Coverage Policy Manual
Policy #: 2018005
Category: Pharmacy
Initiated: February 2018
Last Review: July 2018
  Triamcinolone Acetonide Extended Release (Zilretta)

Description:
Triamcinolone acetonide extended-release injectable suspension is a corticosteroid, given as an intra-articular injection.  It is not intended for repeat administration (Zilretta, 2017).
 
Triamcinolone acetonide extended-release injectable suspension (Zilretta™) is indicated as an intra-articular injection for the management of osteoarthritis of the knee and was approved by the FDA in 2017 (Zilretta, 2017).
 
Coding
Effective January 01, 2019, there is a specific HCPCS code for Triamcinolone Acetonide, Preservative-free, Extended-Release.

Policy/
Coverage:
Effective February 2018
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Triamcinolone acetonide extended-release injectable suspension (Zilretta™) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for intra-articular use for treatment of osteoarthritis of the hip, knee or any other joint.
 
For members with contracts without primary coverage criteria, triamcinolone acetonide extended-release injectable suspension (Zilretta™) is considered investigational for intra-articular use for treatment of osteoarthritis of the hip, knee or any other joint. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
The efficacy and safety of triamcinolone acetonide extended-release injectable suspension (Zilretta™) was evaluated in a multi-center, international, randomized double-blind, parallel arm, placebo- and active-controlled study  in which 484 patients with osteoarthritis of the knee were enrolled.  Enrollment criteria required patients to be ≥40 years of age, meet American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA, have index knee pain for > 15 days over the last month, have a  Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray, have a qualifying mean score on the 24-h average pain score (0-10 numeric rating scale), and have a BMI ≤40kg/m2.  Patients were excluded if they had any other condition that could confound the patient’s assessment of index knee pain (i.e  iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain), fibromyalgia, autoimmune arthritis, history of infection in the knee, recent intra-articular or intramuscular corticosteroid, or recent hyaluronic acid in the index knee. The primary outcome measure was the change in baseline to week 12 in the weekly mean of the average daily (24-hr) pain intensity score (as assessed by a 0-10 Numeric Rating Scale) for triamcinolone acetonide extended-release injectable suspension as compared to placebo.  Secondary outcome measures included the change from baseline to week 12 in the weekly mean of the average daily (24-hr) pain intensity scores for triamcinolone acetonide extended-release injectable suspension relative to triamcinolone immediate-release.  Follow-up occurred for 24 weeks following a single intraarticular injection.   The primary endpoint demonstrated a statistically significant reduction in pain intensity at the primary endpoint vs placebo, but a secondary endpoint did not demonstrate a difference between the study drug and the active control (immediate-release triamcinolone acetonide) (FDA, 2017; Clinical Trials.gov, 2017).
 
Osteoarthritis is a chronic condition requiring evidence of successful long-term therapy.  The existing evidence is insufficient in demonstrating an improvement in net health outcomes over extended treatment intervals.  Triamcinolone acetonide immediate-release is an option for short term pain reduction.  Therefore, triamcinolone acetonide extended-release injectable suspension does not meet primary coverage criteria.  

CPT/HCPCS:
C9469Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
J3304Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
J3490Unclassified drugs
Q9993Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg

References: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).(2017) Study of FX006 for the treatment of pain in patients with osteoarthritis of the knee; Identifier NCT 02357459. 2017 Aug 10 [cited 2017 Dec 29]. Available from: http://clinicaltrials.gov/

U.S. Food and Drug Administration (FDA).(2017) Zilretta. Prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208845s000lbl.pdf Last accessed Feb. 05, 2018.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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