Original Policy Date

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1 MP Specialty Drugs Medical Policy Section Prescription Drug Issue 12:2013 Original Policy Date 12:2013 Last Review Status/ Date Local policy Last updated/12:2013 Return to Medical Policy Index Disclaimer Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. Description Specialty drugs represent an increasing amount of rising health care costs. The average cost per patient year is often over $10,000, but can vary depending on the disease state of the patient. In accordance with the member s policy, FCC will review and assist the member in receiving the most cost effective, appropriate medication given in the most appropriate setting to treat the member s condition, disease or illness. Policy FirstCarolinaCare requires Prior Authorization of various medications including specialty drugs that are scientifically engineered medications used to treat complex or rare conditions including, but not limited to, anemia, asthma, cancer, hemophilia, multiple sclerosis, rheumatoid arthritis, psoriasis, and human growth hormone deficiency. Specialty drugs include but are not limited to intravenous, self-injectable, topical and medications. Policy Guidelines Specialty drugs including but are not limited to, intravenous, self-injectable, topical and medications and are considered medically necessary when the following criteria is met: The most appropriate medication and level of service, considering potential benefits and harms to member. Proven to be effective in improving health outcomes, o o For new treatments, effectiveness is determined by scientific evidence, For existing treatments, effectiveness is determined by first scientific evidence, then by professional standards, then by expert opinion. Not primarily for the convenience of the member or covered provider. Cost-effective for this condition, compared to alternative treatments, including no treatment. Cost-effectiveness does not necessarily mean lowest price. When applied to the care of an Inpatient, it further means that the member s medical symptoms or condition are such that the services cannot be safely and effectively provided to the member as an Outpatient. The fact that a Covered Provider may prescribe, order, recommend, or approve a service or supply does not, in and of itself, necessarily establish that such service or supply is Medically Necessary.

2 The term Medically Necessary as defined and used in the policy is strictly limited to the application and interpretation of this policy, and any determination of whether a service is Medically Necessary hereunder is made solely for the purpose of determining whether services rendered are covered services. The list of medications is not an all-inclusive list, and is subject to change as new medications become available. Coverage for growth hormone under major medical versus prescription benefits is solely determined by member contract language. Brand Name Codes The following drugs, listed with appropriate code(s) require Prior Authorization. In addition to this list, any medication being used for off-label (not FDA approved) use is subject to prior authorization. Generic Name Applicable Code or Indications Actemra tocilizumab C9264 rheumatoid arthritis Adcirca tadalafil J8499 pulmonary artery hypertension Afinitor everolimus J8499 advanced Renal Cell Carcinoma Oral Albuferon albumin interferon J3590 or chronic hepatitis-c Route Aldurazyme laronidase J1931 Hurler Syndrome Alferon N interferon alfa-n3 (human leukocyte J9215 Venereal/Genital Warts Intralesion derived) Amevive alefacept J0215 Psoriasis IM Ampligen J3490 chronic fatigue syndrome Aralast alpha 1-proteinase inhibitor J0256 Alpha 1-Proteinase Deficiency Arzerra ofatumumab C9260 chronic lymphocytic leukemia Avastin bevacizumab J9035 metastatic colorectal cancer, non (10mg) small-cell lung cancer, advance C9257 metastatic breast cancer (0.25mg) Benlysta belimumab J3590, Q2044 systemic lupus erythematosus Berinert human C1 inhibitor J0598 C9269 hereditary angioedema Boniva ibandronate sodium J7140 postmenopausal osteoporosis Bosatria mepolizumab J3590 hypereosinophilic syndrome Botox botulinum toxin type A J0585 Cervical Dystonia IM Dysport abobotulinumtoxin A, 5 J0586 units Cervical Dystonia IM Carimune/Carimune NF immune globulin, J1566 Immunodeficiency

3 lyophilized (IG) Celebrex celecoxib J8499* NSAID Oral Cerezyme imiglucerase J1785 Type 1 Gaucher disease Cinryze Cimzia Factor Products C1 esterase inhibitor (human), 10 units certolizumab multiple generics available C9251 (deleted 12/31/09) J0598 (new code 1/01/10) C9249 (deleted 12/31/09) J0718 (new code 1/01/10) angioedema attacks in adolescent and adult patiens with Hereditary Angioedema (HAE) Crohn`s disease, Rheumatoid Arthritis Elaprase idursulfase J1743 Hunter`s Syndrome Enbrel etanercept J1438 Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis, JIA Fabrazyme agalsidase beta J0180 Fabry Disease Q2023 Q2041 J7185 J1787 J7189 J7190 J7191 J7192 J7193 J7194 J7195 J7199 Bleeding disorders; hemophilia Fampridine SR improve walking ability in MS patients Fentora fentanyl buccal J3490* Breakthrough pain in opioid tolerant adult cancer Feraheme Ferrlecit Fingolimod ferumoxytol sodium ferric gluconate complex Q0138 (non ESRD) Q0139 (ESRD) iron deficiency anemia J2916 anemia relapsing-remitting multiple sclerosis (RRMS) Flebogamma/Flebogamma immune globulin, nonlyophilized (IG) DIF J1572 Immunodeficiency Folotyn pralatrexate J9307 peripheral T-cell lymphoma Forteo teriparatide J3110 Osteoporosis Gamimune N immune globulin, nonlyophilize d (IG) J1567 Immunodeficiency Gammagard Solution immune globulin, nonlyophilized (IG) J1569 Immunodeficiency Gammagard/Gammagard immune globulin, J1566 Immunodeficiency

4 SD lyophilized (IG) Gammaplex immune globulin, nonlyophilized (IG) C9270 Immunodeficiency Gammar-P immune globulin, lyophilized (IG) J1566 Immunodeficiency Gamunex immune globulin, nonlyophilized (IG) J1561 Immunodeficiency Genotropin somatropin J2941 Growth Hormone Gleevec imatinib mesylate S0088 or Chronic myelocytic leukemia and J8999* gastrointestinal stromal tumor (GIST) Oral Humatrope somatropin J2941 Growth Hormone Humira adalimumab J0135 Rheumatoid Arthritis, JIA, psoriatic arthritis, ankylosing spondylitis and Crohn's Hycamtin topotecan J8999 Small Cell Lung Cancer Oral Ilaris canakinumab J3590 cryopyrin-associated periodic syndromes (CAPS), including Muckle- Wells syndrome Implanon etanogestrel implant system J7306 Contraceptive implant Increlex mecasermin J2170 Growth Hormone Intron-A Interferon alfa-2b, recombinant J9214 Hepatitis C or IM Iplex mesasermin rinfabate PF J2170 Growth Hormone Iressa gefitinib J8565 Non small-cell lung cancer Oral Iron dextran (Infed, Dexferrum) J1750 anemia Istodax romidepsin C9265 cutaneous T-cell lymphoma Iveegam immune globulin, lyophilized J1566 Immunodeficiency Ixempra ixabepilone J9207 Advanced breast cancer Kalbitor ecallantide C9263 Hereditary angioedema Kineret anakinra J3590* Rheumatoid Arthritis Letairis ambrisentan J8499* Pulmonary arterial hypertension Leustatin cladribine J9065 relapsing-remitting multiple sclerosis (RRMS) Lovenox enoxaparin J1650 blood clots Lucentis ranibizumab J2778 Neovascular (wet) age-related macular Intravitreal degeneration Lumizyme alglucosidase alfa J3590 Pompe disease Makena hydroxyprogesterone caproate Q2042 reduce risk of repeat preterm birth IM Mircera epoetin beta J3490* anemia in chronic kidney disease or Mozobil plerixafor, 1mg C9252 with GCSF for NHL and multiple (deleted myeloma

5 12/31/09) J2562 (new code 1/01/10) Myobloc botulinum toxin type B J0587 Cervical Dystonia IM Myozyme alglucosidase alfa J0220 Pompe disease Naglazyme galsulfase J1458 Maroteaux-Lamy syndrome (MPS VI) Nexavar sorafenib tosylate J8999* Liver and Kidney Cancer Oral NordiFlex somatropin J2941 Growth Hormone Norditropin somatropin J2941 Growth Hormone Nplate romiplostim C9245 (deleted 12/31/09) J2796 (new code 1/01/10) chronic immune (idiopathic)thrombocytopenic purpura ITP Nutropin/Nutropin AQ somatropin J2941 Growth Hormone Octagam immune globulin, nonlyophilized (IG) J1568 Immunodeficiency remission induction treatment for Onrigin laromustine J3490 patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML) Orencia abatacept J0129 Rheumatoid Arthritis, JIA Panglobulin/Panglobulin immune globulin, NF lyophilized (IG) J1566 Immunodeficiency Perjeta pertuzumab, 10mg C9292 HER-2 metastatic breast cancer Polygam SD immune globulin, lyophilized (IG) J1566 Immunodeficiency Prialt ziconotide acetate J2278 Severe Chronic Pain Intrathecal Prolastin alpha 1-proteinase inhibitor Prolia denosumab C9272 J0256 Alpha 1-Proteinase Deficiency or postmenopausal osteoporosis Protropin sometrem J2940 Growth Hormone Provenge sipuleucel-t C9273, Q2043 hormone refractory prostate cancer Reclast zoledronic acid J3488 Osteoporosis Regranex becaplermin gel S0157 Lower extremity, Diabetic ulcers Topical *Remicade infliximab J1745 Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis RespiGam respiratory syncytial J1565 virus immune globulin RSV

6 (RSV-IG) Revatio sildenafil citrate J8499* pulmonary arterial hypertension Revimmune high-dose cyclophosphamide J3590 refractory multiple sclerosis Revlimid lenalidomide J8499* Multiple Myeloma Rituxan rituximab J9310 Rheumatoid Arthritis, Non-Hodgkin's lymphoma Saizen somatropin J2941 Growth Hormone Sandostatin J2353 (IM) octreotide prolonged J2354 or acromegaly release (/), IM, Serostim somatropin J2941 Growth Hormone Simponi golimumab J3490* C9399 () or Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylosis Soliris eculizumab J1300 Paroxysmal nocturnal hemoglobinuria (PNH) Somatuline lanreotide acetate J1930 or Adult acromegaly Sprycel dasatinib J8999* CML Oral Stelara ustekinumab C9261 or moderate to severe psoriasis Sutent sunitinib malate J8999* Advanced Renal Cell or gastrintestinal Oral stromal tumor respiratory syncytial *Synagis virus immune globulin RSV IM (RSV-IgIM) Tarceva erlotinib J8999* Non small-cell lung cancer (NSCLC) and advanced pancreatic cancer Tasigna nilotinib J8999* Philadelphia Chromosome Positive Chronic Myeloid Leukemia Tev-Tropin somatropin J2941 Growth Hormone Temodar temozolomide J8700 Oral brain tumors J9328 Torisel temsirolimus J3490* Advanced renal cell carcinoma Tykerb lapatinib J8999* HER2+ early breast cancer Tysabri natalizumab J2323 Relapsing/remitting multiple sclerosis Uplyso taliglucerase alfa J3590 Gaucher disease Vpriv velaglucerase alfa C9271 (GA-GCB) J3490 Gaucher disease Velcade bortezomib J9041 Multiple Myeloma Venofer iron sucrose J1756 Chronic kidney disease Venoglobulin-S immune globulin, non- J1567 Immunodeficiency,

7 lyophilized Vivaglobin subcutaneous immune J1562 globulin Immunodeficiency Voraxaze glucarpidase, 10units C9293 toxic methotrexate levels Votrient pazopanib C9399 J8999 advanced renal cell carcinoma Xeloda capecitabine J8520, Metastatic breast or metastatic J8521 colorectal cancer Xgeva denosumab J3590 Skeletal related events from solid tumors Xiaflex clostridial collagenase J3590 Dupuyten's contracture Xigris drotrecogin alfa J3490* Severe sepsis Xolair omalizumab J2357 Asthma Yervoy ipilimumab C9284 melanoma Zemaira alpha 1-proteinase inhibitor J0256 Alpha 1-Proteinase Deficiency Zolinza vorinostat J8499* cutaneous T cell lymphoma Zorbtive somatropin J2941 Growth Hormone Brand Name The following drugs, listed with appropriate code(s) may be reviewed (pre-service and postservice) for most cost-effective procurement and/or setting. Generic Name Applicable Code or Indications Route Actimmune interferon gamma-1b, 3 Chronic Granulomatous J9216 million units Disease or Actiq fentanyl citrate lozenge J8499* Oncology, pain Oral Apokyn apomorphine S0167 Parkinson's Disease or Aranesp darbopoetin alpha (non- ESRD) J0881 Anemia Arixtra fondaparinux J1652 Blood Clots Avonex interferon beta-1a J1825 Multiple Sclerosis IM Betaseron interferon beta-1b J1830 Multiple Sclerosis IM Copaxone glatiramer J1595 Multiple Sclerosis IM Eligard leuprolide acetate, depot J9217 LHRH Agonist, Oncology Epogen epoetin alpha (non-esrd) J0885 Anemia Flolan epoprostenol J1325 Pulmonary Hypertension Fragmin dalteparin J1645 Blood Clots Infergen interferon alfacon-1, recombinant, 1 microgram J9212 Hepatitis C Innohep tinzaparin sodium J1655 Blood Clots Leukine sargramostim (GM-CSF) J2820 or Hematopoietics, Neutrophil Stimulating leuprolide acetate, nondepot Leuprolide Acetate J9218 LHRH Agonist, Oncology Lupron Depot leuprolide acetate, depot J1950 or J9217 LHRH Agonist, Oncology Neulasta pegfilgrastim J2505 Hematopoietics, Neutrophil or

8 Stimulating Neumega oprelvekin J2355 Thrombocytopenia Neupogen filgrastim (G-CSF) J1440 or J1441 Hematopoietics, Neutrophil Stimulating or Peg Intron peginterferon alfa-2b S0146 Hepatitis C Pegasys peginterferon alfa-2a S0145 Hepatitis C Procrit epoetin alpha (non-esrd) J0885 Erythropoietin for Anemia Rebetron interferon alfa-2b/ribavirin J9214 Hepatitis C Rebif interferon beta-1a J1825 Multiple Sclerosis Remodulin treprostinil J3285 Pulmonary Hypertension Roferon-A Interferon alfa-2a, J9213 recombinant, 3 million units Hepatitis C Tracleer bosetan J8499* Pulmonary Hypertension Oral Trelstar triptorelin pamoate J3315 LHRH Agonist, Oncology IM Vantas histrelin implant J9225 LHRH Agonist, Oncology Impla Ventavis Q4080 or iloprost, inhalation solution J7699* Pulmonary Hypertension Inhala Viadur leuprolide acetate implant J9219 LHRH Agonist, Oncology Impla Zoladex goserelin acetate implant J9202 LHRH Agonist, Oncology Impla *J3490, J3590, J7699, J8499 & J8999 require name, strength and NDC# of medication when billed. Index Specialty drugs Drugs that require Prior Authorization