Download RVO/Macular Edema (Word Version)

RVO Letter of Medical Necessity
Provider name, address, and date
Re: patient name
Date of Birth: patient’s date of birth
Policy ID/Group: patient’s information
Policyholder: patient information
Dear name of payer,
I am writing to support coverage (or) prior authorization for treatment of my patient, patient name, with OZURDEX®
(dexamethasone intravitreal implant) 0.7 mg, which is reported under code J7312 (injection, dexamethasone intravitreal
implant, 0.1 mg) for the treatment of macular edema following specify branch or central retinal vein occlusion.
OZURDEX® (dexamethasone intravitreal implant) is delivered via NOVADUR® technology
OZURDEX® intravitreal implant uses the NOVADUR® solid polymer drug delivery system, which is proprietary to
Allergan. OZURDEX® implant is injectable and biodegradable. Each implant comes preloaded in a specially designed,
single-use applicator. OZURDEX® is administered as an in-office procedure by Retina Specialists.
The efficacy of OZURDEX® intravitreal implant was assessed in the GENEVA trials (Global Evaluation of ImplaNtable
DExamethasone in Retinal Vein Occlusion With Macular EdemA), two identical, randomized, prospective, multicenter,
masked, sham-controlled, 6-month, phase 3 trials involving 853 patients with macular edema following branch or central
retinal vein occlusion who received OZURDEX® 0.7mg or sham.1,2
Indication and Usage
Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of macular edema
following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under
controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular
pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis
without delay.
IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with
active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including
active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal
diseases.
Please see additional Important Safety Information on next page.
With OZURDEX® (dexamethasone intravitreal implant), more RVO patients gained 3 lines of vision significantly
faster than with sham in pivotal trials1,3
Twenty percent to 30% of OZURDEX® patients (n = 427) gained 3 lines within 1 to 2 months (vs 7% to 12%
with sham; n = 426).1,3 The duration of effect persists approximately 1 to 3 months after onset of this effect.1
OZURDEX® produced a mean gain of 9.8 letters at day 60 (versus 3.1 letters with sham) with a significant P value
of < .001.1,2
The efficacy of OZURDEX® has been proven in both branch and central retinal vein occlusion1,2
Regardless of RVO type, more OZURDEX® patients gained 3 lines within 1 to 2 months (than sham-treated patients).1
With OZURDEX® intravitreal implant, fewer patients had significant vision loss as compared with sham1,2
By day 90, 3.5% of OZURDEX® patients (n = 427) had a loss of at least 15 letters vs 6.8% of sham patients (n = 426)
(P= .030)1,2
IOP data from phase 3 clinical trials1
A peak of 15.7% of patients receiving OZURDEX® (dexamethasone intravitreal implant) (n = 421) had an increase in
intraocular pressure (IOP) ≥ 10 mm Hg from baseline at day 60 vs 0.2% of sham patients (n = 423).1 Most IOP increases
were managed with topical medication. At day 90, 29.7% of OZURDEX® patients (n = 421) were on IOP-lowering
medications (vs 3.5% of sham patients; n = 423).1 Three OZURDEX® patients (3/421) received IOP-lowering surgery1
(one case was due to neovascular glaucoma).2
IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)
Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is
torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic
patients is not a contraindication for OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of
this product.
Warnings and Precautions
Intravitreal Injection‐related Effects: Intravitreal injections, including those with OZURDEX®, have been associated
with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be
monitored regularly following the injection.
Steroid‐related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts,
increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to
bacteria, fungi, or viruses.
Please see additional Important Safety Information on next page.
2
On date, patient name was diagnosed with macular edema following specify branch or central retinal vein occlusion;
insert relevant ICD-9-CM codes. Specifically, the results of my examination determined that the patient requires
treatment. This condition has impacted the patient's visual acuity.
I determined that it was medically necessary to treat patient name with OZURDEX® intravitreal implant.
Based on my experience treating retinal disease describe expertise, I determined that it was medically necessary to treat
patient name with OZURDEX® because of the low visual acuity.
My clinical expectations for treatment with OZURDEX® is to improve the patient's visual acuity. Follow-up is expected
to involve describe expected additional evaluations.
IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of the potential for
reactivation of the viral infection.
Adverse Reactions
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for
retinal vein occlusion include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%),
conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the
patients who received OZURDEX® required surgical procedures for management of elevated IOP.
Please see accompanying full Prescribing Information.
Sincerely,
Your signature
Your name
1. Data on file, Allergan, Inc.
2. Haller JA, Bandello F, Belfort R Jr, et al; for OZURDEX® GENEVA Study Group. Randomized, sham-controlled
trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion.
Ophthalmology. 2010;117(6):1134-1146.
3. OZURDEX® Prescribing Information.
©2014 Allergan, Inc., Irvine, CA 92612
®
marks owned by Allergan, Inc. APC38BS14 143544
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