Page: 1 of 5. Methylphenidate also has an off-label indication for depression, although published trials are limited in size and duration (12).

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Page: 1 of 5 Last Review Date: June 19, 2015 Description Concerta / Daytrana / Metadate CD / Metadate ER / Methylin / Methylin-ER / Quillivant XR / Ritalin / Ritalin LA / Ritalin-SR and Focalin/ Focalin XR ( and ) Background is a DEA schedule II drug and a CNS stimulant which is FDA approved for attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) and narcolepsy. The exact mechanism by which methylphenidate acts is unknown; however, it presumably increases dopamine and norepinephrine levels in the brain. (1-11). also has an off-label indication for depression, although published trials are limited in size and duration (12). Regulatory Status The products addressed by this policy are FDA-approved for use in one or more of the following conditions: attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) and narcolepsy and have and off-label indication for depression (1-12). has a boxed warning regarding the high potential of abuse and addiction and should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic and or abusive use can lead to marked tolerance and psychological dependence. Quantity limits based on the FDA-approved dosage guidelines help to reduce abuse, addiction, and dose dependent adverse effects (1-11).

2 Page: 2 of 5 Contraindications with the use of methylphenidate include marked anxiety, tension, agitation, glaucoma, tics, or a family history or diagnosis of Tourette s syndrome. is contraindicated in patients currently using or within 2 weeks of using an MAO inhibitor (1-11). Safety and efficacy has not been established in children under six years old (1-11). Related policies Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. and dexmethylphenidate may be considered medically necessary in patients under 22 years of age or younger. and dexmethylphenidate may be considered medically necessary in patients 22 years of age and older for the treatment of narcolepsy, attention deficit disorder, attention deficit hyperactivity disorder, or depression. and dexmethylphenidate may be considered investigational in patients who do not meet the criteria for medical necessity. Prior-Approval Requirements Age Diagnoses 22 years of age or older Under age 22 prior approval not required Patient must have ONE of the following: 1. Narcolepsy 2. Attention deficit disorder 3. Attention deficit hyperactivity disorder 4. Depression Prior Approval Renewal Requirements Same as above Policy Guidelines

3 Page: 3 of 5 Pre - PA Allowance None This is a covered benefit for members less than 22 years of age Prior - Approval Limits Quantity Maximum adult dose for all indications 60mg/day Concerta Maximum adult dose for all indications 72mg/day Focalin/Focalin XR Maximum adult dose for all indications 40mg/day Duration 12 months Prior Approval Renewal Limits Quantity Maximum adult dose for all indications 60mg/day Concerta Maximum adult dose for all indications 72mg/day Focalin/Focalin XR Maximum adult dose for all indications 40mg/day Duration 12 months Rationale Summary is a DEA schedule II drug and a CNS stimulant which is FDA approved for attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) and narcolepsy. is approved for the treatment of ADHD. The exact mechanism by which methylphenidate acts is unknown; however, it is presumed to increase dopamine and norepinephrine levels in the brain. has a boxed warning for a high potential of abuse and addiction. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of methylphenidate and dexmethylphenidate while maintaining optimal therapeutic outcomes. References 1. Concerta [package insert]. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2. Daytrana [package insert]. Miami, FL: Noven Pharmaceuticals, Inc. November Focalin [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.

4 Page: 4 of 5 4. Focalin XR [package insert].east Hanover, NJ: Novartis Pharmaceuticals Corporation. 5. Metadate CD [package insert]. Smyrna, GA: UCB, Inc. August Methylin chewable tablets [package insert]. Hazelwood,MO: Mallinckrodt, Inc. December Methylin oral solution [package insert]. Hazelwood,MO: Mallinckrodt, Inc. 8. Extended-Release [package insert]. Gurabo, PR: Janssen-Cilag Manufacturing, LLC. January Qullivant XR [package insert]. New York, NY: Pfizer, Inc. February Ritalin/Ritalin-SR [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation, Inc. 11. Ritalin LA [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. 12. Paktar AM, Pae C, et al. A randomized, double-blind, placebo-controlled trial of augmentation with an extended release formulation of methylphenidate in outpatients with treatment-resistant depression. J Clin Psychopharm. 26(6): Dec Policy History Date December 2011 October 2010 September 2012 June 2013 September 2014 June 2015 Action New Policy Addition of Focalin XR 40mg to product line with the package insert updated to include a 40mg maximum dose for adults; therefore the maximum daily dose for Focalin products will change from 30mg per day to 40mg per day (9). Annual review and reference update Changed Policy # from and sub-heading from Endocrine and Metabolic Drugs Keywords

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