The Need-to-Know Information on FDA Drug Approvals - November 2015
Posted: Nov 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
Aristada (aripiprazole lauroxil injectable suspension) Atypical antipsychotic indicated for the treatment of schizophrenia Variable and dose dependent;
Ranges from $1,260 to $2,500 per month
  • Drug Information: Extended-release, injectable formulation of aripiprazole given once monthly to reduce risk of medication nonadherence
  • Target Population: Intended for use in patients who are established on oral aripiprazole therapy
  • 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.
Veltassa (patiromer oral suspension) Potassium binder indicated for treatment of hyperkalemia Pricing information not yet available
  • Drug Information: Medication binds to potassium to reduce potassium blood levels. Should not be used in emergency settings due to delayed onset of action
  • Formulary Management: Considered non-preferred upon market entry
  • Control Trak: Subject to Max Dollar and Max Dose edits
Vivlodex (meloxicam capsules) NSAID indicated for management of osteoarthritis (OA) pain Pricing information not yet available
  • Drug Information: Carries black box warning regarding cardiovascular and gastrointestinal risk (similar to other NSAIDS)
  • Formulary Management: Considered non-preferred upon market entry
  • Clinical Concierge: MedTrak’s Clinical Care Center is currently evaluating potential management strategies including PA and inclusion on Non-Essential Drug List
  • Control Trak: Subject to Max Dollar and Max Dose edits
Yondelis Alkyating agent indicated for treatment of liposarcoma or leiomyosarcoma Variable and dose-dependent (determined by patient body surface area)
  • Drug Information: Infused medication that treats malignancies (cancers) of connective tissue
  • Target Population: Intended for use in patients who have received a prior anthracycline-containing regimen
  • 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

The Clinical Care Center (CCC) is MedTrak’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.