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Lucemyra (lofexidine) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1091

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace.

TARGET AGENT(S)

Lucemyra® (lofexidine)

Brand (Generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Lucemyra (lofexidine)

0.18 mg tablet

62805045100315

M, N, O, or Y

228 tablets (2 x 96 count bottles and 1 x 36 count bottle) / 6 months

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The requested agent will be used to mitigate opioid withdrawal symptoms to facilitate abrupt opioid discontinuation

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The patient’s medication history (in the past 6 months) does NOT include previous use of the requested agent AND the requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. The patient’s medication history (in the past 6 months) includes previous use of the requested agent AND BOTH of the following:
      1. The prescriber has provided information in support of another course of therapy with the requested agent

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose and duration

Length of Approval: 6 months

 

FDA APPROVED INDICATIONS AND DOSING1

Agent(s)

Indication(s)

Dosage

Lucemyra®

(lofexidine)

Tablet

Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults

The usual dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals

The total daily dose should not exceed 16 tablets and no single dose should exceed 4 tablets

Treatment may be continued for up to 14 days with dosing guided by symptoms

Discontinue with a gradual dose reduction over 2 to 4 days

Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment (1-3 tablets 4 times daily)

Lucemyra should be stored and dispensed in original container

CLINICAL RATIONALE

American Society of Addiction Medicine (2020) guideline states that comparative data is limited but lofexidine and clonidine appear to have similar efficacy in the treatment of opioid

withdrawal. However, the frequency of hypotension is lower with lofexidine.  As such, the guideline states that lofexidine should be the preferred choice for withdrawal management in an outpatient setting where monitoring of blood pressure and management of

hypotension is more difficult.2

Safety

Lofexidine has no FDA labeled contraindications.1

REFERENCES

  1. Lucemyra prescribing information. US WorldMeds, LLC. September 2020.
  2. National practice guideline for the use of medications in the treatment of addiction involving opioid use, 2020 Focused Update.  The American Society of Addiction Medicine. January 13, 2020.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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