Off Label Uses: Amphetamines can be used as adjunctive therapy in the treatment of resistant depression (9).

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Amphetamines Page: 1 of 4 Last Review Date: June 19, 2015 Amphetamines Description Adderall / Adderall XR (mixed salts of a single entity amphetamine) / Desoxyn (methamphetamine) / Dexedrine / Procentra / Zenzedi (dextroamphetamine) / Evekeo (amphetamine sulfate) / Vyvanse (lisdexamfetamine) Background Amphetamine is a CNS stimulant and DEA schedule II drug, which is FDA approved for attention deficit hyperactivity disorder (ADHD) and narcolepsy. The exact mechanism by which amphetamines exert their action is unknown; however amphetamines are thought to block the reuptake of norepinephrine and dopamine by the presynaptic neuron. This causes an increase in the release of these monoamines into the extra-neuronal space and increases their levels in the brain (4,7). Regulatory Status FDA approved indication: Attention Deficit Hyperactivity Disorder and Narcolepsy (1-8). Vyvanse is also indicated for Moderate to Severe Binge Eating Disorder (6). Off Label Uses: Amphetamines can be used as adjunctive therapy in the treatment of resistant depression (9). Amphetamines have a boxed warning for high abuse and addiction potential. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events (2,4,6,7,8). Other safety issues associated with amphetamines include sudden death in patients who have heart defects. Strokes, myocardial infarction, seizures, visual disturbances, adverse psychiatric reactions and hypertension have been reported (1,2,4,6,8).

2 Subject: Amphetamines Page: 2 of 4 Related policies Provigil-Nuvigil, Methylphenidates Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Amphetamines may be considered medically necessary for patients with narcolepsy, attention deficit disorder with or without hyperactivity, depression disorder, and moderate to severe binge eating disorder (for Vyvanse product only). Amphetamine therapy may be considered investigational for patients who do not have narcolepsy, hypersomnia and any type of depression without anti-depressant therapy within the past 12 months. Prior-Approval Requirements Age 22 years of age or older Prior-Approval is not required for members less than 22 years of age. Diagnoses Patient must have ONE of the following: 1. Narcolepsy 2. Attention deficit disorder with or without hyperactivity 3. Depressive disorder OR (for Vyvanse product only) 1. Moderate to Severe Binge Eating Disorder (BED) Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance None

3 Subject: Amphetamines Page: 3 of 4 This is a covered benefit for members less than 22 years of age PA not required. Prior - Approval Limits Quantity Adderall Maximum adult dose for all indications 60mg/day Dexedrine, Procentra, Zenzedi Maximum adult dose for all indications 60mg/day Desoxyn Maximum adult dose for all indications 25mg/day Evekeo - Maximum adult dose for all indications 60mg/day Vyvanse Maximum adult dose for all indications 70mg/day Duration 12 months Prior Approval Renewal Limits Quantity Adderall Maximum adult dose for all indications 60mg/day Dexedrine, Procentra, Zenzedi Maximum adult dose for all indications 60mg/day Desoxyn Maximum adult dose for all indications 25mg/day Evekeo - Maximum adult dose for all indications 60mg/day Vyvanse Maximum adult dose for all indications 70mg/day Duration 12 months Rationale Summary Amphetamine is a CNS stimulant and DEA schedule II drug, which is FDA approved for attention deficit hyperactivity disorder (ADHD) and narcolepsy (4,7) Amphetamines have a boxed warning for high abuse and addiction potential. Misuse of amphetamines may cause sudden death and serous cardiovascular adverse events (1-8). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of amphetamines while maintaining optimal therapeutic outcomes.

4 Subject: Amphetamines Page: 4 of 4 References 1. Adderall [package insert]. Sellersville, PA. Teva Pharmaceuticals USA. April Adderall XR [package insert]. Wayne, PA. Shire US Inc. December Desoxyn [package insert]. Barceloneta, PR, AbbVie LTD.. December Dexedrine Spansule [package insert]. Middlesex, NJ. Amedra Pharmaceuticals, LLC. October Zenzedi [package insert]. Atlanta, GA. Arbor Pharmaceuticals, LLC. January Vyvanse [package insert]. Wayne, PA. Shire US Inc. January Procentra [package insert]. Newport, KY. Independence Pharmaceuticals, LLC April Evekeo [package insert]. Atlanta, GA. Arbor Pharmaceuticals, LLC. April Stoltz, Gabriele. MD; PhD, Woggon, Brigitte. MD., & Angst, Jules. Psychostimulants in the therapy of treatment-resistant depression Review of the literature and findings from a retrospective study in 65 depressed patients. National Center for Biotechnology Information. 06/23/2014. From Policy History Date March 2002 July 2007 October 2008 September 2012 June 2013 July 2013 January 2014 May 2014 June 2014 September 2014 January 2015 February 2015 June 2015 Keywords Action New to PA Vyvanse is a new form of amphetamine that has less potential for abuse. LiquADD is a new solution of Dextroamphetamine 5mg/5ml. Annual editorial and reference update Annual editorial review and addition of daily limits. Removal of Dextrostat and LiquiADD and the addition of Zenzedi. Addition of quantity limits Addition of 3 new strengths of Zenzedi Annual reference update, Removed non FDA approved indications Removal of off label uses Addition of line extension of Vyvanse 10mg Addition of Evekeo and Vyvanse indication for BED Annual review and reference update Changed Policy # from and sub-heading from Endocrine and Metabolic Drugs

5 Subject: Amphetamines Page: 5 of 4 This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 19, 2015 and effective July 1, Deborah M. Smith, MD, MPH