Actemra. Products Affected ACTEMRA INTRAVENOUS. Covered Uses

Transcription

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. 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 Aranesp ARANESP (IN POLYSORBATE) INJECTION SOLUTION ARANESP (IN POLYSORBATE) INJECTION SYRINGE 100 MCG/0.5 ML, 150 MCG/0.3 ML, 200 MCG/0.4 ML, 25 MCG/0.42 ML, 300 MCG/0.6 ML, 40 MCG/0.4 ML, 500 MCG/ML, 60 MCG/0.3 ML All medically-accepted indications not otherwise excluded worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Plus anemia in patients with HIV(with or without zidovudine). Anemia due to myelodysplastic syndrome (MDS). Anemia of chronic disease: Rheumatoid Arthritis, Systemic Lupus erythematosus, Inflammatory Bowel Disease and patients undergoing Hep C therapy. 4

5 Confirmation of adequate iron stores at intiation of therapy(eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%).Anemia w/crf on and not on dialysis.a hemoglobin (Hb) of less than 10.0 g/dl for patients 18 years and older and less than or equal to 11 g/dl for children required for start,hb has to be less than or equal 11.5 g/dl for patients 18 years of age and older or less than or equal to 12 g/dl in children if currently receiving epoetin alfa (EA) or Aranesp. Anemia due to myelosuppressive chemotx,hb is 10.0 g/dl or less to start.hb less than or equal to 12.0 g/dl if currently on epoetin alfa EA. Anemia in HIV (with or without zidovudine), Hb is 10.0 g/dl or less or endogenous erythropoetin levels are 500 munits/ml or less at tx start. Currently on EA approve if Hb is 12.0 g/dl or less. MDS, approve tx if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start. Anemia of chronic disease: Rheumatoid Arthritis, Systemic Lupus erythematosus, Inflammatory Bowel Disease and patients undergoing Hep C therapy, Hb is 10.0 g/dl or less or HCT is less than 30% to start. If the pt is currently receiving Aranesp or EA, approve only if Hb is 12.0 g/dl or less. All conds, deny if Hb exceeds 12.0 g/dl. Authorization will be for 12 months. Other 5

6 Botulinum Toxin A BOTOX DYSPORT XEOMIN INTRAMUSCULAR RECON SOLN 100 UNIT, 50 UNIT 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. 6

7 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. 7

8 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. 8

9 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). 1 year 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. 9

10 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. 10

11 Epogen/Procrit EPOGEN INJECTION SOLUTION 10,000 UNIT/ML, 2,000 UNIT/ML, 20,000 UNIT/2 ML, 20,000 UNIT/ML, 3,000 UNIT/ML, 4,000 UNIT/ML PROCRIT All medically-accepted indications not otherwise excluded worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Anemia due to myelodysplastic syndrome (MDS). Plus anemia in patients with HIV(with or without zidovudine). Patients using for perisurgical adjuvant therapy. Anemia of chronic disease: Rheumatoid Arthritis, Systemic Lupus erythematosus, Inflammatory Bowel Disease and patients undergoing Hep C therapy. 11

12 Confirmation of adequate iron stores at initiation of therapy (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%). CRF anemia in patients on and not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl for children to start.hb less than or equal to 11.5 g/dl for adults or 12 g/dl or less for children if currently on epoetin alfa or Aranesp. Anemia w/myelosuppressive chemotx. pt must be currently receiving myelosuppressive chemo and Hb 10.0 g/dl or less to start. Hb less than or equal to 12.0 g/dl if currently on epoetin alfa or Aranesp. MDS, approve if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start. Currently receiving Aranesp or EA, approve if Hb is 12.0 g/dl or less. Anemia in HIV (with or without zidovudine), Hb is 10.0 g/dl or less or endogenous erythropoetin levels are 500 munits/ml or less at tx start. Currently on EA approve if Hb is 12.0 g/dl or less. Perisurgical adjuvant therapy, patient is undergoing hip or knee surgery, has Hgb between 10 and 13 g/dl, is not a candidate for autologous blood transfusion, is expected to lose more than 2 units of blood, and anemia has been evaluated to ensure due to chronic disease. Anemia of chronic disease: Rheumatoid Arthritis, Systemic Lupus erythematosus, Inflammatory Bowel Disease and patients undergoing Hep C therapy, Hb is less than 10 g/dl or Hct less than 30% to start. Currently on EA or Aranesp approve if Hb is 12.0 g/dl or less. Authorization will be for 12 months. Other 12

13 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. 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 3 years. 13

14 Other 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 otherwise excluded. Authorization will be for 12 months. Other 15

16 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 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. 16

17 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 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. 17

18 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), patients 18 years of age and older. Juvenile idiopathic arthritis (JIA), patient 6 years of age and older. RA and JIA/JRA prescribed by or in consultation with a rheumatologist. 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 continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 18

19 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 1 year. 19

20 Other Treatment of postmenopausal osteoporosis/treatment of osteoporosis in men (to increase bone mass), approve if the patient has meets one -1. has had inadequate response after 12 months of therapy with an oral bisphosphonate, had osteoporotic fracture while receiving an oral bisphosphonate, or intolerability to an oral bisphospohate, 2. OR pt has tried an IV bisphosphonate (ibandronate or zoledronic acid), 3. 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. 20

21 Provenge PROVENGE All medically-accepted indications not otherwise excluded. 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 21

22 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 1 year. 22

23 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. 23

24 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), patients 18 years of age and older. RA prescribed by or in consultation with a rheumatologist. 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 continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 24

25 Sodium Hyaluronate (Viscosupplementation) GEL-ONE HYALGAN ORTHOVISC SUPARTZ FX All medically-accepted indications not otherwise excluded. Diagnosis is confirmed by radiologic imaging Other 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. 25

26 Stelara STELARA SUBCUTANEOUS SYRINGE 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. 26

27 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. 27

28 Xgeva XGEVA All medically-accepted indications not otherwise excluded. Plus patients continuing use of the product for a covered indication. duration of 12 months Other 28

29 Xolair XOLAIR All medically-accepted indications not otherwise excluded. Patient is 12 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. 29

30 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 30

31 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. 31

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33 Index ACTEMRA INTRAVENOUS... 1 ACTHAR H.P...3 ARANESP (IN POLYSORBATE) INJECTION SOLUTION... 4 ARANESP (IN POLYSORBATE) INJECTION SYRINGE 100 MCG/0.5 ML, 150 MCG/0.3 ML, 200 MCG/0.4 ML, 25 MCG/0.42 ML, 300 MCG/0.6 ML, 40 MCG/0.4 ML, 500 MCG/ML, 60 MCG/0.3 ML... 4 BOTOX... 6 CARIMUNE NF NANOFILTERED INTRAVENOUS RECON SOLN 12 GRAM, 6 GRAM CHOR GONADOTROPIN, HUM (BULK) POWDER 1 MILLION UNIT, 2 MILLION UNIT, 5 MILLION UNIT... 8 CHORIONIC GONADOTROPIN, HUMAN... 8 DUOPA...9 DYSPORT... 6 ENTYVIO...10 EPOGEN INJECTION SOLUTION 10,000 UNIT/ML, 2,000 UNIT/ML, 20,000 UNIT/2 ML, 20,000 UNIT/ML, 3,000 UNIT/ML, 4,000 UNIT/ML...11 GAMMAGARD LIQUID...15 GAMMAGARD S-D (IGA < 1 MCG/ML). 15 GAMUNEX-C...15 GEL-ONE HIZENTRA...15 HYALGAN ILARIS (PF) SUBCUTANEOUS RECON SOLN...13 LEMTRADA MYOBLOC...17 NOVAREL... 8 ORENCIA (WITH MALTOSE) ORTHOVISC PRIVIGEN PROCRIT PROLIA PROVENGE REMODULIN SIMPONI ARIA STELARA SUBCUTANEOUS SYRINGE SUPARTZ FX TYSABRI XEOMIN INTRAMUSCULAR RECON SOLN 100 UNIT, 50 UNIT... 6 XGEVA XOLAIR