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DrugLucemyra™  (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)


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

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