New Drugs January 2014 (Original New Drug Applications: FDA) Generic Name Trade Name Indication(s) CPG Action/Date October 2013 Ferric Injectafer Nutrients & Nutritional 1/6/2014 Carboxymaltose Agents: Trace Elements. Tabled until may Indicated for the 2014 CPG meeting. treatment of iron deficiency anemia in adults with intolerance to Formulary Pg. 5 oral iron Factor IX Rixubis Hematological Agents: 1/6/2014 Antihemophilic Agents. Tabled until May Indicated for the 2014 CPG meeting. prevention and control of bleeding in patients with Formulary Pg. 7 factor IX deficiency. Afatinib Gilotrif Antineoplastic Agents: 1/6/2014 Kinase Inhibitors. CTP holder may Indicated as first-line NOT prescribe. treatment of metastatic non-small cell lung Formulary Pg. 28 cancer. November 2013 Clozapine Versacloz Central Nervous System 1/6/2014 Agents: Antipsychotic The prescribing Agents: Dibenzapine designation of this Derivatives. drug must be Indicated for reducing determined jointly the risk of recurrent by the CTP Holder suicidal behavior in and Collaborating patients with Physician and schizophrenia or specified in the schizoaffective disorder Standard Care and for the treatment of Arrangement. severely ill schizophrenic patients who fail to respond adequately to standard anti-psychotic Formulary Pg. 17 treatment. Neostigmine Bromide Bloxiverz Central Nervous System 1/6/2014 Agents: Cholinergic CTP holder may Muscle Stimulants. prescribe. Indicated for the symptomatic treatment of myasthenia gravis. Formulary Pg. 19

1 January 2014 CPG Updates

Fluocinolone DermOtic Ophthalmic Agents: Otic 1/6/2014 Acetonide Preparations. CTP holder may Indicated for the prescribe. treatment of chronic eczematous external otitis in adults and Formulary Pg. 26 children 2 years of age and older. Vincristine Sulfate Marqibo Antineoplastic Agents: 1/6/2014 Liposome Antimitotic Agents. CTP holder may Indicated for the NOT prescribe. treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic Formulary Pg. 26 leukemia. December 2013 Levomilnacipran Fetzima Central Nervous System 1/6/2014 Agents: CTP holder may Antidepressants: prescribe. Serotonin and Norepinephrine Reuptake Inhibitors. Indicated for the treatment of major depressive disorder Formulary Pg. 16 (MDD). Topiramate Trokendi XR Central Nervous System 1/6/2014 Agents: Anticonvulsants. CTP holder may Indicated as initial prescribe. monotherapy in patients 10 years and older with partial-onset or primary generalized toni-clonic seizures, and as adjunctive therapy in patients 6 years and older with partial- onset seizures associated with Lenox- Gastaut Formulary Pg. 19 Syndrome. Dolutegravir Sodium Tivicay Anti-Infectives: 1/6/2014 Oral Antiretroviral Agents: The prescribing Integrase Inhibitors. designation of this Indicated in combination drug must be with other antiretroviral determined jointly agents for treatment of by the CTP Holder HIV-1 infection in adults and Collaborating Formulary Pg. 23 and children and Physician and

2 January 2014 CPG Updates

adolescents 12 years specified in the and older and weighing Standard Care at least 40kg. Arrangement. Brimonidine Tartate Mirvaso Dermatologic Agents: 1/6/2014 Dermatologic Alpha CTP holder may Adrenergic Agonists. prescribe. Indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 Formulary Pg. 24 years and older. Tazarotene Fabior Dermatologic Agents: 1/6/2014 Retinoids. Tabled until May Indicated for the topical 2014 CPG meeting. treatment of patients with acne vulgaris in patients 12 years and Formulary Pg. 24 older. Mechlorethamine Valchlor Antineoplastic Agents: 1/6/2014 Alkylating Agents: CTP holder may Nitrogen Mustard. NOT prescribe. Indicated for the palliative treatment of Hodgkin disease, lymphosarcoma, chronic myelocytic or chronic leukemia, polucythemia vera, mycosis fundoides, and bronchogenic Formulary Pg. 26 carcinoma.

3 January 2014 CPG Updates

New Drugs Indications/ Warnings January 2014 (New Drug Indications/ Black Box Warnings: FDA Generic Name Trade Name Indication(s) CPG Action/Date October 2013 none November 2013 Lurasidone Latuda Central Nervous System 1/6/2014 Hydrochloride Agents: Antipsychotic No change Agents. New indication for the treatment of patients Formulary Pg. 17 with bipolar depression. December 2013 Canakinumab Ilaris Biologic/ Immunologic 1/6/2014 Agents: Immunologic No change Agents: Immunomodulators. New indication for the treatment of systemic juvenile idiopathic Formulary Pg. 23 arthritis.

Formulary Revision Request January 2014 (Original New Drug Applications: FDA)

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

Formulary Review Revision Request from Cheryl Kollman, CNP Cabergoline Dostinex Endocrine & Metabolic 1/6/2014 Agents: Cabergoline. The prescribing Indicated for the designation of this treatment of drug must be hyperprolactinemic determined jointly disorders, either by the CTP Holder idiopathic or caused by and Collaborating pituitary adenomas. Physician and specified in the Current: CTP holder Standard Care may NOT prescribe. Arrangement.

Requesting: Physician Initiated/ Physician Consult.

Formulary Pg. 10

4 January 2014 CPG Updates

Formulary Review Revision Request from Kim Heim, CNP Hydroxyurea Droxia Hematological Agents: 1/6/2014 Antisickling Agents. The prescribing Indicated to reduce the designation of this frequency of painful drug must be crises and to reduce the determined jointly need for blood by the CTP Holder transfusions in adults and Collaborating with sickle cell anemia Physician and with recurrent moderate specified in the to severe painful crises. Standard Care Arrangement. Current: Physician Initiated/ Physician Consult for CTP holders within a sickle cell clinic only.

Requesting CTP holder may prescribe with hematologist/oncology Formulary Pg. 7 or Physician Initiated.

Formulary Review Revision Request from Cindy Edwards-Tuttle, FNP-BC

Methotrexate Rhematrex Dose Pack, Biologic/ Immunologic 1/6/2014 Trexall Agents: Antirheumatic The prescribing Agents. designation of this drug must be Indicated for the determined jointly treatment of severe, by the CTP Holder active, classical or and Collaborating definite adult Physician and rheumatoid specified in the Standard Care arthritis in adults who Arrangement. have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first line therapy including full dose NSAIDS and for the management of children with active

polyarticular-course

JRA who have had an insufficient therapeutic

5 January 2014 CPG Updates

response to, or are intolerant of, an adequate trial of first- line therapy including full dose NSAIDS

Methotrexate Dermatologic Agents: 1/6/2014 Anti-Psoriatic Agents. The prescribing Indicated for the designation of this symptomatic control of drug must be severe, recalcitrant, determined jointly disabling psoriasis, by the CTP Holder which is not and Collaborating adequately Physician and responsive to other specified in the therapy. Standard Care Arrangement.

Requesting CTP holder may Formulary Pg. 24 prescribe.

Review of Drugs & Drug Categories with Prescribing Designations of PI/PC

Nutrients & Nutritional Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Peritoneal Dialysis Electrolytes: Peritoneal Physician Initiated/ 1/6/2014 Solutions Dialysis Solutions. Physician Consult The prescribing Indicated for acute or designation of this chronic renal failure, drug must be acute poisoning by determined jointly dialyzable toxins, by the CTP Holder intractable edema, and Collaborating hyperkalemia, Physician and hypercalcemia, specified in the azotemia and uremia. Standard Care Arrangement. Formulary Pg. 6 Chelating Agents Chelating Agents. Physician Initiated/ 1/6/2014 Physician Consult The prescribing designation of this Formulary Pg. 6 drug must be

6 January 2014 CPG Updates

determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement. Trientene HCL Chelating Agents. Physician Initiated/ 1/6/2014 (Syprine) Indicated for the Physician Consult CTP holder may treatment of Wilson’s prescribe. disease in patients who are intolerant of Formulary Pg. 6 penicillamine. Succimer Chelating Agents. Physician Initiated/ 1/6/2014 (Chemet) Indicated for treatment Physician Consult The prescribing of lead poisoning in designation of this children with blood drug must be Formulary Pg. 6 levels > 45 mcg/dl. determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement. Dialysis Solutions Dialysis Solutions: Physician Initiated/ 1/6/2014 (Hemodialysis) Hemodialysis. Physician Consult The prescribing designation of this drug must be Formulary Pg. 6 determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement.

Hematological Agents

7 January 2014 CPG Updates

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Hematopoietic Agents Thrombopoietin Hematopoietic Agents: Physician Initiated/ 1/6/2014 Mimetic Agents: Thrombopoietin Mimetic Physician Consult for The prescribing Romiplostim Injection Agents. CTP holder with SCA designation of this (Nplate) Indicated for the with physician drug must be treatment of specializing in determined jointly thrombocytopenia in Hematology/ Oncology by the CTP Holder patients with chronic ONLY. and Collaborating ITP who have had an Physician and insufficient response to specified in the corticosteroids, Standard Care immunoglobulins, or Arrangement. Formulary Pg. 6 splenectomy. Colony-Stimulating Hemotopoietic Agents: Physician Initiated/ 1/6/2014 Factors Colony Stimulating Physician Consult for CTP holder may Factors. CTP holder with SCA prescribe. with physician specializing in Hematology/ Oncology Formulary Pg. 6 ONLY. Filgrastim Hematopoietic Agents: Physician Initiated/ 1/6/2014 Injection Colony Stimulating Physician Consult for CTP holder may (Neupogen) Factors. CTP holder with SCA prescribe. Indicated for reducing with a physician the incidence of febrile specializing in neutropenia in patients Hematology/Oncology receiving ONLY. chemotherapy, reducing duration of neutropenia in patients with non myeloid malignancies undergoing bone marrow transplantation, for mobilization of hematopoietic progenitor cells into the peripheral blood for collection, and for chronic administration to reduce the incidence and duration of sequelae of neutropenia in patients with Formulary Pg. 6 neutropenia. Pegfilgrastim Hematopoietic Agents: Physician Initiated/ 1/6/2014 Injection (Neulasta) Colony Stimulating Physician Consult for CTP holder may

8 January 2014 CPG Updates

Factors. CTP holder with SCA prescribe. Indicated to reduce the with a physician incidence of infection in specializing in patients receiving Hematology/Oncology myelosupporessive ONLY. Formulary Pg. 6 anticancer drugs. Sargramostim Hematopoietic Agents: Physician Initiated/ 1/6/2014 (Leukine) Colony Stimulating Physician Consult for CTP holder may Factors. CTP holder with SCA prescribe. Indicated for patients with a physician with non-Hodgkins specializing in lymphoma, acute Hematology/Oncology lymphoblastic leukemia, ONLY. and Hodgkin’s disease undergoing autologous BMT, and for patients who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed. Stem Cell Mobilizers Hematopoietic Agents: Physician Initiated/ 1/6/2014 Plerixafor Injection Stem Cell Mobilizers. Physician Consult. CTP holder may (Mozobil) Indicated for use in prescribe. combination to mobilize hematopoietic stem cells to the peripheral blood for collection and transplantation in patients with non- Hodgkin lymphoma and Formulary Pg. 6 multiple myeloma. Interleukins Hematopoietic Agents: Physician Initiated/ 1/6/2014 Oprelvekin Interleukins. Physician Consult for CTP holder may (Neumega) Indicated for the CTP holder with SCA prescribe. prevention of severe with a physician thrombocytopenia and specializing in reduction of the need for Hematology/Oncology platelet transfusion ONLY. following myelosuppressive Formulary Pg. 6 chemotherapy.

9 January 2014 CPG Updates

Thrombopoietin Hematopoietic Agents: Physician Initiated/ 1/6/2014 Receptor Agonist Thrombopoietin Physicial Consult for The prescribing Eltrombopag Receptor Agonist. CTP holder with SCA designation of this (Promacta) Indicated for the w/physician specializing drug must be treatment of in Hematology/Oncology determined jointly thrombocytopenia in only. by the CTP Holder patients with chronic and Collaborating ITP who have an Physician and insufficient response to specified in the corticosteroids, Standard Care immunoglobulins, or Arrangement. Formulary Pg. 6 splenectomy. Antiplatelet Agents Glycoprotein Antiplatelet Agents. Physician Initiated/ 1/6/2014 Inhibitors Glycoprotein Inhibitors. Physician Consult The prescribing Indicated for the designation of this treatment of acute drug must be Formulary Pg. 6 coronary syndrome. determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement. Anticoagulants Antithrombin Anticoagulants: Physician Initiated/ 1/6/2014 Agents Antithrombin Agents. Physician Consult The prescribing Indicated for the designation of this treatment of patients drug must be with hereditary AT-III determined jointly deficiency in connection by the CTP Holder with surgical or and Collaborating obstetrical procedures Physician and of when they suffer from specified in the Formulary Pg. 7 thromboembolism. Standard Care Arrangement. Thrombin Inhibitors Anticoagulants: Physician Initiated/ 1/6/2014 Thrombin Inhibitors. Physician Consult The prescribing designation of this Dabigatran Etexilate Indicated to reduce the drug must be (Pradaxa) risk of stroke and determined jointly systemic embolism in by the CTP Holder patients with and Collaborating nonvalvular atrial Physician and fibrillation. specified in the Standard Care Arrangement.

Formulary Pg. 7

10 January 2014 CPG Updates

Direct Factor Xa Anticoagulants: Physician Initiated/ 1/6/2014 Inhibitor Selective Factor Xa Physician Consult The prescribing Inhibitor. designation of this Indicated for the drug must be prophylaxis of deep vein determined jointly thrombosis (DVT), by the CTP Holder which may lead to and Collaborating pulmonary embolism Physician and (PE) and for the specified in the treatment of acute DVT Standard Care and acute PE when Arrangement. administered in conjunction with Formulary Pg. 7 warfarin. Coumarin Anticoagulants: CTP holder may 1/6/2014 Anticoagulants Coumarin prescribe in institutional The prescribing Anticoagulants. setting per instituitional designation of this standards or Physician drug must be Warfarin Sodium Indicated to reduce the Initiated/ Physician determined jointly (Coumadin) risk of death, recurrent Consult. by the CTP Holder MI, and thromboembolic and Collaborating events. For prophylaxis Physician and and/or treatment of specified in the thromboembolic Standard Care complications Arrangement. associated with atrial fibrillation and/or cardiac valve replacement. For the prophylaxis and/or treatment of venous thrombosis and Formulary Pg. 7 pulmonary embolism. Coagulants Heparin Antagonist Coagulants: Heparin CTP holder may 1/6/2014 Antagonist. prescribe in institutional The prescribing setting per institutional designation of this Protamine Sulfate Indicated for the standards or Physician drug must be treatment of heparin Initiated/ Physician determined jointly overdosage. Consult. by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 7 Arrangement. Antisickling Agents Hydroxyurea Antisickling Agents. Physician Initiated/ 1/6/2014 (Droxia) Indicated to reduce the Physician Consult for The prescribing frequency of painful CTP holder within sickle designation of this crises and to reduce the cell clinic only. drug must be need for blood determined jointly

11 January 2014 CPG Updates

transfusions in adult by the CTP Holder patients with sickle cell and Collaborating anemia. Physician and specified in the Standard Care Formulary Pg. 7 Arrangement. Protein C1 Inhibitor C1 Injhibitor, Human Protein C1 Inhibitor. Physician Initiated/ 1/6/2014 (Cinryze) Indicated for the Physician Consult The prescribing treatment of acute designation of this abdominal, facila, or drug must be laryngeal attacks of determined jointly hereditary angioedema by the CTP Holder in adult and adolescent and Collaborating patient and for routine Physician and prophylaxis against specified in the angioedema attacks in Standard Care adolescent and adult Arrangement. patients with hereditary Formulary Pg. 7 angioedema. Kallikrein Inhibitor Ecallantide Kallikrein Inhibitor. Physician Initiated/ 1/6/2014 (Kalbitor) Indicated for treatment Physician Consult The prescribing of acute attacks of designation of this hereditary angioedema drug must be in patients 16 years of determined jointly age and older. by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 7 Arrangement. Bradykinin Inhibitors Icatibant Bradykinin Inhibitors. Physician Initiated/ 1/6/2014 (Firazyr) Indicated for treatment Physician Consult The prescribing of acute attacks of designation of this hereditary angioedema drug must be in adults 18 years and determined jointly older. by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 7 Arrangement. Antihemophilic Agents Antihemophilic Antihemophilic Agents. Physician Initiated/ 1/6/2014 Agents Physician Consult The prescribing designation of this drug must be Formulary Pg. 7 determined jointly

12 January 2014 CPG Updates

by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement. Antihemophilic Factor Combinations Antihemophilic Antihemophilic Factor Physician Initiated/ 1/6/2014 Factor/ von Combination. Physician Consult The prescribing Willebrand Factor Indicated for the designation of this Complex (Factor treatment and drug must be VIII/VWF: AHF/VWF) prevention of bleeding determined jointly (Humate, Wilate) in adult patients with by the CTP Holder hemophilia A and in and Collaborating adults and children with Physician and von Willebrand disease. specified in the Standard Care Formulary Pg. 7 Arrangement. Hemostatics Tranexamic Acid Hemostatics: Systemic. Physician Initiated/ 1/6/2014 Indicated for the Physician Consult CTP holder may treatment of cyclic prescribe. heavy menstrual Formulary Pg. 7 bleeding. Plasma Expanders Plasma Expanders Plasma Expanders. Physician Initiated/ 1/6/2014 Physician Consult – CTP holder may except Albumin, CTP prescribe. Formulary Pg. 7 holder may prescribe.

Endocrine and Metabolic Agents

Drug Category/Drug Indications(s) Current Prescribing CPG Action/Date Name Designation

Sex Hormones Ovulation Stimulants Sex Hormones: Physician Initiated/ 1/6/2014 Ovulation Stimulants. Physician Consult CTP holder may Format Pg. 8 prescribe. Gonadatropin- Sex Hormones: Physician Initiated/ 1/6/2014 Releasing Hormones Gonadotropin- Physician Consult CTP holder may Releasing Hormones. prescribe. Formulary Pg. 8 Gonadatropin- Sex Hormones: Physician Initiated/ 1/6/2014 Releasing Hormone Gonadatropin- Physician Consult CTP holder may Antagonists Releasing Hormone prescribe. Antagonists. Indicated for the inhibition of premature

13 January 2014 CPG Updates

luteinizing hormone surges in women undergoing controlled Formulary Pg. 8 ovarian stimulation Androgens Sex Hormones: Physician Initiated/ 1/6/2014 Androgens. Physician Consult The prescribing Indicated for designation of this replacement therapy in drug must be hypogonadism determined jointly associated with a by the CTP Holder deficiency or absence of and Collaborating endogenous Physician and testosterone, testicular specified in the failure because of Standard Care cryptorchidism, bilateral Arrangement. torsion, orchitis, vanishing testis syndrome or orchidectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals, to treat idiopathic gonadotropin- , or luteinizing hormone- releasing hormone deficiency or pituitary- hypothalamic injury from tumors, trauma, or radiation. Also indicated to stimulate puberty in carefully selected males with clearly delayed puberty, and in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1-5 years Formulary Pg. 8 postmenopausal. Danazol Sex Hormones: Physician Initiated/ 1/6/2014 Danazol. Physician Consult The prescribing Indicated for the designation of this treatment of drug must be endometriosis, determined jointly fibrocystic breast by the CTP Holder disease, and for the and Collaborating prevention of attacks of Physician and angioedema. specified in the Standard Care Formulary Pg. 8 Arrangement.

14 January 2014 CPG Updates

Uterine Active Agents Agents For Cervical Uterine Active Agents: Physician Initiated/ 1/6/2014 Ripening Agents for cervical Physician Consult The prescribing Ripening. designation of this drug must be Dinoprostone Indicated for termination determined jointly (Prepidil, Cervidil, of pregnancy from the by the CTP Holder Prostin E2) 12th through the 20th and Collaborating gestational week as Physician and calculated from the first specified in the day of the last normal Standard Care menstrual period, for Arrangement. evacuation of uterine contents in the management of missed abortion or intrauterine fetal death, management of nonmetastatic gestational trophoblastic disease, and for the initiation or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor. Formulary Pg. 8

Bisphosphonates Pamidronate Bisphosphonates. Physician Initiated/ 1/6/2014 Disodium Indicated for the Physician Consult CTP holder may (Aredia) treatment of prescribe. hypercalcemia of malignancy, Paget disease, osteolytic bone metastases of breast cancer and osteolytic lesion of multiple Formulary Pg. 8 myeloma.

Adrenocortical Steroids Mineralocorticoids Adrenocortical Steroids: Physician Initiated/ 1/6/2014 Mineralocorticoids. Physician Consult CTP holder may Indicated for partial prescribe. replacement therapy for primary and secondary adrenocortical

15 January 2014 CPG Updates

insufficiency in Addison disease and for treatment of salt-losing adrenogenital Formulary Pg. 9 syndrome.

Insulin-Like Growth Factor Mecasermin Rinfabate Insulin-like Growth Physician Initiated/ 1/6/2014 (Iplex) Factor. Physician Consult The prescribing designation of this Indicated for the drug must be treatment of growth determined jointly failure in children with by the CTP Holder severe primary insulin- and Collaborating like growth factor-1 Physician and deficiency or with specified in the growth hormone gene Standard Care deletion who have Arrangement. developed neutralizing antibodies to growth Formulary Pg. 9 hormone.

Growth Hormone Somatropin Growth Hormone. Physician Initiated/ 1/6/2014 Indicated for treatment Physician Consult The prescribing (Genotropin, of growth failure designation of this Omnitrope, Serostim, associated with chronic drug must be Humatrope, Nutropin, renal insufficiency, determined jointly Saizen, HumatroPen, Noonan syndrome, by the CTP Holder Zorbtive, Norditropin, Prader-Willi syndrome, and Collaborating Accretropin, and Turner syndrome. Physician and For the treatment of specified in the growth failure in Standard Care children, growth Arrangement. hormone deficiency in adults, idiopathic short stature, short bowel syndrome, short stature homeobox-containing gene deficiency, and wasting or cachexia Formulary Pg. 9 associated with HIV. Growth Hormone Releasing Factor Tesamorelin Acetate Growth Hormone Physician Initiated/ 1/6/2014 (Egrifta) Releasing Factor. Physician Consult. The prescribing designation of this Indicated for the drug must be reduction of excess determined jointly abdominal fat in HIV- by the CTP Holder infected patients with and Collaborating

16 January 2014 CPG Updates

lipodystrophy. Physician and specified in the Standard Care Arrangement. Formulary pg. 9

Posterior Pituitary Hormone Posterior Pituitary Posterior Pituitary 1/6/2014 Hormone Hormones. CTP holder may prescribe. Desmopressin Acetate Indicated as antidiuretic Physician Initiated/ Oral replacement therapy in Physician Consult (DDAVP) the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Also indicated for the management of primary Formulary Pg. 9 nocturnal enuresis.

Vasopressin Receptor Antagonist Conivaptan Vasopressin Receptor Physician Initiated/ 1/6/2014 Hydrochloride Antagonist. Physician Consult The prescribing (Vaprisol) designation of this Indicated to raise the drug must be serum sodium in determined jointly hospitalized patients by the CTP Holder with euvolemic and and Collaborating hypervolemic Physician and hyponatremia. specified in the Standard Care Formulary Pg. 9 Arrangement. Tolvaptan Vasopressin Receptor Physician Initiated/ 1/6/2014 (Samsca) Antagonist. Physician Consult The prescribing Indicated for the designation of this treatment of clinically drug must be significant hypervolemic determined jointly and euvolemic by the CTP Holder hyponatremia. and Collaborating Physician and specified in the Standard Care Arrangement.

Formulary Pg. 9

17 January 2014 CPG Updates

Velaglucerase Alfa Velaglucerase Alfa Velaglucerase Alfa. Physician Initiated/ 1/6/2014 (VPRIV) Indicated for the long- Physician Consult The prescribing term enzyme designation of this replacement therapy in drug must be children and adults with determined jointly type 1 Gaucher disease by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 9 Arrangement.

Somatostatin Analogs Lanreotide Somatostatin Analogs. Physician Initiated/ 1/6/2014 (Somatuline Depot) Indicated for the long- Physician Consult CTP holder may term treatment of prescribe. acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an Formulary Pg. 9 option.

Galsulfase Galsulfase Galsulfase. Physician Initiated/ 1/6/2014 (Naglazyme) Indicated for patients Physician Consult CTP holder may with prescribe. mucopolysaccharidosis VI.

Formulary Pg. 10

Idursulfase Idursulfase Idursulfase. Physician Initiated/ 1/6/2014 (Elaprase) Indicated for patients Physician Consult CTP holder may with Hunter syndrome to prescribe. improve walking Formulary Pg. 10 capacity. Taliglucerase Alfa

Taliglucerase Alfa Taliglucerase Alfa. Physician Initiated/ 1/6/2014 (Elelyso) Indicated for long-term Physician Consult CTP holder may enzyme replacement prescribe. therapy for adults with a confirmed diagnosis of Formulary Pg. 9 type I Gaucher disease.

18 January 2014 CPG Updates

Calcitonin-Salmon Calcitonin – Salmon Calcitonin-Salmon. Physician Initiated/ 1/6/2014 Injectable Indicated for prevention Physician Consult CTP holder may (Miacalcin) of progressive loss of prescribe. bone mass, for patients with moderate to severe Paget’s disease, and for early treatment of hypercalcemic Formulary Pg. 10 emergencies. Ivacaftor

Ivacaftor Ivacaftor. Physician Initiated/ 1/6/2014 (Kalydeco) Indicated for the Physician Consult. CTP holder may treatment of cystic prescribe. fibrosis in patients 6 years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator Formulary Pg. 10 (CFTR) gene.

Agents for Gout Pegloticase Injection Agents for Gout. Physician Initiated/ 1/6/2014 (Krystexxa) Indicated for the Physician Consult CTP holder may treatment of long-term prescribe. gout in adult patients refractory to Formulary Pg. 10 conventional therapy.

Detoxification Agents Chelating Agents Detoxification Agents: 1/6/2014 Chelating Agents. The prescribing designation of this Deferasirox Indicated for the Physician Initiated/ drug must be (Exjade) treatment of chronic iron Physician Consult for determined jointly overload caused by CTP holder within sickle by the CTP Holder blood transfusions in cell clinic only. and Collaborating patients 2 years of age Physician and and older. specified in the Standard Care Formulary Pg. 10 Arrangement.

Cardiovascular Agents

19 January 2014 CPG Updates

Drug Category/Drug Indications(s) Current Prescribing CPG Action/Date Name Designation Vasodilators Endothelin Vasodilators: Endothelin Physician Initiated/ 1/6/2014 Receptor Receptor Antagonist. Physician Consult The prescribing Antagonist designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 11 Arrangement. Peripheral 1/6/2014 Vasodilators The prescribing designation of this drug must be Epoprostenol Sodium Vasodilators: Peripheral Physician Initiated/ determined jointly Injection Vasodilators. Physician Consult for by the CTP Holder (Flolan) Indicated for the long- CTP holder within and Collaborating term intravenous specialty clinic. Physician and treatment of primary specified in the pulmonary hypertension Standard Care and pulmonary Arrangement. hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to Formulary Pg. 11 conventional therapy. Treprostinil Sodium Vasodilators: Peripheral Physician Initiated/ 1/6/2014 (Remodulin) Vasodilators. Physician Consult for The prescribing Indicated for the CTP holder within designation of this treatment of pulmonary specialty clinic. drug must be arterial hypertension in determined jointly patients with New York by the CTP Holder Heart Association and Collaborating (NYAH) class II to IV Physician and symptoms to diminish specified in the symptoms associated Standard Care with exercise, and to Arrangement. diminish the rate of clinical deterioration in patients requiring transition from

20 January 2014 CPG Updates

epoprostenol.

Treprostinil Inhalation Indicated to increase Physician Initiated/ 1/6/2014 walk distance in patients Physician Consult. The prescribing with World Health designation of this Organization group I drug must be pulmonary arterial determined jointly hypertension and New by the CTP Holder York Heart Association and Collaborating class II symptoms. Physician and specified in the Standard Care Formulary Pg. 11 Arrangement. Agents for Patent Ductus Arteriosus Alprostadil Agents for Patent Physician Initiated/ 1/6/2014 (Prostin VR Pediatric) Ductus Arteriosus. Physician Consult The prescribing Indicated for palliative, designation of this not definitive, therapy drug must be to temporarily determined jointly maintain the patency by the CTP Holder of the ductus and Collaborating arteriosus until Physician and corrective or palliative specified in the surgery can be Standard Care performed in neonates Arrangement. who have congenital heart defects and who depend upon the patent ductus for Formulary Pg. 12 survival. Ibuprofen Lysine Agents for Patent Neonatal NP CTP holder 1/6/2014 (NeoProfen) Ductus Arteriosus. only may prescribe. The prescribing Indicated to close a Physician Initiated/ designation of this clinically significant Physician Consult all drug must be PDA in premature other CTP holders. determined jointly infants who are no by the CTP Holder more than 32 weeks and Collaborating gestational age when Physician and usual medical specified in the management is Standard Care Formulary Pg. 12 ineffective. Arrangement. Indomethacin Agents for Patent Neonatal NP CTP holder 1/6/2014 (Indocin I.V.) Ductus Arteriosus. only may prescribe. The prescribing Indicated for closure Physician Initiated/ designation of this of hemodynamically Physician Consult all drug must be significant PDA in other CTP holders. determined jointly premature infants if, by the CTP Holder after 48 hours, usual and Collaborating medical management Physician and

21 January 2014 CPG Updates

is ineffective. specified in the Standard Care Formulary Pg. 12 Arrangement.

Respiratory Agents

Drug Category/Drug Indications(s) Current Prescribing CPG Action/Date Name Designation

Monoclonal Antibodies Omalizumbab Monoclonal Antibodies. Physician Initiated/ 1/6/2014 (Xolair) Indicated to decrease Physician Consult. The prescribing the incidence of asthma designation of this exacerbations for adults drug must be and adolescents 12 determined jointly years of age and older by the CTP Holder with moderate to severe and Collaborating persistent asthma. Physician and specified in the Standard Care Formulary Pg. 14 Arrangement. Respiratory Enzymes

Respiratory Respiratory Enzymes. CTP holder may 1/6/2014 Enzymes Indicated for chronic prescribe for Neonatal The prescribing augmentation therapy in Nurse Practitioner only. designation of this patients having drug must be congenital deficiency of Physician Initiated/ determined jointly alpha1-PI with clinically Physician Consult all by the CTP Holder evident emphysema. other CTP holders. and Collaborating Physician and specified in the Standard Care Formulary Pg. 14 Arrangement.

Central Nervous System Agents

Drug Category/Drug Indications(s) Current Prescribing CPG Action/Date

22 January 2014 CPG Updates

Name Designation CNS Stimulants Analeptics Central Nervous System Physician Initiated/ 1/6/2014 Agents: CNS Physician Consult CTP holder may Caffeine IV Stimulants: Analeptics. prescribe. Indicated as an aid in staying awake and restoring mental alertness, as an adjunct in analgesic formulations, for the short-term treatment of apnea in premature infants, and in conjunction with supportive measures to treat respiratory depression associated with overdosage with Formulary Pg. 15 CNS depressants. Amphetamines Central Nervous System Physician Initiated/ 1/6/2014 Agents: Amphetamines. Physician Consult for The prescribing Indicated to improve CTP holders without a designation of this wakefulness in patients formal established drug must be with excessive daytime diagnosis. determined jointly sleepiness associated by the CTP Holder with narcolepsy, as part and Collaborating of a treatment plan for Physician and attention deficit specified in the disorder, and as a short- Standard Care term adjunct in a Arrangement. regimen of weight reduction. Formulary Pg. 15 Opioid Analgesics Schedule II Opioid Central Nervous System Physician Initiated/ 1/6/2014 Analgesics Agents: Opioid Physician Consult for The standard care Analgesics CTP holders initiating arrangement must therapy with a schedule state that initial II medication for more prescriptions for than a 14 day supply more than a 14 day supply require physician initiation or consultation.

Formulary Pg. 15 Non-Narcotic Analgesic Combinations Non-Narcotic Central Nervous System Physician Initiated/ 1/6/2014 Analgesic Agents: Non-Narcotic Physician Consult CTP holder may

23 January 2014 CPG Updates

Combinations Analgesic prescribe. Combinations. Formulary Pg. 16 Antidepressants Nefazodone Antidepressants. Physician Initiated/ 1/6/2014 (Nefazodone HCL) Indicated for the Physician Consult The prescribing treatment of depression. designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 17 Arrangement. MAO Inhibitors Antidepressants: Physician Initiated/ 1/6/2014 Monoamine Oxidase Physician consult The prescribing Inhibitors. designation of this Indicated for use in drug must be patients with atypical determined jointly depression and in some by the CTP Holder patients unresponsive to and Collaborating other antidepressive Physician and therapy. specified in the Standard Care Formulary Pg. 17 Arrangement. Antipsychotic Agents Thioridazine Antipsychotic Agents. Physician Initiated/ 1/6/2014 Hydrochloride Indicated for the Physician Consult CTP holder may (Thioridazine HCL) management of prescribe. schizophrenic patients who fail to respond adequately to treatment with other antipsychotic Formulary Pg. 17 drugs. Clozapine Antipsychotic Agents. Physician Initiated/ 1/6/2014 (Clozapine, FazaClo) Indicated for reducing Physician Consult The prescribing the risk of recurrent designation of this suicidal behavior in drug must be patients with determined jointly schizophrenia or by the CTP Holder schizoaffective disorder. and Collaborating Physician and specified in the Standard Care Formulary Pg. 17 Arrangement. Pimozide Antipsychotic Agents. Physician Initiated/ 1/6/2014 (Orap) Indicated for Physician Consult CTP holder may suppression of motor prescribe.

24 January 2014 CPG Updates

and phonic tics in patients with Tourette disorder who have failed to respond to standard Formulary Pg. 17 treatment. Lithium Antipsychotic Agents. Physician Initiated/ 1/6/2014 (Lithium Carbonate, Indicated for the Physician Consult for The prescribing Eskalith) treatment of manic CTP holder other than designation of this episodes of manic- psych. drug must be depressive illness. determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 17 Arrangement. Aripiprazole Antipsychotic Agents: Physician Initiated/ 1/6/2014 (Abilify Maintena) Quinolinone Derivatives. Physician Consult for CTP holder may CTP holder other than prescribe. psych. Formulary Pg. 17 NMDA Receptor Antagonists Memantine NMDA Receptor Physician Initiated/ 1/6/2014 Hydrochloride Antagonists. Physician Consult CTP holder may (Namenda) Indicated for the prescribe. treatment of moderate to severe dementia of Formulary Pg. 17 the Alzheimer type. Miscellaneous Psychotherapeutic Agents Chlordiazepoxide and Miscellaneous Physician Initiated/ 1/6/2014 Amitriptyline Psychotherapeutic Physician Consult CTP holder may (Limbitrol) Agents. prescribe. Indicated for the treatment of moderate to severe depression associated with moderate to severe Formulary Pg. 17 anxiety. Perphenazine and Miscellaneous Physician Initiated/ 1/6/2014 Amitriptyline Psychotherapeutic Physician Consult CTP holder may (Etrafon, Triavil, Agents. prescribe. Indicated for the treatment of moderate to severe anxiety or agitation and depressed Formulary Pg. 17 mood. Ergoloid Mesylates Miscellaneous Physician Initiated/ 1/6/2014 (Gerimal, Hydergine) Psychotherapeutic Physician Consult CTP holder may Agents. prescribe.

25 January 2014 CPG Updates

Indicated for individuals over age 60 who manifest signs and symptoms of an idiopathic decline in Formulary Pg. 17 mental capacity. Sodium Oxybate Miscellaneous Physician Initiated/ 1/6/2014 (Xyrem) Psychotherapeutic Physician Consult The prescribing Agents. designation of this Indicated for the drug must be treatment of excessive determined jointly daytime sleepiness and by the CTP Holder cataplexy in patients and Collaborating with narcolepsy. Physician and specified in the Standard Care Formulary Pg. 17 Arrangement. Olanzapine/ Miscellaneous Physician Initiated/ 1/6/2014 Fluoxetine Psychotherapeutic Physician Consult CTP holder may (Symbyax) Agents. prescribe. Indicated for the acute treatment of depressive episodes associated with bipolar I disorder in adults and for acute treatment of treatment- resistant depression in adults who do not respond to 2 separate trials of different antidepressants during the current episode. Formulary Pg. 17 Atomoxetine Miscellaneous Physician Initiated/ 1/6/2014 (Strattera) Psychotherapeutic Physician Consult for CTP holder may Agents. CTP holder other than prescribe. Indicated for the psych. treatment of ADHD. Formulary Pg. 18 Sedatives and Hypnotics, Nonbarbiturate Chloral Hydrate Sedatives and Physician Initiated/ 1/6/2014 (Somnote, Hypnotics, Physician Consult CTP holder may Aquachloral nonbarbiturate. prescribe. Supprettes) Indicated for preoperative sedation to lessen anxiety and induce sleep, postoperative care and control of pain as an adjunct to opiates and

26 January 2014 CPG Updates

analgesics, and for preventing or suppressing alcohol withdrawal symptoms Formulary Pg. 18 (rectal). Anticonvulsants Ezogabine Anticonvulsants. Physician Initiated/ 1/6/2014 (Potiga) Indicated as an Physician Consult CTP holder may adjunctive treatment for prescribe. partial-onset seizures in patients 18 years and Formulary Pg. 18 older. Antiparkinson Agents Selegiline Antiparkinson Agents. Physician Initiated/ 1/6/2014 Hydrochloride Indicated for the Physician Consult CTP holder may Transdermal treatment of major prescribe. (EMSAM) depressive disorder.

Formulary Pg. 19 Adenosine Phosphate Adenosine Adenosine Phosphate. Physician Initiated/ 1/6/2014 Phosphate Indicated for Physician Consult The prescribing symptomatic relief of designation of this complications with drug must be stasis dermatitis determined jointly (varicose veins). by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 19 Arrangement. Cholinergic Muscle Stimulants Cholinergic Muscle Cholinergic Muscle Physician Initiated/ 1/6/2014 Stimulants Stimulants. Physician Consult CTP holder may prescribe. Formulary Pg. 19 Riluzole Riluzole Riluzole. Physician Initiated/ 1/6/2014 (Rilutek) Indicated for the Physician Consult The prescribing treatment of patients designation of this with amyotrophic lateral drug must be sclerosis. Riluzole determined jointly extends survival and/or by the CTP Holder time to tracheostomy. and Collaborating Formulary Pg. 19 Physician and specified in the Standard Care Arrangement.

27 January 2014 CPG Updates

Physical Adjuncts Hyaluronic Acid Physical Adjuncts. Physician Initiated/ 1/6/2014 Derivatives Indicated for the Physician Consult CTP holder may (Euflexxa, Hyalgan, treatment of pain in prescribe. Supartz, Orthovisc, osteoarthritis of the Synvisc) knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple Formulary Pg. 19 analgesics. Hyaluronic Acid Physical Adjuncts. Physician Initiated/ 1/6/2014 Derivatives Injection Indicated for mid to Physician Consult CTP holder may (Hylaform, Perlane, deep dermal prescribe. Restylane, Juvederm, implantation for the Bionect, Hylira) correction of moderate to severe facial wrinkles and folds. Formulary Pg. 19 Potassium Channel Blocker Dalfampridine Potassium Channel Physician Initiated/ 1/6/2014 (Ampyra) Blocker. Physician Consult CTP holder may Indicated to improve prescribe. walking in patients with Formulary Pg. 19 multiple sclerosis. Botulinum Toxins Botulinum Toxins Botulinum Toxins: CTP holder May NOT 1/6/2014 Type A Botulinum Toxins Type prescribe. The prescribing (Botox, Dysport, A. designation of this Xeomin) Indicated for the Physician Initiated/ drug must be treatment of severe Physician Consult only determined jointly primary axillary for spasticity, cervical by the CTP Holder hyperhydrosis, dystonia, and chronic and Collaborating treatment of cervical migraine in related Physician and dystonia, prophylaxis of specialty clinic; and specified in the headaches in adults these uses must be Standard Care with chronic migraine, addressed specifically in Arrangement. for the temporary the standard care improvement in the arrangement (SCA). appearance of moderate to severe glabellar lines associated with currugator and/or procerus muscle activity in adults 65 years of age and younger, treatment of strabismus

28 January 2014 CPG Updates

and blepharospasm associated with dystonia, and treatment of upper limb spasticity Formulary Pg. 20 in adults. Rimabotulinumtoxin B Botulinum Toxins: CTP holder May NOT 1/6/2014 (Myobloc) Botulinum Toxin Type prescribe. The prescribing B. designation of this Indicated for the Physician Initiated/ drug must be treatment of adults with Physician Consult only determined jointly cervical dystonia. for spasticity, cervical by the CTP Holder dystonia, and chronic and Collaborating migraine in related Physician and specialty clinic; and specified in the these uses must be Standard Care addressed specifically in Arrangement. the standard care Formulary Pg. 20 arrangement (SCA).

Gastrointestinal Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Dextranomer/ Sodium Hyaluronate Dextranolmer/ Dextranolmer/ Sodium Physician Initiated/ 1/6/2014 Sodium Hyaluronate Hyaluronate. Physician Consult CTP holder may Indicated for the prescribe. treatment of fecal incontinence in patients 18 years and older for whom conservative therapy has failed.

Formulary Pg. 20 Gallstone Solubilizing Agents Gallstone Gasllstone Solubilizing Physician Initiated/ 1/6/2014 Solubilizing Agents Agents. Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder Formulary Pg. 20 and Collaborating Physician and specified in the Standard Care Arrangement.

29 January 2014 CPG Updates

Anti-Infectives, Systemic

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Glycylcyclines Tigecycline Glycylcyclines. Physician Initiated/ 1/6/2014 (Tygacil) Indicated for the Physician Consult The prescribing treatment of community- designation of this acquired bacterial drug must be pneumonia, complicated determined jointly intra- abdominal by the CTP Holder infections, and and Collaborating complicated skin and Physician and skin structure infections. specified in the Standard Care Arrangement. Formulary Pg. 21 Streptogramins Quinupristin/ Streptogramins. Physician Initiated/ 1/6/2014 Dalfopristin Indicated for the Physician Consult The prescribing (Synercid) treatment of patients designation of this with serious or life- drug must be threatening infections determined jointly associated with by the CTP Holder vancomycin-resistant and Collaborating Enterococcus faecium Physician and bacteremia, and for specified in the treatment of Standard Care complicated skin and Arrangement. Formulary Pg. 21 skin structure infections. Lipopeptides Daptomycin Lipopeptides. Physician Initiated/ 1/6/2014 (Cubicin) Indicated for the Physician Consult The prescribing treatment of designation of this complicated skin and drug must be skin structure infections determined jointly and for the treatment of by the CTP Holder S. aureus bloodstream and Collaborating infections. Physician and specified in the Standard Care Formulary Pg. 21 Arrangement. Lipoglycopeptides Telavancin Lipoglycopeptides. Physician Initiated/ 1/6/2014 Hydrochloride Indicated for the Physician Consult The prescribing (Vibativ) treatment of adults with designation of this

30 January 2014 CPG Updates

complicated skin and drug must be skin structure infections determined jointly caused by susceptible by the CTP Holder isolates of certain gram- and Collaborating positive Physician and microorganisms. specified in the Standard Care Formulary Pg. 22 Arrangement. Oxazolidones Linezolid Oxazolidinones. Physician Initialed/ 1/6/2014 (Zyvox) Indicated for the Physician Consult The prescribing treatment of community- designation of this acquired pneumonia, drug must be complicated skin and determined jointly skin structure infections, by the CTP Holder nosocomial pneumonia, and Collaborating uncomplicated skin and Physician and skin structure infections, specified in the and vancomycin- Standard Care resistant enterococcal Arrangement. Formulary Pg. 21 infections. Aminoglycosides, Parenteral Aminoglycosides, Aminoglycosides. Physician Initiated/ 1/6/2014 Parenteral; Physician Consult CTP holder may Nebulized prescribe.

Formulary Pg. 22 Antifungal Agents Antifungal Agents Antifungal Agents. Physician Initiated/ 1/6/2014 IV Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 22 Arrangement. Micafungin Sodium Antifungal Agents. Physician Initiated/ 1/6/2014 Injection Indicated for the Physician Consult The prescribing (Mycamine) treatment of patients designation of this with candidemia, acute drug must be disseminated determined jointly candidiases, Candida by the CTP Holder peritonitis, and and Collaborating abscesses, for the Physician and treatment of patients specified in the with esophageal Standard Care

31 January 2014 CPG Updates

candidiases, and for Arrangement. prophylaxis of Candida Formulary Pg. 22 infections.

Triazole Antifungals Antifungal Agents: Physician Initiated/ 1/6/2014 IV Triazole Antifungals. Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 22 Arrangement. Posaconazole Antifungal Agents: Physician Initiated/ 1/6/2014 (Noxafil) Triazole Antifungals Physician Consul The prescribing Indicated for the designation of this treatment of drug must be oropharyngeal determined jointly candidiasis, including by the CTP Holder oropharyngeal and Collaborating candidiasis refractory to Physician and itraconazole and/or specified in the fluconazole, and for Standard Care prophylaxis of invasive Arrangement. Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections because of being severely immunocompromised. Formulary Pg. 22 Antituberculosis Agents Antituberculosis Antituberculosis Agents. Physician Initiated/ 1/6/2014 Agents Indicated for treatment Physician Consult The prescribing of tuberculosis. designation of this INH – CTP holder may drug must be prescribe. determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 22 Arrangement. Antiviral Agents Foscarnet Sodium Antiviral Agents. IV - Physician Initiated/ 1/6/2014

32 January 2014 CPG Updates

(Foscavir) Indicated for the Physician Consult The prescribing treatment of CMV designation of this retinitis in patients with drug must be AIDS, in combination determined jointly therapy with ganciclovir by the CTP Holder for patients who have and Collaborating relapsed after Physician and monotherapy with specified in the either drug, and for Standard Care treatment of acylclovir- Arrangement. resistant mucocutaneous HSV infections in immunocompromised Formulary Pg. 22 patients. Ganciclovir Antiviral Agents. IV- Physician Initiated/ 1/6/2014 (Cytovene) Indicated for treatment Physician Consult 1/6/2014 of CMV retinitis in The prescribing immunocompromised designation of this patients, including drug must be patients with AIDS, and determined jointly for prevention of CMV by the CTP Holder disease in transplant and Collaborating recipients at risk for Physician and CMV disease. specified in the Standard Care Formulary Pg. 22 Arrangement. Valganciclovir Antiviral Agents. IV – Physician Initiated/ 1/6/2014 (Valcyte) Indicated for the Physician Consult The prescribing prevention of CMV designation of this disease in kidney, heart, drug must be and kidney-pancreas determined jointly transplant adult patients by the CTP Holder at high risk, for the and Collaborating prevention of CMV Physician and disease in kidney and specified in the heart transplant Standard Care pediatric patients at high Arrangement. risk, and for the treatment of cytomegalovirus retinitis Formulary Pg. 22 in adults with AIDS. Ribavirin Antiviral Agents. Physician Initiated/ 1/6/2014 (Copegus,Ribasphere Tablets – Indicated in Physician Consult The prescribing , Rebetol, Virazole) combination with designation of this peginterferon alfa-2a for drug must be the treatment of adults determined jointly with chronic HCV by the CTP Holder infection who have and Collaborating compensated liver Physician and disease and have not specified in the

33 January 2014 CPG Updates

previously been treated Standard Care with interferon alpha. Arrangement.

Capsules/Solution - Indicated in combination with interferon alfa-2b for the treatment of chronic HCV in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy.

Inhalation – Indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infection due to severe respiratory Formulary Pg. 23 syncytial virus. Adefovir Dipivoxil Antiviral Agents. Physician Initiated/ 1/6/2014 (Hepsera) Indicated for the Physician Consult The prescribing treatment of chronic designation of this hepatitis B virus in drug must be patients 12 years of age determined jointly and older with evidence by the CTP Holder of active viral replication and Collaborating and either evidence of Physician and persistent elevations in specified in the serum Standard Care aminotransferases (ALT Arrangement. or AST) or histologically Formulary Pg. 23 active disease. Entecavir Antiviral Agents. Physician Initiated/ 1/6/2014 (Baraclude) Indicated for the Physician Consult The prescribing treatment of chronic designation of this HBV infection in adults drug must be with evidence of active determined jointly viral replication and by the CTP Holder either evidence of and Collaborating persistent elevations in Physician and serum specified in the aminotransferases (ALT Standard Care or AST) or histologically Arrangement. Formulary Pg. 23 active disease.

34 January 2014 CPG Updates

Antiretroviral Agents Protease Inhibitors Antiretroviral Agents: Physician Initiated/ 1/6/2014 Protease Inhibitors. Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Nucleotide Analog Antiretroviral Agents. Physician Initiated/ 1/6/2014 Reverse Nucleotide Analog Physician Consult The prescribing Transcriptase Reverse Transcriptase designation of this Inhibitor Inhibitor. drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 22 Arrangement. Nucleoside Reverse Antiretroviral Agents: Physician Initiated/ 1/6/2014 Transcriptase Nucleoside Reverse Physician Consult The prescribing Inhibitors Transcriptase Inhibitors. designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Non-Nucleoside Antiretroviral Agents. Physician Initiated/ 1/6/2014 Reverse Non-Nucleoside Physician Consult The prescribing Transcriptase Reverse Transcriptase designation of this Inhibitors. Inhibitors. drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement.

35 January 2014 CPG Updates

Cellular Chemokine Antiretroviral Agents: Physician Initiated/ 1/6/2014 Receptor Cellular Chemokine Physician Consult The prescribing Antagonist Receptor Antagonist. designation of this drug must be Maraviroc determined jointly (Selzentry) Indicated in combination by the CTP Holder with other antiretroviral and Collaborating agents, for treatment of Physician and adult patients infected specified in the only with chemokine Standard Care receptor 5 (CCR5) – Arrangement. Formulary pg. 23 tropic HIV-1. Integrase Inhibitors Antiretroviral Agents: Physician Initiated/ 1/6/2014 Integrase Inhibitors. Physician Consult The prescribing Raltegravir designation of this (Isentress) Indicated in combination drug must be with other antiretroviral determined jointly agents for the treatment by the CTP Holder of HIV-1 infection in and Collaborating adult patients. Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Fusion Inhibitors Antiretroviral Agents: 1/6/2014 Fusion Inhibitors. The prescribing designation of this Enfuvirtide Indicated in combination drug must be (Fuzeon) with other antiretroviral determined jointly agents for the treatment by the CTP Holder of HIV-1 infection in and Collaborating treatment- experienced Physician and patients with evidence specified in the of HIV-1 replication Standard Care despite ongoing Arrangement. antiretroviral therapy. Formulary Pg. 23 Leprostatics Leprostatics Leprostatics. Physician Initiated/ 1/6/2014 Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement.

Formulary Pg. 23

36 January 2014 CPG Updates

Antiprotozoals Antiprotozoals Antiprotozoals. Physician Initiated/ 1/6/2014 Physician Consult CTP holder may prescribe.

Tinidazole, Nitazoxanie – CTP holder may prescribe.

Formulary Pg. 23

Biologic/Immunologic Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Immune Globulins Immune Globulins Immune Globulins. Physician Initiated/ 1/6/2014 Indicated to provide Physician Consult The prescribing passive immunization to designation of this greater than or equal to drug must be 1 infectious diseases, determined jointly for treatment of immune by the CTP Holder thrombocytopenic and Collaborating purpura, and Physician and suppression of Rh specified in the immunization. Standard Care Formulary Pg. 23 Arrangement. Immune Globulin Immune Globulins. Physician Initiated/ 1/6/2014 (Human) Indicated for the Physician Consult The prescribing Subcutaneous treatment of patients designation of this (Vivaglobulin) with primary immune drug must be deficiency. determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Monoclonal Antibody Denosumab Monoclonal Antibody. Physician Initiated/ 1/6/2014 (Prolia, Xgeva) Indicated for the Physician Consult CTP holder may prevention of skeletal- prescribe. related events in patients with bone metastases from solid tumors, and for the treatment of

37 January 2014 CPG Updates

postmenopausal women with osteoporosis at high risk of fracture.

Formulary Pg. 23 Eculizumab Monoclonal Antibody. Physician Initiated/ 1/6/2014 (Soliris) Indicated for the Physician Consult The prescribing treatment of patients designation of this with paroxysmal drug must be nocturnal determined jointly hemoglobinuria (PNH) by the CTP Holder to reduce hemolysis. and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Belimumab Monoclonal Antibody. Physician Initiated/ 1/6/2014 (Benlysta) Indicated for the Physician Consult The prescribing treatment of adult designation of this patients with active, drug must be autoantibody-positive, determined jointly systemic lupus by the CTP Holder erythematosus who are and Collaborating receiving standard Physician and Formulary Pg. 23 therapy. specified in the Standard Care Arrangement. Allergic Extracts Allergic Extracts Allergic Extracts. Physician Initiated/ 1/6/2014 Indicated for the Physician Consult CTP holder may diagnosis of specific prescribe. allergies, when properly diluted, and for the relief of allergic symptoms due to specifically identified materials by means of a graduated schedule of doses. Formulary Pg. 23 Immunologic Agents Immunostimulants Immunologic Agents: Physician Initiated/ 1/6/2014 Immunostimulants. Physician Consult The prescribing Pegademase Bovine Indicated for enzyme designation of this (Adagen) replacement therapy drug must be for adenosine determined jointly deaminase (ADA) by the CTP Holder deficiency in patients and Collaborating with severe combined Physician and immunodeficiency specified in the disease who are not Standard Care

38 January 2014 CPG Updates

suitable candidates for Arrangement. or who have failed bone marrow therapy Formulary Pg. 23 transplantation. Immunosuppressives Immunologic Agents: Physician Initiated/ 1/6/2014 Immunosuppressives. Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Immunomodulators Immunologic Agents: Physician Initiated/ 1/6/2014 Immunomodulators. Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Certolizumab Pegol Immunologic Agents: Physician Initiated/ 1/6/2014 (Cimzia) Immunomodulators. Physician Consult The prescribing Indicated for reducing designation of this signs and symptoms drug must be of Crohn’s disease determined jointly and maintaining by the CTP Holder clinical response in and Collaborating adult patients with Physician and moderately to severely specified in the active disease who Standard Care have had an Arrangement. inadequate response to conventional therapy. Formulary Pg. 24 Thalidomide Immunologic Agents: Physician Initiated/ 1/6/2014 (Thalomid) Immunomodulators. Physician Consult The prescribing Indicated in designation of this combination with drug must be dexamethasone, for determined jointly the treatment of by the CTP Holder patients with newly and Collaborating diagnosed multiple Physician and myeloma, acute specified in the

39 January 2014 CPG Updates

treatment of the Standard Care cutaneous Arrangement. manifestations of moderate to severe erythema nodosum leprosum, and for prevention and suppression of the cutaneous manifestations of erythema nodosum Formulary Pg. 24 leprosum recurrence. Fingolimod Immunologic Agents: Physician Initiated/ 1/6/2014 (Gilenya) Immunomodulators. Physician Consult The prescribing Indicated for the designation of this treatment of patients drug must be with relapsing forms of determined jointly multiple sclerosis to by the CTP Holder reduce the frequency and Collaborating of clinical Physician and exacerbations and to specified in the delay the Standard Care accumulation of Arrangement. Formulary Pg. 24 physical disability. Antirheumatic Agents Antirheumatic Agents Antirheumatic Agents. Physician Initiated/ 1/6/2014 Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 23 Arrangement. Keratinocyte Growth Factors Palifermin Keratinocyte Growth 1/6/2014 (Kepivance) Factors. The prescribing Indicated to decrease designation of this the incidence and drug must be duration of severe oral determined jointly mucositis in patients by the CTP Holder with hematologic and Collaborating malignancies who are Physician and receiving myelotoxic specified in the therapy requiring Standard Care hematopoietic stem Arrangement. Formulary Pg. 23 cell support.

40 January 2014 CPG Updates

Dermatologic Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Anti-Psoriatic Agents Methotrexate Anti-Psoriatic Agents. Physician Initiated/ 1/6/2014 (Rheumatrex, Trexall) Indicated for the Physician Consult The prescribing symptomatic control of designation of this severe recalcitrant, drug must be disabling psoriasis, determined jointly which is not adequately by the CTP Holder responsive to other and Collaborating therapy. Physician and specified in the Standard Care Formulary pg. 24 Arrangement. Photochemotherapy Methoxsalen Oral Photochemotherapy Physician Initiated/ 1/6/2014 (Oxsoralen Ultra) Agents. Physician Consult for The prescribing Indicated for the CTP holder with SCA designation of this symptomatic control of with physician drug must be severe, recalcitrant, specializing in determined jointly disabling psoriasis not Dermatology. by the CTP Holder adequately responsive and Collaborating to other forms of Physician and therapy and when the specified in the diagnosis has been Standard Care supported by biopsy. Arrangement.

Methoxsalen Topical Indicated as a topical Physician Initiated/ (Oxsoralen) repigmenting agent in Physician Consult for vitiligo, used in CTP holder with SCA conjunction with with physician controlled doses of specializing in ultraviolet A or Dermatology. Formulary Pg. 24 sunlight. Aminolevulinic Acid Photochemotherapy Physician Initiated/ 1/6/2014 (Levulan Kerastick) Agents. Physician Consult for The prescribing Indicated for the CTP holder with SCA designation of this treatment of non- with Dermatology drug must be hyperkeratotic practice only determined jointly keratosis of the face by the CTP Holder or scalp and Collaborating Physician and specified in the Standard Care Arrangement. Formulary Pg. 24

41 January 2014 CPG Updates

Pyrimidine Antagonist, Topical Pyrimidine Pyrimidine Antagonist, Physician Initiated/ 1/6/2014 Antagonist, Topical Topical. Physician Consult CTP holder may prescribe. Formulary Pg. 24 Retinoids First Generation First Generation 1/6/2014 Retinoids Retinoids. The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement. Formulary Pg. 24 Isotretinoin First Generation Physician Initiated/ 1/6/2014 (Accutane, Retinoids. Physician Consult for The prescribing Amnesteem, Claravis, Indicated for the CTP holder with SCA designation of this Sotret) treatment of severe with dermatology drug must be recalcitrant nodular practice only. determined jointly acne. by the CTP Holder and Collaborating Physician and specified in the Standard Care Formulary Pg. 24 Arrangement. Rexinoids Bexarotene Oral Rexinoids. 1/6/2014 (Targretin) Indicated for the The prescribing treatment of designation of this cutaneous drug must be manifestations of determined jointly CTCL in patients who by the CTP Holder are refractory to at and Collaborating least 1 prior systemic Physician and therapy. specified in the Standard Care Formulary Pg. 25 Arrangement.

42 January 2014 CPG Updates

Ophthalmic Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Agents for Glaucoma Agents for Agents for Glaucoma. Physician Initiated/ 1/6/2014 Glaucoma Physician Consult CTP holder may prescribe. Formulary Pg. 25 Corticosteroids Corticosteroids Corticosteroids. Physician Initiated/ 1/6/2014 Indicated for treatment Physician Consult CTP holder may of corneal injury prescribe. (dexamethasone, Dexamethasone: CTP prednisolone acetate), holder may prescribe for the treatment of with hematology/ macular edema oncology specialty. (dexamethasone implant), For the treatment of steroid- responsive inflammatory conditions, for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis (loteprednol suspension), and for visualization during vitrectomy Formulary Pg. 25 (triamcinolone). Cycloplegic Mydriatics Cycloplegic Cycloplegic Mydriatics. Physician Initiated/ 1/6/2014 Mydriatics Indicated for cycloplegic Physician Consult CTP holder may refraction, for pre and prescribe. postoperative states when mydriasis is required, for dilating the pupil, and for the treatment of inflammatory conditions of the iris and uveal tract.

Formulary Pg. 25

43 January 2014 CPG Updates

Cystine-Depleting Agents Cysteamine Cystine-Depleting Physician Initiated/ 1/6/2014 (Cystaran) Agents. Physician Consult The prescribing Indicated for the designation of this treatment of corneal drug must be cysteine crystal determined jointly accumulation in patients by the CTP Holder with cystinosis. and Collaborating Physician and specified in the Standard Care Arrangement.

Formulary Pg. 25 Ophthalmic Antifungals Ophthalmic Ophthalmic Antifungals. Physician Initiated/ 1/6/2014 Antifungals Indicated for the Physician Consult The prescribing treatment of fungal designation of this Natamycin blepharitis, drug must be (Natacyn) conjunctivitis, and determined jointly keratitis caused by by the CTP Holder susceptible organisms. and Collaborating Physician and specified in the Standard Care Arrangement.

Formulary Pg. 25 Antiviral Agents Antiviral Agents Antiviral Agents. Physician Initiated/ 1/6/2014 Physician Consult The prescribing designation of this drug must be determined jointly by the CTP Holder and Collaborating Physician and specified in the Standard Care Arrangement.

Formulary Pg. 25

44 January 2014 CPG Updates

Antineoplastic Agents

Drug Category/ Indication(s): If Current Prescribing CPG Action/Date Drug Name reviewing a specific Designation drug in a drug category Hormones Antiandrogens Antiandrogens Physician Initiated/ 1/6/2014 Physician Consult only The prescribing for prescribers who have designation of this and maintain a standard drug must be care arrangement with a determined jointly collaborating by the CTP Holder hematologist/ oncologist. and Collaborating Physician and specified in the Standard Care Formulary Pg. 27 Arrangement. Antiestrogens Antiestrogens Physician Initiated/ 1/6/2014 Physician Consult only The prescribing for prescribers who have designation of this and maintain a standard drug must be care arrangement with a determined jointly collaborating by the CTP Holder hematologist/ oncologist. and Collaborating Physician and specified in the Standard Care Formulary Pg. 27 Arrangement. Gonadotropin- Gonadotropin-Releasing Physician Initiated/ 1/6/2014 Releasing Hormone Hormone Analog. Physician Consult only The prescribing Analog for CTP holder with a designation of this standard care drug must be arrangement with a determined jointly physician specializing in by the CTP Holder Hematology/ Oncology/ and Collaborating or Urology ONLY for Physician and prostate CA specified in the Standard Care Formulary Pg. 27 Arrangement. Kinase Inhibitors Everolimus mTOR Inhibitors. Physician Initiated/ 1/6/2014 (Zortress) Indicated for the Physician Consult for The prescribing prophylaxis of organ prophylaxis of organ designation of this rejection in adult rejection in kidney drug must be patients at low to transplants. determined jointly moderate immunologic by the CTP Holder risk receiving a kidney and Collaborating transplant. Physician and Formulary Pg. 26 specified in the

45 January 2014 CPG Updates

Ruxolitinib Indicated for the Physician Initiated/ Standard Care (Jakafi) treatment of patients Physician Consult Arrangement. with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post- polycythemia vera myelofibrosis, and post- essential thrombocythemia Formulary Pg. 26 myelofibrosis.

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