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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 Endometrial hyperplasia Endometriosis Secondary physiologic amenorrhea

Diagnostic measures to rule out malignancy

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)

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

Glassia Alpha 1-proteinase inhibitor

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

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

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 Cervical dystonia Rhytide of glabellar skin

Previous trial with Botox

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

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

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)

Chorionic gonadotropin J0725 Cryptorchidism Hypogonadotropic hypogonadism

Serum testosterone levels

Xiaflex Clostridium histolyticum

J0775 Dupuytren’s contracture Involvement of metacarpophalangeal or proximal interphalangeal joints

Positive table top test

Prolia, Xgeva

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

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

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

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

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

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

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

Demonstrated trial with safer and more effective alternatives

Macugen Pegaptanib J2503 Neovascular age-related macular degeneration

Intraocular pressure, baseline visual acuity

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

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

Patient’s weight, serum creatinine, CBC with differential, platelets

Administer after patient has received filgrastim 10mcg/kg daily for 4 days

Lucentis Ranibizumab J2778 Exudative age- related macular degeneration Diabetic macular edema Macular retinal edema – thrombosis of retinal vein

Intraocular pressure, baseline visual acuity ≥18 years of age

Arcalyst Rilonacept J2793 Cryopyrin-Associated Periodic Syndromes

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

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

Nplate Romiplostim J2796 Idiopathic chronic immune thrombocytopenia purpura

Failed trial with corticosteroids, immune globulin, or splenectomy

Patients weight, CBC with differential and platelet count

Actemra Tocilizumab J3262 Rheumatoid arthritis Juvenile idiopathic arthritis Polyarticular juvenile rheumatoid arthritis

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

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

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; Unclassified biologics

J3490 J3590

Appropriate clinical documentation per indication

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

vWF activity, Factor VIII levels

Xyntha Factor VIII, recombinant

J7185 Hemophilia A Patient weight, hemoglobin, hematocrit, heart rate, blood pressure

Factor VIII levels

Novoseven Factor VIIa, recombinant

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 (Multiple)

Factor VIII, recombinant

J7192 Hemophilia A Factor VIII deficiency

Patient weight, hemoglobin, hematocrit, heart rate, blood pressure

Factor VIII levels

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

Alphanine, Mononine

Factor IX, non-recombinant

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 NOC

J7199 Appropriate clinical documentation per indication

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 rejection prophylaxis

Failed trial with standard oral immunosuppressive therapy 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 rejection prophylaxis

Failed trial with standard oral immunosuppressive therapy 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

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

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

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

Immunosuppressive drug not otherwise classified

J7599 Appropriate clinical documentation per indication

Levalbuterol comp J7607 Asthma Documentation of clinical reason why final formulation was inappropriate for use

Albuterol comp J7609 J7610

Asthma Documentation of clinical reason why final formulation was inappropriate for use

Beclomethasone inhalation comp

J7622 Asthma

Documentation of clinical reason why final formulation was inappropriate for use

Betamethasone inhalation comp

J7624 Documentation of clinical reason why final formulation of an inhaled corticosteroid was not used

Bitolterol inhalation comp

J7629 Asthma Documentation of clinical reason why final formulation was inappropriate for use

Budesonide inhalation J7633 J7634

Asthma Compounded formulation: documentation of clinical reason why final formulation was inappropriate for use

Atropine inhalation comp

J7635 J7636

Documentation of clinical reason why final formulation of an inhaled anticholinergic was not used

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

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 inappropriate for use

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 inappropriate for use

Tobramycin comp J7685 Cystic fibrosis infection due to pseudomonas aeruginosa

Documentation of clinical reason why final formulation was inappropriate for use

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

Patient weight, CBC with differential, platelet count, liver function tests

Temodar Temozolomide J8700 Anaplastic astrocytoma of brain, refractory Glioblastoma multiforme of brain, newly diagnosed

Patient weight, height, CBC with differential, platelet count, liver function tests

Trial with nitrosurea and procarbazine for dx anaplastic astrocytoma of brain

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

Yervoy Ipilimumab J9228 Malignant melanoma, unresectable or metastatic

Patient weight, liver function tests, thyroid function tests

Arzerra Ofatumumab J9302 Chronic lymphoid leukemia, refractory

Patient weight, CBC with differential, platelet count Hepatitis B screening Trial with fludarabine and alemtuzumab

Rituxan Rituximab J9310 Oncologic use

Rheumatoid arthritis Wegener’s granulomatosis Microscopic polyarteritis nodosa

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