New FDA Approved Drugs
Posted: Jun 10 2016

FDA Drug Approvals

Each month the FDA approves new medications, and below is a highlight of the most relevant new approvals and/or drugs which have the potential to impact your prescription plan. While the medications below have been evaluated and approved by the FDA, they may not enter the marketplace for several weeks or months. Therefore, pricing information for these medications is typically unavailable at the time of approval.   

New Brand Approvals
Drug NameUses/TreatmentPricing InformationOther Information
Zinbryta® (daclizumab) injectionTreatment for adult patients with relapsing forms of multiple sclerosis (MS).Pricing information not yet available• Drug Information: Daclizumab is a subcutaneous (just under the skin) monthly injection in a single-dose, prefilled syringe, which can be self-administered.  It should generally be used only in patients who have had an inadequate response to two or more other multiple sclerosis treatments.
• Formulary Management: Considered non-preferred upon market entry. 
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network. 
• Control Trak: Subject to Max Dollar and Max Dose edits.
Ocaliva® (obeticholic) oral tabletTreatment of primary biliary cholangitis (PBC)$228 per 5 or 10 mg tablet• Drug Information: Ocaliva is an orphan drug indicated for the treatment of primary biliary cholangitis (PBC). PBC is a rare condition resulting in cirrhosis of the liver.
• Formulary Management: Considered non-preferred upon market entry. 
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network.
• Control Trak: Subject to Max Dollar and Max Dose edits.
Probuphine® (buprenorphine) implantMaintenance treatment of opioid dependencePricing information not yet available• Drug Information: Probuphine implants are used as a maintenance therapy for opioid dependence in patients who have achieved and sustained prolonged clinical stability with another buprenorphine-containing product. Probuphine is inserted subdermally in the upper arm, and releases buprenorphine for six months. Implants must be inserted and removed by a health care provider only.
• Formulary Management: Considered non-preferred upon market entry
• BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network.
• Control Trak: Subject to Max Dollar and Max Dose edits.

The Clinical Care Center (CCC) is MedTrakRx’s comprehensive clinical solution to control costs and increase adherence for our Clients and Members. The Clinical Care Center is made up of 7 Steps to Improved Outcomes: Generics Plus, Formulary Management, Member & Client Education, RightChoice, Control Trak, Best-In-Class (BIC) SpecialtyRx, and Clinical Concierge.