ANTI-PARIKSON'S AGENT- DUOPA DUOPA Patient has a diagnosis of Parkinson's disease. Patient is levodopa-responsive.patient experiences disabling Off periods for a minimum of 3 hours/day. Disabling Off" periods occur despite therapy with both of the following: Oral levodopa-carbidopa and one drug from a different class of anti-parkinson's disease therapy (e.g., COMT inhibitor [entacapone, tolcapone], MAO-B inhibitor [selegiline, rasagiline], dopamine agonist [pramipexole, ropinirole]). Medication will be prescribed by or in consultation with a neurologist. For continuation of therapy of positive clinical response to Duopa therapy. Anti-Parikson's Agent- Duopa PAGE 1 LAST UPDATED 12/2017
ANTIFUNGALS (ORAL)- CRESEMBA CRESEMBA 186 MG CAPSULE Patient has a diagnosis of Invasive aspergillosis or invasive mucormycosis. AntiFungals (Oral)- Cresemba PAGE 2 LAST UPDATED 12/2017
ANTIFUNGALS (ORAL)- NOXAFIL SUSPENSION NOXAFIL 40 MG/ML SUSPENSION PATIENT IS USING MEDICATION FOR PROPHYLAXIS OF INVASIVE ASPERGILLUS AND/OR CANDIDA. PATIENT MUST MEET ONE OF THE FOLLOWING: PATIENT REQUIRES SECONDARY PROPHYLAXIS DUE TO A PRIOR FUNGAL INFECTION, PATIENT IS AT A HIGH RISK OF INFECTION DUE TO IMMUNOSUPPRESSION FROM HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) WITH GRAFT-VERSUS-HOST DISEASE (GVHD), OR PATIENT IS AT HIGH RISK OF INFECTIONS DUE TO SEVERE IMMUNOSUPPRESSION FROM HEMATOLOGIC MALIGNANCIES, SUCH AS ACUTE MYELOID LEUKEMIA (AML) AND MYELODYSPLASTIC SYNDROMES, WITH PROLONGED NEUTROPENIA FROM CHEMOTHERAPY AntiFungals (Oral)- Noxafil Suspension PAGE 3 LAST UPDATED 12/2017
ANTIFUNGALS (ORAL)- NOXAFIL TABLETS NOXAFIL DR 100 MG TABLET Patient is using medication for prophylaxis of invasive aspergillus and/or candida. Patient must meet one of the following: Patient requires secondary prophylaxis due to a prior fungal infection, patient is at a high risk of infection due to immunosuppression from hematopoietic stem cell transplant (HSCT) with graft-versus-host disease (GVHD), or patient is at high risk of infections due to severe immunosuppression from hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndromes, with prolonged neutropenia from chemotherapy AntiFungals (Oral)- Noxafil tablets PAGE 4 LAST UPDATED 12/2017
ANTIFUNGALS (ORAL)- VFEND/VORICONAZOLE VORICONAZOLE 200 MG TABLET, VORICONAZOLE 40 MG/ML SUSP, VORICONAZOLE 50 MG TABLET Patient has a diagnosis of Invasive aspergillosis, Scedosporium apiospermum (asexual form of pseudallescheria), Fusarium spp. Infection, Candida infection in the abdomen, kidney, bladder wall, wounds, Esophageal candidiasis, Disseminated candida infections of skin, or Candidemia in non-neutropenic patients. Patients using medication for Candida infection (in the abdomen, kidney, bladder wall, wounds), Esophageal candidiasis, Disseminated candida infections of skin, or Candidemia in non-neutropenic patient has failed, experienced an intolerance or resistance to, or has a contraindication to fluconazole. AntiFungals (Oral)- Vfend/voriconazole PAGE 5 LAST UPDATED 12/2017
ATYPICAL ANTIPSYCHOTICS-NUPLAZID NUPLAZID Patient is using for continuation of prior therapy or patient has a diagnosis of Parkinson's disease with either hallucinations or delusions. Atypical Antipsychotics-Nuplazid PAGE 6 LAST UPDATED 12/2017
AUSTEDO AUSTEDO MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A NEUROLOGIST. THE PATIENT MUST HAVE A DIAGNOSIS OF CHOREA ASSOCIATED WITH HUNTINGTON S DISEASE. PAGE 7 LAST UPDATED 12/2017
AZOLE ANTIFUNGAL- SPORANOX 10MG/ML SOLUTION SPORANOX 10 MG/ML SOLUTION Patient has diagnosis of esophageal or oropharyngeal candidiasis that is refractory to treatment with fluconazole. Azole Antifungal- Sporanox 10mg/mL Solution PAGE 8 LAST UPDATED 12/2017
AZOLE ANTIFUNGALS- BRAND SPORANOX CAPSULES OR GENERIC ITRACONAZOLE CAPSULES ITRACONAZOLE Patient has a diagnosis of systemic fungal infections, onychomycosis of fingernail, or onychomycosis of toenails. Patient with diagnosis of systemic fungal infection has one of the following diagnoses: Tinea corporis (ring worm), Tinea cruris (jock itch), or Tinea Pedis (athlete's foot). Patient with diagnosis of systemic fungal infection has infection that is resistant to topical antifungal treatment. Patient with diagnosis of fingernail onychomycosis or toenail onychomycosis has diagnosis confirmed by positive potassium hydroxide (KOH) preparation, culture, or histology. Patient with diagnosis of fingernail onychomycosis or toenail onychomycosis has condition that is causing debility, or disruption in their activities of daily living. Patient with diagnosis of fingernail onychomycosis or toenail onychomycosis has had a trial of and inadequate response, intolerance, or hypersensitivity to oral terbinafine. Azole Antifungals- Brand Sporanox capsules or generic itraconazole capsules PAGE 9 LAST UPDATED 12/2017
BELBUCA, BUTRANS BUTRANS Patient is under hospice care. If not, patient has diagnosis of severe pain. Patient with diagnosis of severe pain, requires continous, around-the-clock opiod analgesic for an extended period of time (at least 2 weeks). Patient with a diagnosis of severe pain has a failure or intolerance to at least two generic extended-release opioid product and/or opioid combination products: Oxymorphone ER, Morphine ER, Fentanyl, Methadone, Tramadol ER, OR Opioid Combinations. If not, patient with a diagnosis of severe pain has swallowng difficulties. Belbuca, Butrans PAGE 10 LAST UPDATED 12/2017
BRAND LOTRONEX, GENERIC ALOSETRON ALOSETRON HCL, LOTRONEX Patient has a diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS). Patient has symptoms for at least 6 months. Patient is female. Patient is age greater than or equal to 18 years. Patient has a history of failure, contraindication, or intolerance to both of the following: antispasmodic agent [eg, Bentyl (dicyclomine)] and antidiarrheal agent [eg, loperamide]. For contination of therapy patient has symptoms of IBS that continue to persist, and documentation of positive clinical response to Lotronex therapy. Brand Lotronex, Generic alosetron PAGE 11 LAST UPDATED 12/2017
CORLANOR (IVABRADINE): PRIOR AUTHORIZATION POLICY CORLANOR Patient has a diagnosis of chronic heart failure. Patient has New York Heart Association (NYHA) Class II, III, or IV symptoms. Patient has a left ventricular ejection fraction of less than or equal to 35%. Patient is in sinus rhythm. Patient has a resting heart rate that is greater than or equal to 70 beats per minute. Patient is on a beta-blocker at a maximally tolerated dose or patient has a contraindication or intolerance to beta-blocker therapy. Patient has history of failure, contraindication, or intolerance to one of the following: Maximally tolerated doses of a angiotensinconverting enzyme (ACE) inhibitor or maximally tolerated doses of an angiotensin receptor blocker (ARB). Patient has been hospitalized for worsening heart failure in the previous 12 months. The medication is being prescribed by or in consultation with a cardiologist. For continuation of therapy, patient must have documentation of postive clinical response to Corlanor therapy. Corlanor (ivabradine): Prior Authorization Policy PAGE 12 LAST UPDATED 12/2017
CUSTOM: INGREZZA INGREZZA MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A MOVEMENT SPECIALIST NEUROLOGIST. THE PATIENT MUST HAVE A DIAGNOSIS OF MODERATE TO SEVERE TARDIVE DYSKINESIA AND HAVE PERSISTENT SYMPTOMS OF TARDIVE DYSKINESIA DESPITE A TRIAL OF DOSE REDUCTION, TAPERING, OR DISCONTINUATION OF THE OFFENDING MEDICATION OR NOT BE A CANDIDATE FOR A TRIAL OF DOSE REDUCTION, TAPERING, OR DISCONTINUATION OF THE OFFENDING MEDICATION. PAGE 13 LAST UPDATED 12/2017
CUSTOM: MAVYRET MAVYRET Patient must have medical records (e.g., chart notes, laboratory values) documenting a diagnosis and genotype of chronic hepatitis C virus. Medication must be prescribed by or in consultation with a Hepatologist, Gastroenterologist, Infectious disease specialist, or HIV specialist. Patient must not be receiving Mavyret in combination with another HCV direct acting antiviral agent [e.g., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]. Medication must be used for one of the following scenarios: a.) Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; Treatment-Naïve; without Cirrhosis or with compensated liver disease. b.) Chronic Hepatitis C - Genotype 1; Prior failure to an NS3/4A Protease Inhibitor; without Decompensated Cirrhosis. No previous treatment experience with a treatment regimen that included an NS5A inhibitor. c.) Chronic Hepatitis C - Genotype 3; Treatment-Experienced; without Decompensated Cirrhosis. Patient has experienced treatment failure with a previous treatment regimen that included interferon, peginterferon, ribavirin, and/or Sovaldi (sofosbuvir). Patient has had no previous treatment experience with a treatment regimen that included a HCV NS3/4A protease inhibitor. d.) Chronic Hepatitis C - Genotype 1, 2, 4, 5, or 6; Treatment-Experienced; without Cirrhosis or with compensated cirrhosis. Patient has experienced treatment failure with a previous treatment regimen that included interferon, peginterferon, ribavirin, and/or Sovaldi (sofosbuvir). Patient has had no previous treatment experience with a treatment regimen that included an HCV NS3/4A protease inhibitor. PAGE 14 LAST UPDATED 12/2017
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DALIRESP (ROFLUMILAST): PRIOR AUTHORIZATION POLICY DALIRESP Patient has a diagnosis of severe COPD (defined as forced expiratory volume in 1 second [FEV1] less than or equal to 50% of predicted and FEV1/forced vital capacity [FVC] less than 0.7) associated with chronic bronchitis. Medication will be used in combination with a long-acting inhaled bronchodilator (i.e., long-acting anticholinergic, or long-acting beta2 agonist [LABA] in combination with inhaled corticosteroid [ICS]). Patient has history of COPD exacerbations which required the use of systemic corticosteroids, antibiotics, or hospital admission. For continuation of therapy patient has documentation fo positive clinical response to Daliresp therapy. Daliresp (roflumilast): Prior Authorization Policy PAGE 16 LAST UPDATED 12/2017
DUPIXENT DUPIXENT THE PATIENT MUST BE 18 YEARS OF AGE OR OLDER AND HAVE A DIAGNOSIS OF MODERATE TO SEVERE CHRONIC ATOPIC DERMATITIS. THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A DERMATOLOGIST, ALLERGIST, OR IMMUNOLOGIST. THE PATIENT MUST HAVE A HISTORY OF FAILURE, CONTRAINDICATION, OR INTOLERANCE TO ONE MEDIUM TO HIGH POTENCY TOPICAL CORTICOSTEROID. THE PATIENT MUST HAVE A HISTORY OF FAILURE OR INTOLERANCE TO ONE OF THE FOLLOWING, UNLESS THE PATIENT IS NOT A CANDIDATE FOR THERAPY (E.G., IMMUNOCOMPROMISED): ELIDEL (PIMECROLIMUS) TOPICAL CREAM OR TACROLIMUS TOPICAL OINTMENT. PAGE 17 LAST UPDATED 12/2017
EMFLAZA EMFLAZA THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A NEUROLOGIST WHO HAS EXPERIENCE TREATING CHILDREN. THE PATIENT MUST BE 5 YEARS OF AGE OR OLDER, HAVE A DIAGNOSIS OF DUCHENNE MUSCULAR DYSTROPHY (DMD), AND RECEIVED GENETIC TESTING FOR A MUTATION OF THE DYSTROPHIN GENE. THE PATIENT MUST HAVE DOCUMENTATION OF A CONFIRMED MUTATION OF THE DYSTROPHIN GENE OR A MUSCLE BIOPSY WHICH CONFIRMED AN ABSENCE OF DYSTROPHIN PROTEIN. THE PATIENT MUST HAVE HAD A TRIAL AND FAILURE OR INTOLERANCE TO PREDNISONE OR PREDNISOLONE GIVEN AT A DOSE OF 0.75 MG/KG/DAY OR 10 MG/KG/WEEKEND. THE DOSE MUST NOT EXCEED 0.9 MILLIGRAMS PER KILOGRAM OF BODY WEIGHT ONCE DAILY. PAGE 18 LAST UPDATED 12/2017
EMSAM TRANSDERMAL SYSTEM EMSAM Patient has a history of of failure, contraindication, or intolerance to TWO formulary generic antidepressants (e.g. citalopram, venlafaxine, mirtazapine, bupropion). If not, patient is unable to take medications orally. Emsam Transdermal System PAGE 19 LAST UPDATED 12/2017
ENTRESTO (SACUBITRIL-VALSARTAN): PRIOR AUTHORIZATION POLICY ENTRESTO Patient has a diagnosis of heart failure (with or without hypertension). Patient has an ejection fraction that is less than or equal to 40 percent. Patient has heart failure that is classified as one of the following: New York Heart Association Class II, New York Heart Association Class III, or New York Heart Association Class IV. Patient is receiving concomitant therapy with one of the following beta-blockers at a maximally tolerated dose: Bisoprolol, carvedilol, or metoprolol succinate. If not, patient has a contraindication or intolerance to beta-blocker therapy. Medication will be prescribed by or in consultation with a cardiologist. For continuation of therapy patient must have documentation of positive clinical response to therapy. Entresto (sacubitril-valsartan): Prior Authorization Policy PAGE 20 LAST UPDATED 12/2017
GAUCHER DISEASE AGENTS CERDELGA (ELIGLUSTAT TARTRATE) CERDELGA The patient is using the drug to treat symptoms of Type 1 Gaucher disease and is greater than 18 years. In addition, the patient is a either an extensive metabolizer, intermediate metabolizer or poor metabolizer as determined by an liver enzyme test. If this is continuation of therapy, the patient's condition should not have progressed. Gaucher Disease Agents Cerdelga (eliglustat tartrate) PAGE 21 LAST UPDATED 12/2017
GAUCHER DISEASE AGENTS ZAVESCA (MIGLUSTAT) ZAVESCA The patient is using the drug to treat the symptoms of mild to moderate Type 1 Gaucher disease and is unable to receive enzyme replacement therapy. Gaucher Disease Agents Zavesca (miglustat) PAGE 22 LAST UPDATED 12/2017
GL-14508 COTELLIC (COBIMETINIB) COTELLIC Patient must have a diagnosis of unresctable or metastatic melanoma with either (a) BRAF V600E mutation as detected by an FDA-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) OR (b) BRAF V600K mutation as detected by an FDA-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND is used in combination with vemurafenib. Drug must be prescribed by an oncologist.. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of disease progression while on therapy and meet all of the following criteria (a) Patient has not experienced Grade 4 hemorrhagic event or a Grade 3 hemorrhagic event that does not improve within 4 weeks, (b) Patient has not experienced asymptomatic absolute decrease in left ventricular ejection fraction (LVEF) from baseline of greater than 10% and less than the institutional lower limit of normal (LLN) that does not improve within 2 weeks, (c) patient has not experienced symptomatic LVEF decrease from baseline that persists for 4 weeks, (d) Patient has not experienced serous retinopathy that does not improve within 4 weeks, (e) Patient has not experienced Grade 4 liver abnormality or hepatotoxicity that does not improve within 4 weeks, (f) Patient has not experienced Grade 4 creatine phosphokinase (CPK) elevation or any CPK elevation with myalgia that does not improve within 4 weeks, (g) Patient has not experienced intolerable Grade 2, Grade 3, or Grade 4 photosensitivity that does not improve within 4 weeks, (h) Patient has not experienced retinal vein occlusion, (i) Patient has not experienced any other intolerable Grade 2 or Grade 3 adverse event that does not improve within 4 weeks and (j) patient nt has not experienced any recurrent Grade 4 adverse event. PAGE 23 LAST UPDATED 12/2017
GL-14508 Cotellic (cobimetinib) PAGE 24 LAST UPDATED 12/2017
GL-14582 ALECENSA (ALECTINIB) ALECENSA The patient must have a diagnosis of metastatic non-small cell lung cancer with anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility. Additionally, the patient must have had an inadequate response, progressed on, or had an intolerance or contraindication to XALKORI (crizotinib) and have Alecensa prescribed by or in consultation with an oncologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of progressive disease while on therapy. GL-14582 Alecensa (alectinib) PAGE 25 LAST UPDATED 12/2017
GL-14648 PULMONARY ARTERIAL HYPERTENSION AGENTS ADCIRCA, ADEMPAS 0.5 MG TABLET, ADEMPAS 1 MG TABLET, ADEMPAS 1.5 MG TABLET, ADEMPAS 2 MG TABLET, LETAIRIS, OPSUMIT, ORENITRAM ER, REMODULIN, SILDENAFIL, TRACLEER 125 MG TABLET, TRACLEER 62.5 MG TABLET, TYVASO, TYVASO INSTITUTIONAL START KIT, TYVASO REFILL KIT, TYVASO STARTER KIT, VENTAVIS The patient has a diagnosis of pulmonary arterial hypertension AND Pulmonary arterial hypertension is symptomatic AND One of the following: Diagnosis of pulmonary arterial hypertension was confirmed by right heart catheterization OR Patient is currently on any therapy for the diagnosis of pulmonary arterial hypertension AND Prescribed by or in consultation with a pulmonologist or cardiologist GL-14648 Pulmonary Arterial Hypertension Agents PAGE 26 LAST UPDATED 12/2017
GL-15452 IBRANCE (PALBOCICLIB) IBRANCE The medication must be prescribed by or in consultation with an oncologist and the patient must have a diagnosis of locally advanced or metastatic breast cancer. Patient must have evidence of Estrogen Receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative. Medication must be used in combination with: (1) an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane) in a postmenopausal woman or (2) Faslodex (fulvestrant) in a postmenopausal woman or premenopausal or perimenopausal woman receiving a luteinizing hormone-releasing hormone (LHRH) agonist [eg, Zoladex (goserelin). PAGE 27 LAST UPDATED 12/2017
GL-15467 DAKLINZA (DACLATASVIR) DAKLINZA Patient must have a diagnosis of either: (a) Chronic hepatitis C genotype 1 when the drug is used in combination with Sovaldi (sofosbuvir) and the patient has either (i) no decompensated cirrhosis and is not a liver transplant recipient or (ii) both decompensated cirrhosis and/or is a liver transplant recipient when used in combination with ribavirin. Patient must not have failed a prior HCV NS5A-containing regiment (eg., Daklinza) and have either a history of contraindication or intolerance to both Harvoni and Zepatier or is currently on Daklinza plus Solvadi therapy. The medication must be prescribed by or in consultation with a hepatologist, gastroenterologist, infectious disease specialist or an HIV specialist certified through the American Academy of HIV Medicine. (b) Chronic hepatitis C genotype 3 when medical records (eg., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 3 AND when used in combination of Sovaldi when patient is either (i) without cirrhosis and not a transplant recipient or (ii) ) both decompensated cirrhosis and/or is a liver transplant recipient when used in combination with ribavirin. Patient must not have failed a prior HCV NS5A-containing regiment (eg., Daklinza) and have either a history of contraindication or intolerance to Epclusa or is currently on Daklinza plus Solvadi therapy. The medication must be prescribed by or in consultation with a hepatologist, gastroenterologist, infectious disease specialist or an HIV specialist certified through the American Academy of HIV Medicine. PAGE 28 LAST UPDATED 12/2017
Patient must have a diagnosis of either: (a) Chronic hepatitis C genotype 1 when the drug is used in combination with Sovaldi (sofosbuvir) and the patient has either (i) no decompensated cirrhosis and is not a liver transplant recipient or (ii) both decompensated cirrhosis and/or is a liver transplant recipient when used in combination with ribavirin. Patient must not have failed a prior HCV NS5A-containing regiment (eg., Daklinza) and have either a history of contraindication or intolerance to both Harvoni and Zepatier or is currently on Daklinza plus Solvadi therapy. The medication must be prescribed by or in consultation with a hepatologist, gastroenterologist, infectious disease specialist or an HIV specialist certified through the American Academy of HIV Medicine. (b) Chronic hepatitis C genotype 3 when medical records (eg., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 3 AND when used in combination of Sovaldi when patient is either (i) without cirrhosis and not a transplant recipient or (ii) ) both decompensated cirrhosis and/or is a liver transplant recipient when used in combination with ribavirin. Patient must not have failed a prior HCV NS5A-containing regiment (eg., Daklinza) and have either a history of contraindication or intolerance to Epclusa or is currently on Daklinza plus Solvadi therapy. The medication must be prescribed by or in consultation with a hepatologist, gastroenterologist, infectious disease specialist or an HIV specialist certified through the American Academy of HIV Medicine. PAGE 29 LAST UPDATED 12/2017
GL-15507 SABRIL (VIGABATRIN) SABRIL, VIGABATRIN The patient has one of the following: Diagnosis of infantile spasms OR All of the following: Diagnosis of complex partial seizures AND Used as adjunctive therapy AND History of failure, contraindication, or intolerance to two formulary anticonvulsants [e.g., Lamictal (lamotrigine), Depakene (valproic acid), Dilantin (phenytoin) GL-15507 Sabril (vigabatrin) PAGE 30 LAST UPDATED 12/2017
GL-15513 ZEPATIER (ELBASVIR-GRAZOPREVIR) ZEPATIER The patient has diagnosis of a) Chronic Hepatitis C - Genotype 1a: treatment-naïve or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced without baseline NS5A polymorphisms. Patient has been tested for the presence of NS5A resistance-associated polymorphisms; b) Chronic Hepatitis C - Genotype 1a: treatment-naïve or PegIFN/RBVexperienced or PegIFN/RBV/protease inhibitor-experienced with baseline NS5A polymorphisms; Prior failure to treatment with peg interferon alfa plus ribavirin plus a HCV NS3/4A protease inhibitor (eg, boceprevir, simeprevir, or telaprevir). Patient has been tested for the presence of NS5A resistance-associated polymorphisms. Medication will be used in combination with ribavirin. c) Chronic Hepatitis C - Genotype 1b. Patient is treatment naive or has prior treatment failure. Medication is being used in combination with ribavirin; d) Chronic Hepatitis C - Genotype 4: Treatment-naïve; e) Chronic Hepatitis C - Genotype 4: PegIFN/RBV-experienced. Patient has prior failure to peg interferon alfa plus ribavirin treatment and the medication will be used in combination with ribavirin. Medication is prescribed by or in consultation with Hepatologist, Gastroenterologist, Infectious disease specialist OR HIV specialist. Patient is not receiving Zepatier in combination with another HCV direct acting antiviral agent [eg, Sovaldi (sofosbuvir), Olysio (simeprevir)]. Patient does not have moderate to severe hepatic impairment. PAGE 31 LAST UPDATED 12/2017
GL-15513 Zepatier (elbasvir-grazoprevir) PAGE 32 LAST UPDATED 12/2017
GL-15515 OLYSIO (SIMEPREVIR) OLYSIO Drug is used for the treatment of Chronic Hepatitis C over a 12 week period. Drug must be prescribed by or in consultation with Hepatologist or medical specialist. Patient has not experienced failure with a previous treatment regimen that includes Olysio or other protease inhibitors [eg, Incivek (telaprevir), Victrelis (boceprevir)]. Patient must be diagnosed and meet one of the following: a. Hepatitis C of genotype 1 and 4: Treatment Regimen: Olysio + Alfa Interferons + Ribavirin with documentation one of the following: (i) Diagnosis of chronic hepatitis C genotype 1a infection and patient does not have the NS3 Q80K polymorphism or; (ii) Diagnosis of chronic hepatitis C genotype 1b infection or; (iii) Diagnosis of chronic hepatitis C genotype 4 infection. Patient has a history of failure to Harvoni and Zepatier therapy; or patient is currently on Olysio therapy. b. Hepatitis C of Genotype 1 - without Cirrhosis: Treatment regimen Olysio + Sovaldi with documentation of showing patient is without decompensated liver disease and failure to Harvoni and Zepatier therapy. Patient has NS5A inhibitor resistant-associated variants. c. Hepatitis C of Genotype 1 - with Cirrhosis: Treatment regimen Olysio + Sovaldi with documentated history of failure to Harvoni and Zepatier therapy. Patient has NS5A inhibitor resistant-associated variants. GL-15515 Olysio (simeprevir) PAGE 33 LAST UPDATED 12/2017
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GL-15517 VIEKIRA PAK (OMBITASVIR, PARITAPREVIR, AND RITONAVIR TABLETS, DASABUVIR TABLETS) VIEKIRA PAK, VIEKIRA XR Patient must have medical records (e.g., chart notes, laboratory values) documenting a diagnosis and genotype of chronic hepatitis C virus. Medication must be prescribed by or in consultation with a Hepatologist, Gastroenterologist, Infectious disease specialist, or HIV specialist. Patient must not be receiving Viekira in combination with another HCV direct acting antiviral agent [e.g., Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), Olysio (simeprevir)]. Patient must not have experienced failure with a previous treatment regimen that includes a HCV NS3/4A protease inhibitor. Medication must be a continuation of prior Viekira therapy or the patient must have had a trial and failure of Harvoni and Zepatier. Medication must be used for one of the following scenarios: a.) Chronic Hepatitis C - Genotype 1a or Mixed Genotype 1 Infection with or without Cirrhosis AND without Liver Transplant (with ribavirin). b.) Chronic Hepatitis C - Genotype 1b - without Liver Transplant. c.) Chronic hepatitis C - Genotype 1 (Regardless of Subgenotype) Liver Transplant Recipient. Documentation that the patient is a liver transplant recipient. Submission of medical records documenting normal hepatic function and mild fibrosis (e.g., METAVIR fibrosis score less than or equal to F2). PAGE 35 LAST UPDATED 12/2017
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GL-15520 FARYDAK (PANOBINOSTAT) FARYDAK Patient must have a diagnosis of multiple myeloma when the medication will be used in combination with both Velcade (bortezomib) and dexamethasone. Further, patient must have received at least two prior treatment regimens which included both of the following: Velcade (bortezomib) AND an Immunomodulatory agent [eg, Revlimid (lenalidomide),thalomid (thalidomide)] and be prescribed by or in consultation with an oncologist/hematologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of disease progression while on therapy. GL-15520 Farydak (panobinostat) PAGE 37 LAST UPDATED 12/2017
GL-15525 POMALYST (POMALIDOMIDE) POMALYST Medication is used to treat Multiple myeloma and must be prescribed by or in consultation with hematologist/oncologist. Medication must be used in combination with dexamethasone. Patient must be diagnosed with multiple myeloma. Patient must have received at least two prior therapies including both Revlimid (lenalidomide) and a proteasome inhibitor (eg, Velcade [bortezomib], Kyprolis [carfilzomib]), and have demonstrated disease progression on or within 60 days of completion of the last therapy. GL-15525 Pomalyst (pomalidomide) PAGE 38 LAST UPDATED 12/2017
GL-15547 HARVONI (LEDIPASVIR-SOFOSBUVIR) HARVONI Patient must have medical records (e.g., chart notes, laboratory values) documenting a diagnosis and genotype of chronic hepatitis C virus. Patient must NOT be receiving Harvoni in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]. Medication must be prescribed by or in consultation with a Hepatologist, Gastroenterologist, Infectious disease specialist, or HIV specialist. Medication must be used for one of the following diagnosis: a.) Chronic Hepatitis C - Genotype 1 - Treatment Naive without Cirrhosis. b.) Chronic Hepatitis C - Genotype 1- Treatment Naïve with Cirrhosis, without decompensated liver disease. c.) Chronic Hepatitis C - Genotype 1- Treatment Experienced with or without Cirrhosis. Patient has experienced treatment failure, defined as viral relapse/breakthrough while on therapy or nonresponder to therapy, with a previous treatment regimen that included peginterferon plus ribavirin or an HCV protease inhibitor. d.) Chronic Hepatitis C - Genotype 1 - Decompensated Cirrhosis OR Genotype 1 or 4 - Post-Liver Transplant. Used in combination with ribavirin. Genotype 1 with decompensated cirrhosis OR genotype 1 or 4 post liver transplant and without the decompensated liver disease. e.) Chronic Hepatitis C - Genotype 1- Treatment Experienced with Cirrhosis. Chronic Hepatitis C - Genotype 4, 5, or 6. PAGE 39 LAST UPDATED 12/2017
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GL-15711 COMETRIQ (CABOZANTINIB) COMETRIQ Patient must have a diagnosis of (a) metastatic medullary thyroid cancer (MTC) or unresectable locally advanced MTC with a progressive or symptomatic disease. Medication must be prescribed by an oncologist, hematologist or endocrinologist or (b) non-small cell lung cancer (NSCLC) in a patient with positive RET gene rearrangements. Medication must be prescribed by or in consultation with an oncologist/hematologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of disease progression while on therapy. GL-15711 Cometriq (cabozantinib) PAGE 41 LAST UPDATED 12/2017
GL-15778 XELJANZ, XELJANZ XR (TOFACITINIB) XELJANZ, XELJANZ XR The patient has a diagnosis of moderate to severely active Rheumatoid Arthritis and the medication is perscribed by or in consultation with a rheumatologist: history of failure to a 3 month trial of one of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine: history of failure to TWO of the following: Cimzia(certolizumab), Humira (adalimumab), Simponi(golimumab)/Simponi Aria(golimumab IV) OR the patient has documented needle-phobia to the degree that patient has previously refused any injectable therapy or medical procedure. The patient is not using the medication with a biologic DMARD (ex-enbrel(etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab) and also not receiving tofacitnib in combination wih potent immunosuppressant (ex-azathioprine or cyclosporine). PAGE 42 LAST UPDATED 12/2017
GL-15831 XTANDI (ENZALUTAMIDE) XTANDI The patient has a diagnosis of metastatic, castration-resistant prostate cancer and the medication is prescribed by or in consultation with an Oncologist or a Urologist. The patient has a history of failure, contraindication or intolerance to Zytiga or the drug is being used for continuation of Prior therapy with Xtandi and patient has not shown evidence of progressive disease. GL-15831 Xtandi (enzalutamide) PAGE 43 LAST UPDATED 12/2017
GL-16285 APOKYN (APOMORPHINE HCL INJECTION) APOKYN The patient must have a diagnosis of advanced Parkinson s disease (a) with intermittent hypomobility (defined as off episodes characterized by muscle stiffness, slow movements or difficulty starting movements), (b) be receiving treatment of Apokyn in combination with other medications for Parkinson s disease (e.g., carbidopa/levodopa, pramipexole, ropinirole, benztropine, etc). AND (c) not be using any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron). IF the patient is currently on the medication and requesting continuation of therapy, the patient must have documentation of a positive clinical response to Apokyn AND not be using any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron). GL-16285 Apokyn (apomorphine HCl injection) PAGE 44 LAST UPDATED 12/2017
GL-16323 CAYSTON (AZTREONAM FOR INHALATION SOLUTION) CAYSTON Patient must have a diagnosis of cystic fibrosis with evidence of Pseudomonas aeruginosa in the lungs. Further, patient must be at least seven years of age or older. If the patient is currently on the medication and requesting continuation of therapy, the patient must have evidence of Pseudomonas aeruginosa in the lungs, be at least 7 years of age or older and be benefitting from treatment (i.e., improvement in lung function [forced expiratory volume in one second {FEV1}], decreased number of pulmonary exacerbations). GL-16323 Cayston (aztreonam for inhalation solution) PAGE 45 LAST UPDATED 12/2017
GL-16337 XENAZINE (TETRABENAZINE) TETRABENAZINE The patient has diagnosis of a) Chorea associated with Huntington's disease and prescribed by or in consultation with a neurologist.b) Tardive dyskinesia and associated stereotypes, patient is 18 years or older and the medication is prescribed by or in consultation with a neurologist or psychiatrist.c) Tourette's syndrome and associated tics, patient has a history of failure, contraindication, or intolerance to Haldol(Haloperidol) and the medication is prescribed by or in consultation with a neurologist or psychiatrist. If the patient has been previously approved for this medication by the Prior Authorization program and requesting continuation of therapy then patients must have one of the following diagnoses: Chorea associated with Huntington's disease, Tardive dyskinesia (Off-label) or Tourette's syndrome (Off-label) and there is documentation of positive clinical response to therapy GL-16337 Xenazine (tetrabenazine) PAGE 46 LAST UPDATED 12/2017
GL-16521 CAPRELSA (VANDETANIB) CAPRELSA Patient must have a diagnosis of metastatic medullary thyroid cancer (MTC) or unresectable locally advanced MTC where the disease is symptomatic or progressive and have the medication prescribed by or in consultation with either an oncologist or endocrinologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of disease progression while on therapy. GL-16521 Caprelsa (vandetanib) PAGE 47 LAST UPDATED 12/2017
GL-16554 OTEZLA (APREMILAST) OTEZLA The medication must be prescribed by or in consultation with a specialist. The patient must not be receiving Otezla in combination with a biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept)] or a Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]. The patient must have one of the following diagnosis: (a)psoriatic Arthritis with submission of medical records (e.g., chart notes, laboratory values), history of failure to a 3 month trial of methotrexate, one of the following: 1. History of failure, contraindication, or intolerance to TWO of the following: Cimzia (certolizumab pegol), Humira (adalimumab), Simponi (golimumab), Stelara (ustekinumab) 2. documented needle-phobia to the degree that the patient has previously refused any injectable therapy or medical procedure OR the patient is currently on Otezla therapy, has not received a manufacturer supplied sample at no cost in a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Otezla, has documentation of positive clinical response to Otezla therapy, and patient is compliant (b)plaque Psoriasis with submission of medical records (e.g., chart notes, laboratory values), one of the following: greater than 10% body surface area involvement, palmoplantar involvement, severe scalp psoriasis AND history of failure to both 3 month trial of methotrexate and at least one of the following topical therapies: Corticosteroids (e.g., betamethasone, clobetasol, desonide), Vitamin D analogs (e.g., calcitriol, calcipotriene), Tazarotene, Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), Anthralin, Coal tar. One of the following: 1. history of failure to either Humira (adalimumab) or Stelara (ustekinumab) AND history or failure to Taltz (ixekizumab) 2. documented needle-phobia to the degree that the patient has previously refused any injectable therapy or medical procedure OR the patient is currently on Otezla therapy, has not received a manufacturer supplied sample at no cost in a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Otezla, Documentation of positive clinical response to Otezla therapy, and patient is compliant with therapy. PAGE 48 LAST UPDATED 12/2017
GL-16554 Otezla (apremilast) PAGE 49 LAST UPDATED 12/2017
GL-16573 ERIVEDGE (VISMODEGIB) ERIVEDGE Patient must have a diagnosis of locally advanced basal cell carcinoma and meet one of the following requirements: Disease recurred following surgery, patient is not a candidate for surgery, OR patient is not a candidate for radiation. Medication must be prescribed by or in consultation with an oncologist or dermatologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of disease progression while on therapy. GL-16573 Erivedge (vismodegib) PAGE 50 LAST UPDATED 12/2017
GL-16587 ODOMZO (SONIDEGIB) ODOMZO Medication used for adult patients diagnosed with locally advanced basal cell carcinoma. Medication must be prescribed by or in consultation with dermatologist and oncologist. Patient must have either have (a) cancer has recurred following surgery or radiation therapy ; or (b) not a candidate for surgery or radiation therapy Patient does not show evidence of progressive disease. GL-16587 Odomzo (sonidegib) PAGE 51 LAST UPDATED 12/2017
GL-16737 GILOTRIF (AFATINIB) GILOTRIF The patient has the diagnosis of advanced or metastatic (stage IIIB or IV) non-small cell lung cancer. If this is being used for first-line treatment, then there must be 1) confirmation the patient have known active epidermal growth factor receptor (EGFR) exon 19 deletions, exon 21 (L858R) substitution, exon 18 (G719X, G719) or exon 20 (S7681) mutations as confirmed by an FDAapproved test or at a Clinical Laboratory Improvement Amendments-approved facility and 2) the medication must be approved by or in consultation with an oncologist. If this is being used treat disease that has progressed after platinum-based chemotherapy, the medication must be approved by or in consultation with an oncologist. If the patient is currently on the medication and is requesting continuation of therapy, the patient must not show evidence of progressive disease while on Gilotrif therapy. GL-16737 Gilotrif (afatinib) PAGE 52 LAST UPDATED 12/2017
GL-16782 IMBRUVICA (IBRUTINIB) IMBRUVICA Patient must have one of the following diagnosis and drug must be prescribed by or in consultation with a hematologist/oncologist. (a) Mantle Cell Lymphoma in a patient patient who has tried at least one prior therapy for MCL (e.g., Rituxan [rituximab]) (b) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (c) Waldenstrom's Macroglobulinemia (d) Marginal Zone Lymphoma in a patient who has tried at least one prior anti-cd20-based therapy for MZL [e.g., Rituxan (rituximab), Zevalin (ibritumomab), Gazyva (obinutuzumab, etc.)]. GL-16782 Imbruvica (ibrutinib) PAGE 53 LAST UPDATED 12/2017
GL-16794 SOMAVERT (PEGVISOMANT) SOMAVERT The patient has a Diagnosis of Acromegaly AND One of the following: Inadequate response to one of the following: Surgery, Radiation therapy, Dopamine agonist (e.g., bromocriptine, cabergoline) therapy, OR Not a candidate for all of the following: Surgery,Dopamine agonist (e.g., bromocriptine, cabergoline) therapy,radiation therapy AND History of failure, contraindication, or intolerance to generic octreotide (a somatostatin analogue) GL-16794 Somavert (pegvisomant) PAGE 54 LAST UPDATED 12/2017
GL-16815 ACTEMRA (TOCILIZUMAB-ACTERMA SC ACTEMRA 162 MG/0.9 ML SYRINGE The medication must be prescribed by or in consultation with a rheumatologist and the patient must have one of the following diagnosis a.) moderate to severely active Rheumatoid Arthritis in a patient with a history of failure, contraindication, or intolerance to one nonbiologic disease modifying anti-rheumatic drug (DMARD). Patient must also have a history of failure, contraindication, or intolerance to two of the following: Cimzia, Humira, Simpon/Simponi Aria or patient continuing Actemra therapy. Patient must not be receiving Actemra in combination with a biologic DMARD b.) giant cell arteritis in a patient with a trial and failure, contraindication, or intolerance to a glucocorticoid. Patient must not be receiving Actemra in combination with a biologic DMARD PAGE 55 LAST UPDATED 12/2017
GL-16819 ENBREL (ETANERCEPT) ENBREL, ENBREL MINI, ENBREL SURECLICK Patient must meet the following: Medication must be prescribed by a or in consultation with a medical specialist: Not receiving medication in combination with a biologic DMARD [e.g., Enbrel (etanercept)]: Not receiving medication in combination with a Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]: One of the following diagnosis: (a) Rheumatoid arthritis in a patient who has a history of failure to at least one DMARD [e.g., methotrexate (Rheumatrex/Trexall), Arava (leflunomide), Azulfidine (sulfasalazine)] and history of failure of TWO of the following: Cimzia (certolizumab pegol), Humira (adalimumab), Simponi (golimumab) or Simponi Aria (golimumab IV): (b) Polyarticular Juvenile Idiopathic Arthritis (PJIA) with a history of failure to one of the follwoing : Arava (leflunomide), methotrexate (Rheumatrex/Trexall): history of failure to Humira if not a conitnuation of therapy: (c) Psoriatic Arthritis (PsA) with a history of failure of TWO of the following: Cimzia (certolizumab pegol), Humira (adalimumab), Simponi (golimumab) or Stelara (ustekinumab) AND patient is not receiving Enbrel in combination with a phosphodiesterase-4 (PDE4) inhibitor [e.g., Otezla (apremilast)]: (d) Plaque Psoriasis and patient is 18 years of age or older with history of failure to either Humira (adalimumab) or Stelara (ustekinumab) and history of failure to Taltz (ixekizumab) and not receiving in combination with a phosphodiesterase-4 (PDE4) inhibitor [e.g., Otezla (apremilast)] OR Plaque Psoriasis in a patient younger than 18 years of age not receiving in combination with a phosphodiesterase-4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (e) Ankylosing Spondylitis with a history of failure of TWO NSAIDs AND history of failure to TWO of the following if Cimzia (certolizumab pegol), Humira (adalimumab), Simponi (golimumab) if not a continuation of therapy. PAGE 56 LAST UPDATED 12/2017
PAGE 57 LAST UPDATED 12/2017
GL-16823 HUMIRA (ADALIMUMAB) HUMIRA, HUMIRA PEDIATRIC CROHN'S, HUMIRA PEN, HUMIRA PEN CROHN-UC-HS STARTER, HUMIRA PEN PSORIASIS-UVEITIS "Diagnoses: Rheumatoid Arthritis, Polyarticular JIA, Chronic Plaque Psoriasis, Active Crohn s Disease, Active Ulcerative Colitis, Hidradenitis Suppurativa all moderate to severe, or Active Ankylosing Spondylitis, or Active PsA RA, Polyarticular JIA, or Ankylosing Spondylitis must be prescribed by or in consultation with a Rheumatologist; Plaque Psoriasis or Hidradenitis Suppurative must be prescribed by or in consultation with a Dermatologist; Chrohn s Disease or Ulcerative Colitis RA or Polyarticular JIA, Ankyosing Spondylitis Patient must have a history of failure, contraindication, or intolerance to one nonbiologic disease modifying anti-rheumatic drug (DMARD). Patient is not using in combination with a biologic DMARD or in combination with a Janus kinase inhibitor. For continuation of therapy, patient must have documentation of positive clinical response. PsA, Plaque Psoriasis, or Hidradenitis Suppurativa Not using in combination with a biologic DMARD or in combination with a Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]. For continuation of therapy, patient must have documentation of positive clinical response. Crohn s Disease History of failure, contraindication, or intolerance to one of the following conventional therapies: 6-mercaptopurine (Purinethol), Aminosalicylate, Azathioprine (Imuran), or Corticosteroids. Patient is not using in combination with a biologic DMARD or in combination with a Janus kinase inhibitor. For continuation of therapy, patient must have documentation of positive clinical response. Ulcerative Colitis History of failure, contraindication, or intolerance to one of the following conventional therapies: 6-mercaptopurine (Purinethol), Aminosalicylate, Azathioprine (Imuran), or Corticosteroids. Patient is not using in combination with a biologic DMARD or in combination with a Janus kinase inhibitor. For continuation of therapy, patient must have documentation of positive clinical response." PAGE 58 LAST UPDATED 12/2017
GL-16823 Humira (adalimumab) PAGE 59 LAST UPDATED 12/2017
GL-16836 ORENCIA (ABATACEPT) SC ORENCIA 125 MG/ML SYRINGE, ORENCIA 50 MG/0.4 ML SYRINGE, ORENCIA 87.5 MG/0.7 ML SYRINGE, ORENCIA CLICKJECT THE PATIENT MUST NOT BE RECEIVING ORENCIA IN COMBINATION WITH A BIOLOGIC DMARD AND THE MEDICATION MUST BE USED FOR ONE OF THE FOLLOWING DIAGNOSIS: A.) MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS. THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A RHEUMATOLOGIST. THE PATIENT MUST HAVE A TRIAL AND FAILURE, CONTRAINDICATION, OR INTOLERANCE TO ONE NONBIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUG (DMARD) THE PATIENT MUST HAVE A TRIAL AND FAILURE, CONTRAINDICATION, OR INTOLERANCE TO TWO OF THE FOLLOWING: CIMZIA (CERTOLIZUMAB), HUMIRA (ADALIMUMAB), SIMPONI (GOLIMUMAB) OR SIMPONI ARIA (GOLIMUMAB IV) OR THE MEDICATION IS BEING USED AS A CONTINUATION OF PRIOR ORENCIA THERAPY. B.) MODERATELY TO SEVERELY ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS. THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A RHEUMATOLOGIST. THE PATIENT MUST HAVE A TRIAL AND FAILURE, CONTRAINDICATION, OR INTOLERANCE TO ONE OF THE FOLLOWING DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS): LEFLUNOMIDE OR METHOTREXATE. C.) ACTIVE PSORIATIC ARTHRITIS. THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A RHEUMATOLOGIST OR DERMATOLOGIST. THE PATIENT MUST HAVE A TRIAL AND FAILURE, CONTRAINDICATION, OR INTOLERANCE TO TWO OF THE FOLLOWING: CIMZIA (CERTOLIZUMAB), HUMIRA (ADALIMUMAB), SIMPONI (GOLIMUMAB) OR STELARA (USTEKINUMAB) OR THE MEDICATION IS BEING USED AS A CONTINUATION OF PRIOR ORENCIA THERAPY. PAGE 60 LAST UPDATED 12/2017
PAGE 61 LAST UPDATED 12/2017
GL-16880 XALKORI (CRIZOTINIB) XALKORI The patient has a diagnosis of a) locally advanced or metastatic (stage IIIB or IV) non-small lung cancer(nsclc) and the drug is prescribed by or in consultation with an oncologist.b) Lanaplastic lymphoma kinase(alk)-positive tumor as detected with an FDA approved test or Clinical Laboratory Improvement Amendments- approved facility OR MET amplification or ROS1 rearrangements-positive tumor as detected with an FDA-appoved test or Clinical Laboratory Improvement Amendments approved facility If the patient has been previously approved and requesting for continuation of therapy then patient must not show evidence of progressive disease while on Xalkori therapy GL-16880 Xalkori (crizotinib) PAGE 62 LAST UPDATED 12/2017
GL-16889 SOMATULINE DEPOT (LANREOTIDE) SOMATULINE DEPOT Acromegaly The patient has a Diagnosis of Acromegaly AND One of the following: Inadequate response to one of the following: Surgery or Radiotherapy OR Not a candidate for surgery Advanced or metastatic gastroenteropancreatic neuroendocrine tumor (GEP-NET)- The patient has a Diagnosis of gastroenteropancreatic neuroendocrine tumor (GEP-NET) AND Disease is one of the following: Unresectable, locally advanced Metastatic AND Prescribed by or in consultation with an oncologist GL-16889 Somatuline Depot (lanreotide) PAGE 63 LAST UPDATED 12/2017
GL-16900 AFINITOR (EVEROLIMUS) AFINITOR Patient has one of following diagnosis: (a) Advanced Neuroendocrine Tumors of Pancreatic Origin, (b) Advanced Renal Cell Carcinoma, (c) Renal Angiomyolipoma with Tuberous Sclerosis Complex, (d) Subependymal Giant Cell Astrocytoma, (e) Breast cancer or (f) Neuroendocrine tumors of Gastrointestinal or lung origin. If Progressive neuroendocrine tumors of pancreatic origin, disease must be unresectable OR metastatic.. If Advanced/metastatic renal cell carcinoma, patient must have a history of failure with either Sutent OR Nexavar AND Afinitor must be prescribed by or in consultation with an oncologist. If Renal Angiomyolipoma with Tuberous Sclerosis Complex, medication must be prescribed by a nephrologist. If Subependymal Giant Cell Astrocytoma, (a) diagnosis must be associated with tuberous sclerosis, (b) the patient must not be a candidate for curative surgical resection AND (c) medication must be prescribed by an oncologist. If Breast cancer, (a) it must be hormone receptor positive, HER2-negative advanced breast cancer, (b) patient must have a failure, contraindication or intolerance to Arimidex or Femara, (c) medication must be used in combination with Aromasin AND (d) medication must be prescribed by an oncologist. If Progressive, well-defined, non-functional neuroendocrine tumors of Gastrointestinal OR lung origin, (a) diagnosis must be unresectable, locally advanced disease or metastatic AND (b) medication must be prescribed by or in consultation with an oncologist. If the patient is requesting continuation of therapy, the patient must have diagnosis of either (a) Advanced Neuroendocrine Tumors of Pancreatic Origin, (b) Advanced Renal Cell Carcinoma, (c) Renal Angiomyolipoma with Tuberous Sclerosis Complex, (d) Subependymal Giant Cell Astrocytoma, (e) Breast cancer or (f) Neuroendocrine tumors of Gastrointestinal or lung origin AND show no evidence of progressive disease while on Afinitor. PAGE 64 LAST UPDATED 12/2017
GL-16900 Afinitor (everolimus) PAGE 65 LAST UPDATED 12/2017
GL-16900 AFINITOR DISPERZ (EVEROLIMUS) AFINITOR DISPERZ The patient has the diagnosis of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), not be a candidate for surgical resection and have the medication prescribed by or in consultation with an oncologist. If the patient is currently on the medication and requesting continuation of therapy, the patient must show no evidence of progressive disease while on therapy. GL-16900 Afinitor Disperz (everolimus) PAGE 66 LAST UPDATED 12/2017