8-MOP. Products Affected

Transcription

1 8-MOP 8-MOP Other must be a dermatologist. 1

2 ABILIFY MAINTENA ABILIFY MAINTENA Other Patients must not have a hypersensitivity to Abilify (aripiprazole). For the treatment schizophrenia. The member has a long-term history of oral anti-psychotic medication noncompliance AND documentation of a drug adherence treatment plan was also submitted that indicates the member failed measures to improve compliance with oral medications and/or a reason for why measures were not implemented to improve compliance with oral medications. The member has a documented history of receiving oral risperidone, paliperidone or aripiprazole without any clinically significant side effects. Patient must be 18 years old or older. must be a psychiatrist or psychologist. 2

3 ABRAXANE ABRAXANE Other Abraxane is contraindicated in patients with baseline neutrophil counts less than 1500 cells per cubic millimeter and hypersensitivity to paclitaxel or human albumin. Provider must submit documentation that the patient has a baseline (with in 30 days of the request) neutrophil count of greater than or equal to 1500 cells/mm3. Provider must be an oncologist. 3

4 ACTEMRA ACTEMRA Other Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). Patient must be 2 years old or older. must be an rheumatologist. Documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of Humira (adalimumab) and Enbrel (etanercept) and/or has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 4

5 ACTIMMUNE ACTIMMUNE Other Actimmune should not be used in patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product. 5

6 ADAGEN ADAGEN Other Adagen should not be used as preparatory or support therapy in patients receiving a bone marrow transplantation. In addition, it should be used in caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe. 6

7 ADEMPAS ADEMPAS Other Adempas is contraindicated in women who are pregnant. Documentation of concurrent use of nitrates or phosphodiesterase (PDE) inhibitors including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline). Patient must be 18 years of age or older. must be a pulmonologist or cardiologist 7

8 AFINITOR AFINITOR AFINITOR DISPERZ Other Afinitor is contraindicated in patients with known severe hypersensitivity to everolimus, to other rapamycin derivatives, or any other component of Afinitor. must be an oncologist. For use in patients with advanced renal cell carcinoma the patient must have a documentation of treatment failure which is consistent with pharmacy claims data with an adequate trial (including dates, doses of therapy) with Sutent or Nexavar. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 8

9 ALDURAZYME ALDURAZYME Other 9

10 ALECENSA ALECENSA Other Treatment history and baseline liver function testing, ALT/AST. Patients must be 18 years of age or older. must be an oncologist. 10

11 ALIMTA ALIMTA Other Alimta is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed disodium or to any other ingredient used in the formulation. must be an oncologist. 11

12 ALKERAN melphalan hcl Other Alkeran is contraindicated in patients whose disease has demonstrated a prior resistance to this agent or hypersensitivity to melphalan. 12

13 ALPHA-1 PROTEINASE INHIBITORS ARALAST NP GLASSIA PROLASTIN-C ZEMAIRA Other Patient must have: A documented diagnosis of a congenital deficiency of alpha-1 antitrypsin (ATT). Patient must be at least 18 years old. must be a pulmonologist. If the medication request is for an Alpha1-Proteinase Inhibitor (human) product other than Prolastin, the patient has a documented medical reason (intolerance, hypersensitivity, contraindication, treatment failure, etc) for not using Prolastin to treat their medical condition. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 13

14 AMPYRA AMPYRA Other History of seizure. Moderate or severe renal impairment (creatinine clearance less than or equal to 50 ml/minute). Diagnosis of multiple sclerosis AND patient is ambulatory (able to walk at least 25 feet) AND patient has walking impairment. Ampyra is only recommended in patients 18 years of age or older. must be a neurologist. Documentation was submitted documenting (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) one of the following agents: Avonex, Copaxone or Tecfidera, OR the patient has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. 14

15 ANADROL ANADROL-50 Other Carcinoma of the prostate or breast in male patients. Carcinoma of the breast in females with hypercalcemia. Women who are or may become pregnant. Nephrosis or the nephrotic phase of nephritis. Hypersensitivity to the drug. Severe hepatic dysfunction. Patient weight. 15

16 APOKYN APOKYN Other Apokyn (apomorphine hydrochloride) is contraindicated in patients with hypersensitivity to apomorphine or components of its formulation (notably sodium metabisulfite). It is also contraindicated in concomitant use with serotonin 5-HT3 receptor antagonists. The patient has documented trial and failure or intolerance to two formulary alternatives which include: carbidopa/levodopa, trihexylphenidyl HCL, bromocriptine mesylate, amantadine HCL, selegilene HCL, Atamet, carbidopa/levodopa CR, benztropine mesylate, ropinirole, Tasmar, immediate-release pramipexole, or Mirapex XR. 16

17 ARANESP ARANESP (IN POLYSORBATE) All lab results must be submitted within 30 days of the request: Hemoglobin less than 10g/dl for initial therapy when treating chronic renal failure or chemotherapy related anemia and less than12g/dl for reauthorization or continuation of therapy, Hematocrit, Serum ferritin level (normal is greater than 100ng/ml), Transferrin, saturation (TSAT) (normal is greater than 20%), Serum iron, Total Iron Binding Capacity (TIBC),Vitamin B12 level, Folate level Aranesp ordered dose is consistent with approvable dosing guidelines AND for Approval for anemia of Pre-dialysis chronic kidney disease or anemia due to chemotherapy:initial If the member has low B12 levels and/or Folate levels then documentation submitted that indicates the member is or will be prescribed appropriate supplementation. If the member is iron deficient, the member is in the process of receiving either oral or IV iron supplementation or the treatment plan is to start iron therapy.reauthorization: If the member has been receiving therapy and their hemoglobin is less than 12 g/dl and one of the following apply (if applicable):a.the ordered dose of Aranesp is reduced by 25% of previous dose if the rate of Hgb increase was greater than 1g/dL over a two week period OR the Hgb is increasing and approaching 12 g/dl. b.the ordered dose of Aranesp is increased from the previous dose if the patient's Hgb improved less than 1g/dL over a 4 to 6 week period and iron stores were adequate. c. An increase in dose does not occur more than once per month. If the member is iron deficient, the member is in the process of receiving either oral or IV iron supplementation or the treatment plan is to start iron therapy. If being used to treat a condition caused by end-stage renal disease(esrd) and member is on dialysis, please bill to Medicare Part B. 17

18 Other If all conditions are met, the request will be authorized for 3 months. 18

19 ARCALYST ARCALYST Other Patient must be at least 12 years old. 19

20 ARISTADA ARISTADA INTRAMUSCULAR SUSPENSION,EXTENDED REL SYRING 441 MG/1.6 ML, 662 MG/2.4 ML, 882 MG/3.2 ML Other Patients with dementia-related psychosis, or known hypersensitivity to aripiprazole. The member has a documented history of receiving aripiprazole without any clinically significant side effects. Additionally, the member has a documented medical reason (e.g. intolerance or hypersensitivity) for not utilizing these therapies to manage their medical condition: Invega Sustenna, Invega Trinza or Risperidal Consta. Patient must be 18 years of age or older. must be a psychiatrist or psychologist. 20

21 ARRANON ARRANON Other Arranon is contraindicated in patients who have a history of hypersensitivity to nelarabine or any other component of Arranon. 21

22 ARZERRA ARZERRA INTRAVENOUS SOLUTION 100 MG/5 ML Other Patient must be 18 years old or older. must be an oncologist. 22

23 AUBAGIO AUBAGIO Other Patients must not have severe hepatic impairment, be on current leflunomide treatment or pregnant. For the treatment of patients with relapsing forms of multiple sclerosis. Documentation was submitted documenting (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of two of the following agents: Avonex, Copaxone, or Tecfidera OR the patient has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. Patient must be 18 years old or older. must be a neurologist. 23

24 AVASTIN AVASTIN Other Documentation submitted indicates that the member has an ANC greater than 1000 cells/mm3 and platelet count is greater than 100 x103/mm3 and was taken within past 30 days. AND Documentation submitted indicates the member's blood pressure is less than 200/110 mmhg on 2 blood pressure readings done within the past 30 days. Documentation of a clinical diagnosis of Metastatic Breast Cancer, Metastatic Carcinoma of the Colon or Rectum, OR Non-Squamous, Non-Small Cell Lung Cancer AND Documentation submitted indicates the member has not had a surgical procedure within 28 days prior to the request for Avastin. The surgical incision should be fully healed prior to initiation of Avastin. Documentation submitted indicates that the member had a urine dipstick protein reading of less than 2+ or protein level of less than 2.5gm during a 24-hour urine collection done within the past 30 days. Documentation submitted indicates the member did not have documented hemoptysis or severe hemorrhage occurrences that required medical intervention (i.e., hospitalization) in the past 12 months. Patient must be at least 18 years old. must be an oncologist. 24

25 AZASAN AZASAN Other Azasan should not be given to patients who have shown hypersensitivity to the drug. Should not be used for treating rheumatoid arthritis in pregnant women. Patient must have documented trial and failure or intolerance to generic azathioprine. Clinical reviewer must override criteria when, in his/her professional 25

26 BELEODAQ BELEODAQ Other Patient must be 18 years old or older. must be an oncologist. 26

27 BENDEKA BENDEKA Other History of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol, patients with a creatinine clearance of less than 40mL/min. Laboratory value for creatinine clearance; For the treatment of Indolent B- cell non-hodgkins lymphoma (NHL) documentation of progression during or within six months of treatment with rituximab or a rituximabcontaining regimen. Patient must be 18 years old or older. must be an oncologist. 27

28 BENLYSTA BENLYSTA Other Documentation that the patient has severe active lupus nephritis or severe active central nervous system lupus or that they are receiving concurrent treatment with other biologics or intravenous (IV) cyclophosphamide. Documentation has been provided indicating the patient has had an adequate trial of two or more of the following agents: glucocorticoids, azathioprine, methotrexate, mycophenolate, or hydroxychloroquine. Patient must be 18 years of age or older. is a rheumatologist. 28

29 BICNU BICNU Other Hypersensitivity to carmustine. must be an oncologist. 29

30 BOSULIF BOSULIF Other Patients must not have a hypersensitivity to bosutinib. For the treatment of chronic, accelerated or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. Patient must be 18 years old or older. must be an oncologist. 30

31 BRAND PA CLEOCIN INJECTION CLEOCIN INTRAVENOUS IMITREX STATDOSE KIT REFILL IMITREX STATDOSE PEN PRENATAL VITAMIN PLUS LOW IRON QUESTRAN QUESTRAN LIGHT ORAL POWDER RHEUMATREX ROWASA SFROWASA TEMOVATE E TEMOVATE TOPICAL CREAM Other Documented trial and failure showing an adverse event or an inadequate response associated to the use of the AB rated generic medication. 31

32 BRIVIACT BRIVIACT Other Documented trial and failure or intolerance to one of the following: lamotrigine, gabapentin, carbamazepine, topiramate, tiagabine, oxcarbazepine, levetiracetam, phenytoin, zonisamide, divalproex. Patient must be 16 years of age or older. must be a neurologist. 32

33 BUPHENYL sodium phenylbutyrate Other Buphenyl should not be used to manage acute hyperammonemia, which is a medical emergency. 33

34 BUSULFEX BUSULFEX Other Busulfan is contraindicated in patients with a history of hypersensitivity to any of its components. 34

35 BYDUREON BYDUREON Other Bydureon should not be used in patients with known hypersensitivity to exenatide or any of its components, patients with a personal or family history of medullary thyroid carcinoma and patients with multiple endocrine neoplasia syndrome type 2. Patient must be 18 years old or older. Patient must have documented trial and failure or intolerance to two of the following: glyburide, glipizide XL, glipizide/metformin, glipizide ER, glipizide, glimepiride, metformin, metformin ER or (with prior step therapy requirements) Actoplus Met, Actos, Actoplus Met XR, Avandamet, Avandia, Avandaryl, Duetact, acarbose, Januvia, Janumet, Jamumet XR, Kombiglyze XR, Onglyza, Jentadueto, pioglitazone, pioglitazone/metformin, pioglitazone/glimepiride, Tradjenta, nateglinide, or Starlix. Clinical reviewer must override criteria when, in his/her professional 35

36 BYETTA BYETTA Other Byetta should not be used in patients with known hypersensitivity to the drug of to any of the product components. Patients must be at least 18 years old or older. Patient must have documented trial and failure or intolerance to two of the following: glyburide, glipizide XL, glipizide/metformin, glipizide ER, glipizide, glimepiride, metformin, metformin ER or (with prior step therapy requirements) Actoplus Met, Actos, pioglitazone, pioglitazone/metformin, Actoplus Met XR, Avandamet, Avandia, Avandaryl, Duetact, pioglitazone/glimepiride, acarbose, Januvia, Janumet, Janumet XR, Kombiglyze XR, Onglyza, Tradjenta, Jentadueto, nateglinide, or Starlix. Clinical reviewer must override criteria when, in his/her professional 36

37 CABOMETYX CABOMETYX Other Documentation of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Patient must be 18 years of age or older. must be an oncologist. If all conditions are met the request will be approved until the end of 37

38 CAMPRAL acamprosate Other Hypersensitivity to acamprosate or any of its components and severe renal impairment (CrCl 30 ml/min or less). Documentation that the patient has abstained from alcohol for at least 12 hours. Patient must be at least 18 years old. 38

39 CAMPTOSAR IRINOTECAN Other Camptosar is contraindicated in patients with hypersensitivity to irinotecan or any component of the product. Documentation when used as first-line therapy in patients with metastatic carcinoma of the colon or rectum that it is being used in combination with 5-fluorouracil (5-FU) and leucovorin. The prescriber must be an oncologist. 39

40 CANCIDAS CANCIDAS Other Cancidas is contraindicated in patients with known hypersensitivity to caspofungin acetate. 40

41 CARBAGLU CARBAGLU Other 41

42 CEREZYME CEREZYME INTRAVENOUS RECON SOLN 400 UNIT Other There is documentation that the patient has Gaucher's disease severe enough to result in one of the following: moderate to severe anemia, thrombocytopenia with bleeding tendency, bone disease, and/or significant hepatomegaly or splenomegaly. 42

43 CHOLBAM CHOLBAM Other Documentation of monitoring of AST, ALT, GGT, ALP, bilirubin, and INR. must be a hepatologist or pediatric gastroenterologist. If all conditions are met, the request will be authorized until the end of 43

44 CIMZIA CIMZIA CIMZIA POWDER FOR RECONST CIMZIA STARTER KIT Other Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). Patient must be at least 18 years old. must be a rheumatologist or a gastroenterologist. Documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) of adequate trials and/or has a documented medical reason (e.g. intolerance or hypersensitivity) for not utilizing these therapies to manage their medical condition: 1.For Rheumatoid Arthritis: Humira (adalimumab) and Enbrel (etanercept) 2. Crohn's Disease: Humira (adalimumab) 3. For Psoriatic Arthritis: Humira (adalimumab) and Enbrel (etanercept) 4. Ankylosing spondylitis: Humira (adalimumab) and Enbrel (etanercept). Clinical reviewer must override criteria when, in his/her professional 44

45 CINRYZE CINRYZE Other Patients who have manifested life-threatening immediate hypersensitivity reactions (including anaphylaxis) to the product. 45

46 CLADRIBINE cladribine Other must be an oncologist. If criteria are met, a prior authorization for the generic equivalent will be approved. Otherwise, documentation showing an adverse event or inadequate response associated with use of the generic agent must be submitted for review. Clinical reviewer must override criteria when, in his/her professional 46

47 CLOLAR CLOLAR Other Documentation of relapsed or refractory acute lymphoblastic leukemia after trial and failure with at least two prior regimens. Pediatric patients 1 to 21 years old. must be an oncologist. 47

48 COMETRIQ COMETRIQ Other For the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). Patient must be 18 years old or older. must be an oncologist. 48

49 COSMEGEN COSMEGEN Other Cosmegen should not be given at or about the time of infection with chickenpox or herpes zoster because the risk of severe generalized disease which may result in death. Cosmegen is also contraindicated in patients who are hypersensitive to any component of this product. must be an oncologist. 49

50 COTELLIC COTELLIC Other Patients with wild-type BRAF melanoma Documentation will be taken in combination with vemurafenib (Zelboraf), confirmation of BRAF V600K or V600E mutation status with an approved test, baseline liver function test (ALT/AST), creatinine phosphokinase, serum creatinine, evaluation of left ventricular ejection fraction (LVEF) via echocardiogram or MUGA scan, and dermatologic exam (within 90 days of request). Patient must be 18 years of age or older. must be an oncologist. 50

51 CUBICIN CUBICIN CUBICIN RF Other Cubicin is contraindicated in patients with known hypersensitivity to daptomycin or any other component of the product. Documentation of a consultation with an infectious disease specialist. If being used to treat a condition caused by end-stage renal disease(esrd) and member is on dialysis, please bill to Medicare Part B. 51

52 CYRAMZA CYRAMZA Other must be an oncologist. 52

53 CYSTAGON CYSTAGON Other 53

54 DAKLINZA DAKLINZA Other Patients infected with Hepatitis C Genotypes 5 or 6, co-administration with strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin, and St. John's wort. Labs within 3 months of request: ALT/AST, and detectable HCV RNA viral load. In addition, documentation of genotype, treatment history, and if cirrhotic, documentation of compensated or decompensated cirrhosis. For appropriate genotypes, patient must have documented trial of Harvoni or Sovaldi regimen (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) or provide medical justification (e.g. intolerance or hypersensitivity) for not utilizing Harvoni or Sovaldi to manage medical condition. Patient must be 18 years of age or older. must be a hepatologist, gastroenterologist, infectious disease specialist, or transplant specialist. Authorized for up to 24 weeks. will be applied consistent with current compendia guidance. 54

55 DARZALEX DARZALEX Other Prior treatment history. Patient must be 18 years of age or older. must be an oncologist. 55

56 DEMSER DEMSER Other Patient must be 12 years old or older. 56

57 DEPEN DEPEN TITRATABS Other Patients with a history of penicillamine-related aplastic anemia or agranulocytosis should not be restarted on penicillamine. Penicillamine should not be administered to rheumatoid arthritis patients with a history or other evidence of renal insufficiency. If requested for rheumatoid arthritis, documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) of adequate trial (including dates and doses) of conventional therapy, Humira (adalimumab) and Enbrel (etanercept) and/or has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 57

58 DEPO-PROVERA DEPO-PROVERA INTRAMUSCULAR SOLUTION DEPO-SUBQ PROVERA 104 Other These medications are contraindicated in patients with known or suspected pregnancy, undiagnosed vaginal bleeding, known or suspected malignancy of the breast, active thrombophlebitis, current or past history of thromboembolic disease, cerebral vascular disease, significant liver disease, or known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients. must be a gynecologist, family practice or an oncologist. Patient must have documented trial and failure or intolerance to injectable medroxyprogesterone acetate. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 58

59 DORIBAX DORIBAX INTRAVENOUS RECON SOLN 500 MG Other Doribax (doripenem monohydrate) is contraindicated in patients with a serious hypersensitivity to doripenem or other drugs of the same class and in patients with anaphylactic reactions to other beta-lactam antibiotics. Patient must be at least 18 years old or older. If all conditions are met, the request will be authorized for 14 days of treatment. 59

60 DOXIL DOXIL doxorubicin, peg-liposomal Other Doxil should not be used in patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCL or the components of Doxil. Documentation must be submitted for patients with: Multiple Myeloma that the agent is being used in combination with bortezomib and that the patient has not previously received bortezomib and has received at least 1 prior therapy. Ovarian cancer in the patient whose disease has progressed or recurred after platinum-based chemotherapy. AIDS-related Kaposi sarcoma that the disease has progressed on prior combination chemotherapy or the patient is intolerant to such therapy. must be an oncologist. 60

61 EGRIFTA EGRIFTA Other Active malignancy, pregnancy, disruption of the hypothalamic-pituitary axis (due to hypophysectomy, hypopituitarium or pituitary tumor/surgery, head irradiation or head trauma), or known hypersensitivity to tesamorelin and/or mannitol. Patient must be 18 years old or older. 61

62 ELAPRASE ELAPRASE Other Patients must have a confirmed diagnosis of Hunter syndrome. 62

63 ELELYSO ELELYSO Other Patient current weight. Patient must be 18 years old or older. 63

64 ELITEK ELITEK Other Elitek is contraindicated in patients who are deficient in glucose-6- phosphate dehydrogenase. Elitek is also contraindicated in patients with a known history of anaphylaxis or hypersensitivity, hemolytic reactions or methemoglobinemia reaction to Elitek or any of the excipients. must be an oncologist. If all conditions are met, the request will be approved for a 5 day duration. 64

65 ELOXATIN oxaliplatin Other Oxaliplatin should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds. Documentation that patients with: Stage III colon cancer is using the agent in combination with infused 5-fluorouracil/leucovorin after the patient has undergone complete resection of the primary tumor AND Advanced carcinoma of the colon or rectum that the agent is being used in combination with infused 5-fluorouracil/leucovorin. must be an oncologist. 65

66 EMCYT EMCYT Other Emcyt should not be used in patients with any of the following conditions: known hypersensitivity to either estradiol or to nitrogen mustard, active thrombophlebitis or thromboembolic disorders, except in those cases where the actual tumor mass is the cause of the thromboembolic phenomenon and the physician feels the benefits of therapy may outweigh the risks. must be an oncologist. 66

67 EMPLICITI EMPLICITI Other If drug is being used as monotherapy. Previous treatment history, baseline ALT/AST within 90 days of request. Patients must be 18 years of age or older. must be an oncologist. 67

68 ENBREL ENBREL ENBREL SURECLICK Other Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). Patient must be at least 2 years old when treating juvenile rheumatoid arthritis and at least 18 years old for all other indications. must be a rheumatologist or dermatologist. Documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) of adequate trials and/or has a documented medical reason ( intolerance or hypersensitivity) for not utilizing these therapies to manage their medical condition:for Rheumatoid Arthritis:Methotrexate OR generic leflunomide (Arava). For Juvenile Rheumatoid Arthritis:At least one diseasemodifying antirheumatic drug (DMARD i.e. Methotrexate). For Ankylosing Spondylitis: Two nonsteroidal anti-inflammatory drugs (NSAIDS) [nonselective NSAIDs and/or a cyclo-oxygenase (COX)-2- selective inhibitor]. For Psoriasis: One of the treatment bullet points listed below:othe use of topical steroids othe use of either Tazorac (tazorotene) omethotrexate ouvb phototherapy and/or PUVA therapy. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 68

69 EPIRUBICIN ELLENCE EPIRUBICIN Other Baseline neutrophil count less than 1500 cells/mm3, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, previous treatment with anthracyclines up to the maximum cumulative dose, hypersensitivity to epirubicin, other anthracyclines, or anthracenediones or severe hepatic dysfunction. Documentation that the patient's neutrophil count is greater than 1500 cells/mm3 at least 30 days prior to the request. If criteria are met, a prior authorization for the generic equivalent will be approved. Otherwise, documentation showing an adverse event or inadequate response associated with use of the generic agent must be submitted for review. Clinical reviewer must override criteria when, in his/her professional 69

70 EPOGEN EPOGEN INJECTION SOLUTION 10,000 UNIT/ML, 2,000 UNIT/ML, 20,000 UNIT/2 ML, 20,000 UNIT/ML, 3,000 UNIT/ML, 4,000 UNIT/ML Hemoglobin over the last 3 months results (to determine rolling Hgb) less than 11g/dl for initial treatment and less than 12g/dl for continuation of therapy, Hematocrit over the last 3 months results (to determine rolling Hct) less than 33% for initial therapy and less than 36% for continuation of therapy, Serum ferritin within past 2 months (normal is greater than 100ng/ml),Transferrin saturation (TSAT) within past 2 months (normal is greater than 20%),Serum iron within past 2 months, Vitamin B12 and Folate levels within past 2 months. For allogenic blood transfusion in surgery patients, results within the last 30 days. Hemoglobin greater than 10g/dl but less than 13g/dl, Serum ferritin (normal is greater than 100ng/ml) and Transferrin saturation (TSAT) (normal is greater than 20%). In addition, the patient must fall into at least one of the following categories to be approved for Epogen: treatment naive with normal iron status: The patient is receiving maintenance iron therapy ( mg IV once weekly or elemental iron orally daily). Treatment naive with iron deficiency: The patient is in the process of receiving parental iron supplementation (100 mg IV every hemodialysis for 10 doses or 125 mg IV for 8 doses). Existing therapy with Epogen with normal iron status. The patient is receiving maintenance iron therapy. Dosage increases and decreases are made according to the package insert. Dosage increases are not made more than once per 4 week period. If the dose is greater than 300 units/kg/week then documentation (within the past 2 months) was provided that maximum iron supplementation was attempted. Existing therapy on Epogen with iron deficiency: The patient is currently in the process of receiving iron supplementation. for for Allogeneic Blood Transfusion in Surgery Patients: The patient has normal iron stores and is, or will be, receiving adequate iron supplementation and is scheduled for an elective, noncardiac, nonvascular surgery. 70

71 Other If all conditions are met, the request will be authorized for 3 months. If being used to treat a condition caused by end-stage renal disease(esrd) and member is on dialysis, please bill to Medicare Part B. 71

72 ERAXIS ERAXIS(WATER DILUENT) Other Eraxis is contraindicated in patients with known hypersensitivity to anidulafungin or any component of the solution, or other echinocandins. Documentation of a consultation with an infectious disease specialist. If all conditions are met, the request will be approved for 21 days of treatment. 72

73 ERBITUX ERBITUX Other If all of the above conditions are met, the member will be placed into one of the following categories based on diagnosis and review for medical necessity:for Colorectal Caner:When ordered as monotherapy, submitted documentation indicates patient is intolerant or refractory to irinotecanand oxaliplatin-based chemotherapy regimens.when ordered in combination with irinotecan, submit documentation indicating patient refractory to irinotecan-based chemotherapy. For Head and Neck Caner:If the member has locally or regionally advanced squamous cell carcinoma of the head and neck, documentation was submitted indicating concurrent radiation therapy was ordered with Erbitux.If the member has recurrent or metastatic squamous cell carcinoma of the head and neck, documentation was submitted (consistent with pharmacy claims data) indicating treatment failure on prior platinum-based therapy (i.e. cisplatin or carboplatin) and/or has another documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not utilizing any of these therapies to manage their medical condition. must be an oncologist. 73

74 ERIVEDGE ERIVEDGE Other For use in patients with metastatic basal cell carcinoma or locally advanced basal cell carcinoma documentation that treatment is following surgery or they are not candidates for surgery or radiation. Patient must be 18 years old or older. 74

75 ERWINAZE ERWINAZE Other Erwinaze is contraindicated in patients with history of serious pancreatitis, thrombosis, and hemorrhagic events with prior L- asparaginase therapy. Erwinaze is also contraindicated in patients who have had a previous anaphylactic reaction to it. must be an oncologist. 75

76 ESBRIET ESBRIET Other Conduct LFTs prior to initiating therapy, discontinue if AST or ALT elevations greater than 5 times ULN or greater than 3 times but less than or equal to 5 times ULN but with signs or symptoms of hyperbilirubinemia. must be an pulmonologist. 76

77 ETHYOL amifostine crystalline Other Ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. 77

78 ETOPOPHOS ETOPOPHOS Other Etopophos for injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide, etoposide phosphate, or any other component of the formulations. Documentation for patients with:testicular tumors that the agent is being used in combination with other approved chemotherapeutic agents in patients who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small cell lung cancer that the agent is being used in combination with other approved chemotherapeutic agents. must be an oncologist. 78

79 EVOMELA EVOMELA Other Baseline complete blood count (CBC) within 30 days of request (not required if palliative care diagnosis). Patients must be 18 years of age or older. must be an oncologist. If all conditions are met the request will be approved until the end of 79

80 EXJADE EXJADE Other Exjade sodium is contraindicated in patients with known hypersensitivity to deferasirox or to any component of this product. For patients that are 2 years of age and older and younger than 21 years that have a diagnosis of chronic iron overload due to blood transfusions, documentation that Serum Ferritin concentration is consistently 1000 mcg/l. For adult patients 21 years of age and older that have a diagnosis of chronic iron overload due to blood transfusions, documentation that Serum Ferritin concentration is consistently 1000 mcg/l and documentation patient is unable to use deferoxamine (Desferal) parenterally. For patients 10 years of age and older that have a diagnosis of chronic iron overload in nontransfusion-dependent thalassemia syndromes serum ferritin levels must remain greater than 300mcg/L. Patient must be at least 2 years old of older. 80

81 FABRAZYME FABRAZYME Other 81

82 FARESTON FARESTON Other Patient must be at least 18 years old. must be an oncologist. Patient must have documented trial and failure to tamoxifen. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 82

83 FARYDAK FARYDAK Other For the treatment of multiple myeloma, documentation has been provided that the patient has received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. The patient must also be taking in combination with bortezomib and dexamethasone. Baseline CBC, ECG and electrolytes prior to starting treatment. Farydak is only recommended in patients 18 years of age or older. must be an oncologist. 83

84 FASLODEX FASLODEX Other Faslodex is contraindicated in pregnant women and in patients with known hypersensitivity to the Faslodex or to any of its components. Documentation that therapy will be taken in combination with palbociclib for patient with hormone receptor -positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression after endocrine therapy OR documentation of hormone receptor -positive metastatic breast cancer for patient whose disease progressed following antiestrogen therapy must be an oncologist. 84

85 FENTANYL CITRATE ORAL TRANSMUCOSAL fentanyl citrate Other Fentanyl lozenges and fentanyl buccal tablets are contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. This product must not be used in opiodnontolerant patients and contraindicated in the management of acute or postoperative pain. The patient is currently receiving a long acting narcotic for chronic pain. Patient is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrolled nausea/vomiting. If all conditions are met, the request will be authorized for 6 months. Patient must have documented trial and failure or intolerance to two of the following medications: morphine sulfate, oxycodone/acetaminophen, oxycodone immediate release, hydrocodone/acetaminophen, and hydromorphone. Clinical reviewer must override criteria when, in his/her professional 85

86 FERRIPROX FERRIPROX ORAL TABLET Other Hypersensitivity to deferiprone or any excipients in the formulation. Documentation of the patient's serum ferritin level and absolute neutrophil count (ANC) greater than 1.5x109/L. Patient must be 18 years old or older. 86

87 FIRAZYR FIRAZYR Other Patient must be 18 years old or older. 87

88 FLUDARABINE FLUDARABINE Other Fludarabine is contraindicated in patients who are hypersensitive to fludarabine products. Documentation for patients with B-cell lymphocytic leukemia that they have either not responded to or whose disease has progressived during treatment with at least 1 standard alkylating-agent containing regimen. must be an oncologist. If criteria are met, a prior authorization for the generic equivalent will be approved. Otherwise, documentation showing an adverse event or inadequate response associated with use of the generic agent must be submitted for review. Clinical reviewer must override criteria when, in his/her professional 88

89 FORTEO FORTEO Other Patients with hypersensitivity to teriparatide or to any of its excipients. Documentation showing patient falls into one of the following categories:postmenopausal woman who has a bone mineral density (BMD) value consistent with osteoporosis (i.e., T-scores equal to or less than -2.5) or postmenopausal woman who has had an osteoporotic fracture.postmenopausal woman who has T-scores from -1.5 to -2.5 and at least one of the following risk factors for fracture: thinness [low body mass index (less than 21 kg/m2)], history of fragility fracture since menopause, or history of hip fracture in a parent. Male greater than or equal to 65 years of age with T-score of -2.5 or less. Male less than 65 years of age with T-score of -2.5 or less and 2 or more risk factors for fractures or previous osteoporotic fracture. In addition, the following criteria is also applicable:the patient has a documented (consistent with pharmacy claims data) treatment failure after receiving an adequate trial (including dates of treatment at maximum recommended doses of therapy) or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not utilizing an oral bisphosphonate to manage their medical condition AND The therapy does not exceed the therapy maximum of 2 years. Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 89

90 FUSILEV FUSILEV levoleucovorin calcium intravenous recon soln Other History of a previous allergic reaction attributed to folic acid or folinic acid. For patients with advanced metastatic colorectal cancer: documentation that the medication is being used in combination with 5-fluorouracil. must be an oncologist or a hematologist. 90

91 GATTEX GATTEX 30-VIAL GATTEX ONE-VIAL Other Diagnosis of short bowel syndrome dependent on parenteral support. Patient must be 18 years of age or older Provider is a gastroenterologist Patient has had a colonoscopy within 6 months of starting treatment. 91

92 GEMZAR gemcitabine Other Gemzar is contraindicated in patients who are hypersensitive to Gemzar products. Documentation for patients with: Breast cancer that the agent is being used in combination with paclitaxel for patients who have failed prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.non-small cell lung cancer that the agent is being used in combination with cisplatin. Ovarian cancer the agent is being used in combination with carboplatin for those patients who have relapsed at least 6 months after the completion of platinum-based therapy. Pancreatic cancer for patients with locally advanced or metastatic adenocarcinoma of the pancreas. must be an oncologist. 92

93 GEODON INJECTION GEODON INTRAMUSCULAR Other Patient must be 18 years old or older. 93

94 GILENYA GILENYA Other Patient must be 18 years old or older. must be a neurologist. Documentation was submitted documenting (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of two of the following agents: Avonex, Copaxone, or Tecfidera OR the patient has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. 94

95 GILOTRIF GILOTRIF Other For the treatment of patients with metastatic non-small cell lung cancer. Documentation was submitted confirming the metastatic NSCLC tumors have epidermal grown factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations as detected by an FDA-approved test prior to initiation to treatment. Patient must be 18 years old or older. must be an oncologist. 95

96 GLEEVEC GLEEVEC imatinib Other Hypersensitivity to imatinib or to any other component of imatinib. When used in pediatric patients with Ph+ ALL, must provide documentation that the patient is using the medication in combination with chemotherapy. Patient must be at least 18 years old or older for all indication except for Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL). must be an oncologist. 96

97 GLEOSTINE GLEOSTINE Other must be an oncologist. 97

98 GNRH AGONISTS ELIGARD ELIGARD (3 MONTH) ELIGARD (4 MONTH) ELIGARD (6 MONTH) FIRMAGON FIRMAGON KIT W DILUENT SYRINGE LUPRON DEPOT LUPRON DEPOT (3 MONTH) LUPRON DEPOT (4 MONTH) LUPRON DEPOT (6 MONTH) LUPRON DEPOT-PED LUPRON DEPOT-PED (3 MONTH) TRELSTAR Other For all indications except for central precocious puberty patients must be at least 18 years old. If the medication request is for the treatment of prostate cancer and if the request is for any other GnRH agonist other than Eligard, the patient must have a documented treatment failure after receiving an adequate trial of Eligard and/or has another documented medical reason for not utilizing Eligard to treat their prostate cancer. 98

99 GROWTH HORMONES GENOTROPIN GENOTROPIN MINIQUICK HUMATROPE NORDITROPIN FLEXPRO NORDITROPIN NORDIFLEX NUTROPIN AQ NUSPIN NUTROPIN AQ SUBCUTANEOUS CARTRIDGE 20 MG/2 ML (10 MG/ML) OMNITROPE Other Growth Hormone Stimulattion Test results, Insulin Growth Factor 1 level, height, and weight. The prescriber must be an endocrinologist. 99

100 HALAVEN HALAVEN Other Documentation that the patient has received at least two chemotherapeutic regimens for the treatment of metastatic disease and prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Patient must be 18 years old or older. must be an oncologist. 100

101 HARVONI HARVONI Other Labs within 3 months of request: ALT/AST, and detectable HCV RNA viral load. In addition, documentation of genotype, treatment history, and if cirrhotic, documentation of compensated or decompensated cirrhosis. For cirrhotic patients that have previously been treated, medical justification (e.g. intolerance or hypersensitivity) has been provided why a patient is not able to utilize ribavirin in combination with Harvoni for 12 weeks. Harvoni is only recommended in patients over 18 years of age. must be a hepatologist, gastroenterologist, infectious disease specialist, or transplant specialist. If all conditions are met request will be authorized for up to 24 weeks as defined in other criteria If all conditions are met, the request will be authorized for up to 24 weeks as defined in compendia for appropriate treatment history, genotype, and level of fibrosis. For cirrhotic patients that have previously been treated, the request will be approved for 12 weeks of Harvoni to be taken with Ribavirin. Clinical reviewer must override criteria when, in his/her professional 101

102 HEPSERA ADEFOVIR Other Diagnosis of hepatitis B:Submitted current laboratory values indicating evidence of active viral replication. Submitted current laboratory values indicating persistent elevations in ALT or AST or histologically active disease. Clinical evidence of lamivudine-resistant hepatitis B virus or documented treatment failure with Lamivudine therapy. Patient must be at least 12 years old or older. 102

103 HERCEPTIN HERCEPTIN Other Provider must document that the patient has human epidermal growth factor receptor (HER)-2 positive breast cancer, metastatic gastric, or gastroesophageal junction adenocarcinoma prior to initial authorization. Patient must be at least 18 years old or older. must be an oncologist. 103

104 HETLIOZ HETLIOZ Other Patients with severe hepatic impairment, patients that are currently taking fluvoxamine or other strong CYP1A2 inhibitors, or rifampin or other CYP3A4 inducers (e.g. ketoconazole). Diagnosis of non-24-hour sleep-wake disorder (non-24) in patients that are totally blind. Patient must be 18 years of age or older. Provider is a sleep specialist or neurologist. 104

105 HEXALEN HEXALEN Other Hexalen is contraindicated in patients who have shown hypersensitivity to the drug. Hexalen should not be used in patients with preexisting severe bone marrow depression or severe neurologic toxicity. However, Hexalen has been administered safely to patients heavily pretreated with cisplatin and/or alkylating agents, including patients with preexisting cisplatin neuropathies. Documentation for patients with ovarian cancer of a previous trial and failure with a cisplatin or alkylating agent based combination. must be an oncologist. 105

106 HIGH RISK MEDICATION amitriptyline amitriptyline-chlordiazepoxide ascomp with codeine benztropine oral butalbital compound w/codeine butalbital-acetaminop-caf-cod oral capsule mg carisoprodol carisoprodol-asa-codeine carisoprodol-aspirin chlorzoxazone clemastine oral tablet 2.68 mg clomipramine codeine-butalbital-asa-caff cyclobenzaprine oral tablet 10 mg, 5 mg cyproheptadine dexmethylphenidate dextroamphetamine oral capsule, extended release 10 mg, 15 mg, 5 mg dextroamphetamine oral tablet 10 mg, 5 mg dextroamphetamine-amphetamine oral capsule,extended release 24hr dextroamphetamine-amphetamine oral tablet 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg, 5 mg, 7.5 mg digox oral tablet 250 mcg dihydroergotamine injection dihydroergotamine nasal diphenhydramine hcl injection solution 50 mg/ml dipyridamole oral disopyramide phosphate oral capsule doxepin oral doxepin topical ergoloid ERGOMAR estropipate FOCALIN XR ORAL CAPSULE,ER BIPHASIC MG, 35 MG glyburide micronized oral tablet 1.5 mg, 3 mg, 6 mg glyburide oral tablet 1.25 mg, 2.5 mg, 5 mg glyburide-metformin oral tablet mg, mg, mg guanfacine oral tablet hydroxyzine hcl oral solution 10 mg/5 ml hydroxyzine hcl oral tablet hydroxyzine pamoate imipramine hcl imipramine pamoate indomethacin oral ketorolac injection solution ketorolac intramuscular solution ketorolac oral MEGACE ES megestrol oral suspension megestrol oral tablet MENEST meperidine oral solution meperidine oral tablet meprobamate metadate er methocarbamol oral methyldopa methyldopa-hydrochlorothiazide methyldopate methylphenidate oral tablet methylphenidate oral tablet extended release 20 mg methylphenidate oral tablet extended release 24hr nifedipine oral capsule nitrofurantoin macrocrystal nitrofurantoin monohyd/m-cryst NORPACE CR orphenadrine citrate oral pentazocine-naloxone perphenazine-amitriptyline phenadoz rectal suppository 12.5 mg promethazine oral promethazine rectal suppository 12.5 mg, 25 mg promethazine vc 106

107 promethazine-phenylephrine promethegan rectal suppository 25 mg, 50 mg PRUDOXIN reserpine SURMONTIL thioridazine trihexyphenidyl trimethobenzamide oral trimipramine ZONALON Other For patients 65 years old and older: The prescriber has documented the indication for the continued use of the high risk medication with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. The physician must document the ongoing monitoring plan for the agent AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. If the patient is 64 years old or younger, the request will be approved. If the patient is 65 years old or older, the patient will require prior authorization for the drug. 107

108 HIGH RISK MEDICATION, DIGOXIN digitek oral tablet 250 mcg digoxin oral solution 50 mcg/ml digoxin oral tablet 250 mcg Other For patients 65 years old and older: Patient must have documented trial and failure to doses up to 0.125mg per day OR the prescriber has documented the indication for the continued use of doses greater than 0.125mg per day. The physician must document the ongoing monitoring plan for the agent AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. If the patient is 64 years old or younger, the request will be approved. If the patient is 65 years old or older, the patient will require prior authorization for the drug. 108

109 HUMIRA HUMIRA HUMIRA PEDIATRIC CROHN'S START HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START HUMIRA PEN PSORIASIS-UVEITIS Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). must be a rheumatologist, gastroenterologist, or dermatologist. 109

110 Other Documentation (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) of adequate trials and/or has a documented medical reason (e.g. intolerance or hypersensitivity) for not utilizing these therapies to manage their medical condition:1.for Rheumatoid Arthritis:Methotrexate or generic leflunomide (Arava) or triple combination therapy (Sulfasalazine, Hydroxychloroquine, and methotrexate). 2.For Juvenile Rheumatoid Arthritis:At least one disease-modifying antirheumatic drug (DMARD i.e. Methotrexate) 3.For Ankylosing Spondylitis: Either two nonsteroidal antiinflammatory drugs (NSAIDS) [nonselective NSAIDs or a cyclooxygenase (COX)-2-selective inhibitor] 4.For Psoriasis:At least 1 of the treatment bullet points listed below:othe use of topical steroids othe use of either Tazorac (tazorotene) omethotrexate ouvb phototherapy and/or PUVA treatment 5.For Crohns Disease: Conventional oral therapy for managing Crohns disease (e.g. azathioprine, prednisone, mesalamine products). 6. For Ulcerative Colitis: Conventional oral therapy for managing Ulcerative Colitis (e.g. sulfasalazine, mesalamine, azathioprine, prednisone) Clinical reviewer must override criteria when, in his/her professional 110