Pharmacy Prior Authorization Clinical Guideline for Attention Deficit Disorder/Attention Deficit Hyperactivity CNS Stimulants

Transcription

1 AETNA BETTER HEALTH Pharmacy Prior Authorization Clinical Guideline for Attention Deficit Disorder/Attention Deficit Hyperactivity CNS Stimulants Formulary amphetamine/dextroamphetamine IR, ER (generic for Adderall, Adderall XR) dexmethylphenidate IR, ER (generic for Focalin, Focalin XR) dextroamphetamine IR, ER (generic for Dexedrine and Zenzedi) methamphetamine IR (generic for Desoxyn) methylphenidate IR, ER, LA, CD/CR (generic for Ritalin, Ritalin LA, Concerta, Metadate CR, Metadate ER) methylphenidate oral solution (generic for Methylin) Zenzedi Non-Formulary Aptensio XR Daytrana Evekeo Quillivant XR Vyvanse Authorization guidelines Prior Authorization is required for the following: A. Request is for a non-formulary agent member is currently stable on the requested non-formulary agent see criteria below for non-formulary agents B. Request is for a stimulant with a prescribed quantity that exceeds the quantity limit C. Request is for a member 5 years old or younger (applies to preferred and non-formulary stimulants) see criteria below for this age group

2 D. Request is for a member 18 years or older (applies to preferred and nonformulary stimulants) see criteria below for this age group E. Member is receiving more than one stimulant medication (except when using long-acting and short-acting formulations of the same drug) see criteria below for therapeutic duplication Children age 5 and under Many stimulant medications are not FDA approved for use in children ages 5 and under. The safety and efficacy in this age group has not been established and is not supported by the currently published peer-reviewed medical literature. For preschool-aged children (4 5 years of age), the American Academy of Pediatrics recommends that the primary care or treating clinician prescribe evidence-based parent and/or teacher-administered behavior therapy as the first line treatment. Request for coverage for stimulants in children age 5 and under is generally not considered to be medically necessary. Requests will be reviewed on a case-by-case basis by the plan Medical Director using the following considerations. A. Member has one of the following diagnoses: a. Attention Deficit Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD) b. Brain injury c. Autism B. Chart documentation of a comprehensive evaluation by an appropriate specialist (or in consultation with) such as a Pediatric Neurologist, Child and Adolescent Psychiatrist or Child Development Pediatrician C. There is documentation of failure of evidence-based parent and/or teacheradministered behavior therapy to adequately address symptoms and that this therapy will continue concurrent to medication therapy. D. Documentation of one of the following: 1. Member is stable on non-preferred stimulant

3 2. Documented trial and failure or contraindication with at least one formulation of each stimulant type (amphetamine/dextroamphetamine, dextroamphetamine, methylphenidate) 3. Requests for a non-preferred EXTENDED RELEASE product require failure of extended release formulations of the preferred agents. 4. Requests for a non-preferred IMMEDIATE RELEASE product require failure of the immediate release formulations of the preferred agents. Members 18 years old or older A. Member has one of the following diagnoses: a. Attention Deficit Hyperactivity Disorder/Attention Deficit Disorder (ADHD/ADD) as documented by a history consistent with the most current Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria b. Narcolepsy c. Idiopathic hypersomnia d. Fatigue related to cancer e. Multiple sclerosis B. In addition for a member with a history of co-morbid substance dependency, abuse or diversion, documentation of the following: 1. Is enrolled and actively participating in a substance dependency treatment program 2. Demonstrates compliance with the substance dependency treatment program as documented by a recent urine drug screen (UDS) (including testing for licit and illicit drugs with the potential for abuse, and specific testing for oxycodone, fentanyl, tramadol, and carisoprodol) that is consistent with prescribed controlled substances 3. Has a documented history of recovery and a recent negative urine drug screen

4 C. Prescribing provider confirms that he/she, or delegate, conducted a search of the Pennsylvania Prescription Drug Monitoring Program (PDMP) for the member s controlled substance prescription history before prescribing the stimulant agent D. Documentation of one of the following: 1. Request is for a preferred stimulant agent 2. Member is stable on non-preferred stimulant agent 3. Documented trial and failure or contraindication with at least one formulation of each stimulant type (amphetamine/dextroamphetamine, dextroamphetamine, methylphenidate) 4. Requests for a non-preferred EXTENDED RELEASE product require failure of extended release formulations of the preferred agents. 5. Requests for a non-preferred IMMEDIATE RELEASE product require failure of the immediate release formulations of the preferred agents. Authorization Guidelines for Vyvanse for Binge Eating Disorder (BED) A. Member is 18 to 55 years of age B. Prescribed by, or in consultation with, a psychiatrist C. Member meets DSM-5 criteria for BED diagnosis D. Member has a BMI of >25 kg/m 2 E. Member is receiving nutritional counseling psychotherapy F. Member had an inadequate response or intolerance to at least two (2) formulary medications used for BED such as SSRIs, topiramate, or zonisamide. G. Member has NOT taken monoamine oxidase inhibitors in the past 14 days H. There is no recent history of substance abuse are being appropriately treated I. Member is NOT concurrently taking other stimulants J. There is no history of cardiac disease (arrhythmia, cardiac structural abnormalities, CAD)

5 Authorization Guidelines for non-preferred agents: A. Member is stable on the non-formulary agent B. Documented trial and failure or contraindication with at least one formulation of each stimulant type (amphetamine/dextroamphetamine, dextroamphetamine, methylphenidate) C. Requests for a non-preferred EXTENDED RELEASE product require failure of extended release formulations of the preferred agents. D. Requests for a non-preferred IMMEDIATE RELEASE product require failure of the immediate release formulations of the preferred agents. Authorization guidelines for therapeutic duplication A. The member is being titrated to, or tapered from, a drug in the same class B. Member is using long-acting and short-acting formulations of the same drug C. Supporting peer reviewed literature or national treatment guidelines corroborate concomitant use of the medications being requested Authorization and Limitations Initial Approval (based on age at time of approval) (ADHD/ADD) less than 6 years: 1 year (ADHD/ADD) 6-18 years: Up to age 21 (ADHD/ADD) greater than 18 years: 1 year Narcolepsy: 1 year Binge Eating Disorder (Vyvanse): 12 weeks Renewal:

6 (ADHD/ADD) less than 6 years: 1 year (ADHD/ADD) 6-18 years: up to age 21 (ADHD/ADD) greater than 18 years: 1 year Narcolepsy: 1 year Binge Eating Disorder (Vyvanse): 12 weeks Requirements for ADHD and Narcolepsy: Attestation of response to therapy Attestation of member adherence to therapy Requirements for Binge Eating Disorder renewal: Member continues to receive evidence based behavioral therapy. Decrease in the number of binge days per week. Stimulants are NOT covered for members with the following criteria: A. Use not approved by the FDA; and B. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see Off-Label Use Policy for determining accepted use ) References 1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Arlington, VA, American Psychiatric Association, Mao AR, Findling RL. Comorbidities in adult attention-deficit/hyperactivity disorder: a practical guide to diagnosis in primary care. Postgrad Med Sep;126(5): doi: /pgm Review. PubMed PMID: Post RE, Kurlansik SL. Diagnosis and Management of Attention- Deficit/Hyperactivity Disorder in Adults. Am Fam Physician. 2012;85(9): American Academy of Pediatrics. ADHD: Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics.2011;128; ; 5. National Eating Disorder Foundation. Accessed October 25, 2016.

7 6. APA: American Psychiatric Association. Practice Guideline for the Treatment of Members with Eating Disorders. lines/eatingdisorders.pdf. Third Edition. Accessed October 25, Vyvanse [package insert]. Lexington, MA: Shire Pharmaceuticals; Revised October Morgenthaler TI, Kapur VK, Brown T, et al; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin [published correction appears in Sleep. 2008;31(2):table of contents]. Sleep. 2007;30(12): [PubMed ]