ACTEMRA SC. Products Affected

Transcription

1 Advantra (HMO), Advantra (PPO), Advantra Advantage (HMO), Advantra Cares (HMO SNP), Advantra Choice (HMO), Advantra Freedom (PPO), Advantra Freedom Plus (PPO), Advantra Gold (PPO), Advantra Option 1 (HMO-POS), Advantra Option 2 (HMO), Advantra Platinum (HMO), Advantra Preferred (PPO), Advantra Silver (HMO), Advantra Silver (PPO), Advantra Silver Plus (HMO), Advantra Silver Plus (PPO), Advantra Total Care (HMO), Advantra Value (PPO), AdvantraOne (PPO), Altius Advantra (HMO), Altius Advantra Select (HMO), Coventry Advantage (HMO), Coventry Advantage Plus (HMO-POS), Coventry Advantra Platinum (PPO), Coventry Advantra Silver (HMO), Coventry Medicare Advantage (PPO), Coventry Medicare Advantage Total Care (HMO), Coventry Total Care (HMO), Coventry Total Care (HMO-POS), Coventry Total Care (PPO), Gold Advantage (HMO) Last Updated: 12/01/2017 ACTEMRA SC Actemra INJ 162MG/0.9ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Rheumatologist For moderately to severely active rheumatoid arthritis in adult patients: Patient has a documented trial and failure or contraindication to Enbrel (etanercept) AND Humira (adalimumab). 1 NR_0009_ /2014 Formulary ID: 17025: version 19

2 ACTIMMUNE Actimmune PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 2

3 ADAGEN Adagen PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Contraindicated in bone marrow transplantation and in patients with severe thrombocytopenia due to increased risk of bleeding. Adenosine deaminase deficiency in patients with severe combined immunodeficiency disease who are not suitable candidates for or who have failed bone marrow transplantation. 6 months 3

4 ADEMPAS Adempas PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concurrent use with organic nitrates (i.e. isosorbide mononitrate, isosorbide dinitrate, nitroglycerin) or PDE inhibitors (i.e. sildenafil, Adcirca, dipyridamole, theophylline). Pregnancy. For Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH AND patient has a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography AND Patient has a documented thromboembolic occlusion of the pulmonary vasculature. For Pulmonary Arterial Hypertension (PAH) (WHO Group 1) and WHO functional class II to IV symptoms AND patient has mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography. Pulmonologist or cardiologist 4

5 AFINITOR Afinitor Afinitor Disperz PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist For advanced renal cell carcinoma, prior therapy with Sutent (sunitinib) and Inlyta (axitinib). For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC), Afinitor is being used in combination with exemestane after failure of treatment with letrozole or anastrozole. There are no additional requirements for advanced neuroendocrine tumors of the pancreatic origin, renal angiomyolipoma with tuberous sclerosis complex and subependymal giant cell astrocytoma with tuberculous sclerosis complex. Applies to new starts only. 5

6 ALDURAZYME Aldurazyme PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Mucopolysaccharidosis, Type I (Hurler and Hurler-Scheie forms) and Scheie form with moderate to severe symptoms. Not covered for mildly affected patients with the Scheie form. 6

7 ALECENSA Alecensa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other For anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC): progressed on or intolerance to crizotinib (Xalkori). Oncologist Applies to new starts only. 7

8 ALIMTA Alimta PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Requests for new starts are covered with malignant mesothelioma of pleura in combination with cisplatin in patients who are not candidates for surgical resection. Requests for new starts are covered with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy as a single agent OR as initial therapy in combination with cisplatin OR as maintenance therapy for patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Applies to new starts only. 8

9 ALIQOPA Aliqopa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Through end of plan contract year Applies to new starts only. 9

10 ALPHA1-PROTEINASE INHIBITORS Prolastin-c PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Not covered for patients with the PiMZ or PiMS phenotypes of alpha 1 - antitrypsin deficiency as they appear to be at small risk for panacinar emphysema. Diagnosis of panacinar emphysema AND documentation of a decline in forced expiratory volume in 1 second (fev1) despite optimal medical therapy (bronchodilators, corticosteroids, oxygen if indicated) AND documentation of phenotype (pi*zz, pi*znull or pi*nullnull) associated with causing serum alpha 1-antitrypsin of less than 80 mg/dl AND documentation of an alpha 1-antitrypsin serum level below the value of 35% of normal (less than 80 mg/dl). Prolastin-C is preferred formulary agent. For other Alpha 1 proteinase inhibitors on formulary: patient must have a documented trial and failure or contraindication to Prolastin-C. 10

11 ALUNBRIG Alunbrig PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Hematologist or Oncologist Applies to new starts only. 11

12 AMPYRA Ampyra PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Patients with history of seizures. Creatinine Clearance (CrCl) less than 50mL/min. Documented diagnosis of multiple sclerosis (MS). Patient has sustained walking impairment. Patient is able to walk 25 feet with or without assistance. Neurologist Initial approval: 6 months. Renewal: For renewals: Patient has continued therapeutic response to Ampyra. 12

13 ANALGESICS-AGE EDIT Ketorolac Tromethamine TABS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. For moderate to severe pain: Patient has a trial or failure or a documented contraindication to one non-hrm alternative drug, such as ibuprofen, tramadol, oxycodone/apap, hydrocodone/apap, morphine sulfate). For gout: The patient had an inadequate treatment response OR intolerance to allopurinol or febuxostat (Uloric). 13

14 ANDROGEL Androgel Androgel Pump Testosterone GEL 25MG/2.5GM, 50MG/5GM PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Testosterone levels within normal range (range for the lab doing the testing). Female patients. Men with carcinoma of the breast or suspected carcinoma of the prostate. Use for muscle building purposes. For members initiating testosterone replacement therapy: Testosterone levels (total or free). Require either ONE low total testosterone level OR ONE low free testosterone level. (normal ranges as provided by office or clinic performing labs). Note: Members that are already stabilized on therapy will not be required to provide labs and can be approved as continuation. 14

15 ANTIDEPRESSANTS-AGE EDIT Amitriptyline Hcl TABS Clomipramine Hcl CAPS Doxepin Hcl CAPS Doxepin Hcl CONC Imipramine Hcl TABS Trimipramine Maleate CAPS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 15

16 ANTIHISTAMINES-AGE EDIT Clemastine Fumarate SYRP Clemastine Fumarate TABS 2.68MG Cyproheptadine Hcl TABS Diphenhydramine Hcl INJ 50MG/ML Phenadoz Phenergan SUPP Promethazine Hcl SUPP Promethazine Hcl SYRP Promethazine Hcl TABS Promethegan PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 16

17 ANTIPARKINSON AGENTS-AGE EDIT Benztropine Mesylate INJ Benztropine Mesylate TABS Trihexyphenidyl Hcl PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. Patient has a documented trial and failure or contraindication to one of the following: amantadine, pramipexole, or ropinirole. 17

18 ANTISPASMOTICS-AGE EDIT Dicyclomine Hcl CAPS Dicyclomine Hcl SOLN Dicyclomine Hcl TABS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 18

19 APOKYN Apokyn INJ 30MG/3ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Off label use for erectile dysfunction as treatment for ED are CMS exclusions. Contraindicated when used concomitantly with 5HT3 receptor antagonists such as ondansetron or granisetron. For Parkinson's disease: medical history that documents patient experiences motor fluctuations despite an optimized oral drug regimen which includes levodopa. Requests for Parkinson's disease are covered following an appropriate trial of a levodopa-containing regimen. 19

20 APTIOM Aptiom PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Requests for adjunct therapy for partial-onset seizure disorder are covered with documentation that the patient is currently on an anticonvulsant (including lamotrigine, phenytoin, divalproex, levetiracetam, gabapentin, carbamazepine, topiramate, zonisamide). Applies to new starts only. 20

21 ARANESP Aranesp Albumin Free PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Uncontrolled hypertension For initiation of therapy: adequate iron stores have been demonstrated by means of bone marrow iron or serum ferritin levels or serum iron saturation studies within the prior 12 months (Note: for persons with iron deficiency, erythropoietin analog therapy may be initiated simultaneous with iron replacement), and the following criteria is met: hemoglobin (Hgb) is approaching or has fallen below 10 g/dl (CKD not on dialysisadult, cancer), 11 g/dl (CKD on dialysis), 12 g/dl (pediatric CKD) or hematocrit of 30% OR patient will be starting myelosuppressive therapy and will have an anticipated hemoglobin drop associated with their therapy. For continuation of therapy: documentation of the below: for persons with anemia due to myelosuppressive anticancer chemotherapy: Hgb target of 12 g/dl For persons with chronic renal failure and endstage renal disease (ESRD): Hgb target g/dl. Continued use of the therapy is not covered if the hemoglobin rises less than 1 g/dl (hematocrit rise less than 3%) compared to pretreatment baseline by 12 weeks of treatment and whose hemoglobin level remains less than 10 g/dl (or the hematocrit is less than 30%). 12 weeks Excluded from patients with Hgb at or above 10 g/dl (CKD not on dialysis-adult, cancer), 11 g/dl (CKD on dialysis), 12 g/dl (pediatric CKD). 21

22 ARCALYST Arcalyst PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 12 years of age or older. 22

23 ARZERRA Arzerra PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new starts only. 23

24 AVASTIN Avastin PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new starts only. 24

25 BANZEL Banzel PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Banzel is not covered for members with the diagnosis of Familial Short QT syndrome. Patient has a documented trial and failure or contraindication to lamotrigine. For Lennox-Gastaut Syndrome: Only approved as adjunctive therapy. Applies to new starts only. 25

26 BAVENCIO Bavencio PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or dermatologist Through end of plan contract year Applies to new starts only. 26

27 BELEODAQ Beleodaq PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist For patients with a diagnosis of peripheral T-cell lymphoma (PTCL), patient has relapsed or is refractory to prior therapies. Applies to new starts only. 27

28 BENLYSTA Benlysta PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other A documented diagnosis of systemic lupus erythematosus (SLE) and an active, autoantibody-positive test who are receiving standard therapy comprising any of the following (alone or in combination): anti-malarials, corticosteroids, immunosuppressives (excluding intravenous cyclophosphamide), and non-steroidal anti-inflammatory drugs. 28

29 BESPONSA Besponsa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Through end of plan contract year Applies to new starts only. 29

30 BLINCYTO Blincyto PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new starts only. Drug is also subject to a Part B versus Part D coverage determination. 30

31 BOSULIF Bosulif PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist For diagnosis of chronic or accelerated Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML): documentation of resistance or intolerance to prior therapy with nilotinib (Tasigna) or dasatinib (Sprycel). For diagnosis of blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML): documentation of resistance or intolerance to prior therapy with imatinib (Gleevec),dasatinib (Sprycel), or nilotinib (Tasigna). Applies to new starts only. 31

32 BOTOX Botox PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Cosmetic Use For the treatment of cervical dystonia to decrease the severity of abnormal head position and neck pain. For the treatment of severe primary axillary hyperhidrosis. For the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders. Cerebral Palsy and Spastic hemiplegia. For the treatment of upper or lower limb spasticity. For prophylaxis of headaches in patients with chronic migraine (less than or equal to 15 days per month with headache lasting 4 hours a day or longer) following adequate trial and failure or contraindication to two preventative/prophylactic oral agents. For treatment of incontinence due to detrusor instability, associated with a neurologic condition such as spinal cord injury or MS that had an inadequate response or are intolerant to oxybutynin and tropsium. For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency that had an inadequate response or are intolerant to oxybutynin and tropsium. 12 weeks 32

33 BRIVIACT Briviact PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Through end of plan contract year Applies to new starts only. Requests for adjunct therapy for partial-onset seizure disorder are covered with documentation that the patient is currently on an anticonvulsant such as: lamotrigine, phenytoin, divalproex, levetiracetam, gabapentin, carbamazepine, topiramate, zonisamide. 33

34 BUPHENYL Buphenyl TABS Sodium Phenylbutyrate POWD 3GM/TSP Sodium Phenylbutyrate TABS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Contraindicated for acute hyperammonemia emergency management. Cycle disorders: As adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamoylase (OTC) or argininosuccinic acid synthetase (AAS). In all patients with neonatalonset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). In patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. 34

35 BUTALBITAL-AGE EDIT Ascomp/codeine Butalbital Compound/codeine CAPS 325MG; 50MG; 40MG; 30MG Butalbital/acetaminophen/caffeine CAPS Butalbital/acetaminophen/caffeine TABS 325MG; 50MG; 40MG Butalbital/acetaminophen/caffeine/co deine Butalbital/aspirin/caffeine Butalbital/aspirin/caffeine/codeine Capacet Esgic CAPS Margesic Phrenilin Forte CAPS 300MG; 50MG; 40MG Zebutal CAPS 325MG; 50MG; 40MG PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 35

36 CABOMETYX Cabometyx PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Through end of plan contract year Applies to new starts only. For advanced renal cell carcinoma, prior therapy with Sutent (sunitinib) and Inlyta (axitinib). 36

37 CAMPATH Campath INJ 30MG/ML PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Through end of plan contract year Applies to new starts only. 37

38 CAPRELSA Caprelsa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Do not use in patients with congenital long QT syndrome. Oncologist or Endocrinologist Applies to new Starts Only. 38

39 CARDIOVASCULAR-AGE EDIT Disopyramide Phosphate CAPS Ticlopidine Hcl PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 39

40 CEREZYME Cerezyme PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 40

41 CINRYZE Cinryze PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Member has a history of at least 2 HAE attacks per month AND Diagnosis of HAE is documented based on evidence of a normal C1 level and a low C4 level (C4 less than 14 mg/dl normal range 14 to 40 mg/dl), or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: A low C1 inhibitor (C1INH) antigenic level (C1INH less than 19 mg/dl normal range 19 to 37 mg/dl, or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test) OR A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dl) and a low C1INH functional level (functional C1INH less than 50% or C1INH functional level below the lower limit of normal as defined by the laboratory performing the test) OR A known HAE-causing C1INH mutation. Medications known to cause angioedema (i.e. ACE-Inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate. Member has tried and failed or is intolerant to or has a contraindication to danazol. Immunologist or Rheumatologist Initial approval: 6 months. Extended approval: Through end of plan contract year. 41

42 COLY-MYCIN Colistimethate Sodium INJ PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Administration via nebulizer Infectious disease 3 months Allow intravenous (IV) or intramuscularly (IM) use only. CMS endorsed compendia do not support inhalation/nebulization of colistimethate. 42

43 COMETRIQ Cometriq PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new Starts Only. 43

44 COPAXONE Copaxone INJ 20MG/ML, 40MG/ML Glatopa PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Documentation that other therapies used for treating multiple sclerosis will be discontinued ( Note: This does NOT require having to discontinue Ampyra).The member has a diagnosis of a relapsing form of multiple sclerosis OR has experienced a first clinical episode and has MRI features consistent with multiple sclerosis. Neurologist 44

45 CORLANOR Corlanor PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Acute decompensated heart failure. Blood pressure less than 90/50 mmhg. Sick sinus syndrome, sinoatrial block, or 3rd degree AV block, unless a functioning demand pacemaker is present. Resting heart rate less than 60 bpm prior to treatment. Severe hepatic impairment. Pacemaker dependence (heart rate maintained exclusively by the pacemaker). Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (Examples: azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g., clarithromycin, telithromycin), HIV protease inhibitors (e.g., nelfinavir), and nefazodone). Failure of 1 month of ACE Inhibitor or ACE Inhibitor/HCTZ combination or Angiotensin-Receptor Blocker or Angiotensin-Receptor Blocker/HCTZ combination AND one of the following beta blockers: bisoprolol/bisoprolol-hctz, carvedilol, carvedilol CR, metoprolol succinate/metoprolol succinate-hctz, nevibolol. 45

46 COTELLIC Cotellic PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other For unresectable or metastatic melanoma: confirmation of BRAF V600E or V600K mutation. Oncologist For unresectable or metastatic melanoma with a BRAF V600E or V600K mutation: Must be used with vemurafenib (Zelboraf). Applies to new Starts Only. 46

47 CYCLOSPORINE Cyclosporine CAPS Cyclosporine INJ Cyclosporine Modified Gengraf Sandimmune SOLN PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Drug is also subject to a Part B versus Part D coverage determination. 47

48 CYRAMZA Cyramza PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist For patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma: Patient has had disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. For Non- Small Cell Lung cancer: Used in combination with docetaxel. For colorectal cancer: Used in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), and patient has had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Applies to new Starts Only. 48

49 CYSTAGON Cystagon PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 49

50 DARZALEX Darzalex PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Documentation of previous treatment history. Oncologist or Hematologist Applies to new Starts Only 50

51 DEFERASIROX Exjade PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Deferasirox is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) when the patient is receiving transfusions and has a serum ferritin consistently above 1000 mcg/l. Deferasirox is also covered when used for the indication of the treatment of chronic iron overload with non-transfusion-dependent thalassemia syndromes who have liver iron concentrations of at least 5 mg Fe/g dry weight and serum ferritin levels greater than 300 mcg/l. for this diagnosis is approved based upon laboratory values and when verified as not being used in combination with other iron chelators since safety has not been established. 51

52 DIABETES-AGE EDIT Glyburide TABS Glyburide Micronized Glyburide/metformin Hcl PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. Patient has a documented trial and failure or a contraindication to glipizide and glimepiride. 52

53 DRONABINOL Dronabinol PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other CINV:6 months, PONV:1 month, Other medically accepted indications: through end of plan contract year For the diagnosis of nausea and vomiting associated with cancer chemotherapy, the following must be met: 1. The patient is receiving cancer chemotherapy AND 2. The patient has failed one 5HT-3 receptor antagonist such as ondansetron or granisitron. There are no additional requirements for anorexia associated with weight loss in patients with AIDS. Drug is also subject to a Part B versus Part D coverage determination. 53

54 EGRIFTA Egrifta PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Egrifta is not covered for weight loss management, patients with active malignancy or patients who are pregnant, and in patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. For HIV-infected patients with lipodystrophy, documentation of active antiretroviral therapy. 54

55 ELITEK Elitek PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Glucose-6-phosphate dehydrogenase (G6PD) deficiency. For the treatment of uric acid levels in patient with diagnosis of leukemia, lymphoma or solid tumor malignancies AND are receiving chemotherapy that is expected to cause tumor lysis. 5 days 55

56 EMPLICITI Empliciti PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Documentation of previous treatment history. Oncologist or Hematologist For multiple myeloma: must be used in combination with lenalidomide and dexamethasone. Applies to new Starts Only. 56

57 ENBREL Enbrel Enbrel Sureclick PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other For the treatment of adult patients with moderate to severe chronic plaque psoriasis: PASI score of 10 or more and body surface area (BSA) involvement equal to or greater than 5% OR affecting crucial body areas such as the hands, feet, face, or genitals. For continuation of therapy: patient has shown improvement and dose requested does not exceed the FDA maximum dose. Rheumatologist or Dermatologist Plaque psoriasis: 12 weeks, Other: Initial, 6 months. Then through end of plan contract year For the treatment of adult patients with moderate to severe chronic plaque psoriasis: Documentation of a trial of at least one non-biologic therapy, such as phototherapy, MTX, acitretin or cyclosporine. 57

58 ENTRESTO Entresto PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other History of angioedema related to previous ACE inhibitor or ARB therapy. Concomitant use of ACE inhibitors. Concomitant use of aliskiren (Tekturna) in patients with diabetes. 58

59 EPCLUSA Epclusa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Confirmation of hepatitis C genotype. Previous hepatitis C treatment history (if any). Other medications that will be used with current AASLD/IDSA protocol (if any). Presence or absence of cirrhosis. Infectious disease, gastroenterologist, hepatologist will be applied consistent with current AASLD/IDSA guidance. (A) For Genotypes 1 and 4, patient must have documented failure/contraindication/intolerance to Harvoni (ledipasvir and sofosbuvir) OR Zepatier (elbasvir and grazoprevir), if appropriate based on current AASLD/IDSA guidance. For Genotype 5 and 6, patient must have documented failure/contraindication/intolerance to Harvoni (ledipasvir and sofosbuvir), if appropriate based on current AASLD/IDSA guidance, AND (B) will be applied consistent with current AASLD/IDSA guidance. 59

60 ERAXIS Eraxis PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 6 weeks The patient will need to have tried and failed fluconazole and oral voriconazole. 60

61 ERBITUX Erbitux PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other A documented diagnosis of colorectal cancer AND both of the belowdocumented evidence of positive EGFR expression from primary tumor or metastatic tumor site AND documented K-ras (KRAS) mutation analysis to predict non-response. There are no additional requirements for squamous cell carcinoma of the head and neck. Oncologist Applies to new Starts Only. 61

62 ERGOLOID-AGE EDIT Ergoloid Mesylates TABS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. For treatment of Alzeihmer s/dementia: Patient has a documented trial and failure or a contraindication to one of the following: galantamine, rivastigmine, or donepezil. 62

63 ERIVEDGE Erivedge PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other For diagnosis of locally advanced basal cell carcinoma that has recurred following surgery or patient is not candidate for surgery or radiation. For Metastatic basal cell carcinoma, no additional information required. Oncologist Applies to new Starts Only 63

64 ERWINAZE Erwinaze PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Patient has developed hypersensitivity to E. coli-derived asparaginase. Applies to new Starts Only. 64

65 ESBRIET Esbriet PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D Confirmation of diagnosis of IPF. Pulmonologist Patient has a documented trial and failure or contraindication to Ofev (nintedanib) or clinical rationale as to why patient cannot used preferred agent Ofev (nintedanib). 65

66 ESTROGEN-AGE EDIT Amabelz Estradiol ORAL TABS 0.5MG, 1MG, 2MG Estradiol PTTW Estradiol PTWK Estradiol/norethindrone Acetate Fyavolv Jevantique Lo Jinteli Lopreeza Menest Mimvey Mimvey Lo Norethindrone Acetate/ethinyl Estradiol TABS 2.5MCG; 0.5MG, 5MCG; 1MG PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. 66

67 EVOMELA Evomela PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Applies to new starts only. 67

68 FABRAZYME Fabrazyme PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 68

69 FARYDAK Farydak PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist For multiple myeloma: Must be used with bortezomib and dexamethasone. Applies to new Starts Only. 69

70 FASLODEX Faslodex INJ 250MG/5ML PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new Starts Only. 70

71 FENTANYL ORAL Fentanyl Citrate Oral Transmucosal PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other The drug is not indicated in the management of acute or post-operative pain. This medication must not be used in opioid non-tolerant patients. The patient must not have any of the following contraindications: Not covered for patients with pain not associated with cancer. For the management of breakthrough cancer pain in patients with malignancies already receiving and tolerant to opioid therapy for their underlying cancer pain. Oncologists and pain specialists who are experienced in the use of Schedule II opioids to treat cancer pain. Diagnosis of breakthrough cancer pain in opioid-tolerant patients AND concomitant use of long acting opioid therapy, such as ONE of thesecontrolled-release morphine or extended-release morphine or controlledrelease oxycodone or extended-release oxymorphone or fentanyl transdermal or methadone. 71

72 FERRIPROX Ferriprox PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 72

73 FIRAZYR Firazyr PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Member must have a diagnosis of HAE and where diagnosis is documented by documented based on evidence of a normal C1 level and a low C4 level (C4 less than 14 mg/dl normal range 14 to 40 mg/dl, or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: a) A low C1 inhibitor (C1INH) antigenic level (C1INH less than 19 mg/dl normal range 19 to 37 mg/dl or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test) OR b) A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dl) and a low C1INH functional level (functional C1INH less than 50%, or below the lower limit of normal as defined by the laboratory performing the test) and Member must be experiencing at least one symptom of the moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion) and Medications known to cause angioedema (i.e. ACE- Inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate. Immunologist or Rheumatologist 73

74 FIRMAGON Firmagon PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Not covered for pregnant women or women of child-bearing age. Oncologist Applies to new starts only. 74

75 FORTEO Forteo INJ 600MCG/2.4ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Diagnosis of underlying hypercalcemic disorder such as hypercalcemia, hyperparathyroidism or hypoparathyroidism, or high risk for osteosarcoma (Pagets disease, prior radiation therapy, bone metastases, open epiphyses, etc.). Treatment duration greater than 24 months. Fracture history. Documentation of high risk for fracture for postmenopausal women, high risk defined with the presence of two of the following: low BMD scores (T-score less than or equal to -2.5 at the spine or hip or both), advanced age, or positive family history for osteoporosis in a 1st degree relative (parent, sibling, or offspring), Start date of therapy. 2 years from initiation of therapy For postmenopausal women with osteoporosis at high risk for fracture and men with primary or hypogonadal osteoporosis, require documentation of trial and failure on at least one first-line therapy (alendronate, Evista or ibandronate) or documentation of intolerance to at least two first-line therapies. For patients with glucocorticoid induced osteoporosis, require documentation of trial and failure to alendronate or documented intolerance to alendronate. 75

76 FYCOMPA Fycompa PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Applies to new starts only. 76

77 GATTEX Gattex PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Documentation of the following: Patient has had a colonoscopy (or alternate imaging) of the entire colon with no evidence of neoplastic disease including polyps (or if polyps, they were removed within 6 months prior to starting treatment with Gattex) AND patient has had an initial laboratory assessment (bilirubin, alkaline phosphatase, lipase and amylase) within 6 months prior to starting treatment with Gattex to identify abnormal test levels. Patient has been dependent on parenteral nutrition/intravenous support for at least 12 months AND requires parenteral nutrition at least three times per week. 77

78 GAZYVA Gazyva PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other HBsAGg and anti-hbc. If positive, a physician with expertise in managing hepatitis B has been consulted regarding monitoring and consideration for HBV antiviral therapy. Oncologist For chronic lymphocytic leukemia (CLL): CLL is previously untreated and will be used in combination with chlorambucil. Applies to new Starts Only. 78

79 GILENYA Gilenya PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure. History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker. Baseline QTc interval greater than or equal to 500 ms. Treatment with Class Ia or Class III anti-arrhythmic drugs. Documentation that other therapies used for treating multiple sclerosis will be discontinued ( Note: This does NOT require having to discontinue Ampyra).The member has a diagnosis of a relapsing form of multiple sclerosis OR has experienced a first clinical episode and has MRI features consistent with multiple sclerosis. Neurologist 79

80 GILOTRIF Gilotrif PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new Starts Only. 80

81 GLEEVEC Imatinib Mesylate PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Applies to new starts only 81

82 HALAVEN Halaven PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist A documented diagnosis of metastatic breast cancer AND documented prior therapy with both an anthracycline (i.e. daunorubicin, bleomycin), and a taxane (i.e. paclitaxel, docetaxel). Applies to new Starts Only. 82

83 HARVONI Harvoni PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Confirmation of hepatitis C genotype. Previous hepatitis C treatment history (if any). Other medications that will be used with current AASLD/IDSA protocol (if any). Presence or absence of cirrhosis. Infectious disease, gastroenterologist, hepatologist will be applied consistent with current AASLD/IDSA guidance. will be applied consistent with current AASLD/IDSA guidance. 83

84 HERCEPTIN Herceptin PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other HER2-protein expression test (require positive or equivocal HER2 overexpression). As part of a regimen for the adjuvant treatment of HER2- overexpressing, breast cancer. As first-line therapy for metastatic HER2 positive breast cancer in combination with paclitaxel. As a single agent, for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR negative or with one high-risk feature) or node positive breast cancer, following multi-modality anthracycline based therapy. As a single agent for the treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. As a single agent for the treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. As part of a regimen for HER2-positive esophageal or gastric cancer. As first line treatment for HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in combination with cisplatin and either capecitabine (Xeloda) or 5-FU. Oncologist Applies to new Starts Only. 84

85 HETLIOZ Hetlioz PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other For non-24- hour sleep-wake disorder ( non-24 ): Member is documented to be totally blind and has no light perception AND other sleep disorders have been ruled out or treated appropriately (i.e. sleep apnea). 85

86 HUMIRA Humira Humira Pediatric Crohns Disease Starter Pack Humira Pen Humira Pen-crohns Diseasestarter Humira Pen-psoriasis Starter PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other For the treatment of adult patients with moderate to severe chronic plaque psoriasis: PASI score of 10 or more. For continuation of therapy: patient has shown improvement and dose requested does not exceed the FDA maximum dose. Gastroenterologist, Ophthalmologist, Rheumatologist or Dermatologist Initial for PsO and UC: 12 weeks. Other: 6 months. Continuation: Through end of plan contract year For the treatment of adult patients with moderate to severe chronic plaque psoriasis: Documentation of a trial of at least one non-biologic therapy, such as phototherapy, MTX, acitretin or cyclosporine. 86

87 HYDROXYPROGESTERONE CAPROATE Hydroxyprogesterone Caproate INJ 1.25GM/5ML PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Contraindications per FDA labeling. Applies to new starts only. 87

88 HYDROXYZINE-AGE EDIT Hydroxyzine Hcl INJ PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other must acknowledge that medication benefits outweigh potential risks in patients 65 years of age or older. This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. For alcohol withdrawal syndrome: Patient has a documented trial and failure or a contraindication to clorazepate or diazepam. For N/V: Patient has a documented trial and failure or a contraindication to ondansetron. For anxiety: Patient has a documented trial and failure or a contraindication to one of the following: duloxetine, citalopram, or venlafaxine ER. For Allergic Rhinitis: Patient has a documented trial and failure or a contraindication to one of the following: levocetirizine, desloratadine, azelastine (nasal), or fluticasone (nasal). For pruritus: Patient has a documented trial and failure or a contraindication to one of the following: levocetirizine, desloratadine, or topical steroids. 88

89 IBRANCE Ibrance PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new Starts Only. 89

90 ICLUSIG Iclusig PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist A documented diagnosis of one of the following: 1. Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) AND Documented confirmation of the presence of the T315i mutation OR No other tyrosine kinase inhibitor (TKI) therapy is indicated (i.e., imatinib (Gleevec), dasatinib (Sprycel), or nilotinib (Tasigna)). 2. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) AND Documented confirmation of the presence of the T315i mutation OR No other tyrosine kinase inhibitor (TKI) therapy is indicated (i.e., imatinib (Gleevec). Applies to new Starts Only. 90

91 IDHIFA Idhifa PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist or Hematologist Through end of plan contract year Applies to new starts only. 91

92 ILARIS Ilaris PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other 92

93 IMBRUVICA Imbruvica PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Oncologist Applies to new start only. 93

94 IMFINZI Imfinzi PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Hematologist or Oncologist Applies to new starts only. 94

95 IMMUNE GLOBULIN Gamastan S/d Gammaplex Gamunex-c PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age For dermatomyositis and polymyositis: standard 1st line treatments (corticosteroids or immunosuppressants) have been tried but were unsuccessful or not tolerated OR patient is unable to receive standard therapy because of a contraindication or other clinical reason. For GBS: physical mobility must be severely affected such that the patient requires an aid to walk AND IVIG therapy must be initiated within 2 weeks of symptom onset. For RRMS: a documented failure/contraindication/intolerance to two of the following: interferon beta-1a (Rebif), fingolimod hydrochloride (Gilenya), glatiramer (Copaxone). For CLL: serum IgG less than 600 mg/dl OR a history of recurrent bacterial infections. For BMT/HSCT: serum IgG less than 400 mg/dl. For pediatric HIV infection: serum IgG less than 400 mg/dl OR a history of recurrent bacterial infections. PRCA is secondary to parvovirus B19 infection. For all indications: patients with any of the following risk factors for renal dysfunction must receive the minimum dose or concentration available of IVIG and the minimum infusion rate practicable: pre-existing renal insufficiency, diabetes mellitus, age over 65 years, volume depletion, sepsis, paraproteinemia, or receiving concomitant nephrotoxic drugs. For all indications: patients with any of the following risk factors for thrombosis must receive the minimum dose or concentration available of IVIG and the minimum infusion rate practicable: age 45 years or older, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, or cardiovascular risk factors. 95

96 Other Patient has a documented trial and failure or contraindication to Gammaplex and Gamunex-c. Drug is also subject to a Part B versus Part D coverage determination. 96

97 INCRELEX Increlex PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Increlex is contraindicated for growth promotion in patients with closed epiphyses, for IV administration, in patients with active or suspected neoplasia. Increlex should be discontinued if neoplasia develops while on therapy. Child has one of the following conditions: Severe primary IGF-1 deficiency OR Growth hormone gene deletion with developed neutralizing antibodies to growth hormone OR Genetic mutation of GH receptor (i.e. Laron Syndrome) AND Child has severe growth retardation with height standard deviation score (SDS) more than 3 SDS below the mean for chronological age and sex AND Child with IGF-1 level greater than or equal to 3 standard deviations below normal based on lab reference range for age and sex AND Child with normal or elevated growth hormone (GH) levels based on at least one growth hormone stimulation test AND Evidence of open epiphyses. Pediatrician or Endocrinologist 97