CurrentUnitedHealthcarePolicy CSKYD0229.06

Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension) (for Kentucky Only)

Medical Benefit Drug Policy governing coverage and prior authorization requirements for Zilretta intra-articular injections for treatment of knee osteoarthritis for UnitedHealthcare members in Kentucky.

Policy Summary

PayerUnitedHealthcare

PolicyZilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension) (for Kentucky Only)

Policy CodePolicy CSKYD0229.06

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document age ≥18, ≥12 weeks of conservative therapy and NSAID trial, and prior trials or intolerance to two listed intra-articular corticosteroids.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3304HCPCS code for Zilretta

≥18Minimum member age for coverage

2Required IA steroid trials

30Max authorization (days)

KYApplicable state

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Coverage Criteria for Zilretta (knee osteoarthritis)

Medical necessity criteria for Zilretta

Covered when ALL of the following are met:

Primary coverage criteria: Member has diagnosis of osteoarthritis pain of the knee

Prior conservative therapy: Documentation that the member has not responded adequately to conservative non-pharmacological therapy (e.g., physical therapy) for at least 12 weeks>=12 weeks

NSAID trial: Documentation that the member has not adequately responded to, or is unable to tolerate, or has contraindications to at least a 12-week trial of topical or oral non-steroidal anti-inflammatory drugs (NSAIDs)>=12 weeks

Prior intra-articular corticosteroid requirement

Option 1: Documentation of treatment failure or inadequate response to at least two of the specified intra-articular corticosteroid injections for the knee>=2 agents
Option 2: History of intolerance, contraindication, or severe adverse event to at least two of the specified intra-articular corticosteroid injections for the knee AND physician attests that the same intolerance/contraindication/severe adverse event would not be expected to occur with Zilretta>=2 agents

Age and prior use: Member is 18 years of age or older>=18 years

Prior Zilretta exposure: Member has not previously been treated with Zilretta

Dosing and authorization period: Dosing is in accordance with FDA approved labeling; authorization is for no more than 30 days<=30 days

Listing of a code in this policy does not by itself indicate that the service described by the code is a covered or non‑covered health service. Benefit coverage is determined by the member's specific plan document and applicable law. The inclusion of a code in this policy does not guarantee reimbursement or imply eligibility for coverage.

Relevant Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J3304

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

Relevant ICD-10 Diagnosis CodesICD-10

M17.10	Unilateral primary osteoarthritis, unspecified knee
M17.11	Unilateral primary osteoarthritis, right knee
M17.12	Unilateral primary osteoarthritis, left knee
M17.2	Bilateral post-traumatic osteoarthritis of knee
M17.30	Unilateral post-traumatic osteoarthritis, unspecified knee
M17.31	Unilateral post-traumatic osteoarthritis, right knee
M17.32	Unilateral post-traumatic osteoarthritis, left knee
M17.4	Other bilateral secondary osteoarthritis of knee
M17.5	Other unilateral secondary osteoarthritis of knee
M17.9	Osteoarthritis of knee, unspecified

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zilretta® (J3304). Dosing must follow the FDA‑approved labeling. Authorization is limited to a single course no longer than 30 days.

HCPCS: J3304
Limit: Authorization ≤ 30 days
Dosing: Per FDA‑approved labeling

Step Therapy

Step Therapy — Intra‑articular Corticosteroids Required

A trial and inadequate response to at least two alternative intra‑articular corticosteroid injections for the knee is required before coverage is approved. Acceptable IA corticosteroids include triamcinolone acetonide injection suspension, methylprednisolone acetate injection suspension, betamethasone acetate–betamethasone sodium phosphate injection suspension, or dexamethasone sodium phosphate injection. Alternatively, documentation of intolerance, contraindication, or severe adverse event to at least two of these agents is acceptable if the prescribing physician attests that the same reaction would not be expected with Zilretta®.

Clinical Background

Osteoarthritis of the knee is a common cause of chronic joint pain, stiffness, and functional limitation resulting from degeneration of articular cartilage and periarticular tissues. Risk factors include older age, obesity, prior knee injury, female sex, and genetic predisposition. Diagnosis may be clinical with or without radiographic confirmation, and management emphasizes nonpharmacologic therapies and symptom control. Zilretta is an extended‑release intra‑articular corticosteroid formulation approved for management of knee osteoarthritis pain.

Product Definition

inv-10: Zilretta — extended-release triamcinolone acetonide intra-articular product definition

Generic nameTriamcinolone acetonide extended-release injectable suspension

Brand nameZilretta

Formulation and routePreservative-free, extended‑release intra‑articular injectable microsphere suspension

Indication (FDA)Management of osteoarthritis pain of the knee

Intended use contextSingle‑joint intra‑articular administration to the knee joint as adjunct to conservative therapy

Patient populationAdults (policy requires age ≥ 18 years)

Policy Summary

PayerUnitedHealthcare

PolicyZilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension) (for Kentucky Only)

Policy CodePolicy CSKYD0229.06

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document age ≥18, ≥12 weeks of conservative therapy and NSAID trial, and prior trials or intolerance to two listed intra-articular corticosteroids.

SourceLink

On This Page

Required trial: ≥ 2 IA corticosteroid injections (listed above) with inadequate response

OR documented intolerance/contraindication/severe adverse event to ≥ 2 IA corticosteroids plus physician attestation

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the prior authorization request. Missing or insufficient documentation may result in denial.

Diagnosis of osteoarthritis pain of the knee (ICD‑10 codes such as M17.xx)
Documentation of ≥12 weeks of conservative non‑pharmacologic therapy (e.g., physical therapy)
Documentation of a ≥12‑week trial of topical or oral NSAIDs with inadequate response, intolerance, or contraindication
Records of prior intra‑articular corticosteroid injections (agents, dates, and clinical response) or documentation of intolerance/contraindication/severe adverse events to ≥2 listed IA corticosteroids
Physician attestation that the same intolerance/contraindication/severe adverse event would not be expected with Zilretta®
Member age ≥ 18 and no prior treatment with Zilretta®

Denial Risk

Documentation Gaps Risk Denial

Documentation gaps (for example, missing diagnosis, inadequate trials of conservative therapy or NSAIDs, lack of records for prior IA steroid injections, absent physician attestation, or age/previous‑use information) may lead to denial of the authorization request.

Common gaps: missing diagnosis, no ≥12 weeks conservative therapy documented, no ≥12‑week NSAID trial documented, missing IA steroid trial details, absent physician attestation, or missing age/prior Zilretta® treatment status