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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.
DESCRIPTIONNuvigil (armodafinil) is a single R-enantiomer of modafinil (Provigil), and is approved by the FDA for improving wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea or hypopnea syndrome, narcolepsy, and shift work sleep disorder. Modafinil (Provigil) has the same FDA approved indications.
Previous use of samples or vouchers/coupons will not be considered for authorization.
Nuvigil will be approved when ALL of the following are met:
POLICY EXCEPTIONSNuvigil 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.
07/31/2015: 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.
SOURCE(S)Nuvigil® 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.