| Highmark Commercial Medical Policy in West Virginia |
| Section: | Injections |
| Number: | I-78 |
| Topic: | Intravitreal Implants |
| Effective Date: | April 9, 2012 |
| Issued Date: | April 9, 2012 |
| Date Last Reviewed: | 03/2012 |
Indications and Limitations of Coverage
Ozurdex Ozurdex dexamethasone intravitreal implant employs the Novadur™ solid polymer drug delivery system. Ozurdex implant is injectable and biodegradable. Each implant comes preloaded in a specially designed, single-use applicator. The use of Ozurdex for any other indication is considered experimental/investigational, and therefore, would not be covered. A participating, preferred, or network provider can bill the member for the non-covered service. Ozurdex is not covered under the prescription drug benefit. Date Last Reviewed: 11/2009 Retisert A fluocinolone acetonide intravitreal implant may be an acceptable alternative in patients who are intolerant or refractory to other therapies for chronic noninfectious posterior uveitis, or in patients who are judged likely to experience severe adverse events from systemic corticosteroids. 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 non-covered service. Retisert is not covered under the prescription drug benefit. Date Last Reviewed: 08/2011 Description Ozurdex Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells. Retisert A branch retinal vein occlusion is essentially a blockage of the portion of the circulation that drains the retina of blood. Central retinal vein occlusion is closure of the final retinal vein (located at the optic nerve) which collects all of the blood after it passes through the capillaries. When the distribution of the vein involves the center of the retina (macula), bleeding and fluid leakage occur, producing symptoms. Leakage in the macula causes macular edema in which a patient will have blurred vision and loss of portions of the field of vision (corresponding to the distribution of the obstructed vein). 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. |
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| J7311 | J7312 |
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. |
Provider News
02/2011, Ozurdex covered for treating non-infectious uveitis affecting the posterior segment of the eye
10/2011, Retisert coverage guidelines outlined
Bausch & Lomb, Inc., RetisertTM (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 Ozurdex™ [package insert]. Irvine, CA: Allergan, Inc; 09/2010. Haller JA, Bandello F, Belfort R, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010;117:1134-1146. Pavesio C, Zierhut M, Comstock TL, et al. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010;117(3):567-75. Haller JA, Kuppermann BD, Blumenkranz MS. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010 Mar;128(3):289-96. Kompella UB, Kadam RS, Lee VH. Recent advances in ophthalmic drug delivery. Ther Deliv. 2010 Sep 1;1(3):435-456. Kuno N, Fujii S. Biodegradable intraocular therapies for retinal disorders: progress to date. Drugs Aging. 2010 Feb 1;27(2):117-34. Pavesio C, Zierhut M, Bairi K, Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575. Hunter RS, Lobo AM. Dexamethasone intravitreal implant for the treatment of noninfectious uveitis. Clin Ophthalmol. 2011;5:1613-21. Epub 2011 Nov 11. Sallam A, Taylor SR, Lightman S. Review and update of intraocular therapy in noninfectious uveitis. Curr Opin Ophthalmol. 2011 Nov;22(6):517-22. Schwartz SG, Flynn HW Jr. Fluocinolone acetonide implantable device for diabetic retinopathy. Curr Pharm Biotechnol. 2011 Mar 1;12(3):347-51. |
| [Version 008 of I-78] |
| [Version 007 of I-78] |
| [Version 006 of I-78] |
| [Version 005 of I-78] |
| [Version 004 of I-78] |
| [Version 003 of I-78] |
| [Version 002 of I-78] |
| [Version 001 of I-78] |
Covered Diagnosis Codes
For procedure code J7312:
| 362.35 | 362.36 | 363.00-363.08 | 363.10-363.15 |
| 363.20 |
Covered Diagnosis Codes
For procedure code J7311:
| 363.00-363.08 | 363.10-363.15 | 363.20 |