New FDA Approved Drugs
Posted: May 19 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 Name

Uses/Treatment

Pricing Information

Other Information

Cabometyx® (cabozantinib) tablet

Treatment of advanced renal cell carcinoma (RCC) in patients who have received prior therapy

Estimates have projected a wholesale acquisition of approximately $13,750 per month

·         Drug Information: cabozantinib is an oral chemotherapeutic agent indicated as second-line therapy for patients with kidney cancer (RCC).  The recommended dose is 60 mg by mouth, once daily.

·         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. Will be evaluated for Oncology Split-Fill Program once more post-marketing data has been collected.

Descovy® (emtricitabine; tenofovir alafenamide) tablet

Treatment of HIV-1 infection in adults and pediatric patients 12 years and older

Pricing information not yet available

·         Drug Information: emtricitabine/tenofovir alafenamide combination tablet is an oral antiretroviral therapy for HIV-1 infection. The recommended dose is 1 tablet by mouth, once daily.

·         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.

Inflectra® (infliximab-dyyb) injection

Treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis

Pricing information not yet available

·         Drug Information: infliximab-dyyb has been approved for various inflammatory diseases (see uses/treatment). It is the second biosimilar to be approved. Market availability is pending.

·         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.