ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cosentyx

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This policy governs North Carolina Medicaid prior approval for Cosentyx, a systemic anti-psoriatic agent, for specified inflammatory and psoriatic conditions. It applies to eligible NC Medicaid beneficiaries and establishes diagnosis-specific clinical criteria, screening requirements, biologic therapy restrictions, and approval duration.

Policy Summary

PayerNorth Carolina Medicaid

PolicyNC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cosentyx

Policy CodePolicy N/A

Change TypeModified

Effective DateJanuary 21, 2016

Next Review DateN/A

Key ActionSubmit prior approval for Cosentyx and document the applicable diagnosis, age, treatment history, and required tuberculosis and hepatitis B screening.

SourceLink

POLICY UPDATE CHANGES

Pediatric plaque psoriasis coverage is now specified for beneficiaries age 6 years and older.

The minimum age criterion for psoriatic arthritis changed from 18 years to 2 years.

Criteria for enthesitis-related arthritis were added.

The criteria change log records prior additions of Cosentyx trial-and-failure requirements and non-radiographic axial spondyloarthritis criteria.

6covered diagnosis-specific indication groups

12 monthsmaximum approval duration

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ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cosentyx

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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

PolicyNC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cosentyx

Policy CodePolicy N/A

Change TypeModified

Effective DateJanuary 21, 2016

Next Review DateN/A

Key ActionSubmit prior approval for Cosentyx and document the applicable diagnosis, age, treatment history, and required tuberculosis and hepatitis B screening.

SourceLink

POLICY UPDATE CHANGES

Pediatric plaque psoriasis coverage is now specified for beneficiaries age 6 years and older.

The minimum age criterion for psoriatic arthritis changed from 18 years to 2 years.

Criteria for enthesitis-related arthritis were added.

The criteria change log records prior additions of Cosentyx trial-and-failure requirements and non-radiographic axial spondyloarthritis criteria.

6covered diagnosis-specific indication groups

12 monthsmaximum approval duration

1injectable immunomodulator allowed at a time

Jan 2, 2025most recent amendment date

Covered Indications

Ankylosing Spondylitis

Covered when all core requirements are met and at least one clinical pathway is met.

Core requirements and clinical pathway

Core requirements
- Beneficiary has a diagnosis of ankylosing spondylitis.
- Beneficiary is not on another injectable biologic immunomodulator.
- Beneficiary has been considered and screened for latent tuberculosis infection.
- Beneficiary has been tested with hepatitis B surface antigen and core antibody.
Clinical pathway
- NSAID inadequate response: Beneficiary has experienced inadequate symptom relief from treatment with at least two NSAIDs.At least 2 NSAIDs
- NSAID contraindication: Beneficiary is unable to receive treatment with NSAIDs because of contraindications.
- Severe or rapidly progressing disease: Beneficiary has clinical evidence of severe or rapidly progressing disease.

Pediatric Plaque Psoriasis

Covered when all core requirements and at least one psoriasis extent criterion are met.

Core requirements and psoriasis extent

Core requirements
- Beneficiary is 6 years of age or older.Age 6 years or older
- Beneficiary has a diagnosis of plaque psoriasis and is a candidate for systemic therapy or phototherapy.
- Beneficiary is not on another injectable biologic immunomodulator.
- Beneficiary has been considered and screened for latent tuberculosis infection.

Adult Plaque Psoriasis

Covered when all core requirements, at least one psoriasis extent criterion, and at least one prior-treatment pathway are met.

Core requirements, psoriasis extent, and prior treatment

Core requirements
- Beneficiary has a documented definitive diagnosis of moderate-to-severe chronic plaque psoriasis.
- Beneficiary is 18 years of age or older.Age 18 years or older
- Beneficiary is not on another injectable biologic immunomodulator.
- Beneficiary has been considered and screened for latent tuberculosis infection.

Psoriatic Arthritis

Covered when all of the following are met.

Psoriatic arthritis

Beneficiary has a documented definitive diagnosis of psoriatic arthritis.
Beneficiary is 2 years of age or older.Age 2 years or older
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Non-radiographic Axial Spondyloarthritis

Covered when all of the following are met.

Non-radiographic axial spondyloarthritis

Beneficiary has a diagnosis of non-radiographic axial spondyloarthritis.
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has failed an adequate trial of a non-steroidal anti-inflammatory drug (NSAID), unless contraindicated.
Beneficiary has been considered and screened for latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Enthesitis-related Arthritis

Covered when all of the following are met.

Enthesitis-related arthritis

Beneficiary has a diagnosis of active enthesitis-related arthritis (ERA).
Beneficiary is 4 years of age or older.Age 4 years or older
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Concurrent injectable immunomodulator therapy is excluded. North Carolina Medicaid covers only one injectable immunomodulator at a time; Cosentyx should not be authorized concurrently with another injectable biologic immunomodulator.

Coding and Clinical Thresholds

Therapeutic Class Codemixed

L1A	Anti-psoriatic Agents, Systemic

Plaque psoriasis body surface area

Minimum BSA involvementAt least 3%

Applicable conditionsPediatric and adult plaque psoriasis

Alternative extent criterionInvolvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment

Pediatric plaque psoriasis age

Minimum age6 years and older

Treatment candidacyCandidate for systemic therapy or phototherapy

Required prior treatment

Authorization and Documentation Requirements

Prior Authorization

Prior Approval Required

Prior approval is required for this service. The beneficiary must be enrolled in NC Medicaid on the date of service; eligibility-category service restrictions may make a beneficiary ineligible. EPSDT coverage for beneficiaries under age 21 does not eliminate the prior approval requirement.

Billing Rule

Authorization Duration and Therapy Limit

Authorization may be approved for up to 12 months. Coverage is limited to one injectable immunomodulator at a time.

Maximum authorization period: 12 months.
Only one injectable immunomodulator may be covered concurrently.

Policy Scope and Therapeutic Context

Cosentyx is classified as a systemic anti-psoriatic agent and systemic immunomodulator. The policy addresses inflammatory and psoriatic conditions including ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis.

Key Terms

BSA

DefinitionThe percentage of the body surface affected by plaque psoriasis

Applicable thresholdAt least 3% for the applicable plaque psoriasis pathway

Alternative pathwayQualifying involvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment

NSAID

TermNSAID

DefinitionNon-steroidal anti-inflammatory drug

Policy useAn adequate NSAID trial or inadequate symptom relief from at least two NSAIDs may be required for applicable conditions

Initial Approval Decision Paths

Ankylosing Spondylitis — Initial Approval

Initial approval requires all core requirements and at least one of the following clinical pathways.

Core requirements and clinical pathway

Core requirements
- Beneficiary has a diagnosis of ankylosing spondylitis.
- Beneficiary is not on another injectable biologic immunomodulator.
- Beneficiary has been considered and screened for latent tuberculosis infection.
- Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Required Previous Treatment

Condition	Step therapy requirement	Exception pathway
Ankylosing spondylitis	Inadequate symptom relief after treatment with at least two NSAIDs	Unable to receive NSAIDs because of contraindications, or clinical evidence of severe or rapidly progressing disease

Condition	Step therapy requirement	Exception pathway
Pediatric plaque psoriasis	Therapeutic failure or inadequate response to methotrexate	Methotrexate is contraindicated or not tolerated

Condition	Step therapy requirement	Exception pathway
Adult plaque psoriasis	Failure to respond to or inability to tolerate phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine	Contraindications to phototherapy and the selected medication

Condition	Step therapy requirement	Exception pathway
Psoriatic arthritis	Documented inadequate response to methotrexate	Unable to take methotrexate

Condition	Step therapy requirement	Exception pathway
Non-radiographic axial spondyloarthritis	Failure of an adequate trial of an NSAID	NSAID is contraindicated

Authorization Limits

Cosentyx

MedicationCosentyx

Maximum approval durationUp to 12 months

Approval basisPrior approval coverage for eligible NC Medicaid beneficiaries

Injectable immunomodulator therapy

Concurrent therapy limitOne injectable immunomodulator at a time

Applies toInjectable immunomodulator therapy

Coverage restrictionConcurrent coverage of more than one injectable immunomodulator is excluded

Policy Summary

PayerNorth Carolina Medicaid

PolicyNC Medicaid Outpatient Pharmacy Prior Approval Criteria: Cosentyx

Policy CodePolicy N/A

Change TypeModified

Effective DateJanuary 21, 2016

Next Review DateN/A

Key ActionSubmit prior approval for Cosentyx and document the applicable diagnosis, age, treatment history, and required tuberculosis and hepatitis B screening.

SourceLink

On This Page

Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Beneficiary has experienced therapeutic failure or an inadequate response to methotrexate, or has a contraindication or intolerance to methotrexate.

Psoriasis extent

Body surface area involvement is at least 3%.BSA ≥ 3%
Involvement of the palms, soles, head and neck, or genitalia causes disruption in normal daily activities and/or employment.

Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Psoriasis extent

Body surface area involvement is at least 3%.BSA ≥ 3%
Involvement of the palms, soles, head and neck, or genitalia causes disruption in normal daily activities and/or employment.

Prior-treatment pathway

Beneficiary has failed to respond to or been unable to tolerate phototherapy and Soriatane (acitretin), or has contraindications to these treatments.
Beneficiary has failed to respond to or been unable to tolerate phototherapy and methotrexate, or has contraindications to these treatments.
Beneficiary has failed to respond to or been unable to tolerate phototherapy and cyclosporine, or has contraindications to these treatments.

Beneficiary has a documented inadequate response or inability to take methotrexate.

Therapeutic failure or inadequate response to methotrexate, or methotrexate contraindication or intolerance

Adult plaque psoriasis age

Minimum age18 years or older

Disease requirementDocumented definitive diagnosis of moderate-to-severe chronic plaque psoriasis

Required prior treatmentFailure or intolerance of phototherapy and one of Soriatane (acitretin), methotrexate, or cyclosporine, or contraindications to these treatments

Psoriatic arthritis age

Minimum age2 years or older

Treatment requirementDocumented inadequate response or inability to take methotrexate

Screening requirementLatent tuberculosis screening and hepatitis B surface antigen and core antibody testing

Enthesitis-related arthritis age

Minimum age4 years or older

Disease requirementActive enthesitis-related arthritis

Therapy restrictionBeneficiary must not be on another injectable biologic immunomodulator

Step Therapy

Ankylosing Spondylitis NSAID Requirement

For ankylosing spondylitis, 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.

Diagnosis of ankylosing spondylitis is required.
Document at least one pathway: inadequate relief from two NSAIDs; NSAID contraindication; or severe or rapidly progressing disease.

Step Therapy

Pediatric Psoriasis Methotrexate Step

For pediatric plaque psoriasis, document that the beneficiary is age 6 or older, has plaque psoriasis, and is a candidate for systemic therapy or phototherapy. Methotrexate must have resulted in therapeutic failure or inadequate response, or must be contraindicated or not tolerated.

Methotrexate step: therapeutic failure, inadequate response, contraindication, or intolerance.
Document the required psoriasis extent: BSA of at least 3%, or qualifying palm, sole, head-and-neck, or genital involvement disrupting normal activities and/or employment.

Step Therapy

Adult Psoriasis Treatment Prerequisites

For adults with plaque psoriasis, document a definitive diagnosis of moderate-to-severe chronic plaque psoriasis and age 18 or older. The beneficiary must have failed to respond to or tolerate phototherapy and one specified systemic medication, or have contraindications to these treatments.

Required systemic-treatment history: one of Soriatane (acitretin), methotrexate, or cyclosporine.
Document BSA involvement of at least 3%, or qualifying palm, sole, head-and-neck, or genital involvement disrupting normal activities and/or employment.
Latent tuberculosis and hepatitis B requirements do not apply when the requested product is Otezla, as specified in the criteria.

Step Therapy

Psoriatic Arthritis Methotrexate Step

For psoriatic arthritis, document a definitive diagnosis, age 2 or older, and an inadequate response to methotrexate or inability to take methotrexate.

Methotrexate documentation must show inadequate response or inability to take methotrexate.
The beneficiary must not be receiving another injectable biologic immunomodulator.

Step Therapy

Axial Spondyloarthritis NSAID Step

For non-radiographic axial spondyloarthritis, document failure of an adequate NSAID trial unless NSAIDs are contraindicated.

Diagnosis of non-radiographic axial spondyloarthritis is required.
Document either an adequate NSAID trial or an NSAID contraindication.

Documentation Required

Diagnosis and Treatment History Documentation

Submit clinical and demographic documentation supporting the applicable indication and all required treatment history. Documentation must establish the diagnosis, age requirements, prior therapies, treatment response or intolerance, disease extent or severity when applicable, and absence of concurrent injectable biologic therapy.

Ankylosing spondylitis: diagnosis; NSAID history or contraindication; or severe/rapidly progressing disease.
Pediatric plaque psoriasis: age 6 years or older; plaque psoriasis; candidate for systemic therapy or phototherapy; methotrexate failure, inadequate response, contraindication, or intolerance; and qualifying disease extent.
Adult plaque psoriasis: age 18 years or older; definitive moderate-to-severe chronic plaque psoriasis; qualifying BSA or site involvement; and failure, intolerance, or contraindication to phototherapy plus one of acitretin, methotrexate, or cyclosporine.
Psoriatic arthritis: definitive diagnosis, age 2 years or older, and methotrexate inadequate response or inability to take methotrexate.
Non-radiographic axial spondyloarthritis: diagnosis and adequate NSAID trial or contraindication.
Enthesitis-related arthritis: active diagnosis and age 4 years or older.

Documentation Required

TB and Hepatitis B Screening

Document that the beneficiary has been considered and screened for latent tuberculosis infection and has been tested with hepatitis B surface antigen (Hep B SAG) and hepatitis B core antibody, when required by the applicable indication.

Required for ankylosing spondylitis, pediatric plaque psoriasis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis.
For adult plaque psoriasis and psoriatic arthritis, latent tuberculosis screening and hepatitis B testing are not required when the requested product is Otezla, as specified in the criteria.
Document consideration of latent tuberculosis infection even when the result is negative; address latent infection as clinically appropriate.

Documentation Required

Plaque Psoriasis Extent

For plaque psoriasis, document the disease extent supporting coverage: body surface area involvement of at least 3%, or involvement of the palms, soles, head and neck, or genitalia that disrupts normal daily activities and/or employment.

Minimum BSA threshold: 3%.
Qualifying site involvement may satisfy the extent requirement when functional or employment disruption is documented.

Denial Risk

Failure to Meet Clinical Criteria

Coverage is not approvable when the beneficiary does not satisfy the applicable diagnosis, age, screening, disease-extent, treatment-history, or other clinical criteria. Eligibility restrictions also apply, and EPSDT does not waive prior approval.

The beneficiary must be enrolled in NC Medicaid on the date of service and eligible for the service.
Do not approve when required documentation is absent or when the applicable diagnosis, age threshold, disease severity or extent, NSAID or methotrexate step, phototherapy/systemic-treatment history, or screening requirement is not met.
Do not approve when the beneficiary is receiving another injectable biologic immunomodulator.

Denial Risk

Concurrent Injectable Biologic Therapy

Do not submit or approve concurrent coverage with another injectable biologic immunomodulator. The policy permits coverage of only one injectable immunomodulator at a time.

Verify the medication list and claims history before requesting or renewing authorization.
Concurrent injectable biologic immunomodulator therapy creates a denial risk.

ERA

AbbreviationERA

Full termEnthesitis-related arthritis

Coverage contextActive ERA is considered for beneficiaries age 4 years or older

NSAID or disease-severity pathway

Inadequate symptom relief from treatment with at least two NSAIDs.At least 2 NSAIDs
Unable to receive treatment with NSAIDs because of contraindications.
Clinical evidence of severe or rapidly progressing disease.

Pediatric Plaque Psoriasis — Initial Approval