CurrentAnthemPolicy CC-0177

Zilretta (triamcinolone acetonide extended-release)

Clinical criteria for medical-benefit coverage (prior authorization) of Zilretta for management of osteoarthritis pain of the knee, including approval criteria, exclusions, quantity limits, and relevant procedure/diagnosis codes.

Policy Summary

PayerAnthem

PolicyZilretta (triamcinolone acetonide extended-release)

Policy CodePolicy CC-0177

Change TypeAnnual reviewcoding reviewed

Effective DateJan 30, 2026

Next Review Date

Key ActionProvider must document non-pharmacological therapy, trial of oral prescription-strength NSAID (or topical if not tolerated), and trials of two different injectable corticosteroid chemical ingredients, and ensure Zilretta is limited to one 32 mg (5 mL) injection per knee per lifetime.

SourceLink

POLICY UPDATE CHANGES

Document reviewed 12/08/2025 with coding reviewed and ICD-10-CM M17.9 added.

03/15/2021 clarified dosage and administration allowed in each knee once per lifetime, no repeat administration allowed.

1/lifetimeQuantity limit

32 mgMaximum single dose

M17.0-M17.9Indicated ICD-10 range

Coverage Summary

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Scope: Clinical criteria for medical-benefit coverage (prior authorization) of Zilretta (triamcinolone acetonide extended-release) as an intra-articular injection for management of osteoarthritis pain of the knee (ICD-10 M17.0-M17.9).

Coverage stance: Covered with criteria — requests may be approved when all clinical criteria are met, including diagnosis of knee osteoarthritis, prior therapies, and dosing limits.

Policy subject: Zilretta (triamcinolone acetonide extended-release) intra-articular injection.

FDA indication: Intra-articular injection for management of osteoarthritis pain of the knee.

Headline thresholds: Dose per injection: ≤ 32 mg (5 mL) as a single intra-articular injection to one knee; Repeat dosing: not allowed in the same knee — approval duration: 1 injection per knee per lifetime.

Coverage thresholds / limits

Dose per injection<= 32 mg (5 mL) as a single intra-articular injection to one knee

Repeat dosingNot allowed in same knee; approval duration = 1 injection per knee per lifetime

Prior intra-articular short-acting corticosteroid interval>= 3 months since prior intra-articular short-acting corticosteroid

Injectable corticosteroid trialsAt least 2 trials with different conventional injectable corticosteroid chemical ingredients (e.g., dexamethasone, methylprednisolone acetate, triamcinolone acetonide) unless contraindicated or not tolerated

Initial Therapy Criteria

Initial Approval Criteria

Requests for Zilretta may be approved if ALL of the following criteria are met:

ALL of the following

Individual has a diagnosis of osteoarthritis of the knee (ICD-10 M17.0-M17.9).
Individual has not received previous administration of Zilretta to the requested knee.
Requested dose does not exceed 32 mg as a single once in a lifetime intra-articular injection to one knee.<= 32 mg (5 mL); 1 injection per knee per lifetime
Approval duration: 1 injection per knee per lifetime.
Individual has not received therapy with an intra-articular short-acting corticosteroid type drugs within the previous 3 months.>= 3 months since prior intra-articular short-acting corticosteroid
Therapeutic failure/intolerance/contraindication to the following (ACR 2017):
- Non-pharmacological therapy, e.g. physical therapy.
- ONE of: Oral nonsteroidal anti-inflammatory drug (NSAID) at continuous therapeutic dosing (prescription strength); OR topical NSAID if unable to take oral NSAIDs.
- Two conventional injectable corticosteroids (two different chemical ingredients per trial) have failed or are contraindicated or not tolerated. Examples: dexamethasone injection, methylprednisolone acetate injection, triamcinolone acetonide (Kenalog) injection.At least 2 different chemical-ingredient trials

Exclusion / Not Approved

Requests for Zilretta may not be approved for any of the following:

ANY of the following

Use for management of osteoarthritis pain of the shoulder, hip, or small joints, such as the hand.
Efficacy and safety not evaluated for shoulder/hip; not suitable for small joints.
Requesting a repeat administration in the same knee previously treated with Zilretta for the management of osteoarthritis pain of the knee.Repeat administration in same knee not allowed; approval duration = 1 injection per knee per lifetime.
All other indications not included in the approval criteria.
When the above criteria are not met and for all other indications.

Provider Actions

Prior Authorization

Prior authorization required

Zilretta requests are subject to clinical review and may be approved only if all clinical criteria are met, including diagnosis, prior therapies, and dosing limits.

J3304
M17.0-M17.9

Documentation Required

Document prior therapies and intolerance/contraindication

Provider must document non-pharmacological therapy, trial of oral prescription-strength NSAID (or topical NSAID if oral not tolerated), and trials of two different injectable corticosteroid chemical ingredients or documented contraindication/intolerance.

Non-pharmacological therapy (e.g., physical therapy)
Trial of oral prescription-strength NSAID at continuous therapeutic dosing or topical NSAID if oral not tolerated
Trials of two different injectable corticosteroids (different chemical ingredients) or documented contraindication/intolerance

Billing Rule

Quantity limit / lifetime limit

Limit = One injection (32 mg/5 mL) per knee per lifetime; do not bill for repeat administration to the same knee.

One injection (32 mg/5 mL) per knee per lifetime
Do not bill for repeat administration to the same knee
J3304

Denial Risk

Denial if criteria unmet or non-indicated joint

Claims may be denied when used for shoulder, hip, small joints (e.g., hand), for repeat administration in same knee, or when required prior therapies/conditions are not met.

Use for non-indicated joints (shoulder, hip, small joints such as the hand)
Repeat administration to the same knee previously treated with Zilretta
Missing required prior therapies or documentation (non-pharmacologic therapy, NSAID trial, two injectable corticosteroid trials)

Clinical Evidence & Guidance

Evidence: FDA indication — Intra-articular injection for management of osteoarthritis pain of the knee (FDA/label statement).

Guideline reference: Uses ACR guideline steps (ACR 2017 referenced for therapeutic steps) for required prior therapies and stepwise management.

Background safety/efficacy limits: efficacy and safety for shoulder, hip, and small joints have not been evaluated; repeat administration efficacy and safety for knee management has not been demonstrated per the FDA label and follow-up studies are ongoing.

Background

Zilretta is an extended-release intra-articular formulation of triamcinolone acetonide that delivers 32 mg (5 mL) as a single intra-articular injection to one knee.

The product has not been evaluated for management of osteoarthritis pain of the shoulder or hip and is not suitable for use in small joints such as the hand.

The FDA package label indicates that efficacy and safety for repeat administration in the knee have not been demonstrated; quantity limit is one injection (32 mg/5 mL) per knee per lifetime.

Definition — Short-acting intra-articular corticosteroid: conventional injectable corticosteroids such as dexamethasone, methylprednisolone acetate, and triamcinolone acetonide (Kenalog); prior use of a short-acting intra-articular corticosteroid within 3 months excludes approval.