DOCUMENT NAME: lisdexamfetamine (Vyvanse ) PAGE: 1 of 5 REFERENCE NUMBER: NH.PMN.36 EFFECTIVE DATE: 02/09
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1 PAGE: 1 of 5 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peer-reviewed medical literature, government agency/program approval status, and other indicia of medical necessity. The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits ( Benefit Plan Contract ) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Description: Vyvanse is a once daily oral tablet that is a pro-drug to dextroamphetamine as the active ingredient. Brand: lisdexamfetamine dimesylate (Vyvanse ): 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg tablets FDA Labeled Indications: Criteria for Approval: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age, or other mental health conditions. A. Patient 6 to <18 years of age (refer to CP.PPA.14 for adults) B. Documented failure of Preferred Drug List (PDL) or intolerance to such therapy for each of the following: long acting methylphenidate and long acting amphetamine.
2 PAGE: 2 of 5 Adult Attention Deficit Hyperactivity Disorder (ADHD) A. Diagnosis of ADHD; B. Age 18 years; C. Prescribed by or in consultation with a mental health provider; D. Contraindication to or failure of one PDL extended release amphetamine AND Contraindication to or failure of one PDL extended release methylphenidate; E. Request does not exceed one capsule per day. Binge Eating Disorder (BED) (must meet all) A. Diagnosis of BED; B. Age 18 years; C. Prescribed by or in consultation with a mental health provider; D. Member is overweight/obese (BMI 25); E. Failure of concurrent use of topiramate and cognitive behavioral therapy (CBT) for 3 months with supporting documentation, unless contraindicated AND Failure of two PDL SSRIs, unless contraindicated; F. Dose of 50 mg to 70 mg will be achieved within the next 30 days; G. Request does not exceed 1 capsule/day. Approval: Initial Approval: 12 months. Continued Approval: 12 months.
3 Special Instructions > Stimulant medications generally should not be used in children with known structural cardiac abnormalities due to concern that stimulants may further increase the risk of sudden death above the risk that is already present with such abnormalities. > Vyvanse should be used with extreme caution in patients with documented hypertension. >. > Watch closely for evidence of dependency, personality changes, and severe depression. > Vyvanse will not be approved for combination may therapy with other long acting ADHD stimulant medications as this constitutes polypharmacy, which may increase the likelihood of adverse effects. > Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events. > The physician who elects to use Vyvanse for extended periods should periodically re-evaluate the long-term usefulness of Vyvanse for the individual patient. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.
4 PAGE: 3 of 5 References: 1. Vyvanse prescribing information, Accessed March, USA ENG. pdf 2. Lisdexamfetamine monograph. Clinical Pharmacology. Accessed April Revision Log Revision Updated FDA Labeled Indication and Criteria for Approval item a to reflect the change from >6 to > 6. Revised Criteria for Approval items b and c from a 2 month course of both to a one month course of all of the following. Added the following to Criteria for Approval item c after SR formulation: and/or dextroamphetamine IR at therapeutic dosing. Changed Criteria for Approval item g from Criteria for Approval item c No history of tics or family history of Tourette s syndrome to No history of tics or Tourette s syndrome or with a previous history of tics or Tourette s syndrome, a clinical evaluation by the prescriber that weighs the risk/benefit ratio for use of stimulants in terms of the acuity of the ADHD condition. Changed Criteria for Approval item h from Documentation that Vyvanse will be given as part of an integrated care plan which includes involvement with parents, school, psychologist, and the prescriber as appropriate to age. to Date
5 PAGE: 4 of 5 Intended use of Vyvanse is as mono-therapy. Removed the criteria for adults as directed by the adult IR 04/10 stimulant therapy initiative. References updated to reflect current literature search. Changed approval age limit to 6 years to align with 05/11 FDA- approved labeling. Removed of language on who may prescribe. Removed mono-therapy language. Added the following to the Special Instructions section: 05/11 Vyvanse will not be approved for combination therapy with other long acting ADHD stimulant medications as this constitutes polypharmacy, which may increase the likelihood of adverse effects. References updated to reflect current literature search. 05/11 Removed the review for tics and Tourette s. 05/12 Added the following to the Special Instructions section: 05/12 Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events. Added the following to the Special Instructions section: The 05/12 physician who elects to use Vyvanse for extended periods should periodically re-evaluate the long-term usefulness of Vyvanse for the individual patient. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment. References updated to reflect current literature search. 05/12 References updated. 05/13 Updated Criteria for Approval item A to indicate for guideline 05/14 to be used for children and a separate guideline is to be used for adults. References updated. 06/15 Changed initial approval to 12 months
6 Removed criteria of one month course from criteria for 06/16 approval. Removed continued approval criteria If documentation shows improvement of ADHD treatment measures as evidenced by psychological, educational and social indicators, adherence to therapy and progress notes reflecting no adverse events. Patient must be seen every six months by provider to rule out cardiac problems and other potential adverse events. Removed No history of advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism and; No known hypersensitivity or idiosyncrasy to the sympathomimetic amines; glaucoma; anxiety or agitated states; history of drug abuse; or administration of monoamine oxidase inhibitors (MAOIs). Added ADHD criteria for approval for adult usage with no 4 week trial criteria Added Binge Eating disorder criteria with no 4 week trial criteria Removed at maximum tolerated doses from criteria Added to binge eating criteria Prescribed by or in consultation with a mental 03/17 health provider Annual Review, No Changes 12/17
7 PAGE: 5 of 5 POLICY AND PROCEDURE APPROVAL Pharmacy & Therapeutics Committee: V.P., Pharmacy Operations: Sr. V.P., Chief Medical Officer: Approval on file Approval on file Approval on file
Clinical Policy: Lisdexamfetamine (Vyvanse) Reference Number: CP. PPA.03. Line of Business: Medicaid
Clinical Policy: (Vyvanse) Reference Number: CP. PPA.03 Effective Date: 02/09 Last Review Date: 05/17 Line of Business: Medicaid Coding Implications Revision Log See Important Reminder at the end of this
Clinical Policy: Lisdexamfetamine (Vyvanse) Reference Number: CP.PMN.121 Effective Date: Last Review Date: Line of Business: Medicaid
Clinical Policy: (Vyvanse) Reference Number: CP.PMN.121 Effective Date: 02.01.09 Last Review Date: 02.19 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
Clinical Policy: Lisdexamfetamine (Vyvanse) Reference Number: NH.PMN.36 Effective Date: Last Review Date: Line of Business: Medicaid
Clinical Policy: Lisdexamfetamine (Vyvanse) Reference Number: NH.PMN.36 Effective Date: 02.09 Last Review Date: 02.19 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy
Clinical Policy: Lisdexamfetamine (Vyvanse) Reference Number: CP.PMN.121 Effective Date: Last Review Date: Line of Business: Medicaid
Clinical Policy: (Vyvanse) Reference Number: CP.PMN.121 Effective Date: 02.01.09 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
REFERENCE NUMBER: NH.PMN.47 EFFECTIVE DATE: 11/11
PAGE: 1 of 5 RETIRED: REVIEWED: 11/11, 12/14, 08/16, 07/17 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough
3. Does the member continue to receive nutritional or psychological counseling?
Pharmacy Prior Authorization AETA BETTER HEALTH PESLVAIA & AETA BETTER HEALTH KIDS CS Stimulants (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review
REFERENCE NUMBER: NH.PST.05 EFFECTIVE DATE: 10/10
PAGE: 1 of 5 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
Pharmacy Prior Authorization
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MEDICAL NECESSITY GUIDELINE
PAGE: 1 of 6 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
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3. Does the patient continue to receive nutritional or psychological counseling? Y N
Pharmacy Prior Authorization AETA BETTER HEALTH PESLVAIA & AETA BETTER HEALTH KIDS CS Stimulants (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review
See Important Reminder at the end of this policy for important regulatory and legal information.
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PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 3/15/18 SECTION: DRUGS LAST REVIEW DATE: 3/15/18 LAST CRITERIA REVISION DATE: ARCHIVE DATE:
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Updated: 08/2017 DMMA Approved: 11/2017
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Cardiff & Vale (C&V) UHB Corporate Medicines Management Group (c MMG) SHARED CARE DRUG: LISDEXAMFETAMINE PROTOCOL NUMBER: CV 57
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Amphetamines
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.24 Subject: Amphetamines Page: 1 of 6 Last Review Date: December 8, 2017 Amphetamines Description
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VyvansePro.com Learn how to use the Formulary Look-up Tool for Vyvanse (lisdexamfetamine dimesylate)
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Amphetamines
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.24 Subject: Amphetamines Page: 1 of 6 Last Review Date: September 23, 2016 Amphetamines Description
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.06.24 Subject: Amphetamines Page: 1 of 4 Last Review Date: June 19, 2015 Amphetamines Description Adderall
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Clinical Policy: Reference Number: LA.PPA.12 Effective Date: 02/11 Last Review Date: 01/18 Line of Business: Medicaid Coding Implications Revision Log See Important Reminder at the end of this policy for
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Stimulants. The psychostimulants, or more simply known as stimulants, are used primarily in treating attention-deficit/ Dosing Information
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MEDICAL NECESSITY GUIDELINE
PAGE: 1 of 7 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
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Complete the Qsymia Healthcare Provider Training Program in 2 easy steps:
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.25 Yeah Subject: Methylphenidates Page: 1 of 6 Last Review Date: September 15, 2017 Methylphenidate
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.25 Yeah Subject: Methylphenidates Page: 1 of 5 Last Review Date: December 2, 2016 Methylphenidate
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.06.25 Page: 1 of 5 Last Review Date: June 19, 2015 Description Concerta / Daytrana / Metadate CD / Metadate
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Clinical Policy: Topotecan (Hycamtin) Reference Number: CP.PHAR.64 Effective Date: Last Review Date: Line of Business: Medicaid, HIM
Clinical Policy: (Hycamtin) Reference Number: CP.PHAR.64 Effective Date: 06.01.11 Last Review Date: 05.18 Line of Business: Medicaid, HIM Coding Implications Revision Log See Important Reminder at the
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.CPA.259 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory
Clinical Policy: Mifepristone (Korlym) Reference Number: CP.PHAR.101
Clinical Policy: (Korlym) Reference Number: CP.PHAR.101 Effective Date: 05/12 Last Review Date: 04/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
Methylphenidate Dexmethylphenidate
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Methylphenidates Page: 1 of 7 Last Review Date: November 30, 2018 Methylphenidate Dexmethylphenidate
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Probuphine, Sublocade) Reference Number: CP.PHAR.289 Effective Date: 11.16.16 Last Review Date: 05.18 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the
Overview Purpose Complete the Qsymia Pharmacy Certification in 3 easy steps:
Overview The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for Qsymia to ensure the benefits of Qsymia outweigh the increased risk of teratogenicity.
Clinical Policy: Fluticasone/Salmeterol (Advair Diskus, Advair HFA) Reference Number: CP.PMN.31 Effective Date: 08/16 Last Review Date: 08/17
Clinical Policy: (Advair Diskus, Advair HFA) Reference Number: CP.PMN.31 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Saphris) Reference Number: CP.PMN.15 Effective Date: 12.01.14 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Iressa) Reference Number: CP.PHAR.68 Effective Date: 11.16.16 Last Review Date: 11.18 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy
SHARED CARE GUIDELINE
SHARED CARE GUIDELINE Methylphenidate in the treatment of Attention Deficit Hyperactivity Disorder in Children, Young People and Adults Implementation Date: June 2015 Review Date: June 2017 This guidance
New Hampshire Healthy Families CLINICAL POLICY
New Hampshire Healthy Families CLINICAL POLICY DEPARTMENT: Pharmacy DOCUMENT NAME: Opioid Analgesics PAGE: 1 o f 6 REFERENCE NUMBER: NH.PPA.13 EFFECTIVE DATE: 6/1/2016 REPLACES DOCUMENT: N/A RETIRED: REVIEWED:
Wellbutrin/Wellbutrin-SR/ Wellbutrin-XL (bupropion)
Wellbutrin/Wellbutrin-SR/ Wellbutrin-XL (bupropion) Generic name: Bupropion Available strengths: 75 mg, 100 mg immediate-release tablets; 100 mg, 150 mg, 200 mg sustained-release tablets (Wellbutrin-SR);
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Famvir) Reference Number: HIM.PA.63 Effective Date: 12/14 Last Review Date: 08/17 Line of Business: Health Insurance Marketplace Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Policy Reference Number: CP.PMN.53 Effective Date: 09.12.17 Last Review Date: 11.18 Line of Business: Medicaid, HIM-Medical Benefit Revision Log See Important Reminder at the end of this
Overview. Purpose. Qsymia (phentermine and topiramate extended-release) capsules CIV Pharmacy Training Program
Qsymia (phentermine and topiramate extended-release) capsules CIV Pharmacy Training Program Overview The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS)
It is the policy of health plans affiliated with Centene Corporation that Seroquel XR is medically necessary when the following criteria are met:
Clinical Policy: (Seroquel XR) Reference Number: CP.PMN.64 Effective Date: 12.01.14 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important
CLINICAL POLICY Clinical Policy: Extended Release Opioid Analgesics
Reference Number: AZ.CP.PMN.97 Effective Date: 02.11 Last Review Date: 02.18 Line of Business: Medicaid- AHCCCS Revision Log See Important Reminder at the end of this policy for important regulatory and
Blood pressure and pulse should be recorded on a centile chart at each dose adjustment and then at least every 6 months
Checklist 1: checklist before prescribing Amfexa 5mg, 10mg and 20mg Tablets It is recommended that this checklist be used in conjunction with the SmPCs for Amfexa Tablets (which can be accessed at http://www.medicines.org.uk/emc/search
MRCPsych Pharmacology of ADHD treatment. Dr Xanthe Barkla, Consultant Child and Adolescent Psychiatrist
MRCPsych Pharmacology of ADHD treatment Dr Xanthe Barkla, Consultant Child and Adolescent Psychiatrist 04 01 17 Curriculum mapping MRCPsych Paper A(ii) covers clinical psychopharmacology MRCPsych Syllabus: