Subject:
Triamcinolone Acetonide Extended-Release (Zilretta)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Osteoarthritis (OA), also known as degenerative joint disease, affects more than 30 million Americans. OA is a progressive and incurable condition and the most common form of arthritis. Its effects may range from intermittent discomfort to the loss of function and severe chronic pain associated with irreversible structural damage. As OA progresses, many patients experience intractable joint pain.
Zilretta (triamcinolone acetonide) is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. Zilretta is not intended for repeat administration.
The FDA approval of Zilretta was based on a randomized, double-blind, placebo- and active-controlled study in patients with osteoarthritis pain of the knee. A total of 484 patients were treated with either Zilretta, placebo, or immediate-release formulation of triamcinolone acetonide and followed for up to 24 weeks. Twenty-five percent (25%) of patients had received at least one prior corticosteroid intra-articular injection more than 3 months prior to treatment. The primary efficacy endpoint comparing Zilretta to placebo was change from baseline at Week 12 in the weekly mean of the Average Daily Pain intensity scores (ADP) as assessed by a 0-10 Numeric Rating Scale (NRS). Zilretta demonstrated a statistically significant reduction in pain intensity at the primary endpoint versus placebo. The least squares mean (LSM)-change in ADP-intensity from baseline to week 12 was -3.12 for Zilretta and -2.14 for placebo; treatment difference of -0.98 (95% CI: -1.47, -0.49; p < 0.0001). However, Zilretta was not statistically significantly better versus immediate-release triamcinolone for the change from baseline at week 12 in weekly mean ADP.
The most common adverse reactions (> 1%) with Zilretta use were sinusitis, cough and contusions. Precautions for Zilretta include serious neurologic adverse reactions with epidural and intrathecal administration, hypersensitivity reactions, joint infection and damage, increased risk of infections, alterations in endocrine function, cardiovascular effects, renal effects, increased intraocular pressure, gastrointestinal perforation, alterations in bone density, and behavioral and mood disturbances.
Policy:
I. Zilretta (triamcinolone acetonide extended-release) is medically necessary for the management of osteoarthritis pain of the knee:
Table 1. Osteoarthritis/Degenerative joint disease is classified into the following categories based on radiographic evidence:
| Staging | Description |
| Grade 1 | slight narrowing of the joint, minimum osteophyte formation, and slight sclerosis |
| Grade 2- | moderate joint space narrowing, spur formation, and sclerosis |
| Grade 3- | bone-on-bone changes and sclerosis but no loss of bone stock |
| Grade 4 | complete obliteration of the joint, loss of joint stock and severe sclerosis |
3. Member has failed to respond adequately to conservative non-pharmacologic therapy (e.g. physical activity and exercise); AND
4. Member has tried and has not resulted in functional improvement after at least 3 months, is intolerant or has contraindications to simple analgesics, (e.g., acetaminophen; NSAIDs; and/or topical capsaicin cream); AND
5. The member has tried and failed to respond adequately to previous treatment with generic immediate-release intra‐articular steroids
II. When Zilretta (triamcinolone acetonide extended-release) is considered medically necessary, treatment will be approved only once at the following FDA approved dosing of 32 mg administered as a single intra-articular injection in the knee once.
III. Zilretta is not intended for repeat administration.
[INFORMATIONAL NOTE: Based on the FDA approved package insert, the safety and efficacy of repeat administration have not been demonstrated.
A recent single-arm, open-label, multicenter phase 3b study demonstrated repeat administration of Zilretta in patients with knee osteoarthritis. 208 patients were enrolled and received the first injection; 205 patients were followed for 12 weeks, 179 patients received the second injection (at Week 12, 16, 20, or 24) and were followed for 52 weeks following the initial injection. The median time to the second injection was 16.6 weeks and the duration of the clinical benefit observed following the first injection appeared to be similar to the duration of benefit from the second injection. The study found that both injections were well tolerated with no unexpected adverse events following either injection.]
IV. Zilretta (triamcinolone acetonide extended-release) injections are considered investigational when used for any other indications other than the above criteria.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Triamcinolone Acetonide Extended-Release (Zilretta)
Zilretta (Triamcinolone Acetonide Extended-Release)
References:
1. Zilretta (triamcinolone acetonide extended-release injectable suspension). Flexion Therapeutics, Inc. Burlington, MA. January 2020.
2. Conaghan P, Hunter D, Cohen S, et al. Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. J Bone Joint Surg Am. 2018 Apr 18;100(8):666-677. doi: 10.2106/JBJS.17.00154.
3. FDA Center Watch. Zilretta (triamcinolone acetonide extended-release injectable suspension). October 2017. Available at: https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100230/zilretta-triamcinolone-acetonide-extended-release-injectable-suspension. Accessed June 2018.
4. ClinicalTrials.gov. Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee. Available at: https://clinicaltrials.gov/ct2/show/NCT02357459. Accessed May 2019.
5, Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. US National Library of Medicine National Institutes of Health. August 2016. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925407/. Accessed August 2018.
6. Spitzer AI, Richmond JC, Kraus VB, et al. Safety and efficacy of repeat administration of triamcinolone acetonide extended-release in osteoarthritis of the knee: a phase 3b, open label study. Rheumatol Ther. 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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