The Need-to-Know Information on FDA Drug Approvals - December 2015
Posted: Dec 17 2015

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. 

New Brand Approvals
Drug Name Uses/Treatment Pricing Information Other Information
Nucala (mepolizumab subcutaneous injection) Monoclonal antibody indicated for treatment of severe asthma $3,000 per month
  • Drug Information: Humanized monoclonal antibody administered monthly by a healthcare professional to help control severe asthma
  • Target Population: Intended for use in patients who have a history of severe asthma attacks despite maintenance on other asthma therapies
  • Formulary Management: Considered non-preferred upon market entry
  • BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network
  • Clinical Concierge: Subject to Prior Authorization as a Specialty medication. Drug-specific and evidence-based PA criteria developed and applied by MedTrak’s Clinical Care Center to ensure appropriate utilization
  • Control Trak: Subject to Max Dollar and Max Dose edits
Genvoya (fixed-dose combination tablet of multiple HIV agents) Fixed-dose tablet indicated as a complete regiment for treatment of HIV Pricing information not yet available
  • Drug Information: Single tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, taken once daily as a complete HIV regimen
  • Formulary Management: Considered non-preferred upon market entry
  • BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network
  • Clinical Concierge: Subject to Prior Authorization as a Specialty medication. Drug-specific and evidence-based PA criteria developed and applied by MedTrak’s Clinical Care Center to ensure appropriate utilization
  • Control Trak: Subject to Max Dollar and Max Dose edits
Cotellic (cobimetinib tablet) Chemotherapy agent indicated for treatment of melanoma $7,275 per month
  • Drug Information: For use in combination with another chemotherapeutic agent for the treatment of certain types of melanoma
  • Formulary Management: Considered non-preferred upon market entry
  • BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network
  • Clinical Concierge: Subject to Prior Authorization as a Specialty medication. Drug-specific and evidence-based PA criteria developed and applied by MedTrak’s Clinical Care Center to ensure appropriate utilization
  • Control Trak: Subject to Max Dollar and Max Dose edits
Ninlaro (ixazomib capsule) Chemotherapy agent indicated for treatment of multiple myeloma $10,404 per month
  • Drug Information: For use in combination with two other agents, in patients who have received at least one prior therapy for multiple myeloma
  • Formulary Management: Considered non-preferred upon market entry
  • BIC SpecialtyRx: Comprehensive clinical management and competitive discounts via MedTrak’s BIC Specialty Pharmacy Network
  • Clinical Concierge: Subject to Prior Authorization as a Specialty medication. Drug-specific and evidence-based PA criteria developed and applied by MedTrak’s Clinical Care Center to ensure appropriate utilization
  • Control Trak: Subject to Max Dollar and Max Dose edits