REQUIRED MEDICAL INFORMATION

Transcription

1 ACTEMRA IV - OPTUMRX ACTEMRA 400 MG/20 ML VIAL, ACTEMRA 80 MG/4 ML VIAL All medically accepted indications not otherwise excluded from Part D. Rheumatoid Arthritis (RA) (Initial): Diagnosis of moderately to severely active RA (eg, swollen, tender joints with limited range of motion). Systemic Juvenile Idiopathic arthritis (SJIA) (Initial): Diagnosis of active SJIA (eg, fever, serositis, rash, arthritis). Polyarticular Juvenile Idiopathic Arthritis (PJIA) (Initial): Diagnosis of active PJIA (eg, swollen, tender joints with limited range of motion). Reauthorization for all indications: Documentation of positive clinical response to Actemra therapy. RA, SJIA, PJIA (Initial): Prescribed or recommended by a rheumatologist. All indications (initial, reauth): 12 months RA (initial): Failure, contraindication, or intolerance to one nonbiologic DMARD [eg, Rheumatrex/Trexall (MTX), Arava (leflunomide), Azulfidine (sulfasalazine)]. SJIA (initial): Failure, contraindication, or intolerance to NSAIDs or systemic glucocorticoid. PJIA (initial): Failure, contraindication, or intolerance to one of the following nonbiologic DMARDs: Arava (leflunomide) or Rheumatrex/Trexall (MTX). All indications (Initial and re-auth): Excluded if patient is receiving Actemra in combination with a Biologic Disease Modifying Antirheumatic Drug (DMARD) [eg, Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)]. PAGE 1 LAST UPDATED 11/2016

2 ACTHAR HP GEL PA H.P. ACTHAR All FDA-approved indications not otherwise excluded from Part D. Patient does not have an FDA contraindication to therapy Criteria for approval are ALL of the following: 1. ONE of the following: A. Diagnosis of infantile spasm OR B. Diagnosis of multiple sclerosis AND i. Patient is experiencing an acute exacerbation AND ii. If indicated, the patient is currently on a disease modifying drug (DMD) in the past 90 days (e.g. Aubagio, Avonex, Betaseron, Copaxone (glatiramer acetate), Extavia, Gilenya, Lemtrada, Novantrone (mitoxantrone), Plegridy, Rebif, Tecfidera, or Tysabri) to control disease progression OR has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a DMD AND iii. 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 AND 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 AND Patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy AND 2. The dose is within the FDA labeled dosing for the requested indication 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 PAGE 2 LAST UPDATED 11/2016

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4 ADCIRCA PA ADCIRCA All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient (pt) has an FDA labeled indication or an indication that is supported in CMS approved compendia for requested agent AND 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 AND is at risk if therapy is changed OR C. ALL of the following: i. Pt has a dx of pulmonary arterial hypertension (PAH), WHO Group 1 as determined by right heart catheterization AND ii. Pt's World Health Organization (WHO) functional class is II or greater AND iii. Pt's mean pulmonary arterial pressure is greater than 25 mm Hg AND iv. Pt has a pulmonary vascular resistance greater than 3 Wood units OR D. Pt has an indication that is supported in CMS approved compendia for requested agent AND 3. Pt is not concurrently taking an PDE-5 inhibitor (e.g. Cialis, Viagra) at the same time as requested agent AND 4. If PAH, ONE of the following: A. If requested agent will be utilized for add-on therapy to existing monotherapy, then ALL of the following: i. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND ii. Requested agent is in a different therapeutic class OR B. If requested agent will be utilized for add-on therapy to existing dual therapy, then ALL of the following: i. Pt is WHO functional class III or IV AND ii. A parenteral prostanoid has been started as one of the agents in the triple therapy unless the pt has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a parenteral prostanoid AND iii. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND iv. All three agents in the triple therapy are from a different therapeutic class Criteria for renewal require the following: 1. Pt has been previously approved for therapy through the plan's PA process and is responding to therapy PAGE 4 LAST UPDATED 11/2016

5 Approval will be for 12 months PAGE 5 LAST UPDATED 11/2016

6 ADEMPAS PA ADEMPAS All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient (pt) has an FDA labeled indication for requested agent AND 2. ONE of: 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 the pt is using requested agent AND is at risk if therapy is changed OR C. ALL of: i. Pt has a dx of CTEPH, WHO Group 4 as determined by TWO of the following: a) Ventilation-perfusion scanning OR b) Pulmonary angiography OR c) Spiral computed tomography OR d) Magnetic resonance angiography AND ii. ONE of: a) Pt is NOT a candidate for surgery OR b) Pt has had pulmonary endarterectomy AND has persistent or recurrent disease AND iii. BOTH of: a) Pt has a mean pulmonary artery pressure of greater than 25 mm Hg AND b) Pt has a vascular resistance of more than 300 dyn/sec/cm-5 OR D. ALL of: i. Pt has a dx of PAH, WHO Group 1 as determined by right heart catheterization AND ii. Pt's WHO functional class is II or greater AND iii. Pt has a mean pulmonary artery pressure of greater than 25 mm Hg AND iv. Pt has a vascular resistance of more than 300 dyn/sec/cm-5 AND 3. If requested agent will be utilized for add-on therapy to existing monotherapy, then ALL of the following: A. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND B. Requested agent is in a different therapeutic class AND 4. If requested agent will be utilized for add-on therapy to existing dual therapy, then ALL of the following: A. Pt is WHO functional class III or IV AND B. A parenteral prostanoid has been started as one of the agents in the triple therapy unless the pt has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a parenteral prostanoid AND C. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND D. All three agents in the triple therapy are from a different therapeutic class PAGE 6 LAST UPDATED 11/2016

7 Approval will be for 12 months Criteria for renewal are ALL of the following: 1. Pt has been previously approved for therapy through the plan's PA process and is responding to therapy AND 2. ONE of the following: A. Pt has shown improvement from baseline in the 6-minute walk distance OR B. Pt has a stable 6-minute walk distance AND improvement in at least ONE of the following: i. pulmonary vascular resistance OR ii. WHO functional class OR iii. Borg dyspnea score PAGE 7 LAST UPDATED 11/2016

8 ALECENSA ALECENSA All medically accepted indications not otherwise excluded from Part D. Metastatic non-small cell lung cancer: Diagnosis of metastatic non-small cell lung cancer. Patient has anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility. Patient had an inadequate response, progressed on, or had an intolerance or contraindication to XALKORI (crizotinib) Prescribed by or in consultation with an oncologist 12 months Approve for continuation of therapy. PAGE 8 LAST UPDATED 11/2016

9 AMITIZA PA AMITIZA All FDA-approved indications not otherwise excluded from Part D. Patient does not have any FDA labeled contraindication(s) to therapy 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 AND BOTH of the following: i. Patient has chronic use of an opioid agent in the past 90 days AND ii. Patient is not receiving a diphenylheptane opioid (e.g. methadone) in the past 90 days AND 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 3350 Patient must be an adult at least 18 yrs of age Approval will be for 12 months PAGE 9 LAST UPDATED 11/2016

10 AMPYRA PA AMPYRA All FDA-approved indications not otherwise excluded from Part D. Patient does not have any FDA labeled contraindication(s) to therapy Criteria for approval require ONE of the following: A. ALL of the following: i. Patient has a diagnosis of multiple sclerosis (MS) AND ii. If the patient has relapsing form of MS, ONE of the following: a. Patient is receiving concurrent therapy with a disease modifying agent (e.g. Aubagio, Avonex, Betaseron, Copaxone (glatiramer), Extavia, Gilenya, Lemtrada, Novantrone (mitoxantrone), Plegridy, Rebif, Tecfidera, or Tysabri) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a disease modifying agent AND iii. There is documentation of significant limitations of instrumental activities of daily living attributable to slow ambulation AND iv. ONE of the following: a. Patient is ambulatory with a baseline timed 25 foot walk between 8 to 45 seconds OR b. Patient has a baseline expanded disability status scale (EDSS) of greater than or equal to 4.5 but less than 7 AND v. 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 AND has demonstrated an improvement from baseline in timed walking speed (timed 25 foot walk) OR c. Patient has a documented stabilization or improvement of their baseline EDSS score (must be less than 7) OR B. Patient has a diagnosis of another FDA approved indication for the requested agent The prescriber is a neurologist or has consulted a neurologist Initial approval 3 months for MS and 12 months for all others, 12 months for renewal PAGE 10 LAST UPDATED 11/2016

11 ANABOLIC STEROID PA - DANAZOL DANAZOL 100 MG CAPSULE, DANAZOL 200 MG CAPSULE, DANAZOL 50 MG CAPSULE All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Criteria for approval are ALL of the following: 1. ONE of the following: a. Patient has an FDA labeled indication for the requested agent OR b. Patient has an indication that is supported in CMS approved compendia for the requested agent AND 2. 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 PAGE 11 LAST UPDATED 11/2016

12 ANABOLIC STEROID PA - OXANDROLONE OXANDROLONE 10 MG TABLET, OXANDROLONE 2.5 MG TABLET All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) 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) AND all other causes of weight loss have been ruled out OR B. Patient is a female child or adolescent with Turner syndrome AND 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 AND 2. 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 PAGE 12 LAST UPDATED 11/2016

13 ANABOLIC STEROID PA - OXYMETHOLONE ANADROL-50 All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) 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 AND ONE of the following: i. Patient's medication history indicates previous use of an erythropoiesis-stimulating agent OR ii. Patient has documented intolerance, FDA labeled contraindication or hypersensitivity to an erythropoiesisstimulating agent AND 2. Patient has a hematocrit (Hct) value less than 30% AND 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 PAGE 13 LAST UPDATED 11/2016

14 ANDROGEN INJECTABLE PA TESTOSTERON CYP 1,000 MG/10 ML, TESTOSTERON CYP 2,000 MG/10 ML, TESTOSTERONE CYP 100 MG/ML, TESTOSTERONE CYP 200 MG/ML, TESTOSTERON ENAN 1,000 MG/5 ML, TESTOSTERONE ENAN 200 MG/ML All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) 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 AND 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 AND 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 AND 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 6 months for delayed puberty, 12 months for all other indications PAGE 14 LAST UPDATED 11/2016

15 ANDROGEN ORAL PA ANDROID All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) 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 AND 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 AND 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 6 months for delayed puberty, 12 months for all other indications PAGE 15 LAST UPDATED 11/2016

16 ANDROGEN TOPICAL PA ANDRODERM, ANDROGEL, AXIRON All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) 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 AND all other causes of weight loss have been ruled out OR B. Patient is a male with primary or secondary (hypogonadotropic) hypogonadism AND 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 AND 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 PAGE 16 LAST UPDATED 11/2016

17 ANTIPSYCHOTICS PA ABILIFY DISCMELT 10 MG TABLET, ABILIFY MAINTENA, ARIPIPRAZOLE 10 MG TABLET, ARIPIPRAZOLE 15 MG TABLET, ARIPIPRAZOLE 2 MG TABLET, ARIPIPRAZOLE 20 MG TABLET, ARIPIPRAZOLE 30 MG TABLET, ARIPIPRAZOLE 5 MG TABLET, CHLORPROMAZINE 10 MG TABLET, CHLORPROMAZINE 100 MG TABLET, CHLORPROMAZINE 200 MG TABLET, CHLORPROMAZINE 25 MG TABLET, CHLORPROMAZINE 25 MG/ML AMP, CHLORPROMAZINE 50 MG TABLET, CLOZAPINE, FANAPT, FAZACLO, FLUPHENAZINE DEC 125 MG/5 ML, FLUPHENAZINE DEC 25 MG/ML VIAL, FLUPHENAZINE HCL, GEODON 20 MG/ML VIAL, HALOPERIDOL 0.5 MG TABLET, HALOPERIDOL 1 MG TABLET, HALOPERIDOL 10 MG TABLET, HALOPERIDOL 2 MG TABLET, HALOPERIDOL 20 MG TABLET, HALOPERIDOL 5 MG TABLET, HALOPERIDOL 5 MG/ML AMPUL, HALOPERIDOL DEC 100 MG/ML VIAL, HALOPERIDOL DEC 50 MG/ML VIAL, HALOPERIDOL DECAN 50 MG/ML AMP, HALOPERIDOL DECANOATE 100, HALOPERIDOL LACTATE, INVEGA, INVEGA SUSTENNA, INVEGA TRINZA, LATUDA, LOXAPINE, OLANZAPINE, OLANZAPINE ODT, PERPHENAZINE 16 MG TABLET, PERPHENAZINE 2 MG TABLET, PERPHENAZINE 4 MG TABLET, PERPHENAZINE 8 MG TABLET, QUETIAPINE FUMARATE, RISPERDAL CONSTA, RISPERIDONE, RISPERIDONE ODT, SAPHRIS, SEROQUEL XR 150 MG TABLET, SEROQUEL XR 200 MG TABLET, SEROQUEL XR 300 MG TABLET, SEROQUEL XR 400 MG TABLET, SEROQUEL XR 50 MG TABLET, THIOTHIXENE, TRIFLUOPERAZINE HCL, VERSACLOZ, VRAYLAR 1.5 MG CAPSULE, VRAYLAR 3 MG CAPSULE, VRAYLAR 4.5 MG CAPSULE, VRAYLAR 6 MG CAPSULE, ZIPRASIDONE HCL, ZYPREXA RELPREVV All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. PA does NOT apply to patients less than 65 yrs of age. Criteria for approval require ONE of the following: A. There is evidence of a claim within the past 180 days that the patient is currently being treated with the requested agent OR B. Prescriber states the patient is using the requested agent OR C. ALL of the following: i. ONE of the following: a. Patient has an FDA labeled indication for the requested agent OR b. Patient has an indication that is supported in CMS approved compendia for the requested agent AND ii. If dementia-related psychosis, ALL of the following: a. Dementia-related psychosis is determined to be severe or the associated agitation, combativeness, or violent PAGE behavior 17 puts the patient or others in danger AND b. Non-pharmacologic LAST UPDATED interventions 11/2016 [for

18 example, behavioral management for depression, music therapy, controlled multisensory stimulation, or education programs for caregivers and staff] have been tried and found inadequate for treatment of dementia-related psychosis AND c. Prescriber has documented that s/he has discussed the risk of increased mortality with the patient and/or the patient's surrogate decision maker Approval authorizations will apply to the requested medication only. Approval will be for 12 months PAGE 18 LAST UPDATED 11/2016

19 ARCALYST PA ARCALYST All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy AND Patient does not have an active or chronic infection (for example, tuberculosis, HIV, hepatitis B/C) 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) AND 2. 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 PAGE 19 LAST UPDATED 11/2016

20 ARMODAFINIL PA ARMODAFINIL, NUVIGIL All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for approval are ALL of the following: 1. ONE of the following: A. Patient has an FDA labeled indication for the requested agent OR B. Patient has an indication that is supported in CMS approved compendia for the requested agent AND 2. Patient is receiving only one of the listed agents - Nuvigil/armodafinil OR Provigil/modafinil Patients must be 17 years of age or older Approval will be for 12 months PAGE 20 LAST UPDATED 11/2016

21 BENLYSTA PA BENLYSTA All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Criteria for initial approval are ALL of the following: 1. ONE of the following: A. ALL of the following: i. Patient has a diagnosis of active systemic lupus erythematosus (SLE) disease AND ii. BOTH of the following: a. Patient has positive autoantibody test results [positive antinuclear antibody (ANA greater than or equal to 1:80) and/or anti-dsdna (greater than or equal to 30 IU/mL)] AND b. Patient has a SELENA-SLEDAI score of greater than or equal to 6 at baseline AND iii. ONE of the following: a. Patient is currently on a standard of care SLE treatment regimen comprised of at least one of the following: corticosteroids (e.g. methylprednisolone, prednisone), antimalarials (e.g. hydroxychloroquine, chloroquine), prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g. ibuprofen, naproxen), and/or immunosuppressives (e.g. azathioprine, methotrexate, cyclosporine, oral cyclophosphamide, or mycophenolate) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to any standard of care drug classes listed above OR B. Patient has another FDA labeled diagnosis AND 2. Patient is NOT currently treated with intravenous cyclophosphamide (previous 30 days) AND 3. Patient is NOT currently using another biologic agent (previous 30 days) Approval will be for 12 months Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's PA process AND 2. If SLE, then BOTH of the following: A. ONE of PAGE 21 LAST UPDATED 11/2016

22 the following: i. Patient is currently on a standard of care SLE treatment regimen comprised of at least one of the following: corticosteroids (e.g. methylprednisolone, prednisone), antimalarials (e.g. hydroxychloroquine, chloroquine), prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g. ibuprofen, naproxen), and/or immunosuppressives (e.g. azathioprine, methotrexate, cyclosporine, oral cyclophosphamide, or mycophenolate) OR ii. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to any the standard of care drug classes listed above AND B. Patient has had a greater than or equal to 4 point reduction from the baseline SELENA-SLEDAI score AND 3. Patient is NOT currently treated with intravenous cyclophosphamide (previous 30 days) AND 4. Patient is NOT currently using another biologic agent (previous 30 days) PAGE 22 LAST UPDATED 11/2016

23 BIOLOGIC IMMUNOMODULATORS PA - ENBREL ENBREL All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 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 the patient is using the requested agent AND is at risk if therapy is changed OR c. Patient's medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR d. Patient's diagnosis does NOT require a conventional agent prerequisite OR e. Patient's medication history indicates use of ONE formulary conventional agent prerequisite OR f. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for therapy through the plan's prior authorization process AND 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 3. Patient is NOT currently being treated with another biologic immunomodulator Approval will be for 12 months Formulary conventional agent required for diagnoses of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, or psoriasis Diagnosis of ankylosing spondylitis does NOT require formulary PAGE 23 LAST UPDATED 11/2016

24 conventional therapy 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, or acitretin PAGE 24 LAST UPDATED 11/2016

25 BIOLOGIC IMMUNOMODULATORS PA - HUMIRA HUMIRA, HUMIRA PEN, HUMIRA PEN PSORIASIS-UVEITIS All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 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 the patient is using the requested agent AND is at risk if therapy is changed OR c. Patient's medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR d. Patient's diagnosis does NOT require a conventional agent prerequisite OR e. Patient's medication history indicates use of ONE formulary conventional agent prerequisite OR f. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for therapy through the plan's prior authorization process AND 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 3. Patient is NOT currently being treated with another biologic immunomodulator Approval will be 12 weeks for initial use for ulcerative colitis, 12 months for all others Formulary conventional agent required for diagnoses of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, ulcerative colitis, or crohn's disease Diagnosis of ankylosing PAGE 25 LAST UPDATED 11/2016

26 spondylitis does NOT require formulary conventional therapy 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, or acitretin Formulary conventional agents for crohn's disease or ulcerative colitis include methotrexate aminosalicylates, corticosteroids, cyclosporine, azathioprine, 6-mercaptopurine, metronidazole, or ciprofloxacin PAGE 26 LAST UPDATED 11/2016

27 BIOLOGIC IMMUNOMODULATORS PA - KINERET KINERET All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 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 the patient is using the requested agent AND is at risk if therapy is changed OR c. ONE of the following: i. Patient's medication history indicates use of TWO of the preferred biologic immunomodulator agents (Enbrel and Humira) or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to TWO of the preferred biologic agents OR ii. The request is for an FDA labeled indication that is not covered by TWO of the preferred biologic agents AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for therapy through the plan's prior authorization process AND 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 3. Patient is NOT currently being treated with another biologic immunomodulator Approval will be for 12 months Use of TWO of the preferred biologics (Humira and Enbrel) are required for diagnoses of rheumatoid arthritis NO prerequisites are required for diagnosis of Cryopyrin-Associated Periodic Syndromes PAGE 27 LAST UPDATED 11/2016

28 (CAPS)/Neonatal-Onset Multisystem Inflammatory Disease (NOMID) PAGE 28 LAST UPDATED 11/2016

29 BIOLOGIC IMMUNOMODULATORS PA - REMICADE REMICADE All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 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 the patient is using the requested agent AND is at risk if therapy is changed OR c. ONE of the following: i. Patient's medication history indicates use of TWO of the preferred biologic immunomodulator agents (Enbrel, Humira or Stelara) or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to TWO of the preferred biologic agents OR ii. Patient's diagnosis is indicated in only ONE of the preferred biologic immunomodulators or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to this preferred agent AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for therapy through the plan's prior authorization process AND 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 3. Patient is NOT currently being treated with another biologic immunomodulator Approval will be for 12 months Use of TWO of the preferred biologics (Humira and Enbrel) are required for diagnoses of rheumatoid PAGE 29 LAST UPDATED 11/2016

30 arthritis or ankylosing spondylitis Use of TWO of the preferred biologics (Humira, Enbrel or Stelara) are required for diagnoses of psoriasis or psoriatic arthritis Only the preferred biologic Humira is required for diagnoses of ulcerative colitis or crohn's disease PAGE 30 LAST UPDATED 11/2016

31 BIOLOGIC IMMUNOMODULATORS PA - RITUXAN RITUXAN All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for initial approval include ONE of the following: 1. There is evidence of a claim within the past 180 days that the patient (pt) is currently being treated with the requested agent OR 2. Prescriber states the pt is using the requested agent OR 3. ALL of the following: a. ONE of the following: i. Pt has an FDA labeled indication for the requested agent OR ii. Pt has an indication that is supported in CMS approved compendia for the requested agent AND b. ONE of the following: i. Pt has a diagnosis of rheumatoid arthritis and the pt's medication history indicates use of BOTH preferred biologic immunomodulators, Enbrel and Humira OR ii. Pt has a diagnosis of rheumatoid arthritis and the pt has a documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH preferred agents, Humira and Enbrel OR iii. Pt has any other diagnosis AND c. Pt does NOT have any FDA labeled contraindication(s) to therapy with the requested agent AND d. Pt has been tested for latent TB AND if positive the pt has begun therapy for latent TB AND e. 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 AND f. 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 the pt is currently being treated with the requested agent OR 2. Prescriber states the pt is using the requested agent OR 3. ALL of the following: a. Pt has been previously approved for therapy through the plan's PA process AND b. Pt has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND c. Pt does NOT have any FDA labeled contraindication(s) to therapy with the requested agent AND d. Pt is NOT currently being treated with another biologic immunomodulator PAGE 31 LAST UPDATED 11/2016

32 Approval will be for 12 months PAGE 32 LAST UPDATED 11/2016

33 BIOLOGIC IMMUNOMODULATORS PA - STELARA STELARA 45 MG/0.5 ML SYRINGE, STELARA 90 MG/ML SYRINGE All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 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 the patient is using the requested agent AND is at risk if therapy is changed OR c. Patient's medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR d. Patient's medication history indicates use of ONE formulary conventional agent prerequisite OR e. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval are ALL of the following: 1. Patient has been previously approved for therapy through the plan's prior authorization process AND 2. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 3. Patient is NOT currently being treated with another biologic immunomodulator Approval will be for 12 months Formulary conventional agent required for diagnoses of psoriatic arthritis or psoriasis Formulary conventional agents for psoriatic arthritis include methotrexate, hydroxychloroquine, sulfasalazine, minocycline, or leflunomide Formulary conventional topical or systemic antipsoriatic agents include PAGE 33 LAST UPDATED 11/2016

34 topical corticosteroids, tazarotene, cyclosporine, calcipotriene, methotrexate, or acitretin PAGE 34 LAST UPDATED 11/2016

35 BOSENTAN PA TRACLEER All FDA-approved indications not otherwise excluded from Part D. Patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent AND Patient does NOT have elevated liver enzymes or a bilirubin level of greater than or equal to 2 times ULN (upper limit of normal) Criteria for initial approval are ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 2. ONE of the following: A. There is evidence of a claim within the past 90 days that patient is currently being treated with the requested agent OR B. Prescriber states the patient is using the requested agent AND is at risk if therapy is changed OR C. ALL of the following: i. Patient has a diagnosis of pulmonary arterial hypertension (PAH), WHO Group 1 as determined by right heart catheterization AND ii. Patient's WHO functional class is II or greater AND iii. Patient has a mean pulmonary artery pressure of greater than 25 mm Hg AND iv. Patient has a pulmonary vascular resistance greater than 3 Wood units AND 3. If the requested agent will be utilized for add-on therapy to existing monotherapy, then ALL of the following: A. Patient has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND B. The requested agent is in a different therapeutic class AND 4. If the requested agent will be utilized for add-on therapy to existing dual therapy, then ALL of the following: A. Patient is WHO functional class III or IV AND B. A parenteral prostanoid has been started as one of the agents in the triple therapy unless the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a parenteral prostanoid AND C. Patient has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND D. All three agents in the triple therapy are from a different therapeutic class Criteria for renewal require the following: 1. Patient has been previously approved for therapy through the plan's PA process and is responding to therapy PAGE 35 LAST UPDATED 11/2016

36 Approval will be for 12 months PAGE 36 LAST UPDATED 11/2016

37 BOTOX BOTOX All medically accepted indications not otherwise excluded from Part D. Cervical dystonia:(init) Dx of CD. Hyperhidrosis(HH): (Init) Dx of primary axillary HH. Score of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) or skin maceration with secondary infection.(reauth) At least a 2-point improvement in HDSS. Migraine:(Init) Dx of chronic migraines (greater than or equal to 15 migraine headache days per month with headache lasting 4 hours a day or longer). (Reauth) Reduction in headache frequency and intensity. Submission of chart notes documenting decreased utilization of pain medications (eg, narcotic analgesics, NSAIDs) or triptans, or a reduction in the number of ER visits. Achalasia:(Init)High risk of complication from pneumatic dilation or surgical myotomy, or failure to prior pneumatic dilation or surgical myotomy, or prior dilation caused esophageal perforation, or patient has an epiphrenic diverticulum or hiatal hernia.(reauth)documentation of improvement or reduction in symptoms of achalasia (ie, dysphagia, regurgitation, chest pain). Anal Fissure (AF):(Init) Dx of chronic AF. At least 2 months of either nocturnal pain and bleeding or postdefecation pain.(reauth)incomplete healing of fissure or recurrence of fissure. Improved symptoms with prior treatment with Botox. Chronic Back Pain (CBP) :(Init) Dx of low back pain lasting greater than or equal to six months. Urinary incont:(init) Neurogenic detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis) or detrusor sphincter dyssynergia with SCI. OAB: (initial) Dx of OAB. One of the following symptoms: urge urinary incontinence, urgency, frequency. Migraine (Initial): Prescribed by a neurologist or pain specialist. CBP (Initial): Prescribed by a neurologist, neurosurgeon, orthopedist, or pain specialist. UI, OAB: Prescribed by a neurologist, neurosurgeon, or urologist. PAGE 37 LAST UPDATED 11/2016

38 12 Months PAGE 38 LAST UPDATED 11/2016

39 BUPRENORPHINE PA BUPRENORPHINE 2 MG TABLET SL, BUPRENORPHINE 8 MG TABLET SL All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Criteria for initial approval are ALL of the following: 1. ONE of the following: A. Patient has a diagnosis of opioid dependence AND ONE of the following: i. Patient is compliant with all elements of treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) OR B. Patient has a diagnosis of another FDA approved indication or has an indication that is supported in CMS approved compendia for the requested agent AND 2. 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 AND 2. If opioid dependence, patient meets ALL of the following: a. Patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use) AND b. Patient continues to be compliant with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) AND c. If patient is receiving any other opioid medication, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific pain that the current opioid is being used to treat and the expected duration of therapy with the opioid AND 3. 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 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 PAGE 39 LAST UPDATED 11/2016

40 Approval will be for 6 months PAGE 40 LAST UPDATED 11/2016

41 BUPRENORPHINE-NALOXONE PA BUPRENORPHINE-NALOXONE, SUBOXONE 12 MG-3 MG SL FILM, SUBOXONE 2 MG-0.5 MG SL FILM, SUBOXONE 4 MG-1 MG SL FILM, SUBOXONE 8 MG-2 MG SL FILM All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Criteria for initial approval are ALL of the following: 1. ONE of the following: A. Patient has a diagnosis of opioid dependence AND ONE of the following: i. Patient is compliant with all elements of treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) OR B. Patient has a diagnosis of another FDA approved indication or has an indication that is supported in CMS approved compendia for the requested agent AND 2. 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 AND 2. If opioid dependence, patient meets ALL of the following: a. Patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use) AND b. Patient continues to be compliant with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) AND c. If patient is receiving any other opioid medication, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific pain that the current opioid is being used to treat and the expected duration of therapy with the opioid AND 3. 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 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 PAGE 41 LAST UPDATED 11/2016

42 Approval will be for 6 months PAGE 42 LAST UPDATED 11/2016

43 CABOMETYX CABOMETYX All medically accepted indications not otherwise excluded from Part D. Renal cell carcinoma (RCC): Diagnosis of RCC. History of failure, contraindication, or intolerance to at least one prior anti-angiogenic therapy [eg, Inlyta (axitinib), Votrient (pazopanib), Nexavar (sorafenib), Sutent (sunitinib)]. RCC: Prescribed by or in consultation with an oncologist. 12 months Approve for continuation of prior therapy. PAGE 43 LAST UPDATED 11/2016

44 CHOLBAM CHOLBAM All medically accepted indications not otherwise excluded from Part D. Bile acid synthesis disorders due to single enzyme defects (BAS) (initial): diagnosis of a bile acid synthesis disorder due to a single enzyme defect. Peroxisomal disorders (PD) (initial): All of the following: 1) diagnosis of peroxisomal disorder, 2) patient exhibits at least one of the following: a) liver disease (eg, jaundice, elevated serum transaminases), OR b) steatorrhea, OR c) complications from decreased fat-soluble vitamin absorption (eg, poor growth), AND 3) Cholbam will be used as an adjunctive treatment. All uses (initial): Prescribed by a hepatologist, medical geneticist, pediatric gastroenterologist, OR other specialist that treats inborn errors of metabolism. Initial: 3 months Reauth: 12 months All uses (reauth): documentation of positive clinical response to Cholbam therapy. PAGE 44 LAST UPDATED 11/2016

45 CLONAZEPAM PA CLONAZEPAM MG DIS TAB, CLONAZEPAM 0.25 MG ODT, CLONAZEPAM 0.5 MG DIS TABLET, CLONAZEPAM 0.5 MG TABLET, CLONAZEPAM 1 MG DIS TABLET, CLONAZEPAM 1 MG TABLET, CLONAZEPAM 2 MG ODT, CLONAZEPAM 2 MG TABLET All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: A. There is evidence of a claim within the past 180 days that the patient is currently being treated with the requested agent OR B. Prescriber states the patient is using the requested agent OR C. Patient has a diagnosis of seizure disorder OR D. Patient has a diagnosis of panic disorder and ONE of the following: i. Patient's medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR ii. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR E. Patient has an indication that is supported in CMS approved compendia for the requested agent Approval will be for 12 months PAGE 45 LAST UPDATED 11/2016