2017 PRIOR AUTHORIZATION CRITERIA

Transcription

1 2017 PRIOR AUTHORIZATION CRITERIA UCare Connect (SNBC) MinnesotaCare Prepaid Assistance Program (PMAP) Minnesota Senior Care Plus (MSC+) UCare requires your physician to get prior authorization for certain drugs. This means that you will need to get approval from UCare before you fill your prescriptions. If you don t get approval, UCare may not cover the drug. PMAP, MinnesotaCare, and MSC+ members with questions should call UCare Customer Services at toll free. UCare Connect members with questions should call toll free. TTY machine users can call Hours of operation are 7:45 a.m. - 6 p.m., Monday-Friday. PMAP MnCare MSC+ SNBC_042215_2 DHS Approved ( ) Updated 08/2017 U6429 (08/17)

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6 Actemra ACTEMRA INTRAVENOUS PA All medically-accepted indications not otherwise excluded. Must not be used in combination with a targeted synthetic DMARD (e.g., Xeljanz) or another biologic DMARD for an inflammatory condition (e.g., Cimzia, Enbrel, Humira, Kineret, Orencia (IV or SC), Remicade, Rituxan, or Simponi [Aria or SC]). Other 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. For Still's Disease must have tried a corticosteroid and one conventional synthetic DMARD such as methotrexate given for at least 2 months or was not intolerant to a conventional synthetic DMARD.For RA must have had a 3 month trial of a biologic DMARD (e.g., Orencia (SC, IV), Rituxan, TNF antagonists [e.g., Humira, Cimzia, Enbrel, Remicade, Simponi (SC), or Simponi Aria]) OR targeted synthetic DMARD (i.e., Xeljanz) for RA OR that the patient was intolerant to one of these medications.for SJIA must have tried one other systemic agent(e.g., a corticosteroid [oral, IV], a conventional synthetic DMARD [e.g., MTX, leflunomide, sulfasalazine], or a biologic DMARD[e.g., Kineret, a TNF inhibitorsuch as Enbrel, Humira or Remicade or Ilaris], or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID].For PJIA must have tried at least one TNF inhibitor (e.g., Enbrel, Humira). 1

7 Alecensa ALECENSA PA All FDA-approved indications not otherwise excluded from Part D. Other 1 Year Metastatic NSCLC - is anaplastic lymphoma kinase (ALK)-positive AND has either progressed on or is intolerant to Xalkori. 2

8 Ampyra AMPYRA PA All FDA-approved indications not otherwise excluded. Other Prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS. Authorization will be for 12 months. Used to improve mobility in a patient with MS. 3

9 Anabolic Steroids oxandrolone PA All FDA-approved indications not otherwise excluded. Girls w/turner's Syndrome or Ullrich-Turner Syndrome (oxandrolone only), management of protein catabolism w/burns or burn injury (oxandrolone only), AIDS wasting and cachexia. Authorization will be for 12 months, unless otherwise specified. Other 4

10 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 PA All FDA-approved 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. 5

11 PA 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 6

12 Aubagio AUBAGIO PA All FDA approved indications not otherwise excluded. Plus patients already started on Aubagio for a Covered Use. Concurrent use of Aubagio with other disease-modifying agents used for multiple sclerosis (MS) [eg, Avonex, Rebif, Betaseron, Extavia, Copaxone, Tysabri, Tecfidera, or Gilenya]. MS, patient must have a relapsing form of MS (RRMS, SPMS with relapses, or PRMS). MS, previous MS therapies tried. Other Prescribed by or in consultation with a neurologist or MS specialist. Authorization will be for 12 months For use in a relapsing form of MS, approve if: 1) Patient is currently taking teriflunomide (Aubagio), OR2) Patient has tried fingolimod (Gilenya) or dimethyl fumarate (Tecfidera) AND the patient has tried one of the following injectables: interferon beta-1a intramuscular (Avonex), interferon beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone). If the patient has not yet tried an injectable, the patient must try one of Avonex, Rebif, Betaseron, or Copaxone 20 mg. Exceptions to having tried an injectable product can be made if the patient is unable to administer injections due to dexterity issues or visual impairment. 7

13 Avonex AVONEX (WITH ALBUMIN) AVONEX INTRAMUSCULAR PEN INJECTOR KIT AVONEX INTRAMUSCULAR SYRINGE KIT PA All FDA-approved indications not otherwise excluded. Concurrent use of other disease-modifying agent used for multiple sclerosis (ie, interferon beta-1a, interferon beta-1b, glatiramer, natalizumab, fingolimod, teriflunomide, dimethyl fumarate DR) Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months. Other 8

14 Betaseron Extavia BETASERON SUBCUTANEOUS KIT EXTAVIA SUBCUTANEOUS KIT PA All FDA-approved indications not otherwise excluded. Concurrent use with other disease-modifying agent used for multiple scelorosis (ie, interferon beta-1a, glatiramer, natalizumab, fingolimod, teriflunomide, dimethyl fumerate ER) Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months. Other 9

15 Bosulif BOSULIF PA All FDA-approved indications not otherwise excluded. Diagnosis for which Bosulif is being used. For chronic myelogenous leukemia (CML), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For CML, prior therapies tried must be reported to confirm resistance or intolerance. Other Authorization will be for 12 months. For CML, patient must have Ph-positive CML and must have resistance or intolerance to prior therapy for approval. 10

16 Botox BOTOX PA All FDA-approved indications not otherwise excluded. Plus Achalasia, anal fissure, headache (chronic tension HA, whiplash, chronic daily HA), primary focal hyperhidrosis, salivary hypersecretion, spasticity (eg, due to cerebral palsy, stroke, brain injury, spinal cord injury, MS, hemifacial spasm), dystonia other than cervical (eg, focal dystonias, tardive dystonia, anismus), ophthalmic disorders (eg, strabismus), speech/voice disorders (eg, dysphonias). Cosmetic uses Headache and chronic migraine if prescribed by, or after consultation with, a neurologist or HA specialist. Authorization for 12 months 11

17 PA Other Primary axillary and focal hyperhydrosis after trial with at least 1 topical agent (eg, aluminum chloride). Headache (eg, migraine, chronic tension headache, whiplash, chronic daily headache) after a trial with at least 2 other pharmacologic therapies (eg, anticonvulsants, antidepressants, beta-blockers, calcium channel blockers, non-steroidal anti-inflammatory drugs). 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). 12

18 Cabometyx CABOMETYX PA All FDA-approved indications not otherwise excluded from Part D. Plus patients with Non-Small Cell Lung Cancer with RET Gene Rearrangements. Plus patients already taking Cabometyx for a Covered Use. Diagnosis, medication history, histology, RET gene rearrangement status Authorization will be for 12 months Other Advance Renal Cell Carcinoma-Patients must meet both 1 AND 2. 1) Patient has RCC with predominant clear-cell histology 2) Patient has tried one tyrosine kinase inhibitor therapy (e.g., Sutent [sunitinib malate capsules], Votrient [pazopanib tablets], Inlyta [axitinib tablets], Nexavar [sorafenib tosylate tablets]). 13

19 Cometriq COMETRIQ PA All medically-accepted indications not otherwise excluded. Other Authorization will be for 12 months. If not used for the FDA-approved indication of progressive, metastatic, medullary thyroid cancer, the diagnosis must be an unlabeled indication for Anti-Cancer Chemotherapeutic Drugs. 14

20 Copaxone COPAXONE SUBCUTANEOUS SYRINGE 40 MG/ML GLATOPA PA All FDA-approved indications not otherwise excluded. Given in combination with another disease- modifying agent used for MS (such as, Rebif, Betaseron, Tysabri, Gilenya, Aubagio, and Tecfidera) Diagnosis of Multiple Sclerosis (MS) or patient has experienced an attack and is at risk for MS. Other Prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis. Authorization will be for 12 months. Must not be given in combination with another disease modifying agent used for MS (such as, Rebif, Betaseron, Tysabri, Gilenya, Aubagio, and Tecfidera). 15

21 Corlanor CORLANOR PA All FDA-approved indications not otherwise excluded. Previous use of a Beta-blocker, LVEF, sinus rhythm, and resting HR Other Prior Authorization will be approved for 12 months HF in pts not currently receiving Corlanor - must all of the following: have LVEF of less than or equal 35 percent, have sinus rhythm and a resting HR of greater than or equal to 70 BPM, AND tried or is currently receiving a Beta-blocker for HF (e.g., metoprolol succinate sustained-release, carvedilol, bisoprolol, carvedilol ER) unless the patient has a contraindication to the use of beta blocker therapy (e.g., bronchospastic disease such as COPD and asthma, severe hypotension or bradycardia). HF in pts currently receiving Corlanor - had a LVEF of less than or equal to 35 percent prior to initiation of Corlanor therapy AND has tried or is currently receiving a Betablocker for HF unless the patient has a contraindication to the use of beta blocker therapy. 16

22 Cosentyx COSENTYX COSENTYX (2 SYRINGES) COSENTYX PEN COSENTYX PEN (2 PENS) PA Other All FDA-approved indications not otherwise excluded plus patients already started on secukinumab for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis and other medications tried for the diagnosis provided. Patients 18 years of age and older. For 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 plaque psoriasis (PP), must be prescribed by or in consultation with a dermatologist. 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 AS, 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. 17

23 Cotellic COTELLIC PA All FDA-approved indications not otherwise excluded from Part D. Melanoma initial - must have BRAF V600 mutation Other 1 Year Melanoma - being prescribed in combination with Zelboraf. 18

24 DDAVP desmopressin injection desmopressin oral PA All FDA-approved indications not otherwise excluded. For Primary nocturnal enuresis - greater than or equal to 6 years of age. Other Authorization will be for 12 months. For diagnosis of primary nocturnal enuresis less than 18 years of age, only tablets are covered. 19

25 DUPIXENT DUPIXENT PA All FDA-approved indications not otherwise excluded. Other Diagnosis, prescriber specialty, other medications tried and length of trials 18 years of age and older (initial and continuation) Prescribed by or in consultation with a an allergist, immunologist or dermatologist (initial and continuation) Initial-16 weeks, Continuation-1 year Initial Therapy- Patient meets all both of the following criteria: Patient has used at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid for at least 28 consecutive days OR patient has atopic dermatitis affecting ONLY the face, eyes/eyelids, skin folds, and/or genitalia and has tried tacrolimus ointment for at least 28 consecutive days, AND Inadequate efficacy was demonstrated with these previously tried topical prescription therapies, according to the prescribing physician. Continuation- Approve if the patient has responded to Dupixent therapy as determined by the prescribing physician (e.g., marked improvements erythema, induration/papulation/edema, excoriations, and lichenification, reduced pruritus, decreased requirement for other topical or systemic therapies, reduced body surface area (BSA) affected with atopic dermatitis, or other responses observed). 20

26 Dysport DYSPORT PA All FDA-approved indications not otherwise excluded. Plus Spasticity and anal fissures. Use in the management of cosmetic uses. Authorization for 12 months Other 21

27 Enbrel ENBREL ENBREL SURECLICK PA All FDA-approved indications not otherwise excluded plus patient already started on etanercept for a covered use. Graft versus host disease (GVHD). Behcet's disease. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris, mucous membrane pemphigoid [cicatricial pemphigoid]) (AMBD). Uveitis. 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 and other medications tried for the diagnosis provided. Rheumatoid arthritis (RA), Psoriatic arthritis (PA), and Ankylosing spondylitis (AS), patients 18 years of age and older. Plaque psoriasis (PP), patients 4 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (JIA)/ Juvenile Rheumatoid Arthritix (JRA) in patients 2 years of age and older. All other conditions, patients 18 years of age or older. RA/AS/JIA/JRA, prescribed by or in consult with rheumatologist. PA, prescribed by or in consultation with rheumatologist or dermatologist. PP/Cic Pemphigoid AMBD, prescribed by or in consult with a dermatologist. GVHD, prescribed by or in consult with an oncologist, hematologist, or physician affiliated with a transplant center. Behcets disease, prescribed by or in consult with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist. Authorization will be for 12 months. 22

28 PA Other For RA, the patient must have had a trial with a conventional DMARD regimen (eg, methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide) including concurrent use of two or three of the conventional DMARDs for 3 months unless the patient experienced intolerance, or the patient has tried and failed at least one biologic DMARD for 3 months unless the patient experienced intolerance. For JIA/JRA, tried another agent (eg, MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if the patient has absolute contraindication to MTX, sulfasalazine, or leflunomide or if the patient has aggressive disease. For PP, the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, adalimumab, infliximab, or apremilast) 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 AS, must have active disease despite treatment with one or more NSAIDs. For GVHD, has tried or currently is receiving one conventional GVHD treatment (high-dose SC, CSA, tacrolimus, MM, thalidomide, antithymocyte globulin, etc.). For Behcet's, have not responded to at least one conventional treatment (eg, CS, immunosuppressant, interferon alfa, MM, etc) or adalimumab or infliximab. For Cic Pemp AMBD, tried 2 conventional treatments (eg, systemic corticosteroids, azathioprine, cyclophosphamide, dapsone, MTX, cyclosporine, mycophenolate mofetil). For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 23

29 Entresto ENTRESTO ORAL TABLET MG, MG, MG PA All FDA-approved indications not otherwise excluded. Combination therapy with an ACE inhibitor/ace inhibitor containing product, an ARB containing product, or Tekturna (aliskiren tablets) or a Tekturna-Containing Product in patients with diabetes Must have LVEF less than or equal to 40 percent prior to initiation with Entresto Other Prescribed by, or in consultation with, a cardiologist Prior Authorization will be approved for 12 months Chronic HF - Must meet both of the following: Have tried ONE ACE inhibitor for HF (e.g., captopril, enalapril, lisinopril, quinapril, fosinopril) or ARB(e.g. valsartan, candesartan) or have a contraindication to use an ACE inhibitor or ARB (e.g., history of angioedema, hypotension, impaired renal function, hyperkalemia) AND Have tried or is currently receiving one beta blocker for heart failure treatment (e.g., metoprolol succinate sustained release, carvedilol, bisoprolol, Coreg CR) and/or Corlanor or have a contraindication to use of beta blocker therapy (e.g., bronchospastic disease such as COPD and asthma, severe hypotension). 24

30 Entyvio ENTYVIO PA All FDA-approved indications not otherwise excluded. Other Prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months Tried at least one TNF blocker for Crohn's disease (for example, Humira, Cimzia, or Remicade) for at least 2 months, unless intolerant. Tried at least one TNF blocker for Ulcerative Colitis (for example, Humira, Remicade, or Simponi [subcutaneous])for at least 2 months, unless intolerant. 25

31 Epclusa EPCLUSA PA All FDA-approved indications not otherwise excluded from Part D. Other will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. 18 years of age or older Must be prescribed by (or had a documented consult with) a gastroenterologist, infectious disease specialist, or a practitioner specializing in the treatment of hepatitis. Consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria Genotype 1 and Genotype 3 preferred product. will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. Please see zation_dhs.pdf 26

32 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 PA All FDA-approved 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. 27

33 PA 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 28

34 Erivedge ERIVEDGE PA All FDA-approved indications not otherwise excluded. Other Authorization will be for 12 months. to be used for the FDA-approved indication of metastatic basal cell carcinoma, locally-advanced basal cell carcinoma that has recurred following surgery, or locally-advanced basal cell carcinoma in a patient who is not a candidate for surgery or radiation. 29

35 Esbriet ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET 267 MG, 801 MG PA All FDA-approved indications not otherwise excluded. Authorization will be for 12 months Other 30

36 Farydak FARYDAK PA All FDA-approved indications not otherwise excluded. Other Authorization is for 12 months MM - must be used in combination with Velcade and dexamethasone AND previously tried Velcade and one immunomodulatory drug (i.e., Thalomid, Revlimid, or Pomalyst). 31

37 Forteo FORTEO PA All FDA-approved indications not otherwise excluded. 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 up to 2 years in a patient's lifetime. 32

38 PA Other Treatment of PMO, approve if pt has tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried an IV bisphosphonate (ibandronate or zoledronic acid), OR pt has severe renal impairment (creatinine clearance less than 35 ml/min) or CKD or pt has had multiple osteoporotic fractures. Increase bone mass in men with primary or hypogondal osteoporosis/treatment of men and women with GIO, approve if pt tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the patient cannot swallow or has difficulty swallowing or the patient cannot remain in an upright position post oral bisphosphonate administration or has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried zoledronic acid (Reclast), OR pt has severe renal impairment (CrCL less than 35 ml/min) or has CKD or has had multiple osteoporotic fractures. 33

39 Gilenya GILENYA PA All FDA-approved indications not otherwise excluded. Must not be given in combination with Avonex, Betaseron, Extavia, Copaxone, Rebif or Tysabri. Other Authorization will be for 12 months. Must have tried one of the following injectable medications: Avonex (interferon beta-1a IM), Rebif (interferon beta-1a SC), Betaseron or Extavia (interferon beta 1b) or Copaxone (glatiramer acetate), or that the patient is unable to administer injections such as these due to dexterity issues or visual impairment, or has tried Tysabri. 34

40 Gilotrif GILOTRIF ORAL TABLET 20 MG, 30 MG, 40 MG PA All FDA-approved indications not otherwise excluded. Diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) Other Authorization will be for 12 months. Patient must have epidermal growth factor receptor (EGFR) exon 19 deletion as detected by a Food and Drug Administration (FDA)- approved test OR the patient does not have exon 21 (L858R) substitution as detected by an FDA-approved test. 35

41 Glucagon-like Peptide-1 Agonists BYDUREON BYETTA SUBCUTANEOUS PEN INJECTOR 10 MCG/DOSE(250 MCG/ML) 2.4 ML, 5 MCG/DOSE (250 MCG/ML) 1.2 ML VICTOZA 3-PAK PA All FDA-approved indications not otherwise excluded. Authorization will be for 12 months. Other 36

42 Growth Hormones NUTROPIN AQ NUSPIN PA All FDA-approved indications not otherwise excluded. Growth hormone (GH) deficiency (DF). Non-GH deficient short stature (idiopathic short stature, ISS). Turner's syndrome (TS). SHOX (short stature homeobox-containing gene) deficiency. Chronic kidney disease (CKD) Prader-Willi syndrome (PW). Noonan syndrome (NS). Short bowel syndrome (SBS) Use in the management of acute critical illness due to complications of surgery, trauma, or with acute respiratory failure, as antiaging therapy, to improve functional status in elderly, somatopause, enhancement of athletic ability, bone marrow transplant (BMT) without total body irradiation, bony dysplasias, burn injury, cardiac transplantation, central precocius puberty, chronic fatigue syndrome, congenital adrenal hyperplasia, constitutional delay of growth and puberty, corticosteroid-induced short stature including a variety of chronic glucocorticoid-dependent conditions, such as asthma, juvenile rheumatoid arthritis, after renal, heart, liver, or BMT, Crohn's disease, cystic fibrosis, dilated cardiomyopathy/heart failure, end-stage renal disease in adults undergoing hemodialysis, Down's syndrome, familial dysautonomia, fibromyalgia, HIV-infected patients with alterations in body fat distribution, infertility, kidney transplant patients (children) with a functional renal allograft, liver transplantation, multiple system atrophy, myelomeningocele, obesity, osteogenesis imperfecta, osteoporosis (postmenopausal, idiopathic in men, glucocorticoid-induced), thalassemia, and X-linked hypophosphatemic rickets (familial hypophosphatemia, hypophosphatemic rickets). 37

43 PA Child/adol GH DF initial tx, eval by an endocrin, documented GH stim test w/gh response less than 10 ng/ml AND base Ht less than the 10th pct for gender/age + pretx Ht growth rate (GR) child less than 3 yrs of less than 7 cm/yr and child greater than or equal to 3 yrs of less than 4 cm/yr OR child/adol less than 18 yrs of age GR less than the 10th pct for age/gender based on min 6 mo data.child w/brain radiation does not have to meet bas Ht crit.congenital hypopituit does not have to meet Ht or GR crit.child w/hypophysectomy,approve.child/adol GH DF cont tx, GR increased by 4 cm/yr or more in most recent yr (MRY) + epiphyses open (between 12 and 18 yrs),both crit exclude adol w/hypopituit.review GR annually.adoles/yng adult w/completed linear growth (GR less than 2 cm/yr), review for adult GH DF.Greater than 18 yrs,gr increased by 4 cm/yr or more in MRY AND epiphyses open, auth not allowed if midparental ht attained.iss child w/open epiphyses,6 mo trial if base Ht less than 5th pct + pretx GR child greater than or equal to 7 yrs of less than 4 cm/yr and child 3 or more yrs of less than 4 cm/yr OR child any age GR less than the 10th pct for age/gender based on min 6 mo of data and has condition which GH effective + endocrinol certifies via bone-age x-ray, + the pt doesn t have constitutional delay of growth and puberty (CDGP).Auth after initial tx based on adequate clinical response (annualized GR doubles).cont tx, at least 7 yrs and received somatropin on 6 mo trial, if GR has doubled in comparison to previous yr. At least 7 and less than 12 yrs, GR increased by 4 cm/yr or more in MRY. At least 12 and less than or equal to 18 yrs), GR increased by 4 cm/yr or more in MRY AND epiphyses open).greater than 18 yrs, GR increased by 4 cm/yr or more in MRY,+ epiphyses open auth not allowed if midparental ht attained.adult GH DF or PW/trans adoles, eval by endocrinol (start and annually).ns/shox/child PW, eval by an endocrinol, CKD, eval by an endocrin or nephrologist. Child/adolesc w/gh DF (initial tx), adolescent is less than or equal to 18 years of age.ts, children. SHOX/CRI/NS, children/adolescents.hiv infection w/wasting or cachexia, less than or equal to 18 years of age.sbs/hiv cachexia/wasting, adults. For adults, the endocrinologist must certify that the somatropin is not being prescribed for anti-aging therapy or to enhance athletic ability. 38

44 PA GH DF 12 mos.sbs 4-8wks/yr.Non-GH DF ISS 6 mos.hiv wast/cach 24 wks. Other 39

45 Harvoni HARVONI PA All FDA-approved indications not otherwise excluded from Part D. Other will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. 18 years of age or older Must be prescribed by (or had a documented consult with) a gastroenterologist, infectious disease specialist, or a practitioner specializing in the treatment of hepatitis. Consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria Genotype 5 and Genotype 6 preferred product. will be applied consistent with Minnesota Department of Human Services hepatitis C prior authorization criteria. Please see zation_dhs.pdf 40

46 Humira HUMIRA HUMIRA PEDIATRIC CROHN'S START HUMIRA PEN HUMIRA PEN PSORIASIS-UVEITIS PA All FDA-approved indications not otherwise excluded plus patients already started on adalimumab 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 and other medications tried for the diagnosis provided. Rheumatoid arthritis (RA), Psoriatic arthritis (PA), Ankylosing spondylitis (AS), Ulcerative colitis (UC), and Plaque psoriasis (PP), patients 18 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years and older. Crohn's disease (CD), patients 6 years of age and older. All other conditions, patients 18 years of age and older. RA/JIA/JRA/AS, prescribed by or in consultation with rheumatologist. PA, prescribed by or in consultation with a rheumatologist or dermatologist. PP, prescribed by or in consultation with a dermatologist. UC/CD, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months 41

47 PA Other For RA, the patient must have had a trial with a conventional DMARD regimen (eg, methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide) including concurrent use of two or three of the conventional DMARDs for 3 months unless the patient experienced intolerance, or the patient has tried and failed at least one biologic DMARD for 3 months unless the patient experienced intolerance. For JIA/JRA, tried another agent (eg, MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if the patient has absolute contraindication to MTX, sulfasalazine, or leflunomide or if the patient has aggressive disease. For PP, the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, etanercept, infliximab, or apremilast) 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 AS, must have active disease despite treatment with one or more NSAIDs. For CD, 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, infliximab, ustekinumab, vedolizumab) 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, infliximab, 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 continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 42

48 Ibrance IBRANCE PA All-FDA approved indications not otherwise excluded. Plus breast cancer in men and liposarcoma. Other Authorization for 12 months Breast cancer in women - approve in advanced (metastatic) ER positive disease and HER2-negative breast cancer. Ibrance will be used in combination with letrozole as initial endocrine-based therapy in postmenopausal women OR in combination with Faslodex in women with disease progression following endocrine therapy. Breast Cancer in men - approve in advanced (metastatic) ER positive disease and HER2-negative breast cancer. The patient is receiving a leutinizing hormone-releasing hormone (LHRH) agonist (e.g., Lupron [leuprolide], Trelstar [triptorelin], Zoladex (goserelin]) AND Ibrance will be used as first-line endocrine therapy in combination with anastrozole, exemestane, or letrozole. Liposarcoma - approve is the patient has welldifferentiated/dedifferentiated liposarcoma. 43

49 Iclusig ICLUSIG ORAL TABLET 15 MG, 45 MG PA All medically-accepted indications not otherwise excluded plus patients already started on Iclusig for a covered use. Authorization will be for 12 months. 44

50 PA Other For Chronic Myeloid Leukemia (CML) That is Philadelphia Chromosome Positive. Approve if the patient meets ONE of the following criteria: the patient is T315I-positive, OR the patient has tried two other tyrosine kinase inhibitors indicated for use in Philadelphia chromosome positive CML (e.g., Gleevec [imatinib tablets], Sprycel [dasatinib tablets], Tasigna [nilotinib capsules]). Also approve in adult patients with T315I-positive CML (CP, AP, or BP)or CP, AP, BP for whom no other TKI therapy is indicated or CML with T315I mutation or for patients with disease that has not responded to two or more TKIs. For Acute Lymphoblastic Leukemia (ALL) That is Philadelphia Chromosome Positive (Ph+). Approve if the patient meets ONE of the following criteria: the patient is T315Ipositive, OR the patient has tried two other tyrosine kinase inhibitors that are used for Philadelphia chromosome positive ALL (e.g., Gleevec [imatinib tablets], Sprycel [dasatinib tablets]). Also approve in adult patients with T315I-positive Ph+ ALL or adult patients with Ph+ ALL for whom no other TKI therapy is indicated or patient with relapsed or refactory ALL. Approve if patient has been started on Inclusig for indication or condition addressed above. 45

51 Kalydeco KALYDECO ORAL TABLET PA All FDA-approved indications not otherwise excluded. Combination use with Orkambi Other Two years of age and older Prescribed by or inconsultation with a pulmonologist or a physician who specializes in CF Authorization will be for 3 years. CF - must have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D, OR R117H AND must NOT be Homozygous for the F508del Mutation in the CFTR Gene or have unknown CFTR gene mutations. 46

52 Lemtrada LEMTRADA PA All FDA approved indications not otherwise excluded. 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. 47

53 Lenvima LENVIMA PA All FDA-approved indications not otherwise excluded. Other Authorization for 12 months DTC - must be locally recurrent or metastatic, progressive refractory to radioactive iodine treatment for approval. 48

54 Letairis Tracleer LETAIRIS TRACLEER PA All medically-accepted indications not otherwise excluded. The patient has a diagnosis of PAH (WHO Group 1) For Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) must be prescribed by or in consultation with a cardiologist or a pulmonologist Authorization will be for 12 months. 49

55 PA Other For PAH patient must have had a right heart catheterization to confirm the diagnosis of PAH (WHO Group 1). For Digital Ulcers/Systemic Sclerosis approve if patient has tried two other therapies for this condition such as calcium channel blockers (CCBs) [e.g., amlodipine, felodipine, nifedipine], alpha-adrenergic blockers (e.g., prazosin), nitroglycerin, phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil tablets, Levitra [vardenafil tablets]), or angiotensin converting enzyme (ACE) inhibitors OR the patient has tried one vasodilator/prostanoid therapy (e.g., epoprostenol injection, alprostadil injection). For Chronic Thromboembolic Pulmonary Hypertension (CTEPH) approve if he patient meets ONE of the following: The patient has tried Adempas ORThe patient has a specific contraindication to use of Adempas according to the prescribing physician (e.g., the patient is receiving nitrates or nitric oxide donors, the patient is receiving a phosphodiesterase inhibitor [e.g., Revatio, Adcirca], the patient is hypotensive or is at risk for hypotension) OR The patient is currently receiving Tracleer for CTEPH. 50

56 Lonsurf LONSURF PA All FDA-approved indications not otherwise excluded Other Authorization is for 12 months Metastatic CRC - As per labeling, the patient has been previously treated with a fluoropyrimidine (e.g., capecitabine, 5-FU) AND oxaliplatin AND irinotecan AND if the tumor or metastases are wildtype KRAS and/or NRAS (that is, the tumors or metastases are KRAS and/or NRAS mutation negative) Erbitux or Vectibix has been tried. 51

57 Lynparza LYNPARZA PA All FDA-approved indications not otherwise excluded. Plus patients already started on Lynparza. Other Authorization will be for 12 months. Ovarian cancer approve if the patient has a germline BRCA mutation AND as per product labeling, has progressed on 3 or more prior lines of chemotherapy. 52

58 Makena hydroxyprogesterone caproate MAKENA PA All medically accepted indications not otherwise excluded from Part D. Preterm labor - Patients pregnant with multiple gestations (e.g., twins, triplets, or other multiples). Other Preterm Labor - Medication being prescribed by (or with a documented consultation from) a Maternal Fetal Medicine specialist, or OBGYN specialty. Preterm Labor - 21 weeks. All other indications - 12 months. Preterm Labor - Patient is pregnant with a singleton pregnancy, AND Patient has a history of singleton spontaneous preterm birth (SPTB) prior to 37 weeks gestation, AND Treatment will begin in patients who are at least 16 weeks, 0 days of gestation, according to the prescribing physician or other prescriber. 53

59 Mekinist MEKINIST PA All medically-accepted indications not othewise excluded. The patient does not have a BRAF V600E or BRAF V600K mutation, as detected by an FDA-approved test. Diagnosis of Melanoma, Unresectable or Metastatic with BRAF V600E or BRAF V600K Mutation that has been detected by an FDA-approved test. Other Authorization will be for 12 months. For monotherapy approve in patients who have not experienced disease progression on prior BRAF inhibitor treatment (e.g., Tafinlar or Zelboraf). Note: This does not include patients who have experienced a prior intolerance to BRAF inhibitors. For combination therapy with Tafinlar approve even if patients have experienced disease progression on a BRAF inhibitor (e.g., Zelboraf or Tafinlar). 54

60 Natpara NATPARA PA All FDA-approved indications not otherwise excluded. Other Prescribed by or in consultation with an endocrinologist. Authorization for 12 months Chronic hypoparathyroidism - Before starting Natpara, serum calcium concentration is greater than 7.5 mg/dl and 25- hydroxyvitamin D stores are sufficient per the prescribing physician AND as per product labeling, patient cannot be well-controlled on calcium supplements and active forms of vitamin D alone 55

61 Neulasta NEULASTA PA All FDA-approved indications not otherwise excluded plus patients undergoing PBPC collection and therapy Cancer patients receiving chemotherapy, if prescribed by or in consultation with an oncologist or hematologist. RS - prescribed by, or in consultation with, a physician with expertise in treating acute radiation syndrome. PBPC - prescribed by or in consultation with an oncologist, hematologist, or physician that specializes in tranplantation. Cancer pts receiving chemo - 6 months, RS - 1 month, PBPC - 1 dose 56

62 PA Other Cancer patients receiving chemotherapy, approve if the patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), OR the patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years]), history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status, OR the patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor and a reduced dose or frequency of chemotherapy may compromise treatment. 57

63 Neupogen NEUPOGEN PA All FDA-approved indications not otherwise excluded plus patients with acute myeloid leukemia (AML) receiving chemotherapy, cancer patients receiving bone marrow transplantation (BMT), patients undergoing peripheral blood progenitor cell (PBPC) collection and therapy, and patients with severe chronic neutropenia [SCN] (e.g., congenital neutropenia, cyclic neutropenia, idiopathic neutropenia). Neutropenia associated with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Treatment of myelodysplastic syndromes (MDS). Drug induced agranulocytosis or neutropenia. Aplastic anemia (AA). Acute lymphocytic leukemia (ALL). AML, HIV/AIDS, MDS - adults Cancer/AML, MDS, ALL, oncologist or a hematologist. Cancer patients receiving BMT and PBPC, prescribed by or in consultation with an oncologist, hematologist, or a physician who specializes in transplantation. SCN, AA - hematologist. HIV/AIDS neutropenia, infectious disease (ID) physician (MD), hematologist, or MD specializing in HIV/AIDS. chemo/scn/aml-6 mo.hiv/aids-4 mo.mds-3 mo.pbpc,drug induce A/N,AA,ALL,BMT-1 mo.all others=12mo. 58

64 PA Other Cancer patients receiving chemotherapy, approve if the patient meets one of the following conditions: patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years], history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status), patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor (eg, Leukine, Neulasta, Neupogen) and a reduced dose or frequency of chemotherapy may compromise treatment, patient has received chemotherapy has febrile neutropenia and has at least one risk factor (eg, sepsis syndrome, aged greater than 65 years, severe neutropenia [absolute neutrophil account less than 100 cells/mm3], neutropenia expected to be greater than 10 days in duration, invasive fungal infection). 59

65 Ninlaro NINLARO ORAL CAPSULE 2.3 MG, 3 MG, 4 MG PA All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Ninlaro. Other 1 Year MM - be used in combination with Revlimid and dexamethasone AND pt had received at least ONE previous therapy for multiple myeloma (e.g., Velcade, Kyprolis, Thalomid, Revlimid, Pomalyst, Alkeran, dexamethasone, prednisone). 60

66 Nucala NUCALA PA All FDA-approved indications not otherwise excluded Concurrent use with Xolair 12 years of age and older Prescribed by or in consultation with an allergist, immunologist, or pulmonologist Authorization will be for 6 months initial, 12 months continuation. 61

67 PA 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 receptor antagonist, or D. Theophylline AND Patients asthma continues to be uncontrolled as defined by ONE of the following A. patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year, B. patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year C. patient has a FEV1 less than 80 percent predicted D. Patient has an FEV1/FVC less than 0.80, E. Patients asthma worsens upon tapering of oral corticosteroid therapy. Continuation - The patient has responded to Nucala 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 Patient continues to receive therapy with BOTH an inhaled corticosteroid AND one of the following inhaled LABA, inhaled longacting muscarinic antagonist, leukotriene receptor antagonist, or Theophylline 62