Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Opioid use disorder 
Treatment: Suboxone Film
The insurer denied: Suboxone Film
The denial is overturned.

The case involves an adult female diagnosed with opioid use disorder in full remission. The patient has been prescribed Suboxone (buprenorphine/naloxone) Film Strips 8 milligrams/2 milligrams as medication assisted treatment of the opioid use disorder   with tolerability and satisfactory effect. There are no current general medical or psychiatric diagnoses or other relevant conditions noted in this case other than a history of depressive disorder in adolescence and a past history of tobacco dependence.  The patient has a history of a trial of treatment with Zubsolv resulting in adverse effects and a lack of efficacy.  The patient is monitored for abstinence and has maintained her sobriety while in treatment with the current clinician. The patient's physician have requested coverage for the Suboxone (buprenorphine/naloxone) Film Strips at the current dosage of 8/2 milligrams in view of a satisfactory clinical response, and as a formulary exception due to the adverse effects with Zubsolv.  The denial determination was on the basis of plan criteria for a coverage exception indicating that the patient must have failed a formulary alternative or that a formulary alternative would be contraindicated or pose a risk for an adverse effect. Formulary alternatives include buprenorphine-naloxone SL (sublingual) tablets or Zubsolv. The issue under review is Suboxone 8MG (milligrams) - 2 MG (milligrams) Film Strips.

The health plan should cover the proposed formulary exception for Suboxone Film Strips.
In this case, the patient is in outpatient substance use disorder treatment with medication-assisted treatment of opioid use disorder. The continued use of Suboxone Film Strips is clinically appropriate and reasonable in this case scenario, and the management of the patient's substance use disorder is in keeping with prevailing standards of professional practice, published guidelines, and Food and Drug Administration (FDA) indications for the use of Suboxone targeting opioid dependence as part of a comprehensive substance abuse treatment program. The patient has a documented history of intolerance and adverse effects with the formulary alternative Zubsolv, and has been effectively managed with the Suboxone film strips at the current dosing strategy.   To change from a medication that is well tolerated and effective to the remaining formulary alternative is not reasonable or in the patient's best interest as noted in the appeal, and a formulary exception is reasonable in this case scenario. Moreover, there is no evidence that the remaining formulary alternative will be effective or well tolerated versus the current treatment with Suboxone Film Strips. The appeal reasonably argues that the patient has been successfully treated with Suboxone Film Strips for many years, and indicates that to change to an alternative medication is not reasonable and would be detrimental to the patient and/or harm the patient.

Buprenorphine/naloxone as a maintenance therapy for treatment of opioid dependence has generally been evaluated in randomized, controlled trials evaluating safety and efficacy. This medication has been established by the Food and Drug Administration (FDA) as a safe and efficacious treatment; and, the data, as reflected in peer reviewed medical literature, supports this assertion. The patient's opioid use disorder treatment is consistent with prevailing standards of professional practice and published practice guidelines and the scientific literature, referenced below.  However, to change from a medication that is well tolerated and effective to the remaining formulary alternative is not reasonable.