Lucemyra - NC Standard

Restricted Product(s):

Restriction applies to brand and generic products

• Lucemyra (lofexidine)

FDA Approved Use:

• For mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
• Lucemyra is not a treatment for opioid use disorder. Lucemyra should only be used in conjunction with a comprehensive management program in patients with opioid use disorder.

Criteria for Approval of Restricted Product(s):

1. The patient will be using Lucemyra to mitigate the symptoms of abrupt opioid discontinuation (detoxification); AND
2. The patient has an FDA labeled contraindication to clonidine [medical record documentation required]; OR
3. The provider submits patient specific documentation that indicates that undue harm will come to the patient with the use of clonidine (ex. a history of hypotension) [medical record documentation required]; AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 14 days per 6 months

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The patient meets the criteria for the initial use of the medication; AND
   1. The provider is aware the patient received a 14 day course of the medication in the past 6 months; AND
   2. The provider has fully assessed the reason for previous treatment failure and adjusted; OR
2. The patient has not been fully tapered off the medication and additional supply is required to complete the transition.

References:

All information referenced is from FDA package insert unless otherwise noted below.

Center for Substance Abuse Treatment (US).Medications for Opioid Use Disorder. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2018. (Treatment Improvement Protocol (TIP) Series, No. 63.) Available from: https://store.samhsa.gov/shin/content//SMA18-5063FULLDOC/SMA18-5063FULLDOC.pdf

Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. Journal of Addiction Medicine. 2015;9(5):358-367. doi:10.1097/ADM.0000000000000166.

U.S. Department of Veteran Affairs, Department of Defense. Clinical Practice Guidelines for the Management of Substance Use disorders; Revised December, 2015. Available from: https://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGRevised22216.pdf

Sevarino, MD. Medically supervised opioid withdrawal during treatment for addiction. In R. Herman (Ed.), UpToDate. Available From: https://www-uptodate-com./contents/medically-supervised-opioid-withdrawal-during-treatment-for-addiction.

Policy Implementation/Update Information:

September 2024: Criteria update: Restriction applies to brand and generic products.

January 2021: Criteria change: Clarified that medical records are required for FDA labeled contraindication to clonidine and patient specific documentation that indicates that undue harm will come to the patient with the use of clonidine.

Sept 2020: Annual criteria review. Format updates. No changes to criteria.

Aug 2018: Removed criteria points on: abstinence from illicit drug use; co-administration with methadone and buprenorphine; contraindications to methadone and buprenorphine; psychosocial treatment plan; these items are addressed specifically in Medication Assisted Therapy policies.

June 2018: Original utilization management criteria issued.