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Intravitreal Corticosteroid Implants

Policy Number: MP-451

Latest Review Date: July 2019

Category:  Pharmacology                                                      

Policy Grade:  C

POLICY:

FDA approved fluocinolone acetonide intravitreal implants may be considered medically necessary for their specific indications:

  • Retisert® (0.59mg) may be considered medically necessary for the treatment of chronic noninfectious intermediate, posterior, or panuveitis, in one or both eyes.
  • Iluvien™ (0.19mg) may be considered medically necessary for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
  • Yutiq™ (0.18mg) may be considered medically necessary for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

An FDA approved dexamethasone intravitreal implant 0.7mg (i.e., Ozurdex®) may be considered medically necessary for treatment of the following indications:

  • Noninfectious uveitis affecting the intermediate or posterior segment of the eye; OR
  • Macular edema following branch or central retinal vein occlusion; or
  • Diabetic macular edema

All other uses of a corticosteroid intravitreal implant are considered not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OF SERVICE:

An intravitreal implant is a drug delivery system, injected or surgically implanted in the vitreous of the eye, for sustained release of a pharmacologic agent to the posterior and intermediate segments of the eye. Three intravitreal corticosteroid implants, i.e., fluocinolone acetonide 0.59 mg (Retisert), fluocinolone acetonide 0.19 mg (Iluvien),fluocinolone acetonide 0.18 mg (Yutiq™), and dexamethasone 0.7 mg (Ozurdex) are reviewed herein. Fluocinolone acetonide implants are nonerodible and deliver drug up to 30 to 36 months while dexamethasone implants are bioerodible and last up to 6 months.

Eye Conditions

Uveitis

Uveitis encompasses a variety of conditions, of either infectious or noninfectious etiologies, that are characterized by inflammation of any part of the uveal tract of the eye (iris, ciliary body, choroid). Infectious etiologies include syphilis, toxoplasmosis, cytomegalovirus retinitis, and candidiasis. Noninfectious etiologies include sarcoidosis, Bechet’s disease, and “white dot” syndromes such as multifocal choroiditis or “birdshot” chorioretinopathy. Uveitis may also be idiopathic, have a sudden or insidious onset, a duration that is limited (less than three months) or persistent, and a course that may be acute, recurrent, or chronic.

The classification scheme recommended by the Uveitis Study Group and the Standardization of Uveitis Nomenclature (SUN) Working Group is based on anatomic location. Patients with anterior uveitis typically develop symptoms such as light sensitivity, pain, tearing, and redness of the sclera. In posterior uveitis, which comprises approximately 5% to 38% of all uveitis cases in the U.S., the primary site of inflammation is the choroid or retina (or both). Patients with intermediate or posterior uveitis typically experience minimal pain, decreased visual acuity, and the presence of floaters (bits of vitreous debris or cells that cast shadows on the retina). Chronic inflammation associated with posterior segment uveitis can lead to cataracts and glaucoma and to structural damage to the eye, resulting in severe and permanent vision loss.

Treatment

Intravitreal injections of triamcinolone are used to treat macular edema associated with CRVO, with a modest beneficial effect on visual acuity. The treatment effect lasts about 6 months, and repeat injections may be necessary. Cataracts are a common side effect, and steroid-related pressure elevation occurs in about one-third of patients, with 1% requiring filtration surgery.

Macular photocoagulation with grid laser improves vision in BRVO but is not recommended for CRVO. Although intravitreal injections of triamcinolone have also been used for BRVO, the serious adverse events have stimulated the evaluation of new treatments, including intravitreal steroid implants or the intravitreal injection of antivascular endothelial growth factor.

Diabetic Macular Edema

Diabetic retinopathy is a common microvascular complication of diabetes and a leading cause of blindness in adults. The two most serious complications for vision are diabetic macular edema and proliferative diabetic retinopathy. At its earliest stage (nonproliferative retinopathy), microaneurysms occur. As the disease progresses, blood vessels that provide nourishment to the retina are blocked, triggering the growth of new and fragile blood vessels (proliferative retinopathy). Severe vision loss with proliferative retinopathy arises from leakage of blood into the vitreous. Diabetic macular edema is characterized by swelling of the macula due to gradual leakage of fluids from blood vessels and breakdown of the blood-retinal barrier. Moderate vision loss can arise from the fluid accumulating in the center of the macula (macular edema) during the proliferative or nonproliferative stages of the disease. Although proliferative disease is the main blinding complication of diabetic retinopathy, macular edema is more frequent and is the leading cause of moderate vision loss in people with diabetes.

Treatment

Tight glycemic and blood pressure control is the first line of treatment to control diabetic retinopathy, followed by laser photocoagulation for patients whose retinopathy is approaching the high-risk stage. Although laser photocoagulation is effective at slowing the progression of retinopathy and reducing visual loss, it does not restore lost vision. Alternatives to intravitreal implants include intravitreal injection of triamcinolone acetonide, which is used as an off-label adjunctive therapy for DME. Angiostatic agents such as injectable vascular endothelial growth factor (VEGF) inhibitors, which block some stage in the pathway leading to new blood vessel formation (angiogenesis), have demonstrated efficacy in DME.

Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is a degenerative disease of retina that results in loss of central vision with increasing age. Two distinctively different forms of degeneration, known as dry and wet, may be observed. The dry form (also known atrophic or areolar) is more common and is often a precursor to the wet form (also known as exudative neovascular or disciform). The wet form is more devastating and characterized by serous or hemorrhagic detachment of the retinal pigment epithelium and development of choroidal neovascularization (CNV), which greatly increases the risk of developing severe irreversible loss of vision. CNV is categorized as classic or occult.

Treatment

Effective specific therapies for exudative or wet AMD are intravitreous injection of a vascular endothelial growth factor inhibitor, possibly thermal laser photocoagulation (in selected patients), and photodynamic therapy.

Intravitreal Implants

Intravitreal implants deliver a continuous concentration of a pharmacologic agent to the eye over a prolonged period. The goal of therapy is to reduce inflammation in the eye while minimizing the adverse events of the therapeutic regimen.

Selection of the route of corticosteroid administration (topical, systemic, periocular, or intraocular injection) is based on the cause, location, and severity of the disease. Each therapeutic approach has drawbacks. For example, topical corticosteroids require frequent (e.g., hourly) administration and may not adequately penetrate the posterior segment of the eye due to their poor ability to penetrate ocular tissues. Systemically administered drugs penetrate poorly into the eye because of the blood-retinal barrier, and high-dose or long-term treatments may be necessary. Long-term systemic therapies can be associated with substantial adverse events such as hypertension and osteoporosis, while repeated (every 4-6 weeks) intraocular corticosteroid injections may result in pain, intraocular infection, globe perforation, fibrosis of the extraocular muscles, reactions to the delivery vehicle, increased intraocular pressure, and cataract development.

Corticosteroid implants are biodegradable or nonbiodegradable. Nonbiodegradable systems are thought to be preferable for treating chronic, long-term disease, while biodegradable products may be preferred for conditions that require short-term therapy. Although the continuous local release of steroid with an implant may reduce or eliminate the need for intravitreal injections and/or long-term systemic therapy, insertion or surgical implantation of the device carries risks, and the device could increase ocular toxicity due to increased corticosteroid concentrations in the eye over a longer duration. With any route of administration, cataracts are a frequent complication of long-term corticosteroid therapy.

Intraocular corticosteroid implants being evaluated include:

  • Retisert (nonbiodegradable fluocinolone acetonide intravitreal implant; Bausch & Lomb) is a sterile implant that consists of a tablet containing fluocinolone acetonide 0.59 mg, a synthetic corticosteroid that is less soluble in aqueous solution than dexamethasone. The tablet is encased in a silicone elastomer cup with a release orifice and membrane; the entire elastomer cup assembly is attached to a suture tab. Following implantation (via pars plana incision and suturing) in the vitreous, the implant releases the active drug at a rate of 0.3 to 0.4 μg/d over 2.5 years.
  • ILUVIEN (nonbiodegradable injectable intravitreal implant with fluocinolone acetonide; Alimera Sciences) is a rod-shaped device made of polyimide and polyvinyl alcohol. It is small enough to be placed using a 25-gauge applicator. It is expected to provide sustained delivery of fluocinolone acetonide for up to 3 years.
  • Ozurdex (previously known as Posurdex; biodegradable dexamethasone intravitreal implant; Allergan, Irvine, CA) is composed of a biodegradable copolymer of lactic acid and glycolic acid with micronized dexamethasone. This implant is placed into the vitreous cavity through the pars plana using a customized, single-use, 22-gauge applicator. The implant provides intravitreal dexamethasone for up to 6 months. The mean number of Ozurdex injections reported in the literature is 4.2 injections per year, and more than 6 consecutive injections have been reported.
  • Yutiq (non-biodegradable injectable intravitreal implant with fluocinolone acetonide; EyePoint Pharmaceuticals US, Inc.) is a sterile implant consisting of fluocinolone acetonide 0.18 mg within a 36-month sustained-release drug delivery system. Yutiq is preloaded into a single-dose applicator and injected directly into the vitreous. It designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day.

KEY POINTS:

The most recent update with literature review was performed through February 5, 2019.

SUMMARY OF EVIDENCE:

Uveitis

For individuals with chronic noninfectious intermediate or posterior uveitis who receive an intravitreal fluocinolone acetonide implant (0.59 mg), the evidence includes 4 randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Two of the 4 RCTs compared 2 doses of implants and 2 trials compared implants with systemic steroids (and immunosuppression when indicated). All trials supported the efficacy of intravitreal fluocinolone acetonide implants in preventing recurrence and improving visual acuity over 4-year follow-up. The head-to-head trial comparing implants with systemic corticosteroids did not show substantial superiority in the overall effectiveness of either approach. After 24 and 54 months of follow-up, visual acuity improved from baseline in the implant groups compared to the systematic therapy groups by +6.0 and +3.2 letters (p=0.16) and +2.4 and 3.1 letters (p=0.073), respectively. However, nearly all phakic patients receiving implants developed cataracts and required cataract surgery. Further, most also developed glaucoma, with 75% of patients requiring intraocular pressure (IOP) - lowering medications and 35% requiring filtering surgeries. Systemic adverse events such as hyperlipidemia, diabetes, osteoporosis, fractures, and blood count/chemistry abnormalities were infrequent and not statistically distinguishable between groups. The incidence of hypertension was greater in the systemic therapy group (27%) compared to the implant group (13%), but rates of antihypertensive treatment initiation did not differ. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with noninfectious intermediate or posterior uveitis who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Results of this trial at 8 weeks showed that the implant was effective in reducing inflammation (the proportion of eyes with no inflammation was 47% and 12% with implant and sham, respectively) and resulted in clinically meaningful improvement in vision at week 8 compared to sham controls (the proportion of patients with a gain of ≥15 letters in best-corrected visual acuity [BCVA] from baseline was ~40% with implants and 10% with sham). Further, at week 26, patients treated with implants reported meaningful increases in vision-related functioning. The major limitation of this trial was its lack of long-term follow-up. Use of implants resulted in higher incidences of cataracts and elevated IOP. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Macular Edema

For individuals with macular edema after retinal vein occlusion who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes 2 RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Compared to sham controls, implants resulted in clinically meaningful improvements in visual acuity within 1 to 3 months postimplant and improvement in vision occurred faster. The difference in the proportion of patients with gain of 15 or more letters in BCVA from baseline was more than 10% in favor implants versus sham in both studies at 30, 60 and 90 days, but not at 180 days postimplant. Use of implants resulted in higher incidences of cataracts and elevated IOP. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with macular edema after retinal vein occlusion who receive an intravitreal fluocinolone acetonide implant (0.59 mg), no studies were identified. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.

Diabetic Macular Edema

For individuals with refractory (persistent or recurrent) diabetic macular edema (DME) who receive an intravitreal fluocinolone acetonide implant (0.59 mg), the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Compared to standard of care (as needed laser or observation), a greater proportion of patients with implants reported clinically significant improvement in vision at 6 months (1.4% vs 16.8% respectively) and subsequent time points assessed but not at or beyond 30 months of follow-up. Ninety percent of patients with phakic eyes who received implants required cataract surgery and 60% developed elevated IOP. Due to the substantial increase in adverse events and availability of agents with safer tolerability profiles (e.g., anti-vascular endothelial growth factor [anti-VEGF] inhibitors), implant use in DME is questionable. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with DME who receive an intravitreal fluocinolone acetonide implant (0.19 mg), the evidence includes 2 RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Implant-treated eyes showed in clinically meaningful improvements in vision at 2 and 3 years postimplant. The percentage of patients who gained 15 letters or more was 28.7% in the implant group versus 18.9% in the sham group at 3 years. Subgroup analysis showed greater improvements in visual acuity in patients who were pseudophakic compared to those who were phakic (difference in mean change in number of letters at 2 years from baseline was 5.6 letters in pseudophakic patients vs 1 letter in phakic patients). A major limitation of these implants is that nearly 80% all phakic patients will develop cataracts and will require cataract surgery. Further, IOP was elevated in 34% of patients who received this implant compared with 10% of controls. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with DME who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes 3 RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Compared to sham control, 2 identically designed RCTs showed clinically meaningful improvements in vision with dexamethasone implants that peaked at 3 months and maintained 39 months (with retreatment). The difference in proportion of patients with a gain of 15 or more letters in BCVA from baseline was 9.3% and 13.0% in the 2 trials, respectively, favoring implant versus sham at 39 months postimplant. Subgroup analysis of these trials showed greater improvements in visual acuity in patients who were pseudophakic compared to those who were phakic. Results of 1 small RCT showed that, compared to bevacizumab, implant-treated patients at 1 year had similar improvement rates on the primary end point, but experienced greater rates of vision loss (0% vs 10.9%), greater frequency of side effects such as cataracts (4.8% vs 13%), and elevated IOP (0% vs 19.6%), all respectively. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with DME who receive an intravitreal dexamethasone implant (0.7 mg) plus anti-VEGF therapy, the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. One small RCTs with a 1-year follow-up demonstrated that combination implants plus bevacizumab compared to bevacizumab alone resulted in similar gain in visual acuity (5.4 letters vs 4.9 letters), but greater frequency of side effects with combined treatment. A larger RCT with adequate power is needed to confirm these findings. The use of dexamethasone implant resulted in higher incidence of cataract and elevated IOP. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with DME who receive an intravitreal dexamethasone implant (0.7 mg) plus laser photocoagulation, the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. One RCT with 1-year follow-up demonstrated that combination implants plus laser photocoagulation compared to laser photocoagulation alone resulted in better visual acuity (as measured by gain of ≥10 letters) at 9 months but not at 12 months. However, the generally acceptable standard outcome measure for change is 15 or more letters and it was not used in this trial. The use of dexamethasone implants resulted in higher incidences of cataracts and elevated IOP Further, a differential loss to follow-up, lack of power calculations for sample size estimation, and lack of intention-to-treat analysis preclude interpretation of results. A larger RCT with adequate power is needed to confirm these findings. The evidence is insufficient to determine the effects of the technology on health outcomes.

Age-Related Macular Degeneration

For individuals with age-related macular degeneration who receive an intravitreal dexamethasone implant (0.7 mg) plus anti-VEGF inhibitor, the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Results of this trial did not demonstrate clinically meaningful reductions in the ranibizumab injection-free interval between combined treatments (34 days) and anti-VEGF alone (29 days; p=0.016). Further, IOP was elevated in a greater proportion of patients receiving implants without any additional clinical benefit. The evidence is insufficient to determine the effects of the technology on health outcomes.

Other Conditions

For individuals with birdshot retinochoroidopathy refractory or intolerant to standard therapy who receive an intravitreal fluocinolone acetonide implant (0.59 mg) or intravitreal dexamethasone implant (0.7 mg), the evidence includes multiple observational studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Multiple observational studies have noted improvements in anatomic and visual acuity outcomes. Long-term follow-up for efficacy and safety is limited. RCTs are needed to permit conclusions on the efficacy of corticosteroid implants in refractory or intolerant patients with birdshot retinopathy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with cystoid macular edema related to retinitis pigmentosa who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes multiple case reports. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Case reports have noted mix results for anatomic and visual acuity outcomes. Long-term follow-up for efficacy and safety is limited. Larger RCTs are needed to permit conclusions on the efficacy of corticosteroid implants in patients with cystoid macular edema related to retinitis pigmentosa. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with idiopathic macular telangiectasia type 1 who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes multiple case reports. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Case reports have noted mix results for visual acuity and inflammation-related outcomes. Long-term follow-up for efficacy and safety is limited. Better quality studies with long-term follow-up are needed to permit conclusions on the efficacy of corticosteroid implants in patients with idiopathic macular telangiectasia type 1. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with postoperative chronic macular edema who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes multiple observational studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Of multiple observational studies, 1 large retrospective analysis of 100 patients showed that 2 of every 5 patients experienced clinically meaningful improvements in vision at 1-year follow-up. An RCT is needed to confirm the efficacy of corticosteroid implants in patients with postoperative chronic macular edema. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with circumscribed choroidal hemangiomas who receive an intravitreal dexamethasone implant (0.7 mg) plus photodynamic therapy, the evidence includes a 1 case report. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Results of the case report do not permit conclusions about the efficacy and safety of adding dexamethasone implants for circumscribed choroidal hemangiomas to photodynamic therapy. RCTs are needed to permit conclusions on the efficacy of corticosteroid implants in patients with circumscribed choroidal hemangiomas. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with proliferative vitreoretinopathy who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes 1 case series and 1 case report. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. These studies have reported multiple interventions, including dexamethasone implants in conjunction with surgery and laser for preventing proliferative retinopathy after retinal detachment surgery. RCTs are needed to permit conclusions on the efficacy of corticosteroid implants in patients with proliferative retinopathy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with radiation retinopathy who receive an intravitreal dexamethasone implant (0.7 mg), the evidence includes multiple observational studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Multiple observational studies have noted improvements in anatomic and visual acuity outcomes. Long-term follow-up for efficacy and safety is limited. RCTs are needed to permit conclusions on the efficacy of corticosteroid implants in patients with radiation retinopathy. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Academy of Ophthalmology

In 2015, the American Academy of Ophthalmology published it preferred practice guidelines for retinal vein occlusions. These guidelines stated: “The safest treatment for the associated macular edema is the use of anti-VEGFs [anti-vascular endothelial growth factors]. Intravitreal corticosteroids, with the associated risk of glaucoma and cataract formation, have demonstrated efficacy. Also, laser photocoagulation in BRVO [branch retinal vein occlusion] has a potential role in treatment.” The pivotal GENEVA trials were not rated for quality.

National Institute for Health and Care Excellence

In 2017, the National Institute for Health and Care Excellence (NICE) released guidance on the use of dexamethasone intravitreal implant (with adalimumab) for the treatment of noninfectious uveitis. NICE recommended the implant only in cases of “active disease” with “worsening vision” and the “risk of blindness.”

In 2011, the National Institute for Health and Clinical Excellence (NICE) provided guidance on the use of the dexamethasone intravitreal implant for macular edema secondary to retinal vein occlusion. The dexamethasone implant is recommended as an option for the treatment of macular edema following central retinal vein occlusion. It is recommended as an option for the treatment of macular edema following branch retinal vein occlusion when treatment with laser photocoagulation has not been beneficial, or if laser photocoagulation is not considered suitable because of the extent of macular hemorrhage.

In November 2013, NICE updated its guidance on the intravitreal fluocinolone acetonide implant (Iluvien), recommending Iluvien as an option for treating chronic diabetic macular edema that is insufficiently responsive to available therapies only if:

  • The implant is to be used in an eye with an intraocular (pseudophakic) lens and
  • The manufacturer provides fluocinolone acetonide intravitreal implant with the discount agreed in the patient access scheme.

In 2015, NICE provided guidance on the dexamethasone intravitreal implant (Ozurdex) for treating diabetic macular edema (DME). Ozurdex was recommended as a possible treatment for DME if there is “an artificial lens” and the edema either has “not improved with non-corticosteroid treatment or such treatment is not suitable.”

U.S. PREVENTATIVE SERVICES TASK FORCE RECOMMENDATIONS:

The U.S. Preventive Services Task Force has not addressed the use of intravitreal corticosteroid implants.

KEY WORDS:

Intravitreal implant, fluocinolone acetonide, Retisert®, Ozurdex®, dexamethasone intravitreal implant, Iluvien™, Yutiq

APPROVED BY GOVERNING BODIES:

In June 2009, Ozurdex® (dexamethasone 0.7 mg intravitreal implant; Allergan) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion. Subsequently, in September 2010, the indication was expanded to include treatment of noninfectious uveitis affecting the posterior segment of the eye. In June 2014, the indication was again expanded to include treatment of diabetic macular edema.

In September 2014, Iluvien® (fluocinolone acetonide 0.19 mg intravitreal implant; Alimera Sciences) was approved by FDA for the treatment of diabetic macular edema in patients previously treated with a course of corticosteroids and without a clinically significant rise in intraocular pressure.

In November 2014, Retisert™ (fluocinolone acetonide 0.59 mg intravitreal implant; Bausch & Lomb) was approved by FDA for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

In October 2018, Yutiq (fluocinolone acetonide 0.18 mg intravitreal implant; EyePoint Pharmaceuticals) was approved by the FDA for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

For Retisert implantation:

J7311

Injection, Fluocinolone acetonide, intravitreal implant  0.01mg

67027

Implantation of intravitreal drug delivery system (e.g., ganciclovir implant), includes concomitant removal of vitreous

 

 

For Iluvien implantation:

J7313

Injection, fluocinolone acetonide, intravitreal implant, 0.01mg

67028

Intravitreal injection of a pharmacologic agent (separate procedure)

 

 

For Ozurdex implantation:

J7312

Injection, dexamethasone, intravitreal implant, 0.1 mg

67028

Intravitreal injection of a pharmacologic agent (separate procedure)

 

 

For Yutiq implantation effective 10/1/19 and after:

J7314

Injection, fluocinolone acetonide, intravitreal implant (Yutiq), 0.01 mg (Effective 10/1/19)

 

Previous Coding:

For Yutiq prior to 10/1/19:

J3490

Unclassified Drugs

For Iluvien implantation:

J3490

Unclassified drugs

REFERENCES:

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  2. Alimera Sciences Inc. Iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg for Intravitreal Injection: Prescribing Label. //www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf. Accessed February 10, 2017.
  3. Allergan Inc. Ozurdex® (dexamethasone intravitreal implant): Prescribing Label 2014; //www.allergan.com/assets/pdf/ozurdex_pi.pdf. Accessed February 9, 2017.
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  23. Cunha-Vaz J, Ashton P, Iezzi R, et al. Sustained Delivery Fluocinolone Acetonide Vitreous Implants: Long-Term Benefit in Patients with Chronic Diabetic Macular Edema. Ophthalmology. Jun 13 2014.
  24. Degoumois A, Akesbi J, Laurens C, et al. [Efficacy of intravitreal dexamethasone implants in macular edema excluding venous occlusions: results for a cohort of 80 patients]. J Fr Ophtalmol. Feb 2015; 38(2):126-133.
  25. Dutra Medeiros M, Navarro R, Garcia-Arumi J, et al. Dexamethasone intravitreal implant for treatment of patients with recalcitrant macular edema resulting from Irvine-Gass syndrome. Invest Ophthalmol Vis Sci. May 07 2013; 54(5):3320-3324.
  26. Erdogan G, Aydogan T, Unlu C, et al. Dexamethasone Implant for the treatment of type 1 idiopathic macular telangiectasia. J Ocul Pharmacol Ther. May 2016; 32(4):211-215.
  27. Gado AS, Macky TA. Dexamethasone intravitreous implant versus bevacizumab for central retinal vein occlusion-related macular oedema: a prospective randomized comparison. Clin Experiment Ophthalmol. Mar 10 2014.
  28. Gillespie BW, Musch DC, Niziol LM, et al. Estimating minimally important differences for two vision-specific quality of life measures. Invest Ophthalmol Vis Sci. Jun 06 2014; 55(7):4206-4212.<
  29. Gillies MC, Lim LL, Campain A, et al. A Randomized Clinical Trial of Intravitreal Bevacizumab versus Intravitreal Dexamethasone for Diabetic Macular Edema: The BEVORDEX Study. Ophthalmology. Aug 21 2014.
  30. Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev 2008; (1):CD005656.
  31. Haller JA, Bandello F, Belfort R, Jr. et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology 2011; 118(12):2453-60.
  32. Haller JA, Bandello F, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 2010; 117(6):1134-46.e3.
  33. Haller JA, Kuppermann BD, Blumenkranz MS et al. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol 2010; 128(3):289-96.
  34. Holbrook JT, Sugar EA, Burke AE, et al. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol. Apr 2016; 164:29-36.
  35. Iluvien™ Prescribing Information. //www.alimerasciences.com/wp-content/uploads/2014/09/iluvien-prescribing-information.pdf.
  36. Jaffe GJ, Martin D, Callanan D et al. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology 2006; 113(6):1020-7.
  37. Kapoor KG, Wagner MG, Wagner AL. The Sustained-Release Dexamethasone Implant: Expanding Indications in Vitreoretinal Disease. Semin Ophthalmol. Aug 21 2015:1-7.
  38. Keilani C, Halalchi A, Wakpi Djeugue D, et al. Evaluation of best corrected visual acuity and central macular thickness after intravitreal dexamethasone implant injections in patients with Irvine-Gass syndrome: A retrospective study of six cases. Therapie. Oct 2016; 71(5):457-465.
  39. Kempen JH, Altaweel MM, Holbrook JT et al. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology 2011; 118(10):1916-26.
  40. Kempen JH, Altaweel MM, Holbrook JT, et al. The multicenter uveitis steroid treatment trial: rationale, design, and baseline characteristics. Am J Ophthalmol. Apr 2010; 149(4):550-561 e510.
  41. Kiddee W, Trope GE, Sheng L, et al. Intraocular pressure monitoring post intravitreal steroids: a systematic review. Surv Ophthalmol. Jul-Aug 2013; 58(4):291-310.
  42. Klamann A, Bottcher K, Ackermann P, et al. Intravitreal dexamethasone implant for the treatment of postoperative macular edema. Ophthalmologica. 2016; 236(4):181-185.
  43. Kuppermann BD, Blumenkranz MS, Haller JA et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007; 125(3):309-17.
  44. Kuppermann BD, Goldstein M, Maturi RK, et al. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. Sep 2015; 234(1):40-54.
  45. Landre C, Zourdani A, Gastaud P, et al. [Treatment of postoperative cystoid macular edema (Irvine-Gass syndrome) with dexamethasone 0.7 mg intravitreal implant]. J Fr Ophtalmol. Jan 2016; 39(1):5-11.
  46. Lei S, Lam WC. Efficacy and safety of dexamethasone intravitreal implant for refractory macular edema in children. Can J Ophthalmol. Jun 2015;50(3):236-241.
  47. Lightman S, Belfort R, Jr., Naik RK, et al. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. Jul 2013; 54(7):4864-4870.
  48. Loutfi M, Papathomas T, Kamal A. Macular oedema related to idiopathic macular telangiectasia type 1 treated with dexamethasone intravitreal implant (ozurdex). Case Rep Ophthalmol Med. 2014; 2014:231913.
  49. Lowder C, Belfort R, Jr., Lightman S et al. Dexamethasone Intravitreal Implant for Noninfectious Intermediate or Posterior Uveitis. Arch Ophthalmol 2011; 129(5):545-53.
  50. Massin P, Erginay A, Dupas B, et al. Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study. Clin Ophthalmol. 2016; 10:1257-1264.
  51. Maturi RK, Bleau L, Saunders J, et al. A 12-month, single-masked, randomized controlled study of eyes with persistent diabetic macular edema after multiple anti-VEGF injections to assess the efficacy of the dexamethasone-delayed delivery system as an adjunct to bevacizumab compared with continued bevacizumab monotherapy. Retina. Mar 30 2015; 35(8):1604-1614.
  52. Maturi RK, Chen V, Raghinaru D, et al. A 6-month, subject-masked, randomized controlled study to assess efficacy of dexamethasone as an adjunct to bevacizumab compared with bevacizumab alone in the treatment of patients with macular edema due to central or branch retinal vein occlusion. Clin Ophthalmol. 2014; 8:1057-1064.
  53. Mayer WJ, Kurz S, Wolf A, et al. Dexamethasone implant as an effective treatment option for macular edema due to Irvine-Gass syndrome. J Cataract Refract Surg. Sep 2015; 41(9):1954-1961.
  54. Mohammad DA, Sweet BV, Elner SG. Retisert: is the new advance in treatment of uveitis a good one? Ann Pharmacother 2007; 41(3):449-54.
  55. Multicenter Uveitis Steroid Treatment Follow-up Study Research Group. Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study. Ophthalmology. Aug 19 2015.
  56. Multicenter Uveitis Steroid Treatment Trial Research Group. Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Ophthalmology. Oct 2015.
  57. National Institute for Health and Care Excellence (NICE). Adalimumab and dexamethasone for treating non-infectious uveitis [TA460]. 2017; https://www.nice.org.uk/guidance/ta460. Accessed February 22, 2017.
  58. National Institute for Health and Care Excellence (NICE). Dexamethasone intravitreal implant for treating diabetic macular oedema [TA349]. 2015; www.nice.org.uk/guidance/ta349. Accessed March 15, 2016.
  59. National Institute for Health and Clinical Excellence (NICE). Dexamethasone intravitreal implant for the treatment of macular edema secondary to retinal vein occlusion. NICE technology appraisal guidance 229. 2011. Available online at: www.nice.org.uk/nicemedia/live/13541/55590/55590.pdf. Accessed March 2016.
  60. National Institute for Health and Clinical Excellence (NICE). Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy TA 301 (rapid review of technology appraisal guidance 271). 2013. Available online at: guidance.nice.org.uk/TA301. Accessed March 2016.
  61. Ornek N, Ornek K, Erbahceci IE. Intravitreal dexamethasone implant (Ozurdex) for refractory macular edema secondary to retinitis pigmentosa. Turk J Ophthalmol. Aug 2016; 46(4):179-181.
  62. Ozurdex® Prescribing Information – www.allergan.com/assets/pdf/ozurdex_pi.pdf.
  63. Patil L, Lotery AJ. Coat's-like exudation in rhodopsin retinitis pigmentosa: successful treatment with an intravitreal dexamethasone implant. Eye (Lond). Apr 2014; 28(4):449-451.
  64. Pavesio C, Zierhut M, Bairi K et al. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology 2010; 117(3):567-75, 75 e1.
  65. Pearson PA, Comstock TL, Ip M et al. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology 2011; 118(8):1580-7.
  66. Pichi F, Specchia C, Vitale L et al. Combination therapy with dexamethasone intravitreal implant and macular grid laser in patients with branch retinal vein occlusion. Am J Ophthalmol 2014; 157(3):607-15 e1.
  67. Pulido JS, Flaxel CJ, Adelman RA, et al. Retinal vein occlusions Preferred Practice Pattern((R)) Guidelines. Ophthalmology. Jan 2016; 123(1):P182-208.
  68. Regnier SA, Larsen M, Bezlyak V, et al. Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion: a network meta-analysis. BMJ Open. 2015; 5(6):e007527.
  69. Reibaldi M, Russo A, Longo A, et al. Rhegmatogenous retinal detachment with a high risk of proliferative vitreoretinopathy treated with episcleral surgery and an intravitreal dexamethasone 0.7-mg implant. Case Rep Ophthalmol. Jan 2013; 4(1):79-83.
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  71. Rush RB, Goldstein DA, Callanan DG, et al. Outcomes of birdshot chorioretinopathy treated with an intravitreal sustained-release fluocinolone acetonide-containing device. Am J Ophthalmol. Apr 2011; 151(4):630-636.
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  73. Sherif M, Wolfensberger TJ. Intraocular dexamethasone implant as adjunct to silicone oil tamponade for proliferative vitreoretinopathy. Klin Monbl Augenheilkd. Feb 01 2017.
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POLICY HISTORY:

Medical Policy Panel, June 2010

Medical Policy Group, September 2010 (2)

Medical Policy Administration Committee, October, 2010

Available for comment October 21 through December 6, 2010

Medical Policy Administration Committee, October, 2010

Available for comment November 4 – December 20, 2010

Medical Policy Group, December 2010; 2011 Coding update (1): added J7312

Medical Policy Group, May 2011 (1): Update to Policy, Key Points and References

Medical Policy Administration Committee, May 2011

Available for comment May 11 – June 27, 2011

Medical Policy Group, April 2012 (1): Update to Policy, Key Points and References related to MPP update to include coverage criteria for Retisert for intermediate and panuveitis and for Ozurdex to include coverage criteria for uveitis affecting the intermediate segment of the eye

Medical Policy Administration Committee, May 2012

Medical Policy Panel, March 2013

Medical Policy Group, June 2013 (1): Update to Key Points, Governing Bodies, Coding, with the addition of CPT code 67028, and References; no change to policy statements

Medical Policy Administration Committee, July 2013

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (1): Update to Key Points, Governing Bodies and References; no change to policy statement

Medical Policy Group, July 2014 (1): Update to Policy statement, Key Points, Governing Bodies and References related to addition of new criteria for coverage for Ozurdex for DME, effective 06/28/14.

Medical Policy Administration Committee, September 2014

Available for comment August 21 through October 4, 2014

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (1): Updated Policy statement, Key Points, Governing Bodies, Key Words, Coding and References related to addition of coverage criteria for FDA approved drug Iluvien for DME, effective 09/26/14 using codes J3490 and 67028; also noted that Ozurdex is now approved for general DME population

Medical Policy Administration Committee, November 2014

Available for comment October 24 through December 4, 2014

Medical Policy Panel, October 2015

Medical Policy Group, October 2015 (6): Updates to Key Points and References; no change to policy statement.

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added J7313 to current coding.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Key Points, Coding, and References; no change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, May 2017 (6): Updates to Description, Key Points, Approved by Governing Bodies, and References. Policy intent unchanged.

Medical Policy Panel, March 2018

Medical Policy Group, April 2018 (6): Updates to Description, Key Points, Practice Guidelines, and References. Policy intent unchanged.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Key Points; edited name to "Intravitreal Corticosterioid Implants",no changes to policy statement.

Medical Policy Group, July 2019 (6):Updated Description, Policy statement, Key Words, Coding and Governing Bodies to include Yutiq

Medical Policy Group, September 2019: October 2019 quarterly coding update.  Added new CPT code J7314 to Current Coding.  Moved Yutiq’s previous unclassified code J3490 to Previous Coding section.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, Revised codes J7311, J7313.


This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.