8-MOP. Products Affected 8-mop. Prior Authorization Criteria Tier-Alameda Last Updated: 02/26/2014

Transcription

1 Prior Authorization Tier-Alameda Last Updated: 02/26/ MOP Products Affected 8-mop PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other must be a dermatologist. 1

2 ABILIFY INJECTION Products Affected Abilify INJ PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Abilify is contraindicated in patients with known hypersensitivity to aripiprazole or to any component of the product. For the treatment of schizophrenia, then the patient must have documented trial and failure or intolerance to two of the following: clozapine, olanzapine, risperidone, quetiapine, lurasidone, iloperidone, asenapine and/or ziprasidone. For the treatment of bipolar I disorder, then the patient must have documented trial and failurw or intolerance to one of the following: olanzapine, risperidone, quetiapine, asenapine and/or ziprasidone. Physician reviewer must override criteria when, in his/her professional 2

3 ABILIFY MAINTENA Products Affected Abilify Maintena INJ 300MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 3

4 ABRAXANE Products Affected Abraxane PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 4

5 ACTEMRA Products Affected Actemra INJ 162MG/0.9ML, 200MG/10ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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) or Enbrel (etanercept) and/or has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 5

6 ACTIMMUNE Products Affected Actimmune PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 6

7 ADAGEN Products Affected Adagen PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 7

8 AFINITOR Products Affected Afinitor Afinitor Disperz PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Afinitor is contraindicated in patients with known severe hypersensitivity to everolimus, to other rapamycin derivatives, or any other component of Afinitor. Patient must be 3 years old or older. 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 8

9 ALDURAZYME Products Affected Aldurazyme PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other 9

10 ALIMTA Products Affected Alimta INJ 500MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 10

11 ALKERAN Products Affected Melphalan Hydrochloride PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Alkeran is contraindicated in patients whose disease has demonstrated a prior resistance to this agent or hypersensitivity to melphalan. 11

12 ALPHA-1 PROTEINASE INHIBITORS Products Affected Aralast Np INJ 400MG Glassia Prolastin-c Zemaira PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 12

13 AMPYRA Products Affected Ampyra PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other A history of seizures. A creatinine clearance of greater than 50 ml/min. 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) one of the following agents: Avonex, Rebif, Betaseron, Copaxone, or Extavia. OR the patient has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. Physician reviewer must override criteria when, in his/her professional 13

14 APOKYN Products Affected Apokyn PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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, Requip, Tasmar, or Mirapex. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 14

15 ARANESP Products Affected Aranesp Albumin Free INJ 100MCG/0.5ML, 100MCG/ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug 15

16 Age Other 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. If all conditions are met, the request will be authorized for 3 months. 16

17 ARCALYST Products Affected Arcalyst PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patient must be at least 12 years old. 17

18 ARRANON Products Affected Arranon PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Arranon is contraindicated in patients who have a history of hypersensitivity to nelarabine or any other component of Arranon. 18

19 ARZERRA Products Affected Arzerra INJ 100MG/5ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patient must be 18 years old or older. must be an oncologist. 19

20 AUBAGIO Products Affected Aubagio PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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 Extavia. 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. 20

21 AVASTIN Products Affected Avastin INJ 100MG/4ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 21

22 AZASAN Products Affected Azasan PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 22

23 BICNU Products Affected Bicnu PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Hypersensitivity to carmustine. must be an oncologist. 23

24 BONIVA INJECTION Products Affected Boniva INJ PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Patients must not have hypocalcemia, hypovitaminosis D, or other disturbances of bone and mineral metabolism. 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. 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. 24

25 Other 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 25

26 BOSULIF Products Affected Bosulif PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 26

27 BRAND PA Products Affected Azactam INJ 2GM Caduet Cerubidine Claforan INJ 500MG Cleocin Pediatric Granules Cleocin Phosphate INJ 900MG/6ML Ddavp INJ Depacon Depakene Depakote Depakote Er Depakote Sprinkles Diprolene LOTN Elocon LOTN Fml Liquifilm Haldol Decanoate 100 Haldol Decanoate 50 Imitrex NASAL SOLN Imitrex Statdose Refill Neurontin Prenatabs Obn Questran PACK Rheumatrex Rocephin INJ 500MG Sfrowasa Temovate CREA Tiazac CP24 420MG Verelan CP24 360MG Zithromax PACK PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Documented trial and failure showing an adverse event or an inadequate response associated to the use of the AB rated generic medication. 27

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29 BUPHENYL Products Affected Buphenyl TABS Sodium Phenylbutyrate PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Buphenyl should not be used to manage acute hyperammonemia, which is a medical emergency. 29

30 BUSULFEX Products Affected Busulfex PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Busulfan is contraindicated in patients with a history of hypersensitivity to any of its components. 30

31 BYDUREON Products Affected Bydureon PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 31

32 BYETTA Products Affected Byetta PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 32

33 CAMPRAL Products Affected Acamprosate Calcium Dr Campral PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 33

34 CAMPTOSAR Products Affected Camptosar INJ 100MG/5ML Irinotecan INJ 100MG/5ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 34

35 CANCIDAS Products Affected Cancidas PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Cancidas is contraindicated in patients with known hypersensitivity to caspofungin acetate. 35

36 CARBAGLU Products Affected Carbaglu PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other 36

37 CEREZYME Products Affected Cerezyme INJ 200UNIT PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 37

38 CIMZIA Products Affected Cimzia PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). Patient must be 18 years old or older. 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) or Enbrel (etanercept) 2. Crohn's Disease: Humira (adalimumab) 3. For Psoriatic Arthritis: Humira (adalimumab) or Enbrel (etanercept) 4. Ankylosing spondylitis: Humira (adalimumab) or Enbrel (etanercept). Physician reviewer must override criteria when, in his/her professional 38

39 CINRYZE Products Affected Cinryze PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patients who have manifested life-threatening immediate hypersensitivity reactions (including anaphylaxis) to the product. 39

40 CLADRIBINE Products Affected Cladribine PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other reactions (including anaphylaxis) to the product. 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. Physician reviewer must override criteria when, in his/her professional 40

41 CLOLAR Products Affected Clolar PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 41

42 COMETRIQ Products Affected Cometriq ORAL KIT 0, 0, 20MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 42

43 COSMEGEN Products Affected Cosmegen PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 43

44 CYSTAGON Products Affected Cystagon PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other 44

45 DEPO-PROVERA Products Affected Depo-provera Depo-subq Provera 104 PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 45

46 DIAMOX SEQUELS Products Affected Diamox PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patient must have documented trial and failure or intolerance to acetazolamide regular release tablets. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 46

47 DORIBAX Products Affected Doribax INJ 500MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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 up to 14 days of treatment. 47

48 DOXIL Products Affected Doxil PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 48

49 EGRIFTA Products Affected Egrifta PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 49

50 ELAPRASE Products Affected Elaprase PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patients must have a confirmed diagnosis of Hunter syndrome. 50

51 ELELYSO Products Affected Elelyso PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patients current weight Patient must be 18 years old or older. 51

52 ELITEK Products Affected Elitek INJ 1.5MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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 up to a 5 day duration. 52

53 ELOXATIN Products Affected Eloxatin INJ 100MG/20ML Oxaliplatin INJ 100MG/20ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Eloxatin should not be administered to patients with a history of known allergy to Eloxatin 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. 53

54 EMCYT Products Affected Emcyt PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 54

55 ENBREL Products Affected Enbrel PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 55

56 EPIRUBICIN Products Affected Ellence INJ 200MG/100ML Epirubicin Hcl INJ 50MG/25ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 56

57 EPOGEN Products Affected Epogen PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug 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 naïve with normal iron status: The patient is receiving maintenance iron therapy ( mg IV once weekly or elemental iron orally daily). Treatment naïve 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. 57

58 Age 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. 58

59 ERAXIS Products Affected Eraxis INJ 100MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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 up to 21 days of treatment. 59

60 ERBITUX Products Affected Erbitux INJ 100MG/50ML PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 60

61 ERIVEDGE Products Affected Erivedge PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 61

62 ETHYOL Products Affected Amifostine PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. 62

63 ETOPOPHOS Products Affected Etopophos PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 63

64 EXJADE Products Affected Exjade PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 64

65 FABRAZYME Products Affected Fabrazyme INJ 35MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other 65

66 FARESTON Products Affected Fareston PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patient must be at least 18 years old. must be an oncologist. Patient must have documented trial and failure to tamoxifen. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 66

67 FASLODEX Products Affected Faslodex PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Faslodex is contraindicated in pregnant women and in patients with known hypersensitivity to the Faslodex or to any of its components. Documentation that the patient has hormone receptor-positive metastatic breast cancer whose disease progressed following antiestrogen therapy. must be an oncologist. 67

68 FENTANYL CITRATE ORAL TRANSMUCOSAL Products Affected Fentanyl Citrate Oral Transmucosal PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 68

69 FERRIPROX Products Affected Ferriprox PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 69

70 FIRAZYR Products Affected Firazyr PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Patient must be 18 years old or older. 70

71 FLUDARABINE Products Affected Fludarabine Phosphate INJ 50MG PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional 71

72 FORTEO Products Affected Forteo PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 72

73 73

74 FUSILEV Products Affected Fusilev PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 74

75 GEMZAR Products Affected Gemcitabine Hcl INJ 1GM Gemzar INJ 1GM PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. must be an oncologist. 75

76 GILENYA Products Affected Gilenya PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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 Extavia. OR the patient has another documented medical reason (intolerance, hypersensitivity, etc) for not taking any of these therapies to manage their medical condition. 76

77 GILOTRIF Products Affected Gilotrif PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 77

78 GLEEVEC Products Affected Gleevec PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 78

79 GNRH AGONISTS Products Affected Eligard Firmagon Lupron Depot INJ 22.5MG, 3.75MG, 30MG, 45MG, 7.5MG Lupron Depot-ped INJ 11.25MG, 11.25MG, 15MG Trelstar Depot Mixject Trelstar La Mixject Trelstar Mixject PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other For all indications except for central precious 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. 79

80 GOLYTELY Products Affected Golytely SOLR 236GM; 2.97GM; 6.74GM; 5.86GM; 22.74GM PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Golytely (PEG 3350/KCL/Sodium Bicarbonate/Sodium Chloride/Sodium Sulfate) is contraindicated in patients with hypersensitivity to any component of the medication, in patients with bowel perforation, gastric retention, gastrointestinal obstruction, ileus, toxic colitis, and/or toxic megacolon. Patient must have documented failure or intolerance to one of the following: Trilyte, Gavilyte, or PEG3350/Electrolytes. Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. 80

81 GROWTH HORMONES Products Affected Genotropin Genotropin Miniquick Humatrope INJ 12MG, 24MG, 6MG Humatrope Combo Pack Norditropin Flexpro Norditropin Nordiflex Pen Nutropin Nutropin Aq Nuspin 5 Nutropin Aq Pen INJ 20MG/2ML Omnitrope PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age Other Growth Hormone Stimulattion Test results, Insulin Growth Factor 1 level, height, and weight. The prescriber must be an endocrinologist. 81

82 HALAVEN Products Affected Halaven PA Details *ly accepted indications are defined using the following sources: for the Healthcare Professional (USP DI), and the Drug Age 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. 82