Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Opiate Disorder

Treatment: suboxone film (buprenorphine-naloxone)

The insurer denied coverage for suboxone film (buprenorphine-naloxone).

The denial is overturned.

This patient reportedly had a diagnosis of Opiate Disorder and was taking Suboxone Film (Buprenorphine-Naloxone) with efficacy. It was reported that the patient had tried the formulary medication, Zubsolv in the past with intolerable side effects. It was reported that the patient has been taking Suboxone Film (Buprenorphine-Naloxone) for many years with efficacy and tolerability. 
    
The reviewer disagrees with the decision to deny coverage for Suboxone Film (Buprenorphine-Naloxone) as not medically necessary treatment as this patient did reportedly try a preferred formulary medication, Buprenorphine-Naloxone sublingual tablet, Zubsolv. The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Substance Use Disorders reports that Methadone, levo-a-acetylmethadol (LAAM), Buprenorphine, and Buprenorphine/Naloxone which is Suboxone are all medications used for the maintenance treatment of opiate dependence or for opioid withdrawal. In this case this patient had tried the formulary medication, Buprenorphine-Naloxone sublingual tablet, Zubsolv, which is brand name for buprenorphine naloxone sublingual, in the past with intolerable side effects. The Food and Drug Administration (FDA) reportedly approved Zubsolv for maintenance treatment of opioid dependence in 2013. Zubsolv is a sublingual table formulation of buprenorphine which is a partial mu-opioid receptor agonist and also naloxone which is a kappa opioid antagonist This medication reportedly is used to help the patient in substance treatment or to level the suppression of opioid withdrawal. However, even though this was considered formulary medication for treatment of the patient's opiate use disorder, the patient reportedly had intolerable side effects, so the patient was now taking Suboxone film (Buprenorphine-Naloxone) which is also an FDA approved medication maintenance treatment of opioid dependence and considered medically necessary treatment for opiate use disorder maintenance treatment. The patient reportedly was being successfully treated with this medication so it was considered medically necessary for the patient to continue with this treatment. Because the patient did not have intolerable side effects and had reported efficacy in the maintenance treatment of their opiate use disorder, this medication, Suboxone Film (Buprenorphine-Naloxone), which is an FDA approved medication for maintenance treatment of opiate use disorder, was considered to be more effective than the formulary medication that they had reported intolerable side effects to. The formulary medication, Zubsolv, was more likely to cause another adverse reaction and intolerable side effects as it was reported that this patient had intolerable side effects when taking the formulary medication, Zubsolv, in the past. As a result, the recommendation is to reverse the previous decision and approve coverage for the request for Suboxone Film (Buprenorphine-Naloxone). It did not appear that the health care plan acted reasonably or in the best interests of the patient then.  

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for suboxone film (buprenorphine-naloxone) is reversed.