Blue Cross Blue Shield - Iowa Kevzara Coverage

Coverage Criteria for Kevzara (sarilumab)

Polymyalgia Rheumatica (Initial)

Covered when ALL of the following are met:

PMR initial: A. Diagnosis of polymyalgia rheumatica according to ACR/EULAR classification criteria; B. Member has been tested for RF, anti-CCP, and CRP and/or ESR; C. Other possible causes of signs and symptoms have been ruled out (e.g., rheumatoid arthritis, polymyositis, fibromyalgia, osteoarthritis); D. Member has had an inadequate response to systemic corticosteroids or cannot tolerate a corticosteroid taper.

Authorization of 12 months may be granted if met.

Rheumatoid Arthritis (Initial)

Moderately to severely active Rheumatoid Arthritis — Covered when ANY of the following are met:

RA initial path A: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Enbrel, adalimumab-aacf, Rinvoq, Simponi, and Xeljanz/Xeljanz XR).

See Preferred Drug Plan Design requirement; prior preferred product trials may be required.

RA initial path B: Member has a clinical reason to avoid TNF-inhibitors (Enbrel, adalimumab-aacf, and Simponi) AND has had an inadequate response to treatment or intolerable adverse event with the preferred products, Rinvoq AND Xeljanz or Xeljanz XR.

Clinical reasons to avoid referenced in Appendix A.

RA initial path C: Member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.

Continuation documentation required for ongoing approval.

Polyarticular Juvenile Idiopathic Arthritis (Initial)

Polyarticular Juvenile Idiopathic Arthritis (members ≥63 kg) — Covered when ANY of the following are met:

pJIA initial path A: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (adalimumab-aacf, Enbrel, and Xeljanz/Xeljanz Oral Solution).weight >= 63 kg

Submission of chart notes detailing outcomes/intolerable AEs/contraindications required where applicable.

pJIA initial path B: Member has a clinical reason to avoid Enbrel and adalimumab-aacf AND has had an inadequate response to treatment or intolerable adverse event with the preferred product Xeljanz or Xeljanz Oral Solution.weight >= 63 kg

See Appendix A for reasons to avoid.

pJIA initial path C: Member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.

Giant Cell Arteritis (Initial)

Covered when ALL of the following are met:

GCA initial: Diagnosis of giant cell arteritis confirmed by either temporal artery biopsy or cross-sectional imaging OR by acute-phase reactant elevation (high ESR and/or high CRP).

Authorization of 12 months may be granted if met.

Immune Checkpoint Inhibitor-related Toxicity (Initial)

Immune checkpoint inhibitor-related inflammatory arthritis — Covered when ANY of the following are met:

ICI toxicity path A: Member has moderate or severe immunotherapy-related inflammatory arthritis and has had an inadequate response to corticosteroids or a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).

Authorization of 12 months may be granted.

ICI toxicity path B: Member has an intolerance or contraindication to corticosteroids and a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).

Prescriber specialty requirement applies (oncologist, hematologist, or rheumatologist).

Continuation Therapy

Covered when evidence of positive clinical response is provided:

PMR continuation: Documentation of improvement from baseline in any of: morning stiffness; hip or shoulder pain; hip or shoulder range of motion; or CRP and/or ESR.

Authorization may be granted for 12 months.

RA continuation: Disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.>=20% improvement

Authorization may be granted for 12 months.

GCA continuation: Improvement or low disease activity demonstrated by improvement in any of: headaches; scalp tenderness; temporal artery findings; constitutional symptoms; jaw/tongue claudication; acute visual symptoms; PMR symptoms; or limb claudication.

Authorization may be granted for 12 months.

Rheumatoid arthritis (initial and continuation therapy)

Moderately to severely active rheumatoid arthritis — Covered when ALL of the following are met:

RA initial/continuation criteria: Member is using Kevzara for moderately to severely active RA; member achieves or maintains a positive clinical response evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability; authorization duration = 12 months.>=20% improvement

Applies to all members including new members.

Giant cell arteritis

Covered when ALL of the following are met:

GCA criteria: Member is using Kevzara for giant cell arteritis; member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms with improvement in any of the following from baseline: headaches; scalp tenderness; tenderness/thickening of superficial temporal arteries; constitutional symptoms; jaw/tongue claudication; acute visual symptoms; PMR symptoms; limb claudication; authorization duration = 12 months.improvement in >=1 listed symptom

Applies to all members including new members.

Immune checkpoint inhibitor-related inflammatory arthritis

Covered when ALL of the following are met:

ICI-related inflammatory arthritis: Member is using Kevzara for immunotherapy-related inflammatory arthritis; member achieves or maintains a positive clinical response evidenced by low disease activity or improvement in signs and symptoms of the condition; authorization duration = 12 months.low disease activity or clinical improvement

Applies to all members including new members.

Polyarticular juvenile idiopathic arthritis

Covered when ALL of the following are met:

pJIA criteria: Member weighs >=63 kg; member is using Kevzara for active polyarticular juvenile idiopathic arthritis; member achieves or maintains a positive clinical response evidenced by low disease activity or improvement in number of joints with active arthritis, number of joints with limitation of movement, or functional ability; authorization duration = 12 months.weight >=63 kg

Applies to all members including new members.

Safety and concomitant therapy requirements

Covered when ALL of the following are met:

TB screening and concomitant therapy: Documented negative TB test (TST or IGRA) within 6 months prior to initiating therapy for biologic/targeted synthetic DMARD–naïve persons; if TB testing is positive, further evaluation to exclude active disease is required and active TB is a contraindication; latent TB must be treated before initiation; member must not use Kevzara concomitantly with any other biologic DMARD or targeted synthetic DMARD for the same indication.TB test within 6 months

Applies to all indications.

This medical policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP are governed by the applicable FEP contract language and are made by the Federal Employee Program; providers should verify member benefits with FEP prior to requesting coverage or submitting prior authorization documentation.

Do not administer the requested medication to members with active tuberculosis (TB) infection. For biologic or targeted synthetic DMARD–naïve persons, document a negative TB test (tuberculin skin test [TST] or interferon-gamma release assay [IGRA]) within 6 months prior to initiating therapy. If TB screening is positive, perform further evaluation (e.g., chest x-ray) to exclude active disease; if latent TB is identified, TB treatment must be started before initiation of the requested medication.

Members must not use the requested medication concomitantly with any other biologic DMARD or targeted synthetic DMARD for the same indication. Concomitant use of two biologic or targeted synthetic disease-modifying antirheumatic drugs for the same condition is not allowed under this policy and is a pre-initiation safety requirement for all indications.

Kevzara is considered not medically necessary for members who do not meet the coverage criteria and requirements set forth in this policy. Requests that lack required documentation, do not meet indication‑specific criteria, or violate safety requirements (for example, active TB or prohibited concomitant therapy) will be denied as not medically necessary.

Procedures, Billing, and Key Coding Details

Procedures and billing guidancemixed

No codes listed

pJIA weight threshold

Threshold>= 63 kg

ContextApplies to initial and continuation pJIA authorization — member must weigh 63 kg or greater

Authorization durationUp to 12 months when criteria met

Weight threshold for pJIA (duplicate)

Threshold>= 63 kg

Applies toActive polyarticular juvenile idiopathic arthritis (pJIA) initial and continuation requests

Evidence required

Prior Authorization, Documentation, and Exceptions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kevzara. Providers must submit a prior authorization request with supporting clinical documentation before the medication will be approved.

Prior authorization required for all indications
Requests without required documentation may be denied

Prior Authorization

Authorization Duration and Required Demonstration of Response

Authorization may be granted for up to 12 months for members who achieve or maintain a positive clinical response. Documentation of response must be provided for continuation/renewal requests and may include objective measures of disease activity or clinical improvement from baseline as specified by indication.

RA: ≥20% improvement in tender/swollen joint count, pain, or disability
GCA: improvement in headaches, scalp tenderness, temporal artery findings, constitutional symptoms, jaw/tongue claudication, visual symptoms, or PMR symptoms
Immune checkpoint inhibitor-related toxicity: improvement in inflammatory arthritis signs/symptoms or low disease activity

Drug Background and Indications

Kevzara (sarilumab) is approved and addressed in this policy for several inflammatory conditions including moderately to severely active rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for patients weighing ≥63 kg; compendial uses in the policy include immune checkpoint inhibitor–related inflammatory arthritis and giant cell arteritis. Providers should note benefit applicability may vary by contract and that this policy may not apply to FEP members; verify benefits prior to initiating therapy.

Key Definitions and Response Thresholds

FDA‑approved indications

Rheumatoid arthritis (RA)Kevzara indicated for adult patients with moderately to severely active RA after inadequate response or intolerance to one or more DMARDs.

Polymyalgia rheumatica (PMR)Kevzara indicated for adult patients with PMR who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

Polyarticular juvenile idiopathic arthritis (pJIA)Kevzara indicated for patients with active pJIA who weigh 63 kg or greater.

Positive clinical response / low disease activity — definition and examples

DefinitionEvidence of improvement from baseline in disease-specific signs or symptoms or low disease activity (e.g., >=20% improvement in joint counts or related measures for RA; symptom improvements listed for GCA; reduction in active joint count/function for pJIA).

RA example

Policy Revision History

procedures_billing_guidanceLatest

Procedures and billing guidance provided: use appropriate CPT, HCPCS, revenue, and ICD codes to report provider services.

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Kevzara (sarilumab) — Coverage Criteria

Coverage Criteria for Kevzara (sarilumab)

Procedures, Billing, and Key Coding Details

Prior Authorization, Documentation, and Exceptions

Drug Background and Indications

Key Definitions and Response Thresholds

Policy Revision History