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 NC Medicaid prior approval and coverage criteria for Avsola, an anti-inflammatory tumor necrosis factor inhibitor, for specified inflammatory and autoimmune conditions, including EPSDT provisions for beneficiaries under 21.
No material clinical or coverage changes in this revision.
8Covered indication groups
12 monthsMaximum approval duration
1Injectable immunomodulators allowed at a time
3% BSAAdult plaque psoriasis minimum BSA
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.
Humira trial or exception
Non-preferred medication requirement
Covered Indications and Eligibility
Ankylosing spondylitis
Covered when the diagnosis and screening requirements are met and at least one clinical treatment pathway applies. Non-preferred products also require the applicable preferred-product exception pathway.
Diagnosis and screening: Beneficiary has a diagnosis of ankylosing spondylitis; is not receiving another injectable biologic immunomodulator; has been considered and screened for latent tuberculosis infection; and has been tested with Hepatitis B surface antigen and core antibody.
Clinical treatment pathway
NSAID treatment failure: Beneficiary has experienced inadequate symptom relief from treatment with at least two NSAIDs.
NSAID contraindication: Beneficiary is unable to receive NSAID treatment because of contraindications.
Severe or rapidly progressing disease: Beneficiary has clinical evidence of severe or rapidly progressing disease.
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or there is a clinical reason the beneficiary cannot try those products.
Applies to non-preferred medications.
Crohn's disease
Covered when all applicable diagnosis, screening, concurrent-therapy, and preferred-product requirements are met.
Adult Crohn's disease
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Humira or there is a clinical reason the beneficiary cannot try Humira.
Applies to non-preferred medications.
Pediatric Crohn's disease
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Humira or there is a clinical reason the beneficiary cannot try Humira.
Applies to non-preferred medications.
Adult plaque psoriasis
Covered when all age, diagnosis, concurrent-therapy, screening, disease-involvement, and treatment-history requirements are met.
Disease involvement
Body-surface-area pathway: Beneficiary has body-surface-area involvement of at least 3%.BSA at least 3%
High-impact-site pathway: Beneficiary has involvement of the palms, soles, head and neck, or genitalia that causes disruption in normal daily activities and/or employment.
Prior treatment: 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.
Psoriatic arthritis
Covered when all applicable diagnosis, age, concurrent-therapy, screening, methotrexate, and preferred-product requirements are met.
Age requirement: Beneficiary is 18 years of age or older, or is 2 years of age or older when requesting Simponi Aria.
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or there is a clinical reason the beneficiary cannot try those products.
Applies to non-preferred medications.
Rheumatoid arthritis
Covered when the diagnosis, screening, concurrent-therapy, and disease-modifying treatment requirements are met. At least one clinical treatment pathway applies; non-preferred products also require the applicable preferred-product pathway.
Clinical treatment pathway
Disease-modifying treatment response: Beneficiary has experienced therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug, such as leflunomide, hydroxychloroquine, minocycline, or sulfasalazine.
Contraindication or intolerance: Beneficiary is unable to receive methotrexate or a disease-modifying antirheumatic drug because of contraindications or intolerability.
Severe or rapidly progressing disease: Beneficiary has clinical evidence of severe or rapidly progressing disease.
Ulcerative colitis
Covered when all applicable diagnosis, screening, concurrent-therapy, and preferred-product requirements are met.
Adult ulcerative colitis
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Humira or there is a clinical reason the beneficiary cannot try Humira.
Applies to non-preferred medications.
Pediatric ulcerative colitis
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Humira or there is a clinical reason the beneficiary cannot try Humira.
Applies to non-preferred medications.
Pediatric ulcerative colitis
Coverage for pediatric ulcerative colitis requires all of the following.
Pediatric ulcerative colitis criteria
Required clinical prerequisites
Ulcerative colitis diagnosis: Beneficiary has a diagnosis of ulcerative colitis.
No concurrent injectable biologic immunomodulator: Beneficiary is not receiving another injectable biologic immunomodulator.
Latent tuberculosis screening: Beneficiary has been considered and screened for latent tuberculosis infection.
Hepatitis B testing:
Non-preferred medication requirement
For non-preferred medications, one of the following must apply.
Preferred-product exception
Humira trial and failure: Beneficiary has had a trial and failure of Humira.
Clinical exception to Humira: There is a clinical reason the beneficiary cannot try Humira.
For beneficiaries under 21, EPSDT requires coverage of medically necessary services, products, or procedures that correct or ameliorate an identified physical or mental illness or condition. Clinical-policy limitations on scope, amount, duration, frequency, location, or other criteria may be exceeded when provider documentation supports medical necessity under EPSDT. EPSDT does not require coverage for 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.
Concurrent use of Avsola with another injectable biologic immunomodulator is excluded. The beneficiary must not be receiving another injectable biologic immunomodulator at the time of coverage.
Coding and Clinical Thresholds
Therapeutic Class Codemixed
S2J
Systemic Immunomodulators
Plaque psoriasis disease involvement
Minimum BSA involvementAt least 3% body surface area (BSA)
Prior approval is required for this medication. Approvals may be granted for up to 12 months, and coverage is limited to one injectable immunomodulator at a time.
Beneficiaries must be enrolled in NC Medicaid on the date of service.
Approval period: up to 12 months.
Only one injectable immunomodulator may be covered at a time.
Documentation Required
Disease-Specific Clinical Criteria
Requests must satisfy the applicable clinical criteria for the beneficiary’s diagnosis and indication, including required diagnosis, disease severity, treatment history, screening, and preferred-product requirements.
Applicable indications include ankylosing spondylitis, Crohn’s disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
Policy Background
Avsola (infliximab-axxq) is a systemic immunomodulator classified as an anti-inflammatory tumor necrosis factor inhibitor. This policy establishes NC Medicaid prior approval and coverage requirements for Avsola when used for specified inflammatory musculoskeletal, dermatologic, and gastrointestinal conditions. Coverage pathways include ankylosing spondylitis, moderate-to-severe Crohn’s disease, adult moderate-to-severe chronic plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and adult or pediatric ulcerative colitis. Applicable requirements include disease-specific eligibility, infection screening, treatment history, preferred-product rules, and avoidance of concurrent injectable biologic immunomodulators.
MeaningEarly and Periodic Screening, Diagnostic, and Treatment (EPSDT)
Eligible beneficiariesMedicaid beneficiaries under 21 years of age
Coverage standardMedically necessary services, products, or procedures that correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination
Initial Avsola Therapy
Initial Avsola therapy
Initial coverage requires the applicable disease-specific criteria for the requested indication.
Disease-specific eligibility: Beneficiary meets the applicable diagnosis, age, screening, concurrent-therapy, disease-severity or disease-involvement, prior-treatment, and preferred-product requirements for the requested indication.
Apply the indication-specific criteria for ankylosing spondylitis, Crohn's disease, adult plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, or ulcerative colitis.
Initial pediatric ulcerative colitis therapy
Initial coverage for pediatric ulcerative colitis requires all of the following.
Initial pediatric ulcerative colitis requirements
Ulcerative colitis diagnosis: Beneficiary has a diagnosis of ulcerative colitis.
Continuation and Procedure Limits
Approval duration and concurrent therapy
Continuation approval is subject to the following limits.
Continuation limits: Approval may be issued for up to 12 months, and coverage is limited to one injectable immunomodulator at a time.12 months maximum approval; one injectable immunomodulator at a time
Preferred-Product and Conventional Therapy Steps
Step
Requirement
Applicable indications
1
For non-preferred medications, document a trial and failure of the specified preferred product(s), or a clinical reason the beneficiary cannot try them.
Ankylosing spondylitis, adult plaque psoriasis, and psoriatic arthritis: Cosentyx, Enbrel, or Humira. Crohn's disease and ulcerative colitis: Humira. Rheumatoid arthritis: Enbrel or Humira.
Step
Conventional therapy requirement
Accepted alternative pathway
2
Ankylosing spondylitis: inadequate symptom relief with at least two NSAIDs.
Unable to receive NSAIDs because of contraindications, or clinical evidence of severe or rapidly progressing disease.
2
Adult plaque psoriasis: failure to respond to or inability to tolerate phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine.
Contraindications to these treatments.
2
Rheumatoid arthritis: therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug, including leflunomide, hydroxychloroquine, minocycline, or sulfasalazine.
Unable to receive methotrexate or a disease-modifying antirheumatic drug because of contraindications or intolerability, or clinical evidence of severe or rapidly progressing disease.
Step
Requirement
Exception
1
For a non-preferred medication, the beneficiary must have a trial and failure of Humira.
A clinical reason the beneficiary cannot try Humira.
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or there is a clinical reason the beneficiary cannot try those products.
Applies to non-preferred medications.
Non-preferred product pathway: For a non-preferred medication, the beneficiary has tried and failed Enbrel or Humira, or there is a clinical reason the beneficiary cannot try either product.
Applies to non-preferred medications.
Beneficiary has been tested with Hepatitis B surface antigen and core antibody.
Hepatitis B surface antigen and core antibody
Beneficiary is not on another injectable biologic immunomodulator
Psoriatic arthritis age requirements
Standard minimum age18 years or older
Simponi Aria minimum age2 years or older
Additional requirementDocumented inadequate response or inability to take methotrexate
Disease-specific criteria must be documented before approval.
Prior Authorization
Ulcerative Colitis Prior Approval
Prior approval is required for ulcerative colitis. For non-preferred therapy, document a trial and failure of Humira or a clinical reason the beneficiary cannot try Humira.
Document the ulcerative colitis diagnosis.
Document that the beneficiary is not receiving another injectable biologic immunomodulator.
Document required latent tuberculosis and hepatitis B screening.
Step Therapy
Conventional Therapy Requirements
Document the required conventional-treatment pathway for the applicable indication. For ankylosing spondylitis, the beneficiary must have inadequate relief from at least two NSAIDs, be unable to receive NSAIDs because of contraindications, or have severe or rapidly progressing disease. For plaque psoriasis, document failure or intolerance of phototherapy and one specified conventional medication, or contraindications.
Ankylosing spondylitis: inadequate response to at least two NSAIDs, NSAID contraindication, or severe/rapidly progressing disease.
Plaque psoriasis: failure or intolerance of phototherapy and Soriatane, methotrexate, or cyclosporine, or contraindications to these treatments.
Unsupported block type: step_therapy
Unsupported block type: step_therapy
Step Therapy
Indication-Specific Preferred Biologics
Document the preferred biologic pathway for the requested indication before requesting non-preferred coverage.
Ankylosing spondylitis: Cosentyx, Enbrel, or Humira.
Plaque psoriasis: Cosentyx, Enbrel, or Humira.
Psoriatic arthritis: Cosentyx, Enbrel, or Humira.
Rheumatoid arthritis: Enbrel or Humira.
Crohn’s disease and ulcerative colitis: Humira.
Step Therapy
Humira Step Requirement
For ulcerative colitis, Crohn’s disease, and other indications requiring Humira step therapy, document a trial and failure of Humira or a clinical reason the beneficiary cannot try it.
The exception must be clinically specific and supported by documentation.
This requirement applies to non-preferred medication requests when Humira is the designated preferred product.
Unsupported block type: documentation
Unsupported block type: documentation
Unsupported block type: step_therapy
Documentation Required
EPSDT Documentation for Beneficiaries Under 21
For beneficiaries under 21, EPSDT may allow service limitations to be exceeded or not applied when the provider documents that the requested service is medically necessary to correct or ameliorate the beneficiary’s condition. EPSDT does not eliminate a prior approval requirement.
Submit medical-necessity documentation addressing the beneficiary’s condition and requested treatment.
The service must be safe, effective, and not experimental or investigational.
The requested treatment should be provided in the most economic mode that is similarly efficacious.
Unsupported block type: documentation
Unsupported block type: step_therapy
Denial Risk
Failure to Meet Indication Criteria
Requests may be denied when the applicable indication criteria are not documented or are not met.
Missing or unsupported diagnosis, age, disease severity, or disease involvement.
Missing required treatment history or conventional-therapy documentation.
Missing latent tuberculosis or hepatitis B screening when required.
Failure to document the required preferred-product trial or clinical exception.
Denial Risk
Concurrent Injectable Biologic Therapy
Coverage may be denied when the beneficiary is receiving another injectable biologic immunomodulator. Confirm and document the beneficiary’s current biologic therapy before requesting approval.
The criteria require that the beneficiary not be on another injectable biologic immunomodulator.
Coverage is limited to one injectable immunomodulator at a time.
Denial Risk
Preferred-Product Requirement Not Met
A request for a non-preferred medication may be denied when the required preferred medication trial, failure, intolerance, contraindication, or clinical exception is not documented.
Document the preferred product required for the indication.
Document treatment failure or inadequate response, intolerance, contraindication, or another specific clinical reason the preferred product cannot be tried.
Denial Risk
Authorization Limit Exceeded
Authorization may be denied or limited when the requested duration exceeds the allowable approval period or when concurrent injectable immunomodulator therapy would result.
Approval is limited to up to 12 months.
Only one injectable immunomodulator may be covered at a time.
Denial Risk
Concurrent Therapy or Incomplete Infection Screening
For ulcerative colitis requests, coverage may be denied when another injectable biologic immunomodulator is being used or when required tuberculosis and hepatitis B screening is incomplete.
Confirm no concurrent injectable biologic immunomodulator therapy.
Document latent tuberculosis screening.
Document hepatitis B surface antigen and core antibody testing.
Denial Risk
Humira Preferred-Product Requirement
For non-preferred ulcerative colitis therapy, document a trial and failure of Humira or a supported clinical exception explaining why Humira cannot be tried.
The Humira step applies to adult and pediatric ulcerative colitis criteria.
Requests without the required trial, failure, or clinical exception may be denied.
No other injectable biologic immunomodulator: Beneficiary is not receiving another injectable biologic immunomodulator.
Latent tuberculosis screening: Beneficiary has been considered and screened for latent tuberculosis infection.
Hepatitis B testing: Beneficiary has been tested with Hepatitis B surface antigen and core antibody.Hepatitis B surface antigen and core antibody