Prior authorization required — submit required clinical documentation

Prior authorization is required for Kineret (anakinra). Submit the specified clinical documentation for the requested indication, including prior medication trials or clinical reasons to avoid preferred products where applicable. Authorization of up to 12 months may be granted when criteria are met.

• Submit chart notes, medical records, or claims history documenting prior medications tried and responses (or clinical reason to avoid therapy).
• Provide laboratory or biomarker results when required by indication (e.g., RF, anti-CCP, CRP/ESR for RA).

Authorization period and continuation — typically 12 months

Authorizations for continuation or initial therapy may be granted for up to 12 months when the member meets the coverage criteria and has not experienced disease progression or unacceptable toxicity. Continuation requests must document ongoing positive clinical response as specified by indication.

• Multicentric Castleman's disease: 12‑month reauthorization if no progression or unacceptable toxicity.
• CAR T– and immune checkpoint inhibitor–related toxicities: continuation only if all coverage requirements are met.
• All other indications: 12‑month authorization if positive clinical response or maintained low disease activity.

Preferred-product step therapy — two preferred products required for RA

For rheumatoid arthritis initial approvals, the program requires inadequate response or intolerable adverse events to at least TWO plan-preferred products (Enbrel, adalimumab-aacf, Rinvoq, Simponi, Xeljanz/Xeljanz XR) unless exception criteria apply.

• Exceptions include clinical reasons to avoid TNF inhibitors (see policy Appendix A) with additional trial requirements, or current effective therapy with the requested product through insurance.
• Preferred‑product requirement enforces use of two preferred agents before non‑preferred use unless excluded by documented clinical circumstances.

No concomitant biologic/tsDMARD use; dosing and quantity limits

The member may not receive Kineret concomitantly with any other biologic or targeted synthetic drug. Approvals may be subject to dosing limits consistent with FDA labeling, compendia, or evidence‑based guidelines.

• Quantity limits: RA — 28 syringes per 28 days; all other indications — 112 syringes per 28 days.
• NOMID and DIRA pediatric dosing: initial 1 mg/kg, maintenance 3–4 mg/kg, maximum 8 mg/kg daily; dosing must align with labeling.

Rheumatoid arthritis — required documentation for initial and continuation requests

For RA initial requests, provide chart notes, medical record documentation, or claims history documenting prior medications tried and responses (or reasons to avoid therapy) and laboratory/biomarker testing results (RF, anti‑CCP, and CRP and/or ESR) when applicable. For continuations, provide documentation of positive clinical response.

• Document a ≥3‑month trial of methotrexate at adequate dosing (titrated to ≥15 mg/week) with inadequate response, or intolerance/contraindication to methotrexate.
• Document prior inadequate response to a ≥3‑month trial of a biologic or targeted synthetic DMARD (e.g., Rinvoq, Xeljanz) or intolerance to such agents.

AOSD and sJIA — documentation of prior therapy and response

For AOSD and sJIA initial requests, submit chart notes, medical records, or claims history showing prior medications tried and responses; for continuation requests, submit documentation of positive clinical response.

• If therapy is not advisable, provide documentation of clinical reason to avoid the prior therapy.

NOMID — continuation documentation of positive response

For NOMID continuation requests, provide chart notes, medical records, or laboratory results that support a positive clinical response to therapy.

• Continuation approvals require evidence of maintained benefit (improvement in signs/symptoms or laboratory markers).

DIRA — IL1RN mutation testing required for initial requests

For DIRA initial requests, IL1RN mutation status must be provided as part of the prior authorization documentation.

• Submit genetic testing results confirming IL1RN mutation status with the initial request.

Recurrent pericarditis — prior therapy documentation required

For recurrent pericarditis initial requests, submit chart notes, medical records, or claims history documenting prior medications tried and responses; for continuation, submit documentation of positive clinical response.

• If prior therapies were not tried, document the clinical reason to avoid those therapies.

HIDS/MKD — documentation of flares and global assessment/CRP

For HIDS/MKD initial requests, provide chart notes, medical records, or laboratory results indicating the number of active flares within the last 6 months and a Physician's Global Assessment score or CRP level.

• Continuation requests should include documentation of positive clinical response as applicable.

Other compendial uses — prior therapy or reason to avoid required

For compendial uses such as gout/pseudogout flares, CAR T‑related toxicities, and immune checkpoint inhibitor–related toxicity, initial requests must include chart notes, medical records, or claims history documenting prior medications tried and responses, or a clinical reason to avoid prior therapies.

• Must meet both the Preferred Drug Plan Design and the Criteria for Initial Approval/Continuation when applicable.

Required documentation — TB screening and evidence of response for reauthorization

Documentation for all indications must include TB screening results (TST or IGRA within 12 months for persons naïve to biologic/targeted synthetic drugs) and evidence of clinical response or absence of disease progression for reauthorization; dosing must align with FDA labeling/compendia.

• If TB screening is positive, further testing (e.g., chest x‑ray) must confirm no active disease; do not administer Kineret if active TB is present.
• If latent TB is present, TB treatment must be started before initiating Kineret.

Documentation required — missing documentation may cause denial

Failure to submit required documentation — including chart notes, lab results, claims history, mutation testing when specified, or evidence of prior medication trials and responses — may result in denial of prior authorization.

• Ensure inclusion of biomarker test results for RA and genetic confirmation for DIRA where applicable.
• Include clear documentation of trials (duration and dose) for methotrexate and prior biologic/tsDMARDs when required.

Denial triggers — active TB, unresolved positive TB screening, missing or nonconforming documentation

Treatment requests may be denied if the member has active TB, if TB screening is positive without appropriate further evaluation or treatment for latent infection, if dosing exceeds approved limits, or if the member does not meet the policy criteria.

• Do not administer Kineret to members with active TB infection.
• Positive TB screening requires further evaluation (e.g., chest x‑ray) to exclude active disease; latent TB must be treated prior to initiation.