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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Generic Name: Lisdexamfetamine
The intent of the prior authorization (PA) criteria for the brand attention deficit hyperactivity disorder (ADHD) agents, stimulants and non-stimulants, is to appropriately select patients under the age of 18 according to product labeling and/or clinical guidelines and/or clinical studies, and to direct use to more cost-effective generic agents as appropriate. The PA edit will target brand Vyvanse only, including all available dosage forms. These criteria use the term ADHD to encompass both ADHD and ADD.
The intent of the ADHD agents quantity limit is to encourage appropriate prescribing quantities as recommended by FDA approved product labeling and to encourage cost-effective prescribing when lower quantities of a higher strength are equivalent to the prescribed dose. Determination of daily limits also takes into account the lowest number of tablets, capsules, milliliters or patches required to achieve the maximum dose (dose optimization).
Vyvanse is indicated for the treatment of moderate to severe binge eating disorder. The efficacy of Vyvanse for binge eating disorder was evaluated in two 12 week trials. The placebo substracted difference in binge days per week was -1.35 and -1.66 in the trials. Doses below 50mg/day were not shown to be superior to placebo.
Vyvanse® (lisdexamfetamine) is indicated for:
Previous use of samples or vouchers/coupons will not be considered for authorization.
Vyvanse® will be approved when ALL of the following are met for ADHD and narcolepsy:
**If the brand name medication is approved, the Plan will only reimburse the same amount that is reimbursed for generic amphetamine/dextramphetamine immediate release (2 tablets per day) prescriptions.
Vyvanse will be approved when ALL of the following are met for binge eating disorder:
POLICY EXCEPTIONSVyvanse® prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
01/01/2014: New policy added.
07/23/2015: Code Reference section updated for ICD-10.
10/27/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Investigative definition updated in policy guidelines section.
04/01/2016: Policy description updated to add binge eating disorder as an indication for Vyvanse. Policy statement revised to state that Vyvanse will be approved for ADHD and narcolepsy when certain criteria are met. Added policy statement that Vyvanse will be approved for binge eating disorder when certain criteria are met.
SOURCE(S)Vyvanse® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.