Example #3 - EYLEA® (aflibercept) Injection
Example #3Sample Letter of Medical Necessity: All IndicationsThis letter provides an example of the types of information that may be provided when responding to a request from a patient’s health plan to provide a letter of medical necessity for EYLEA? (aflibercept) Injection treatment.Use of the information in this letter does not guarantee that the health plan will provide reimbursement for EYLEA and is not intended to be a substitute for or an influence on the independent medical judgment of the physician.A copy of the full Prescribing Information for EYLEA is available for download on .Some Key Reminders:Use a letter of medical necessity when one is required by the plan. It can also be used to accompany your appeal as an additional letter written by another treating physicianThe letter of medical necessity should come from a treating physician and be signed only by that physicianRefer to the ICD-10 Coding Guidelines here regarding certain codes that may be applicable to the patient’s diagnosisIMPORTANT SAFETY INFORMATION AND INDICATIONSCONTRAINDICATIONSEYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.WARNINGS AND PRECAUTIONSIntravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) ? 2020, Regeneron Pharmaceuticals, Inc. All rights reserved.03/2020 EYL.20.02.0057in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.ADVERSE REACTIONSSerious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.INDICATIONSEYLEA (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).? 2020, Regeneron Pharmaceuticals, Inc. All rights reserved.03/2020 EYL.20.02.0057EXAMPLE[Date][Plan name][Plan street address] [Plan city, state, zip code]Dear [contact name]:Re: [Patient full name]Date of Birth [Patient date of birth] Member ID [Patient ID number]Group Number [Patient group number]I am writing on behalf of [Patient Full Name] to document the medical necessity for administering EYLEA? (aflibercept) Injection. I have included information about the patient's medical history and diagnosis (ICD-10-CM code: [insert code]), a statement summarizing my treatment rationale, and other documents that support the medical necessity of EYLEA in this clinical case.Since [Date of Onset], [Patient Full Name] has been under my care for [Neovascular (Wet) Age-related Macular Degeneration (AMD)] [Macular Edema following Retinal Vein Occlusion (RVO)][Diabetic Macular Edema (DME)][Diabetic Retinopathy (DR)] Summary of Patient History[Treatment history][Response to past therapies][Recent symptoms and condition][Explain why EYLEA is medically necessary for this patient.]Based on the patient’s clinical condition and a review of the supporting documentation, I am confident you will agree that EYLEA, which is explicitly indicated for this condition, is the appropriate treatment option. In order for me to provide appropriate care for my patient, it is important that [Plan Name] provide adequate coverage for EYLEA. I would appreciate a prompt review.Please call me at [Phone Number] if I can be of further assistance or if you require additional information.Thank you in advance for your immediate attention to this request.Sincerely,[Treating physician’s signature][Treating physician’s name, MD/DO]Enclosures (suggested):Appeal form (if provided by the plan)Chart notes Test resultsSupporting medical studies EYLEA Prescribing Information Patient narrative ................
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