4/7/22, 12:13 PM
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`ASRS Fights Novitas Decision to Interpret Eylea Usage More Frequently than qS as Off Label - The American Society of Retina Specialists
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`Clinical Updates - Clinical Updates
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`ASRS Fights Novitas Decision to Interpret Eylea Usage
`More Frequently than q8 as "Off Label"
`
`ASRS is fighting a recent decision by Novitas Solutions, a Medicare Administrator Contractor, to
`interpret the Aflibercept (Eylea) FDA label as to not cover Eylea use more frequently than 8 weeks
`after the initial load. This interpretation came to our attention as a result of a Medicare utilization
`audit in which Novitas indicated that it is seeking recoupment of reimbursement for Eylea doses that
`it deems as "off label" under this definition.
`
`The current FDA label states the following:
`
`"The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4
`weeks (monthly) for the first 3 months, followed by 2 m (0.05 mL) via intravitreal injection once
`every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks
`(monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks
`compared to every 8 weeks."
`
`ASRS Board member, David Brown, discussed this issue with Wiley Chambers, Deputy Director for
`the Division of Transplant and Ophthalmology at the FDA, and was assured that it was not the
`intention of the FDA label to restrict Eylea use to every 8 weeks, and the label was specifically
`designed to permit monthly dosing in patients. ASRS is trying to coordinate a meeting between the
`FDA and CMS to resolve the misinterpretation.
`
`In the meantime, Regeneron is aware of the situation and has submitted a revised label to the FDA
`for clarification. A response is expected shortly.
`
`Please contact the ASRS if you are being audited for "off label" use of Eylea.
`
`(Posted May 24,2016)
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`EXHIBIT
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`10
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`April 26, 2022
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`Mylan Exhibit 1139
`Mylan v. Regeneron, IPR2021-00881
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`4/7/22,12:13 PM
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`ASRS Fights Novitas Decision to Interpret Eylea Usage More Frequently than qS as Off Label - The American Society of Retina Specialists
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`2/2
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`Mylan Exhibit 1139
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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