Patrick Kurunwune, PharmD Candidate Cone Health Family Medicine News You Can Use… Patrick Kurunwune, PharmD Candidate Alyson Leonard, PharmD Pete Koval, PharmD Cone Health Family Medicine April, 2017

FDA Approval Qtern® (dapagliflozin and saxagliptin) The first FDA approved DPP-4 inhibitor and SGLT-2 inhibitor combination Formulation /Dosing Tablet: 10 mg dapagliflozin/5 mg saxagliptin FDA approved 2/28/2017 however, no availability date at this time https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209091s000lbl.pdf

FDA Approval Emflaza® (deflazacourt) Formulation/Dosing Pricing Corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older Formulation/Dosing Tablets: 6mg, 18mg, 30mg, and 36mg Oral Suspension: 22.75 mg/mL Pricing $89,000 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf

FDA Approval Dupixent® (dupilumab) Formulation/ Dosing Pricing injection to treat adults with moderate-to- severe eczema Class: Interleukin-4 Receptor Antagonist; Monoclonal Antibody Formulation/ Dosing Injection: 300 mg/2 mL Pricing $37,000 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm

FDA Approval Ocrevus® (ocrelizumab) Formulation/Dosing Pricing First drug approved by the FDA for primary progressive multiple sclerosis (PPMS) Class: Monoclonal Antibody Formulation/Dosing Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial Pricing $65,000 per year (2 shots per year) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17

Viberzi: FDA Drug Safety Viberzi® (eluxadoline) For the treatment of IBS FDA Drug Safety Alert Do NOT prescribe Viberzi (eluxadoline) in patients who do not have a gallbladder FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm

Basaglar® – Insulin Glargine Biosimilar Insulin Glargine AKA “Lantus®” Now available in the market place! Dose conversion – Direct 1:1 Consider when insurance dictates At this time insurance coverage is in transition Expect plans to consider this as price appears to be competitive $330 vs $ 380 (Lantus Solostar) for 5 pens Pricing from GoodRx.com - Accessed 4/3/2017

Biosimilar Coming Soon! Currently about 30 “biologic specialty drugs” pending approvals at the FDA 73 biologic patent expirations by 2021 Biologic “biosimilars” serve as competing brands Biosimilar Naming (FDA 1/17) Named by their reference biologics’ generic names plus a four-letter suffix, such as “filgrastim-sndz” for Sandoz’s biosimilar http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/fda-approvals-specialty-drugs-pick-2017