Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Substance abuse.
Treatment:  Buprenorphine Extended-Release (sublocade) Injection, Pre-service.
The insurer denied the  Buprenorphine Extended-Release (sublocade) Injection, Pre-service.
The denial is overturned. 

The patient is a male diagnosed with severe opioid use disorder and receiving medication assisted treatment together with monitoring for abstinence and compliance with ongoing treatment. The patient is prescribed Sublocade, extended-release buprenorphine, once monthly injectable buprenorphine, as maintenance treatment and medication assisted treatment of the opioid use disorder. The patient has taken Suboxone Film Strips and tablets in the past order to maintain abstinence and support a recovery from opioid use disorder. However, the patient failed to fully benefit from either Suboxone tablets or film strips with continued cravings and risk for misuse of these formulations. Currently, the clinician is prescribing Subsolv brand of buprenorphine/naloxone sublingual tab at a dose of 5.7/1.4 mg (milligrams) per day decreased from a previous dose of 8.6/2.1 mg (milligrams). The current dose of Subsolv is equivalent to Suboxone (buprenorphine/naloxone) at 8.2 mg (milligrams). The patient is receiving twice monthly appointments with counseling and subjected to drug screening to assure abstinence from illicit drugs. He reportedly is abstinent with plans for proceeding and switching to the Sublocade 300 mg (milligrams)/1.5 ml (milliliters) (extended-release injectable buprenorphine) treatment in order to address intolerance to the Subsolv which has been associated with adverse effects including withdrawal symptoms with nausea and vomiting, and a tendency to skip doses due to the tolerability problems.

The health plan denied coverage on the basis of medical necessity indicating that the patient/member must be on at least 8 mg (milligrams) of buprenorphine per day in order for the requested Sublocade, extended-release buprenorphine to be approved, and that the requested Sublocade, extended-release buprenorphine is a covered service and meets plan definition of medical necessity.

The prescribing clinician on appeal argues that the use of Sublocade, extended-release buprenorphine will likely result in more effective control of craving with better compliance and better tolerability with regard to post-acute withdrawal symptoms of nausea and vomiting. Moreover, the patient would be likely to be compliant with the treatment plan while receiving monthly injections of Sublocade, extended-release buprenorphine with the goal of a satisfactory response and clinical course that includes continued in-office counseling with monthly visits and urine drug screening. Additionally, the prescribing clinician correctly points out that the patient is on a dose of buprenorphine at 8 mg (milligrams) per day and previously on an equivalent of 12 mg (milligrams) per day with the use of Subsolv which is more potent than generic Suboxone. Again, buprenorphine-naloxone tabs and film strips were previously tried and failed without a satisfactory clinical response, and the current treatment with Subsolv at the lower dose of 5.7/1.4 mg (milligrams) has also resulted in continued adverse effects, as noted on appeal.

Yes, the treatment with Sublocade is medically necessary for this patient.
The requested Sublocade is medically necessary and should be covered in this case. The patient's opioid use disorder treatment with Sublocade and other treatments provided are consistent with prevailing standards of professional practice and published practice guidelines, referenced below. Specifically, the patient has a diagnosis of opioid use disorder and is receiving medication assisted treatment to prevent relapse and address post-acute withdrawal symptoms and/or craving. Prevailing standards of medical practice calls for comprehensive treatment with counseling and social supports, as well as ongoing monitoring to ensure abstinence from opioid agonists with urine drug screens that serves to inform the clinical provider that the patient is adherent to the medication regimen and remains abstinent of opioid class substances of abuse. The patient is receiving counseling and support as clinically appropriate with drug screening to monitor for compliance with treatment and abstinence from substances of abuse/illicit drugs.

In this case, the patient is in outpatient substance use disorder treatment with medication-assisted treatment of opioid use disorder. The use of Sublocade is clinically appropriate and reasonable in this case scenario because alternative buprenorphine agents are not clinically appropriate in this case scenario due to adverse effects and risk for non-compliance and relapse. A previous trial of Suboxone strips and tabs and with Subsolv resulted in an unsatisfactory clinical response, as noted in the clinical summary. Thus, the management of the patient's substance use disorder with the use of Sublocade, extended-release, once monthly injectable buprenorphine, as maintenance treatment and medication assisted treatment of the opioid use disorder is in keeping with prevailing standards of professional practice, published practice guidelines, and FDA (United States Food and Drug Administration) indications for the use of buprenorphine preparations targeting opioid use disorder as part of a comprehensive substance abuse treatment program.

The reason for denial is not valid in this case as the patient is on a dose of 8 mg (milligrams) of buprenorphine per day as required, contrary to the reason for denial. Moreover, the appeal reasonably argues for the switch from Subsolv formulation to Sublocade-see below.

The health plan denied coverage on the basis of medical necessity indicating that the patient/member must be on at least 8 mg (milligrams) of buprenorphine per day in order for the requested Sublocade, extended-release buprenorphine to be approved, and that the requested Sublocade, extended-release buprenorphine is a covered service and meets plan definition of medical necessity.

The prescribing clinician on appeal argues that the use of Sublocade, extended-release buprenorphine will likely result in more effective control of craving with better compliance and better tolerability with regard to post-acute withdrawal symptoms of nausea and vomiting. Moreover, the patient would be likely to be compliant with the treatment plan while receiving monthly injections of Sublocade, extended-release buprenorphine with the goal of a satisfactory response and clinical course that includes continued in-office counseling with monthly visits and urine drug screening. Additionally, the prescribing clinician correctly points out the the patient is on a dose of buprenorphine at 8 mg (milligrams) per day and previously on an equivalent of 12 mg (milligrams) per day with the use of Subsolv which is more potent than generic Suboxone. Again, buprenorphine-naloxone tabs and film strips were previously tried and failed without a satisfactory clinical response, and the current treatment with Subsolv at the lower dose of 5.7/1.4 mg (milligrams) has also resulted in continued adverse effects, as noted on appeal.