CUSTOM - BAXDELA (2018)

Transcription

1 CUSTOM - BAXDELA (2018) BAXDELA 450 MG TABLET Requires a FDA approved indication and prescribed by or in consultation with Infectious disease specialist. PAGE 1 LAST UPDATED 06/2018

2 CUSTOM - ENDARI (L-GLUTAMINE) (2018) ENDARI The medication is prescribed by or in consultation with an oncologist or hematologist, the patient must have a diagnosis of sickle cell disease and the medication must be used to reduce acute complications of sickle cell disease. The patient must be using Endari with concurrent hydroxyurea therapy OR have a contraindication or intolerance to hydroxyurea. The patient must have had 2 or more painful sickle cell crises within the past 12 months. Patients must be 5 years of age or older. PAGE 2 LAST UPDATED 06/2018

3 CUSTOM - SOLOSEC (2018) SOLOSEC Requires a FDA-approved indication and history of failure, contraindication, or intolerance to metronidazole and clindamycin vaginal products. PAGE 3 LAST UPDATED 06/2018

4 CUSTOM: ANTIFUNGALS (ORAL)- CRESEMBA (2018) CRESEMBA 186 MG CAPSULE PATIENT HAS A DIAGNOSIS OF INVASIVE ASPERGILLOSIS OR INVASIVE MUCORMYCOSIS. PAGE 4 LAST UPDATED 06/2018

5 CUSTOM: ANTIFUNGALS (ORAL)- VFEND/VORICONAZOLE (2018) 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. PAGE 5 LAST UPDATED 06/2018

6 CUSTOM: EMSAM TRANSDERMAL SYSTEM (2018) 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. PAGE 6 LAST UPDATED 06/2018

7 CUSTOM: HYCAMTIN (2018) HYCAMTIN 0.25 MG CAPSULE, HYCAMTIN 1 MG CAPSULE PATIENT HAS DIAGNOSIS OF SMALL CELL LUNG CANCER, AND THE MEDICATION IS BEING PRESCRIBED BY OR IN CONSULTATION WITH AN ONCOLOGIST. FOR CONTINUATION OF THERAPY, THERE IS NO EVIDENCE OF DISEASE PROGRESSION. PAGE 7 LAST UPDATED 06/2018

8 CUSTOM: SEROPHENE - CLOMIPHENE (2018) CLOMIPHENE CITRATE THE PATIENT MUST HAVE ONE OF THE FOLLOWING DIAGNOSIS: (A) DIAGNOSIS OF INFERTILITY (B) FEMALE PATIENT USING FOR FIBROID REDUCTION PRIOR TO SURGICAL PROCEDURE (C) DIAGNOSIS OF HYPOGONADISM IN A MALE PATIENT USING TO INCREASE TESTOSTERONE PAGE 8 LAST UPDATED 06/2018

9 CUSTOM: TOPICAL RETINOID AGENTS (2018) ADAPALENE 0.1% CREAM, ADAPALENE 0.1% GEL, ADAPALENE 0.3% GEL, ADAPALENE 0.3% GEL PUMP IF PATIENT IS OVER 35 YEARS OLD THEN MUST HAVE A DIAGNOSIS OF ACNE VULGARIS. ALL AGES: PATIENT MUST HAVE A HISTORY OF FAILURE, CONTRAINDICATION, OR INTOLERANCE TO THE PREFERRED PRODUCT, OVER THE COUNTER DIFFERIN 0.1% GEL. PAGE 9 LAST UPDATED 06/2018

10 STANDARD - ADDYI (FLIBANSERIN) ADDYI The patient has a diagnosis of acquired, generalized hypoactive sexual disorder OR female sexual interest/arousal disorder. The patient has symptoms of acquired, generalized hypoactive sexual disorder OR female sexual interest/arousal disorder that has persisted for at least 6 months. Patient is female and premenopausal. The prescriber is certified/enrolled in the Addyi REMS Program. Patient has no known history of alcohol abuse, or if patient does have known history of alcahol abuse, patient has abstained from alcohol abuse for the past 6 months. The patient will abstain from alcohol use during treatment with Addyi. For continuation of therapy, there must be documentation of positive clincial response ot Addyi Therapy. Patient continues to be premenopausal and continues to abstain from alcohol use during treatement with Addyi. PAGE 10 LAST UPDATED 06/2018

11 STANDARD - AFREZZA (INSULIN HUMAN, INHALATION POWDER) AFREZZA This patient has s a diagnosis of Type 2 Diabetes Mellitus OR a diagnosis of Type 1 Diabetes Mellitus. If patient has a diagnosis of Type 1 Diabetes Mellitus, patient will be taking Afrezza in combination with a long-acting insulin. Patient is unable to self-inject short-acting insulin multiple times daily due to physical impairment, visual impairment, or lipohypertrophy. Patient has documentation of FEV1 within the last 60 days of being greater than or equal to 70% of expected normal as determined by the physician. Afrezza will be prescribed by or in consulation with an endocrinologist. The patient must not smoke cigarettes, and must not have any chronic lung disease. It must be more than 6 months since patient has quit smoking. For continution of therapy, the patient must have positive clinical response to Afrezza therapy. The patient must also have a repeat pulmonary function test after the first 6 months of therapy confirming the patient has not experienced a decline of positive clinical response to Afrezza therapy. PAGE 11 LAST UPDATED 06/2018

12 STANDARD - ALUNBRIG ALUNBRIG MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH AN ONCOLOGIST. THE PATIENT MUST HAVE A DIAGNOSIS OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC). THE PATIENT MUST HAVE AN ANAPLASTIC LYMPHOMA KINASE (ALK)- POSITIVE TUMOR AND A TRIAL AND FAILURE OR INTOLERANCE TO XALKORI (CRIZOTINIB). PAGE 12 LAST UPDATED 06/2018

13 STANDARD - ANADROL-50 (OXYMETHOLONE) ANADROL-50 The patient has a diagnosis of anemia caused by deficient red cell production. The patient has a history of failure or intolerance to multiple standard therapies for anemia, such as erythropoiesisstimulating agents, immunosuppressants, blood transfusions. Treatment will replace other supportive measures. For continuation of therapy, patient has improvement in anemia. PAGE 13 LAST UPDATED 06/2018

14 STANDARD - 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. PAGE 14 LAST UPDATED 06/2018

15 STANDARD - 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. PAGE 15 LAST UPDATED 06/2018

16 STANDARD - AUSTEDO AUSTEDO The patient must have one of the following diagnosis (a) chorea associated with Huntington s disease, medication must be prescribed by or in consultation with a neurologist. (b) Tardive Dyskinesia, medication must be prescribed by or in consultation with a neurologist or psychiatrist, the patient must have persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication OR the patient must not be a candidate for a trial of dose reduction, tapering, or discontinuation of the offending medication. PAGE 16 LAST UPDATED 06/2018

17 STANDARD - 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. PAGE 17 LAST UPDATED 06/2018

18 STANDARD - BENLYSTA BENLYSTA 200 MG/ML AUTOINJECT, BENLYSTA 200 MG/ML SYRINGE The patient must have a diagnosis of active systemic lupus erythematosus with autoantibody positive (i.e., anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsdna level greater than or equal to 30 IU/mL). The patient must be currently receiving at least one standard of care treatment for active systemic lupus erythematosus (eg, antimalarials [eg, Plaquenil (hydroxychloroquine)], corticosteroids [eg, prednisone], or immunosuppressants [eg, methotrexate, Imuran (azathioprine)]). The drug must be prescribed by or recommended by a rheumatologist. PAGE 18 LAST UPDATED 06/2018

19 STANDARD - BRAND LOTRONEX, GENERIC ALOSETRON ALOSETRON HCL 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. PAGE 19 LAST UPDATED 06/2018

20 STANDARD - BRAND PENNSAID TOPICAL SOLUTION, GENERIC DICLOFENAC TOPICAL SOLUTION KLOFENSAID DICLOFENAC 1.5% TOPICAL SOLN Patient has a diagnosis of osteoarthritis of the knee(s). Patient also has one of the following: History of failure, contraindication, or intolerance to at least two prescription strength oral NSAID; documented swallowing disorder; history of peptic ulcer disease/gastrointestinal bleed; or patient is older than 65 years of age with one additional risk factor for gastrointestinal adverse events (e.g., use of anticoagulants, chronic corticosteroids). For continuation of therapy, patient must have documentation of positive clinical response (e.g., improvement in pain symptoms of osteoarthritis) to therapy. PAGE 20 LAST UPDATED 06/2018

21 STANDARD - BRAND XENAZINE (TETRABENAZINE) XENAZINE THE PATIENT MUST HAVE A TRIAL AND FAILURE OR INTOLERANCE TO GENERIC TETRABENAZINE AND ONE OF THE FOLLOWING DIAGNOSIS A.) CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE AND PRESCRIBED BY OR IN CONSULTATION WITH A NEUROLOGIST. B.) 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. C.) TARDIVE DYSKINESIA AND ASSOCIATED STEREOTYPIES, PATIENT IS 18 YEARS OR OLDER AND THE MEDICATION IS PRESCRIBED BY OR IN CONSULTATION WITH A NEUROLOGIST OR PSYCHIATRIST. PAGE 21 LAST UPDATED 06/2018

22 STANDARD - CALQUENCE (ACALABRUTINIB) (2018) CALQUENCE The medication must be prescribed by or in consultation with an oncologist or hematologist. The patient must have a diagnosis of mantle cell lymphoma (MCL) and have received at least one prior therapy for MCL. PAGE 22 LAST UPDATED 06/2018

23 STANDARD - CESAMET CESAMET Patient has a diagnosis of chemotherapy-induced nausea and vomiting. Patient is receiving cancer chemotherapy. Patient has a history of failure, contraindication, or intolerance to formulary generic dronabinol. Patient has a history of failure, contraindication, or intolerance to a 5HT-3 receptor antagonist [eg, Anzemet (dolasetron), Kytril (granisetron), or Zofran (ondansetron)]. Patient has a history of failure, contraindication, or intolerance to one of the following: Ativan (lorazepam), Compazine (prochlorperazine), Decadron (dexamethasone), Haldol (haloperidol), Phenergan (promethazine), Reglan (metoclopramide), or Zyprexa (olanzapine). PAGE 23 LAST UPDATED 06/2018

24 STANDARD - 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. PAGE 24 LAST UPDATED 06/2018

25 STANDARD - COSENTYX - SECUKINUMAB COSENTYX (2 SYRINGES), COSENTYX PEN, COSENTYX PEN (2 PENS), COSENTYX SYRINGE The patient must have one of the following diagnosis (a) moderate to severe plaque psoriasis, prescribed by or in consultation with a dermatologist, history of failure, contraindication, or intolerance to ONE of the following: Humira (adalimumab), Stelara (ustekinumab) or Tremfya (guselkumab) OR continuation of prior Cosentyx therapy. Patient is not receiving Cosentyx in combination with a biologic DMARD (b) active ankylosing spondylitis, prescribed by or in consultation with a rheumatologist, history of failure, contraindication, or intolerance to two nonsteroidal anti-inflammatory drugs (NSAIDs), history of failure, contraindication, or intolerance to TWO of the following or attestation demonstrating a trial may be inappropriate: Cimzia (certolizumab pegol), Humira (adalimumab), or Simponi (golimumab) OR continuation of prior Cosentyx therapy, patient is not receiving Cosentyx in combination with a biologic DMARD (c) active psoriatic arthritis, prescribed by or in consultation with a dermatologist or rheumatologist, history of failure, contraindication, or intolerance to TWO of the following: Cimzia (certolizumab pegol), Humira (adalimumab), Simponi/Simponi Aria (golimumab), Stelara (ustekinumab) OR continuation of prior Cosentyx therapy, patient is not receiving Cosentyx in combination with a biologic DMARD. PAGE 25 LAST UPDATED 06/2018

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27 STANDARD - DAKLINZA DAKLINZA 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. 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 either Harvoni or Mavyret OR is currently on Daklinza plus Solvadi therapy. (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 either Epclusa or Mavyret OR is currently on Daklinza plus Solvadi therapy. PAGE 27 LAST UPDATED 06/2018

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29 STANDARD - 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. PAGE 29 LAST UPDATED 06/2018

30 STANDARD - 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 30 LAST UPDATED 06/2018

31 STANDARD - 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 31 LAST UPDATED 06/2018

32 STANDARD - ENBREL ENBREL, ENBREL MINI, ENBREL SURECLICK Medication must be prescribed by or in consultation with a medical specialist, the patient must not be receiving medication in combination with a biologic DMARD, and the patient must meet 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 antirheumatic drug (DMARD). The patient must meet one of the following: i.) history of failure, contraindication, or intolerance to two of the following or attestation demonstrating a trial may be inappropriate: Cimzia, Humira, Simpon/Simponi Aria AND a history of failure, contraindication, or intolerance to both Kevzara and Xeljanz/Xeljanz XR ii.) patient is continuing prior Enbrel therapy (b) polyarticular juvenile idiopathic arthritis (PJIA) with a history of failure to one of the following : Arava (leflunomide) or methotrexate (Rheumatrex/Trexall). History of failure to Humira OR continuation of prior Enbrel therapy, (c) psoriatic arthritis (PsA) with a history of failure of TWO of the following: Cimzia (certolizumab pegol), Humira (adalimumab), Simponi/Simponi Aria (golimumab), Stelara (ustekinumab) and a history of failure, contraindication, or intolerance to both Kevzara and Xeljanz/Xeljanz XR OR continuation of prior Enbrel therapy (d) plaque psoriasis and one of the following apply: i.) patient is 18 years of age or older with history of failure to ONE of the following: Humira (adalimumab), Stelara (ustekinumab), or Tremfya (guselkumab) AND history of failure to Cosentyx (secukinumab) OR continuation of prior Enbrel therapy ii.) patient is younger than 18 years of age (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/Simponi Aria (golimumab) OR continuation of prior Enbrel therapy. PAGE 32 LAST UPDATED 06/2018

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34 STANDARD - 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. PAGE 34 LAST UPDATED 06/2018

35 STANDARD - EPCLUSA EPCLUSA Patient must have medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus. Patient must NOT be receiving sofosbuvir-velpatasvir 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 Hep C (without decompensation) - Genotype 1, 2, 3, 4, 5, or 6 in a patient that patient does not have decompensated liver disease and Epclusa is used alone (b) Chronic Hep C - Genotype 1, 2, 3, 4, 5, or 6 in a patient has decompensated liver disease using Epclusa in combination with ribavirin (c) Chronic Hep C - Genotype 1, 4, 5, or 6 - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir-based Treatment Failure -patients with decompensated liver disease who are ribavirin intolerant or ineligible OR have prior failure to Sovaldi or NS5A-based treatment and Epclusa is used in combination with ribavirin. PAGE 35 LAST UPDATED 06/2018

36 STANDARD - FENTANYL (GENERIC LOZENGE) FENTANYL CIT OTFC 1,200 MCG, FENTANYL CIT OTFC 1,600 MCG, FENTANYL CITRATE OTFC 200 MCG, FENTANYL CITRATE OTFC 400 MCG, FENTANYL CITRATE OTFC 600 MCG, FENTANYL CITRATE OTFC 800 MCG The patient is using the drug to manage breakthrough cancer pain and the patient shows a tolerance to opioids as demonstrated by using one of the following drugs for at least one week: Morphine sulfate at doses of greater than or equal to 60mg/day, or fentanyl transdermal patch at doses greater than or equal to 25 mcg/hour or oxycodone at a dose of greater than or equal to 30mg/day or oral hydromorphone at a dose of greater than or equal to 8mg/day or oral oxymorphone at a dose of greater than or equal to 25mg/day or an alternative opioid at an equianalgesic dose, such as oral methadone greater than or equal to 20mg/day. The patient is currently taking a long-acting opioid around the clock for cancer pain. The drug is prescribed by or in consultation with one of the following: Pain specialist, oncologist, hematologist, hospice care specialist or palliative care specialist. PAGE 36 LAST UPDATED 06/2018

37 STANDARD - FORTEO FORTEO Treatment duration of parathyroid hormones [Forteo (teriparatide), Tymlos (abaloparatide)] must not exceed a total of 24 months during the patient's lifetime. The medication must be used for one of the following diagnosis: a.) Postmenopausal women with osteoporosis or osteopenia, men with primary or hypogonadal osteoporosis or osteopenia at high risk for fracture and one of the following scenarios must apply: i.) bone mineral density (BMD) T-score of -2.5 or lower in the lumbar spine, femoral neck, total hip, or radius (one-third radius site). History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm OR Trial and failure, contraindication, or intolerance to one osteoporosis treatment. ii.) BMD T-score between -1.0 and in the lumbar spine, femoral neck, total hip, or radius (one-third radius site). History of lowtrauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm OR Trial and failure, contraindication, or intolerance to one osteoporosis treatment AND One of the following FRAX 10- year probabilities: Major osteoporotic fracture at 20% or more OR Hip fracture is 3% or more. b.) Glucocorticoid-induced osteoporosis at high risk for fracture. History of prednisone or its equivalent at a dose greater than or equal to 5 mg/day for greater than or equal to 3 months and one of the following scenarios must apply: i.) BMD T-score less than or equal to ii.) BMD T- score between -1.0 and -2.0 and history of vertebral compression fracture, fracture of the hip, or fracture of the distal radius resulting from minimal trauma. Iii.) History of vertebral compression fracture, fracture of the hip, or fracture of the distal radius resulting from minimal trauma AND trial and failure to one bisphosphonate. PAGE 37 LAST UPDATED 06/2018

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39 STANDARD - 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. PAGE 39 LAST UPDATED 06/2018

40 STANDARD - 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. PAGE 40 LAST UPDATED 06/2018

41 STANDARD - GENERIC DRONABINOL: PRIOR AUTHORIZATION POLICY DRONABINOL Patient is using for diagnosis of chemotherapy-induced nausea and vomiting or anorexia in patients with AIDS. If patient is using for diagnosis of chemotherapy-induced nausea and vomiting, patient is receiving cancer chemotherapy. Also if patient is using for diagnosis of chemotherapy-induced nausea and vomiting, patient must have a history of failure, contraindication, or intolerance to a 5HT-3 receptor antagonist [eg, Anzemet (dolasetron), Kytril (granisetron), or Zofran (ondansetron)]. Also if patient is using for diagnosis of chemotherapyinduced nausea and vomiting, patient has a history of failure, contraindication, or intolerance to one of the following: Ativan (lorazepam), Compazine (prochlorperazine), Decadron (dexamethasone), Haldol (haloperidol), Phenergan (promethazine), Reglan (metoclopramide), or Zyprexa (olanzapine). If patient is using for diagnosis of anorexia with weight loss in patient with AIDS, patient is on antiretroviral therapy. Also if patient is using for diagnosis of anorexia with weight loss in patient with AIDS, patient is 65 years of age or greater. If patient is less than 65 years of age and using medication for anorexia in patients with AIDS,patient must have a history of failure, contraindication, or intolerance to Megace (megestrol). PAGE 41 LAST UPDATED 06/2018

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43 STANDARD - GL COTELLIC (COBIMETINIB) COTELLIC Medication must be prescribed by or in consultation with an oncologist. Patient must have a diagnosis of unresectable or metastatic melanoma with either: (a) BRAF V600E mutation as detected by an FDA-approved test OR (b) BRAF V600K mutation as detected by an FDAapproved test. Medication must be used in combination with vemurafenib. PAGE 43 LAST UPDATED 06/2018

44 STANDARD - GL 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. PAGE 44 LAST UPDATED 06/2018

45 STANDARD - GL PULMONARY ARTERIAL HYPERTENSION AGENTS ADCIRCA, LETAIRIS, OPSUMIT, ORENITRAM ER, REMODULIN, SILDENAFIL, TRACLEER 32 MG TABLET FOR SUSP, 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 PAGE 45 LAST UPDATED 06/2018

46 STANDARD - GL 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 46 LAST UPDATED 06/2018

47 STANDARD - GL 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) PAGE 47 LAST UPDATED 06/2018

48 STANDARD - GL 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. PAGE 48 LAST UPDATED 06/2018

49 STANDARD - GL 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. PAGE 49 LAST UPDATED 06/2018

50 STANDARD - GL 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. PAGE 50 LAST UPDATED 06/2018

51 STANDARD - GL XELJANZ, XELJANZ XR (TOFACITINIB) XELJANZ 5 MG TABLET, XELJANZ XR The medication is prescribed by or in consultation with a dermatologist or rheumatologist. The patient must not be receiving Xeljanz/Xeljanz XR in combination with a potent immunosuppressant. The patient must have one of the following diagnosis: (a) moderate to severely active rheumatoid arthritis (RA) in a patient with a history of failure to a 3 month trial to a DMARD. The patient must meet one of the following: i.) history of failure, contraindication, or intolerance to two of the following or attestation demonstrating a trial may be inappropriate: Cimzia, Humira, Simpon/Simponi Aria ii.) patient has a documented needle-phobia to the degree that the patient has previously refused any injectable therapy or medical procedure iii.) patient is continuing prior Xeljanz therapy. (b) active psoriatic arthritis (PsA) in a patient with a history of failure to a 3 month trial to a DMARD. The patient must meet one of the following: i.) history of failure, contraindication, or intolerance to two of the following: Cimzia, Humira, Simpon/Simponi Aria, Stelara ii.) patient has a documented needle-phobia to the degree that the patient has previously refused any injectable therapy or medical procedure iii.) patient is continuing prior Xeljanz therapy. PAGE 51 LAST UPDATED 06/2018

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53 STANDARD - GL XTANDI (ENZALUTAMIDE) XTANDI The medication must be prescribed by or in consultation with an Oncologist or a Urologist. The patient must have a diagnosis of metastatic, castration-resistant prostate cancer. PAGE 53 LAST UPDATED 06/2018

54 STANDARD - GL CYSTARAN (CYSTEAMINE) CYSTARAN Patient must have a diagnosis of cystinosis confirmed by elevated leukocyte cystine levels (LCL), genetic analysis of the CTNS gene or corneal cystine crystal accumulation. Patient must also be concomitantly receiving treatment with oral cysteamine. PAGE 54 LAST UPDATED 06/2018

55 STANDARD - GL 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). PAGE 55 LAST UPDATED 06/2018

56 STANDARD - GL 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). PAGE 56 LAST UPDATED 06/2018

57 STANDARD - GL 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 PAGE 57 LAST UPDATED 06/2018

58 STANDARD - GL 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. PAGE 58 LAST UPDATED 06/2018

59 STANDARD - GL 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. PAGE 59 LAST UPDATED 06/2018

60 STANDARD - GL 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. PAGE 60 LAST UPDATED 06/2018

61 STANDARD - GL 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. PAGE 61 LAST UPDATED 06/2018

62 STANDARD - GL COPPER CHELATING AGENTS CUPRIMINE CUPRIMINE Patient must have a diagnosis of Wilson s disease (hepatolenticular degeneration), cystinuria or severe active rheumatoid arthritis with a history of failure or intolerance to Depen (penicillamine) PAGE 62 LAST UPDATED 06/2018

63 STANDARD - GL COPPER CHELATING AGENTS SYPRINE SYPRINE, TRIENTINE HCL Patient must have a diagnosis of Wilson s disease (hepatolenticular degeneration) with a history of failure or intolerance to Depen (penicillamine) PAGE 63 LAST UPDATED 06/2018

64 STANDARD - GL IMBRUVICA (IBRUTINIB) IMBRUVICA THE MEDICATION MUST BE PRESCRIBED BY OR IN CONSULTATION WITH A HEMATOLOGIST/ONCOLOGIST OR A PHYSICIAN EXPERIENCED IN THE MANAGEMENT OF TRANSPLANT PATIENTS. THE PATIENT MUST HAVE ONE OF THE FOLLOWING DIAGNOSIS: A.) MANTLE CELL LYMPHOMA IN A 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.)]. E.) CHRONIC GRAFT VERUS HOST DISEASE (CGCHD) AND TRIAL AND FAILURE OF AT LEAST ONE OR MORE LINES OF SYSTEMIC THERAPY (E.G., CORTICOSTEROIDS, MYCOPHENOLATE). PAGE 64 LAST UPDATED 06/2018

65 STANDARD - GL 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) PAGE 65 LAST UPDATED 06/2018

66 STANDARD - GL 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). The patient must meet one of the following: i.) history of failure, contraindication, or intolerance to two of the following or attestation demonstrating a trial may be inappropriate: Cimzia, Humira, Simpon/Simponi Aria AND a history of failure, contraindication, or intolerance to both Kevzara and Xeljanz/Xeljanz XR ii.) patient is continuing prior 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 66 LAST UPDATED 06/2018

67 STANDARD - GL 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 67 LAST UPDATED 06/2018

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69 STANDARD - GL 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 PAGE 69 LAST UPDATED 06/2018

70 STANDARD - GL 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 70 LAST UPDATED 06/2018

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72 STANDARD - GL 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. PAGE 72 LAST UPDATED 06/2018

73 STANDARD - GL ICLUSIG (PONATINIB) ICLUSIG Patient must have one of the following diagnosis and drug must be prescribed by or in consultation with a hematologist or oncologist :a. Chronic Myelogenous Leukemia with confirmed T315I mutation and has failed all the following drug (i)bosulif (bosutinib), (ii) Gleevec (imatinib), (ii) Sprycel (dasatinib), (iii) Tasigna (nilotinib). b. Acute Lymphoblastic Leukemia with confirmed T3i5I mutuation and has failed all other FDA-approved tyrosine kinase inhibitors. Patient does not show evidence of progressive disease while on Iclusig PAGE 73 LAST UPDATED 06/2018

74 STANDARD - GL BOSULIF (BOSUTINIB) BOSULIF The patient must have a diagnosis of Philadelphia chromosome-positive chronic myelogenous/myeloid leukemia (Ph+CML) with (a) a history of failure, contraindication, or intolerance to ONE of the following: Gleevec (imatinib), Tasigna (nilotinib), OR Sprycel (dasatinib) AND (b) the T315I or V299L mutation. The therapy must be prescribed by or in consultation with a hematologist/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. PAGE 74 LAST UPDATED 06/2018

75 STANDARD - GL GLEEVEC (IMATINIB MESYLATE) IMATINIB MESYLATE The patient has a diagnosis of: a) Philadelphia chromosome-positive chronic myelogenous/myeloid leukemia (Ph+CML); has Philadelphia chromosome positive or BCR-ABL positive as detected by bone marrow cytogenetics, FISH or PCR and the medication must be prescribed by or in consultation with a hematologist/oncologist. b) Philadelphia chromosomepositive acute lymphoblastic leukemia (Ph+ALL)and the medication must be prescribed by or in consultation with a hematologist/oncologist. c) myelodysplastic/myeloproliferative disease (MDS/MPD) which is associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements and the medication must be prescribed by or in consultation with a hematologist/oncologist. d) aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation or c-kit mutational status is unknown; and medication is prescribed by or in consultation with a hematologist/oncologist. e) Hypereosinophilic syndrome (HES) or Chronic eosinophilic leukemia (CEL); and medication is prescribed by or in consultation with a hematologist/oncologist. f) unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP); and medication is prescribed by or in consultation with a hematologist/oncologist. or g) gastrointestinal stromal tumors (GIST) with 1) documented c-kit (CD117) positive unresectable or metastatic malignant GIST or 2) has had resection of c-kit (CD117) positive and GIST Gleevec (imatinib) will be used as adjuvant therapy; and must be Prescribed by or in consultation with an oncologist. If the patient is currently on the medication and is requesting continuation of therapy, the patient does not show evidence of progressive disease while on Gleevec therapy. PAGE 75 LAST UPDATED 06/2018