ModifiedmhnPolicy CP.PHAR.371

Triamcinolone ER Injection (Zilretta)

Defines medical necessity, prior authorization, and coverage criteria for single-dose intra-articular Zilretta (triamcinolone acetonide ER) for management of knee osteoarthritis for applicable Centene-affiliated lines of business.

Policy Summary

Payermhn

PolicyTriamcinolone ER Injection (Zilretta)

Policy CodePolicy CP.PHAR.371

Change TypeMaterial coverage clarifications and state-level step therapy update

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with imaging-confirmed diagnosis and documentation that the member has not received prior Zilretta in the same knee.

SourceLink

POLICY UPDATE CHANGES

Added requirement that member is not receiving re-treatment of knee(s) previously treated with Zilretta.

Approval duration clarified as one dose per knee lifetime.

Added step therapy bypass for Illinois HIM per IL HB 5395.

32 mgmax dose per knee

3 monthsapproval duration

one dose per kneelifetime limit

≥18min age

J3304

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IL bypassstate change

Coverage Criteria for Triamcinolone ER (Zilretta)

Initial Therapy — Covered when ALL of the following are met for osteoarthritis of the knee.

Covered when ALL of the following are met for osteoarthritis of the knee:

Osteoarthritis of the Knee - Initial Approval Criteria: 1. Diagnosis of osteoarthritis of the knee supported by imaging (e.g., X-ray, MRI); 2. Prescribed by or in consultation with a rheumatologist, orthopedist, or sports medicine physician; 3. Age ≥ 18 years; 4. Failure of a ≥ 4-week trial of one of the following unless clinically significant adverse effects or contraindications: a) oral prescription-strength NSAID at continuous therapeutic dosing, OR b) topical NSAID if member is ≥ 75 years or unable to take oral NSAIDs; 5. Trial of at least one other intra-articular glucocorticoid injection for the target knee with documented positive but inadequate response (e.g., inadequate pain relief, frequent need for rescue medication, or steroid-induced hyperglycemia); 6. Member is not receiving re-treatment of knee(s) previously treated with Zilretta; 7. Dose does not exceed 32 mg as a single intra-articular injection into the knee.

Approval duration: 3 months; one dose per knee lifetime.

Continuation / Re-treatment — Re-authorization / repeat administration rules.

Re-authorization / repeat administration rules:

Re-authorization is not permitted. Zilretta is not indicated for repeat administration in the same knee. For an untreated knee, members must meet the initial approval criteria.

Approval duration: Not applicable

Initial and single-dose coverage — Covered when ALL of the following are met.

Covered when ALL of the following are met

Primary coverage requirements: Member has a diagnosis of knee osteoarthritis confirmed by imaging; member has not previously received Zilretta in the same knee (no re-treatment); prior authorization requested for J3304 with documentation provided.one dose per knee lifetime

Imaging confirmation requirement and non-re-treatment requirement were added in annual reviews; prior authorization for J3304 is implied when documentation is provided.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off-label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

This policy was amended to add a specific prohibition on re-treatment: members who have previously received Zilretta in a knee are not eligible to receive re-treatment of that same knee with Zilretta. The amendment clarifies that approval is limited to one dose per knee lifetime.

Repeat administration of Zilretta in the same knee is considered not medically necessary because the efficacy and safety of repeat administration have not been demonstrated. Clinical trial data reported higher rates of arthralgia and other treatment-emergent adverse events during second injection periods, and the FDA labeling states that existing data are insufficient to fully characterize safety of repeat dosing; therefore repeat administration in the same knee is not supported by available evidence.

Coding and Billing

Referenced HCPCS CodesHCPCS

J3304

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

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Approval granted when all listed initial approval criteria are met. Provider must submit documentation (such as office chart notes, lab results, imaging, or other clinical information) supporting that the member has met all applicable criteria. Approval duration: 3 months (one dose per knee lifetime).

Provider must document that diagnosis of osteoarthritis of the knee is confirmed by imaging (e.g., X‑ray, MRI).
Provider must document specialist involvement: prescribed by or in consultation with a rheumatologist, orthopedist, or sports medicine physician.
Documentation must include evidence of prior therapy trials (e.g., trial of ≥4 weeks of prescription‑strength oral NSAID or topical NSAID if ≥75 years or unable to take oral NSAIDs, and trial of at least one other intra‑articular glucocorticoid injection with documented positive but inadequate response).
Dose limit: does not exceed 32 mg as a single intra‑articular injection into the knee.
Prior treatment: member must not be receiving re‑treatment of knee(s) previously treated with Zilretta.

Background

Zilretta (triamcinolone acetonide extended-release injectable suspension) is an extended-release corticosteroid formulation intended for intra-articular injection into the knee for management of osteoarthritis pain. The product is supplied as a single-dose vial of preservative-free microspheres containing 32 mg/5 mL and is designed to provide prolonged local release of triamcinolone over approximately 12 weeks compared with immediate-release formulations. The FDA-approved indication is for intra-articular management of knee osteoarthritis pain, but the label notes that the efficacy and safety of repeat administration have not been demonstrated.

Definitions and Product Details

Zilretta definition — Extended-release triamcinolone acetonide formulation for intra-articular injection.

Generic nameTriamcinolone acetonide extended-release injectable suspension (Zilretta)

Drug classExtended‑release synthetic corticosteroid

Route and useIntra-articular injection for management of knee osteoarthritis pain

FDA indication noteIndicated as an intra-articular injection for the management of osteoarthritis pain of the knee

TA-ER — Triamcinolone acetonide extended-release description and intended duration of effect.

AbbreviationTA-ER (triamcinolone acetonide extended‑release)

Policy Summary

Payermhn

PolicyTriamcinolone ER Injection (Zilretta)

Policy CodePolicy CP.PHAR.371

Change TypeMaterial coverage clarifications and state-level step therapy update

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with imaging-confirmed diagnosis and documentation that the member has not received prior Zilretta in the same knee.

SourceLink

On This Page

Billing Rule

Coding inclusion/exclusion note

Providers should be aware that inclusion or exclusion of any codes in this policy is for informational purposes only and does not guarantee coverage. Claims may still be denied if coding or coverage criteria are not met. Reference current professional coding guidance prior to claim submission.

Documentation Required

Required Documentation and Documentation Requirements

Provider must submit supporting documentation (office chart notes, lab results, imaging, procedure notes, or other clinical information) that demonstrates the member meets ALL applicable criteria. Documentation should explicitly confirm: diagnosis by imaging, specialist prescribing or documented consult, age, prior therapy trials (NSAID trial, intra‑articular steroid trial) and that the member has not previously received Zilretta in the knee to be treated.

Acceptable documentation: imaging reports (X‑ray, MRI), office visit notes, procedure notes for prior intra‑articular injections, medication trial documentation (dates, agents, dosing, response), and relevant lab results (if applicable).
Lack of supporting documentation (diagnosis with imaging, specialist prescribing/consult, age, prior therapy trials, prior intra‑articular products) may trigger denial of the request.

Step Therapy

Step Therapy Bypass (Illinois HIM)

Per IL HB 5395, the step therapy requirements do not apply for Illinois HIM requests effective 1/1/2026 — a step therapy bypass has been added for Illinois HIM.

For Illinois HIM requests (effective 01/01/2026), the requirement for prior failure of a 4‑week trial of an oral prescription‑strength NSAID or topical NSAID and related step therapy elements are bypassed.
All other documentation and prior authorization criteria remain applicable unless otherwise exempted by state law.

Mechanism/technology

Extended‑release microsphere technology to provide prolonged intra‑articular drug residency

Intended duration of effectDesigned to deliver triamcinolone acetonide over approximately 12 weeks

Pharmacokinetic noteProlonged joint residency vs immediate‑release formulation with diminished systemic peak levels

Triamcinolone ER (FX006 / Zilretta) — Product presentation: 32 mg/5 mL single-dose vial information.

Product formulationInjectable suspension of microspheres (preservative‑free), single‑dose vial for reconstitution

Strength per vial32 mg per vial (32 mg / 5 mL)

PresentationSingle‑dose vial: 32 mg / 5 mL for intra‑articular injection

Synonyms/identifiersFX006 (investigational designation) / Zilretta (commercial) — triamcinolone ER