Drugs That Require Prior Authorization (PA) Before Being Approved for Coverage PRIOR AUTHORIZATION MEDICATIONS

Transcription

1 That Require Prior Authorization (PA) Before Being Approved for Coverage PRIOR AUTHORIZATION MEDICATIONS ACNE Approve for those 12 years of age and older AVITA, RETIN-A MICRO, TRETINOIN ACTHAR HP All FDA-approved indications not otherwise excluded from Part D. ACTHAR HP ADAPALENE Cosmetic use Approve for those 12 years of age and older ADAPALENE, DIFFERIN 1

2 AMITIZA Pregnancy, history of mechanical gastrointestinal obstruction (e.g., due to adhesions, tumors, hernias, cysts, abscess, etc.), severe diarrhea If female of child bearing potential, pregnancy excluded by negative urine or serum pregnancy tests. approved for those 18 years of age or older AMITIZA AMPHETAMINES MAOI concurrent use or within the last 14 days Sleep studies for narcolepsy diagnosis Approve for those 3 years of age and older Monitor for weight loss, decreased growth velocity in children, increased heart rate and blood pressure, appearance or worsening of aggressive behavior or hostility, sleep disturbances and long-term usefulness of the drug AMPHETAMINE/DEXTROAMPHETAMINE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE ER, PROCENTRA, ZENZEDI ARALAST NP coverage is not provided in patients with lung disease in whom congenital alpha 1 antitrypsin deficiency has not been established. Alpha-1 Antitrypsin (ATT) Deficiency as defined by clinically evident emphysema, and congenital deficiency of alpha 1 protease inhibitor, and serum ATT levels less than or equal to 11 Micromoles per Liter, or less than or equal to 80 mg/dl. Reauthorization: demonstration of clinical response to therapy ARALAST NP 2

3 ARANESP Transferrin saturation less than 20% and patient not receiving iron supplementation where clinically appropriate. Hemoglobin level of the patient (not the result of a recent blood transfusion) greater than 12 g/dl. Lack of initial diagnosis of anemia (hematocrit less than 30% and/or hemoglobin less than 10 g/dl and/or symptomatic with hemoglobin 10-11g/dL). Iron status of the patient has been evaluated (serum transferrin saturation). Hemoglobin level of the patient be monitored prior to each dose when initiating therapy, for dose changes, and at regular intervals when the dose is stabilized. Blood pressure of the patient will be monitored throughout therapy. Patient will be monitored for the occurrence of thrombotic events. Initiation of therapy and/or dose changes - 6 weeks. Stable on therapy - 12 weeks. Once on therapy, compared to pretreatment baseline, the patient must show an objective clinical response (e.g., hemoglobin rise greater than 1 g/dl and/or hematocrit rise greater than 3%) to an appropriate dose/dose increase and duration of therapy. If hemoglobin rise greater than 1 g/dl in a 2 week period then physician should consider stopping therapy and/or restarting at a reduced dose. ARANESP ALBUMIN FREE ARCALYST ARCALYST BARBITURATES All medically accepted indications not otherwise excluded from Part D The prescriber must indicated the requested medication is being used for epilepsy, cancer, or a chronic mental health disorder. Lifetime PHENOBARBITAL 3

4 BOSULIF Coverage is not provided in those that have the BCR-ABL1 T315I mutation and use Bosulif in combination with other kinase inhibitors (for example sorafenib, sunitinib, etc.) Coverage is provided for the treatment of chronic, accelerated, or blast phase Philadelphia chromosomepositive chronic myelogenous leukemia (CML) in situations where the patient has experienced resistance or intolerance to prior therapy with imatinib. Coverage is only provided in patients at least 18 years of age and older BOSULIF BUTORPHANOL NASAL SPRAY All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for the treatment of migraine headache pain. Coverage for acute pain is provided in situations where the use of oral opioid therapy is not warranted or therapy with a rapid-acting agent is desirable. Coverage for migraine headache pain is provided in situations where the use serotonin agonists or ergotamine derivatives are not warranted as determined by the prescriber or have been attempted. for migraine pain / 3 month for acute pain BUTORPHANOL TARTRATE CELEBREX Post-operative pain following CABG surgery, allergic-type reaction to aspirin, NSAIDs, or sulfonamides Evaluation of cardiovascular disease or risk factors for cardiovascular disease 6 months for JRA, for dysmenorrhea, OA, RA, AS, 1 month for acute pain CELEBREX 4

5 CHANTIX All FDA-approved indications not otherwise excluded from Part D. The patient must be enrolled in a behavioral support/ modification program (e.g., community program, manufacturer sponsored program, counseling by the physician, internet, or telephone quitline). The patient must be 18 years of age or older '9 months lifetime CHANTIX, CHANTIX STARTING MONTH PAK CIALIS Coverage is not provided for erectile dysfunction. CIALIS CIMZIA All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for use in combination with other biologics e.g., Humira, Kineret, Remicade, etc Coverage is provided in situations where the patient has been evaluated and screened for the presence of latent TB infection, where warranted, prior to initiating treatment with Cimzia. Coverage for Crohn's disease is provided in situations where the patient experienced intolerance/failure to Humira. Coverage for rheumatoid arthritis is provided in situations where the patient experienced intolerance/failure to Humira AND Enbrel Patient must be 18 years of age or older Crohn's -, Rheumatoid arthritis - 5 years Renewal coverage is provided in situations where treatment has provided clinical benefit. CIMZIA 5

6 CINRYZE All FDA-approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for acute treatment of angioedema attacks in patients with HAE. For routine prophylaxis of HAE, patients must have inadequate response or intolerance to danazol or other attenuated androgen AND meet one of the following: 1. had at least one laryngeal attack in the past, 2. have a history of at least one severe event per month, OR 3. disabling symptoms for at least 5 days per month. Acute treatment -, Routine prophylaxis - Lifetime CINRYZE CLOBAZAM monotherapy for seizures Monitor for signs and symptoms of CNS depression (lethargy, drowsiness, unsteadiness, falls) and for worsening depression, suicidal thoughts or behaviors, and unusual changes in mood or behavior. Adjust dosage in elderly and in patients with mild to moderate hepatic insufficiency. For renewals: evidence of decreased frequency or resolution of seizures ONFI CLONAZEPAM Benzodiazepine allergy or hypersensitivity, liver disease (severe and/or encephalopathy), acute narrow angle glaucoma, pregnancy Periodic blood counts and liver function tests during long term therapy. Adjust dose in elderly. Evaluate patients for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior throughout duration of therapy. For renewals: evidence of improvement of symptoms CLONAZEPAM, CLONAZEPAM ODT 6

7 COLONY STIMULATING FACTORS (Leukine) All FDA-approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for neutropenia due to other drugs and chemotherapy, AIDS/HIV, severe chronic neutropenia, and myelodysplasia. Combination therapy with Neulasta, Neupogen or Leukine. Patient has experienced neutropenia from previous chemotherapy OR for patient is considered to be at high risk for the development of neutropenia. High risk for neutropenia is define by pre-existing neutropenia due to disease, chemo regimen associated with a high incidence of febrile neutropenia, extensive prior chemotherapy, previous radiation to areas containing large amounts of bone marrow, pts at high risk for infection (such as advanced cancer, decreased immune function, open wounds, and active infection). Coverage is provided for: Myelodysplasia when ANC is less than or equal to 1000/mm3, Severe chronic neutropenia (i.e., Neutropenic disorder, cyclic neutropenia) when ANC is less than or equal to 1500/mm3, bone marrow transplant when ANC is less than or equal to 1000/mm3, Current or post peripheral blood progenitor cell (PBPC) mobilization/transplantation (i.e., harvesting of peripheral blood stem cells) when ANC is less than or equal to 1500/mm3 LEUKINE COMETRIQ All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Covered Use. Diagnosis of progressive, metastatic medullary thyroid cancer. Authorization will be for. COMETRIQ 7

8 CRINONE All FDA approved indications not otherwise excluded from Part D. Additional coverage for off-label use is provided to support established pregnancy Coverage is not provided for infertility 9 months for support of established pregnancy, for secondary amenorrhea CRINONE DIAZEPAM All FDA approved indications not otherwise excluded from Part D. benzodiazepine allergy or hypersensitivity, severe hepatic insufficiency, acute narrow angle glaucoma, pregnancy, myasthenia gravis, sleep apnea syndrome DIAZEPAM, DIAZEPAM INTENSOL DIFICID For C. dificile associated diarrhea pt must have experienced failure or intolerance to metronidazole or oral vancomycin 1 month DIFICID 8

9 ENBREL All FDA-approved indications not otherwise excluded from Part D Patients are excluded if they have an active infection or on are on concurrent biologic response modifier e.g., Humira, Kineret or Remicade. Patient must be evaluated for latent TB with a PPD test and be treated if positive. Patient must also be assessed for the risk of hepatitis B. Patient who are identified as being high risk must be tested for hepatitis B prior to initiation of treatment (e.g. patients at high risk for hepatitis B include patients with early stage kidney disease or on dialysis, patients who received blood products for a medical condition etc). Reauthorization: demonstration of clinical response to therapy RA/JRA - patient must demonstrate inadequate response to at least 1 DMARD or intolerance to two DMARDs. Psoriasis - patient must be a candidate for phototherapy. ENBREL EPO All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for anemia associated with myelodysplatic syndromes, anemia of chronic disease (associated with rheumatoid arthritis or heart failure), anemia associated with management of chronic hepatitis C. Transferrin saturation less than 20% and patient not receiving iron supplementation where clinically appropriate. For patients with anemia due to CKD and zidovudine treated HIV patients only: Hemoglobin level of the patient (not the result of a recent blood transfusion) greater than 12 g/dl. Lack of initial diagnosis of anemia (applies to all indications except elective surgery indication) (hematocrit less than 30% and/or hemoglobin less than 10 g/dl and/or symptomatic with hemoglobin 10-11g/dL). Iron status of the patient has been evaluated (serum transferrin saturation). Hemoglobin level of the patient be monitored prior to each dose when initiating therapy, for dose changes, and at regular intervals when the dose is stabilized. Blood pressure of the patient will be monitored throughout therapy. Patient will be monitored for the occurrence of thrombotic events. Initiation of therapy and/or dose changes - 6 weeks. Stable on therapy - 12 weeks. Once on therapy, compared to pretreatment baseline, the patient must show an objective clinical response (e.g., hemoglobin rise greater than 1 g/dl and/or hematocrit rise greater than 3%) to an appropriate dose/dose increase and duration of therapy. If hemoglobin rise greater than 1 g/dl in a 2 week period then physician should consider stopping therapy and/or restarting at a reduced dose. EPOGEN, PROCRIT 9

10 FENTANYL TRANSMUCOSAL All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for concurrent use with other transmucosal fentanyl products Coverage is provided for use in the management of breakthrough CANCER pain that cannot be managed successfully with oral immediate-release narcotics and where the patient is already tolerant to long-acting narcotic analgesics FENTANYL CITRATE ORAL TRANSMUCOSAL, LAZANDA GILOTRIF All FDA-approved indications not otherwise excluded from Part D. For NSCLC - EGFR exon deletions or mutations Authorization will be for. For the treatment of metastatic non small cell lung cancer (NSCLC) must be used in tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations GILOTRIF 10

11 GROWTH HORMONES All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for (note - some growth hormone drugs may be labeled for 1 or more of these indications): adult growth hormone deficiency, growth failure in children small for gestational age or with intrauterine growth retardation, idiopathic short stature, GH deficiency associated with Turner Syndrome, growth failure secondary to chronic renal failure/insufficiency in children who have not received a renal transplant, short stature associated with Noonan Syndrome, and for the treatment of Prader-Willi Syndrome. Coverage is not provided for constitutional delayed growth Pediatric GHD: epiphyses must be confirmed open in patients 10 years of age and older, AND 1. diagnosis confirmed by any 2 provocative tests or by both low IGF-1 and IGFBP-3 levels in patients who meet the height related conditions of coverage, 2. diagnosis confirmed by 2 provocative tests and both low IGF-1 and IGF-BP3 in patients not meeting height related coverage conditions, or 3. 3 pituitary hormone deficiencies in pt with irreversible hypothalamic-pituitary structural lesions or panhypopituitarism. Growth failure from CRF: PGHD criteria must be met without the provocative tests or IGF-1 and IGF-BP3 related conditions. Idiopathic Short Stature: epiphyses must be confirmed as open in patients greater than or equal 10 years of age, height must be less than or equal sds from the mean. Small for Gestational Age: failure to manifest catch up growth by age 2 defined as birth weight, birth length, or both that are more than 2 sds mean normal values following adjustment for age and gender. Turner s syndrome and Noonan Syndrome: epiphyses must be confirmed as open and when on therapy. Adult GHD: requires either 1. a negative GH provocative test when the AGHD is due to childhood onset GHD, pituitary or hypothalamic disease, surgery or radiation therapy, or trauma, OR 2. 3 pituitary hormone deficiencies and baseline serum IGF-I levels below the ageand sex-appropriate reference range when the AGHD is due to irreversible hypothalamic-pituitary structural lesions or panhypopituitarism not acquired as a child, OR 3. 3 pituitary hormone deficiencies if adult panhypopit or irreversible hypothalamic-pituitary structural lesions are from childhood. Short bowel syndrome: when receiving specialized nutritional support. Pediatric endocrinologist for ISS 1 month for short bowel syndrome, for other indications 11

12 Height related conditions of coverage 1. height below the third percentile for their age and gender related height, 2. growth velocity subnormal greater than or equal 2 standard deviations (sds) from the age related mean, 3. delayed skeletal maturation greater than or equal 2 sds below the age/gender related mean. Renewals for PGHD, CFR, SGA, Turner's and Noonan Syndromes require growth response of greater than or equal 4.5 cm/yr (pre-pubertal) or greater than or equal 2.5 cm/yr (post-pubertal) AND open epiphyses. For pediatric patients with irreversible hypothalamic-pituitary structural lesions or panhypopituitarism coverage is renewable if the patient has had 3 pituitary hormone deficiencies. Renewals for short bowel syndrome is provided in the presence of clinical benefit (such as, decreasing the patient s intravenous nutritional requirements). Renewals for Prader-Willi syndrome is provided if pt has increase in lean body mass or decrease in fat mass. Renewals for ISS is provided in the presence of a growth response of greater than or equal 1.5 cm/yr AND open epiphyses. Renewals for AGHD is provided in the presence of clinical benefit (e.g., increase in total lean body mass, increase in IGF-1 and IGFBP-3 levels, or increase in exercise capacity). GENOTROPIN, GENOTROPIN MINIQUICK, HUMATROPE, HUMATROPE COMBO PACK, NORDITROPIN FLEXPRO, NORDITROPIN NORDIFLEX PEN, NUTROPIN, NUTROPIN AQ NUSPIN 5, NUTROPIN AQ PEN, SAIZEN, SAIZEN CLICK.EASY HUMIRA Patients are excluded if they have an active infection or are on concurrent biologic response modifier (e.g. Enbrel, Kineret or Remicade) Patient must be evaluated for latent TB with a PPD test and be treated if positive. Patient must also be assessed for the risk of hepatitis B. Patient who are identified as being high risk must be tested for hepatitis B prior to initiation of treatment (e.g. patients at high risk for hepatitis B include patients with early stage kidney disease or on dialysis, patients who received blood products for a medical condition etc). Reauthorization: demonstration of clinical response to therapy RA/JIA - patient must demonstrate inadequate response to at least 1 DMARD or intolerance to two DMARDs. Psoriasis - patient must be a candidate for systemic therapy or phototherapy. Crohn's disease - patient must demonstrate an inadequate response or intolerance to Remicade or one conventional therapy drug such as a corticosteroid, sulfasalazine, azathioprine, or mesalamine. HUMIRA, HUMIRA PEN-CROHNS DISEASESTARTER 12

13 ICLUSIG All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Iclusig for a Covered Use. Diagnosis for which Iclusig is being used. For chronic myelogenous leukemia (CML), prior therapies tried must be reported to confirm resistance or intolerance to prior tyrosine kinase inhibitor therapy. For acute lymphoblastic leukemia (ALL), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For ALL, prior therapies must be reported to document resistance or intolerance to prior tyrosine kinase inhibitor therapy. Authorization will be for. For CML, patient must have resistance or intolerance to prior tyrosine kinase inhibitor therapy for approval. For ALL, patient must have Ph-positive ALL and must have resistance or intolerance to prior tyrosine kinase inhibitor therapy for approval. ICLUSIG INCIVEK - HEP C - PROTEASE INHIBITORS All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for genotypes other than type 1. Previous failure to Incivek or Victrelis. Chronic Hep C, in patients with genotype 1 who have a quantifiable viral load. Must be used in combination with a pegylated interferon and ribavirin. 3 months INCIVEK 13

14 INCRELEX All FDA-approved indications not otherwise excluded from Part D. For severe primary IGFD coverage is provided if patient s height standard deviation score must be less than or equal -3.0 AND the basal IGF-1 score must be below the lower limits of normal for the reporting lab AND the patient must have normal or elevated growth hormone AND epiphyses must be confirmed as open in patients greater than or equal 10 years of age. For GH gene deletion coverage is provided if presence of neutralizing antibodies to growth hormones and open epiphyses in patients older than 10 years old. A growth response of greater than or equal 4.5 cm/yr (pre-pubertal growth phase) or greater than or equal 2.5 cm/yr (post-pubertal) must occur for continuation of coverage. Coverage is provided in situations where the diagnosis of IGF-1 deficiency has been made by an endocrinologist. INCRELEX INFERGEN All FDA approved indications not otherwise excluded from Part D. Patient must have compensated liver disease with detectable levels of hepatitis C virus RNA in the serum 3 to 9 months depending on genotype and initial vs. renewal therapy 2-log decrease in viral load for renewals INFERGEN 14

15 ITRACONAZOLE All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for pityriasis versicolor, tinea corporis, tineas crutis, tinea pedis, Chromomycosis, Coccidioidomycosis, Chronic Mucocutaneous Candidiasis, Cryptococcosis, Cryptococcal Meningitis, Leishmaniasis, Paracoccidioidomycosis, Paronychia, Penicillium marneffei, Fungal pneumonia and septicemia, Sporotrichosis disseminated, Tinea manuum, Vulvovaginal Candidiasis, histoplasmosis suppression in immunocompromised patients For onychomycosis only: Congestive heart failure, history of congestive heart failure, evidence of left ventricular dysfunction LFTs, fungal diagnostic test (e.g., KOH preparation, fungal culture, or nail biopsy) 1 mth: t.versicolor,t.corporis,t.cruris,t.pedis 2mth: fingernail 3mth: toenail 6mth:all others ITRACONAZOLE KALYDECO All FDA-approved indications not otherwise excluded from Part D. Coverage is NOT provided in patients who are homozygous for F508 deletion or who have other mutations in the CFTR gene. Coverage is provided in the treatment of cystic fibrosis in patients who have a G551D mutation in the CFTR gene as detected by a FDA cleared CF mutation test. Coverage may be renewed in situations where the patient is continuing to derive benefit from treatment (for example, improved or stable lung function measured by FEV1) KALYDECO 15

16 LETAIRIS All FDA-approved indications not otherwise excluded from Part D. WHO Group II, III, IV, or V PAH. If female of childbearing potential, pregnancy must be excluded and patient must be advised to practice more than one method of contraception. hemoglobin and hematocrit, monthly negative pregnancy test if a female of childbearing potential Coverage is provided in situations where it is being prescribed under the care or referral of a cardiologist or pulmonologist. Coverage is provided for use in combination with two or more PAH therapies when treatment with one PAH agent failed to adequately control the patient s symptoms. LETAIRIS LIDODERM All FDA-approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for diabetic neuropathy. For the off-label use of diabetic neuropathy: the patient must have previous use and inadequate response or intolerance to any ONE neuropathic pain medication, including (but not limited to): tri-cyclic antidepressants, gabapentin, Lyrica, opioids, venlafaxine, Cymbalta. LIDODERM LORAZEPAM benzodiazepine allergy or hypersensitivity, liver disease (severe and/or encephalopathy), acute narrow angle glaucoma, pregnancy LORAZEPAM, LORAZEPAM INTENSOL 16

17 MEKINIST All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Mekinist for a Covered Use. Diagnosis for which Mekinist is being used. For unresectable or metastatic melanoma must have documentation of BRAF V600E or V600K mutations Authorization will be for. For unresectable or metastatic melanoma must be used in patients with BRAF V600E or V600K mutations MEKINIST METHYLPHENIDATES MAOI concurrent use or within the last 14 days Sleep studies for narcolepsy diagnosis Monitor for weight loss, decreased growth velocity in children, increased heart rate and blood pressure, appearance or worsening of aggressive behavior or hostility, sleep disturbances and long-term usefulness of the drug CONCERTA, DEXMETHYLPHENIDATE HCL, METADATE CD (20 MG, 30 MG, 40 MG), METADATE ER, METHYLIN, METHYLPHENIDATE HCL, METHYLPHENIDATE HCL CD, METHYLPHENIDATE HCL ER, METHYLPHENIDATE HYDROCHLORIDE MULTIPLE SCLEROSIS THERAPY- GILENYA All FDA-approved indications not otherwise excluded from Part D. Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product or Copaxone is not covered. Patient must still either be able to walk at least a few steps or alternatively must have some functional arm/ hand use consistent with performing activities of daily living. GILENYA 17

18 NEULASTA Neulasta treatment within the last 14 days. Treatment of acute afebrile neutropenia. Current and periodic monitoring of WBC count at initiation of and during therapy. 6 months Neulasta administration will be delayed a minimum of 24 hours after the administration of cytotoxic chemotherapy. NEULASTA NEUMEGA All FDA-approved indications not otherwise excluded from Part D. Patient has experienced severe thrombocytopenia (e.g., platelet count less than equal to 20,000/mcL) from previous chemotherapy OR for patient is considered to be at high risk for the development of severe thrombocytopenia. NEUMEGA NEUTROPHIL (NEUPOGEN) All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for drug-induced neutropenia, myelodysplastic syndrome, neutropenia associated with AIDS Treatment of acute afebrile neutropenia. Patients not at at high risk for infection-associated complications or not having prognostic factors that are predictive of poor clinical outcomes. Current and periodic monitoring of WBC count at initiation of and during therapy. 3 months NEUPOGEN 18

19 OCTREOTIDE OCTREOTIDE ACETATE ONSOLIS All FDA approved indications not otherwise excluded from Part D. coverage is not provided for opiod non-tolerant patients Confirmed diagnosis of management of breakthrough cancer pain. Patient must be an Opiod tolerant patient (i.e. one who are already receiving and who is tolerant to opioid therapy) The patient must be 18 years of age or older ONSOLIS ORENCIA - SUBCUTANEOUS All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for use in combination with other biologics e.g., Humira, Kineret, Remicade, etc Coverage is provided in situations where the patient has been evaluated and screened for the presence of latent TB infection, where warranted, prior to initiating treatment. Coverage is provided in situations where the patient experienced intolerance/failure to Humira AND Enbrel. 18 years of age or older 5 years Renewal coverage is provided in situations where treatment has provided clinical benefit. ORENCIA 19

20 OSTEOPOROSIS (FORTEO) Paget's disease, unexplained elevation of alkaline phosphatase, open epiphyses, bone cancer or cancer that has metastasized to the bone, history of breat cancer, prior radiation therapy involving the skeleton, hypercalcemia, treatment with Forteo for greater than or equal to 24 months, concurrent bisphosphonate therapy during treatment with Forteo For diagnosis of primary osteoporosis or hypogonadal osteoporosis patient must have at least one of the following: history of osteoporotic fractures, multiple risk factors for fractures, OR has failed or is intolerant to traditional osteoporosis therapy FORTEO PEGASYS For chronic hepatitis C, patient must have compensated liver disease with detectable levels of HCV RNA in the serum. For chronic hepatitis B, patient must have a positive serum marker for HBV replication, persistently elevated aminotransferase levels greater than 2 times ULN, or signs of chronic hepatitis B on liver biopsy, or cirrhosis of the liver as evidenced by radiological or clinical data, or extrahepatic complications. Chronic hepatitis C -. Chronic hepatitis B -. For chronic hepatitis C, patient must have 2-log decrease in viral load for renewals. PEGASYS, PEGASYS PROCLICK PEGINTRON Patient must have compensated liver disease with detectable levels of hepatitis C virus RNA in the serum 2-log decrease in viral load for renewals PEG-INTRON, PEG-INTRON REDIPEN 20

21 PERJETA All FDA approved indications not otherwise excluded from Part D. Coverage is provided for the off-label use of iher2 positive metastatic breast cancer in patients with disease progression following treatment with trastuzumab. Patients must have HER2 overexpression of advanced or metastatic breast cancer AND either 1. have not received previous anti-her2 therapy or chemotherapy and pertuzumab will be used in combination with trastuzumab and docetaxel OR 2. had disease progression following treatment with trastuzumab and pertuzumab will be used in combination with trastuzumab. Lifetime PERJETA PROMACTA All FDA approved indications not otherwise excluded from Part D. Coverage is not provided when used in combination with Nplate. For ITP - Patients must have had an inadequate response, intolerance to, or not be a candidate for treatment with corticosteroids, immunoglobulins, or splenectomy. For HepC thrombocytopenia - the degree of thrombocytopenia would not allow the initiation and maintenance of interferon-based therapy. Renewal is provided for patients who continue to have a response to therapy (for example, platelet count has increased) PROMACTA 21

22 PROVIGIL All FDA-approved indications not otherwise excluded from Part D. For narcolepsy, require polysomnography. Coverage is provided for SWSD when: (1) Prescriber must confirm that the patient is a night worker and (2) has complaints of persistent and frequent excessive sleepiness and/or falling asleep while at work and (3) any medical conditions known to cause or contribute to sleepiness have been considered and treated. Coverage is provided for idiopathic hypersomnolence that is confirmed by polysomnography where excessive sleepiness is not due to other sleep disorders such as narcolepsy, obstructive sleep apnea or posttraumatic hypersomnia. If diagnosis of OSAHS require polysomnography and whether patient using CPAP For OSAHS require polysomnography. Coverage is also provided for patients who are receiving nasal continuous positive airway pressure therapy (CPAP) or who are not candidates for CPAP. Coverage is provided for depression associated with fatigue and/or sleepiness when the patient is receiving antidepressant therapy MODAFINIL PULMONARY ARTERIAL HYPERTENSION Concurrent nitrate therapy. REVATIO, SILDENAFIL CITRATE RELISTOR RELISTOR 22

23 REMICADE All FDA-approved indications not otherwise excluded from Part D. Remicade doses greater than 5 mg/kg in moderate to severe CHF Patient must be evaluated for latent TB with a PPD test and be treated if positive. Patient must also be assessed for the risk of hepatitis B. Patient who are identified as being high risk must be tested for hepatitis B prior to initiation of treatment (e.g. patients at high risk for hepatitis B include patients with early stage kidney disease or on dialysis, patients who received blood products for a medical condition etc). Reauthorization: demonstration of clinical response to therapy RA - patient must demonstrate inadequate response to at least 1 DMARD or intolerance to two DMARDs. Remicade is to be used in combination with methotrexate. Crohn's disease - patient must demonstrate an inadequate response or intolerance to one first-line agent such as corticosteroids, sulfasalazine, azathioprine, or mesalamine unless the patient has multiple draining enterocutaneous or rectovaginal fistulae. Ulcerative colitis - patient must demonstrate an inadequate response or intolerance to two first-line agents such as oral or rectal 5-ASA products or glucocorticosteroids. Psoriasis - patient must be a candidate for systemic therapy or phototherapy. REMICADE REVLIMID Pregnancy If female of child bearing potential, pregnancy excluded by 2 negative urine or serum pregnancy tests. For MM requirement of combination therapy with dexamethasone and at least one prior MM treatment. For MDS: diagnosis of anemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality, transfusion dependent. Instruction regarding importance and proper utilization of appropriate contraceptive methods. Monitor CBC on regular basis. REVLIMID 23

24 RIBAVIRIN All FDA-approved indications not otherwise excluded from Part D. 'History of unstable heart disease, hemoglobin less than 8.5, creatinine clearance less than 50, pregnancy, hemoglobinopathy. 'Patient must have detectable levels of HCV RNA in the serum and be on an alfa interferon product concurrently. REBETOL, RIBAPAK, RIBASPHERE, RIBAVIRIN RITUXAN All FDA approved indications not otherwise excluded from Part D. Additional coverage for off-label use is provided for relapsed or refractory Waldenstrom s macroglobulinemia. Coverage is not provided for use of Rituxan in combination with other biologics e.g., Humira, Kineret or Remicade, etc. Prescriber has not assessed the patient s risk for latent hepatitis B infection and, if indicated, tested the patient for latent hepatitis B infection before initiation or continuation of therapy with Rituxan. 1 month for rheumatoid arthritis, for other indications Assess the patient's risk for latent hepatitis B infection. For rheumatoid arthritis: inadequate response to at least one TNF inhibitor or been intolerant to treatment with at least two TNF inhibiting drugs. RITUXAN SANDOSTATIN LAR Patient had prior therapy with sandostatin injection (not depot form) and treatment was effective and tolerated. SANDOSTATIN LAR DEPOT 24

25 SENSIPAR All FDA approved indications not otherwise excluded from Part D. Additional off-label coverage is provided to normalize serum calcium and lower parathayroid hormone in primary hyperparathyroidism. Primary hyparathyroidism: plasma parathyroid hormone concentration less than 45 pg/ml. Plasma PTH level. Patient has serum calcium, phosphorus, and ipth levels monitored during therapy. For Primary hyperparathyroidism: not a surgical candidate or had unsuccessful parathyroidectomy. For CKD: receives regular dialysis treatments. SENSIPAR SIGNIFOR All FDA-approved indications not otherwise excluded from Part D. Diagnosis for which Signifor is being used. Cushing's - 18 years of age and older Initial course - Prescribed by or in consultation with an endocrinologist 3 months for initial therapy and for continuation therapy For Cushing's disease, Signifor will be approved if according to the prescribing physician the patient is not a candidate for surgery or surgery has not been curative. Patients who have already been started on Signifor for Cushing's disease will be approved if the patient has had a response, as determined by the prescribing physician and patient is continuing therapy to maintain response. SIGNIFOR SIMPONI All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for use in combination with other biologics e.g., Humira, Kineret, Remicade, etc Coverage is provided in situations where the patient has been evaluated and screened for the presence of latent TB infection, where warranted, prior to initiating treatment with Simponi. For RA or AS - Coverage is provided in situations where the patient experienced intolerance/failure to Humira AND Enbrel. For UC - Coverage is provided in situations where the pt experienced intolerance/failure to Humira. For rheumatoid arthritis, Simponi must be used in combination with methotrexate, per labeling. Renewal coverage is provided in situations where treatment has provided clinical benefit. SIMPONI 25

26 SIMPONI ARIA All FDA-approved indications not otherwise excluded from Part D. Concurrent use with another biologic (for example, tocilizumab, certolizumab, etanercept, adalimumab, anakinra, abatacept, infliximab, rituximab) or tofacitinib. Diagnosis for which Simponi Aria is being prescribed, concurrent medications, previous therapies tried. RA - adults RA - Prescribed by or in consultation with a rheumatologist Authorization will be for. For RA - in patients who have not been receiving Simponi or Simponi Aria, approve if they will be taking Simponi Aria in combination with MTX or one other traditional disease-modifying antirheumatic drug (DMARD) [e.g., leflunomide, sulfasalazine, hydroxychloroquine], unless intolerant or contraindicated AND meets one of the following criteria: i. Patient has tried one DMARD (brand or generic, oral or injectable) for at least 3 months, (this includes patients who have tried other biologic DMARDs for at least 3 months) OR ii. Patient has a contraindication or intolerance to MTX and leflunomide, as determined by the prescribing physician OR iii. Patient has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis - functional limitation (e.g., based on health assessment questionnaire disability index (HAQ-DI) score), extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibodies, or bony erosions by radiograph. SIMPONI ARIA SOMATULINE DEPOT Either surgery and/or radiotherapy is not a therapeutic option for the patient or the patient has had inadequate response to surgery and/or radiotherapy SOMATULINE DEPOT 26

27 SOMAVERT All FDA-approved indications not otherwise excluded from Part D. Coverage is provided when patients have had an inadequate response to surgery, radiation, or other medical therapies or in situations where the patient is not a candidate for other therapies. SOMAVERT STEROIDS, ANABOLIC 6 months OXANDROLONE STIVARGA All FDA-approved indications not otherwise excluded from Part D. For metastatic colorectal cancer, as per labeling coverage, is provided when the patient has been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapy AND anti-vegf therapy (for example, bevacizumab, etc), AND for known KRAS wild type tumors, when the patient was previously treated with an anti-egfr therapy (for example, panitumumab, cetuximab, etc). Coverage is NOT provided for use in combination with other kinase inhibitors (for example sorafenib, etc.) For gastrointestinal stromal tumors (GIST), as per labeling, authorization for Stivarga may be given in patients who have been previously treated with imatinib and sunitinib. STIVARGA 27

28 SYNRIBO All FDA approved indications not otherwise excluded from Part D. For chronic phase or accelerated phase CML pts must have resistance or intolerance to prior therapy with at least TWO tyrosine kinase inhibitors (for example, dasatinib, nilotinib, imatinib, bosutinib, etc) and Synribo must NOT be used in combination with other kinase inhibitors (for example sorafenib, sunitinib, etc.) 18 years of age or older SYNRIBO TAFINLAR All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Tafinlar for a Covered Use. Diagnosis for which Tafinlar is being used. For unresectable or metastatic melanoma must have documentation of BRAF V600E mutation Authorization will be for. For unresectable or metastatic melanoma must be used in patients with BRAF V600E mutation TAFINLAR 28

29 TECFIDERA All FDA approved indications not otherwise excluded from Part D. The patient must have a relapsing form of MS, (relapsing forms of MS include relapsing-remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive-relapsing multiple sclerosis [PRMS]) and Tecfidera must not be used concurrently with other disease-modifying agents used for MS (i.e., Avonex, Rebif, Betaseron, Extavia, Copaxone, Tysabri, Gilenya, and Aubagio). Patients who have not yet received Tecfidera must also meet one of the following conditions: 1. be unable to administer injections due to dexterity issues or visual impairment, 2. have tried two of the following: Avonex, Rebif, Betaseron/Extavia, or Copaxone, 3. the patient has tried Copaxone but cannot take an interferon beta therapy (i.e., Avonex, Rebif, and Betaseron/Extavia) due to any of the following A. having depression, being suicidal, or having a severe psychiatric disorder B. being a woman who is pregnant or plans to become pregnant C. having active liver disease or a history of significant liver disease or D. having a history of seizures. Prescribed by, or in consultation with, a neurologist or a physician who specializes in the treatment of MS TECFIDERA, TECFIDERA STARTER PACK TERBINAFINE All FDA approved indications not otherwise excluded from Part D. LFTs, fungal diagnostic test (e.g., KOH preparation, positive fungal culture, or nail biopsy) 3 months: Tinea capitis, Onychomycosis (toenail) 2 months: Onychomycosis (fingernail) TERBINAFINE HCL 29

30 TESTOSTERONES Female, prostate cancer, breast cancer Before the start of testosterone therapy patient has (or patient currently has) a confirmed low testosterone level (i.e. total testosterone less than 300 ng/dl, free or bioavailable, testosterone less than 5 ng/dl) or absence of endogenous testosterone ANDRODERM, ANDROGEL, ANDROGEL PUMP, ANDROGEL PUMP THALIDOMIDE All FDA approved indications not otherwise excluded from Part D. Additional coverage for off-label uses include Crohn's disease, aphthous ulcers in the presence of HIV or AIDS, prostate cancer, malignant melanoma, myelofibrosis, myelodysplastic syndromes, and advanced hepatocellular carcinoma. THALOMID TOPICAL-ULCERS Known neoplasm at site of application, drug not used as an adjunct to, but as a substitute for good ulcer practices like initial sharp debridement, pressure relief, infection control Ulcer size after 10 weeks of therapy, does ulcer have adequate blood supply, ulcer extending into subcutaneous tissue or beyond 3 months, then additional 2 months upon renewal REGRANEX 30

31 TRACLEER All FDA-approved indications not otherwise excluded from Part D. Patient currently taking cyclosporine A or glyburide. WHO Group II, III, IV, or V PAH. If female of childbearing potential, pregnancy must be excluded and patient must be advised to practice more than one method of contraception. Aminotransferase (AST, ALT) levels. Hemoglobin levels. Pregnancy status if femal of childbearing potential. Coverage is provided in situations where it is being prescribed under the care or referral of a cardiologist or pulmonologist. Patient has hemoglobin levels monitored after one and three months of treament and then every three months during therapy. TRACLEER ULORIC All FDA-approved indications not otherwise excluded from Part D. Patient must have experienced intolerance/inadequate therapeutic response to generic allopurinol OR have a creatinine clearance less than 50 ml/min. Lifetime ULORIC VICTRELIS- HEP C - PROTEASE INHIBITORS All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for genotypes other than type 1. Previous failure to Incivek or Victrelis. Chronic Hep C, in patients with genotype 1 who have a quantifiable viral load. Must be used in combination with a pegylated interferon and ribavirin. 11 months VICTRELIS 31

32 XELJANZ All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Xeljanz for a Covered Use. Concurrent use with a biologic for an inflammatory condition (eg, tocilizumab, anakinra, abatacept, rituximab) or a TNF inhibitor (eg, certolizumab pegol, etanercept, adalimumab, infliximab, golimumab). Concurrent use with potent immunosuppressants that are not methotrexate (MTX) [eg, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil]. Rheumatoid Arthritis (RA), adults. RA, prescribed by or in consultation with a rheumatologist. Authorization will be for. Approve in RA patients who have had a trial with at least two of the following - tocilizumab, anakinra, abatacept, rituximab, certolizumab, etanercept, adalimumab, infliximab, golimumab. Approve in RA patients who have tried one of the following- etanercept (Enbrel) OR adalimumab (Humira) or Orencia SC for at least 3 months unless intolerant. XELJANZ XIFAXAN All FDA approved indications not otherwise excluded from Part D. XIFAXAN 32

33 XOLAIR Baseline IgE must be greater than or equal to 30 IU/mL. The patient is currently receiving therapy with an inhaled steroid or oral steroid unless the patient should not receive steroids AND either 1. The dose of inhaled or systemic steroid must be reduced to help control adverse side effects and addition of Xolair is the only option that may achieve the needed dosage reduction OR 2. The patient has moderate to severe asthma defined as having had two or more ER visits for an asthma exacerbation AND/OR more than 2 courses of short pulse oral or parenteral corticosteroids for exacerbations within the previous Coverage is provided for patients 12 years of age and older Coverage may be renewed in situations where treatment if providing clinical benefit as evidenced by a reduction in asthma exacerbations from baseline. XOLAIR XYREM XYREM ZALTRAP Coverage is provided for the treatment of metastatic colorectal cancer in situations where the patient had evidence of disease progression or resistance to an oxaliplatin containing regimen AND when used in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI). ZALTRAP 33

34 The following drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Drug Name ACETYLCYSTEINE Route of Administration / Dosage Form INHALATION SOLUTION ALBUTEROL SULFATE AZASAN AZATHIOPRINE BROVANA BUDESONIDE CALCITRIOL CALCITRIOL CALCITRIOL CELLCEPT CHORIONIC GONADOTROPIN COLISTIMETHATE SODIUM CROMOLYN SODIUM CUBICIN CYCLOPHOSPHAMIDE CYCLOSPORINE CYCLOSPORINE MODIFIED CYCLOSPORINE MODIFIED DECAVAC EMEND ENGERIX-B INHALATION NEBULIZATION SOLUTION ORAL TABLET ORAL TABLET INHALATION NEBULIZATION SOLUTION INHALATION SUSPENSION ORAL CAPSULE INJECTION SOLUTION ORAL SOLUTION ORAL SUSPENSION RECONSTITUTED INJECTION SOLUTION RECONSTITUTED INJECTION SOLUTION RECONSTITUTED INHALATION NEBULIZATION SOLUTION INJECTION SOLUTION RECONSTITUTED ORAL TABLET ORAL CAPSULE ORAL CAPSULE ORAL SOLUTION INJECTION INJECTABLE ORAL CAPSULE INJECTION SUSPENSION 34

35 FOSCARNET SODIUM GAMMAGARD LIQUID GAMUNEX-C GENGRAF GENGRAF GRANISETRON HCL GRANISOL HECTOROL HECTOROL IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE/ALBUTEROL SULFATE LEVALBUTEROL LEVALBUTEROL HCL LEVOCARNITINE LEVOCARNITINE LEVOCARNITINE LIORESAL INTRATHECAL MIACALCIN MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL MYFORTIC NEORAL NEORAL ONDANSETRON HCL ONDANSETRON HCL INJECTION SOLUTION INJECTION SOLUTION INJECTION SOLUTION ORAL SOLUTION ORAL CAPSULE ORAL TABLET ORAL SOLUTION INJECTION SOLUTION ORAL CAPSULE INHALATION SOLUTION INHALATION SOLUTION INHALATION NEBULIZATION SOLUTION INHALATION NEBULIZATION SOLUTION ORAL TABLET INJECTION SOLUTION ORAL SOLUTION INJECTION SOLUTION INJECTION SOLUTION ORAL TABLET ORAL CAPSULE ORAL TABLET DELAYED RELEASE ORAL CAPSULE ORAL SOLUTION ORAL SOLUTION ORAL TABLET 35

36 ONDANSETRON ODT PERFOROMIST PULMICORT PULMOZYME RAPAMUNE RAPAMUNE RECOMBIVAX HB SANDIMMUNE SANDIMMUNE SANDIMMUNE TACROLIMUS TETANUS TOXOID ADSORBED TETANUS/DIPHTHERIA TOXOIDS-ADSORBED ADULT TOBI TYVASO VANCOMYCIN HCL VENTAVIS XOPENEX ZEMPLAR ZORTRESS ORAL TABLET DISPERSIBLE INHALATION NEBULIZATION SOLUTION INHALATION SUSPENSION INHALATION SOLUTION ORAL SOLUTION ORAL TABLET INJECTION SUSPENSION ORAL CAPSULE INJECTION SOLUTION ORAL SOLUTION ORAL CAPSULE INJECTION SOLUTION INJECTION SUSPENSION INHALATION NEBULIZATION SOLUTION INHALATION SOLUTION INJECTION SOLUTION RECONSTITUTED INHALATION SOLUTION INHALATION NEBULIZATION SOLUTION ORAL CAPSULE ORAL TABLET 36