Download Vivitrol® (naltrexone) (Intramuscular)

Vivitrol® (naltrexone)
(Intramuscular)
Last Review Date: 02/25/2014
Effective Date of Guideline: 1/1/12
Dates Reviewed: 12/13/11, 02/07/2013, 02/25/2014
Prior Auth Available:
Medical Necessity Criteria Number: IC-0139
√ Post-service edit:
These medical necessity criteria were developed by ICORE Healthcare for the purpose of making clinical review
determinations for requests for medications commonly used in various diseases. The developers of the criteria sets
included representatives from the disciplines of oncology, hematology, rheumatology, neurology, internal medicine,
nursing, and pharmacy were consulted as part of the criteria development. The development followed an extensive
literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual
drug. The indications for the medications are generally consistent with the National Comprehensive Cancer Network
(NCCN) guidelines, FDA labeling, CMS coverage guidelines, or other published peer reviewed research literature.
I.
Medication Description:
Naltrexone is an oral opiate receptor antagonist. It is derived from thebaine and is very similar in structure to
oxymorphone. Like parenteral naloxone, naltrexone is a pure antagonist (i.e., agonist actions are not apparent),
but naltrexone has better oral bioavailability and a much longer duration of action than naloxone. Clinically,
naltrexone is used to help maintain an opiate-free state in patients who are known opiate abusers. Naltrexone
is of greatest benefit in patients who take the drug as part of a comprehensive occupational rehabilitative
program or other compliance-enhancing program. Unlike methadone or LAAM, naltrexone does not reinforce
medication compliance and will not prevent withdrawal.
Naltrexone supports abstinence, prevents relapse, and decreases alcohol consumption in patients treated for
alcoholism. Naltrexone is not beneficial in all alcoholic patients and may only provide a small improvement in
outcome when added to conventional therapy. The FDA approved Vivitrol, a once-monthly intramuscular
naltrexone formulation used to help control cravings for alcohol in April 2006, and then in October 2010, the
FDA approved Vivitrol for the prevention of relapse to opioid dependence after opioid detoxification.
II.
Length of Authorization:
Coverage will be for 6 months and is eligible for renewal
III.
Review Criteria:
o Patient must be 18 years old or over; AND
o Patient does not have acute hepatitis or liver failure; AND
Alcohol dependence:
o Documented participation in a comprehensive management program including psychosocial support;
AND
o Patient has failed oral naltrexone (Revia), Antabuse® (disulfiram), or Campral® (acamprosate) therapy;
AND
o Patient has not had an alcoholic drink for 7 days prior to initiation with Vivitrol; AND
o Patient is not taking any opioid medications as evidenced by a urine screen
Opioid dependence:
o Patient is in a comprehensive rehabilitation program; AND
Page 1 of 3
Vivitrol (naltrexone)
Last Review Date: 02/25/2014
o
o
Medical Necessity Criteria
Number: IC-0139
Patient has undergone opioid detoxification for at least 7 days; AND
Patient has tested negative for opioids as evidenced by a urine screen or naloxone challenge test
IV.
Renewal Criteria:
o Documented continued clinical benefit to the Patient as defined by complete abstinence from or
reduction in the use of alcohol/opioids; AND
o Documented participation in a comprehensive management program including psychosocial support;
AND
o Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity includethe following:
symptoms or signs of acute hepatitis; severe injection site reactions; eosinophilic (allergic) pneumonia;
hypersensitivity reactions, including anaphylaxis; development of depression or suicidal thinking.
V.
Dosage/Administration:
Indication
All indications
VI.
Dose
380mg administered IM every 4 weeks
Billing/Code Information :
JCode:
J2315 – Vivitrol (Alkermes) 380mg injection: 1mg = 1 billable unit
NDC:
Vivitrol 380 mg vial: 65757-0300-xx (Alkermes)
Max Units (per dose and over time):
380 billable units every 28 days
Quantity Limits:
1 syringe (380mg) every 28 days
Covered Diagnosis:
ICD-9 Codes Diagnosis
303.00
Acute alcoholic intoxication in alcoholism, unspecified
303.01
Acute alcoholic intoxication in alcoholism, continuous
303.02
Acute alcoholic intoxication in alcoholism, episodic
303.03
Acute alcoholic intoxication in alcoholism, in remission
303.90
Other and unspecified alcohol dependence, unspecified
303.91
Other and unspecified alcohol dependence, continuous
303.92
Other and unspecified alcohol dependence, episodic
303.93
Other and unspecified alcohol dependence, in remission
304.00
Opioid type dependence, unspecified
304.01
Opioid type dependence, continuous
Page 2 of 3
Vivitrol (naltrexone)
Last Review Date: 02/25/2014
304.02
304.03
Medical Necessity Criteria
Number: IC-0139
Opioid type dependence, episodic
Opioid type dependence, in remission
VII.
Centers for Medicare and Medicaid Services (CMS):
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2),
Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage
Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be
found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional
indications may be covered at the discretion of the health plan.
VIII.
Criteria Exclusions:
o Treatment for diagnoses not FDA approved
o All indications not described in Section III Review criteria are not covered and may be considered
experimental or investigational.
IX.
Black Box Warnings/Contraindications:
Contraindications:
o Hypersensitivity to naltrexone or any component of the formulation
o Narcotic dependence or current use of opioid analgesics
o Failure to pass naloxone challenge or positive urine screen for opioids
o Acute hepatitis
o Liver failure
X.
References:
1. Vivitrol [package insert]. Waltham, MA; Alkermes, Inc; July 2013. Accessed February 2014.
Page 3 of 3