Brand Generic J-Code Covered Uses Required Medical Information and Criteria

FIDELIS CARE NEW YORK DEPARTMENT OF PHARMACY SERVICES J-Code Prior Authorizations & Required Clinical Information Medicaid, Family Health Plus, Child Health Plus, NY State of Health Brand Generic J-Code Covered Uses Required Medical Information and Criteria Orencia Abatacept J0129 Rheumatoid arthritis Juvenile idiopathic arthritis for ages 6 and older Failed TNF blockers +/- DMARDS Patient weight, CBC with differential, tuberculin skin test results, immunization history Depo-Provera Medroxyprogesterone J0150 Abnormal uterine bleeding Diagnostic measures to rule out malignancy Endometrial hyperplasia Endometriosis Secondary physiologic amenorrhea Fabrazyme Algalsidase beta J0180 Fabry Disease for ages 8 and older Enzyme assay showing deficiency of alpha-galactosidase activity or DNA testing Patient's weight, IgG, IgE, serum creatinine, BUN Premedicate with antipyretics Ceredase Alglucerase J0205 Gaucher Disease (type 1) for ages 2 and over Patient's weight, CBC, platelets, acid phosphatase (AP), liver function tests, plasma glucocerebroside, IgG antibody Amevive Alefacept J0215 Plaque psoriasis CD4 + T-lymphocyte, immunization history transaminase, body surface area affected, tuberculin skin test results Previous trial of phototherapy Previous trial with adalimumab and etanercept Myozyme Alglucosidase alfa J0220 Pompe Disease Patient weight, liver enzymes, IgG & IgE antibodies Lumizyme Alglucosidase alfa J0221 Pompe Disease Patient weight, liver enzymes, IgG & IgE antibodies Enrolled in Lumizyme ACE program Prolastin, Aralast (Multiple) Glassia Alpha 1-proteinase inhibitor Alpha 1-proteinase inhibitor J0256 Alpha 1-antitrypsin deficiency Patient weight, pulmonary function tests, non-smoker COPD diagnosis - emphysema, concomitant COPD treatment, normal CRP levels Absence of IgA deficiency/ anti- IgA antibodies J0257 Alpha 1-antitrypsin deficiency Patient weight, pulmonary function tests, non-smoker COPD diagnosis - emphysema, concomitant COPD treatment, CRP levels Absence of IgA deficiency/ anti- IgA antibodies 1

Caverject Alprostadil J0270 Covered for diagnostic purposes Appropriate clinical documentation per indication Lioresal Baclofen intrathecal J0476 Spasticity Spinal cord injury, multiple sclerosis, or other spinal disease Previous trial of baclofen oral therapy Simulect Basiliximab J0480 Renal transplant rejection Concomitant use of cyclosporine and corticosteroid CBC, renal function Benlysta Belimumab J0490 Systemic lupus erythematosus Patient weight, serum creatinine, immunization history No concurrent use of cyclophosphamide or biological therapies Concomitant use of conventional lupus treatment Botox Onabotulinum toxina J0585 Blepharospasm 12 years of age Cervical dystonia 16 years of age Migraine prophylaxis Hyperhidrosis of axilla Incontinence overactive bladder Strabismus 12 years of age Upper limb spasticity Previous trial of 2 migraine prophylaxis agents, 15 headaches per month with 4 hours/day duration Previous trial of a topical agent for hyperhidrosis of axilla dx, hyperhidrosis disease severity scale score Previous trial with an anticholinergic medication for overactive bladder dx, detrusor overactivity related to a neurologic condition Dysport Abobotulinum toxina J0586 Cervical dystonia Failed trial with muscle relaxant Myobloc Rimabotulinum toxinb J0587 Cervical dystonia Failed trial with muscle relaxant Xeomin Incobotulinum toxin A J0588 Blepharospasm Previous trial with Botox Cervical dystonia Rhytide of glabellar skin Buprenex Buprenorphine J0592 Moderate-to-severe pain Patient liver enzyme levels Previous trial of long acting opioids, adequate dose based on conversion Berinert C1-esterase inhibitor J0597 Hereditary angioedema Patient weight, history of attacks Previous medication trials and outcome 12 years of age 2

Cinryze C1-esterase Inhibitor J0598 Hereditary angioedema, prophylaxis Patient weight, history of attacks Previous medication trials and outcome 9 years of age Ilaris Canakinumab J0638 Cryopyrin associated periodic syndrome Familial cold urticarial 4 years of age Muckle-Wells syndrome 4 years of age Systemic onset juvenile chronic arthritis 2 years of age Patient weight, CRP and amyloid A levels, CBC with differential, immunization history, tuberculin skin test results Failed TNF blockers +/- DMARDS for juvenile chronic arthritis dx Cafcit Caffeine citrate J0706 Apnea of prematurity Patient weight, serum caffeine levels Previous outcome with theophylline if applicable Novarel, Pregnyl (Multiple) Xiaflex Prolia, Xgeva Chorionic gonadotropin J0725 Cryptorchidism Hypogonadotropic hypogonadism Clostridium histolyticum Serum testosterone levels J0775 Dupuytren s contracture Involvement of metacarpophalangeal or proximal interphalangeal joints Positive table top test Denosumab J0897 Prolia: postmenopausal osteoporosis, osteoporosis in men, osteopenia in men receiving androgen deprivation therapy, osteopenia in women receiving aromatase inhibitor therapy Xgeva: prophylaxis of skeletal related events in patients with bone metastases, unresectable giant cell tumor of bone Documented corresponding cancer and use of chemotherapy agent if applicable Bone mineral density (T score), serum creatinine, calcium, vitamin D, phosphorus, and magnesium levels Concurrent calcium and vitamin D intake Previous mediation trials Kalbitor Ecallantide J1290 Hereditary angioedema 16 years of age Patient weight, history of attacks Previous medication trials and outcome 3

Soliris Eculizumab J1300 Hemolytic uremic syndrome Paroxysmal nocturnal hemoglobinuria (PNH) Meningococcal vaccine at least 2 weeks prior to treatment Immunization history, CBC with differential, lactic dehydrogenase (LDH), AST, urinalysis, serum creatinine Flolan Epoprostenol J1325 Pulmonary arterial hypertension Patient weight, blood pressure, heart rate, baseline 6 minute walking distance test Failed therapy to oral CCB, conventional oral medications WHO Group 1, NYHA Class III or IV Privigen, GamaStan, Gammaplex Carimune (Multiple brand names) IV immune Globulin J1459 J1460 J1557 J1559 J1560 J1561 J1566 J1568 J1569 J1572 J1599 Bacterial infection prophylaxis Hepatitis A prophylaxis Idiopathic thrombocytopenic purpura Inflammatory demyelinating polyradiculoneuropathy Kawasaki disease Measles post exposure prophylaxis Motor neuropathy with multiple conduction block Rubella post-exposure prophylaxis Primary immune deficiency disorder Varicella *FDA approved indications vary based on brand name* Patient weight, serum creatinine/bun, hemoglobin, hematocrit, platelets, blood viscosity, anti-neutrophil antibodies, immunization history Absence of risk factors for acute renal failure and IgA deficiency Boniva Ibandronate J1740 Postmenopausal osteoporosis Bone mineral density (T score), serum creatinine, calcium, vitamin D, phosphorus, and magnesium levels Concurrent calcium and vitamin D intake Failed trial with oral bisphosphonates 4

Corvert Ibutilide fumarate J1742 Atrial arrhythmia Patient weight, onset of arrhythmia Anticoagulation for atrial fibrillation with a 3 day duration Elaprase Idursulfase J1743 Hunter syndrome (Mucopolysaccharidosis II) Patient weight Enzyme assay demonstrating a deficiency of iduronate 2- sulfatase enzyme activity or DNA testing Remicade Infliximab J1745 Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis Plaque psoriasis Crohn s disease Ulcerative colitis Patient weight, tuberculin skin test results, hepatitis B screening Failed trial with more cost-effective agents and conventional therapy depending on dx o Psoriatic arthritis, ankylosing spondylitis failed trial with a NSAID and DMARD o RA failed trial with at least 2 nonbiologic DMARDS (one of which is methotrexate) o Plaque psoriasis failed trial of phototherapy and conventional systemic therapy o Crohn s disease failed trial with at least 2 conventional therapies o Ulcerative colitis failed trial with at least 1 conventional therapy Concomitant use of methotrexate for dx of RA Cerezyme Imiglucerase J1786 Type 1 Gaucher's Disease Patient's weight, CBC, platelets, hemoglobin, hematocrit, liver function tests, IgG antibody, acid phosphatase, MRI/CT results of liver and spleen β-glucocerebrosidase enzyme assay, DNA testing, or bone marrow histology confirming dx Somatuline Lanreotide J1930 Acromegaly Serum GH, IGF-1, glucose levels, heat rate, gall bladder ultrasonography, TRH tests, CT results of pituitary Previous history of surgery and/or radiotherapy Aldurazyme Laronidase J1931 Hurler & Hurler-Scheie forms of mucopolysaccharidosis (Type 1) Patient weight, baseline disease status Alpha-L iduronidase activity or DNA testing confirming dx 5

Zyvox Linezolid J2020 Community acquired pneumonia Nosocomial pneumonia VRE faecium infection Skin/subcutaneous infection Culture, antibiotic sensitivity results, CBC with differential Tysabri Natalizumab J2323 Crohn s disease Multiple sclerosis MRI results/medical records confirming dx of relapsing forms of MS, enrolled in the TOUCH prescribing program Failed trial with conventional therapy for MS dx Failed trial with conventional therapy and a TNF- α inhibitor for Crohn s dx Xolair Omalizumab J2357 Allergic asthma IgE levels, positive allergy tests, pulmonary function tests, non-smoker Moderate to severe persistent asthma as indicated by number of asthma exacerbations, ER visits, significant functional impairment 12 years of age Failed trial with high-dose ICS, LABA, and leukotriene modifier Zyprexa Relprevv Olanzapine J2358 Schizophrenia History of non-adherence with oral antipsychotics, history of violent behavior, failed trial with at least one typical and atypical antipsychotic Previous history with oral olanzapine Invega Sustenna Paliperidone J2426 Schizophrenia History of non-adherence with oral antipsychotics, history of violent behavior, failed trial with at least one typical and atypical antipsychotic Previous history with oral paliperidone Papacon Papaverine J2440 Angina Cerebrovascular disease Ischemic heart disease Peripheral vascular disease with vasospasm Smooth muscle spasm Thromboembolic disorder Macugen Pegaptanib J2503 Neovascular age-related macular degeneration Demonstrated trial with safer and more effective alternatives Intraocular pressure, baseline visual acuity 6

Krystexxa Pegloticase J2507 Gout Serum uric acid level, G6PD deficiency screening Number of gout attacks, gout tophus or gouty arthritis Failed trial with conventional therapy Prophylaxis with NSAID or colchicine one week before administration Mozobil Plerixafor J2562 Harvesting of peripheral blood stem cells in patients with non- Hodgkin's lymphoma and multiple myeloma Lucentis Ranibizumab J2778 Exudative age- related macular degeneration Diabetic macular edema Macular retinal edema thrombosis of retinal vein Arcalyst Rilonacept J2793 Cryopyrin-Associated Periodic Syndromes Patient s weight, serum creatinine, CBC with differential, platelets Administer after patient has received filgrastim 10mcg/kg daily for 4 days Intraocular pressure, baseline visual acuity 18 years of age Patient weight, lipid profile, CBC with differential, C-reactive protein, serum amyloid A, immunization history, tuberculin skin test results 12 years of age Risperdal Consta Risperidone J2794 Schizophrenia Bipolar I disorder Nplate Romiplostim J2796 Idiopathic chronic immune thrombocytopenia purpura Actemra Tocilizumab J3262 Rheumatoid arthritis Juvenile idiopathic arthritis Polyarticular juvenile rheumatoid arthritis 7 History of non-adherence with oral antipsychotics, history of violent behavior Failed trial with at least one typical and atypical antipsychotic Previous history with oral risperidone Failed trial with corticosteroids, immune globulin, or splenectomy Patients weight, CBC with differential and platelet count Failed TNF blockers +/- DMARDS Patient weight, CBC with differential, liver function tests, lipid panel, tuberculin skin test results, immunization history, hepatitis B screening Remodulin Treprostinil J3285 Pulmonary arterial hypertension Patient weight, blood pressure, heart rate, baseline 6 minute walking distance test Failed therapy to oral CCB, conventional oral medications WHO Group 1, NYHA Class II- IV

Bravelle Urofollitropin J3355 Polycystic ovary syndrome Concomitant use of human chorionic gonadotropin Stelara Ustekinumab J3357 Plaque psoriasis Psoriatic arthritis Patient weight, CBC with differential, tuberculin skin test results, immunization history, body surface area affected Failed therapy with NSAIDS and DMADs for dx psoriatic arthritis Failed therapy with conventional systemic therapy and phototherapy for dx plaque psoriasis VPRIV Velaglucerase alfa J3385 Non-neuropathic Gaucher s disease Patient's weight, CBC, platelets, hemoglobin, hematocrit, liver function tests, IgG antibody, acid phosphatase, MRI/CT results of liver and spleen Visudyne Verteporfin J3396 Age related macular degeneration Histoplasmosis Myopia CBC with differential, liver function tests, fluorescein angiography, baseline visual acuity Unclassified drugs; J3490 Appropriate clinical documentation per indication Unclassified biologics J3590 Corifact Factor XIII, human J7180 Factor XIII deficiency Patient weight, hemoglobin, hematocrit Factor XIII levels Wilate Humate P Von Willebrand Factor Complex, human J7183 J7187 Hemophilia A Von Willebrand disorder Patient weight, hemoglobin, hematocrit, heart rate, blood pressure Xyntha Novoseven Factor VIII, recombinant Factor VIIa, recombinant vwf activity, Factor VIII levels J7185 Hemophilia A Patient weight, hemoglobin, hematocrit, heart rate, blood pressure Factor VIII levels J7189 Factor VII deficiency Hemophilia Patient weight, prothrombin time, aptt, factor VII levels Hematocrit, hemoglobin Koate Factor VIII, human J7190 Hemophilia A Patient weight, hemoglobin, hematocrit, heart rate, blood pressure Factor VIII levels Helixate FS Factor VIII, J7192 Hemophilia A Patient weight, hemoglobin, hematocrit, heart rate, blood (Multiple) recombinant Factor VIII deficiency pressure Factor VIII levels 8

Alphanine, Mononine Factor IX, nonrecombinant J7193 Hemophilia B Patient weight, aptt, blood pressure, heart rate Factor IX levels Bebulin VH (Multiple) Factor IX, complex J7194 Hemophilia B Patient weight, aptt, blood pressure, heart rate Factor IX levels Benefix Factor IX recombinant J7195 Hemophilia B Patient weight, aptt, blood pressure, heart rate Factor IX levels Feiba VH (Multiple) Anti-inhibitor coagulant complex J7198 Hemophilia Patient weight, fibrinogen, platelets, thrombin time Blood pressure, heart rate, hemoglobin, hematocrit Hemophilia clot factor J7199 Appropriate clinical documentation per indication NOC Ozurdex Dexamethasone J7312 Macular edema due to BRVO or CRVO Noninfective uveitis Intraocular pressure, baseline visual acuity Failed trial with corticosteroid ophthalmic drops Synvisc (Multiple) Hyaluronic acid J7321 J7323 J7324 J7325 J7326 Osteoarthritis of the knee Failed trial with either NSAIDS or intra-articular corticosteroid injections and physical therapy Qutenza Capsaicin J7335 Postherpetic neuralgia Failed trial wit h at least 2 oral agents (i.e. TCA, gabapentin) Thymoglobulin Antithymocyte globulin J7511 Renal transplant rejection Failed trial with standard oral immunosuppressive therapy Concomitant use of standard immunosuppressive therapy Patient weight, CBC with differential, platelet count, renal function Sandimmune Cyclosporine J7516 Kidney, liver, and heart transplant Failed trial with standard oral immunosuppressive therapy rejection prophylaxis Concomitant use of adrenal corticosteroids for kidney, liver, and heart transplant Patient weight, CBC with differential, liver enzyme, serum creatinine, and BUN levels Prograf Tacrolimus J7525 Heart, kidney, liver, transplant Failed trial with standard oral immunosuppressive therapy rejection prophylaxis Concomitant use of azathioprine or mycophenolate mofetil and adrenal corticosteroids for heart and kidney transplant Concomitant use of adrenal corticosteroids for liver transplant Patient weight, CBC with differential, calcium, magnesium, potassium, liver enzyme, serum creatinine, and BUN levels 9

Afinitor Everolimus J7527 Angiomyolipoma of kidney Breast cancer, hormone receptor positive, HER2 negative Liver transplant rejection prophylaxis Neuroendocrine tumor, pancreatic Renal cell carcinoma, Renal transplant rejection prophylaxis Subependymal giant cell astrocytoma Immunosuppressive J7599 drug not otherwise classified CBC with differential, liver function tests, serum creatinine, BUN, immunization history Failed trial with tyrosine kinase inhibitor (i.e. sunitinib) for dx renal cell carcinoma Appropriate clinical documentation per indication Levalbuterol comp J7607 Asthma Documentation of clinical reason why final formulation was Albuterol comp J7609 J7610 Asthma Documentation of clinical reason why final formulation was Beclomethasone inhalation comp Betamethasone inhalation comp Bitolterol inhalation comp J7622 Asthma Documentation of clinical reason why final formulation was J7624 Documentation of clinical reason why final formulation of an inhaled corticosteroid was not used J7629 Asthma Documentation of clinical reason why final formulation was Budesonide inhalation J7633 J7634 Asthma Compounded formulation: documentation of clinical reason why final formulation was Atropine inhalation comp J7635 J7636 Documentation of clinical reason why final formulation of an inhaled anticholinergic was not used 10

Dexamethasone inhalation comp J7637 J7638 Documentation of clinical reason why final formulation of an inhaled corticosteroid was not used Pulmozyme Dornase alfa J7639 Cystic fibrosis Pulmonary function tests (i.e. FEV1, FVC) Concomitant use of standard therapy for CF (i.e. antibiotics, bronchodilators, ICS) 5 years of age Flunisolide inhalation comp J7641 Asthma Documentation of clinical reason why final formulation was Glycopyrrolate inhalation comp J7642 J7643 Asthma Documentation of clinical reason why final formulation of an inhaled anticholinergic was not used Terbutaline inhalation comp J7680 J7681 Asthma Documentation of clinical reason why final formulation of a beta agonist was not used Triamcinolone inhalation comp J7683 J7684 Asthma Documentation of clinical reason why final formulation was Tobramycin comp J7685 Cystic fibrosis infection due to pseudomonas aeruginosa Documentation of clinical reason why final formulation was Tyvaso Treprostinil inhalation J7686 Pulmonary arterial hypertension Patient weight, blood pressure, heart rate, baseline 6 minute walking distance test Failed therapy to oral CCB, conventional oral medications WHO Group 1, NYHA Class III- IV Myleran Busulfan J8510 Palliative treatment of chronic myelogenous leukemia Hemopoietic stem cell transplant conditioning Temodar Temozolomide J8700 Anaplastic astrocytoma of brain, refractory Glioblastoma multiforme of brain, newly diagnosed Patient weight, CBC with differential, platelet count, liver function tests Patient weight, height, CBC with differential, platelet count, liver function tests Trial with nitrosurea and procarbazine for dx anaplastic astrocytoma of brain 11

Yervoy Ipilimumab J9228 Malignant melanoma, unresectable or metastatic Arzerra Ofatumumab J9302 Chronic lymphoid leukemia, refractory Rituxan Rituximab J9310 Oncologic use Rheumatoid arthritis Wegener s granulomatosis Microscopic polyarteritis nodosa Patient weight, liver function tests, thyroid function tests Patient weight, CBC with differential, platelet count Hepatitis B screening Trial with fludarabine and alemtuzumab No prior authorization needed Patient weight, height, CBC with differential, platelet count Hepatitis B screening Failed trial with TNF blockers + oral DMARD for dx rheumatoid arthritis 12