Primary navigation

    Lucemyra™

    Drug - Lucemyra™  (lofexidine) [US WorldMeds, LLC]

    April 2019

    Therapeutic area - Opiate Dependence

    Initial approval criteria

    • Patient must be ≥ 18 years of age AND
    • Patient has a diagnosis of opioid withdrawal symptoms AND
    • Patient is NOT pregnant or breastfeeding AND
    • Patient must NOT have a prolonged QT interval (>450 msec for males, >470 msec for females) AND
    • Prescriber to provide attestation that if patient is currently taking methadone, baseline electrocardiogram (ECG) has been performed AND
    • Patient has tried and failed, had a contraindication to, or experienced an adverse reaction/intolerance to buprenorphine and methadone AND
    • Patient must have tried and failed, had a contraindication to, or experienced an adverse reaction/intolerance to clonidine AND
    • Prescriber provides documentation of a comprehensive treatment plan between provider and patient including:
      • Instruction on how to self-monitor for hypotension, orthostasis, bradycardia, and associated symptoms AND
      • A copy of patient education material regarding a tapering schedule and instructions on when and how to contact the prescriber for further guidance (including weekends and holidays)
    • In the case of opioid use disorder (OUD), provide attestation that patient:
      • Has a referral to OR active involvement in substance abuse counseling OR
      • Is unable to have counseling AND provides attestation that patient has been offered medication-assisted treatment (MAT) as part of a comprehensive treatment plan AND
    • Prescriber provides attestation that patient is NOT prescribed concurrent opioid medication without explanation AND
    • If patient has hepatic impairment, provide Child-Pugh score at time of request AND
    • If the patient has renal impairment, provide estimated GFR at time at request
    • Initial approval is for 7 day supply

    Renewal criteria

    • If the renewal is a continuation of the initial approval because additional therapy is needed, approve up to 7 additional days (for a total of 14 days of treatment)
    • A tapering schedule must be included with the renewal request

    Quantity limits

    • Initial approval: 112 tablets (7 days)
    • Renewal approval: 112 tablets (7 days)

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

    back to top