CurrentCignaPolicy DQM008

Kineret Drug Quantity Management Policy - Per Days

Defines quantity limits, exceptions, and approval criteria for Kineret (anakinra subcutaneous injection) for Cigna-administered health benefit plans. Affects providers requesting coverage or quantity overrides for Kineret prescriptions.

Policy Summary

PayerCigna

PolicyKineret Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM008

Change TypeNo material change

Effective DateNov 1, 2025

Next Review Date

Key ActionRequest quantity overrides only when one of the specified exception criteria (CAPS or DIRA dosing up to 8 mg/kg/day; SJIA/Still's disease limits; or CAR T-cell therapy one-time override) is met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

28Retail 28-day max

84Home delivery 84-day max

≤8 mg/kg/dayMax dose for CAPS/DIRA

56Retail max for SJIA

112One-time CAR T override

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Exceptions to quantity limits (covered scenarios)

Exceptions to base quantity limits are covered as medically necessary when ONE of the following is met:

CAPS or DIRA dosing up to 8 mg/kg/day: If the patient has cryopyrin-associated periodic syndromes (CAPS) or deficiency of interleukin-1 receptor antagonist (DIRA), approve a quantity sufficient to allow for a dose of up to 8 mg per kg per day for 28 days at retail or for 84 days at home delivery. Use the weight-based table (Table 1) to determine the maximum number of syringes; when the patient weight falls between two listed weights, use the higher weight to ensure an adequate quantity is approved.<= 8 mg/kg/day

Refer to Table 1 for syringes per weight; consult UM pharmacist for >100 kg

SJIA or Still's disease: If the patient has systemic juvenile idiopathic arthritis (SJIA) or Still's disease, approve the requested quantity not to exceed 56 syringes per 28 days at retail or 168 syringes per 84 days at home delivery.<= 56 syringes per 28 days

Policy specifies these maximums for SJIA/Still's disease

CAR T-cell therapy (one-time override): If the patient has been or will be treated with Chimeric Antigen Receptor (CAR) T-cell therapy, approve a one-time override for the requested quantity not to exceed 112 syringes. This quantity is sufficient for dosing up to 200 mg per day.<= 112 syringes one-time

One-time approvals are provided for 30 days in duration per policy statement

Exceptions to the base quantity limits for Kineret (anakinra 100 mg/0.67 mL prefilled syringe) are covered as medically necessary only when one of the specific criteria in this policy is met. The policy lists three exception criteria (CAPS or DIRA dosing up to 8 mg/kg/day with weight-based syringe counts, systemic juvenile idiopathic arthritis/Still's disease dosing limits, and a one-time override for CAR T‑cell therapy). Any other exception to the listed quantity limits is considered not medically necessary.

Requests that exceed the program's base quantity limits (Retail maximum 28 syringes per 28 days; Home Delivery maximum 84 syringes per 84 days) but do not meet one of the specified exception criteria are considered not medically necessary and will not be approved.

Provider Actions and Billing Guidance

Note

Decision Context and Approval Duration

If a Drug Quantity Management rule is not met at the point of service, coverage will be determined by the applicable Coverage Policy criteria and the request may require prior review. Approvals are provided for 1 year in duration unless otherwise noted; one-time approvals are provided for 30 days. Coverage determinations require consideration of: (1) the terms of the applicable benefit plan document in effect on the date of service; (2) any applicable laws and regulations; (3) relevant collateral materials including Coverage Policies; and (4) the specific facts of the particular situation. Medical directors retain clinical discretion in individual coverage decisions.

Approvals default to 1 year; one-time approvals = 30 days
Coverage determined by policy criteria when quantity management rule not met at point of service

Denial Risk

Coverage Coding Requirement

Claims submitted with codes that are not listed as covered in the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate and current diagnosis and procedure codes as of the date of submission.

Claims lacking covered code(s) per the Coverage Policy will be denied

Billing Rule

Quantity Management and Exceptions

Quantity limits apply at point of service for Kineret (anakinra 100 mg/0.67 mL prefilled syringe): Retail maximum = 28 syringes per 28 days; Home Delivery maximum = 84 syringes per 84 days. Exceptions to these limits are covered as medically necessary only when ONE of the specified exception criteria is met; other exceptions are not medically necessary.

Kineret retail max: 28 syringes per 28 days
Kineret home delivery max: 84 syringes per 84 days
Exceptions covered only when ONE of the listed criteria is met

Background

Kineret (anakinra) is an interleukin‑1 (IL‑1) receptor antagonist available as a 100 mg/0.67 mL prefilled syringe and indicated for conditions including cryopyrin‑associated periodic syndromes (CAPS), deficiency of interleukin‑1 receptor antagonist (DIRA), and rheumatoid arthritis. Dosing varies by indication and patient weight; for the rare autoinflammatory conditions CAPS and DIRA the policy permits dosing up to 8 mg/kg/day with syringe counts determined from the weight‑based table to establish the maximum approved quantity.

Definitions

Kineret (anakinra subcutaneous injection) — product name/key identifier

Product name (formulation)Kineret (anakinra) 100 mg/0.67 mL prefilled syringe

RouteSubcutaneous injection

Availability noteGraduated syringes allow partial doses between 20 mg and 100 mg (use new syringe for each dose)

CAPS — Cryopyrin-associated periodic syndromes (includes FCAS, MWS, NOMID/CINCA)

TermCAPS: Cryopyrin-associated periodic syndromes (includes FCAS, MWS, NOMID/CINCA)

Included syndromesFamilial cold autoinflammatory syndrome (FCAS); Muckle‑Wells syndrome (MWS); neonatal‑onset multisystem inflammatory disease (NOMID) / CINCA

Indication noteKineret indicated for CAPS (treatment of NOMID) per prescribing information

DIRA — Deficiency of interleukin-1 receptor antagonist

TermDIRA: Deficiency of interleukin-1 receptor antagonist

Indication noteKineret indicated for DIRA per prescribing information

Dosing relevancePatients with DIRA may be eligible for weight‑based dosing up to 8 mg/kg/day under criteria

Step	Requirement	Notes / Policy language
1	Failure of one or more disease-modifying antirheumatic drugs (DMARDs)	Rheumatoid arthritis indication in prescribing information notes prior failure of ≥1 DMARDs (given ± DMARDs other than TNFis); the policy does not impose additional step edits beyond recognizing this labeled requirement.

Quantity Limits and Exceptions

Kineret (anakinra) 100 mg/0.67 mL prefilled syringe — retail base limit 28 syringes

Retail base limit28 syringes per 28 days (100 mg/0.67 mL prefilled syringe)

Formulation100 mg/0.67 mL prefilled syringe

Policy IDCoverage Policy Number: DQM008

Kineret (anakinra) 100 mg/0.67 mL prefilled syringe — home delivery base limit 84 syringes

Home delivery base limit84 syringes per 84 days (100 mg/0.67 mL prefilled syringe)

Formulation100 mg/0.67 mL prefilled syringe

ContextBase home delivery maximum; exceptions may be approved per criteria

Kineret (anakinra) — weight-based dosing up to 8 mg/kg/day for CAPS or DIRA

Weight‑based dosing ceilingUp to 8 mg/kg/day for CAPS or DIRA (dose may be adjusted in 0.5–1 mg/kg increments)

Dosing frequencyQD dosing generally recommended; may be split into twice‑daily administration if needed

Use in weight tablesTable 1 provides mg/day, syringes/day, and syringes per 28/84 days by weight to determine approvals

Kineret (anakinra) — retail max per 28 days for SJIA/Still's disease (56 syringes)

Retail max for SJIA/Still's disease56 syringes per 28 days (approve requested quantity not to exceed this)

Home delivery equivalent168 syringes per 84 days

Clinical noteCovers systemic juvenile idiopathic arthritis (SJIA) or Still's disease dosing per criteria

Kineret (anakinra) — 168 (contextual quantity; include per source)

Contextual quantity (example from weight table)Table 1 lists larger syringe counts (e.g., up to 224 syringes per 28 days at 90–100 kg for CAPS dosing at 8 mg/kg/day)

Consultation noteFor patients > 100 kg, consult Utilization Management Pharmacist to calculate quantity

Table purposeProvides mg/day, syringes/day, and syringes per 28 and 84 days for multiple weights to determine approvals

Kineret (anakinra) — one-time override max for CAR T-cell therapy (112 syringes)

One‑time override for CAR T‑cell therapy112 syringes (one‑time override), quantity sufficient for up to 200 mg/day

PurposeSupports supportive/management dosing around CAR T‑cell therapy

Limit typeOne‑time course limit (does not change ongoing base or exception limits)

Policy Summary

PayerCigna

PolicyKineret Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM008

Change TypeNo material change

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Kineret Drug Quantity Management Policy - Per Days

Coverage Criteria

Coding and Identifiers

Provider Actions and Billing Guidance

Background

Definitions

Approval Duration and Continuation Criteria

Step Therapy Notes

Quantity Limits and Exceptions