FIDELIS CARE NEW YORK DEPARTMENT OF PHARMACY SERVICES J Code Prior Authorizations & Required Clinical Information 2011 (Updated 3/14/11)

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1 FIDELIS CARE NEW YORK DEPARTMENT OF PHARMACY SERVICES J Code Prior Authorizations & Required Clinical Information 2011 (Updated 3/14/11) Brand Generic J Code Covered Uses Required Medical Information and Actemra Tocilizumab J3262 Rheumatoid arthritis Failed TNF blockers +/ DMARDS Patient weight, CBC with differential, liver function tests, lipid panel, tuberculin skin test Actimmune Interferon gamma 1b J9216 Chronic granulomatous disease Malignant osteoporosis Aldurazyme Lanronidase J1931 Hurler & Hurler Scheie forms of mucopolysaccharidosis (MPS1) Alphanate antihemophilic J7184 Von Willebrand's Disease, Humate P factor/von J7186 hemophilia A Wilate Willebrand factor J7187 complex (human) Alphanine, Mononine 1 Patient weight, CBC with differential, platelets, liver function tests, electrolytes, BUN, creatinine, urinalysis, adverse reactions Age 5 or older Patient weight, Factor VIII, development of factor VIII antibodies, AHF levels, hematocrit, vwf activity Active infection Concurrent use of biological DMARDs, BCG, natalizumab, live vaccines Live rotavirus vaccine factor IX J7193 Factor IX deficiency Patient weight, Factor IX levels, PPT Concurrent use with aminocaproic acid Amevive alefacept J0215 Psoriasis, adults only CD4 + T lymphocyte, immunization history transaminase, BSA affected, results of TB screening Previous trial of Phototherapy Previous trial with adalimumab and etanercept. Arcalyst Rilonacept J2793 Cryopyrin Associated Periodic Syndromes (CAPS, FCAS, MWS) Arzerra ofatumumab J9302 Chronic lymphoid leukemia (refractory) Atryn antithrombin J7196 Hereditary antithrombin III recombinant deficiency Patient weight, lipid profile, CBC with differential, C reactive protein, serum amyloid A, vaccination history Age 12 or older History of severe malignancy HIV infection or other significant infections Use of immunosuppressant drugs, phototherapy, BCG, natalizumab, or live vaccines in the last 3 months CD4 + T lymphocyte count <250 cells/microliter Use of TNF blockers, BCG, canakinumab, natalizumab, live vaccines Live viral vaccines

2 Avastin Bevacizumab J9035 Oncologic use NO PRIOR AUTHORIZATION REQUIRED Non oncology use (see Avastin J code J3590 below) J3590 Non oncology only Age related macular degeneration Avonex interferon beta 1a J1826 Multiple sclerosis, relapsing forms Live rotavirus vaccine Baygam Carimune Gammagard Sandoglobulin Gamimune N Vivaglobin Gammar P Hizentra (Multiple) IV immune Glob J1459 J1460 J1559 J1561 J1566 J1568 J1569 J1572 Idiopathic Thrombocytopenic Purpura (ITP) Immunodeficiency syndromes Kawasaki disease Chronic inflammatory demyelization polyneuropathy (CIDP) Bacterial infection prophylaxis Patient weight, serum creatinine/bun, hemoglobin, hematocrit, platelets, blood viscosity, anti neutrophil antibodies CrCl <10ml/minute Fluid overload or hypovolemia incl. multiple sclerosis, Guillain Barre syndrome, myasthenia gravis, & prevention of infections in hematopoietic stem cell transplantation Hyperprolinemia IgA deficiency with antibodies against IgA Severe thrombocytopenia or any coagulation disorder which would C/I IM injections Benefix Factor IX recomb J7195 Factor IX deficiency Patient weight, factor IX levels, PPT Concurrent use with aminocaproic acid Berinert C 1 esterase inhibitor J0597 Hereditary angioedema Patient weight (human) Boniva Ibandronate J1740 Osteoporosis, postmenopausal only Serum calcium, serum creatinine, T score Previous trial with alendronate, Actonel, and Boniva tablets Currently on calcium supplementation incl. hypercalcemia, corticosteroid induced osteoporosis, Paget's disease Uncorrected hypocalcemia 2

3 Botox Onabotulinum toxina J0585 Strabismus and blepharospasm assoc. with dystonia, age 12 and older Cervical dystonia, age 16 and older Primary axillary hyperhidrosis in adults Chronic migraine prophylaxis Ceredase alglucerase J0205 Gaucher's Disease (type 1) Patient's weight, CBC, platelets, acid phosphatase (AP), liver function tests, plasma glucocerebroside, IgG antibody Age 2 or older Cerezyme Imiglucerase J1785 J1786 Gaucher's Disease (type 1) Cimzia Certolizumab J0718 Rheumatoid arthritis Crohn s disease (second line) Cinryze C 1 esterase inhibitor (human) J0598 C1 Deficiency Hereditary angioedema (HAE) Patient's weight, CBC, platelets, liver function tests, IgG antibody, acid phosphatase, MRI/CT of liver and spleen, skeletal x rays Tuberculin skin test Hepatitis B screening Demonstrated trial of more cost effective agents Previous medication trials and outcome Elaprase Idursulfase J1743 Mucopolysaccharidosis II (MPSII, Hunter Syndrome) Patient weight, IgG antibodies Ages 5 65 years old Fabrazyme Algalsidase beta J0180 Fabry's Disease Age 8 or older Patient's weight, IgG, IgE, serum creatinine, BUN Premedicate with antipyretics Infection at the injection site(s) Myasthenia gravis or Eaton Lambert syndrome incl. oromandibular dystonia, spasmodic dysphonia and other dystonias (ie, writer's cramp, focal task specific dystonias), migraine treatment/prophylaxis, dynamic muscle contracture in pediatric cerebral palsy patients Concurrent use with anakinra, biologic DMARDS, TNF blockers, abatacept, BCG, canakinumab, natalizumab, rilonacept, rituximab, live vaccines (within 3 months) 3

4 Feiba VH, Autoplex T Anti inhibitor coagulant complex Flolan Epoprostenol J1325 Idiopathic pulmonary arterial hypertension (IPAH) J7198 Hemophilia Patient weight, fibrinogen, platelets, thrombin time Patient weight Folotyn pralatrexate J9307 Peripheral T cell lymphoma Hycamptin topotecan J9351 Carcinoma of cervix Chronic myelomonocytic leukemia Metastatic ovarian tumor Myelodysplastic syndrome, NSCLC, SCLC Ilaris canakinumab J0638 Cryopyrin associated periodic syndrome Familial cold urticaria Muckle Wells syndrome Increlex Mecasermin J2170 IGF 1 Deficiency, or GH deletions with neutralizing antibodies to GH Children over 2 years of age Patient weight, IGF1, growth velocity Growth charts Invega Sustenna Paliperidone J2426 Schizophrenia Istodax romidepsin J9315 Primary cutaneous T cell lymphoma Kalbitor ecallantide J1290 Hereditary angioedema, acute attacks Patients with normal coagulation Concurrent use with antifibrinolytic agents incl. nonhemophiliac patients Bleeding episodes resulting from coagulation factor deficiencies without inhibitors to coagulation factor VIII or IX, Significant signs of DIC Heart failure due to left ventricular systolic dysfunction : acute vasodilator testing in PAH, pediatrics Chronic use in patients who may develop pulmonary edema during initiation Presence of closed epiphyses, active or suspected neoplasia IV administration 4

5 Lucentis Ranibizumab J2778 Age related macular Age 18 or older degeneration Macugen Pegaptanib J2503 Age related macular degeneration Metvixia aminolevulinate J7309 Actinic keratosis 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 10 mcg/kg daily for 4 days Under 18 years old Ocular or periocular infection Ocular or periocular infection Pre existing cutaneous photosensitivity Hypersensitivity to peanut and almond oil Multiple factor IX complex J7194 Hemolytic anemia Multiple (Human) antihemolytic factor J7190 Hemolytic anemia Multiple (Recomb.) antihemolytic factor J7192 Hemolytic anemia Multiple, Sinvisc One Hyaluronic acid Osteoarthritis of the knee Myobloc RimabotulinumtoxinB J7321 J7323 J7324 J7325 J0586 J0587 Cervical dystonia (resistant to onatotulinumtoxina or abobotulinumtoxina) Previous trials with or contraindications to NSAIDS Previous trial with intra articular steroid injections Previous trial with physical therapy Myozyme alglucosidase alfa J0220 Pompe Disease Patient weight, liver enzymes, IgG & IgE antibodies Naglazyme Galsulfase J1468 Maroteaux Lamy Syndrome Ages 5 29 years old Patient weight Novoseven Factor VIIa (recomb) J7189 Hemophilia Prothrombin time, aptt, factor VII Congenital factor VII deficiency clotting Presence of knee joint infections or infection/skin disease at the site of injection incl. refractory interstitial cystitis Infection at injection site Concurrent use of onabotulinumtoxina or abobotulinumtoxina Use within <4 months of rimabotulinumtoxinb 5

6 Nplate Romiplostim J2796 Chronic immune thrombocytopenia purpura Oforta fludaribine J8562 Acute myeloid leukemia in combination B cell chronic lymphocytic leukemia (relapsed or refractory) Ozurdex Dexamethasone J7312 Anti inflammatory or immunosuppressant Prolastin alpha 1 proteinase inhibitor [human] Failed corticosteroids, immune globulin, or splenectomy Patients weight, CBC with differential and platelet count Register with Nplate NEXUS program, ( or Patient weight, height, hemoglobin, occult blood loss, serum potassium and glucose J0256 Alpha 1 antitrypsin deficiency Live rotavirus vaccine Systemic fungal infection, cerebral malaria, ophthalmic use in viral, fungal, or tuberculosis diseases of the eye Concurrent use with aldesleukin, BCG, dronedarone, everolimus, natalizumab, nilotinib, nisoldipine, pazopanib, ranolazine romidepsin, tolvaptan, or live vaccines IgA deficient patients with antibodies against IgA Prolia denosumab J3590 Postmenopausal osteoporosis Patient's T score Pre existing hypocalcemia Provenge sipuleucel T J3490 Metastatic prostate cancer (hormone refractory) Qutenza capsaicin patch J7335 Analgesic, neuropathic pain agent Reclast Zolendronic acid J3488 Paget's Disease Osteoporosis Hyperalcemia of malignancy Serum creatinine, alkaline phosphatase, calcium, phosphorus, and magnesium levels, T score Previous trial with alendronate, Actonel, and Boniva Currently on Calcium supplementation CrCl <35ml/min All off label uses incl. prevention of aromatase inhibitor induced bone loss in breast cancer, prevention of androgen deprivation induced bone loss Hypocalcemia 6

7 Remicade Infliximab J1745 Rheumatoid arthritis Crohn's disease Psoriasis Psoriatic arthritis Ankylosing spondylitis Ulcerative colitis Tuberculin skin test, Hepatitis B screening Demonstrated trial of more costeffective agents Concurrent use with anakinra, biologic DMARDS, TNF blockers, abatacept, BCG, canakinumab, natalizumab, rilonacept, rituximab, live vaccines (within 3 months) Moderate to severe heart failure Remodulin Treprostinil J3285 Pulmonary arterial hypertension Patient weight, blood pressure Replagal agalsidase alfa J3490 Fabry's disease Soliris Eculizumab J1300 Paroxysmal nocturnal Meningococcal vaccine at least 2 hemoglobinuria (PNH) weeks prior to treatment Immunization history, CBC with differential, lactic dehydrogenase (LDH), AST, urinalysis Lanreotide J1930 Acromegaly Serum GH, IGF 1, glucose levels, heart rate, gall bladder ultrasonography Meningococcal infection Concurrent use with BCG, natalizumab, live vaccine in the last 3 months Somavert pegvisomant J3590 Acromegaly Liver function tests, GH secreting tumor size, serum glucose, serum IGF I Stelara ustekinumab J3357 Plaque psoriasis (mod severe) Tuberculosis testing (PDD) Previous history of treatments tried Stimate Desmopressin J2597 Von Willebrand's Disease Serum creatinine, fluid intake, urine acetate Diabetes insipidus volume Uremic bleeding CrCl < 50ml/min History of hyponatremia Thyrogen Thyrotropin alfa J3240 Radioiodine imaging or ablation Age 16 or older Under 16 years old Tyvaso treprostinil J7686 Pulmonary hypertensive arterial disease Vantas, Supprelin LA Histrelin J9225 J9226 Precocious puberty Advanced prostate cancer LH, FSH, estradiol, or testosterone, height, bone age, tanner staging, PSA Pregnancy Pediatric patients Women Ventavis Iloprost Q4074 Pulmonary arterial hypertension (PAH) Heart rate, blood pressure, respiratory rate at baseline, adverse reactions 7

8 Vibativ telavancin J3095 Skin or subcutaneous tissue infection Visudyne Verteporfin J3396 Macular degeneration BSA, fluorescein angiography Occult subvofeal choroidal neovascularaization Vivaglobin Immune Globulin SQ J1562 Primary immune deficiency (PID) Patient weight, IgG levels Live vaccine in the previous 3 months Vpriv velaglucerase alfa J3385 Non neuropathic Gaucher's Disease Xgeva denosumab J3590 Bone metastasis, prophylaxis Pre existing hypocalcemia Xiaflex clostridium histolyticum J0775 Dupuytren's contracture with palpable cord Xyntha antihemophilic factor J7185 Hemophilia Patient weight, plasma factor VIII, factor VIII inhibitors, hemoglobin, hematocrit Zyprexa Relprevv olanzapine J2358 Schizophrenia 8