CurrentNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria — Xeljanz

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This policy governs NC Medicaid prior approval and coverage criteria for Xeljanz tablets and oral solution for selected systemic inflammatory and autoimmune conditions.

Policy Summary

PayerNorth Carolina Medicaid

PolicyXeljanz outpatient pharmacy prior approval

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateAugust 15, 2014

Next Review DateN/A

Key ActionObtain prior approval and document that the indication-specific coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy separated the criteria by individual agent and replaced step therapy through methotrexate or other DMARDs with step therapy through a tumor necrosis factor blocker.

The policy added ankylosing spondylitis as a covered indication for Xeljanz tablets.

The policy added Xeljanz oral solution as an option for polyarticular juvenile idiopathic arthritis.

The policy added criteria addressing malignancy and major adverse cardiovascular event risk, thrombosis risk, and avoidance of live vaccines.

5Covered indication groups

12 monthsMaximum approval duration

1Injectable immunomodulators allowed

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CurrentNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria — Xeljanz

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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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This policy governs NC Medicaid prior approval and coverage criteria for Xeljanz tablets and oral solution for selected systemic inflammatory and autoimmune conditions.

Policy Summary

PayerNorth Carolina Medicaid

PolicyXeljanz outpatient pharmacy prior approval

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateAugust 15, 2014

Next Review DateN/A

Key ActionObtain prior approval and document that the indication-specific coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy separated the criteria by individual agent and replaced step therapy through methotrexate or other DMARDs with step therapy through a tumor necrosis factor blocker.

The policy added ankylosing spondylitis as a covered indication for Xeljanz tablets.

The policy added Xeljanz oral solution as an option for polyarticular juvenile idiopathic arthritis.

The policy added criteria addressing malignancy and major adverse cardiovascular event risk, thrombosis risk, and avoidance of live vaccines.

5Covered indication groups

12 monthsMaximum approval duration

1Injectable immunomodulators allowed

2Available formulations

18+Minimum age for psoriatic arthritis

Covered Indications

Ankylosing spondylitis

Covered when all of the following are met for Xeljanz tablets.

Ankylosing spondylitis criteria

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of ankylosing spondylitis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.
- 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.
- Vaccination: Beneficiary will not receive live vaccines during therapy.
- TNF blocker history: Beneficiary has tried at least one TNF blocker with inadequate response or is unable to take TNF blockers because of intolerance or contraindications.
Non-preferred requirement: For non-preferred medications, beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Polyarticular juvenile idiopathic arthritis

Covered when all of the following are met for Xeljanz tablets or oral solution.

Polyarticular juvenile idiopathic arthritis criteria

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of polyarticular juvenile idiopathic arthritis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis:

Psoriatic arthritis

Covered when all of the following are met for Xeljanz tablets.

Psoriatic arthritis criteria

Diagnosis, age, and safety
- Diagnosis: Beneficiary has a documented definitive diagnosis of psoriatic arthritis.
- Age: Beneficiary is 18 years of age or older.>=18 years
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment:

Rheumatoid arthritis

Covered when all of the following are met for Xeljanz tablets.

Rheumatoid arthritis criteria

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of rheumatoid arthritis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis:

Adult ulcerative colitis

Covered when all of the following are met for adult Xeljanz tablets.

Adult ulcerative colitis criteria

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of ulcerative colitis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis:

For beneficiaries under 21 years of age, Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) may require coverage of medically necessary services, products, or procedures needed to correct or ameliorate a defect, illness, or condition identified through screening. Policy limits on scope, amount, duration, frequency, location, or other criteria may be exceeded when provider documentation demonstrates that the requested treatment meets EPSDT medical-necessity requirements.

EPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental, investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment. Documentation must support the medical necessity of the requested service and show how it will improve, maintain, or prevent worsening of the beneficiary’s condition.

Therapeutic Class Coding

Therapeutic Class Codemixed

Z2Z	Immunomodulatory Agents

Prior Approval and Documentation Requirements

Prior Authorization

Prior Approval Required

Prior approval is required for Xeljanz when required by the outpatient pharmacy criteria. Beneficiaries under age 21 are not exempt from prior approval requirements; providers should follow applicable NCTracks and EPSDT guidance.

Confirm prior approval requirements before dispensing or continuing therapy.
For EPSDT and billing assistance, consult the NCTracks Provider Claims and Billing Assistance Guide and the NC Medicaid EPSDT provider page.

Step Therapy

Ankylosing Spondylitis Step Therapy

For ankylosing spondylitis, document an inadequate response to at least one tumor necrosis factor (TNF) blocker, or that the beneficiary cannot use TNF-blocker therapy because of intolerance or contraindication.

Requested product: Xeljanz tablets.
Non-preferred therapy requires a trial and failure of Cosentyx, Enbrel, or Humira, or a documented clinical reason the beneficiary cannot try the applicable preferred therapy.

Policy Background

Xeljanz is a systemic immunomodulatory therapy covered under this policy for selected inflammatory and autoimmune diseases. Covered indications include ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and adult ulcerative colitis; the authorized formulation varies by indication, with tablets covered across the listed conditions and oral solution available for polyarticular juvenile idiopathic arthritis.

Coverage is subject to indication-specific clinical criteria, safety assessment, and prior approval. The policy addresses screening for latent tuberculosis and hepatitis B, thrombotic risk, consideration of malignancy and major adverse cardiovascular event risk, avoidance of live vaccines, and sequencing after specified biologic therapies.

Definitions and Special Provisions

Therapeutic class

Therapeutic classSystemic Immunomodulators

Therapeutic class descriptionImmunomodulatory Agents

Medication coveredXeljanz tablets

Additional formulationXeljanz oral solution

EPSDT special provision

Age groupMedicaid beneficiaries under 21 years of age

Coverage standardServices, products, or procedures must be medically necessary health care to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination.

Initial Approval Criteria

Ankylosing spondylitis initial therapy

Initial approval requires all of the following criteria.

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of ankylosing spondylitis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.

Required Treatment Pathways

Indication	Step 1 requirement	Failure or exception
Ankylosing spondylitis	Trial of at least one tumor necrosis factor (TNF) blocker	Inadequate response, or unable to take TNF blockers because of intolerance or contraindication
Polyarticular juvenile idiopathic arthritis	Trial of at least one TNF blocker	Inadequate response, or unable to take TNF blockers because of intolerance or contraindication
Psoriatic arthritis	At least one TNF blocker	Inadequate response, intolerance, or contraindication
Rheumatoid arthritis	At least one TNF blocker	Therapeutic failure or inadequate response, or unable to receive a TNF blocker because of contraindication or intolerance

Indication	Preferred drug requirement for non-preferred coverage	Clinical exception
Ankylosing spondylitis	Trial and failure of Cosentyx, Enbrel, or Humira	Documented clinical reason the beneficiary cannot try one of these medications
Polyarticular juvenile idiopathic arthritis	Trial and failure of Enbrel or Humira	Documented clinical reason the beneficiary cannot try Enbrel or Humira
Psoriatic arthritis	Trial and failure of Cosentyx, Enbrel, or Humira	Documented clinical reason the beneficiary cannot try one of these medications
Rheumatoid arthritis	Trial and failure of Enbrel or Humira	Documented clinical reason the beneficiary cannot try Enbrel or Humira
Adult ulcerative colitis	Trial and failure of Humira	Documented clinical reason the beneficiary cannot try Humira

Policy Summary

PayerNorth Carolina Medicaid

PolicyXeljanz outpatient pharmacy prior approval

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateAugust 15, 2014

Next Review DateN/A

Key ActionObtain prior approval and document that the indication-specific coverage criteria are met.

SourceLink

On This Page

Beneficiary is not considered to be at high risk for thrombosis.

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.

Vaccination: Beneficiary will not receive live vaccines during therapy.

TNF blocker history: Beneficiary has tried at least one TNF blocker with inadequate response or is unable to take TNF blockers because of intolerance or contraindications.

Non-preferred requirement: For non-preferred medications, beneficiary has tried and failed Enbrel or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.

Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.

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.

Vaccination: Beneficiary will not receive live vaccines during therapy.

TNF blocker history: Beneficiary has a documented inadequate response, intolerance, or contraindication to at least one TNF blocker.

Non-preferred requirement: For non-preferred medications, beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Beneficiary is not considered to be at high risk for thrombosis.

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.

Vaccination: Beneficiary will not receive live vaccines during therapy.

TNF blocker history

Inadequate response: Beneficiary has experienced therapeutic failure or inadequate response with at least one TNF blocker.
Unable to receive TNF blocker: Beneficiary is unable to receive a TNF blocker due to contraindications or intolerability.

Non-preferred requirement: For non-preferred medications, beneficiary has tried and failed Enbrel or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Beneficiary is not considered to be at high risk for thrombosis.

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.

Vaccination: Beneficiary will not receive live vaccines during therapy.

Non-preferred requirement: For non-preferred medications, beneficiary has tried and failed Humira, or has a clinical reason the beneficiary cannot try Humira.

Step Therapy

PJIA Step Therapy

For polyarticular juvenile idiopathic arthritis (PJIA), document that the beneficiary has tried at least one TNF blocker with inadequate response or cannot take TNF-blocker therapy because of intolerance or contraindication.

Requested product may be Xeljanz tablets or Xeljanz oral solution.
Non-preferred therapy requires a trial and failure of Cosentyx, Enbrel, or Humira, or a documented clinical reason the beneficiary cannot try the applicable preferred therapy.

Step Therapy

Psoriatic Arthritis Step Therapy

For psoriatic arthritis, document an inadequate response, intolerance, or contraindication to at least one TNF blocker.

Non-preferred therapy requires a trial and failure of Cosentyx, Enbrel, or Humira, or a documented clinical reason the beneficiary cannot try the applicable preferred therapy.

Step Therapy

Rheumatoid Arthritis Step Therapy

For rheumatoid arthritis, document therapeutic failure or inadequate response to at least one TNF blocker, or that the beneficiary cannot receive TNF-blocker therapy because of contraindications or intolerance.

Non-preferred therapy requires a trial and failure of Enbrel or Humira, or a documented clinical reason the beneficiary cannot try the applicable preferred therapy.

Unsupported block type: step_therapy вЂњ

Documentation Required

Diagnosis and Formulation

Document the definitive diagnosis, any applicable age requirement, and the requested Xeljanz formulation.

Ankylosing spondylitis: Xeljanz tablets.
Polyarticular juvenile idiopathic arthritis: Xeljanz tablets or Xeljanz oral solution.
Psoriatic arthritis: documented definitive diagnosis; beneficiary must be 18 years of age or older; Xeljanz tablets.
Rheumatoid arthritis: Xeljanz tablets.
Ulcerative colitis: adult diagnosis; Xeljanz tablets.

Documentation Required

Concomitant Biologic Therapy

Document that the beneficiary is not receiving another injectable biologic immunomodulator while Xeljanz is prescribed.

Concurrent treatment with another injectable biologic immunomodulator does not meet the approval criteria.

Documentation Required

Safety Assessment and Screening

Document that individual risks and benefits have been considered before initiating or continuing therapy, particularly for beneficiaries at higher risk for malignancy or major adverse cardiovascular events (MACE), and complete the required safety screening.

Document that the beneficiary is not considered to be at high risk for thrombosis.
Consider and screen for latent tuberculosis infection.
Document testing for hepatitis B surface antigen (Hep B SAG) and hepatitis B core antibody (Core Ab).

Documentation Required

Prior Treatment History

Document the beneficiary’s relevant prior treatment history, including outcomes with TNF blockers and any preferred-drug trials required for non-preferred therapy.

Record inadequate response, therapeutic failure, intolerance, or contraindication as applicable.
For ankylosing spondylitis, PJIA, and psoriatic arthritis, document the applicable TNF-blocker history.
For rheumatoid arthritis, document TNF-blocker therapeutic failure, inadequate response, contraindication, or intolerance.
For non-preferred therapy, document the required preferred-drug trial and failure or the clinical reason it cannot be attempted.

Denial Risk

Unmet Indication or Treatment History

Approval may be denied when the requested use does not meet the covered diagnosis, formulation, age, or treatment-history requirements.

Unsupported or undocumented diagnosis.
Requested formulation does not match the indication criteria.
Psoriatic arthritis requested for a beneficiary younger than 18 years of age.
Required TNF-blocker history or other indication-specific treatment history is absent.

Denial Risk

Concurrent Injectable Biologic

Approval may be denied when the beneficiary is receiving another injectable biologic immunomodulator.

Verify the medication profile and document that no other injectable biologic immunomodulator is being administered concurrently.

Denial Risk

Required Safety Screening Not Met

Approval may be denied when required safety assessment or screening is incomplete or indicates an excluded risk.

Beneficiary is considered at high risk for thrombosis.
Required consideration of malignancy or MACE risks and benefits is not documented.
Latent tuberculosis screening is not documented.
Hep B SAG and Core Ab testing is not documented.

Denial Risk

Live Vaccine During Treatment

Document that the beneficiary will not receive live vaccines during Xeljanz therapy.

Planned administration of live vaccines during therapy may prevent approval.

Denial Risk

Preferred-Drug Requirement

For non-preferred Xeljanz therapy, approval may be denied when the required preferred-drug trial and failure or documented clinical rationale for not trying the preferred drug are absent.

Ankylosing spondylitis and PJIA: Cosentyx, Enbrel, or Humira.
Psoriatic arthritis: Cosentyx, Enbrel, or Humira.
Rheumatoid arthritis: Enbrel or Humira.
Adult ulcerative colitis: Humira.

Service limitationsLimitations on scope, amount, duration, frequency, location, or other criteria may be exceeded or may not apply when provider documentation shows the service meets all EPSDT criteria.

ExclusionsEPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment.

Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.

Screening: Beneficiary has been considered and screened for latent tuberculosis infection and tested with hepatitis B surface antigen and core antibody.

Vaccination: Beneficiary will not receive live vaccines during therapy.

TNF blocker step therapy: Beneficiary has tried at least one TNF blocker with inadequate response or is unable to take TNF blockers because of intolerance or contraindications.

Non-preferred step therapy: For non-preferred medications, beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Polyarticular juvenile idiopathic arthritis initial therapy

Initial approval requires all of the following criteria.

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of polyarticular juvenile idiopathic arthritis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.
- Screening: Beneficiary has been considered and screened for latent tuberculosis infection and tested with hepatitis B surface antigen and core antibody.
- Vaccination: Beneficiary will not receive live vaccines during therapy.
TNF blocker step therapy: Beneficiary has tried at least one TNF blocker with inadequate response or is unable to take TNF blockers because of intolerance or contraindications.
Non-preferred step therapy: For non-preferred medications, beneficiary has tried and failed Enbrel or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Psoriatic arthritis initial therapy

Initial approval requires all of the following criteria.

Diagnosis, age, and safety
- Diagnosis: Beneficiary has a documented definitive diagnosis of psoriatic arthritis.
- Age: Beneficiary is 18 years of age or older.>=18 years
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.
- Screening: Beneficiary has been considered and screened for latent tuberculosis infection and tested with hepatitis B surface antigen and core antibody.
- Vaccination: Beneficiary will not receive live vaccines during therapy.
TNF blocker step therapy: Beneficiary has a documented inadequate response, intolerance, or contraindication to at least one TNF blocker.
Non-preferred step therapy: For non-preferred medications, beneficiary has tried and failed Cosentyx, Enbrel, or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Rheumatoid arthritis initial therapy

Initial approval requires all of the following criteria.

Diagnosis and safety
- Diagnosis: Beneficiary has a diagnosis of rheumatoid arthritis.
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.
- Screening: Beneficiary has been considered and screened for latent tuberculosis infection and tested with hepatitis B surface antigen and core antibody.
- Vaccination: Beneficiary will not receive live vaccines during therapy.
TNF blocker step therapy
- Inadequate response: Beneficiary has experienced therapeutic failure or inadequate response with at least one TNF blocker.
- Unable to receive TNF blocker: Beneficiary is unable to receive a TNF blocker due to contraindications or intolerability.
Non-preferred step therapy: For non-preferred medications, beneficiary has tried and failed Enbrel or Humira, or has a clinical reason the beneficiary cannot try one of these medications.

Adult ulcerative colitis initial therapy

Initial approval requires all of the following criteria.

Diagnosis and safety
- Adult diagnosis: Beneficiary is an adult with a diagnosis of ulcerative colitis.Adult
- No concurrent injectable biologic: Beneficiary is not on another injectable biologic immunomodulator.
- Risk assessment: Individual risks and benefits have been considered before initiating or continuing therapy in beneficiaries at higher risk for malignancy and/or major adverse cardiovascular events.
- Thrombosis: Beneficiary is not considered to be at high risk for thrombosis.
- Screening: Beneficiary has been considered and screened for latent tuberculosis infection and tested with hepatitis B surface antigen and core antibody.
- Vaccination: Beneficiary will not receive live vaccines during therapy.
Non-preferred step therapy: For non-preferred medications, beneficiary has tried and failed Humira, or has a clinical reason the beneficiary cannot try Humira.