: diagnosis, no concurrent injectable biologic immunomodulator, tuberculosis and hepatitis B evaluation, and applicable NSAID or severe-disease criterion.
Approval Duration and Concurrent Therapy Limits
Enbrel Approval Limit
DrugEnbrel
Approval durationUp to 12 months
Limit typeMaximum approval period
Injectable Immunomodulator Limit
Permitted at one timeOne injectable immunomodulator
Concurrent therapyCoverage is limited to one injectable immunomodulator at a time
Limit typeConcurrent therapy limit
Key Policy Definitions
Plaque Psoriasis Extent Criterion
BSA thresholdAt least 3% body surface area involvement
Special sitesPalms, soles, head and neck, or genitalia
Functional impactSpecial-site involvement must cause disruption in normal daily activities and/or employment
EPSDT
Who qualifiesMedicaid beneficiaries under 21 years of age
Medical-necessity standardServices, products, or procedures must be medically necessary to correct or ameliorate a defect, physical or mental illness, or condition
Prior approval
Therapeutic Context
Enbrel is classified as a systemic immunomodulator in the anti-inflammatory tumor necrosis factor inhibitor class. The policy supports its use for inflammatory rheumatologic conditions and plaque psoriasis when the applicable diagnosis-specific disease activity, screening, and prior-treatment criteria are met.
Policy Summary
PayerNorth Carolina Medicaid
PolicyEnbrel outpatient pharmacy prior approval
Policy CodePolicy N/A
Change TypeAdministrative revisionno material clinical or coverage change
Effective DateAugust 15, 2014
Next Review DateN/A
Key ActionSubmit prior approval only when the beneficiary meets the clinical criteria for a covered indication.
BSA involvement: Beneficiary has body surface area involvement of at least 3%.at least 3% BSA
Special-site involvement: Beneficiary has involvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment.
Prior therapy: Beneficiary has failed to respond to, or has been unable to tolerate, phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine, or has contraindications to these treatments.Phototherapy plus 1 listed medication
Non-preferred medication requirement: For a non-preferred medication, beneficiary has had a trial and failure of Cosentyx, Enbrel, or Humira, or has a clinical reason the beneficiary cannot try one of these medications.
Siliq REMS: For Siliq, the beneficiary, provider, and pharmacy are appropriately registered in the Siliq Risk Evaluation and Mitigation Strategy program.
Beneficiary has been considered and screened for latent tuberculosis infection and has been tested with Hepatitis B surface antigen and core antibody.
Tuberculosis and hepatitis B requirements are not required for Otezla.
Methotrexate response or intolerance: Beneficiary has a documented inadequate response to methotrexate or is unable to take methotrexate.
A documented definitive diagnosis is required
Psoriatic Arthritis Age Requirements
Enbrel minimum age18 years of age or older
Simponi Aria minimum age2 years of age or older
Applicable conditionPsoriatic arthritis
Approval Duration
Maximum approval periodUp to 12 months
Applies toEnbrel approval
Approval unitApproval period
Concurrent Injectable Immunomodulators
Concurrent therapy limitOne injectable immunomodulator at a time
Concurrent biologic restrictionCoverage is not approved when the beneficiary is receiving another injectable biologic immunomodulator
ApplicabilityThe limit applies to injectable immunomodulator coverage
PJIA: diagnosis, no concurrent injectable biologic immunomodulator, tuberculosis and hepatitis B evaluation, and required prior systemic therapy or enthesitis-related arthritis subtype.
Pediatric plaque psoriasis: diagnosis, candidacy for systemic therapy or phototherapy, no concurrent injectable biologic immunomodulator, required screening, methotrexate response or intolerance, and applicable disease-severity or affected-area criterion.
Adult plaque psoriasis: definitive moderate-to-severe chronic plaque psoriasis, age 18 or older, no concurrent injectable biologic immunomodulator, applicable screening, disease-severity or affected-area criterion, and required prior therapy.
Psoriatic arthritis: definitive diagnosis, applicable age requirement, no concurrent injectable biologic immunomodulator, required screening, and documented methotrexate response or inability to take it.
Rheumatoid arthritis: diagnosis, no concurrent injectable biologic immunomodulator, required screening, and qualifying prior therapy failure, intolerance, contraindication, or severe or rapidly progressing disease.
Step Therapy
Ankylosing Spondylitis NSAID Therapy
For ankylosing spondylitis requests, document inadequate symptom relief after treatment with at least two NSAIDs, inability to receive NSAIDs because of contraindications, or clinical evidence of severe or rapidly progressing disease.
Document the NSAIDs tried and the inadequate response, or identify the contraindication preventing NSAID treatment.
Severe or rapidly progressing disease may satisfy the applicable alternative criterion when clinically documented.
Step Therapy
PJIA Prior Therapy
For PJIA requests, document a trial of one systemic corticosteroid, such as prednisone or methylprednisolone, or methotrexate, leflunomide, or sulfasalazine, with inadequate response. An inability to take these therapies because of contraindications may satisfy the alternative criterion; enthesitis-related arthritis is an additional qualifying PJIA subtype.
Document the prior agent and therapeutic response or the contraindication preventing use.
A PJIA subtype of enthesitis-related arthritis may qualify as an alternative to the required prior-therapy response.
Step Therapy
Pediatric Psoriasis Methotrexate Therapy
For pediatric plaque psoriasis, document therapeutic failure or inadequate response to methotrexate, or a contraindication or intolerance to methotrexate, when the beneficiary is a candidate for systemic therapy or phototherapy.
The beneficiary must have plaque psoriasis and be a candidate for systemic therapy or phototherapy.
Document the methotrexate response, intolerance, or contraindication.
Step Therapy
Adult Psoriasis Prior Therapy
For adult plaque psoriasis, document failure to respond to or inability to tolerate phototherapy and one of the following, or contraindications to these treatments: Soriatane (acitretin), methotrexate, or cyclosporine. Non-preferred medications also require trial and failure of Cosentyx, Enbrel, or Humira, unless there is a documented clinical reason the beneficiary cannot try one of them.
Document phototherapy failure or intolerance and prior therapy with one specified medication, or the applicable contraindications.
For non-preferred medications, document trial and failure of Cosentyx, Enbrel, or Humira, or the clinical reason the beneficiary cannot try one of these agents.
Step Therapy
Psoriatic Arthritis Methotrexate Therapy
For psoriatic arthritis requests, document an inadequate response to methotrexate or the beneficiary's inability to take methotrexate.
Document the methotrexate treatment history and inadequate response, or the contraindication, intolerance, or other clinical basis for inability to take it.
The age requirement is 18 years or older, or 2 years or older for Simponi Aria.
Step Therapy
Rheumatoid Arthritis Prior Therapy
For rheumatoid arthritis requests, document therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug. If these therapies cannot be used, document the contraindication or intolerance; clinical evidence of severe or rapidly progressing disease is an additional qualifying pathway.
Qualifying disease-modifying therapies include leflunomide, hydroxychloroquine, minocycline, and sulfasalazine.
Document prior treatment response, contraindications, intolerabilities, or severe or rapidly progressing disease.
Documentation Required
Clinical Eligibility Documentation
Submit clinical documentation supporting the applicable diagnosis and all diagnosis-specific requirements. Documentation should establish treatment response or intolerance, disease severity, and the affected body areas when those criteria apply.
Provide a definitive diagnosis for the requested indication.
Document inadequate response, therapeutic failure, intolerance, contraindication, or inability to use required prior therapy, as applicable.
For psoriasis, document BSA involvement of at least 3%, or involvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment.
For adult psoriasis, document moderate-to-severe chronic plaque psoriasis and age 18 years or older.
For pediatric psoriasis, document candidacy for systemic therapy or phototherapy.
Documentation Required
Tuberculosis and Hepatitis B Screening
Document that latent tuberculosis infection has been considered and screened for, and document testing with hepatitis B surface antigen and core antibody for applicable requests.
Tuberculosis and hepatitis B documentation is required for ankylosing spondylitis, PJIA, pediatric psoriasis, psoriatic arthritis, and rheumatoid arthritis criteria.
For adult plaque psoriasis, tuberculosis and hepatitis B requirements are not required for Otezla.
Prior Authorization
Siliq REMS Registration
For Siliq requests, the beneficiary, provider, and pharmacy must be appropriately registered in the Siliq Risk Evaluation and Mitigation Strategy (REMS) Program.
Verify registration of all three parties before submitting or dispensing a Siliq request.
Denial Risk
Diagnosis-Specific Criteria Not Met
Requests may be denied when the beneficiary does not have a covered diagnosis or when the applicable indication-specific clinical criteria are not documented or are not met.
Deny when the requested indication is not one of the covered diagnoses.
Deny when required diagnosis, prior-therapy, disease-severity, affected-area, age, or other clinical criteria are absent or unsatisfied.
Deny when required tuberculosis, hepatitis B, or other screening documentation is missing, except where an expressly stated exception applies.
Denial Risk
Concurrent Injectable Biologic
Do not approve coverage when the beneficiary is receiving another injectable biologic immunomodulator, unless the policy provides an applicable exception.
The concurrent injectable-biologic restriction applies to ankylosing spondylitis, PJIA, pediatric psoriasis, adult psoriasis, psoriatic arthritis, and rheumatoid arthritis criteria.
For adult psoriasis, Otezla-specific exceptions apply to tuberculosis and hepatitis B screening, not to the concurrent injectable-biologic restriction.
Billing Rule
Duration and Concurrent Therapy Limit
Approvals may be issued for up to 12 months, and coverage is limited to one injectable immunomodulator at a time.
Maximum approval duration: up to 12 months.
Maintain the one-injectable-immunomodulator-at-a-time restriction.
Being under 21 years of age does not eliminate a prior approval requirement