BELEODAQ. Prior Authorization Criteria Memorial Hermann HMO Formulary ID: Version 19 Effective Date: 10/27/2015. PRODUCT(s) AFFECTED BELEODAQ
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1 BELEODAQ BELEODAQ All FDA approved indications not otherwise excluded from Part D. Plan Year PAGE 1
2 BEXAROTENE BEXAROTENE All Medically Accepted Indications not otherwise excluded from Part D Patient must have tried one systemic therapy Prescriber is an oncologist 12/31/2015 PAGE 2
3 BOSULIF BOSULIF Signed statement of diagnosis from the physician, hepatic panel and CBC, trial and failure ofofimiatinib or dasatinibi and documentation of a 90 day response 12/31/15 PAGE 3
4 CIALIS - CIALIS TAB 2.5 MG - CIALIS TAB 5 MG Supporting statement of diagnosis from the physician and prior trial and failure of at least one alpha blocker and one alpha reductase inhibitor 12/31/15 PAGE 4
5 DELESTROGEN DELESTROGEN OIL 10 MG/ML All FDA approved indications not otherwise excluded from Part D diagnosis of menopause and must have documented trial/failure, contraindication or intolerance to formulary generic estrogen oral product 12/31/2015 PAGE 5
6 ENTRESTO ENTRESTO 1. Must have diagnosis of CHF (II-IV) AND 2. Must have concurrent therapy with BB AND 3. EF less than or equal 40% AND 4. No documented case of angiodema from prior ACEI/ARB therapy Must be prescribed by cardiologist 12/31/2015 PAGE 6
7 ERWINAZE ERWINAZE Supporting statement of diagnosis from the physician 12/31/15 PAGE 7
8 ESBRIET ESBRIET Appropriate diagnosis (idopathic pulmonary fibrosis [IPF]) and monitoring (hepatiac function/lfts) Prescriber must be a pulmonologist 12/31/2015 PAGE 8
9 ESRD THERAPY PROCRIT Hemogloblin less than 10 g/dl for patients receiving Cancer Chemotherapy and Hemoglobin less than 12 and Hematacrit less than 33 for other approved FDA indications in addition to supporting statement of diagnosis from physician 3 months PAGE 9
10 FARYDAK FARYDAK Statement of diagnosis from physician 12/31/2015 PAGE 10
11 FENTANYL - FENTORA TAB 200 MCG - FENTORA TAB 600 MCG - FENTORA TAB 400 MCG - FENTORA TAB 800 MCG - LAZANDA Supporting statement of diagnosis from the physician 12/31/15 PAGE 11
12 FULYZAQ FULYZAQ All FDA approved indications not otherwise excluded from Part D. Dx of non-infectious diarrhea and HIV, member must be on antiretroviral therapy. 12/31/15 PAGE 12
13 GILOTRIF GILOTRIF Supporting statement of diagnosis from the physician in patients with EGFR exon 19 deletions or exon 21 (L858R) substitution as detected by an FDA-approved test. 12/31/15 PAGE 13
14 GROWTH HORMONE - HUMATROPE RECON SOLN 12 MG - - NUTROPIN AQ NUSPIN NUTROPIN AQ PEN SOLUTION 20 MG/2ML - HUMATROPE RECON SOLN 24 MG NUTROPIN AQ NUSPIN 5 SAIZEN - SAIZEN CLICK.EASY Supporting statement of diagnosis from the physician 12/31/15 PAGE 14
15 HARVONI HARVONI Must submit documentation of chronic hepatitis C genotype (confirmed by HCV RNA level within the last 6 months) and subtype. Must submit laboratory results within 6 weeks of initiating therapy including: 1) CBC w Platelets, 2) AST/ALT, 3)Total Bilirubin, 4)Serum Albumin, 5)PT/INR, 6)Serum Creatinine, and 7)GFR. Patient must be age 18 or over Prescriber must be a gastroenterologist, hepatologist, or infectious disease specialist 24 weeks: treatment-experienced with cirrhosis, 12 weeks: All others PAGE 15
16 HRM - AMITRIPTYLINE HCL TAB 10 MG - - AMITRIPTYLINE HCL TAB 150 MG - - AMITRIPTYLINE HCL TAB 50 MG - - ASCOMP-CODEINE - - BENZTROPINE MESYLATE TAB 1 MG - - BUTALBITAL-APAP-CAFF-COD CAP MG - CHLORDIAZEPOXIDE-AMITRIPTYLINE - - CLOMIPRAMINE HCL CAP 25 MG - - CLOMIPRAMINE HCL CAP 75 MG - - CYCLOBENZAPRINE HCL TAB 5 MG - - CYPROHEPTADINE HCL TAB 4 MG - - DIGOX TAB 250 MCG - - DIGOXIN SOLUTION 0.25 MG/ML - - DIPYRIDAMOLE TAB 25 MG - - DIPYRIDAMOLE TAB 75 MG - - DISOPYRAMIDE PHOSPHATE CAP 150 MG - - DOXEPIN HCL CAP 100 MG - - DOXEPIN HCL CAP 25 MG - - DOXEPIN HCL CAP 75 MG - - ESTRADIOL TAB 0.5 MG - - ESTRADIOL TAB 2 MG - - GLYBURIDE 2.5 MG - - GLYBURIDE TAB 1.25 MG - AMITRIPTYLINE HCL TAB 100 MG AMITRIPTYLINE HCL TAB 25 MG AMITRIPTYLINE HCL TAB 75 MG BENZTROPINE MESYLATE TAB 0.5 MG BENZTROPINE MESYLATE TAB 2 MG BUTISOL SODIUM TAB 30 MG CHLORPROPAMIDE CLOMIPRAMINE HCL CAP 50 MG CYCLOBENZAPRINE HCL TAB 10 MG CYPROHEPTADINE HCL 4 MG DIGITEK TAB 250 MCG DIGOXIN SOLUTION 0.05 MG/ML DIGOXIN TAB 250 MCG DIPYRIDAMOLE TAB 50 MG DISOPYRAMIDE PHOSPHATE CAP 100 MG DOXEPIN HCL CAP 10 MG DOXEPIN HCL CAP 150 MG DOXEPIN HCL CAP 50 MG DOXEPIN HCL CONC 10 MG/ML ESTRADIOL TAB 1 MG GLYBURIDE 1.25 MG GLYBURIDE MICRONIZED GLYBURIDE TAB 2.5 MG GLYBURIDE-METFORMIN - GLYBURIDE TAB 5 MG - PAGE 16
17 - GUANFACINE HCL ER - - HYDROXYZINE HCL 25 MG - - HYDROXYZINE HCL SOLUTION 10 MG/5ML - - HYDROXYZINE HCL TAB 10 MG - - HYDROXYZINE HCL TAB 50 MG - - HYDROXYZINE PAMOATE CAP 25 MG - - IMIPRAMINE HCL TAB 10 MG - - IMIPRAMINE HCL TAB 50 MG - - INDOMETHACIN CAP 25 MG - - INDOMETHACIN ER - - KETOROLAC TROMETHAMINE 30 MG/ML - - KETOROLAC TROMETHAMINE SOLUTION - 15 MG/ML - KETOROLAC TROMETHAMINE SOLUTION - 60 MG/2ML - MACRODANTIN CAP 50 MG - - MEGESTROL ACETATE SUSPENSION 40 - MG/ML - MEGESTROL ACETATE TAB 20 MG - - MENEST - - METHOCARBAMOL TAB 500 MG - - METHYLDOPA TAB 250 MG - - METHYLDOPA-HYDROCHLOROTHIAZIDE - - METHYLPHENIDATE HCL ER TAB ER 24H - 27 MG - NIFEDIPINE CAP 10 MG - - NITROFURANTOIN MACROCRYSTAL CAP MG - NITROFURANTOIN MONOHYD MACRO - HYDROXYZINE HCL 10 MG HYDROXYZINE HCL 50 MG HYDROXYZINE HCL SYRUP 10 MG/5ML HYDROXYZINE HCL TAB 25 MG HYDROXYZINE PAMOATE CAP 100 MG HYDROXYZINE PAMOATE CAP 50 MG IMIPRAMINE HCL TAB 25 MG IMIPRAMINE PAMOATE INDOMETHACIN CAP 50 MG KETOROLAC TROMETHAMINE 15 MG/ML KETOROLAC TROMETHAMINE 60 MG/2ML KETOROLAC TROMETHAMINE SOLUTION 30 MG/ML KETOROLAC TROMETHAMINE TAB 10 MG MEGACE ES MEGESTROL ACETATE SUSPENSION 400 MG/10ML MEGESTROL ACETATE TAB 40 MG MEPROBAMATE METHOCARBAMOL TAB 750 MG METHYLDOPA TAB 500 MG METHYLDOPATE HCL METHYLPHENIDATE HCL ER TAB ER 27 MG NIFEDIPINE CAP 20 MG NITROFURANTOIN MACROCRYSTAL CAP 50 MG ORPHENADRINE CITRATE ER PAGE 17
18 - ORPHENADRINE CITRATE SOLUTION 30 MG/ML - PERPHENAZINE-AMITRIPTYLINE - PREMARIN TAB 0.45 MG - PREMARIN TAB 0.9 MG - PREMPHASE - RESERPINE TAB 0.1 MG - SURMONTIL - THIORIDAZINE HCL TAB 100 MG - THIORIDAZINE HCL TAB 50 MG - TRIHEXYPHENIDYL HCL - PENTAZOCINE-NALOXONE HCL - PREMARIN TAB 0.3 MG - PREMARIN TAB MG - PREMARIN TAB 1.25 MG - PREMPRO - SECONAL - THIORIDAZINE HCL TAB 10 MG - THIORIDAZINE HCL TAB 25 MG - TICLOPIDINE HCL - ZALEPLON 10 MG - ZALEPLON CAP 10 MG - ZOLPIDEM TARTRATE High risk medication. Automatically approved for beneficiaries less than or equal to 64 years. Attestation to the medical necessity for using this high risk medication, AND Monitoring plan for adverse side effects, AND Anticipated treatment course/duration, AND If formulary alternatives considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to the alternative(s). Less than or equal to 64 years old, claim for target drug automatically pays. Greater than or equal to 65 years old, prior authorization exception request is required indicating medically accepted indication not otherwise excluded from Part D. PAGE 18
19 12/31/15 PAGE 19
20 HRM2 MEGESTROL ACETATE SUSPENSION 625 MG/5ML High risk medication. Automatically approved for beneficiaries less than or equal to 64 years. Attestation to the medical necessity for using this high risk medication, AND Monitoring plan for adverse side effects, AND Anticipated treatment course/duration, AND If formulary alternatives considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to the alternative(s). Less than or equal to 64 years old, claim for target drug automatically pays. Greater than or equal to 65 years old, prior authorization exception request is required indicating medically accepted indication not otherwise excluded from Part D. NONE 12/31/2015 PAGE 20
21 IBRANCE IBRANCE All FDA approved indications not otherwise excluded from part D Appropriate diagnosis (used in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced breast cancer) 12/31/2015 PAGE 21
22 ICLUSIG ICLUSIG Must have documented trial and failure of another tyrosine kinase inhibitor Plan Year PAGE 22
23 IMBRUVICA IMBRUVICA Supporting statement of diagnosis from the physician 12/31/15 PAGE 23
24 KALYDECO KALYDECO Supporting statement of diagnosis from the physician 12/31/15 PAGE 24
25 KEYTRUDA KEYTRUDA Must have documented trial and failure or contraindication to Yervoy. If patient is BRAF V600 mutation positive, must also try a BRAF inhibitor prior to approval of Keytruda Plan Year PAGE 25
26 KORLYM KORLYM Pregnancy Supporting statement of diagnosis and relevant medical information from physician 12/31/15 PAGE 26
27 LIDODERM LIDODERM 12/31/15 PAGE 27
28 LYNPARZA LYNPARZA Appropriate diagnosis and testing for BRCA mutation (deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA approved test) advanced ovarian cancer that has been treated with 3 or more prior lines of chemotherapy) none none 12/31/2015 none PAGE 28
29 NORTHERA NORTHERA Prior authorization will be approved for the following indication(s): orthostatic dizziness, lightheadedness, or "the feeling that you are about to black out" in adults with neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (i.e., Parkinson disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy) Plan Year PAGE 29
30 OLYSIO OLYSIO Must have chronic hepatitis C genotype 1 infection. Must not have Q80K polymorphism resistance (confirmed by Genosure NS3/4 resistance testing). Patient must be age 18 or over Prescriber must be a gastroenterologist, hepatologist, or infectious disease specialist 12 weeks PAGE 30
31 OPDIVO OPDIVO Appropriate diagnosis (unresectable or metastatic melanoma and disease progression following ipilimumab [Yervoy]) and testing for BRAF V600 mutation. none none 12/31/2015 none PAGE 31
32 ORENITRAM ORENITRAM All FDA approved indications not otherwise excluded from Part D. Supporting statement of diagnosis from the physician 12/31/15 PAGE 32
33 ORKAMBI ORKAMBI "Initial Therapy: Must have 1. diagnosis of cystic fibrosis (CF) with documented homozygous F508del mutation confirmed by FDA-approved CF mutation test AND 2. Baseline FEV1 greater than or equal to 40% AND 3. Baseline liver function tests (ALT/AST and bilirubin) provided AND 4. If less than 18 years of age, baseline ophthalmological exam completed Continuation of therapy: 1. Documentation patient is tolerating and responding to medication (i.e. improved FEV1, weight gain, decreased exacerbations, etc.) AND 2. Adherence to therapy is confirmed (supported by documentation from patient s chart notes or electronic claim history) AND 3. Liver function tests (ALT/AST and bilirubin) provided with each renewal during first year of treatment and annually thereafter AND 4. ALT or AST does not exceed 5 times the upper limit of normal AND 5. ALT or AST does not exceed 3 times upper limit of normal with bilirubin greater than 2 times upper limit of normal" Must be greater than or equal to 12 years of age Must be prescribed by, or in conjunction with, a pulmonologist or is from a CF center accredited by PAGE 33
34 the Cystic Fibrosis Foundation 12/31/2015 PAGE 34
35 PART D VS PART B - ABRAXANE - ALBUTEROL SULFATE NEBU SOLN (2.5 MG/3ML) 0.083% - ALBUTEROL SULFATE NEBU SOLN 0.63 MG/3ML - AMBISOME - AMINOSYN II SOLUTION 7 % - AMINOSYN II/ELECTROLYTES - AMINOSYN-HBC - AMINOSYN-RF - ARRANON - ASTAGRAF XL - AZATHIOPRINE TAB 50 MG - BICNU - BUDESONIDE SUSPENSION 1 MG/2ML - CARBOPLATIN SOLUTION 150 MG/15ML - CARBOPLATIN SOLUTION 50 MG/5ML - CISPLATIN SOLUTION 100 MG/100ML - CALCITONIN (SALMON) - CELLCEPT INTRAVENOUS - CHLORPROMAZINE HCL SOLUTION 50 MG/2ML - CLADRIBINE - CLINIMIX E/DEXTROSE (2.75/5) - CLINIMIX E/DEXTROSE (4.25/25) - ADRUCIL - ALBUTEROL SULFATE NEBU SOLN (5 MG/ML) 0.5% - ALBUTEROL SULFATE NEBU SOLN 1.25 MG/3ML - AMINOSYN II SOLUTION 10 % - AMINOSYN II SOLUTION 8.5 % - AMINOSYN M - AMINOSYN-PF - AMINOSYN/ELECTROLYTES - ARZERRA - ATGAM - AZASAN - BIVIGAM - BUSULFEX - CARBOPLATIN SOLUTION 450 MG/45ML - CARBOPLATIN SOLUTION 600 MG/60ML - CISPLATIN SOLUTION 50 MG/50ML - CARIMUNE NF - CHLORPROMAZINE HCL SOLUTION 25 MG/ML - CHLORPROMAZINE HCL TAB 10 MG - CLINIMIX E/DEXTROSE (2.75/10) - CLINIMIX E/DEXTROSE (4.25/10) - CLINIMIX E/DEXTROSE (4.25/5) PAGE 35
36 - CLINIMIX E/DEXTROSE (5/15) - - CLINIMIX E/DEXTROSE (5/25) - - CLINIMIX/DEXTROSE (4.25/10) - - CLINIMIX/DEXTROSE (4.25/25) - - CLINIMIX/DEXTROSE (5/15) - - CLINIMIX/DEXTROSE (5/25) - - COSMEGEN - - CYCLOSPORINE 100 MG - - CYCLOSPORINE CAP 25 MG - - CYCLOSPORINE SOLUTION 50 MG/ML - - CYCLOPHOSPHAMIDE CAP 50 MG - - CYTARABINE (PF) - - DAUNORUBICIN HCL - - DACARBAZINE RECON SOLN 200 MG - - DEPO-PROVERA SUSPENSION 400 MG/ML - - DEXAMETHASONE SODIUM PHOSPHATE - SOLUTION 10 MG/ML - DOXIL - - ELLENCE - - EMEND CAP 40 MG - - EMEND CAP 80 MG - - EPIRUBICIN HCL SOLUTION 200 MG/100ML - - ETOPOPHOS - - ETOPOSIDE SOLUTION 100 MG/5ML - - FLEBOGAMMA DIF SOLUTION 10 - GM/100ML - FLEBOGAMMA DIF SOLUTION 5 GM/50ML - - FLUOROURACIL SOLUTION 2.5 GM/50ML - CLINIMIX E/DEXTROSE (5/20) CLINIMIX/DEXTROSE (2.75/5) CLINIMIX/DEXTROSE (4.25/20) CLINIMIX/DEXTROSE (4.25/5) CLINIMIX/DEXTROSE (5/20) CLOLAR CROMOLYN SODIUM NEBU SOLN 20 MG/2ML CYCLOSPORINE CAP 100 MG CYCLOSPORINE MODIFIED CYCLOPHOSPHAMIDE CAP 25 MG CYRAMZA CYTARABINE SOLUTION 20 MG/ML DOXORUBICIN HCL DAUNOXOME DEXAMETHASONE SOD PHOSPHATE PF DOCEFREZ RECON SOLN 20 MG ELIGARD EMEND CAP 125 MG EMEND CAP 80 & 125 MG ENGERIX-B EPIRUBICIN HCL SOLUTION 50 MG/25ML ETOPOSIDE SOLUTION 1 GM/50ML ETOPOSIDE SOLUTION 500 MG/25ML FLEBOGAMMA DIF SOLUTION 20 GM/200ML FLUOROURACIL SOLUTION 1 GM/20ML FLUOROURACIL SOLUTION 5 GM/100ML PAGE 36
37 - FLUOROURACIL SOLUTION 500 MG/10ML - - FREAMINE HBC - - GAMMAGARD S/D - - GAMMAKED - - GANCICLOVIR SODIUM - - GRANISETRON HCL - - HERCEPTIN - - IDAMYCIN PFS - - IFOSFAMIDE - - IPRATROPIUM BROMIDE SOLUTION 0.02 % - - IRINOTECAN HCL SOLUTION 100 MG/5ML - - IXEMPRA KIT - - KEPIVANCE - - MELPHALAN HCL - - METHOTREXATE SODIUM - - METHOTREXATE TAB 2.5 MG - - MIRCERA SOLN PRSYR 100 MCG/0.3ML - - MIRCERA SOLN PRSYR 75 MCG/0.3ML - - MITOMYCIN RECON SOLN 20 MG - - MITOMYCIN RECON SOLN 5 MG - - MYCOPHENOLATE MOFETIL CAP 250 MG - - MYCOPHENOLIC ACID - - NEPHRAMINE - - ONCASPAR - - ONDANSETRON HCL 4 MG - - ONDANSETRON HCL 40 MG/20ML - - ONDANSETRON HCL SOLUTION 4 MG/2ML - FOLOTYN GAMMAGARD GAMMAGARD S/D LESS IGA GAMMAPLEX GENGRAF HEPATAMINE IDARUBICIN HCL IFEX INTRALIPID EMULSION 20 % IPRATROPIUM-ALBUTEROL IRINOTECAN HCL SOLUTION 40 MG/2ML JEVTANA LEVOLEUCOVORIN CALCIUM MESNA METHOTREXATE SODIUM (PF) METRONIDAZOLE IN NACL MIRCERA SOLN PRSYR 50 MCG/0.3ML MITOMYCIN 20 MG MITOMYCIN RECON SOLN 40 MG MUSTARGEN MYCOPHENOLATE MOFETIL TAB 500 MG NEBUPENT NULOJIX ONDANSETRON ONDANSETRON HCL 4 MG/2ML ONDANSETRON HCL 8 MG ONDANSETRON HCL SOLUTION 4 MG/5ML PAGE 37
38 - ONDANSETRON HCL SOLUTION 40 MG/20ML - ONDANSETRON HCL TAB 4 MG - OXALIPLATIN - PACLITAXEL CONC 30 MG/5ML - PARICALCITOL SOLUTION 2 MCG/ML - PROCALAMINE - PROSOL - RABAVERT - RECOMBIVAX HB - SANDIMMUNE CAP 100 MG - SANDIMMUNE SOLUTION 100 MG/ML - SIROLIMUS TAB 1 MG - TACROLIMUS CAP 0.5 MG - TACROLIMUS CAP 5 MG - TETANUS-DIPHTHERIA TOXOIDS TD - THYMOGLOBULIN - TOPOSAR - TORISEL - TREANDA RECON SOLN 100 MG - TREXALL - VENTAVIS - VINBLASTINE SULFATE SOLUTION 1 MG/ML - VINCASAR PFS - VORICONAZOLE RECON SOLN 200 MG - ZEMPLAR CAP 2 MCG - ONDANSETRON HCL TAB 24 MG - ONDANSETRON HCL TAB 8 MG - PACLITAXEL CONC 100 MG/16.7ML - PACLITAXEL CONC 300 MG/50ML - PREMASOL SOLUTION 6 % - PROGRAF SOLUTION 5 MG/ML - PULMOZYME - RAPAMUNE SOLUTION 1 MG/ML - RHEUMATREX - SANDIMMUNE CAP 25 MG - SIROLIMUS TAB 0.5 MG - SIROLIMUS TAB 2 MG - TACROLIMUS CAP 1 MG - TAXOTERE - THIOTEPA RECON SOLN 15 MG - TOBRAMYCIN NEBU SOLN 300 MG/5ML - TOPOTECAN HCL RECON SOLN 4 MG - TRAVASOL - TREANDA RECON SOLN 25 MG - UVADEX - VINBLASTINE SULFATE RECON SOLN 10 MG - VINCRISTINE SULFATE SOLUTION 1 MG/ML - VINORELBINE TARTRATE - ZEMPLAR CAP 1 MCG - ZINECARD - ZORTRESS PAGE 38
39 DETAILS This drug may be covered under Medicare Part B or D depending on the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. PAGE 39
40 PRIFTIN PRIFTIN. 12/31/2015 PAGE 40
41 PROVIGIL - MODAFINIL TAB 100 MG - MODAFINIL TAB 200 MG Supporting statement of diagnosis from the physician 12/31/15 PAGE 41
42 QUININE QUININE SULFATE CAP 324 MG All FDA approved indications not otherwise excluded from Part D. Supporting statement of diagnosis and relevant medical information from physician 12/31/15 PAGE 42
43 REGRANEX REGRANEX Diabetic Neuropathic Ulcers: Diabetic patient with ulcer wound. Treatment will be given in combination with ulcer wound care (eg, debridement, infection control, and/or pressure relief). Diabetic Neuropathic Ulcers: Maximum 5 months. PAGE 43
44 RELISTOR - RELISTOR SOLUTION 12 MG/0.6ML - RELISTOR SOLUTION 8 MG/0.4ML. 12/31/2015 PAGE 44
45 REVATIO - REVATIO SOLUTION 10 MG/12.5ML - SILDENAFIL CITRATE TAB 20 MG Supporting statement of diagnosis from the physician 12/31/15 PAGE 45
46 REXULTI REXULTI All Medically Accepted Indications not otherwise excluded from Part D. Statement of Diagnosis from the prescriber and documented trial and failure, contraindication, or intolerance to aripiprazole. 12/31/2015 PAGE 46
47 SAMSCA SAMSCA Supporting statement of diagnosis from the physician 12/31/15 PAGE 47
48 SOVALDI SOVALDI Must have genotype 1,2,3,4,5, or 6 Patient must be age 18 or over. Prescriber must be a gastroenterologist, hepatologist, or infectious disease specialist 12 weeks:genotype 1,2,or4_24 wks:genotype 3 OR no interferon_48 wks:liver cancer awaiting transplant PAGE 48
49 STIVARGA STIVARGA Supporting statement of diagnosis from the physician 12/31/15 PAGE 49
50 XALKORI XALKORI Supporting statement of diagnosis from the physician that establishes the cancer as anaplastic lymphoma kinase (ALK)-positive must be prescribed by an oncologist 12/31/15 PAGE 50
51 XTANDI XTANDI Supporting statement of diagnosis from the physician and prior trial and failure of docetaxel 12/31/15 PAGE 51
52 ZOHYDRO ZOHYDRO ER All FDA approved indications not otherwise excluded from Part D. Must have severe pain requiring around the clock long term opioid, AND all of these: 1- ONE of the following formulary opioid options, hydrocodone IR, oxycodone IR, morphine IR, hydromorphone IR, methadone, OR oxymorphone IR are ineffective,not tolerated or inadequate for controlling pain AND fentanyl patches are ineffective, not tolerated, or inadequate for controlling pain 2-Must discontinue all other around-the-clock opioids when initiated 3-Care plan/agreement for opioid therapy has been established 4-Pt advised of risks and provides informed consent for chronic opioid therapy 5-Pt assessed for all these (i)pain severity (ii)suitability of non-opioids (iii)physical & emotional functional status (iv)risk of or current aberrant drug behavior 5-Prescriber will monitor for signs of misuse, abuse and addiction during therapy AND ONE of these: A-Opioid naive/non-tolerant must start at 10mg twice day for 7 days before titrating up OR B-Opioid tolerant, receiving one of these doses per day for at least 1 week: 60mg oral morphine, 25mcg transdermal fentanyl/hr, 30mg oral oxycodone, 8mg oral hydromorphone, 25mg oral oxymorphone Adults: 18 years and older. Prescriber is knowledgeable in the use of potent opioids for the management of chronic pain PAGE 52
53 90 days PAGE 53
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