Download Posterior Segment Uveitis only

Denied Claims
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) to appeal denial of a claim 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 noninfectious uveitis affecting the posterior
segment of the eye.
OZURDEX® 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® was assessed in the HURON (CHronic Uveitis: Evaluation of the IntRavitreal
DexamethasONe Implant) trial, an 8-week, multicenter, masked, randomized trial (with an 18-week masked
extension) involving 153 patients with noninfectious uveitis affecting the posterior segment of the eye.1
Indication and Usage
Posterior Segment Uveitis
OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of noninfectious uveitis affecting
the posterior segment of the eye.
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 page 2.
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OZURDEX® (dexamethasone intravitreal implant) significantly reduced vitreous haze versus sham1,2
At week 8 (primary endpoint), 46.8% of OZURDEX® intravitreal implant patients (n = 77) had a vitreous haze
score of 0, compared with 11.8% of sham-treated patients (n = 76) (P < .001).1,2
OZURDEX® achieved statistically significant 3-line improvement in best-corrected visual acuity (BCVA)
versus sham1
At week 8, 42.9% of OZURDEX® patients (n = 77) achieved ≥ 15-letter (3-line) gain from baseline BCVA versus
6.6% of sham-treated patients (n = 76) (P < .001).1,2
IOP data from this phase 3 clinical trial1
A peak of 7.1% of patients (n = 70) receiving OZURDEX® had intraocular pressure (IOP) ≥ 25 mm Hg at week 3
(versus 1.4% of sham-treated patients, n = 70).1 At week 26, 1.4% of OZURDEX® patients (n = 74) had an IOP
increase of at least 10 mm Hg from baseline (versus 2.8% with sham, n = 72). At week 26, 16.9% of OZURDEX®
patients (n = 77) were on IOP-lowering medications (versus 9.2% of sham-treated patients, n = 76).1 One
OZURDEX® patient (1/77) received IOP-lowering surgery.2
On date, patient name was diagnosed with noninfectious uveitis affecting the posterior segment of the eye; insert
relevant ICD-9-CM codes. Specifically, the results of my examination were include details such as physical exam
results and clinical impressions. This condition has describe impact on patient and caregiver.
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.
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of the
potential for reactivation of the viral infection.
Please see additional Important Safety Information on page 3.
2
If the patient received other treatments for this condition before OZURDEX® (dexamethasone intravitreal implant),
describe the outcomes of that treatment that led to your determination to begin treatment with OZURDEX ®. Given
the limitations of those previous treatments, I determined that it was medically necessary to treat patient name with
OZURDEX® intravitreal implant.
I treated patient name by intravitreal injection of OZURDEX® (dexamethasone intravitreal implant). OZURDEX®
is reported on the claim form using code J7312 (injection, dexamethasone intravitreal implant, 0.1 mg), and the
intravitreal injection is reported using insert relevant code and descriptor with appropriate modifier indicating
whether the injection was administered to the right, left, or both eyes.
If this is not the first treatment with OZURDEX® intravitreal implant, describe outcomes from previous treatment
with OZURDEX® intravitreal implant. This patient’s response to earlier doses to OZURDEX® has been describe
response. Based on this outcome, I plan to treat patient name with OZURDEX® as follows: describe planned course
of treatment and duration.
IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
Adverse Reactions
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX ®
(dexamethasone intravitreal implant) for posterior segment uveitis 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. OZURDEX® Prescribing Information.
©2014 Allergan, Inc., Irvine, CA 92612
®
marks owned by Allergan, Inc. APC30XP14 143548
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