Actemra. Products Affected ACTEMRA INTRAVENOUS. Covered Uses

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1 Actemra ACTEMRA INTRAVENOUS All medically accepted indications not otherwise excluded plus patients already started on tocilizumab for a covered use. Castleman's disease. Still's disease. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis, previous medication use Rheumatoid arthritis (RA), patients 18 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA), patients 2 years of age and older. All other conditions, 18 years of age and older. Cytokine release syndrome (CRS), patients 2 years of age and older. For Castleman's disease must be prescribed by or in consultation with an oncologist or hematologist. For RA, PJIA, SJIA, and Still's Disease, must be prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. 1

2 Other For RA, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For Still's Disease must have tried a corticosteroid and one conventional DMARD, such as methotrexate, given for at least 2 months or was intolerant to a conventional DMARD. For SJIA (IV only), must have tried one other systemic agent (e.g., a corticosteroid [oral, IV] or a conventional DMARD [e.g., MTX, leflunomide, sulfasalazine] or a biologic DMARD or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID]. For PJIA (IV only) must have tried one other systemic agent (e.g., a corticosteroid [oral, IV] or a conventional DMARD [e.g., MTX, leflunomide, sulfasalazine] or a biologic DMARD or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID]. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 2

3 Acthar ACTHAR H.P. Other All medically-accepted indications not otherwise excluded. is not provided for diagnostic procedure. MS exacerbation, history of corticosteroid use. Infantile spasms- less than 2 yr. Acute MS exac-adult Infantile spasms, prescribed by or in consultation with a neurologist or an epileptologist. MS exacerbation, prescribed by or in consultation with a neurologist or physician that specializes in the treatment of MS. Infantile spasms, 1 month. MS exacerbation, approve 1 month. For acute MS exacerbation, approve if the patient cannot use highdose IV corticosteroids because IV access is not possible or if the patient has tried high-dose corticosteroids administered IV for an acute MS exacerbation and has experienced a severe or limiting adverse effect. 3

4 Benlysta BENLYSTA All FDA-approved indications not otherwise excluded from Part D. Concurrent Use with Other Biologics (e.g., Rituxan [rituximab injection]) or with Cyclophosphamide Intravenous (IV) Other The patient is an adult 18 years of age or older The agent is prescribed by or in consultation with rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist Authorization will be for 1 year The patient has autoantibody-positive SLE (i.e., positive for antinuclear antibodies [ANA] and/or anti-double-stranded DNA antibody [anti-dsdna] AND The agent is being used concurrently with at least one other standard therapy (i.e., antimalarials [e.g., hydroxychloroquine], a systemic corticosteroid [e.g., prednisone], and/or other immunosuppressants [e.g., azathioprine, mycophenolate mofetil, methotrexate]) unless the patient is determined to be intolerant due to a significant toxicity, as determined by the prescribing physician. Cont The patient has responded to Benlysta subcutaneous or intravenous (e.g., reduction in flares, reduction in corticosteroid dose, decrease of anti-dsdna titer, improvement in complement levels [i.e., C3, C4], or improvement in specific organ dysfunction [e.g., musculoskeletal, blood, hematologic, vascular, others]), as determined by the prescriber 4

5 Botulinum Toxin A BOTOX DYSPORT XEOMIN All medically accepted indications not excluded from coverage. Cosmetic uses Headache and chronic migraine if prescribed by, or after consultation with, a neurologist or HA specialist. Authorization will be for 12 months. 5

6 Other Primary axillary and focal hyperhidrosis after trial with at least 1 topical agent (e.g., aluminum chloride). Chronic migraine - must have 15 or more migraine headache days per month with headache lasting 4 hours per day or longer AND have tried at least two other prophylactic pharmacologic therapies, each from a different pharmacologic class (e.g., beta-blocker, anticonvulsant, tricyclic antidepressant). OAB and urinary incontinence associated with a neurological condition (e.g., spinal cord injury, multiple sclerosis) approve after a trial with at least one other pharmacologic therapy (e.g., anticholinergic medication). Sialorrhea - treatment of sialorrhea due to conditions such as motor neuron disease or Parkinson's disease in those patients who have failed to respond to a reasonable trial of traditional therapies (eg., anticholinergics and speech therapy) or who have a contraindication to or cannot tolerate anticholinergic therapy, will be allowed for coverage. Anal Fissure - treatment for chronic anal fissure may be considered for the patient who has not responded satisfactorily to conventional therapy (e.g., nitroglycerin ointment). For continuation of therapy for all conditions, prescriber attests the patient has a response to treatment. 6

7 Chorionic Gonadotropins CHOR GONADOTROPIN, HUM (BULK) POWDER 1 MILLION UNIT, 2 MILLION UNIT, 5 MILLION UNIT CHORIONIC GONADOTROPIN, HUMAN NOVAREL All medically accepted indications not otherwise excluded. Plus patients continuing use for a covered indication. Other Authorization will be for 12 months For continuation of therapy for all conditions, prescriber attests the patient has a response to treatment. 7

8 Cimzia CIMZIA CIMZIA POWDER FOR RECONST CIMZIA STARTER KIT All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on certolizumab pegol for a Covered Use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. Diagnosis, concurrent medications, previous therapies tried Patients 18 years of age and older. For rheumatoid arthritis (RA) and ankylosing spondylitis (AS) must be prescribed by or in consultation with a rheumatologist. For Psoriatic arthritis (PA), must be prescribed by or in consultation with a rheumatologist or dermatologist. For Crohn's disease (CD), must be prescribed by or in consultation with a gastroenterologist Authorization will be for 1 year Other For CD, the patient has tried adalimumab or infliximab for at least 3 months unless the patient experienced intolerance. For RA and AS, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For PA, patient has tried at least 2 of the following biologic or target synthetic DMARDs adalimumab, etanercept, infliximab, and apremilast for at least 3 months unless the patient experienced intolerance. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 8

9 Cinqair CINQAIR All medically accepted indications not excluded from coverage. Concurrent use with Xolair or Nucala 18 years of age and older Prescribed by or in consultation with an allergist, immunologist, or pulmonologist Authorization will be for 12 months 9

10 Other Initial therapy, approve if the patient meets all of the following criteria: 1)must have peripheral blood eosinophil count of greater than or equal to 400 cells per microliter within the previous 4 weeks (prior to treatment with Cinqair), AND 2)pt has received at least 3 consecutive months of combination therapy with an inhaled corticosteroid and ONE of the following: inhaled LABA, inhaled long-acting muscarinic antagonist, leukotriene receptor antagonist, or theophylline, AND 3)Pt's asthma continues to be uncontrolled as defined by ONE of the following: patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year, or patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year, or patient has a FEV1 less than 80 percent predicted, orpatient has an FEV1/FVC less than 0.80, or Patient's asthma worsens upon tapering of oral corticosteroid therapy. Continuation therapy, approve if the patient meets all of the following criteria:1) The patient has responded to Cinqair therapy as determined by the prescribing physician (e.g., decreased asthma exacerbations, decreased asthma symptoms, decreased hospitalizations, emergency department (ED)/urgent care, or physician visits due to asthma, decreased requirement for oral corticosteroid therapy), AND 2)Patient continues to receive therapy with BOTH an inhaled corticosteroid and ONE of the following: inhaled LABA, inhaled long-acting muscarinic antagonist, leukotriene receptor antagonist, or theophylline. 10

11 DUOPA DUOPA All medically accepted indications not otherwise excluded plus those already started on Duopa for a covered use. Patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor Diagnosis, medication history Other Prescribed by or in consultation with a neurologist or a provider specializing in the treatment of Parkinson's disease (PD). Authorization will be for 12 months Advanced Parkinson's disease (PD) with complicated motor fluctuations that have not been adequately controlled with oral levodopa-carbidopa AND dopamine agonist AND catechol-omethyl transferase (COMT) inhibitor OR Monoamine oxidase B (MAO-B) inhibitor. For continuation of therapy for all conditions, prescriber attests the patient has a response to treatment. 11

12 Entyvio ENTYVIO Other All medically accepted indications not otherwise excluded plus patients already started on vedolizumab for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis, previous medication use Patients 18 years of age and older. For Crohn's disease (CD) and ulcerative colitis (UC), prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months For CD and UC, the patient has tried adalimumab or infliximab for at least 3 months unless the patient experienced intolerance. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 12

13 Exondys 51 EXONDYS 51 All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, prescriber specialty 14 years or younger for new starts Prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy (DMD) and/or neuromuscular disorders Authorization will be for 1 year. Member has a confirmed mutation of the DMD gene amenable to exon 51 skipping and Eteplirsen has been initiated in childhood (before 14 years of age) and Member is able to achieve an average distance of at least 180m while walking independently over six minutes 13

14 Ilaris ILARIS (PF) SUBCUTANEOUS RECON SOLN All medically-accepted indications not otherwise excluded. When used in combination with concurrent biologic therapy (e.g.tnf antagonists, (etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept. Other CAPS-4 years of age and older. SJIA-2 years of age and older. CAPS/MWS/FCAS initial- Prescribed by or in consultation with a rheumatologist, geneticist, allergist/immunologist, or dermatologist. SJIA initial- prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. For renewal of CAPS/MWS/FCAS - After pt had been started on Ilaris, approve if the pt had a response to therapy as determined by prescribing physician and the pt is continuing therapy to maintain a response/remission. For treatment of SJIA, initial therapy approve if the pt meets one of the following 1. has tried at least 2 other biologics for SJIA (tocilizumab, abatacet, TNF antagonists (e.g. etanercept, adalimumab, infliximab) OR 2. pt has features of poor prognosis (e.g. arthritis of the hip, radiographic damage, 6-month duration of significant active systemic diease, defined by fever, elevated inflammatory markers, or requirement for treatment with systemic glucocorticoids AND tried Actemra or Kineret. SJIA renewal approve if it patient was already started on Ilaris and the pt had a response (e.g. resolution of fever, improvement in limitions of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, improved function or ADLs, reduced dosage of CS) and the pt is continuing therapy to maintain response/remission. 14

15 Immune Globulin CARIMUNE NF NANOFILTERED INTRAVENOUS RECON SOLN 12 GRAM, 6 GRAM GAMMAGARD LIQUID GAMMAGARD S-D (IGA < 1 MCG/ML) GAMUNEX-C HIZENTRA PRIVIGEN All medically accepted indications not excluded from coverage. Diagnosis Authorization will be for 12 months. Other 15

16 Kanuma KANUMA All medically accepted indications not excluded from coverage. Diagnosis Authorization will be for 12 months Other 16

17 Lemtrada LEMTRADA All medically-approved indications not otherwise excluded. Plus patients continuing use of the product for a covered indication. Other The patient has a relapsing form of MS (relapsing forms of MS are RRMS, SPMS with relapses, and PRMS) The patient is 17 years of age or older. Lemtrada is prescribed by or in consultation with a neurologist or a physician that specializes in the treatment of MS. Authorization will be for 12 months The patient has had an inadequate response according to the prescribing physician to two of the following medications for MS: Avonex, Rebif, Betaseron, Extavia, Copaxone, Plegridy, Gilenya, Aubagio, Tecfidera, or Tysabri. For continuation of therapy for all conditions, prescriber attests the patient has a response to treatment. 17

18 Lysosomal Storage Disease Enzyme Replacement Therapies ALDURAZYME CEREZYME INTRAVENOUS RECON SOLN 400 UNIT ELAPRASE ELELYSO FABRAZYME LUMIZYME NAGLAZYME VPRIV All medically accepted indications not excluded from coverage. Diagnosis Lumizyme: 8 years of age or older Authorization will be for 12 months 18

19 Other Lumizyme Initial treatment must meet all of the following: The member has a diagnosis of late-onset (noninfantile) Pompe disease. The member's diagnosis of late-onset Pompe disease is based on both of the following: Acid alpha-glucosidase (GAA) enzyme assay that shows reduced enzyme activity at less than 40 percent of the lab-specific normal mean value AND Confirmation by a second GAA enzyme activity assay in a separate sample (from purified lymphocytes, fibroblast, or muscle) or by GAA gene sequencing. The member has a forced vital capacity (FVC) 30 percent to 79 percent of predicted value while in the sitting position, The member has a postural drop in FVC (in liters) of 10 percent or more from upright to supine position, The member has the ability to walk 40 meters on a six minute walk test (assistive devices permitted), AND The member has muscle weakness in the lower extremities. Continuation: The clinical criteria for approval of a subsequent PA request for Lumizyme are both of the following: The member is ambulatory (assistive devices permitted) The member is not ventilator dependent. Note: The prescriber should indicate the member's ambulation and ventilator status on the PA request. Continuation for other therapies - prescriber attests the patient has had a response to treatment. 19

20 Myobloc MYOBLOC All medically-accepted indications not otherwise excluded. Plus bladder muscle dysfunction (overactive or incontinence), excessive salvation, hyperhidrosis, spastic dysphonia, and upper limb spasticity. Plus patients continuing use of the product for a covered indication. Cosmetic use Diagnosis Authorization will be for 12 months Other Primary axillary and focal hyperhydrosis after trial with at least 1 topical agent (eg, aluminum chloride). OAB and urinary incontinence associated with a neurological condition (e.g., spinal cord injury, multiple sclerosis) approve after a trial with at least one other pharmacologic therapy (e.g., anticholinergic medication). For continuation of therapy for all conditions, prescriber attests the patient has a response to treatment. 20

21 Nucala NUCALA All medically accepted indications not excluded from coverage. Concurrent use with Xolair 12 years of age and older Prescribed by or in consultation with an allergist, immunologist, orpulmonologist Authorization will be for 12 months 21

22 Other Initial - must have peripheral blood eosinophil count of greater than or equal to 150 cells per microliter within the previous 6 weeks(prior to treatment with Nucala) AND Patient has received at least 3 consecutive months of combination therapy with an inhaled corticosteroid AND one of the following A. inhaled LABA, B.inhaled long-acting muscarinic antagonist, C. Leukotriene receptorantagonist, or D. Theophylline. Patient's asthma continues to be uncontrolled as defined by ONE of the following - patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year, patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year, patient has a FEV1 less than 80 percent predicted, Patient has an FEV1/FVC less than 0.80, or Patient's asthma worsens upon tapering of oral corticosteroid therapy. Continuation- The patient has responded to Nucala therapy as determined bythe prescribing physician (e.g., decreased asthma exacerbations,decreased asthma symptoms, decreased hospitalizations, emergency department (ED)/urgent care, or physician visits due to asthma, decreased requirement for oral corticosteroid therapy) AND Patient continues to receive therapy with an inhaled corticosteroid. 22

23 Ocrevus OCREVUS All FDA-approved indications not otherwise excluded from Part D. 18 years of age and older Prescribed by, or in consultation with, a physician who specializes in the treatment of MS and/or a neurologist Authorization will be for 1 year Other 23

24 Orencia IV ORENCIA (WITH MALTOSE) Other All medically-accepted indications not otherwise excluded plus patients who have already been started on abatacept for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis, previous medication use Rheumatoid arthritis (RA) and Psoriatic arthritis (PA), patients 18 years of age and older. Juvenile idiopathic arthritis (JIA), patient 2 years of age and older. RA and JIA/JRA prescribed by or in consultation with a rheumatologist. For Psoriatic arthritis (PA), must be prescribed by or in consultation with a rheumatologist or dermatologist. Authorization will be for 12 months. For RA, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For JIA, approve abatacept IV only if the patient has tried adalimumab or etanercept (abatacept SC is not FDAapproved for the treatment of JIA/JRA). For Juvenile Rheumatoid Arthritis (JRA), approve abatacept IV only if the patient has tried adalimumab or etanercept for at least 2 months or was intolerant to one of these therapies (abatacept SC is not FDA-approved for the treatment of JIA/JRA). For PA, patient has tried at least 2 of the following biologic or target synthetic DMARDs: adalimumab, etanercept, infliximab, and apremilast for at least 3 months unless the patient experienced intolerance For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 24

25 Programmed Death Receptor/Ligand Pathway Inhibitors BAVENCIO IMFINZI KEYTRUDA OPDIVO TECENTRIQ All medically accepted indications not excluded from coverage. Diagnosis Authorization will be for 12 months Other 25

26 Prolia PROLIA All medically-accepted indications not otherwise excluded. Plus patients continuing use of the product for a covered indication. Concomitant use with other medications for osteoporosis (eg, denosumab [Prolia], bisphosphonates, raloxifene, calcitonin nasal spray [Miacalcin, Fortical]), except calcium and Vitamin D. Authorization will be for 12 months. 26

27 Other Treatment of postmenopausal osteoporosis/treatment of osteoporosis in men (to increase bone mass), approve if the patient meets one of the following - 1. has had inadequate response after 12 months of therapy with an oral bisphosphonate or IV bisphosphonate, had osteoporotic fracture while receiving an oral bisphosphonate or IV bisphosphonate, or intolerability or contraindication to BOTH an oral bisphospohate AND IV bisphosphonate, 2. OR the patient has severe renal impairment (eg, creatinine clearance less than 35 ml/min) or chronic kidney disease, or if the patient has multiple osteoporotic fractures. Treatment of bone loss in men at high risk for fracture receiving ADT for nonmetastatic prostate cancer, approve if the patient has prostate cancer that is not metastatic to the bone and the patient is receiving ADT (eg, leuprolide, triptorelin, goserelin) or the patient has undergone a bilateral orchiectomy. Treatment of bone loss (to increase bone mass) in patients at high risk for fracture receiving adjuvant AI therapy for breast cancer, approve if the patient has breast cancer that is not metastatic to the bone and in receiving concurrent AI therapy (eg, anastrozole, letrozole, exemestane). For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 27

28 Provenge PROVENGE All medically-accepted indications not otherwise excluded. Diagnosis Other duration of 12 months Documentation to support patient is asymptomatic or minimally symptomatic and has metastatic castrate resistant (hormone refractory) disease AND Patient's testosterone levels less than 50 ng/dl. 28

29 Remicade REMICADE INTRAVENOUS RECON SOLN 100 MG All medically accepted indications not otherwise excluded plus patients already taking infliximab for a covered use. Behcet's disease (BD). Still's disease (SD). Uveitis (UV). Undifferentiated spondylarthroplasty, Pyoderma gangrenosum (PG). Hidradenitis suppurativa (HS). Graft-versus-host disease (GVHD). Juvenile Idiopathic Arthritis (JIA). Sarcoidosis Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. Diagnosis, previous medication use For CD and UC, patients aged 6 years of age and older. All other conditions, patients aged 18 years of age and older RA/JIA/JRA/AS, prescribed/consult by rheumatologist. PsA, prescribed/consult by rheumatologist or dermatologist. PP, prescribed/consult by dermatologist. UC/CD, prescribed/consult by gastroenterologist. Uveitis, prescribed/consult by ophthalmologist. GVHD, prescribed/consult by oncologist, hematologist, or transplant physician. Sarcoidosis, prescribed/consult by pulmonologist, ophthalmologist, or dermatologist. Authorization will be for 12 months 29

30 Other For RA and AS, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For PP, the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, adalimumab, apremilast, or etanercept) for 3 months unless the patient experienced intolerance or PUVA for 3 months. For PA, the patient must have had a trial with a conventional DMARD (eg, methotrexate, sulfasalazine, and leflunomide) for at least 3 months unless the patient experienced intolerance or has severe disease activity. For CD, approve if the patient has failed corticosteroid (CS) or if CS contraindicated or if currently on CS and unable to taper off or if the patient has tried one other agent for CD for 3 months (eg, azathioprine, 6-MP, MTX, certolizumab, adalimumab, vedolizumab, ustekinumab) or the patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas or the patient has had ileocolonic resection. For UC, the patient has tried a systemic therapy (eg, 6- mercaptopurine, azathioprine, CSA, tacrolimus, adalimumab, vedolizumab, golimumab, or a corticosteroid such as prednisone or methylprednisolone) for 3 months or was intolerant to one of these agents, or the patient has pouchitis and has tried therapy with an antibiotic, probiotic, corticosteroid enema, or mesalamine (Rowasa) enema. For Behcet's, the patient has tried at least one conventional treatment (eg, systemic CSs, immunosuppressants [e.g., AZA, MTX, MM, CSA, tacrolimus, chlorambucil, cyclophosphamide] or interferon alfa), entanercept or adalimumab or has ophthalmic manifestations. For Stills disease, the patient has tried CS and one non-biologic DMARD (eg, MTX) for 2 months, or was intolerant. For Uveitis, the patient has tried periocular/intraocular CS, systemic CS, immunosuppressant (eg, MTX, MM, CSA, AZA, CPM), etanercept, or adalimumab. For sarcoidosis, the patient has tried CS and immunosuppressant (eg, MTX, AZA, CSA, chlorambucil), or chloroquine, or thalidomide. For Pyoderma gangrenosum (PG), the patient has tried one systemic CS or immunosuppressant (eg, mycophenolate, CSA) for 2 months. For Hidradenitis suppurativa (HS), the patient has tried one previous treatment (eg, intralesional/oral CS, systemic antibiotic, isotretinoin). For GVHD, the patient has tried one previous treatment (eg, high-dose CS, antithymocyte globulin, CSA, thalidomide, tacrolimus, MM, etc.) or is receiving IFB concurrently. For JIA (regardless of type of onset), approve if infliximab is started in combination with MTX or one other traditional DMARD (eg, methotrexate, leflunomide, sulfasalazine) and the patient has tried one other agent for this condition (eg, MTX, sulfasalazine, or leflunomide, an NSAID, or one biologic DMARD or the patient has aggressive disease. For 30

31 continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 31

32 Remodulin REMODULIN All medically-accepted indications not otherwise excluded. Plus patients continuing use of the product for a covered indication. PAH WHO group, right heart catherization results, WHO functional status, previous drugs tried. PAH WHO Group 1, prescribed by or in consultation with a cardiologist or a pulmonologist. Authorization will be for 12 months. 32

33 Other PAH WHO Group 1, patients not currently on Remodulin pt required to have had a right-heart catheterization to confirm the diagnosis of PAH (mpap greater than 25 mm Hg at rest, PCWP equal to or less than 15 mm Hg, and PVR greater than 3 Wood units) AND either have functional Class III or IV, OR have functional Class II and meet ONE of the following a. tried or is currently receiving one oral agent for PAH (e.g., Tracleer, Letairis, Opsumit, Adempas, Revatio, Adcirca, or Orenitram) or unable to take any of the agents above (e.g., those with liver abnormalities (Tracleer), women of childbearing potential (Tracleer, Letairis), concomitant use with nitrates(sildenafil, Cialis), hypotension, drugdrug interactions) OR b. tried one inhaled or parenteral prostacyclin product for PAH (e.g., Ventavis, Tyvaso, epoprostenol injection) AND if the pt has idiopathic PAH, they must have one of the following: 1. had an acute response to vasodilator testing that occured during the right heart cath (defined as decrease in mpapof at least 10 mm Hg to an absolute mpap of less than 40 mm Hg without a decrease in cardiac output) AND has tried an oral CCB (e.g. amlodipine, nifedipine extended-release tablets)or 2. pt did not have an acute response to vasodilator testing or 3. cannot undergo vasodilator test or cannot take CCB due to right heart failure or decreased cardiac output or 4. has tried a CCB. PAH WHO Group1, patients currently on Remodulin- pt must have had a right heart catherization to confirm the diagnosis of PAH. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 33

34 Simponi Aria SIMPONI ARIA Other All medically accepted indications not otherwise excluded plus patients who have already been started on golimumab (IV) for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. Diagnosis, previous medication use Rheumatoid arthritis (RA), Psoriatic arthritis (PA), and Plaque Psoriasis (PP), patients 18 years of age and older. RA prescribed by or in consultation with a rheumatologist. For Psoriatic Arthritis (PA) must be prescribed by or in consultation with a rheumatologist or a dermatologist. For Plaque Psoriasis (PP) must prescribed by or in consultation with a dermatologist. Authorization will be for 12 months. For RA, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For PA and PP, patient has tried at least 2 of the following biologic or target synthetic DMARDs: adalimumab, etanercept, infliximab, and apremilast for at least 3 months unless the patient experienced intolerance. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 34

35 Sodium Hyaluronate (Viscosupplementation) GEL-ONE HYALGAN ORTHOVISC SUPARTZ FX All medically-accepted indications not otherwise excluded. Diagnosis is confirmed by radiologic imaging Other Authorization will be for 12 months For initial treatment of OA of the knee - member has documented symptomatic osteoarthritis of the knee AND has symptoms such as pain and knee stiffness, which interferes with the functions and activities of daily living such as ambulation, prolonged standing, and interrupting sleep AND conservative, non-pharmacologic therapy, including physical therapy and simple analgesics (e.g., non-steroidal anti-inflammatory drugs, steroid injections and/or topical capsaicin cream) has been attempted, and has not resulted in functional improvement after at least 3 months trial, or the member has been unable to tolerate conservative therapy because of adverse side effects. Cont tx - significant improvement in pain and functional capacity was achieved as a result of the previous injections, pain has recurred and at least 6 months have passed since the prior course of treatment. 35

36 Soliris SOLIRIS All medically accepted indications not excluded from coverage. Diagnosis Authorization will be for 12 months Other 36

37 Spinraza SPINRAZA (PF) All FDA-approved indications not otherwise excluded from Part D. Other The medication is prescribed by or in consultation with a physician who specializes in the management of patients with spinal muscular atrophy and/or neuromuscular disorders Authorization will be for 1 year Spinal Muscular Atrophy - meets all of the following criteria - The patient has type I, II or III spinal muscular atrophy AND The patient has had a genetic test confirming the diagnosis of spinal muscular atrophy (homozygous gene deletion, homozygous mutation, or compound heterozygous mutation) 37

38 Stelara STELARA Other All medically accepted indications not otherwise excluded plus patients already started on ustekinumab for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis, previous medication use Patients 18 years of age and older Plaque psoriasis (PP), prescribed by or in consultation with a dermatologist. Psoriatic Arthritis (PA), prescribed by or in consultation with a rheumatologist or dermatologist. Crohn's Disease (CD), prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months. For PA and PP, patient has tried at least 2 of the following biologic or target synthetic DMARDs: adalimumab, etanercept, infliximab, and apremilast for at least 3 months unless the patient experienced intolerance. For CD, the patient has tried adalimumab or infliximab for at least 3 months unless the patient experience intolerance. For SQ formulation, must have received or will receive a single IV induction dose. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 38

39 Tysabri TYSABRI Other All medically accepted indications not otherwise excluded. Plus patients already started on Tysabri for a Covered Use. CD - Concurrent Use of Tysabri with an Immunosuppressant nt in Patients with Crohn's Disease. MS - Current Use of Tysabri with Other Disease-Modifying nts or immunosuppressants used for MS. Per warning and precautions, coverage is not provided for immune compromised patients with MS or CD. Adults with MS. Patient has a relapsing form of MS (relapsing forms of MS are relapsing remitting [RRMS], secondary progressive [SPMS] with relapses, and progressive relapsing [PRMS]). Patients 18 years of age and older MS. Prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of MS. CD. Prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 Months Adults with a relapsing form of MS. Patient has had an inadequate response to, or is unable to tolerate, therapy with at least one of the following MS medications: interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), glatiramer acetate (Copaxone/Glatopa), Plegridy, fingolimod (Gilenya), Tecfidera, Lemtrada, or Aubagio OR the patient has highly active or aggressive disease according to the prescribing physician. Adults with CD. Patient has tried two biologics for CD for at least 3 months each (eg., adalimumab, certolizumab, ustekinumab, or infliximab) and had an inadequate response or was intolerant. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 39

40 Xgeva XGEVA All medically-accepted indications not otherwise excluded. Plus patients continuing use of the product for a covered indication. Diagnosis Authorization will be for 12 months Other 40

41 Xolair XOLAIR All medically-accepted indications not otherwise excluded. Diagnosis, previous medications, baseline IgE level, allergen test results Patient is 6 years of age or older. For Asthma in Patients with Moderate to Severe Persistent Disease and Allergic Rhinitis, Seasonal or Perennial must be prescribed by or in consultation with an allergist, immunologist, or pulmonologist. For Chronic Idiopathic Urticaria (Chronic Spontaneous Urticaria) must be prescribed by or in consultation with, an allergist, immunologist, or dermatologist. For Eosinophilic Gastroenteritis (EG) must be prescribed by or in consultation with an allergist, immunologist, or gastroenterologist. Authorization will be for 12 months. 41

42 Other Asthma in Patients with Moderate to Severe Persistent Disease Patient must meet the following: Baseline IgE level is greater than or equal to 30 IU/mL, AND The patient has a baseline positive skin test or in vitro testing (i.e., a blood test for allergen-specific IgE antibodies such as an enzyme-linked immunoabsorbant assay [e.g., ImmunoCAP, ELISA] or the radioallergosorbent test [RAST]) for one or more perennial aeroallergens (e.g., house dust mite [Dermatophagoides farinae, D. pteronyssinus], animal dander [dog, cat], cockroach, feathers, mold spores), AND/OR for one or more seasonal aeroallergens (grass, pollen, weeds) AND The patient's asthma symptoms have not been adequately controlled, as determined by the prescriber, by at least 3 months of therapy with inhaled corticosteroids taken in combination with one of the following agents: A long-acting beta agonist (LABA) OR If the patient has a contraindication or intolerance to use of LABAs, sustained-release theophylline or leukotriene modifier (e.g., montelukast). For Chronic Idiopathic Urticaria (Chronic Spontaneous Urticaria) approve if the patient meets the following: Patient has urticaria for greater than 6 weeks, with symptoms present greather than 3 days per week despite daily non-sedating H1-antihistamine therapy with doses that have been titrated up to a maximum of four times the standard FDA-approved dose AND Patient has tried therapy with a leukotriene modifier (e.g., montelukast) with a daily non-sedating H1 antihistamine. Allergic Rhinitis, Seasonal or Perennial approve if the patient meets the following Baseline IgE level of greater than or equal to 30 IU/mL AND Patient has seasonal or perennial allergic rhinitis as demonstrated by baseline positive skin testing (e.g., grass, tree, or weed pollen, mold spores, house dust mite, animal dander, cockroach) AND/OR baseline positive in vitro testing (i.e., a blood test for allergen-specific IgE antibodies) for one or more relevant allergens (e.g., grass, tree, or weed pollen, mold spores, house dust mite, animal dander, cockroach) AND Patient meets one of the following: Patient has tried therapy with at least one drug from two of the following groups of drugs at the same time: A non-sedating or low-sedating H1 antihistamine[rx or OTC] OR a nasal antihistamine, A nasal corticosteroid, or Montelukast OR Patient must have tried therapy with at least one drug from all 3 of the above groups individually or in any combination during one allergy season (i.e., 6 months). Eosinophilic Gastroenteritis (EG), Eosinophilic Esophagitis (EE), or Eosinophilic Colitis approve if the patient meets the following: Patient has tried therapy with a systemic or oral administered topical corticosteroid AND Diagnosis has been confirmed based on biopsy showing greater than or equal 42

43 to 15 eosinophils per high-power field. Continuing Xolair: approve if request meets prescriber restrictions AND patient has has responded to therapy as determined by the prescriber. 43

44 44

45 Index ACTEMRA INTRAVENOUS... 1 ACTHAR H.P...3 ALDURAZYME BAVENCIO BENLYSTA...4 BOTOX... 5 CARIMUNE NF NANOFILTERED INTRAVENOUS RECON SOLN 12 GRAM, 6 GRAM CEREZYME INTRAVENOUS RECON SOLN 400 UNIT CHOR GONADOTROPIN, HUM (BULK) POWDER 1 MILLION UNIT, 2 MILLION UNIT, 5 MILLION UNIT... 7 CHORIONIC GONADOTROPIN, HUMAN... 7 CIMZIA... 8 CIMZIA POWDER FOR RECONST... 8 CIMZIA STARTER KIT... 8 CINQAIR...9 DUOPA...11 DYSPORT... 5 ELAPRASE...18 ELELYSO ENTYVIO...12 EXONDYS FABRAZYME...18 GAMMAGARD LIQUID...15 GAMMAGARD S-D (IGA < 1 MCG/ML) 15 GAMUNEX-C...15 GEL-ONE HIZENTRA...15 HYALGAN ILARIS (PF) SUBCUTANEOUS RECON SOLN...14 IMFINZI...25 KANUMA KEYTRUDA LEMTRADA LUMIZYME MYOBLOC...20 NAGLAZYME NOVAREL... 7 NUCALA OCREVUS...23 OPDIVO...25 ORENCIA (WITH MALTOSE) ORTHOVISC PRIVIGEN PROLIA PROVENGE REMICADE INTRAVENOUS RECON SOLN 100 MG REMODULIN SIMPONI ARIA SOLIRIS SPINRAZA (PF)...37 STELARA SUPARTZ FX TECENTRIQ...25 TYSABRI VPRIV...18 XEOMIN... 5 XGEVA XOLAIR

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