2015 PRIOR AUTHORIZATION CRITERIA TABLE OF CONTENTS ACTHAR HP GEL... 8 ADCIRCA... 9 AFINITOR AFINITOR DISPERZ AMITIZA...

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1 2015 PRIOR AUTHORIZATION CRITERIA TABLE OF CONTENTS ACTHAR HP GEL... 8 ADCIRCA... 9 AFINITOR AFINITOR DISPERZ AMITIZA amitriptyline AMPYRA ANADROL RODERM ROGEL ROID ROXY ARANESP ARCALYST ascomp/codeine AVONEX AVONEX PEN benztropine BETASERON BOSULIF buprenorphine buprenorphine-naloxone butalbital/acetaminophen/caffeine/codeine cap butalbital/aspirin/caffeine/codeine cap CAPRELSA CINRYZE Updated 10/2014 NORTH CAROLINA Formulary 1

2 clomipramine clonazepam clonazepam odt clorazepate COMETRIQ COPAXONE danazol DIAZEPAM conc, soln diazepam tablet digox 0.25 mg tab digoxin 0.25 mg tab DIVIGEL doxepin 10 mg, 25 mg, 50 mg, 100 mg, 150 mg cap DOXEPIN 75 mg cap doxepin oral conc EGRIFTA ENBREL EPOGEN ergoloid mesylates ERIVEDGE estradiol estradiol/norethindrone estropipate 0.75mg, 1.5mg ESTROPIPATE 3 mg fentanyl oral lozenge FIRAZYR FORTEO GAMMAPLEX Updated 10/2014 NORTH CAROLINA Formulary 2

3 GAMUNEX-C GATTEX GILOTRIF GLEEVEC glyburide GLYBURIDE glyburide micronized glyburide/metformin GRASTEK HETLIOZ HEXALEN HUMIRA hydroxyzine soln, syrup, tab ICLUSIG ILARIS IMBRUVICA imipramine imiquimod INLYTA JAKAFI JUXTAPID ketorolac 10 mg tab KINERET KUVAN KYNAMRO LANOXIN 0.25 mg tab LAZA LETAIRIS Updated 10/2014 NORTH CAROLINA Formulary 3

4 lidocaine transdermal patch lorazepam MATULANE megestrol susp, tabs MEKINIST MENEST mimvey mimvey lo modafinil MYALEPT NEXAVAR NOXAFIL NUVIGIL octreotide OLYSIO OMNITROPE ONFI OPSUMIT oxandrolone PEGASYS PEGASYS PROCLICK PEG-INTRON PEG-INTRON REDIPEN phenadoz supp phenergan 12.5 mg, 25 mg supp PHENOBARBITAL 15 mg, 30 mg, 60 mg, 64.8 mg, 97.2 mg, 100 mg tab phenobarbital 16.2 mg, 32.4 mg tab phenobarbital elixir, soln Updated 10/2014 NORTH CAROLINA Formulary 4

5 PHENOBARBITAL inj POMALYST PREMARIN PREMPHASE PREMPRO PROCRIT PROLIA PROMACTA promethazine promethegan supp RAGWITEK REBIF RELISTOR REMICADE REVLIMID RITUXAN SAMSCA SENSIPAR SIGNIFOR sildenafil SOMATULINE DEPOT SOMAVERT SOVALDI SPRYCEL STIVARGA SUBOXONE SUBSYS SURMONTIL Updated 10/2014 NORTH CAROLINA Formulary 5

6 SUTENT SYLATRON TAFINLAR TARCEVA TARGRETIN TASIGNA TECFIDERA TECFIDERA STARTER PACK testosterone cypionate testosterone enanthate THALOMID thioridazine TRACLEER tretinoin cap trimipramine TYKERB TYSABRI voriconazole VOTRIENT XALKORI XENAZINE XOLAIR XTI XYREM ZELBORAF ZOHYDRO ER ZOLINZA ZYDELIG Updated 10/2014 NORTH CAROLINA Formulary 6

7 ZYKADIA ZYTIGA ZYVOX Updated 10/2014 NORTH CAROLINA Formulary 7

8 Prior Authorization Group Acthar HP Gel PA ACTHAR HP GEL Criteria for approval are ALL of the following: 1. ONE of: A. Diagnosis of infantile spasm OR B. Diagnosis of multiple sclerosis i. Patient is experiencing an acute exacerbation ii. Patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy OR C. Other FDA approved indications: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, severe erythema multiforme, Stevens- Johnson syndrome, systemic lupus erythematosus, systemic dermatomyositis (polymyositis), serum sickness, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation and symptomatic sarcoidosis Patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy OR D. Use is supported by clinical evidence or the prescriber has submitted documentation in support of therapy with H.P. Acthar Gel for the intended diagnosis Patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy 2. Patient does not have an FDA contraindication to therapy 3. For infantile spasms and multiple sclerosis, the dose is within the FDA labeled dose For diagnosis of infantile spasm patient must be less than 24 months of age 6 months for infantile spasm, 1 month for all other indications Updated 10/2014 NORTH CAROLINA Formulary 8

9 Prior Authorization Group Adcirca PA ADCIRCA This program applies to new starts only. Criteria for initial approval require ONE of the following: 1. There is evidence of a claim within the past 90 days that patient is currently being treated with requested agent OR 2. Prescriber states patient is using requested agent is at risk if therapy is changed OR 3. ALL of the following: A. ONE of the following: i. Patient has a diagnosis of pulmonary arterial hypertension, WHO Group 1 as determined by right heart catheterization OR ii. Prescriber has submitted documentation in support of the use of the prescribed agent for the intended diagnosis (erectile dysfunction is not a covered diagnosis) B. The patient s mean pulmonary arterial pressure is greater than 25 mm Hg C. The patient has a pulmonary vascular resistance greater than 3 Wood units D. Patient s NYHA functional class is II or greater E. Patient is not concurrently taking oral erectile dysfunction agents (e.g. Cialis, Viagra, Levitra) F. Patient does not have any FDA labeled contraindications to therapy Criteria for renewal require BOTH of the following: 1. Patient has been previously approved for therapy through the plan s PA process and is responding to therapy 2. Patient does not have any FDA labeled contraindications to therapy Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 9

10 Prior Authorization Group Amitiza PA AMITIZA Criteria for approval require ALL of the following: 1. Patient has a diagnosis of ONE of the following: a. chronic idiopathic constipation with documentation of symptoms for at least 3 months OR b. irritable bowel syndrome with constipation with documentation of symptoms for at least 3 months in a woman OR c. opioid-induced constipation with chronic non-cancer pain BOTH of the following: i. patient has chronic use of an opioid agent in the past 90 days ii. patient is not receiving a diphenylheptane opioid (e.g. methadone) in the past 90 days 2. ONE of the following: a. Patient has tried at least one standard laxative treatment for constipation lactulose or polyethylene glycol 3350 OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one standard laxative treatment for constipation lactulose or polyethylene glycol Patient does not have any FDA labeled contraindications to therapy Patient must be an adult at least 18 yrs of age Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 10

11 Prior Authorization Group Ampyra PA AMPYRA Criteria for approval require ALL of the following: 1. Patient has a diagnosis of multiple sclerosis 2. Patient is receiving concurrent therapy with a disease modifying agent (e.g. Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Novantrone, Rebif, Tecfidera, or Tysabri) if indicated 3. There is documentation of significant limitations of instrumental activities of daily living attributable to slow ambulation 4. Patient is ambulatory with a baseline timed 25 foot walk between 8 to 45 seconds OR patient has an expanded disability status scale (EDSS) of greater than or equal to 4.5 but less than 7 5. Patient does not have any FDA labeled contraindications to therapy 6. ONE of the following: A. Patient is being started on initial therapy with Ampyra OR B. Patient is currently receiving Ampyra and has been receiving Ampyra therapy for 2 months or longer has demonstrated an improvement from baseline in timed walking speed (timed 25 foot walk) OR C. Patient has a documented EDSS score of less than 7 The prescriber is a neurologist or has consulted a neurologist Approval will be 3 months for initial, 12 months for renewal. Updated 10/2014 NORTH CAROLINA Formulary 11

12 Prior Authorization Group Anabolic Steroid PA - Danazol danazol Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient has fibrocystic breast disease OR B. Patient has hereditary angioedema OR C Patient has endometriosis 2. Patient does NOT have any FDA labeled contraindication(s) 3. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 12

13 Prior Authorization Group Anabolic Steroid PA - oxandrolone oxandrolone Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient is a male or female with AIDS/HIV-associated wasting syndrome (defined as unexplained involuntary weight loss greater than 10% baseline body weight with obvious wasting or body mass index less than 18.5 kg/m2) all other causes of weight loss have been ruled out OR B. Patient is a female child or adolescent with Turner syndrome is currently receiving growth hormone OR C. Patient has weight loss following extensive surgery, chronic infections, or severe trauma OR D. Patient has chronic pain from osteoporosis OR E. Patient is on long-term administration of oral or injectable corticosteroids 2. Patient does NOT have any FDA labeled contraindication(s) 3. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 13

14 Prior Authorization Group Anabolic Steroid PA - oxymetholone ANADROL-50 All medically accepted indications not otherwise excluded from Part D. Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient has anemia caused by deficient red cell production, including acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs OR B. Patient has anemia associated with chronic renal failure ONE of the following: i. Patient s medication history indicates previous use of an erythropoiesisstimulating agent OR ii. Patient has documented intolerance, FDA labeled contraindication or hypersensitivity to an erythropoiesis-stimulating agent 2. Patient has a hematocrit (Hct) value less than 30% 3. Patient does NOT have any FDA labeled contraindication(s) 4. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 14

15 Prior Authorization Group Androgen Injectable PA testosterone cypionate testosterone enanthate Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient is a male with AIDS/HIV-associated wasting syndrome, defined as unexplained involuntary weight loss (greater than 10% baseline body weight) with obvious wasting OR body mass index less than 18.5 kg/m2 all other causes of weight loss have been ruled out OR B. Patient is a female with metastatic/inoperable breast cancer OR C. Patient is a male with primary or secondary (hypogonadotropic) hypogonadism OR D. Patient is an adolescent male with delayed puberty 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is less than 300 ng/dl or is below the testing laboratory s lower limit of the normal range if greater than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range 3. Patient does NOT have any FDA labeled contraindication(s) 4. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be 6 months for delayed puberty, 12 months for all other indications Updated 10/2014 NORTH CAROLINA Formulary 15

16 Prior Authorization Group Androgen Oral PA ROID ROXY Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient is a male with cryptorchidism OR B. Patient is a male with hypogonadism OR C. Patient is an adolescent male with delayed puberty OR D. Patient is a female with metastatic/inoperable breast cancer 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is less than 300 ng/dl or is below the testing laboratory s lower limit of the normal range if greater than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range 3. Patient does NOT have any FDA labeled contraindication(s) 4. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be 6 months for delayed puberty, 12 months for all other indications Updated 10/2014 NORTH CAROLINA Formulary 16

17 Prior Authorization Group Androgen Topical PA RODERM ROGEL Criteria for approval are ALL of the following: 1. Patient has ONE of the following diagnoses: A. Patient is a male or female with AIDS/HIV-associated wasting syndrome, defined as unexplained involuntary weight loss (greater than 10% baseline body weight) with obvious wasting OR body mass index less than 18.5 kg/m2 all other causes of weight loss have been ruled out OR B. Patient is a male with primary or secondary (hypogonadotropic) hypogonadism 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is less than 300 ng/dl or is below the testing laboratory s lower limit of the normal range if greater than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range 3. Patient does NOT have any FDA labeled contraindication(s) 4. ONE of the following: A. Patient will be receiving only one androgen or anabolic agent OR B. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 17

18 Prior Authorization Group Arcalyst PA ARCALYST Criteria for approval are ALL of the following: 1. Patient has been diagnosed with Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) 2. Patient does NOT have any FDA labeled contraindication(s) to therapy 3. Patient does not have an active or chronic infection (for example, tuberculosis, HIV, hepatitis B/C) 4. If patient has been previously treated with another IL-1 inhibitor (for example, Kineret [anakinra] or Ilaris) or a TNF-alpha blocking agent (for example, Enbrel [etanercept], Remicade [infliximab], Humira [adalimumab], Cimzia [certolizumab], Simponi [golimumab]) the agent will be discontinued before initiating Arcalyst. Patients must be 12 years of age or older Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 18

19 Prior Authorization Group Biologic Immunomodulators PA - Enbrel ENBREL Criteria for initial approval are ALL of the following: 1. Patient has a FDA labeled indication for the requested agent 2. ONE of the following: A. There is evidence of a claim within the past 90 days that the patient is currently being treated with the requested agent OR B. Prescriber states patient is using requested agent is at risk if therapy is changed OR C. Diagnosis is ankylosing spondylitis OR D. Diagnosis is rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, or psoriasis patient s medication history indicates use of one formulary conventional agent prerequisite OR E. Diagnosis is rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, or psoriasis patient has documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary conventional agents OR F. Patient s medication history indicates use of another biologic agent for an FDA labeled indication 3. Patient does not have any FDA labeled contraindications to therapy with the requested agent 4. Patient has been tested for latent TB if positive patient has begun therapy for latent TB 5. Patient is not currently being treated with another biologic immunomodulator Criteria for renewal approval are: 1. Patient has been previously approved for therapy through the plan's prior authorization process 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) 3. Patient does not have any FDA labeled contraindications to therapy with the requested agent 4. Patient is not currently being treated with another biologic immunomodulator Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 19

20 Formulary conventional agents for rheumatoid arthritis, juvenile idiopathic arthritis, or psoriatic arthritis include methotrexate, hydroxychloroquine, sulfasalazine, minocycline, or leflunomide Formulary conventional topical or systemic antipsoriatic agents include topical corticosteroids, tazarotene, cyclosporine, calcipotriene, methotrexate, and acitretin No formulary conventional agents are required for ankylosing spondylitis Updated 10/2014 NORTH CAROLINA Formulary 20

21 Prior Authorization Group Biologic Immunomodulators PA - Humira HUMIRA Criteria for initial approval are ALL of the following: 1. Patient has a FDA labeled indication for the requested agent 2. ONE of the following: A. There is evidence of a claim within the past 90 days that the patient is currently being treated with the requested agent OR B. Prescriber states patient is using requested agent is at risk if therapy is changed OR C. Diagnosis is ankylosing spondylitis OR D. Diagnosis is rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, ulcerative colitis, or Crohn s disease patient s medication history indicates use of one formulary conventional agent prerequisite OR E. Diagnosis is rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, ulcerative colitis, or Crohn s disease patient has documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary conventional agents OR F. Patient s medication history indicates use of another biologic agent for an FDA labeled indication 3. Patient does not have any FDA labeled contraindications to therapy with the requested agent 4. Patient has been tested for latent TB if positive patient has begun therapy for latent TB 5. Patient is not currently being treated with another biologic immunomodulator Criteria for renewal approval are: 1. Patient has been previously approved for therapy through the plan's prior authorization process 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) 3. Patient does not have any FDA labeled contraindications to therapy with the requested agent 4. Patient is not currently being treated with another biologic immunomodulator Approval will be 12 weeks for initial use for UC, 12 months for all others Updated 10/2014 NORTH CAROLINA Formulary 21

22 Formulary conventional agents for rheumatoid arthritis, juvenile idiopathic arthritis, or psoriatic arthritis include methotrexate, hydroxychloroquine, sulfasalazine, minocycline, or leflunomide Formulary conventional topical or systemic antipsoriatic agents include topical corticosteroids, tazarotene, cyclosporine, calcipotriene, methotrexate, and acitretin Formulary conventional agents for Crohn's disease include aminosalicylates, methotrexate, corticosteroids (budesonide EC), metronidazole, ciprofloxacin, cyclosporine, or immunomodulators such as 6-mercaptopurine or azathioprine No formulary conventional agents are required for ankylosing spondylitis Updated 10/2014 NORTH CAROLINA Formulary 22

23 Prior Authorization Group Biologic Immunomodulators PA - Kineret KINERET Criteria for initial approval are: 1. Patient (pt) has FDA labeled indication for requested agent 2. ONE of the following: A. There is evidence of a claim within the past 90 days that pt is currently being treated with requested agent OR B. Prescriber states pt is using requested agent is at risk if therapy is changed OR C. Pt s diagnosis is rheumatoid arthritis ONE of the following: i. Pt s medication history indicates use of BOTH preferred biologic agents (Humira and Enbrel) OR ii. Pt has documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH preferred biologic agents (Humira and Enbrel) OR D. Pt s diagnosis is Cryopyrin-Associated Periodic Syndrome (CAPS)/Neonatal-Onset Multisystem Inflammatory Disease (NOMID) 3. Pt does not have any FDA labeled contraindications to therapy 4. Pt has been tested for latent TB if positive has begun therapy for latent TB 5. Pt is not currently being treated with another biologic immunomodulator Criteria for renewal approval are: 1. Pt has been previously approved for therapy through the plan's prior authorization process 2. Pt has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) 3. Pt does not have any FDA labeled contraindications to therapy 4. Pt is not currently being treated with another biologic immunomodulator Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 23

24 Prior Authorization Group Biologic Immunomodulators PA - Remicade REMICADE Criteria for initial approval are: 1. Patient (pt) has FDA labeled indication for requested agent 2. ONE of the following: A. There is evidence of a claim within the past 90 days that pt is currently being treated with requested agent OR B. Prescriber states pt is using requested agent is at risk if therapy is changed OR C. ONE of the following: i. Pt s medication history indicates use of BOTH preferred biologic agents (Humira and Enbrel, Humira only for Crohn s Disease [CD] or Ulcerative Colitis [UC]) OR ii. Pt has documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH preferred biologic agents (Humira and Enbrel, Humira only for CD or UC) 3. Pt does not have any FDA labeled contraindications to therapy 4. Pt has been tested for latent TB if positive has begun therapy for latent TB 5. Pt is not currently being treated with another biologic immunomodulator Criteria for renewal approval are: 1. Pt has been previously approved for therapy through the plan's prior authorization process 2. Pt has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) 3. Pt does not have any FDA labeled contraindications to therapy 4. Pt is not currently being treated with another biologic immunomodulator Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 24

25 Prior Authorization Group Biologic Immunomodulators PA - Rituxan RITUXAN All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for initial approval include ONE of: 1. There is evidence of a claim within the past 180 days that patient (pt) is currently being treated with requested agent OR 2. Prescriber states pt is using requested agent OR 3. ALL of the following: A. ONE of: i. Diagnosis is Non-Hodgkin s lymphoma, chronic lymphocytic leukemia, Wegener s granulomatosis, or microscopic polyangiitis OR ii. Use of the target agent is for an indication that is supported by compendia or prescriber has submitted additional documentation supporting the requested therapeutic use OR iii. Diagnosis is rheumatoid arthritis ONE of: a. Pt s medication history indicates use of BOTH preferred biologic agents (Humira and Enbrel) OR b. Pt has documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH preferred agents (Humira and Enbrel) B. Pt does not have any FDA labeled contraindications to therapy with requested agent C. Pt has been tested for latent TB if positive pt has begun therapy for latent TB D. Pt has been screened for hepatitis B infection measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-hbc) and has begun therapy if appropriate prior to receiving Rituxan E. Pt is not currently being treated with another biologic immunomodulator Criteria for renewal approval are: 1. There is evidence of a claim within the past 180 days that pt is currently being treated with requested agent OR 2. Prescriber states pt is using requested agent OR 3. ALL of: A. Pt has been previously approved for therapy through the plan s PA process B. Pt has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) C. Pt does not have any FDA labeled contraindications to therapy with requested agent D. Pt is not currently being treated with another biologic immunomodulator Updated 10/2014 NORTH CAROLINA Formulary 25

26 Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 26

27 Prior Authorization Group bosentan PA TRACLEER Criteria for initial approval are ALL of the following: 1. Patient has a diagnosis of pulmonary arterial hypertension, WHO Group 1 as determined by right heart catheterization 2. The patient s NYHA functional class is II or greater 3. The patient s mean pulmonary arterial pressure is greater than 25 mm Hg 4. The patient has a pulmonary vascular resistance greater than 3 Wood units 5. The patient does not have any FDA labeled contraindications to therapy 6. Patient does not have elevated liver enzymes or a bilirubin level of greater than 2 times upper limit of normal (ULN) Criteria for renewal require BOTH of the following: 1. Patient has been previously approved for therapy through the plan s PA process and is responding to therapy 2. Patient does not have any FDA labeled contraindications to therapy Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 27

28 Prior Authorization Group buprenorphine PA buprenorphine Criteria for initial approval are ALL of the following: 1. Patient has a diagnosis of opioid dependence 2. Patient is compliant with all elements of treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) 3. Prescriber has confirmed that patient is not diverting requested medication, according to patient s records in the state s prescription drug monitoring program (PDMP), if applicable Criteria for renewal are ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's prior authorization process 2. Patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use) 3. Patient continues to be compliant with all elements of the treatment plan (including recoveryoriented activities, psychotherapy, and/or other psychosocial modalities) 4. Prescriber has confirmed that the patient is not diverting the requested medication, according to the patient s records in the state s prescription drug monitoring program (PDMP), if applicable 5. If patient is receiving any other opioid medication, prescriber has submitted information supporting medical necessity of opioid, including specific pain that current opioid is being used to treat and expected duration of therapy with opioid Patients must be 16 years of age or older Prescriber meets qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is qualified prescriber under the DATA to prescribe buprenorphine Approval will be for 6 months Updated 10/2014 NORTH CAROLINA Formulary 28

29 Prior Authorization Group buprenorphine-naloxone PA buprenorphine-naloxone SUBOXONE Criteria for initial approval are ALL of the following: 1. Patient has a diagnosis of opioid dependence 2. Patient is compliant with all elements of treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) 3. Prescriber has confirmed that patient is not diverting requested medication, according to patient s records in the state s prescription drug monitoring program (PDMP), if applicable Criteria for renewal are ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's prior authorization process 2. Patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use) 3. Patient continues to be compliant with all elements of the treatment plan (including recoveryoriented activities, psychotherapy, and/or other psychosocial modalities) 4. Prescriber has confirmed that the patient is not diverting the requested medication, according to the patient s records in the state s prescription drug monitoring program (PDMP), if applicable 5. If patient is receiving any other opioid medication, prescriber has submitted information supporting medical necessity of opioid, including specific pain that current opioid is being used to treat and expected duration of therapy with opioid Patients must be 16 years of age or older Prescriber meets qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is qualified prescriber under the DATA to prescribe buprenorphine/naloxone Approval will be for 6 months Updated 10/2014 NORTH CAROLINA Formulary 29

30 Prior Authorization Group Clonazepam PA clonazepam clonazepam odt Program applies to new starts only. Criteria for approval require ONE of: 1. There is evidence of a claim within the past 180 days that the patient is currently being treated with the requested agent OR 2. Prescriber states the patient is using the requested agent OR 3. Patient has a diagnosis of seizure disorder OR 4. Patient has a diagnosis of panic disorder and ONE of the following: A. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR 5. Prescriber has submitted documentation in support of the requested therapeutic use of the requested agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 30

31 Prior Authorization Group Clorazepate PA clorazepate Program applies to new starts only. Criteria for approval require ONE of: 1. There is evidence of a claim within the past 180 days that the patient is currently being treated with the requested agent OR 2. Prescriber states the patient is using the requested agent OR 3. Patient has a diagnosis of seizure disorder OR 4. Patient has a diagnosis of anxiety disorder and ONE of the following: A. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR 5. Patient has a diagnosis of alcohol withdrawal OR 6. Prescriber has submitted documentation in support of the requested therapeutic use of the requested agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 31

32 Prior Authorization Group Diazepam PA DIAZEPAM conc, soln diazepam tablet Program applies to new starts only. Criteria for approval require ONE of: 1. There is evidence of a claim within the past 180 days that the patient is currently being treated with the requested agent OR 2. Prescriber states the patient is using the requested agent OR 3. Patient has a diagnosis of seizure disorder OR 4. Patient has a diagnosis of anxiety disorder and ONE of the following: A. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR 5. Patient has a diagnosis of skeletal muscle spasms OR 6. Patient has a diagnosis of alcohol withdrawal OR 7. Prescriber has submitted documentation in support of the requested therapeutic use of the requested agent Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 32

33 Prior Authorization Group Egrifta PA EGRIFTA Criteria for initial approval are ALL the following: 1. Patient has a diagnosis of HIV infection 2. Patient has lipodystrophy defined for men as waist circumference of 95 cm [37.4 inches] or greater and waist-to-hip ratio of 0.94 or greater OR for women as waist circumference of 94 cm [37.0 inches] or greater and waist-to-hip ratio of 0.88 or greater 3. Patient has a CD4 cell count greater than 100 cells/mm3 and a viral load less than 10,000 copies/ml 4. Patient is currently on anti-retroviral therapy (ART) 5. Patient has a BMI greater than 20 kg/m2 6. Patient does not have any FDA labeled contraindications 7. Patient is not planning to become pregnant or currently breastfeeding 8. Patient does not have a diagnosis of diabetes mellitus or a fasting blood glucose of greater than 150 mg/dl 9. Patient is not currently being treated with growth hormone(gh), GH secretagogues, GHreleasing hormone/gh-releasing factor products, insulin-like growth factor (IGF)-1, or IGF-binding protein-3 Criteria for renewal are ALL the following: 1. Patient has been approved for Egrifta previously through the plan s PA process 2. The patient has had and/or maintained an 8% decrease in visceral adipose tissue (VAT) from baseline or maintained or decreased waist circumference 3. The patient has a CD4 cell count greater than 100 cells/mm3 and a viral load less than 10,000 copies/ml 4. Patient is currently on ART 5. Patient has a BMI greater than20 kg/m2 6. Patient does not have any FDA labeled contraindications 7. Patient is not planning to become pregnant or currently breastfeeding 8. Patient does not have a diagnosis of diabetes mellitus or a fasting blood glucose of greater than 150 mg/dl 9. Patient is not currently being treated with GH, GH secretagogues, GH-releasing hormone/ghreleasing factor products, IGF-1, or IGF-binding protein-3 Patient must be between 18 and 65 yrs of age Initial approval 6 months. Renewal approval 12 months Updated 10/2014 NORTH CAROLINA Formulary 33

34 Prior Authorization Group Erythropoietin Stimulating Agents PA - Aranesp ARANESP Criteria for approval are ALL of: 1. ONE of: A. Erythropoietin Stimulating Agent (ESA) is prescribed to reduce the possibility of allogeneic blood transfusion in a surgery patient (pt) patient s (pt s) hemoglobin level is greater than 10 g/dl but less than or equal to 13 g/dl OR B. ESA is prescribed for anemia due to myelosuppressive chemotherapy for a non-myeloid malignancy ALL of: i. Pt s hemoglobin level is less than 10 g/dl for pts initiating ESA therapy or stabilized on therapy (measured within the previous 4 weeks) ii. Pt is being concurrently treated with chemotherapy, with or without radiation (treatment period extends to 8 weeks post chemotherapy) iii. Intent of chemotherapy is non-curative OR C. ESA is prescribed for a pt with anemia associated with chronic renal failure in a pt NOT on dialysis pt s hemoglobin level is less than 10 g/dl for pts initiating ESA therapy or stabilized on therapy (measured within the previous 4 weeks) BOTH of: i. Rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion ii. Goal is to reduce risk of alloimmunization and/or other RBC transfusion related risks OR D. ESA is prescribed for a pt with anemia due to myelodysplastic syndrome pt s hemoglobin level is less than 12 g/dl for pts initiating ESA therapy or less than or equal to 12 g/dl for pts stabilized on therapy (measured within the previous four weeks) OR E. ESA is prescribed for another indication BOTH of: i. There is clinical evidence supporting therapy with an ESA for intended use or prescriber has submitted documentation in support of requested therapeutic use for requested agent ii. Pt s hemoglobin level is less than 12 g/dl for pts initiating ESA therapy or less than or equal to 12 g/dl for pts stabilized on therapy (measured within the previous 4 weeks) 2. Pt does not have any FDA labeled contraindications to therapy 1 month for surgery (reduce transfusion possibility), 6 months for chemo, 12 months for other Drug is also subject to Part B versus Part D review. Updated 10/2014 NORTH CAROLINA Formulary 34

35 Prior Authorization Group Erythropoietin Stimulating Agents PA - Epogen/Procrit EPOGEN PROCRIT Criteria for approval are ALL of: 1. ONE of: A. Erythropoietin Stimulating Agent (ESA) is prescribed to reduce the possibility of allogeneic blood transfusion in a surgery patient (pt) patient s (pt s) hemoglobin level is greater than 10 g/dl but less than or equal to 13 g/dl OR B. ESA is prescribed for anemia due to myelosuppressive chemotherapy for a nonmyeloid malignancy ALL of: i. Pt s hemoglobin level is less than 10 g/dl for pts initiating ESA therapy or stabilized on therapy (measured within the previous 4 weeks) ii. Pt is being concurrently treated with chemotherapy, with or without radiation (treatment period extends to 8 weeks post chemotherapy) iii. Intent of chemotherapy is non-curative OR C. ESA is prescribed for a pt with anemia associated with chronic renal failure in a pt NOT on dialysis pt s hemoglobin level is less than 10 g/dl for pts initiating ESA therapy or stabilized on therapy (measured within the previous 4 weeks) BOTH of: i. Rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion ii. Goal is to reduce risk of alloimmunization and/or other RBC transfusion related risks OR D. ESA is prescribed for a pt with anemia due to myelodysplastic syndrome or a pt with anemia resulting from zidovudine treatment of HIV infection pt s hemoglobin level is less than 12 g/dl for pts initiating ESA therapy or less than or equal to 12 g/dl for pts stabilized on therapy (measured within the previous four weeks) OR E. ESA is prescribed for another indication BOTH of: i. There is clinical evidence supporting therapy with an ESA for intended use or prescriber has submitted documentation in support of requested therapeutic use for requested agent ii. Pt s hemoglobin level is less than 12 g/dl for pts initiating ESA therapy or less than or equal to 12 g/dl for pts stabilized on therapy (measured within the previous 4 weeks) 2. Pt does not have any FDA labeled contraindications to therapy 1 month for surgery (reduce transfusion possibility), 6 months for chemo, 12 months for other Updated 10/2014 NORTH CAROLINA Formulary 35

36 Drug is also subject to Part B versus Part D review. Updated 10/2014 NORTH CAROLINA Formulary 36

37 Prior Authorization Group fentanyl Nasal PA LAZA All medically accepted indications not otherwise excluded from Part D. Criteria for approval are ALL of the following: 1. One of the following: a. ALL of the following: i. Patient has a diagnosis of chronic cancer pain due to an active malignancy ii. There is evidence of a claim within the past 90 days that the patient is currently taking a long-acting opioid concurrently with the nasal fentanyl OR b. Patient has a diagnosis that is a CMS-approved compendia accepted indication for the requested medication 2. Patient is receiving only one oral or nasal fentanyl agent in one strength Patients must be 18 years of age or older Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 37

38 Prior Authorization Group fentanyl Oral PA - lozenge fentanyl oral lozenge All medically accepted indications not otherwise excluded from Part D. Criteria for approval are ALL of the following: 1. One of the following: a. ALL of the following: i. Patient has a diagnosis of chronic cancer pain due to an active malignancy ii. There is evidence of a claim within the past 90 days that the patient is currently taking a long-acting opioid concurrently with the oral fentanyl OR b. Patient has a diagnosis that is a CMS-approved compendia accepted indication for the requested medication 2. Patient is receiving only one oral or nasal fentanyl agent in one strength Patients must be 16 years of age or older Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 38

39 Prior Authorization Group fentanyl Oral PA - Subsys SUBSYS All medically accepted indications not otherwise excluded from Part D. Criteria for approval are ALL of the following: 1. One of the following: a. ALL of the following: i. Patient has a diagnosis of chronic cancer pain due to an active malignancy ii. There is evidence of a claim within the past 90 days that the patient is currently taking a long-acting opioid concurrently with the oral fentanyl OR b. Patient has a diagnosis that is a CMS-approved compendia accepted indication for the requested medication 2. Patient is receiving only one oral or nasal fentanyl agent in one strength Patients must be 18 years of age or older Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 39

40 Prior Authorization Group Forteo PA FORTEO Criteria for approval are ALL of the following: 1. Patient has a diagnosis of osteoporosis defined as ONE of the following: A. Patient has severe osteoporosis with a very low BMD defined as a T-score that is 3.5 or lower (3.5 or more standard deviations below the mean (BMD) value for a young adult) OR B. Patient has a history of vertebral fracture(s) or low trauma or fragility fracture(s) [e.g., prior fracture from minor trauma such as falling from standing height or less] within the past 5 years OR C. Patient has a T-score that is 2.5 or lower (2.5 or more SD below the mean BMD value for a young adult) ONE of the following: i. Patient s medication history includes a first-line agent (bisphosphonate or SERM for women, bisphosphonate for men) OR ii. Patient has documented intolerance, FDA labeled contraindication, or hypersensitivity to SERM or bisphosphonate (bisphosphonate only if male) 2. The patient does NOT have any FDA labeled contraindication(s) 3. The patient does not have any of the following conditions where Forteo should not be used: Paget s disease of bone, Unexplained elevations of alkaline phosphatase, Open epiphyses (i.e., pediatric or young adult patient), Prior radiation therapy involving the skeleton, History of skeletal malignancy, Bone metastases, Metabolic bone disease other than osteoporosis, Pre-existing hypercalcemia 4. Patient is not receiving concomitant bisphosphonate, SERM, or Prolia (denosumab) therapy 5. Total duration of treatment with Forteo has not exceeded 2 years 6. Dose requested is within FDA approved labeling No prior Forteo use approve 2 yrs, Prior Forteo use approve remainder of 2 yrs of total therapy Updated 10/2014 NORTH CAROLINA Formulary 40

41 Prior Authorization Group Gattex PA GATTEX Criteria for initial approval are ALL of the following: 1. Patient has a diagnosis of short bowel syndrome (SBS) 2. Patient is currently receiving parenteral nutrition (PN) or intravenous fluids (IV) at least 3 days per week 3. Patient has had a colonoscopy with any polyps removed within the last 6 months 4. Patient does not have any FDA labeled contraindications to therapy Criteria for renewal are ALL of the following: 1. Patient has been previously approved through the plan s PA process 2. Patient has had at least a 20% reduction from baseline in PN or IV fluids 3. Patient does not have any FDA labeled contraindications to therapy Initial approval 6 months. Renewal approval 12 months Updated 10/2014 NORTH CAROLINA Formulary 41

42 Prior Authorization Group Growth Hormone PA OMNITROPE All medically accepted indications not otherwise excluded from Part D. Criteria for approval of initial Growth Hormone (GH) for children are: 1. ONE of the following: A. Patient (Pt) is neonate less than or equal to 4 months of age with hypoglycemia in absence of metabolic disorder GH level is less than 20 ng/ml OR B. Diagnosis (Dx) is Turner Syndrome, Prader-Willi Syndrome, Noonan Syndrome, or SHOX gene deficiency OR C. Pt has deficiencies in 3 or more pituitary axes (panhypopituitarism) serum IGF-I levels below the age- and sex-appropriate reference range when off GH therapy OR D. Dx is chronic renal insufficiency BOTH: i. Pt height (ht) is more than 2 standard deviations (SD) below mean (less than 3rd percentile) compared to same age normal children ii. Other growth retardation etiologies have been ruled out OR E. Dx is GH deficiency, short stature (SS), or other BOTH: i. Pt has ONE of: a) Ht more than 2 SD below the mean for age and sex OR b) Ht more than 1.5 SD below the midparental ht OR c) A decrease in ht SD of more than 0.5 over one year in children greater than 2 years of age OR d) Ht velocity more than 2 SD below mean over 1 yr or more than 1.5 SD sustained over 2 yrs ii. Pt has failed at least 2 GH stimulation tests 2. Pt does NOT have any FDA labeled contraindication(s) to therapy Criteria for approval of renewal GH for children are: 1. Pt has been approved for GH previously through the plan's PA process 2. ALL of the following: i. Pt doesn t have closed epiphysis and ii. Pt is being monitored for GH therapy side effects and iii. Pt ht has increased or ht velocity has improved since initiation or last renewal of GH 3. Pt does NOT have any FDA labeled contraindications to therapy Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 42

43 Criteria for approval of initial Growth Hormone (GH) for adults are: 1. ONE of the following: A. Diagnosis is childhood GH deficiency (GHD) with genetic/organic origin ONE of the following: i. Pt has low IGF-1 level without GH replacement OR ii. Pt failed at least 1 GH stim test as adult OR B. Diagnosis is acquired adult GHD secondary to structural lesions/trauma ONE of the following: i. Pt deficient in 3 or more pituitary hormones and pt s IGF-1 level is low OR ii. Pt failed at least 1 GH stimulation test as adult OR C. Other diagnosis (e.g., childhood or adult-onset idiopathic GHD) and pt failed at least 2 GH stimulation tests as adult 2. Pt does NOT have any FDA labeled contraindications to therapy Criteria for approval of renewal (GH) for adults are ALL of: 1. Pt has been approved for GH previously through the plan's PA process 2. ALL of the following: A. Pt has been evaluated for development of adverse events due to GH therapy B. Prescriber evaluated pt s serum insulin-like growth factor-1 to confirm appropriateness of current dose C. GH therapy has shown benefits to pt in any of the following response parameters: body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life 3. Pt does NOT have any FDA labeled contraindications to therapy Updated 10/2014 NORTH CAROLINA Formulary 43

44 Prior Authorization Group HAE PA- Cinryze CINRYZE All FDA-approved indications not otherwise excluded from Part D, plus the off-label use for acute attacks. Criteria for initial approval are ALL of: 1. Patient does not have any FDA labeled contraindications to therapy 2. Patient has a diagnosis of hereditary angioedema (HAE) which has been diagnosed with measurement of C1-INH antigenic level, C1-INH functional level, and C4 level as follows: a. Type I HAE: 2 separate measurements indicating decreased quantities of C4 and C1- INH OR b. Type II HAE: 2 separate measurements indicating decreased quantities of C4 and decreased C1-INH function (C1-INH protein level may be normal) OR c. Type III HAE: Normal levels of C4 and C1-INH (at baseline and during an attack) ONE of: i. Family history of angioedema treatment with high dose antihistamine therapy was not effective OR ii. Patient demonstrates a Factor XII mutation associated with HAE 3. Medications known to cause angioedema have been evaluated and discontinued when appropriate 4. ONE of: a. Requested agent will be used to treat HAE acute attacks OR b. Requested agent will be used for prophylaxis against HAE attacks BOTH of: i. Patient has a history of at least 2 acute attacks per month OR 2 severe attacks (laryngeal or abdominal attacks) per year OR for short-term prophylaxis if prior to medical, surgical, dental procedure ii. Patient has tried a formulary 17 alpha-alkylated androgen or antifibrinolytic agent OR has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a formulary 17 alpha-alkylated androgen or antifibrinolytic agent. Criteria for renewal approval are ALL of: 1. Patient has been previously approved for therapy through the plan's PA process 2. Patient has received benefit from use of the requested agent to prevent or treat HAE acute attacks 3. Patient does not have any FDA labeled contraindications to therapy Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 44

45 Updated 10/2014 NORTH CAROLINA Formulary 45

46 Prior Authorization Group HAE PA - Firazyr FIRAZYR Criteria for initial approval are ALL of the following: 1. Patient does not have any FDA labeled contraindications to therapy 2. Patient has a diagnosis of hereditary angioedema (HAE) which has been diagnosed with measurement of C1-INH antigenic level, C1-INH functional level, and C4 level as follows: a. Type I HAE: Two separate measurements indicating decreased quantities of C4 and C1-INH OR b. Type II HAE: Two separate measurements indicating decreased quantities of C4 and decreased C1-INH function (C1-INH protein level may be normal) OR c. Type III HAE: Normal levels of C4 and C1-INH (at baseline and during an attack) ONE of the following: i. Family history of angioedema treatment with high dose antihistamine therapy was not effective OR ii. Patient demonstrates a Factor XII mutation that is associated with the disease 3. Medications known to cause angioedema (i.e. ACE-Inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate 4. Requested agent will be used to treat HAE acute attacks Criteria for renewal are ALL of the following: 1. Patient has been previously approved for therapy through the plan s PA process 2. Patient has received benefit from use of the requested agent to treat HAE acute attacks 3. Patient does not have any FDA labeled contraindications to therapy Approval will be for 12 months Updated 10/2014 NORTH CAROLINA Formulary 46