ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Arcalyst

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This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Arcalyst (rilonacept), including diagnosis-specific clinical criteria, safety screening requirements, and authorization limits.

Policy Summary

PayerNorth Carolina Medicaid

PolicyArcalyst coverage and prior approval

Policy CodePolicy N/A

Change TypeModified

Effective DateJune 27, 2018

Next Review DateN/A

Key ActionSubmit documentation of a qualifying CAPS, DIRA, or recurrent pericarditis indication and completion of the required safety screening for prior approval.

SourceLink

POLICY UPDATE CHANGES

Recurrent pericarditis and reduction in risk of recurrence was added as a covered indication for Arcalyst.

Deficiency of Interleukin-1 Receptor Antagonist (DIRA) criteria were separated out by drug for Arcalyst.

3Covered diagnosis groups

12 monthsMaximum approval period

1Injectable immunomodulator covered at a time

12 years

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ModifiedNorth Carolina MedicaidPolicy N/A

NC Medicaid Outpatient Pharmacy Prior Approval Criteria: Arcalyst

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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

PolicyArcalyst coverage and prior approval

Policy CodePolicy N/A

Change TypeModified

Effective DateJune 27, 2018

Next Review DateN/A

Key ActionSubmit documentation of a qualifying CAPS, DIRA, or recurrent pericarditis indication and completion of the required safety screening for prior approval.

SourceLink

POLICY UPDATE CHANGES

Recurrent pericarditis and reduction in risk of recurrence was added as a covered indication for Arcalyst.

Deficiency of Interleukin-1 Receptor Antagonist (DIRA) criteria were separated out by drug for Arcalyst.

3Covered diagnosis groups

12 monthsMaximum approval period

1Injectable immunomodulator covered at a time

12 years

Minimum age for recurrent pericarditis

10 kgMinimum weight for DIRA

Covered Indications and General Criteria

Cryopyrin-associated periodic syndromes

Covered for CAPS when ALL of the following are met.

CAPS criteria

Beneficiary has a diagnosis of cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Deficiency of Interleukin-1 Receptor Antagonist

Covered for DIRA when ALL of the following are met.

DIRA criteria

Beneficiary has a diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.
Arcalyst is being used for maintenance of remission.
Beneficiary weighs at least 10 kg.>= 10 kg

Recurrent pericarditis

Covered for recurrent pericarditis and reduction in risk of recurrence when ALL of the following are met.

Recurrent pericarditis criteria

Beneficiary has a diagnosis of recurrent pericarditis.
Beneficiary is at least 12 years of age.>= 12 years
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

Coverage excludes concurrent use of another injectable biologic immunomodulator. Arcalyst coverage is limited to one injectable immunomodulator at a time; the beneficiary must not be receiving another injectable biologic immunomodulator when coverage is requested or provided.

Coverage Limits and Thresholds

DIRA Threshold

Minimum beneficiary weight for DIRAAt least 10 kg

Recurrent Pericarditis Threshold

Minimum age for recurrent pericarditisAt least 12 years

Authorization Duration

Maximum approval durationUp to 12 months

Prior Approval Documentation and Denial Risks

Documentation Required

Document a Qualifying Indication and Safety Criteria

Document a qualifying indication and confirm the beneficiary meets the applicable safety criteria before requesting Arcalyst.

CAPS: Diagnosis of Cryopyrin-Associated Periodic Syndromes, including Familial Cold Autoinflammatory Syndrome or Muckle-Wells Syndrome; no other injectable biologic immunomodulator; latent tuberculosis screening considered and completed; Hep B surface antigen and core antibody testing completed.
DIRA: Diagnosis of Deficiency of Interleukin-1 Receptor Antagonist; no other injectable biologic immunomodulator; latent tuberculosis screening considered and completed; Hep B surface antigen and core antibody testing completed; agent used for maintenance of remission; beneficiary weighs at least 10 kg.
Recurrent pericarditis: Diagnosis of recurrent pericarditis with reduction in risk of recurrence; beneficiary is at least 12 years old; no other injectable biologic immunomodulator; latent tuberculosis screening considered and completed; Hep B surface antigen and core antibody testing completed.

Prior Authorization

Medication and Policy Context

Arcalyst is a systemic immunomodulator and an anti-inflammatory interleukin-1 receptor antagonist. North Carolina Medicaid covers Arcalyst, subject to diagnosis-specific criteria and safety requirements, for cryopyrin-associated periodic syndromes, deficiency of interleukin-1 receptor antagonist, and recurrent pericarditis with reduction in risk of recurrence.

Covered Condition Abbreviations

Definitions

CAPSCryopyrin-associated periodic syndromes, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Definitions

DIRADeficiency of Interleukin-1 Receptor Antagonist.

Definitions

RPRecurrent pericarditis and reduction in risk of recurrence.

Initial Approval Decision Criteria

CAPS

Initial approval for CAPS requires ALL of the following criteria.

CAPS initial therapy

Beneficiary has a diagnosis of cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.

DIRA

Policy Summary

PayerNorth Carolina Medicaid

PolicyArcalyst coverage and prior approval

Policy CodePolicy N/A

Change TypeModified

Effective DateJune 27, 2018

Next Review DateN/A

Key ActionSubmit documentation of a qualifying CAPS, DIRA, or recurrent pericarditis indication and completion of the required safety screening for prior approval.

SourceLink

On This Page

Authorization Duration and Exclusivity

Approval may be granted for up to 12 months, subject to continued eligibility and policy requirements. Coverage is limited to one injectable immunomodulator at a time.

Request authorization for a duration of no more than 12 months.
Do not request or bill coverage concurrently with another injectable immunomodulator.

Documentation Required

Submit Complete Clinical and Safety Documentation

Include clinical documentation supporting the requested diagnosis, treatment rationale, and all applicable safety requirements. Infection-related evidence must be present in the request.

Document the qualifying diagnosis and relevant clinical facts supporting treatment.
Document consideration and screening for latent tuberculosis infection.
Document Hep B surface antigen and core antibody testing.
For DIRA, document maintenance-of-remission use and beneficiary weight of at least 10 kg.
For recurrent pericarditis, document that the beneficiary is at least 12 years old.

Documentation Required

DIRA-Specific Documentation

For DIRA requests, establish that Arcalyst is being used to maintain remission and that the beneficiary meets the minimum weight requirement.

Document maintenance of remission as the treatment purpose.
Document beneficiary weight of at least 10 kg.

Documentation Required

Recurrent Pericarditis Age Requirement

For recurrent pericarditis requests, document that the beneficiary meets the minimum age requirement.

Beneficiary must be at least 12 years of age.
Document the diagnosis of recurrent pericarditis and the request's purpose of reducing recurrence risk.

Prior Authorization

EPSDT Exception Documentation

When requesting an exception to policy limitations for a beneficiary under 21, provide documentation establishing medical necessity under EPSDT. Being under 21 does not eliminate a prior approval requirement.

Explain how the requested service is medically necessary to correct or ameliorate a defect, illness, or condition and to improve, maintain, or prevent worsening of the beneficiary's health.
Document why the requested treatment is appropriate and similarly efficacious treatment is not a suitable more economic alternative, when applicable.
EPSDT does not require coverage of services that are unsafe, ineffective, experimental/investigational, nonmedical, or not generally accepted medical practice.
Submit prior approval whenever the service requires it, including for beneficiaries under 21.

Denial Risk

Uncovered or Inadequately Documented Indication

Coverage is at risk of denial when the request does not document one of the covered indications or does not establish the applicable clinical criteria.

Document CAPS, DIRA, or recurrent pericarditis as applicable.
Include all indication-specific requirements, including DIRA maintenance of remission and minimum weight or recurrent pericarditis minimum age.
Requests lacking diagnosis, supporting clinical facts, or required criteria may be denied.

Denial Risk

Concurrent Injectable Immunomodulator

Coverage may be denied when the beneficiary is receiving another injectable biologic immunomodulator or when the request would result in coverage of more than one injectable immunomodulator at a time.

Verify and document that the beneficiary is not on another injectable biologic immunomodulator.
Coverage is limited to one injectable immunomodulator at a time.
Coordinate discontinuation or noncoverage of the other injectable agent before requesting coverage, when applicable.

Denial Risk

Incomplete Infection Screening

Coverage may be denied when required infection screening and testing are absent or inadequately documented in the prior approval request.

Document that the beneficiary has been considered and screened for latent tuberculosis infection.
Document testing for Hep B surface antigen (Hep B SAG) and hepatitis B core antibody (Core Ab).
Incomplete or missing tuberculosis or hepatitis B evidence may result in denial.

Initial approval for DIRA requires ALL of the following criteria.

DIRA initial therapy

Beneficiary has a diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.
Arcalyst is being used for maintenance of remission.
Beneficiary weighs at least 10 kg.>= 10 kg

Recurrent pericarditis

Initial approval for recurrent pericarditis requires ALL of the following criteria.

Recurrent pericarditis initial therapy

Beneficiary has a diagnosis of recurrent pericarditis.
Beneficiary is at least 12 years of age.>= 12 years
Beneficiary is not on another injectable biologic immunomodulator.
Beneficiary has been considered and screened for the presence of latent tuberculosis infection.
Beneficiary has been tested with hepatitis B surface antigen and core antibody.