CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Kineret (anakinra) Coverage Criteria

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Georgia Medicaid pharmacy prior authorization for Kineret (anakinra), including initial and renewal coverage for rheumatoid arthritis, CAPS/NOMID, and DIRA.

Policy Summary

PayerCareSource Georgia

PolicyKineret (anakinra) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateJan 1, 2025

Next Review DateNot specified

Key ActionObtain pharmacy prior authorization and submit indication-specific clinical documentation before requesting Kineret coverage.

SourceLink

POLICY UPDATE CHANGES

Genetic testing for a gain-of-function NLRP3 mutation was added to the CAPS/NOMID initial authorization criteria.

The rheumatoid arthritis criteria were revised to require trials of at least two preferred biologic DMARDs, with treatment failure defined as at least 12 weeks of therapy with each drug.

CAPS and DIRA dosing and renewal criteria were revised to specify weight-based dosing limits and clinical response requirements.

3Covered disease indications

12 monthsInitial authorization period

12 monthsRenewal authorization period

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Kineret (anakinra) Coverage Criteria

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Georgia Medicaid pharmacy prior authorization for Kineret (anakinra), including initial and renewal coverage for rheumatoid arthritis, CAPS/NOMID, and DIRA.

Policy Summary

PayerCareSource Georgia

PolicyKineret (anakinra) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateJan 1, 2025

Next Review DateNot specified

Key ActionObtain pharmacy prior authorization and submit indication-specific clinical documentation before requesting Kineret coverage.

SourceLink

POLICY UPDATE CHANGES

Genetic testing for a gain-of-function NLRP3 mutation was added to the CAPS/NOMID initial authorization criteria.

The rheumatoid arthritis criteria were revised to require trials of at least two preferred biologic DMARDs, with treatment failure defined as at least 12 weeks of therapy with each drug.

CAPS and DIRA dosing and renewal criteria were revised to specify weight-based dosing limits and clinical response requirements.

3Covered disease indications

12 monthsInitial authorization period

12 monthsRenewal authorization period

RA dosage and quantity limit

8 mg/kg/dayMaximum CAPS and DIRA dose

Not medically necessaryConditions not listed in the policy

Coverage Criteria

Rheumatoid Arthritis — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Medication is prescribed by or in consultation with a rheumatologist.
Member has a documented diagnosis of moderately to severely active rheumatoid arthritis (RA).
Member has tried and failed, or is intolerant to, methotrexate for at least 3 months.
If methotrexate is contraindicated, the member must instead trial one of the following conventional DMARDs: leflunomide, sulfasalazine, or hydroxychloroquine.
Member has tried and failed treatment with at least two preferred biologic DMARDs.
Treatment failure requires at least 12 weeks of therapy with each drug.
Member has had a negative tuberculosis test within the past 12 months.
Dosage does not exceed 100 mg subcutaneously once daily.28 syringes per 28 days

Rheumatoid Arthritis — Continuation Therapy

Covered when the following criterion is met:

ALL of the following

Chart notes demonstrate improvement of RA signs and symptoms, such as fewer painful and swollen joints, achievement of remission, or slowed progression of joint damage.
If the criterion above is met, therapy may be approved for an additional 12 months.

CAPS/NOMID — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Medication is prescribed by or in consultation with a rheumatologist or other specialist familiar with CAPS.
Member has a diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).
Genetic testing results show a gain-of-function mutation in the NLRP3 gene.
Member has elevated inflammatory markers, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate (SAA, CRP, or ESR).
Member has symptoms of NOMID, such as rash, neurologic findings, skeletal abnormalities, or hearing loss.

CAPS/NOMID — Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Chart notes demonstrate a positive clinical response, including decreased inflammatory marker values and symptom improvement.
If the criterion above is met, therapy may be approved for an additional 12 months.

DIRA — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Medication is prescribed by or in consultation with a rheumatologist, dermatologist, or geneticist.
Member has a diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) confirmed by loss-of-function mutations of the IL1RN gene.
Member has elevated inflammatory markers, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate (SAA, CRP, or ESR).
Member has symptoms of skin and/or bone inflammation.
Member has had a negative tuberculosis test within the past 12 months.

DIRA — Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Member demonstrates a positive clinical response to therapy, such as improved skin and/or bone inflammation.
If the criterion above is met, therapy may be approved for an additional 12 months.

CareSource considers Kineret (anakinra) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the applicable Off-Label policy.

Conditions not listed in this document are excluded from Kineret coverage and are directed to the applicable Off-Label policy.

Treatment Parameters and Coding Details

RA Methotrexate Trial

Minimum methotrexate trialAt least 3 months

Required outcomeTrial and failure of, or intolerance to, methotrexate

Alternative if contraindicatedTrial leflunomide, sulfasalazine, or hydroxychloroquine

RA Preferred Biologic DMARD Trials

Minimum number of preferred biologic DMARDsAt least 2 drugs

Minimum treatment durationAt least 12 weeks of therapy with each drug

Required outcomeTried and failed treatment with each preferred biologic DMARD

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Pharmacy prior authorization is required for Kineret (anakinra). Coverage is considered only when the applicable indication-specific authorization criteria are met.

Applicable indications include rheumatoid arthritis (RA), cryopyrin-associated periodic syndromes (CAPS), including NOMID, and deficiency of interleukin-1 receptor antagonist (DIRA).

Step Therapy

RA Conventional and Biologic DMARD Prerequisites

For RA, the member must have documented failure of or intolerance to methotrexate for at least 3 months, followed by failure of at least two preferred biologic DMARDs.

If methotrexate is contraindicated, the member must instead trial one of the following conventional DMARDs: leflunomide, sulfasalazine, or hydroxychloroquine.
Each preferred biologic DMARD trial must last at least 12 weeks.
A negative tuberculosis test within the past 12 months is also required.

Policy Background

Kineret (anakinra) is an interleukin-1 receptor antagonist that reduces inflammatory and immune-mediated signaling. This policy addresses pharmacy prior authorization for rheumatoid arthritis and rare interleukin-1-mediated autoinflammatory diseases, including CAPS/NOMID and DIRA.

Condition Definitions

CAPS Definition

Full nameCryopyrin-associated periodic syndromes

Disease typeRare systemic autoinflammatory diseases

Mediating pathwayInterleukin-1-mediated

NOMID/CINCA Definition

Full nameNeonatal-onset multisystem inflammatory disease

Relationship to CAPSA severe phenotype of cryopyrin-associated periodic syndromes

Alternative nameChronic infantile neurological cutaneous and articular syndrome (CINCA)

Initial Therapy Criteria

Rheumatoid Arthritis Initial Therapy

Covered for initial RA authorization when all of the following are met.

RA initial therapy

Age: Member is at least 18 years of age.>=18 years
Prescriber: Medication is prescribed by or in consultation with a rheumatologist.
Diagnosis: Member has a documented diagnosis of moderately to severely active rheumatoid arthritis.

Continuation and Renewal Criteria

Rheumatoid Arthritis Continuation

Covered for RA renewal when the following is met.

RA response: Chart notes demonstrate improvement in rheumatoid arthritis signs and symptoms.

Examples include fewer painful or swollen joints, achievement of remission, or slowed progression of joint damage.

CAPS/NOMID Continuation

Covered for CAPS/NOMID renewal when the following is met.

CAPS/NOMID response: Decreased inflammatory marker values and symptom improvement are documented.

DIRA Continuation

Covered for DIRA renewal when the following is met.

Step Therapy Requirements

Step	Therapy requirement	Required duration	Requirement before Kineret authorization
1	Trial and failure of, or intolerance to, methotrexate	At least 3 months	Required
1A	If methotrexate is contraindicated, trial leflunomide, sulfasalazine, or hydroxychloroquine	Not specified	Required alternative conventional DMARD trial
2	Trial and failure of at least two preferred biologic DMARDs	At least 12 weeks of therapy with each drug	Required

Quantity and Dose Limits

Kineret (anakinra) for RA

IndicationRheumatoid arthritis

Dose and route100 mg subcutaneously

FrequencyOnce daily

Quantity limit28 syringes per 28 days

Kineret (anakinra) for CAPS/NOMID

Starting dose1–2 mg/kg subcutaneously

Maximum dose8 mg/kg per day

Policy Summary

PayerCareSource Georgia

PolicyKineret (anakinra) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateJan 1, 2025

Next Review DateNot specified

Key ActionObtain pharmacy prior authorization and submit indication-specific clinical documentation before requesting Kineret coverage.

SourceLink

On This Page

Member has had a negative tuberculosis test within the past 12 months.

Dosage is within the allowed range: starting dose 1–2 mg/kg subcutaneously; once-daily administration is generally recommended, but the dose may be split into twice-daily administration; dose may be adjusted up to a maximum of 8 mg/kg per day.

Dosage is within the allowed range: starting dose 1–2 mg/kg subcutaneously daily; dose may be adjusted up to a maximum of 8 mg/kg per day.

RA Dosing and Quantity

Dose100 mg

RouteSubcutaneous (subQ) injection

FrequencyOnce daily

Quantity limit28 syringes per 28 days

CAPS/NOMID Dosing

Starting dose1–2 mg/kg

RouteSubcutaneous (subQ) injection

FrequencyOnce daily generally recommended; may be split into twice-daily administration

Maximum dose8 mg/kg per day

DIRA Dosing

Starting dose1–2 mg/kg

RouteSubcutaneous (subQ) injection

FrequencyDaily

Maximum dose8 mg/kg per day

Tuberculosis Testing

Required resultNegative tuberculosis test

Testing timeframeWithin the past 12 months

Applicable indicationsRheumatoid arthritis, CAPS/NOMID, and DIRA initial authorization

Documentation Required

RA Initial Authorization Documentation

Submit documentation supporting each RA initial-authorization requirement.

Member is at least 18 years of age.
Prescription is written by or issued in consultation with a rheumatologist.
Diagnosis of moderately to severely active RA is documented.
Methotrexate trial and failure or intolerance for at least 3 months is documented; if contraindicated, document a trial of leflunomide, sulfasalazine, or hydroxychloroquine.
Failure of at least two preferred biologic DMARDs, with at least 12 weeks of therapy for each, is documented.
Negative tuberculosis test within the past 12 months is documented.
Requested dose and quantity do not exceed 100 mg subcutaneously once daily, or 28 syringes per 28 days.
Initial approval, when criteria are met, is for 12 months.

Documentation Required

RA Renewal Documentation

For RA renewal, submit chart notes demonstrating clinical improvement with Kineret therapy.

Examples include fewer painful or swollen joints, achievement of remission, or slowed progression of joint damage.
Renewal approval, when criteria are met, is for an additional 12 months.

Documentation Required

CAPS/NOMID Documentation

For CAPS/NOMID, submit specialist, diagnostic, genetic, laboratory, symptom, and tuberculosis documentation with the initial request.

Prescription is written by or issued in consultation with a rheumatologist or other specialist familiar with CAPS.
Diagnosis of neonatal-onset multisystem inflammatory disease (NOMID) is documented.
Genetic testing shows a gain-of-function mutation in the NLRP3 gene.
Elevated inflammatory markers are documented, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate (SAA, CRP, or ESR).
Symptoms of NOMID are documented, such as rash, neurologic findings, skeletal abnormalities, or hearing loss.
Negative tuberculosis test within the past 12 months is documented.
Starting dose is 1–2 mg/kg subcutaneously daily; dosing may be split twice daily and adjusted up to a maximum of 8 mg/kg per day.
Initial approval, when criteria are met, is for 12 months.

Documentation Required

CAPS/NOMID Renewal Documentation

For CAPS/NOMID renewal, submit chart notes demonstrating a positive clinical response to therapy.

Document decreased inflammatory marker values and improvement in symptoms.
Renewal approval, when criteria are met, is for an additional 12 months.

Documentation Required

DIRA Documentation

For DIRA, submit specialist, diagnostic, genetic, laboratory, symptom, and tuberculosis documentation with the initial request.

Prescription is written by or issued in consultation with a rheumatologist, dermatologist, or geneticist.
Diagnosis of DIRA is confirmed by loss-of-function mutations of the IL1RN gene.
Elevated inflammatory markers are documented, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate (SAA, CRP, or ESR).
Symptoms of skin and/or bone inflammation are documented.
Negative tuberculosis test within the past 12 months is documented.
Starting dose is 1–2 mg/kg subcutaneously daily, adjustable up to a maximum of 8 mg/kg per day.
Initial approval, when criteria are met, is for 12 months.

Documentation Required

DIRA Renewal Documentation

For DIRA renewal, submit documentation demonstrating a positive clinical response to therapy.

Document improved skin and/or bone inflammation.
Renewal approval, when criteria are met, is for an additional 12 months.

Denial Risk

Unlisted Indication

Kineret is not medically necessary for treatment of conditions not listed in this policy.

For any other indication, refer to the Off-Label policy.

Denial Risk

RA Criteria Not Met

An RA request does not meet policy criteria when required age, specialist, diagnosis, treatment history, safety testing, dosing, or documentation requirements are absent.

Member is younger than 18 years of age.
Medication is not prescribed by or in consultation with a rheumatologist.
Moderately to severely active RA is not documented.
Methotrexate was not tried for at least 3 months and is not documented as failed or intolerable; when contraindicated, an allowable conventional DMARD alternative was not tried.
At least two preferred biologic DMARDs were not tried and failed for at least 12 weeks each.
Negative tuberculosis test within the past 12 months is not documented.
Requested dose or quantity exceeds 100 mg subcutaneously once daily or 28 syringes per 28 days.
Required initial or renewal documentation is not submitted.

Denial Risk

Rare Disease Criteria Not Met

A CAPS/NOMID or DIRA request does not meet policy criteria when the required specialist, diagnosis, genetic, laboratory, symptom, tuberculosis, response, or dosing documentation is absent.

For CAPS/NOMID, required documentation includes specialist involvement, NOMID diagnosis, NLRP3 gain-of-function mutation, elevated inflammatory markers, qualifying symptoms, and a negative tuberculosis test within the past 12 months.
For DIRA, required documentation includes specialist involvement, DIRA diagnosis confirmed by an IL1RN loss-of-function mutation, elevated inflammatory markers, skin and/or bone inflammation, and a negative tuberculosis test within the past 12 months.
Renewals require documented clinical response: decreased inflammatory markers and symptom improvement for CAPS/NOMID, or improved skin and/or bone inflammation for DIRA.
Requested dosing must remain within the applicable policy maximum of 8 mg/kg per day.

DIRA Definition

Full nameDeficiency of interleukin-1 receptor antagonist

Disease typeInterleukin-1-mediated autoinflammatory disease

Genetic associationLoss-of-function mutations of the IL1RN gene

Conventional DMARD trial:

Member has tried and failed or is intolerant to methotrexate for at least 3 months.

If methotrexate is contraindicated, one of the following conventional DMARDs must be trialed instead: leflunomide, sulfasalazine, or hydroxychloroquine.

Preferred biologic DMARD trials: Member has tried and failed treatment with at least two preferred biologic DMARDs.At least 12 weeks of therapy with each drug

Tuberculosis testing: Member has had a negative tuberculosis test within the past 12 months.Within 12 months

CAPS/NOMID Initial Therapy

Covered for initial CAPS/NOMID authorization when all of the following are met.

CAPS/NOMID initial therapy

Specialist prescriber: Medication is prescribed by or in consultation with a rheumatologist or other specialist familiar with CAPS.
Diagnosis: Member is diagnosed with neonatal-onset multisystem inflammatory disease (NOMID).
Genetic confirmation: Genetic testing results show a gain-of-function mutation in the NLRP3 gene.
Inflammatory markers: Member has elevated inflammatory markers, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate.Elevated SAA, CRP, or ESR
NOMID symptoms: Member has symptoms of NOMID, such as rash, neurologic findings, skeletal abnormalities, or hearing loss.
Tuberculosis testing: Member has had a negative tuberculosis test within the past 12 months.Within 12 months

DIRA Initial Therapy

Covered for initial DIRA authorization when all of the following are met.

DIRA initial therapy

Specialist prescriber: Medication is prescribed by or in consultation with a rheumatologist, dermatologist, or geneticist.
Genetically confirmed diagnosis: Member has a diagnosis of DIRA confirmed by loss-of-function mutations of the IL1RN gene.
Inflammatory markers: Member has elevated inflammatory markers, such as serum amyloid A, C-reactive protein, or erythrocyte sedimentation rate.Elevated SAA, CRP, or ESR
Disease manifestations: Member has symptoms of skin and/or bone inflammation.
Tuberculosis testing: Member has had a negative tuberculosis test within the past 12 months.Within 12 months

DIRA response: Positive clinical response to therapy is documented, such as improved skin and/or bone inflammation.

Once daily generally recommended

Alternative administrationDose may be split into twice-daily administration

Kineret (anakinra) for DIRA

Starting dose1–2 mg/kg subcutaneously daily

Maximum dose8 mg/kg per day

IndicationDeficiency of interleukin-1 receptor antagonist (DIRA)