New Drugs Reviewed by CPG January 11, 2016

Home , Uridine triacetate

New Drugs Reviewed by CPG January 11, 2016 (Original New Drug Applications: FDA) Generic Name Trade Name Indication(s) CPG Action Cangrelor Injection Kengreal Hematological Agents: In accordance with Antiplatelet Agents: the SCA. Platelet P2Y12 Receptor Antagonists. Indicated as an adjunct to percutaneous coronary intervention to reduce the risk of periprocedural MI. Deoxycholic Acid Kybella Endocrine & Metabolic CTP holder may Injection Agents: Lipolytic Agents NOT prescribe. (new classification). Indicated to improve the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Tiotropium Bromide/ Stiolto Respiratory Agents: CTP holder may Olodaterol Respiratory Inhalant prescribe. Hydrochloride Products. Inhalation Indicated for maintenance treatment of airflow obstruction in patients with COPD. Brexpiprazole Oral Rexulti Central Nervous System CTP holder may Agents: Antipsychotic prescribe. Agents: Quinolinone Derivatives. Indicated for treatment of major depressive disorder and schizophrenia. Daclatasvir Daklinza Anti-Infectives, In accordance with Dihydrochloride Oral Systemic: Antiviral the SCA. Agents: Hepatitis C Virus Direct-Acting Antiviral (new classification). Indicated for treatment of chronic hepatitis C virus infection in combination with sofosbuvir.

1 New Drugs January 2016

Ombitasvir/ Technivie Anti-Infectives, In accordance with Paritaprevir/ Ritonavir Systemic: Antiviral the SCA. Oral Agents: Hepatitis C Virus Direct-Acting Antiviral (new classification). Indicated for treatment of chronic hepatitis C virus without cirrhosis in combination with ribavirin. Fibrin Sealant, Raplixa Dermatologic Agents: CTP holder may Human Topical Fibrin Agents. prescribe. Indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

Sonidegib Oral Odomzo Antineoplastic Agents: CTP holder may Miscellaneous NOT prescribe. Antineoplastic Agents. Indicated for treatment of adult patients with locally advanced basal cell carcinoma. Ferric Pyrophosphate Triferic Nutrients & Nutritional CTP holder may Citrate Injection Agents: Trace Elements. prescribe. Indicated for replacement of iron to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

Flibanserin Oral Addyi Central Nervous System In accordance with Agents: Mixed 5-HT1A the SCA. Agonist/ 5-HT2A Antagonist (new classification). Indicated for treatment of premenopausal women with hypoactive sexual desire disorder.

2 New Drugs January 2016

Factor IX Alprolix Hematological Agents: In accordance with Recombinant Antihemophilic Agents. the SCA. Injection Indicated for prevention and control of bleeding in patients with factor IX deficiency.

Ariprpraxole Lauroxil Aristada Central Nervous System CTP holder may Injection Agents: Antipsychotic prescribe. Agents. Indicated for treatment of schizophrenia. Ferric Citrate Oral Auryxia Nutrients & Nutritional CTP holder may Agents: Trace Elements. prescribe. Indicated for the control of serum phosphorus levels in patients with chronic kidney disease. Eliglustat Tartrate Cerdelga Endocrine & Metabolic In accordance with Oral Agents: the SCA. Glucosylceramide Synthase Inhibitor. Indicated for the treatment of adult patients with Gaucher disease type 1. Cholic Acid Oral Cholbam Endocrine & Metabolic In accordance with Agents: Bile Acids (new the SCA. classification). Indicated for the treatment of bile acid synthesis disorders due to singly enzyme deficits. Ivabradine Oral Corlanor Cardiovascular Agents: In accordance with Miscellaneous the SCA. Antianginal Agents. Indicated to reduce the risk of hospitalization for worsening heart failure patients. Cobimetinib Cotellic Antineoplastic Agents: CTP holder may Fumarate Oral Kinase Inhibitors. NOT prescribe. Indicated for treatment of unresectable or metastatic melanoma in patients with a BRAF V600E or V600K mutation.

3 New Drugs January 2016

Antihemophilic Eloctate Hematological Agents: In accordance with Factor, Recombinant Antihemophilic Agents. the SCA. Injection Indicated for routine prophylactic treatment to reduce the frequency of bleeding episodes in adults and children with hemophilia A.

Sacubitril/Valsartan Entresto Cardiovascular Agents: CTP holder may Oral Antihypertensive prescribe. Combinations. Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure patients with chronic heart failure and reduced ejection fraction.

Elvitegravir/ Genvoya Anti-Infective Agents, In accordance with Cobicistat/ Systemic: Antiretroviral the SCA. Emtricitabine/ Agents: Miscellaneous Tenofovir Antiretroviral Alafenamide Combinations. Fumarate Oral Indicated for treatment of HIV-1 infection and adults and pediatric patients 12 years and older. Talimogene Imlygic Antineoplastic Agents: CTP holder may Laherparepvec Oncolytic Virus (new NOT prescribe. Injection classification). Indicated for treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patient with melanoma recurrent after initial surgery.

Olaparib Oral Lynparza Antineoplastic Agents: CTP holder may Parp Enzymes Inhibitor. NOT prescribe. Indicated for treatment of deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer.

4 New Drugs January 2016

Phenylephrine Omidria Ophthalmic & Otic CTP holder may Hydrochloride/ Agents: Ophthalmic prescribe. Ketorolac Surgical Adjunts. Tromethamine Indicated to prevent Intraocular. intraoperative miosis and to reduce postoperative ocular pain during cataract surgery or intraocular lens replacement. Lumacaftor/ Ivacaftor Orkambi Endocrine & Metabolic In accordance with Oral Agents: Cystic Fibrosis the SCA. Transmembrane Regulator Protein (new classification). Indicated for treatment of cystic fibrosis. Alirocumab Injection Praluent Cardiovascular Agents: CTP holder may Antihyperlipidemic prescribe. Agents. Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with familiar hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. Idarucizumab Praxbind Endocrine & Metabolic In accordance with Injection Agents: Detoxification the SCA. Agents: Antidotes. Indicated for reversal of the anticoagulant effects of dabigatran for emergency surgery/ urgent procedures or in life-threatening or uncontrolled bleeding. Perindopril/ Prestalia Cardiovascular Agents: CTP holder may Amlodipine Oral Antihypertensive prescribe. Combinations. Indicated for treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy in patients who

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require multiple antihypertensives for adequate control . Evolocumab Injection Repatha Cardiovascular Agents: CTP holder may Antihyperlipidemic prescribe. Agents. Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia. Asfotase Alfa Strensiq Endocrine & Metabolic CTP holder may Injection Agents: Asfotase Alfa prescribe. (new classification). Indicated for treatment of patients with perinatal/infantile – and juvenile-onset hypophosphatasia. Empagliflozin/ Synjardy Endocrine & Metabolic CTP holder may Metformin Agents: Antidiabetic prescribe. Hydrochloride Oral Agents: Antidiabetic Combination Products. Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Oxycodone Targiniq ER Central Nervous System In accordance with Hydrochloride/ Agents: Opioid the SCA. Naloxone Analgesic Combinations. Hydrochloride Oral Indicated for the management of severe pain requiring daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Abacavir Sulfate/ Triumeq Anti-Infectives, In accordance with Dolutegravir Sodium/ Systemic: Antiretroviral the SCA. Lamivudine Oral Agents: Miscellaneous Antiretroviral Combinations. Indicated for treatment of HIV-1 infection.

6 New Drugs January 2016

Eluxadoline Oral Viberzi Gastrointestinal Agents: In accordance with Eluxadoline (new the SCA. classification). Indicated for treatment of irritable bowel syndrome with diarrhea in adults. Oxycodone/ Xartemis XR Central Nervous System In accordance with Acetaminophen Oral Agents: Schedule II the SCA. (Schedule II) Analgesics. Indicated for management of acute pain severe enough to require opioid treatment while reducing the risk of serous adverse outcomes resulting for inappropriate prescribing, misuse, and abuse. Uridine Triacetate Xuriden Endocrine & Metabolic CTP holder may Oral Agents: Uridine prescribe. Triacetate (new classification). Indicated for treatment of hereditary orotic aciduria. Trabectedin Injection Yondelis Antineoplastic Agents: CTP holder may Miscellaneous NOT prescribe. Antineoplastics. Indicated for treatment of unresectable or metastatic soft issue sarcoma. Antihemophilic Nuwiq Hematologic Agents: In accordance with Factor, Human Antihemophilic Agents. the SCA. Indicated for the prevention and control of hemorrhagic episodes in patients with classical hemophilia in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Daratumumab Darzalex Antineoplastic Agents: CTP holder may Monoclonal Antibodies. NOT prescribe. Indicated for the treatment of patients with multiple myeloma.

7 New Drugs January 2016

Antihemophilic Factor Adynovate Hematological Agents: In accordance with Recombinant Antihemophilic Agents. the SCA. Indicated for on-demand treatment and control of bleeding episodes and for routine prophylaxis to reduce the frequency of bleeding episodes.

Osimertinib Oral Tagrisso Antineoplastic Agents: CTP holder may Kinase Inhibitors. NOT prescribe. Indicated for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation positive non- small cell lung cancer.

Mepolizumab Nucala Respiratory Agents: CTP holder may Injection Monoclonal Antibodies. prescribe. Indicated for add-on maintenance treatment of patients with severe asthma.

Indacaterol/ Utibron Respiratory Agents: CTP holder may Glycopyrrolate Oral Bronchodilators. prescribe. Inhalation Indicated for the long- term maintenance treatment of airflow obstruction in patients with COPD.

Irinotecan Liposome Onivyde Antineoplastic Agents: CTP holder may Injection Topoisomerase Inhibitor. NOT prescribe. Indicated in combination with fluorouracil and leucovorin for treatment of patients with advanced metastatic pancreatic cancer.

Patiromer Oral Veltassa Cardiovascular Agents: CTP holder may Potassium Removing prescribe. Agents. Indicated for treatment

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of hyperkalemia.

Coagulation Factor X, Coagadex Hematological Agents: In accordance with Human Antihemophilic Agents. the SCA. Indicated for on-demand treatment and control of bleeding episodes in patients with hereditary factor X deficiency.

Insulin Degludec Tresiba Endocrine & Metabolic CTP holder may Agents: Antidiabetic prescribe. Agents: Insulin. Long acting insulin indicated to improve glycemic control in adults with diabetes mellitus. Insulin Degludec/ Ryzodeg 70/30 Endocrine & Metabolic CTP holder may Insulin Aspart Agents: Antidiabetic prescribe. Agents: Insulin. Indicated to improve glycemic control in adults with diabetes mellitus.

Trifluridine/ Tipiracil Lonsurf Antineoplastic Agents: CTP holder may Antimetabolites. NOT prescribe. Indicated for the treatment of patients with metastatic colorectal cancer. Cariprazine Vraylar Central Nervous System CTP holder may Agents: Antipsychotic prescribe. Agents. Indicated for the treatment of adults with schizophrenia and short- term treatment of manic or mixed episodes associated with bipolar 1 disorder. Uridine Triacetate Xuriden Endocrine and CTP holder may Metabolic: treatment of prescribe. hereditary orotic aciduria

Gefitinib Oral Iressa Antineoplastic Agents: CTP holder may Kinase Inhibitors: NOT prescribe. Tyrosine Kinase Inhibitors.

9 New Drugs January 2016

Rolapitant Varubi Central Nervous System CTP holder may Agents:Antiemtic/Anti- prescribe. vertigo Agents. Indicated in combination with other antiemtic agents, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of chemotherapy.

New Drugs Indications/ Warnings Reviewed by CPG January 2016 (New Drug Indications/ Black Box Warnings: FDA) Generic Name Trade Name Indication(s) CPG Action/Date Perampanel Oral Fycompa Central Nervous System Current: Agents: Anticonvulsants. CTP holder may New indication for prescribe. treatment of primary generalized tonic-clonic January 11, 2016 seizures. No Change Aflibercept Eylea Ophthalmic & Otic Current: Ophthalmic Agents: Selective In accordance with Vascular Endothelia the SCA. Growth Factor Antagonists. January 11, 2016 New indication of No Change treatment of diabetic retinopathy in patients with diabetic macular edema. Sirolimus Oral Sirolimus Biologic/ Immunologic Current: Agents: Immunologic In accordance with Agents: the SCA. Immunosuppressives. New indication for the January 11, 2016 treatment of lymphangio- No Change leiomyomatosis. Eslicarbazepine Aptiom Central Nervous System Current: Acetate Oral Agents: Anticonvulsants. CTP holder may Expanded indication for prescribe. treatment of partial- onset seizures as January 11, 2016 monotherapy. No Change

Moxifloxacin Avelox Anti-Infective Agents, Current: Hydrochloride Oral Systemic: CTP holder may Flouroquinolones. prescribe. New indication for treatment of Plaque. January 11, 2016 No Change Abobotulinumtoxina Dysport Central Nervous System Current: Injection Agents: Botulinum CTP holder may Toxins. prescribe. New indication for treatment of upper limb January 11, 2016 spasticity. No Change

1 New Drug Indications January 2016

Ferumoxytol Injection Feraheme Nutrients and Nutritional Current: Agents: Trace Elements. CTP holder may New black box warning prescribe. for fatal and serious hypersensitivity January 11, 2016 reactions including No Change anaphylaxis. Adalimumab Injection Humira Biologic/ Immunologic Current: Agents: Immunologic In accordance with Agents: the SCA. Immunomodulators. Expanded indication for January 11, 2016 treatment of moderate to No Change severe hidradenitis suppurativa Ibrutinib Oral Imbruvica Antineoplastic Agents: Current: Kinase Inhibitors. CTP holder may New indication for NOT prescribe. treatment of patients with Waldenstrom January 11, 2016 macroglobulinemia No Change

Pembrolizumab Keytruda Biologic/Immunologic Current: Injection Agents: Immunologic In accordance with Agents: the SCA. Immunomodulators. Expanded indication for January 11, 2016 treatment of patients No Change with metastatic non- small cell lung cancer Ranibizumab Lucentis Ophthalmic & Otic Current: Intravitreal Agents: Selective In accordance with Vascular Endothelial the SCA. Growth Factor Antagonists. January 11, 2016 New indication for No Change treatment of diabetic retinopathy in patients with diabetic macular edema

Lisdexamfetamine Vyvanse Central Nervous System Current: Dimesylate Oral Agents: Stimulants: CTP holder may Amphetamines. prescribe with New indication for formal established treatment of binge eating diagnosis. May disorder prescribe in

2 New Drug Indications January 2016

accordance with the SCA without a formal establish diagnosis.

January 11, 2016 No Change Nivolumab Opdivo Antineoplastic Agents: Current: Monoclonal Antibodies. CTP holder may New indication for NOT prescribe. treatment of patients with BRAF V600 wild- January 11, 2016 type unresectable or No Change metastatic melanoma. Pegfilgrastim Neulasta Hematological Agents: Current: Hematopoietic Agents: CTP holder may Colony Stimulating prescribe. Factors. Expanded indication for January 11, 2016 use for increased No Change survival in patients acutely exposed to myelosuppressive doses of radiation. Rifaxamin Xifaxan Anti-Infective Agents, Current: Systemic: Rifaximin. CTP holder may New indication for prescribe. treatment of irritable bowel syndrome with January 11, 2016 diarrhea. No Change

Formulary Revision Request January 2016 (Original New Drug Applications: FDA)

Generic Name Trade Name Indication(s) CPG Action/Date

Formulary Review Revision Request from Kim Kombrinck Ketamine Ketalar Procedural sedation in Current: For urgent procedures not requiring and emergent skeletal muscle respiratory care. relaxation.

January 11, 2016 In accordance with the SCA for analgesia, mild and moderate sedation only Vasopressin Vasostrict Treatment of diabetes Current: May not insipidus prescribe for diabetes insipidus

January 11, 2016 , In accordance with the SCA

Formulary Review Revision Request from Cheryl Kollman

Desmopressin DDAVP Treatment of diabetes Current: May not insipidus prescribe for diabetes insipidus

January 11, 201 6, In accordance with the SCA

Formulary Review Revision Request from Heather Ryle

Buprenorphine Subutex Treatment of Opioid Current: May not dependence. prescribe

January 11, 2016 In accordance with SCA only for treatment of NAS

CPG Review of Prescribing Designations In Accordance with Standard Care Arrangement and CTP Holder May NOT Prescribe Nutrients and Nutritional Agents Hematologic Agents (January 2016)

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Nutrients and Nutritional Agents Peritoneal Dialysis Electrolytes: In accordance with January 11, 2016 Solutions Peritoneal Dialysis SCA No change Solutions. Indicated for acute or chronic renal failure, acute poisoning by dialyzable toxins, intractable edema, hyperkalemia, hypercalcemia, azotemia and uremia. Hemodialysis Dialysis Solutions: In accordance with January 11, 2016 Solutions Hemodialysis. SCA No change

Hematologic Agents Hematopoietic Agents Thrombopoientin Hematopoietic In accordance with January 11, 2016 Receptor Agonist Agents: SCA No change Eltrombopag Thrombopoietin Receptor Agonist. Indicated for the treatment of thrombocytopenia in patients with chronic ITP who have an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

1 Review of Hematological Agents May 2011

Thombopoietin Hematopoietic In accordance with January 11, 2016 Mimetic Agents: Agents: SCA No change Romiplostim Thrombopoietin Injection Mimetic Agents. Indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Antiplatelet Agents Glycoprotein Antiplatelet Agents. In accordance with January 11, 2016 Inhibitors Glycoprotein SCA No change Inhibitors. Indicated for the treatment of acute coronary syndrome. Anticoagulants Antithrombin Anticoagulants: In accordance with January 11, 2016 Agents Antithrombin Agents. SCA No change Indicated for the treatment of patients with hereditary AT-III deficiency in connection with surgical or obstetrical procedures of when they suffer from thromboembolism. Thrombin Inhibitors Anticoagulants: In accordance with January 11, 2016 Thrombin Inhibitors. SCA No change Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Factor Xa Inhibitor Anticoagulants: In accordance with January 11, 2016 Selective Factor Xa SCA No change Inhibitor. Indicated for the prophylaxis of deep vein thrombosis

2 Review of Hematological Agents May 2011

(DVT), which may lead to pulmonary embolism (PE) and for the treatment of acute DVT and acute PE when administered in conjunction with warfarin. Coumarin Anticoagulants: In accordance with January 11, 2016 Anticoagulants Coumarin SCA No change Anticoagulants. Indicated to reduce the risk of death, recurrent MI, and thromboembolic events. For prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. For the prophylaxis and/or treatment of venous thrombosis and pulmonary embolism. Coagulants: Coagulants: Heparin In accordance with January 11, 2016 Heparin Antagonist. SCA No change antagonists Indicated for the treatment of heparin overdosage. Thrombolytic Acute myocardial May not prescribe January 11, 2016 Agents infarction and (exception: may No change restoration of function prescribe for catheter to central venous occlusions only) access device. Antisickling Antisickling Agents. In accordance with January 11, 2016 Agents: Indicated to reduce SCA No change Hydroxyurea the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia.

3 Review of Hematological Agents May 2011

Protein C1 Protein C1 Inhibitor. In accordance with January 11, 2016 Inhibitor Indicated for the SCA No change treatment of acute abdominal, facila, or laryngeal attacks of hereditary angioedema in adult and adolescent patient and for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. Antihemophilic Antihemophilic In accordance with January 11, 2016 Agents Agents. SCA No change Antihemophilic Antihemophilic Factor In accordance with January 11, 2016 Factor Combination. SCA No change Combinations Indicated for the treatment and prevention of bleeding in adult patients with hemophilia A and in adults and children with von Willebrand disease Hemostatics Fibrinogen Treatment of acute May not prescribe January 11, 2016 Concentrate bleeding episodes in No change (Human) patients with congenital fibrinogen deficiency. Aminocaproic Acid Enhances hemostatis In accordance with January 11, 2016 when fibrinolysis SCA No change contributes to bleeding. Prothrombin Urgent treatment of In accordance with January 11, 2016 complex acquired coagulation SCA No change Concentrate factor deficiency induced by Vitamin K antagonist therapy in adult patients with acute major bleeding.

4 Review of Hematological Agents May 2011

Plasma Expanders: Plasma Expanders. In accordance with January 11, 2016 Tetrastarch Used in treatment and SCA No change prevention of hypovolemia Hemin Mangement of May not prescribe January 11, 2016 recurrent attacks of No change acute intermittent porphyria Kallikrein Kallikrein Inhibitor. In accordance with January 11, 2016 Inhibitors: Indicated for SCA No change Ecallanatide treatment of acute attacks of hereditary angioedema in patients 16 years of age and older. Bradykinin Bradykinin Inhibitors. IN accordance with January 11, 2016 Inhibitors: Indicated for SCA No change Icatibant treatment of acute attacks of hereditary angioedema in adults 18 years and older.