ACTEMRA. Cigna Medicare Rx (PDP) 2014 Cigna Medicare Rx Secure-Xtra Plan (PDP) Formulary. Products Affected Actemra. Prior Authorization Criteria

Transcription

1 Cigna Medicare Rx (PDP) Medicare Part D Prescription Drug Plans 2014 Cigna Medicare Rx Secure-Xtra Plan (PDP) Formulary Prior Authorization ACTEMRA Products Affected Actemra PA Details Age Other Authorization is limited to patients 2 years old and older. Treatment of rheumatoid arthritis (RA) when ANY of the following criteria are met: 1) history of positive clinical response to tocilizumab therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying anti-rheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine). For RA new starts that meet the above criteria, the patient must also have failure, contraindication or intolerance to Enbrel or Humira before authorization of Actemra. 1

2 ACTHAR HP Products Affected Acthar HP PA Details Age Other Authorization is for up to one year. Patient must have failure, contraindication or intolerance to intravenous corticosteroid therapy and currently maintained on one of the following formulary drugs Avonex, Copaxone or Rebif before Acthar HP is authorized. 2

3 ADCIRCA Products Affected Adcirca PA Details Age Other 3

4 ALPHA-1 PROTEINASE INHIBITOR THERAPY Products Affected Aralast NP Glassia Prolastin-C Zemaira PA Details Age Other Intravenous alpha1-proteinase inhibitor (human) is authorized for the treatment of congenital alpha1-proteinase inhibitor deficiency-associated lung disease when all of the following criteria are met: 1) alpha1- antitrypsin (AAT) concentration less than 80mg/dl or less than 11 micromolar and 2) obstructive lung disease as defined by a forced expiratory volume in one second (FEV1) of 30 to 65% of predicted or a rapid decline in lung function defined as a change in FEV1 of greater than 120ml per year. 4

5 AMPYRA Products Affected Ampyra PA Details Age Other Initial authorization 3 months. Reauthorization is one year. Approval for continuation of therapy is contingent upon a demonstrated improvement in walking. 5

6 ANZEMET INJ Products Affected Anzemet INJ PA Details Age Other 6

7 ARANESP Products Affected Aranesp PA Details Age Other Aranesp is authorized for the treatment of anemia [Hemoglobin (Hgb) less than 10 g/dl] in the presence of adequate iron stores (i.e., normal transferrin or serum ferritin level) associated with one of the following conditions: 1) chronic kidney disease, including patients who are predialysis or on dialysis, or 2) cancer chemotherapy regimens planned for at least two months in duration. Continued authorization is considered medically necessary when the following criteria are met: Hgb does not exceed 11 g/dl. Anemia associated with chronic kidney disease - 6 months. Anemia due to chemo - 8 weeks. 7

8 ARCALYST Products Affected Arcalyst PA Details Age Other Authorization is limited to patients 12 years old and older. 8

9 AUBAGIO Products Affected Aubagio PA Details Age Other Aubagio will be used as monotherapy for the treatment of multiple sclerosis. Patient must also have failure, contraindication or intolerance to one of the following formulary alternatives Avonex, Rebif or Copaxone before Aubagio will be authorized. 9

10 AVONEX Products Affected Avonex PA Details Age Other Avonex will be used as monotherapy. 10

11 BENLYSTA Products Affected Benlysta PA Details Age Other The patient must have a positive autoantibody test (i.e., anti-nuclear antibody [ANA] greater than or equal to 1:80 and/or anti-double-stranded DNA [anti-dsdna] greater than or equal to 30 IU/ml) AND active disease state as documented by a SELENA-SLEDAI score of 6 or greater on the current treatment regimen. The patient must be receiving one standard therapy for SLE with any of the following: corticosteroids, hydroxychloroquine, immunosuppressives (cyclophosphamide, azathioprine, mycophenolate, methotrexate, cyclosporine) or nonsteroidal anti-inflammatory drugs AND there must be an absence of severe active lupus nephritis or severe active central nervous system lupus before Benlysta is authorized. 11

12 BERINERT Products Affected Berinert PA Details Age Other Berinert is authorized for the treatment of acute angioedema attacks with hereditary angioedema (HAE) when BOTH of the following criteria are met: 1) confirmed diagnosis of (HAE) as evidenced by a C4 level below the lower limit of normal as defined by the laboratory performing the test AND EITHER a) C1 inhibitor (C1INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test or b) C1INH functional level below the lower limit of normal as defined by the laboratory performing the test AND 2) history of a moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion). Authorization is limited to patients 10 years old and older. 12

13 CANCIDAS Products Affected Cancidas PA Details Age Other 13

14 CIALIS Products Affected Cialis ORAL TABS 2.5MG, 5MG PA Details Age Other Cialis 2.5mg and 5mg are only covered for the treatment of benign prostatic hyperplasia (BPH). 14

15 CINRYZE Products Affected Cinryze PA Details Age Other Patient must have a confirmed diagnosis of HAE as evidenced by a C4 level below the lower limit of normal as defined by the laboratory performing the test AND EITHER of the following: 1) C1 inhibitor (C1INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test 2) C1INH functional level below the lower limit of normal as defined by the laboratory performing the test or 3) known HAE-causing C1INH mutation. The patient must have a history of more than one severe event per month and have failure, contraindication or intolerance to one conventional therapy for HAE prophylaxis such as aminocaproic acid, danazol or tranexamic acid. 15

16 COPAXONE Products Affected Copaxone INJ 20MG/ML PA Details Age Other Copaxone will be used as monotherapy. 16

17 COPAXONE 40MG/ML Products Affected Copaxone INJ 40MG/ML PA Details Age Other Copaxone will be used as monotherapy. The patient must also have failure, contraindication or intolerance to Copaxone 20mg/ml before Copaxone 40mg/ml is authorized. 17

18 DIFICID Products Affected Dificid PA Details Age Other Authorized for patients 18 years of age and older. Authorization is for ten days. 18

19 EGRIFTA Products Affected Egrifta PA Details Age Other Males must have a waist circumference of at least 95cm (37.5in) and a waist-to-hip ratio of at least Females must have a waist circumference of at least 94cm (37in) and a waist-to-hip ratio of at least Patients must have a baseline CT documenting increased visceral adipose tissue (VAT). Reauthorization is contingent upon ONE of the following: 1) decrease in VAT measured by CT scan or 2) reduction of waist circumference and waist-to-hip ratio from baseline measurement. Patient must be on a stable antiretroviral regimen for at least 8 weeks. 19

20 ELIGARD Products Affected Eligard PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Patient must have failure, contraindication or intolerance to Trelstar before Eligard is authorized. 20

21 ENBREL Products Affected Enbrel Enbrel Sureclick PA Details Age Other JRA - 2 to 17 years old. RA and plaque psoriasis 18 years of age and older. Treatment of rheumatoid arthritis (RA) and when ANY of the following criteria are met: 1) history of positive clinical response to etanercept therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying anti-rheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine). Treatment of chronic plaque psoriasis and 1) history of positive clinical response to etanercept therapy OR 2) patient is a candidate for, or has previously received ONE of the following: a) systemic therapy (e.g., methotrexate, cyclosporin, soriatane) OR b) phototherapy [narrow or broad band ultraviolet B (UVB), or psoralen plus ultraviolet A (PUVA)]. Treatment of ankylosing spondylitis and either of the following criteria are met: history of positive clinical response to etanercept therapy OR the patient had failure, contraindication, or intolerance to one non-steroidal anti-inflammatory drug (NSAIDs). 21

22 EPOGEN Products Affected Epogen PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from part D and anemia of chronic disease including myelodysplastic syndrome, ribavirin use in individuals infected with hepatitis C, rheumatoid arthritis, rheumatic disease and prematurity. Epogen is authorized for the treatment of anemia [Hemoglobin (Hgb) less than 10 g/dl (Hgb less than 12 g/dl for patients with HIV and 13 g/dl for surgery patients] in the presence of adequate iron stores (i.e., normal transferrin or serum ferritin level) associated with ANY of the following conditions: 1) chronic kidney disease, including patients who are predialysis or on dialysis, 2) cancer chemotherapy regimens planned for at least two months in duration, 3) human immunodeficiency virus (HIV) infection in patients receiving zidovudine therapy, 4) surgical patients or 5) chronic disease including myelodysplastic syndrome, ribavirin use in individuals infected with hepatitis C, rheumatoid arthritis, rheumatic disease and prematurity. Continued authorization is considered medically necessary when the following criteria are met: Hgb does not exceed 11 g/dl (12 g/dl for patients with HIV and 13 g/dl for surgery patients). Anemia associated with chronic kidney disease - 6 mos. Anemia for other covered uses - 8 wks. Patients must also have failure, contraindication or intolerance to Procrit or Aranesp before Epogen will be authorized. 22

23 EXTAVIA Products Affected Extavia PA Details Age Other Extavia will be used as monotherapy. 23

24 FENTANYL CITRATE ORAL TRANSMUCOSAL Products Affected Fentanyl Citrate Oral Transmucosal PA Details Age Other Authorized for patients 16 years of age and older. Authorization is for 6 months. 24

25 FIRAZYR Products Affected Firazyr PA Details Age Other Patient must have a confirmed diagnosis of HAE as evidenced by a C4 level below the lower limit of normal as defined by the laboratory performing the test AND EITHER of the following: 1) C1 inhibitor (C1INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test 2) C1INH functional level below the lower limit of normal as defined by the laboratory performing the test. Authorized for patients 18 years of age and older. The patient must have a history of a moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion). 25

26 GATTEX Products Affected Gattex PA Details Age Other As long as the patient requires TPN, up to 1 year. 26

27 GENOTROPIN Products Affected Genotropin Genotropin Miniquick PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 27

28 Age Other For GHD in children or adults, Turner Syndrome, SGA, SHOX gene deletion or growth delay in children with chronic kidney disease, the patient must have failure, contraindication or intolerance to Humatrope or Saizen before coverage of Genotropin. 28

29 GILENYA Products Affected Gilenya PA Details Age Other Gilenya will be used as monotherapy for the treatment of multiple sclerosis. Patients must also have failure, contraindication or intolerance to one of the following formulary alternatives Avonex, Rebif or Copaxone before Gilenya will be authorized. 29

30 HIZENTRA Products Affected Hizentra INJ PA Details Age Other Initial authorization up to 3 months. Reauthorization up to 6 months. Note: A reauthorization of Hizentra for any clinically appropriate use for up to 6 months is covered as medically necessary when ALL of the following criteria are met: 1) the medical condition or disease under treatment has not fully resolved and the treatment has not exceeded the clinically accepted duration of therapy where applicable 2) there continues to be a sustained beneficial response to Hizentra as evidenced by treatment notes or a clinical narrative detailing progress to date and the expected frequency and duration of any proposed Hizentra use going forward 3) the requested frequency and dosage of Hizentra is supported by evidence-based literature 4) where clinically appropriate, titration has occurred to the minimum dose and frequency to achieve sustained clinical effect. 30

31 HUMATROPE Products Affected Humatrope Humatrope Combo Pack PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 31

32 Age Other 32

33 HUMIRA Products Affected Humira Humira Pen PA Details Age JIA - 4 to 17 years old. RA and plaque psoriasis 18 years of age and older. 33

34 Other Treatment of rheumatoid arthritis (RA) and when ANY of the following criteria are met: 1) history of positive clinical response to adalimumab therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying anti-rheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine). Treatment of ankylosing spondylitis and either of the following criteria are met: history of positive clinical response to adalimumab therapy OR the patient had failure, contraindication, or intolerance to one non-steroidal anti-inflammatory drug (NSAIDs). Treatment of active Crohn's disease AND when ANY of the following criteria are met: history of positive clinical response to adalimumab therapy OR failure, inadequate response, contraindication or intolerance to one of the following conventional therapies (aminosalicylate, corticosteroids, or immunomodulators) OR failure or intolerance to infliximab therapy. Treatment of chronic plaque psoriasis AND when ANY of the following criteria are met: history of positive clinical response to adalimumab therapy OR patient is a candidate for, or has previously received ONE of the following: 1) systemic therapy (e.g., methotrexate, cyclosporin, soriatane) OR 2) phototherapy [narrow or broad band ultraviolet B (UVB), or psoralen plus ultraviolet A (PUVA)]. Treatment of psoriatic arthritis. Treatment of ulcerative colitis AND either or the following: 1) history of positive clinical response to adalimumab therapy OR 2) failure, inadequate response, contraindication or intolerance to at least one conventional therapy (aminosalicylate, corticosteroids or immunomodulators). 34

35 IGIM Products Affected Gamastan S/D PA Details Age Other 35

36 ILARIS Products Affected Ilaris PA Details Age Other Authorized for patients 4 years of age and older. 36

37 INCIVEK Products Affected Incivek PA Details Age Other 1) HCV genotype other than one. 2) Incivek not being used in combination with pegylated interferon and ribavirin. 3) Previous failure with Incivek or another HCV NS3/4A protease inhibitor. 4) Patient has decompenstated liver disease such as ascites, hepatic encephalopathy or bleeding esophagogastric varicies. Authorization is for 12 weeks. 37

38 INCRELEX Products Affected Increlex PA Details Age Other Increlex will be re-authorized when ALL of the following criteria are met: 1) Yearly reassessment for reauthorization of coverage is required. 2) for continuation of therapy requires meeting current initial use criteria and evidence of a beneficial response as shown by growth curve chart. 3) for growth promotion will cease when the bony epiphyses have closed. 38

39 INFERGEN Products Affected Infergen PA Details Age Infergen is authorized as monotherapy or in combination with ribavirin for the treatment of Hepatitis C (HCV) in adults age 18 years or older who have compensated liver disease with intolerance to peginterferon alfa therapy (i.e., injection-site reaction) OR are classified as a nonresponder/relapser after treatment with a peginterferon alfa therapy AND ANY of the following conditions: 1) Genotype 1 - approval of 16 weeks as initial authorization. Subsequent authorizations are contingent on clinical response of at least a 2 log (100 fold decrease in quantitative HCV RNA by week 16 as follows: a) If HCV RNA is undetectable (less than 50 IU/ml), an additional 32 weeks (total 48 weeks) will be authorized. OR b) If HCV RNA is detectable (greater than 50 IU/ml), an additional 8 weeks will be authorized and HCV RNA re-evaluated at 24 weeks. An additional 24 weeks (total 48 weeks) will be authorized if there is no detectable virus at 24 weeks (less than 50 IU/ml). 2) Genotype 2 and 3 treatment authorized for 24 weeks although genotype 3 with steatosis and initial high viral loads (HCV RNA greater than 600,000 IU/mL) treatment authorized for 48 weeks. 3) Genotype 4, 5, or 6 treatment authorized for 48 weeks. 4) Patients with bridging fibrosis or cirrhosis treatment authorized for 48 weeks regardless of HCV genotype and changes in HCV RNA levels at week 12. 5) Patients who have coinfection with human immunodeficiency virus (HIV) treatment authorized for 48 weeks. Authorization is limited to patients 18 years old and older. Approval duration ranges between 16 to 48 weeks depending on diagnosis and clinical information. 39

40 Other Note: When medical necessity criteria have been met, CIGNA HealthCare covers Infergen on a 3 times per week dosing schedule. Daily dosing may be indicated in select populations including liver transplantation candidates and non-responders to pegylated interferon treatment. 40

41 IVIG Products Affected Bivigam Carimune NF Gammagard Liquid Gammaplex Gamunex-C Privigen PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from part D and multiple myeloma, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy (CIDP), relapsing-remitting multiple sclerosis (RRMS), dermatomyositis, polymyositis, autoimmune mucocutaneous blistering diseases such as Pemphigus, Pemphigoid, and Epidermolysis Bullosa Acquisita. IVIG authorized for chronic ITP when ALL of the following: 1) duration greater than 6 months 2) no illness explaining thrombocytopenia 3) prior treatment with a reasonable course of corticosteroids or splenectomy 4) platelet count less than 30,000mm3 in children or less than 20,000mm3 in adults. IVIG authorized for CIDP when ALL: 1) symptomatic polyradiculoneuropathy with BOTH: a) progressive or relapsing motor or sensory impairment of more than one limb and b) widespread hyporeflexia or areflexia 2) any 3 of 4 of the following a) partial conduction block of 1 or more motor nerve, b) reduced conduction velocity of 2 or more motor nerves, c) prolonged distal latency of 2 or more motor nerves, d) prolonged F-wave latencies of 2 or more motor nerves or absence of F waves 3) lumbar puncture with a) white blood cell count less than 10/mm3 and b) negative VDRL. For reauth, significant improvement in clinical condition documented by Rankin, Modified Rankin, or MRC scales and, if applicable, a reduction in the level of sensory loss. IVIG authorized for 1) dermatomyositis or polymyositis on biopsy and failure of standard medical therapy as reflected by persistently elevated serum CK levels and/or lack of improvement on muscle strength improvement scales OR 2) multiple myeloma or B-cell CLL when the serum IgG is below the lower limits of normal on at least two occasions. 41

42 Other Myathenia gravis 1 course. Other uses: initial auth up to 3 months and reauth up to 6 months. IVIG is authorized for any of the following: 1) chronic treatment of RRMS as a single agent when there is failure of standard immunomodulatory therapy (e.g. interferon beta, glatiramer) or 2) treatment of Myasthenia gravis when any of the following is present: a) before planned thymectomy or during the postoperative period following thymectomy or b) during an acute crisis (e.g. significant dysphagia, respiratory failure, inability to perform physical activity) duration of treatment should not exceed 5 days or c) during initiation of immunosuppressive treatment 3) prevention of infection during the first 100 days following transplantation in BMT recipients or 4) acute treatment of Kawasaki disease when given in conjunction with aspirin within ten days of onset of symptoms or 5) treatment of autoimmune mucocutaneous blistering diseases when either of the following: a) failure, contraindication or intolerance of at least one of the following conventional therapies (corticosteroids, azathioprine, cyclophosphamide, CellCept) or b) rapidly progressive disease in which a clinical response cannot be affected quickly enough using conventional agents. In these situations, IVIG therapy should be given along with conventional treatment(s) and the IVIG used only until conventional therapy takes effect. Note: A reauthorization of IVIG for any clinically appropriate use for up to 6 months is covered as medically necessary when ALL of the following criteria are met: 1) the medical condition or disease under treatment has not fully resolved and the treatment has not exceeded the clinically accepted duration of therapy where applicable 2) there continues to be a sustained beneficial response to IVIG as evidenced by treatment notes or a clinical narrative detailing progress to date and the expected frequency and duration of any proposed IVIG use going forward 3) the requested frequency and dosage of IVIG is supported by evidencebased literature 4) where clinically appropriate, titration has occurred to the minimum dose and frequency to achieve sustained clinical effect. 42

43 KALBITOR Products Affected Kalbitor PA Details Age Other Kalbitor is authorized for the treatment of acute angioedema attacks with hereditary angioedema (HAE) when BOTH of the following criteria are met: 1) confirmed diagnosis of (HAE) as evidenced by a C4 level below the lower limit of normal as defined by the laboratory performing the test AND EITHER a) C1 inhibitor (C1INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test or b) C1INH functional level below the lower limit of normal as defined by the laboratory performing the test AND 2) history of a moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion). Authorization is limited to patients 16 years old and older. 43

44 KALYDECO Products Affected Kalydeco PA Details Age Other Authorized for patients 6 years of age and older. 44

45 KORLYM Products Affected Korlym PA Details Age Other Female patients of reproductive potential must have a negative pregnancy test before authorization of Korlym. 45

46 LAZANDA Products Affected Lazanda PA Details Age Other Authorized for patients 18 years of age and older. Authorization is for 6 months. Patient must have failure, contraindication or intolerance to fentanyl citrate lozenge before Lazanda is authorized. 46

47 LEUPROLIDE ACETATE INJ Products Affected Leuprolide Acetate INJ Lupron Depot Lupron Depot-Ped PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other For central precocious puberty the onset of secondary sexual characteristics must be earlier than 8 years of age in females and 9 years of age in males. For the treatment of prostate cancer, the patient must have failure, contraindication or intolerance to Trelstar before Lupron is authorized. 47

48 LOTRONEX Products Affected Lotronex PA Details Age Other 48

49 MAKENA Products Affected Makena PA Details Age Other Makena is authorized to reduce the risk of preterm birth when ALL of the following are met: 1) current singleton pregnancy AND 2) previous singleton spontaneous preterm birth (preterm birth defined as birth from the period of viability through week 36, 6 days gestation) AND 3) treatment will be initiated between week 16, 0 days and week 20, 6 days of gestation and not continue beyond week 36, 6 days of gestation or time of delivery (whichever occurs first). Authorization is for up to 21 weeks. 49

50 METHAMPHETAMINE HCL Products Affected Methamphetamine Hcl PA Details Age Other Patient must have failure, contraindication or intolerance to one formulary alternative such as dextroamphetamine, amphetamine/dextroamphetamine, methylphenidate or dexmethylphenidate before methamphetamine hcl is authorized. 50

51 NEUMEGA Products Affected Neumega PA Details Age Other Authorization duration is 1 to 12 months based on number of chemo cycles. 51

52 NITROFURANTOIN Products Affected Furadantin Nitrofurantoin SUSP Nitrofurantoin Macrocrystals Nitrofurantoin Monohydrate PA Details Age Other This prior authorization only applies to customers 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Customers under 65 years of age are not subject to the prior authorization requirements. This prior authorization only applies when the duration of therapy exceeds 90 days in a year. 52

53 NORDITROPIN Products Affected Norditropin Flexpro Norditropin Nordiflex Pen PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 53

54 Age Other For GHD in children or adults, Turner Syndrome, SGA, SHOX gene deletion or growth delay in children with chronic kidney disease, the patient must have failure, contraindication or intolerance to Humatrope or Saizen before coverage of Norditropin. 54

55 NUTROPIN Products Affected Nutropin INJ 10MG Nutropin Aq PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 55

56 Age Other For GHD in children or adults, Turner Syndrome, SGA or SHOX gene deletion, the patient must have failure, contraindication or intolerance to Humatrope or Saizen before coverage of Nutropin. 56

57 NUVIGIL Products Affected Nuvigil PA Details Age Other Treatment of obstructive sleep apnea/hypopnea syndrome (OSAHS) AND patient has been evaluated through a sleep study. For the treatment of narcolepsy, the patient must have failure, contraindication, or intolerance to methylphenidate or dextroamphetamine sulfate before Nuvigil is authorized. 57

58 OLYSIO Products Affected Olysio PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Previous failure to respond to treatment with other HCV direct-acting protease inhibitors or repeated courses of simeprevir will result in exclusion of coverage for Olysio. Documentation from the medical record of diagnosis including genotype, current medication regimen, and HCV-RNA levels. Authorization is for 12 weeks. Concurrent therapy with peginterferon alfa and ribavirin is required for Olysio, unless being used in combination with sofosbuvir. 58

59 OMNITROPE Products Affected Omnitrope PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. Age For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 59

60 Other For GHD in children or adults, Turner Syndrome, SGA, SHOX gene deletion or growth delay in children with chronic kidney disease, the patient must have failure, contraindication or intolerance to Humatrope or Saizen before coverage of Omnitrope. 60

61 ORENCIA IV Products Affected Orencia IV 250MG PA Details Age Other Authorization is limited to patients 6 years old and older. Treatment of rheumatoid arthritis (RA) and when ANY of the following criteria are met: 1) history of positive clinical response to abatacept therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying anti-rheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine) AND when the following condition is met: the patient has had failure, contraindication, or intolerance to Enbrel or Humira. 61

62 PEG-INTRON Products Affected Peg-Intron Peg-Intron Redipen PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Peg-Intron is authorized as monotherapy or in combination with ribavirin for the treatment of Hepatitis C (HCV) in patients who have compensated liver disease AND ANY of the following conditions: 1) Genotype 1 - approval of 16 weeks as initial authorization. Subsequent authorizations are contingent on clinical response of at least a 2 log (100 fold decrease in quantitative HCV RNA by week 16 as follows: a) If HCV RNA is undetectable (less than 50 IU/ml), an additional 32 weeks (total 48 weeks) will be authorized. OR b) If HCV RNA is detectable (greater than 50 IU/ml), an additional 8 weeks will be authorized and HCV RNA reevaluated at 24 weeks. An additional 24 weeks (total 48 weeks) will be authorized if there is no detectable virus at 24 weeks (less than 50 IU/ml). 2) Genotype 2 and 3 treatment authorized for 24 weeks although genotype 3 with steatosis and initial high viral loads (HCV RNA greater than 600,000 IU/mL) treatment authorized for 48 weeks. 3) Genotype 4, 5, or 6 treatment authorized for 48 weeks. 4) Patients with bridging fibrosis or cirrhosis treatment authorized for 48 weeks regardless of HCV genotype and changes in HCV RNA levels at week 12. 5) Patients who have coinfection with human immunodeficiency virus (HIV) treatment authorized for 48 weeks. 6) Patients who are classified as a nonresponder or relapser after treatment with a non-pegylated interferon. of therapy should be based on the patient s genotype. Peg-Intron is approved as part of hepatitis C triple therapy with either Incivek or Victrelis along with ribavirin when Incivek or Victrelis criteria are met. Treatment duration is based on the FDA Recommended Dosing Tables for hepatitis C triple therapy based on prior hepatitis C therapy usage and response to therapy determined by measurement of Hepatitis C virus levels or HCV-RNA levels. Authorization is limited to patients 3 years old and older. 62

63 Other Approval duration ranges between 16 to 48 weeks depending on diagnosis and clinical information. Treatment of chronic myelogenous leukemia (CML) when the patient is unable to tolerate one formulary alternative such as Gleevec, Sprycel or Tasigna. 63

64 POTENTIALLY HIGH RISK MEDICATION Products Affected Amitriptyline Hcl ORAL TABS Carisoprodol TABS 350MG Carisoprodol/aspirin Carisoprodol/aspirin/codeine Chlordiazepoxide/amitriptyline Clomipramine Hcl ORAL CAPS Cyclobenzaprine Hcl ORAL TABS 10MG, 5MG Doxepin Hcl CONC Doxepin Hcl ORAL CAPS Imipramine Hcl ORAL TABS Imipramine Pamoate Megestrol Acetate ORAL TABS Methocarbamol ORAL TABS Orphenadrine/asa/caffeine TABS 385MG; 30MG; 25MG Perphenazine/amitriptyline Phenobarbital ELIX Phenobarbital ORAL TABS Thioridazine Hcl ORAL TABS Trimipramine Maleate ORAL CAPS PA Details Age Other This prior authorization only applies to customers 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Customers under 65 years of age are not subject to the prior authorization requirements. The prescriber is required to provide clinical information which documents the need for continued use of the high risk medication (HRM) in the patient 65 years of age and older. The clinical information should provide an explanation which demonstrates that the benefit of the continued use of the medication outweighs the potential risk of the medication. 64

65 PROCRIT Products Affected Procrit PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from part D and anemia of chronic disease including myelodysplastic syndrome, ribavirin use in individuals infected with hepatitis C, rheumatoid arthritis, rheumatic disease and prematurity. Procrit is authorized for the treatment of anemia [Hemoglobin (Hgb) less than 10 g/dl (Hgb less than 12 g/dl for patients with HIV and 13 g/dl for surgery patients] in the presence of adequate iron stores (i.e., normal transferrin or serum ferritin level) associated with ANY of the following conditions: 1) chronic kidney disease, including patients who are predialysis or on dialysis, 2) cancer chemotherapy regimens planned for at least two months in duration, 3) human immunodeficiency virus (HIV) infection in patients receiving zidovudine therapy, 4) surgical patients or 5) chronic disease including myelodysplastic syndrome, ribavirin use in individuals infected with hepatitis C, rheumatoid arthritis, rheumatic disease and prematurity. Continued authorization is considered medically necessary when the following criteria are met: Hgb does not exceed 11 g/dl (12 g/dl for patients with HIV and 13 g/dl for surgery patients). Anemia associated with chronic kidney disease - 6 mos. Anemia for other covered uses - 8 wks. 65

66 QUALAQUIN Products Affected Qualaquin Quinine Sulfate CAPS PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from part D and babesiosis. For malaria the authorization is for 7 days. For babesiosis the authorization is 10 days. 66

67 REBIF Products Affected Rebif Rebif Rebidose PA Details Age Other Rebif will be used as monotherapy. 67

68 REGRANEX Products Affected Regranex PA Details Age Other Authorization is for 20 weeks. 68

69 REMICADE Products Affected Remicade PA Details Age RA and plaque psoriasis 18 years of age and older. Crohn's or ulcerative colitis 6 years of age and older. 69

70 Other Treatment of rheumatoid arthritis (RA) in combination with methotrexate and when ANY of the following criteria are met: 1) history of positive clinical response to infliximab therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying antirheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine) AND failure, contraindication or intolerance to Enbrel or Humira. Treatment of chronic plaque psoriasis AND EITHER the following: 1) history of a beneficial clinical response to infliximab OR 2) failure, contraindication or intolerance to Enbrel or Humira. Treatment of active Crohn's disease in an adult AND when ANY of the following criteria are met: 1) history of positive clinical response to infliximab therapy OR 2) failure, inadequate response, contraindication or intolerance to one conventional therapy (aminosalicylate, corticosteroids, or immunomodulators) AND failure or intolerance to Humira. Treatment of active Crohn's disease in a child AND when ANY of the following criteria are met: 1) history of positive clinical response to infliximab therapy OR 2) failure, inadequate response, contraindication or intolerance to one conventional therapy (aminosalicylate, corticosteroids, or immunomodulators). Treatment of ulcerative colitis (UC) AND when either of the following criteria are met: 1) history of positive clinical response to infliximab therapy OR 2) failure, inadequate response, contraindication or intolerance to one conventional therapy: corticosteroids (e.g, prednisone, methylprednisolone), 5-aminosalicylic acid agents (e.g., sulfasalazine, mesalamine, balsalazide), immunosuppressants (e.g., azathioprine, cyclosporine, 6-mercaptopurine). Treatment of ankylosing spondylitis AND EITHER of the following: 1) history of beneficial clinical response to infliximab or 2) failure, contraindication, or intolerance to one nonsteroidal anti-inflammatory drug (NSAID) AND to failure, contraindication, or intolerance to Enbrel or Humira. Treatment of psoriatic arthritis AND EITHER of the following: 1) history of beneficial clinical response to infliximab or 2) failure, contraindication, or intolerance to Enbrel or Humira. 70

71 RITUXAN Products Affected Rituxan PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Treatment of neuromyelitis optica (NMO) when there has been a diagnosis of optic neuritis, myelitis, and at least TWO of the following: 1) contiguous spinal cord lesion on MRI extending three or more segments 2) initial brain MRI does not meet diagnostic criteria for multiple sclerosis (MS) 3) seropositivity of NMO-IgG. For RA, authorization is limited to patients 18 years old and older. Treatment of rheumatoid arthritis (RA) in combination with methotrexate and when EITHER of the following criteria are met: 1) history of positive clinical response to rituximab therapy OR 2) inadequate response, intolerance, or contraindication to at least one disease-modifying antirheumatic drug (DMARD) (i.e., Methotrexate (MTX) Azathioprine, gold, Hydroxychloroquine, Penicillamine, Sulfasalazine) AND failure, contraindication, or intolerance to Enbrel or Humira. 71

72 SAIZEN Products Affected Saizen Saizen Click.easy PA Details Growth Hormone Use in Children: (1) growth hormone deficiency in children (2) small for gestational age (SGA) (3) growth delay in children with chronic renal failure (4) Turner Syndrome (5) Prader-Willi Syndrome (6) Noonan Syndrome (7) SHOX Gene Deletion. Growth Hormone Use in Adults: (1) for growth hormone deficiency in adults (2) for the continuation of therapy from growth hormone deficiency in childhood. For GHD in children: 1) growth failure demonstrated by growth velocity or height more than two standard deviations below average AND 2) diagnosis confirmed by at least two GH stimulation tests. Note: For children with documented panhypopituitarism, it may be assumed that growth hormone is absent and no stimulation testing is required. For SGA: 1) birth weight and/or length at least 2 standard deviations below the mean for gestational age AND 2) child fails to manifest catch-up growth by 2 y/o. For growth delay in children with chronic kidney disease: 1) renal function at stage 2 or more advanced CKD (or GFR at or below 60ml/min/1.73m2) AND 2) patient s height is more than 2 SD below average. For Turner Syndrome, Prader-Willi Syndrome, SHOX gene deletion or Noonan Syndrome: 1) diagnosis confirmed by appropriate genetic testing AND 2) patient s height is more than 2 SD below average. For all covered uses in children, a yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria and evaluation of response as shown by growth curve chart. for growth promotion ends when bony epiphyses have closed. For GHD in adults: 1) the etiology of GHD is a result of destructive hypothalamic or pituitary disease, radiation therapy, surgery or trauma OR is a result of documented GHD in childhood AND 2) diagnosis confirmed by at least one GH stimulation test. Note: No stimulation testing is required for a diagnosis of panhypopituitarism. A yearly reassessment for reauthorization of coverage is required. for continuation of therapy requires meeting current initial use criteria. 72

73 Age Other 73

74 SANCUSO Products Affected Sancuso PA Details Age Other Patient must have failure, contraindication or intolerance to ondansetron before authorization of Sancuso. 74

75 SEDATIVES HRM Products Affected Eszopiclone Lunesta Zaleplon Zolpidem Tartrate Zolpidem Tartrate ER PA Details Age Other This prior authorization only applies to customers 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Customers under 65 years of age are not subject to the prior authorization requirements. This prior authorization only applies when the duration of therapy exceeds 90 days in a year. The prescriber is required to provide clinical information which documents the need for continued use of the high risk medication (HRM) in the patient 65 years of age and older. The clinical information should provide an explanation which demonstrates that the benefit of the continued use of the medication outweighs the potential risk of the medication. 75

76 SEROSTIM Products Affected Serostim PA Details Age Other Initial authorization to be limited to 12 weeks. Treatment of AIDS Wasting when ALL of the following criteria are met: 1) there has been weight loss greater than 10% of pre-illness baseline body weight or body mass index (BMI) less than 20kg/m2, 2) there has been documented failure, intolerance, or contraindication to one appetite stimulant and/or one anabolic agent and 3) there is continuous use antiviral therapy. Reauthorizations (if initial criteria are met) will be provided for an additional 12 weeks if base line body weight and BMI are not achieved at the end of prior authorization period for a total duration of 48 weeks. 76