Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Opiate Use Disorder

Treatment: Buprenorphine-Naloxone Sublingual (SL) Film

The insurer denied coverage for buprenorphine-naloxone sublingual (SL) film

The denial is overturned

This is a patient with a diagnosis of Opiate Use Disorder and a history of legal charges that would reportedly be dismissed if she completed a treatment program. It was reported that she was engaging and coming to meetings. She reportedly was a secretary. She was noted to have had difficulty taking Suboxone tablets. It was reported that she had difficulty and adverse reactions to taking the recommended formulary medication alternatives-Subsolv and Buprenorphine-naloxone tablets.

The insurer denied coverage for formulary exception for buprenorphine-naloxone sublingual (SL) film. They stated that formulary exception is when one has tried and had either inadequate treatment response or intolerance to the required formulary medications, or when there is expected adverse reactions or contraindications. The recommended formulary medications were Zubsolv and Buprenorphine-naloxone tablets. 

The records submitted have provided enough specific evidence to support that the patient could not tolerate the recommended formulary medications, Zubsolv and Buprenorphine-naloxone tablets. The provider documented that this patient took the 2 formulary recommended medications and had adverse effects from them. It was reported that she had difficulty taking Suboxone tablets. It was reported that she had difficulty and adverse reactions to taking the recommended formulary medication alternatives-Subsolv and Buprenorphine-naloxone tablets. She reportedly had an adverse reaction to Subsolv requiring hospitalization so that was discontinued. She also reportedly had an adverse reaction to Buprenorphine-naloxone tablets as she stated that she was gagging and that it tasted like rotten antibiotics so adherence was a problem. It also was reported that she could not take Suboxone tablets so she did require buprenorphine-naloxone sublingual (SL) film. 

The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Substance Use Disorders reports that there are two forms of the sublingual tablet: a buprenorphine-only tablet and a combination tablet of buprenorphine and the opioid antagonist naloxone which is Suboxone. Either one is appropriate for treatment of opioid dependence. It states that both forms of buprenorphine tablets are schedule III medications in the United States. Like methadone, buprenorphine can suppress opioid withdrawal and block the effects of other opioids. Another notable difference from methadone is that overdose with buprenorphine or buprenorphine-naloxone generally does not produce significant respiratory depression which probably reflects buprenorphine's partial agonist effects. 

The requested medication of buprenorphine-naloxone sublingual (SL) film is likely to be more effective than formulary medications as she could not tolerate tablets so she required sublingual buprenorphine-naloxone. 

The requested drug (buprenorphine-naloxone sublingual (SL) film) is expected to produce a more clinically beneficial outcome than the formulary alternatives which have been tried and failed.

The insurer's denial of coverage for Request for Formulary Exception for buprenorphine-naloxone sublingual (SL) film is overturned.