Fluocinolone acetonide intravitreal implant (Retisert^TM) is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (363.00-363.08, 363.10-363.15, 363.20).

Retisert is surgically implanted into the posterior segment of the affected eye through a pars plana incision. The implant contains one tablet of 0.59 mg of fluocinolone acetonide. Retisert is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 µg/day, decreasing over the first month to a steady state between 0.3-0.4 µg/day over approximately 30 months. Following depletion of fluocinolone acetonide from Retisert as evidenced by recurrence of uveitis, Retisert may be replaced.

The use of fluocinolone acetonide for any indication other than chronic non-infectious uveitis affecting the posterior segment of the eye is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service.

Description

Non-infectious uveitis affecting the posterior segment of the eye encompasses a heterogeneous group of inflammatory diseases, many of which are idiopathic and/or systemic in origin. Based on anatomical classification, posterior segment uveitis involves inflammation of various structures of the uvea and includes intermediate uveitis, posterior uveitis, and panuveitis. The disease is characterized by chronic inflammation, ultimately leading to cellular and structural dysfunction and eventual vision loss. Due to the aggressive and invasive nature of the disease, it is associated with a high incidence of complications which contribute to overall visual morbidity. The main cause of visual impairment in uveitis affecting the posterior segment is the ultimate development of cystoid macular edema, cataracts, or a combination thereof. Of particular importance is the fact that visual morbidity does not result from a single episode of uveitis, but rather recurrent episodes of inflammation cause cumulative damage. Poor visual outcomes are significantly associated with duration of inflammation and recurrent episodes of inflammation. Therefore, inflammation must be controlled long term if patients are going to be spared visual impairment or blindness.

The goals of therapy are to reduce inflammation, prevent damage to ocular structures, and prevent long-term visual loss. Corticosteroids have been the mainstay of treatment for posterior segment uveitis and are commonly administered systemically, or as periocular injections. Topical administration is seldom used to treat this form of disease as therapeutic drug levels do not reach the posterior segment of the eye. Periocular corticosteroid injections, which typically consist of triamcinolone acetonide, often need to be repeated at 2 to 4 month intervals in order to maintain adequate control. Complications of this form of treatment include globe perforation, orbital fibrosis, and ptosis.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition.

Bausch & Lomb, Inc., Retisert^TM (fluocinolone acetonide intravitreal implant) package insert, Bausch & Lomb, Inc., Rochester, NY

Long-Term Follow-up Results of a Pilot Trial of a Fluocinolone Acetonide Implant to Treat Posterior Uveitis, Ophthalmology, Vol. 112, No. 7, 2005

Fluocinolone Acetonide Implant (Retisert) for Noninfectious Posterior Uveitis: Thirty-Four-Week Results of a Multicenter Randomized Clinical Study, Ophthalmology, Vol. 113, No. 6, 06/2006

Management of Diabetic Retinopathy: A Systematic Review, JAMA, Vol. 298, No. 8, 2007

Reimplantation of a Fluocinolone Acetonide Sustained Drug Delivery Implant for Chronic Uveitis, American Journal of Ophthalmology, Vol. 145, 2008

Fluocinolone Acetonide Sustained Drug Delivery Device for Chronic Central Retinal Vein Occlusion: 12-Month Results, American Journal of Ophthalmology, 06/2008