Drug Guide. April New Specialty Drug Approvals. New Formulations for Existing Drugs

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1 April 2013 The MedTrak Drug Guide provides a monthly update on recent approvals by the Food and Drug Administration (FDA). Use the chart below as a valuable reference tool. Additional detailed information can be found on the following pages. Product Name Drug Class (Ingredient Name) New Brand Approvals Invokana Tablet Quartette Tablet Anti-diabetic Oral contraceptive New Specialty Drug Approvals Tecfidera Capsule Neurological Similar Drugs Uses/Treatment Impact to Benefit N/A Type 2 diabetes First in class diabetes drug used to improve glucose control in adults with type 2 diabetes. Will be non-formulary upon market entry. N/A Contraception First ascending-dose extended regimen birth control. Designed to minimize break through bleeding (BTB) between periods, a reason many women discontinue extended regimens. Gilenya Aubagio New Formulations for Existing Drugs Aciphex 5 mg & 10 mg Capsule Karbinal ER Suspension Tobi Podhaler Antiulcer Agent Aciphex 20 mg Antihistamine Antibacterial Carbinoxamin e Solution Relapsing Remitting Multiple Sclerosis (RRMS) Ulcer, gastroesophageal reflux disease (GERD) Sealsona and perennial allergies Another blockbuster oral for use in patients with relapsing forms of multiple sclerosis. Will be subject to MedTrak s Prior Authorization (PA) process for specialty medications. Lower dosage forms approved for use in pediatric patients (ages 1 11) for the treatment of GERD. Will be nonformulary upon market entry. Aciphex 20 mg scheduled to go generic at the end of Extended-release version of carbinoxamine solution. Will reduce dosing frequency from 3 or 4 times per day to twice a day. Not yet commercially available. Will be nonformulary upon market entry. Tobi Inhalation Cystic fibrosis (CF) Specialty drug used for the management of cystic fibrosis (CF) in patients with Pseudomonas aeruginosa. Only nebulized version of medication available prior to approval of Podhaler. See following pages for further description of CF and the use of Tobi in this population of patients.

2 Drug Name New Generic Approvals Amlodipine/Valsartan Tablet Drug Class Blood pressure Brand Equivalent Exforge Uses/Treatment High blood pressure Impact to Benefit Not yet commercially available. No significant impact to plan anticipated. Eszopiclone Tablet Sleep Agent Lunesta Insomnia Generic approved but not yet available for this blockbuster sleep. Will be a single-source generic upon market entry; no significant savings anticipated initially. Once available as a multisource generic (typically after 6 month exclusivity), plans should see significant savings. Desvenlafaxine ER Tablet Fenofibric Acid Tablet Fluvoxamine Extended-Release Capsule Travoprost Ophthalmic Solution Zoledronic Acid (4 mg/5 ml) Zoledronic Acid (5 mg/5 ml) Antidepressant Pristiq Depression Not yet commercially available. Will be a single-source generic upon market entry; no significant savings anticipated until after 6 month exclusivity period. Cholesterol Agent Psychiatric Glaucoma Agent Bone resorption inhibitor Bone resorption inhibitor Trilipix High triglycerides Not yet commercially available. No significant impact to plan anticipated as a single-source generic. Most new generics in this class have remained higher-priced generics. Luvox CR Travatan Z Zometa Injection Reclast Injection Obsessivecomplulsive disorder (OCD) & social phobia (social anxiety disorder) Glaucoma Ocular pressure Hypercalcemia of malignancy and bone metastases from solid tumors Osteopenia and osteoporosis No significant impact to plan expected. Currently available as a single-source generic and only 15% less than the cost of the brand. Not yet commercially available. Not a highly utilized drug across MedTrak Book of Business; no significant savings anticipated with this approval. Considered a specialty medication and administered via IV infusion. Requests for coverage more often seen on the medical side of the plan. Will be subject to plan design edits as well as MedTrak s PA process for specialty injectable medications if requested under pharmacy benefit. Zoledronic Acid is the active ingredient in the specialty drug Reclast, given as a once yearly infusion. Not yet commercially available. Requests for coverage more often seen on the medical side. Will be subject to plan design edits as well as MedTrak s PA process for specialty injectable medications if requested under pharmacy benefit.

3 New Approvals: Brand Medications that are new to the marketplace Invokana Tablet: Invokana is a first in class sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated to improve glycemic control in adults with type 2 diabetes. Invokana will be considered a nonformulary drug upon market entry. Quartette Tablet: Quartette oral contraceptive is the first ascending-dose extended regimen birth control. Other extended cycle birth controls are already commercially available Seasonale, Seasonique, LoSeasonique, and generics. Quartette is designed to minimize disruptive and unscheduled bleeding in between periods, which is a reason many women discontinue extended regimens. Quartette will be considered a non-formulary drug upon market entry. New Approvals Specialty: Typically Brand Drugs, these medications are new to the marketplace Tecfidera Capsule: Multiple Sclerosis (MS) is an auto-immune disease in which the body s immune system attacks the insulation surrounding the nerve fibers causing symptoms such as blurred vision, fatigue, walking difficulties, loss of sensation, speech impediment, dizziness, etc. Approximately 350,000 Americans and more than 2 million individuals worldwide have MS. Patients with relapsingremitting MS (RRMS) make up approximately 65%-80% of the MS population. In RRMS, patients may experience a series of attacks followed by periods of complete or partial remission until another relapse occurs. Tecfidera is specifically indicated for patients with RRMS and will be subject to MedTrak s Prior Authorization (PA) process for specialty medications. New Indications for Existing Drugs: Already available in the marketplace, these medications have been approved for additional treatment options None to Report New Formulations for Existing Drugs Aciphex 5 mg & 10 mg Tablet: New, lower strengths of the existing drug Aciphex have been approved for use in pediatric patients. The lower strengths will provide options for patients ages 1 to 11 who require treatment for gastroesophageal reflux disease (GERD). The generic for Aciphex 20 mg, a known blockbuster, is anticipated to launch in the third quarter of Karbinal ER Suspension: Karbinal extended-release suspension contains the active ingredient carbinoxamine, which is an antihistamine used to treat seasonal and perennial allergic rhinitis in adults and children 2 years and older. Carbinoxamine is already commercially available in an immediaterelease solution. This new formulation is an extended-release formulation that will allow for less frequent

4 dosing (twice per day vs. 3-4 times per day). Karbinal ER suspension will be non-formulary upon market entry. Tobi Podhaler: Cystic fibrosis (CF) is a genetic disorder that predominantly affects infants, children, and young adults. With a prominence of 1 case per 3,200 newborns in the US alone, CF is characterized as the most common life-limiting genetic disorder in Caucasians. Because CF causes the mucus in all epithelial lining fluid to be stickier to bacteria, patients suffering with CF are more prone to infection and inflammation, particularly in the areas of the lung, pancreas, and GI tract. Tobi (tobramycin) is an antibacterial commonly used in CF patients with the bacteria Pseudomonas aeruginosa. Prior to the approval of Tobi Podhaler, patients in need of tobramycin have used a nebulized version of Tobi. The Tobi Podhaler will provide some patients a more convenient dosing option. Since Tobi is considered a specialty medication, it will be subject to MedTrak s PA process for specialty medications. New Generic Approvals: Drugs previously available only as a brand medication Amlodipine/Valsartan Tablet (Exforge): Amlodipine/valsartan is a combination product used to treat adults with high blood pressure (hypertension). This new generic is not yet commercially available. Desvenlafaxine ER Tablet (Pristiq): Desvenlafaxine is in a class of antidepressants known as the serotonin-norepinephrine reuptake inhibitors or (SNRIs) and is used to treat major depressive disorder. Pristiq is the second drug in this class to be approved generically. The first was Effexor/XR, which is the precursor of desvenlafaxine. Cymbalta s generic, a third SNRI, is anticipated to be approved later this year. Desvenlafaxine ER is not yet commercially available, and plans may not see significant savings until desvenlafaxine ER is available as a multi-source generic. Eszopiclone Tablet (Lunesta): Eszopiclone, an used to treat insomnia, has gained recent FDA approval but is not yet commercially available. Currently, the brand name Lunesta is considered a Step Two drug in MedTrak s Step Therapy Program. If the new generic remains high costing, it will also be a Step Two option until its price drops considerably. Fenofibric Acid Tablet (Trilipix): A new generic for Trilipix has been recently approved but is not commercially available. Fenofibric acid is a lipid-lowering specifically approved to treat high tryiglyceride levels and high lipid (fat) in the blood. No significant savings to the plan is anticipated since fenofibric acid has been approved as a single-source generic. Fluvoxamine ER Capsule (Luvox CR): Fluvoxamine is an antidepressant in the serotonin reuptake inhibitor SSRI category that is used to treat obsessive-compulsive disorder (OCD) and social phobia (social anxiety disorder). Since Luvox CR is considered a Step Two drug in MedTrak s Step Therapy Program, the newly approved single-source generic will also be considered Step Two until it becomes multi-source and the price drops significantly.

5 Travoprost Opthalmic Solution (Travatan Z): Travoprost is used to reduce intraocular pressure (IOP) in patients with certain types of glaucoma or ocular hypertension. This new generic is not yet commercially available. Zoledronic Acid Injection 4 mg/5 ml (Zometa): Zoledronic acid is a specialty drug used to treat hypercalcemia of malignancy, patients with multiple myeloma taking standard chemotherapy, and patients with documented bone metastases from solid tumors. Requests for coverage for this drug are more likely to be seen on the medical side of the plan, since zoledronic acid is an infused medication. If it is requested under the prescription benefit, zoledronic acid will be subject to plan design edits for injectable medications, as well as MedTrak s PA process for specialty medications. Zoledronic Acid Injection 5 mg/5 ml (Reclast): The newly approved generic for Reclast (zoledronic acid 5 mg/5 ml) has been approved but is not yet commercially available. This version of zoledronic acid is approved to treat osteoporosis, osteopenia (pre-osteoporosis), and Paget s disease, a bone disease that causes bones to grow larger and weaker than normal. As stated above, requests for coverage are more likely on the medical side of the plan since it s an IV infused medication. If it is requested under the prescription benefit, zoledronic acid will be subject to plan design edits for injectable medications, as well as MedTrak s PA process for specialty medications. FDA Drug Alerts None to Report Note: The drugs listed in this report have recently been approved by the Food and Drug Administration (FDA). Most drugs reach the market place very quickly after approval. However, there are situations where the availability of a newly approved drug could be delayed.