Orexo: Change of policy positive for Zubsolv
Redeye Research Note 2021/01/20
On January 12th the US Department of Human and Health Services issued an announcement that it eliminates the requirement for physicians with a DEA registration to dispense medicines – to have a separate waiver to prescribe buprenorphine for opioid use disorder (OUD) treatment. This means that hundreds of thousands more doctors around the US will be able to prescribe buprenorphine-naloxone tablets to treat OUD patients (albeit only 30 patients each, except emergency and hospital doctors). Currently, less than 4% of all doctors in the US have undergone the additional training and certification required to be able to prescribe buprenorphine medications. The new regulation will make the life-saving medicine widely accessible.
As a background to this decision, the DHHS points out that for the 12 months that ended in May 2020 there were more than 81,000 overdose deaths, an 18% year on year increase, and access to “medication-assisted-treatment (MAT), including buprenorphine that can be prescribed in office-based settings, is the gold-standard” of narcotic use disorder treatment. Previously, the dispersion of MAT was regulated through an additional DEA registration, obtained annually, for the dispense of narcotic drugs to individuals for maintenance treatment or detoxification (or both). It does not apply to methadone.
We believe this decision to improve access to MAT has been coordinated with the incoming administration and likely to remain in place. We expect it to have a positive impact on Zubsolv revenues. As the MAT must include counselling, we will also see a positive impact on the digital therapy revenues for modia and vorvida.