Example #2

Sample Medical Exception Letter for Avastin®(bevacizumab)
Step Edit Requirement

This 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 foror an influence on the independent medical judgment of the physician.

A copy of the full Prescribing Information for EYLEA is available for download on .

SomeKeyReminders:

•Use a medical exception letter when coverage is denied due to a step edit requirement for Avastin

•The medical exception letter should come from the physician but should be signed by both the physician and patient

•If the patient is covered by a Medicare Advantage plan ONLY, consider including the following paragraph in your letter. Don’t forget to include the citations at the bottom of the letter:

It is important to note that the American Society of Retina Specialists (ASRS) has stated that it is inappropriate for any health plan to require the use of tiered therapy with respect to anti-VEGF agents.1 Additionally, in 2012, the Centers for Medicare & Medicaid Services (CMS) reinforced its policy with Medicare Advantage plans stating that “the imposition of additional requirements for access to certain Part B drugs or services, such as step-therapy requirements, is not permitted unless also required through Original Medicare.” Medicare Advantage plans are required to follow Medicare guidelines and cannot establish more restrictive policies.2

1.AmericanSocietyofRetinaSpecialistswebsite.PhysicianChoice ofMedication. AccessedSeptember7,2016.

2.CenterforMedicaidMedicareServices. ProhibitiononImposingMandatoryStepTherapyforAccess toPartBDrugs andServices.September17,2012.

  • RefertotheICD-10CodingGuidelineshereregardingcertain codes that may beapplicabletothepatient’sdiagnosis

© 2017, Regeneron Pharmaceuticals, Inc. All rights reserved

US-LEA-13737 01/17

[Date]

[Plan name]

[Plan street address]

[Plan city, state, zip code]

Re: [Patient full name]

Date of Birth [Patient date of birth]

Member ID [Patient ID number]

Group Number [Patient group number]

Dear [contact name]:

I acknowledge your health plan’s policy requiring the use ofAvastin®(bevacizumab) prior to use of EYLEA®(aflibercept) Injection.In this letter, I will explain why this is not appropriate for [Patient Full Name].

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) with Diabetic Macular Edema (DME)]

I have included information about [Patient First Name]’s medical history and diagnosis (ICD-10 code: [insert code]), a statement summarizing my treatment rationale, and a copy of the Prescribing Information for EYLEA.

Summary of Patient History

[Treatment history]

[Response to past therapies]

[Recent symptoms and condition]

[Summarize your professional opinion explaining why you consider Avastin inappropriate for this patient.]

[For Medicare Advantage plans only, consider adding the paragraph from the third bullet point on the previous page.]

It is important to note that Avastin prescribed for this condition is currentlyoff-label, and the potential risks for the patient include[risks for patient]. [Plan Name]should provide coverage for EYLEA, which is FDA-approved for the patient’s condition. On behalf of [Patient Full Name], we would appreciate your approval for the patient’s exemption from the step edit requirement for Avastin.

Please call me at[Phone number]if I can be of further assistance or if you require additional information.

Sincerely,

[Treating physician’s signature][Patient/Legal representative signature]

[Treating physician’s name, MD/DO][Patient/Legal representative name]

Enclosures (suggested):Appeal form (if provided by the plan)
Chart notes
Test results
Supporting medical studies
EYLEA Prescribing Information
Patient narrative