Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Opioid dependence uncomplicated.
Treatment Suboxone 8-2 milligrams (mg) sublingual film.
The insurer denied coverage for Suboxone 8-2 milligrams (mg) sublingual film.
The denial is overturned.

This patient had a diagnosis of opioid dependence uncomplicated and reportedly was controlled on Suboxone 8-2 mg sublingual film. He reportedly tried Suboxone generic film, buprenorphone-naloxone sublingual film, Zubsolv, and Buprenorphine-naloxone tablets and had lack of efficacy and side effects. He reportedly was stable with the Suboxone 8-2 mg sublingual film and the request the physician assistant was to continue this.
  
This reviewer disagrees with the decision to deny coverage for Suboxone 8-2 mg sublingual film as this patient tried 3 other medications and had lack of efficacy and side effects as well as withdrawal symptoms but was well controlled with this medication. Suboxone and Zubsolv are brand names of the same drug combination, buprenorphine and naloxone. The FDA (Food and Drug Administration) reportedly approved Suboxone, Zubsolv, which is brand name Suboxone film, for maintenance treatment of opioid dependence, and buprenorphine-naloxone which is the generic of these medications. Suboxone is a formulation of buprenorphine which is a partial opioid receptor agonist and also naloxone which is a kappa opioid antagonist. This medication is reportedly used to help the patient in substance treatment or to level the suppression of opioid withdrawal. He reportedly was taking Suboxone brand name film with efficacy and no adverse effects, so it was recommended that he continue with this as he was at high risk for relapse and overdose and death if he relapsed. According to the medical records, there were no complaints, and his condition was well controlled so continue Suboxone 8-2 mg film. 

The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Substance Use Disorders reports that Methadone, Buprenorphine, and Buprenorphine/Naloxone which also have Suboxone and Zubsolv as brand name versions of this generic medication are all medications used for the maintenance treatment of opiate dependence or for opioid withdrawal. The brand name Suboxone 8 mg-2 mg film was considered standard treatment for opioid dependence or withdrawal and considered more effective than other formulary medications as he reportedly had lack of efficacy and withdrawal symptoms as well as side effects including nausea and even vomiting with formulary medications. It was reported that he took Suboxone generic film (Buprenorphine naloxone film) and had lack of efficacy, withdrawal symptoms, and side effects of nausea. It was reported that he took Zubsolv and had lack of efficacy, withdrawal symptoms including GI (gastroenterology) upset, restlessness, and irritable mood, as well as nausea and vomiting. It was reported that he took buprenorphine tablets and had lack of efficacy, withdrawal and nausea. He reportedly was considered at risk of continued use of opiates and at risk for overdose and severe withdrawal if he were to stop the medication, Suboxone 8-2 mg sublingual film, as that was the only effective medication for his opioid dependence, and he was able to tolerate it without side effects or withdrawal symptoms. The other medications tried including formulary medications were reported to be clinically ineffective and also to cause side effects. As a result, the recommendation is to overturned the previous decision and approve coverage for Suboxone 8-2 mg sublingual film daily for 30 days at a time. 

The insurer's denial of coverage for Formulary Exception for Suboxone 8-2 milligrams (mg) sublingual film is overturned.