FDA Drug Update
Posted: Nov 14 2016

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
Amjevita™
(adalimumab-ATTO) injectable
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years or older, psoriatic arthritis, ankylosing spondylitis, adults Crohn’s disease, ulcerative colitis, and plaque psoriasisPricing information not yet available• Drug Information: Amjevita is a tumor necrosis factor (TNF) blocker and biosimilar to Humira. Launch date for Amjevita has not been determined.
• Formulary Management: Considered non-preferred upon market entry (pending clinical evaluation). 
• BIC Specialty Rx: Comprehensive clinical management and competitive discounts via MedTrakRx’s BIC Specialty Pharmacy Network.
• Control Trak: Subject to Max Dollar and Max Dose edits.
Yosprala™
(aspirin and omeprazole)
tablet
Treatment of patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcersAWP $180/month• Drug Information: Yosprala is the combination of aspirin and the PPI omeprazole.
• Formulary Management: Considered non-preferred upon market entry (pending clinical evaluation). 
• Clinical Concierge: Yosprala is being added to MedTrak’s Non-Essential Drug Program, since both ingredients are available generically and are very inexpensive.
Lartruvo®
(olaratumab)


Treatment of soft tissue sarcoma.Pricing information not yet available • Drug Information: Olaratumab is an IV chemotherapeutic agent indicated in combination with doxorubicin.
• 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:
    o Subject to Max Dollar & Max Dose edits.
    o Subject to prior authorization as a component of the specialty program.
Carnexiv®
(carbamazepine)
EpilepsyPricing information not yet available• Drug Information: Indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible.  Anticipated availability of early 2017.
• 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 & Max Dose edits.

New Generic Approvals
Drug NameUses/TreatmentsPricing InformationOther Information
Abacavir Sulfate; Lamivudine TabletHuman Immunodeficiency Virus (HIV) Pricing information not yet available• Drug Information: Abacavir sulfate; lamivudine is the generic for Epzicom and is used in combination with other antiretroviral agents to treat HIV infection.
• 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.
OlmesartanHypertensionPricing information not yet available• Drug Information: Olmesartan is the generic for Benicar.  It is used alone or with other antihypertensive agents to lower blood pressure.
• Control Trak: Subject to Max Dollar & Max Dose edits.
• Clinical Concierge: Currently a step-two agent under the Step Therapy Program.  Prices will continue to be monitored and adjustments will be made when appropriate.

New Indications
Drug NameUses/TreatmentPricing InformationOther Information
Stelara®
(ustekinumab) injectable
Treatment of Crohn's diseaseAWP approximately $21,200 every 8 weeks for Crohn''s indication• Drug Information: Stelara is an interleukin (IL)-12 and IL-23 antagonist and has been granted extended indication approval for Crohn’s disease. Dosing is indication specific as well as weight-based.
• Formulary Management: Considered preferred upon market entry.
• BIC Specialty Rx: Comprehensive clinical management and competitive discounts via MedTrakRx’s BIC Specialty Pharmacy Network.
• 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.