Overview

This document addresses the use of Zilretta (triamcinolone acetonide extended-release) injection. Zilretta is FDA indicated as an intraarticular injection for the management of osteoarthritis pain of the knee. The efficacy and safety of Zilretta for management of osteoarthritis pain of shoulder and hip have not been evaluated. In addition, Zilretta is not suitable for use in small joints, such as the hand. Zilretta is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL) in one dose. Zilretta has not been evaluated and should not be administered by any of the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous. The FDA package label states the efficacy and safety in the repeat administration for the management of osteoarthritis pain of the knee has not been demonstrated. Follow up studies focusing on Zilretta efficacy duration and need for repeat dosing are undergoing.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Zilretta (triamcinolone acetonide extended-release)

Requests for Zilretta (triamcinolone acetonide extended-release) may be approved if the following criteria are met:

1. Individual has a diagnosis of osteoarthritis of the knee; AND
2. Individual has not received previous administration of Zilretta to the requested knee; AND
3. Requested dose does not exceed 32 mg as a single once in a lifetime intra-articular injection to one knee; AND
4. Individual has not received therapy with an intra-articular short-acting corticosteroid type drugs within the previous 3 months; AND
5. Individual has had a therapeutic failure, a contraindication, or is intolerant to all of the following (ACR 2017):
   • Non-pharmacological therapy, e.g. physical therapy; AND
   • Oral nonsteroidal anti-inflammatory drug (NSAID) at continuous therapeutic dosing (prescription strength); OR topical NSAID if unable to take oral NSAIDs; AND
   • Two (different chemical ingredients per trial) conventional injectable corticosteroids [e.g. Dexamethasone injection, methylprednisolone acetate injection, Kenalog injection (triamcinolone acetonide)].

Requests for Zilretta may not be approved for the following:

1. Individual is using for management of osteoarthritis pain of the shoulder, hip, or small joints, such as the hand; OR
2. Individual is requesting a repeat administration in the same knee previously treated with Zilretta for the management of osteoarthritis pain of the knee; OR
3. All other indications not included above; OR
4. When the above criteria are not met and for all other indications.

Approval duration: 1 injection per knee per lifetime.

Quantity Limits

Zilretta (triamcinolone acetonide extended-release) Quantity Limits

Drug: Zilretta 32mg (5 mL) injection
Limit: One injection (32 mg/5 mL) per knee per lifetime

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.

Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J3304

ICD-10 Diagnosis

Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg

M17.0-M17.5

Bilateral primary osteoarthritis of the knee

Document History

Revised: 12/11/2023