Prior Authorization Requirements. Effective: 01/01/2016

Transcription

1 Effective: 01/01/2016 Updated 11/2015

2 5HT3 ANTI-NAUSEA AGENT BVD DETERMINATION GRANISETRON HCL ONDANSETRON HCL ONDANSETRON ODT THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

3 ABATACEPT IV ORENCIA RENEWAL: RHEUMATOID ARTHRITIS/JUVENILE IDIOPATHIC ARTHRITIS: EXPERIENCED OR MAINTAINED 20% OR GREATER IMPROVEMENT IN TENDER AND SWOLLEN JOINT COUNT. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS, POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. PSORIASIS: DERMATOLOGIST. CROHNS DISEASE/ULCERATIVE COLITIS: GASTROENTEROLOGIST. INITIAL: 4 MONTHS RENEWAL: INITIAL: RHEUMATOID ARTHRITIS (RA)/ JUVENILE IDIOPATHIC ARTHRITIS (JIA): PREVIOUS TRIAL WITH HUMIRA AND ONE DMARD (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENT SUCH AS METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE, OR SULFASALAZINE. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), OR A TNF (TUMOR NECROSIS

4 FACTOR) INHIBITOR: HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA.

5 ABATACEPT SQ ORENCIA RENEWAL: RHEUMATOID ARTHRITIS: EXPERIENCED OR MAINTAINED 20% OR GREATER IMPROVEMENT IN TENDER AND SWOLLEN JOINT COUNT. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), OR A TNF (TUMOR NECROSIS FACTOR) INHIBITOR: HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA. 18 YEARS OR OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOLOGIST. INITIAL: 4 MONTHS RENEWAL: INITIAL: PREVIOUS TRIAL WITH HUMIRA AND ONE DMARD (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENTS SUCH AS METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE, OR SULFASALAZINE. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), OR A TNF (TUMOR NECROSIS FACTOR) INHIBITOR: HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA.

6 ABIRATERONE ZYTIGA

7 ADALIMUMAB HUMIRA HUMIRA CROHN'S INITIAL: POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS: CURRENT WEIGHT. PLAQUE PSORIASIS: MODERATE TO SEVERE PLAQUE PSORIASIS INVOLVING GREATER THAN OR EQUAL TO 5 PERCENT BODY SURFACE AREA OR PSORIATIC LESIONS AFFECT THE HANDS, FEET, OR GENITAL AREA. RENEWAL: RHEUMATOID ARTHRITIS/JUVENILE IDOPATHIC ARTHRITIS/PSORIATIC ARTHRITIS: EXPERIENCED OR MAINTAINED 20 PERCENT IMPROVEMENT IN TENDER OR SWOLLEN JOINT COUNT WHILE ON THERAPY. ANKYLOSING SPONDYLITIS: EXPERIENCED OR MAINTAINED IMPROVEMENT OF AT LEAST 50 PERCENT OR 2 UNITS IN THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX (BASDAI). PLAQUE PSORIASIS: ACHIEVED OR MAINTAINED CLEAR OR MINIMAL DISEASE OR A DECREASE IN PSORIASIS AREA AND SEVERITY INDEX (PASI) OF AT LEAST 50% OR MORE. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS, POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. PSORIASIS: DERMATOLOGIST. CROHNS DISEASE/ULCERATIVE COLITIS: GASTROENTEROLOGIST.

8 INITIAL: RA /PSA/AS: 4 MOS. PJIA: 5 MOS. PSO/CD/UC: 3 MOS. RENEWAL: 12 MOS FOR ALL DIAGNOSES. INITIAL: RHEUMATOID ARTHRITIS (RA)/POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA)/PSORIATRIC ARTHRITIS (PSA): PREVIOUS TRIAL WITH ONE DMARD (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENT SUCH AS METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE, OR SULFASALAZINE. PLAQUE PSORIASIS (PSO): PREVIOUS TRIAL WITH ONE OF THE FOLLOWING CONVENTIONAL THERAPIES SUCH AS PUVA (PHOTOTHERAPY ULTRAVIOLET LIGHT A), UVB (ULTRAVIOLET LIGHT B), TOPICAL CORTICOSTEROIDS, CALCIPOTRIENE, ACITRETIN, METHOTREXATE, OR CYCLOSPORINE. CROHNS DISEASE (CD)/ULCERATIVE COLITIS (UC): PREVIOUS TRIAL WITH ONE OF THE FOLLOWING CONVENTIONAL AGENTS SUCH AS CORTICOSTEROIDS (I.E., BUDESONIDE, METHYLPREDNISOLONE), AZATHIOPRINE, MERCAPTOPURINE, METHOTREXATE, OR MESALAMINE). NOT APPROVED FOR PATIENT ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), ORENCIA (ABATACEPT), RITUXAN (RITUXIMAB), OR A TNF INHIBITOR (ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA).

9 AFATINIB DIMALEATE GILOTRIF

10 ANAKINRA KINERET RENEWAL: RHEUMATOID ARTHRITIS: EXPERIENCED OR MAINTAINED 20% OR GREATER IMPROVEMENT IN TENDER AND SWOLLEN JOINT COUNT. RA: 18 YEARS OR OLDER PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS: RHEUMATOLOGIST. INITIAL: RA : 4 MOS. NOMI OR CAPS: 12 MOS. RENEWAL: 12 MOS FOR ALL DIAGNOSES. INITIAL: RHEUMATOID ARTHRITIS (RA)): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENTS: ORENCIA, XELJANZ, OR CIMZIA.. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH A TNF (TUMOR NECROSIS FACTOR) INHIBITOR: HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA.

11 APREMILAST OTEZLA 18 YEARS OF AGE OR OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. PSORIASIS: DERMATOLOGIST. INITIAL: PSORIARTIC ARTHRITIS 4 MONTHS. PSORIASIS: 5 MONTHS RENEWAL: 12 MONTHS. INITIAL: PSORIATRIC ARTHRITIS (PSA): PREVIOUS TRIAL WITH HUMIRA AND ONE DMARD (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENT SUCH AS METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE, OR SULFASALAZINE. PLAQUE PSORIASIS (PSO): PREVIOUS TRIAL WITH HUMIRA AND ONE OF THE FOLLOWING CONVENTIONAL THERAPIES SUCH AS PUVA (PHOTOTHERAPY ULTRAVIOLET LIGHT A), UVB (ULTRAVIOLET LIGHT B), TOPICAL CORTICOSTEROIDS, CALCIPOTRIENE, ACITRETIN, METHOTREXATE, OR CYCLOSPORINE.

12 APREPITANT BVD DETERMINATION EMEND THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

13 ASPARAGINASE ONCASPAR 3 MONTHS

14 AXITINIB INLYTA TRIAL OF AT LEAST ONE SYSTEMIC THERAPY FOR THE TREATMENT OF RCC SUCH AS NEXAVAR (SORAFENIB), TORISEL (TEMSIROLIMUS), SUTENT (SUNITINIB), VOTRIENT (PAZOPANIB), OR AVASTIN (BEVACIZUMAB) IN COMBINATION WITH INTERFERON.

15 BACILLUS OF CALMETTE AND GUERIN VACCINE BVD DETERMINATION BCG (TICE STRAIN) THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

16 BEDAQUILINE FUMARATE SIRTURO 18 YEARS OF AGE AND OLDER. 24 WEEKS SIRTURO USED IN COMBINATION WITH AT LEAST 3 OTHER ANTIBIOTICS FOR IN THE TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS.

17 BELIMUMAB BENLYSTA AUTOANTIBODY POSITIVE LUPUS TEST. INITIAL: 6 MONTHS. RENEWAL: INITIAL: SELENA-SELDAI SCORE GREATER THAN OR EQUAL TO 6. RENEWAL: MAINTAIN AT LEAST A 4 POINT REDUCTION IN SELENA-SELDAI SCORE FROM BASELINE. MEMBER IS CURRENTLY TAKING CORTICOSTEROIDS, ANTIMALARIALS, NSAIDS, OR IMMUNOSUPPRESSIVE AGENTS. NO APPROVAL FOR DIAGNOSIS OF SEVERE ACTIVE LUPUS NEPHRITIS OR SEVERE CENTRAL NERVOUS SYSTEM LUPUS OR CONCURRENT USE OF BIOLOGIC AGENTS, OR INTRAVENOUS CYCLOPHOSAMIDE.

18 BELINOSTAT BELEODAQ

19 BEVACIZUMAB AVASTIN

20 BEXAROTENE TARGRETIN

21 BORTEZOMIB VELCADE

22 BOSUTINIB BOSULIF CML: BCR-ABL MUTATIONAL ANALYSIS CONFIRMING THAT BOTH T315I AND V299L MUTATIONS ARE NOT PRESENT.

23 C1 ESTERASE INHIBITOR CINRYZE HEMATOLOGIST, IMMUNOLOGIST

24 CABOZANTINIB COMETRIQ

25 CANAKINUMAB ILARIS CAPS: 4 YEARS AND OLDER. SJIA: 2 YEARS AND OLDER. PRESCRIBED OR SUPERVISED BY RHEUMATOLOGIST

26 CERITINIB ZYKADIA POSITIVE FOR ANAPLASTIC LYMPHOMA KINASE (ALK) FUSION ONCOGENE.

27 CERTOLIZUMAB PEGOL CIMZIA RENEWAL: RHEUMATOID ARTHRITIS/ACTIVE PSORIATIC ARTHRITIS: EXPERIENCED OR MAINTAINED 20% OR GREATER IMPROVEMENT IN TENDER AND SWOLLEN JOINT COUNT. FOR ANKYLOSING SPONDYLITIS: EXPERIENCED OR MAINTAINED IMPROVEMENT OF AT LEAST 50 PERCENT OR 2 UNITS IN THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX (BASDAI). PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS/ ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. CROHNS DISEASE: GASTROENTEROLOGIST. INITIAL: RA /PSA/AS: 4 MONTHS. CD:. RENEWAL: FOR ALL DIAGNOSES. INITIAL: RHEUMATOID ARTHRITIS (RA)//PSORIATRIC ARTHRITIS (PSA)/: TRIAL OF HUMIRA AND PREVIOUS TRIAL WITH ONE DMARD (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENT SUCH AS METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE, OR SULFASALAZINE. ANKYLOSING SPONDYLITIS: TRIAL

28 OF HUMIRA. CROHNS DISEASE (CD): PREVIOUS TRIAL WITH HUMIRA AND ONE OF THE FOLLOWING CONVENTIONAL AGENTS SUCH AS CORTICOSTEROIDS (I.E., BUDESONIDE, METHYLPREDNISOLONE), AZATHIOPRINE, MERCAPTOPURINE, METHOTREXATE, OR MESALAMINE). NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH ANOTHER TNF INHIBITORS (HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA) OR ANY OTHER BIOLOGIC DMARDS (DISEASE-MODIFYING ANTIRHEUMATIC DRUG) AGENTS SUCH AS (ACTEMRA, KINERET, STELARA, COSENTYX, ENTYVIO, TYSABRI, ORENCIA, OR RITUXAN).

29 CLOBAZAM ONFI 2 YEARS OF AGE OR OLDER TRIAL OF LAMOTRIGINE OR TOPIRAMATE. REQUESTS FOR ORAL SUSPENSION APPROVABLE IF PATIENT IS UNABLE TO SWALLOW OR IS UNDER THE AGE OF 5 YEARS.

30 CORTICOSTEROID BVD DETERMINATION A-HYDROCORT CORTISONE ACETATE DEXAMETHASONE DEXAMETHASONE SODIUM PHOSPHATE HYDROCORTISONE METHYLPREDNISOLONE METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SOD SUCC PREDNISOLONE SODIUM PHOSPHATE PREDNISONE SOLU-CORTEF THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

31 CRIZOTINIB XALKORI LOCALLY ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER IS ANAPLASTIC LYMPHOMA KINASE POSITIVE.

32 CYCLOPHOSPHAMIDE BVD DETERMINATION CYCLOPHOSPHAMIDE THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

33 DABRAFENIB MESYLATE TAFINLAR

34 DALFAMPRIDINE AMPYRA WALKING DISABILITY SUCH AS MILD TO MODERATE BILATERAL LOWER EXTREMITY WEAKNESS OR UNILATERAL WEAKNESS PLUS LOWER EXTREMITY OR TRUNCAL ATAXIA. NEUROLOGIST INITIAL: 3 MONTHS. RENEWAL: RENEWAL: PATIENT HAS EXPERIENCED OR MAINTAINED AT LEAST 15% IMPROVEMENT IN WALKING ABILITY.

35 DASATINIB SPRYCEL PREVIOUSLY TREATED CML REQUIRES MUTATIONAL ANALYSIS NEGATIVE FOR THE FOLLOWING MUTATIONS FOLLOWING BCR-ABL MUTATIONAL ANALYSIS - T315I, V299L, T315A, F317L/V/I/C.

36 DICLOFENAC EPOLAMINE FLECTOR

37 DIMETHYL FUMARATE TECFIDERA 18 YEARS AND OLDER 120 MG: 1 MONTH MG: 1 MONTH. 240 MG:

38 DROXIDOPA NORTHERA 3 MONTHS

39 ELIGLUSTAT TARTRATE CERDELGA

40 ELTROMBOPAG PROMACTA INITIAL:1 MOS. RENEWAL: CLINICAL RESPONSE: 12 MOS. MAX DOSE FOR 4 WEEKS: 1 MOS. HEP C: 12 MOS. CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA PURPURA (ITP): INITIAL: TRIAL OF OR CONTRAINDICATION TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR AN INSUFFICIENT RESPONSE TO SPLENECTOMY. ITP: RENEWAL: PATIENT HAS A CLINICAL RESPONSE AS DEFINED BY AN INCREASE IN PLATELET COUNT OF GREATER THAN OR EQUAL TO 50 X10^9/L (GREATER THAN OR EQUAL TO 50,0000 PER UL) AT THE MAX DOSE OF 75MG PER DAY FOR 4 WEEKS. HEPATITIS C: CONCURRENT INTERFERON THERAPY.

41 ENDOTHELIN RECEPTOR ANTAGONISTS LETAIRIS OPSUMIT TRACLEER CARDIOLOGIST OR PULMONOLOGIST.

42 ENZALUTAMIDE XTANDI TRIAL OF OR CONTRAINDICATION TO DOCETAXEL. TRIAL OF ZYTIGA (ABIRATERONE ACETATE) IS ALSO REQUIRED IN PATIENTS WHO DO NOT HAVE A CONTRAINDICATION OR INTOLERANCE TO PREDNISONEDOCETAXEL

43 ERLOTINIB TARCEVA

44 ERYTHROPOIESIS STIMULATING AGENTS - EPOETIN ALFA EPOGEN PROCRIT ADDITIONAL OFF LABEL ANEMIA IN HEPATITIS C BEING TREATED IN COMBINATION WITH RIBAVIRIN AND AN INERFERON ALFA OR PEGINTERFERON ALFA. INITIAL: CHRONIC RENAL FAILURE (CRF) AND ANEMIA RELATED TO ZIDOVUDINE THERAPY REQUIRES HEMOGLOBIN LEVEL LESS THAN 10G/DL, CANCER CHEMOTHERAPY REQUIRES HEMOGLOBIN LESS THAN 11 G/DL OR HEMOGLOBIN LEVEL HAS DECREASED AT LEAST 2G/DL BELOW BASELINE, ANEMIA DUE TO CONCURRENT HEPATITIS C TREATMENT WITH RIBAVIRIN AND INTERFERON ALFA/PEGINTERFERON ALFA REQUIRES HEMOGLOBIN LESS THAN 10G/DL AND RIBAVIRIN DOSE REDUCTION (UNLESS CONTRAINDICATED), ELECTIVE NONCARDIAC OR NONVASCULAR SURGERY REQUIRES HEMOGLOBLIN LESS THAN 13G/DL RENEWAL: CRF HEMOGLOBIN LEVELS LESS THAN 10 G/DL IF NOT ON DIALYSIS AND LESS THAN 11 G/DL IF ON DIALYSIS OR HEMOGLOBIN HAS REACHED 11 G/DL IF ON DIALYSIS AND DOSE REDUCTION/INTERRUPTION IS REQUIRED TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS OR HEMOGLOBIN HAS REACHED 10 G/DL IF NOT ON DIALYSIS AND DOSE REDUCTION/INTERRUPTION IS REQUIRED TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS. ANEMIA DUE TO EFFECT OF CONCOMITANTLY ADMINISTERED CANCER CHEMOTHERAPY OR ANEMIA DUE TO CONCURRENT HEPATITIS C TREATMENT WIITH RIBAVIRIN AND INTERFERON ALFA/PEGINTERFERON ALFA OR ANEMIA DUE TO ZIDOVUDINE THERAPY REQUIRES HEMOGLOBIN LEVELS BETWEEN 10 AND 12 G/DL.

45 ANEMIA FROM MYELOSUPPRESSIVE CHEMO/CKD W/O DIALYSIS/ZIDOVUDINE:12 MOS. SURGERY:1 MO. HEP C:6 MOS. ALL INDICATIONS: TRIAL OF PROCRIT. PART D MEMBER RECEIVING DIALYSIS OR IDENTIFIED AS A PART D END STAGE RENAL DISEASE MEMBER: PAYS UNDER PART B.

46 ERYTHROPOIESIS STIMULATING AGENTS -MIRCERA MIRCERA CHRONIC RENAL FAILURE: INITIAL: HEMOGLOBIN LEVELS LESS THAN 10 G/DL RENEWAL: HEMOGLOBIN LEVELS LESS THAN 10 G/DL IF NOT ON DIALYSIS AND LESS THAN 11 G/DL IF ON DIALYSIS OR HEMOGLOBIN HAS REACHED 11 G/DL IF ON DIALYSIS AND DOSE REDUCTION/INTERRUPTION IS REQUIRED TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS OR HEMOGLOBIN HAS REACHED 10 G/DL IF NOT ON DIALYSIS AND DOSE REDUCTION/INTERRUPTION IS REQUIRED TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS. ANEMIA DUE TO CKD WITH OR WITHOUT DIALYSIS:. TRIAL OF PROCRIT. PART D MEMBER RECEIVING DIALYSIS OR IDENTIFIED AS A PART D END STAGE RENAL DISEASE MEMBER: PAYS UNDER PART B.

47 ESRD BVD DETERMINATION CALCITRIOL DOXERCALCIFEROL HEPARIN SODIUM IBANDRONATE SODIUM LEVOCARNITINE LIDOCAINE LIDOCAINE HCL LIDOCAINE-PRILOCAINE MIACALCIN PARICALCITOL ZEMPLAR ZOMETA THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

48 ETANERCEPT ENBREL PATIENT IS NOT CURRENTLY TAKING KINERET (ANAKINRA) OR ORENCIA (ABATACEPT). INITIAL: PLAQUE PSORIASIS: MODERATE TO SEVERE PLAQUE PSORIASIS INVOLVING GREATER THAN OR EQUAL TO 5 PERCENT BODY SURFACE AREA OR PSORIATIC LESIONS AFFECT THE HANDS, FEET, OR GENITAL AREA. RENEWAL: RHEUMATOID ARTHRITIS/JUVENILE IDIOPATHIC ARTHRITIS/PSORIATIC ARTHRITIS: EXPERIENCED OR MAINTAINED 20 PERCENT OR GREATER IMPROVEMENT IN TENDER OR SWOLLEN JOINT COUNT WHILE ON THERAPY. ANKYLOSING SPONDYLITIS: EXPERIENCED OR MAINTAINED IMPROVEMENT OF AT LEAST 50 PERCENT OR 2 UNITS IN THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX (BASDAI). PLAQUE PSORIASIS: ACHIEVED OR MAINTAINED CLEAR OR MINIMAL DISEASE OR A DECREASE IN PSORIASIS AREA AND SEVERITY INDEX (PASI) OF AT LEAST 50% OR MORE. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS, POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. PSORIASIS: DERMATOLOGIST.

49 INITIAL: RA /PJIA: 3 MONTHS. PSA/AS/PSO: 4 MONTHS. RENEWAL: FOR ALL DIAGNOSES. INITIAL: RHEUMATOID ARTHRITIS (RA): PREVIOUS TRIAL OF HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENTS: ORENCIA XELJANZ, OR CIMZIA. POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA):PREVIOUS TRIAL OF HUMIRA AND ORENCIA. PSORIATRIC ARTHRITIS (PSA): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENT: CIMZIA, OR OTEZLA. ANKYLOSING SPONDYLITIS: PREVIOUS TRIAL WITH HUMIRA AND CIMZIA. PLAQUE PSORIASIS (PSO): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENT: COSENTYX OR OTEZLA. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH KINERET (ANAKINRA) OR ORENCIA (ABATACEPT).

50 EVEROLIMUS AFINITOR AFINITOR DISPERZ ADVANCED RENAL CELL CARCINOMA (RCC): TRIAL OF OR CONTRAINDICATION TO SUTENT OR NEXAVAR.

51 FENTANYL NASAL SPRAY LAZANDA 6 MONTHS CANCER: CURRENTLY ON A MAINTENANCE DOSE OF CONTROLLED-RELEASE OPIOID PAIN MEDICATION (SUCH AS MORPHINE SULFATE SR, OXYCODONE SR, OR FENTANYL). EITHER A TRIAL OR CONTRAINDICATION TO AT LEAST ONE (1) IMMEDIATE-RELEASE ORAL OPIOID PAIN AGENT (SUCH AS MORPHINE SULFATE IR, OXYCODONE/ASPIRIN, OXYCODONE/ACETAMINOPHEN, CODEINE/ACETAMINOPHEN, HYDROMORPHONE, OR MEPERIDINE) OR MEMBER HAS DIFFICULTY SWALLOWING TABLETS/CAPSULES AND TRIAL OR CONTRAINDICATION TO GENERIC FENTANYL CITRATE LOZENGE.

52 FENTANYL TRANSDERMAL PATCH FENTANYL OPIOID TOLERANCE (DEFINED AS THOSE WHO ARE TAKING, FOR ONE WEEK OR LONGER, AT LEAST 60 MG ORAL MORPHINE PER DAY, 25 MCG TRANSDERMAL FENTANYL/HOUR, 30 MG ORAL OXYCODONE/DAY, 25 MG ORAL OXYMORPHONE/DAY, 8 MG ORAL HYDROMORPHONE/DAY, OR AN EQUIANALGESIC DOSE OF ANOTHER OPIOID). EVERY 48 HOUR DOSING CONSIDERED FOR PATIENTS WHO FAIL EVERY 72 HOUR DOSING. NO APPROVAL WHEN PRESCRIBED FOR AS NEEDED DOSAGE FREQUENCY.

53 FENTANYL TRANSMUCOSAL AGENTS - FENTANYL CITRATE FENTANYL CITRATE 6 MONTHS CANCER: CURRENTLY ON A MAINTENANCE DOSE OF CONTROLLED-RELEASE OPIOID PAIN MEDICATION (SUCH AS MORPHINE SULFATE SR, OXYCODONE SR, OR FENTANYL). EITHER A TRIAL OR CONTRAINDICATION TO AT LEAST ONE (1) IMMEDIATE-RELEASE ORAL OPIOID PAIN AGENT (SUCH AS MORPHINE SULFATE IR, OXYCODONE/ASPIRIN, OXYCODONE/ACETAMINOPHEN, CODEINE/ACETAMINOPHEN, HYDROMORPHONE, OR MEPERIDINE) OR MEMBER HAS DIFFICULTY SWALLOWING TABLETS/CAPSULES.

54 FINGOLIMOD GILENYA RECENT (WITHIN THE PAST 6 MONTHS) OCCURRENCE OF MYOCARDIAL INFARCTION, UNSTABLE ANGINA, STROKE, TRANSIENT ISCHEMIC ATTACK, DECOMPENSATED HEART FAILURE REQUIRING HOSPITALIZATION, OR CLASS III/IV HEART FAILURE. HISTORY OR PRESENCE OF MOBITZ TYPE II 2ND DEGREE OR 3RD DEGREE AV BLOCK OR SICK SINUS SYNDROME, UNLESS PATIENT HAS A PACEMAKER. BASELINE QTC INTERVAL OF 500MS OR ABOVE. TREATMENT WTIH CLASS 1A (QUINIDINE, PROCAINAMIDE, OR DISOPYRAMIDE) OR CLASS III ANTI- ARRHYTHMIC DRUGS (AMIODARONE, DOFETILIDE, DRONEDARONE, IBUTILIDE, OR SOTALOL). MEDICATION WILL NOT BE APPROVED FOR PATIENTS WITH ONE OF THE FOLLOWING CONDITIONS: RECENT (WITHIN PAST 6 MONTHS) OCCURRENCE OF MYOCARDIAL INFARCTION, UNSTABLE ANGINA, STROKE, TRANSIENT ISCHEMIC ATTACK, DECOMPENSATED HEART FAILURE REQUIRING HOSPITALIZATION, OR CLASS III/IV HEART FAILURE. HISTORY OR PRESENCE OF MOBITZ TYPE II 2ND

55 DEGREE OR 3RD DEGREE AV BLOCK OR SICK SINUS SYNDROME, UNLESS PATIENT HAS PACEMAKER. BASELINE QTC INTERVAL 500MS OR ABOVE. OR TREATMENT WITH CLASS IA (QUINIDINE, PROCAINAMIDE, OR DISOPYRAMIDE) OR CLASS III ANTI-ARRHYTHMIC DRUGS (AMIODARONE, DOFETILIDE, DRONEDARONE, IBUTILIDE, OR SOTALOL.

56 GLYCEROL PHENYLBUTYRATE RAVICTI TRIAL OF OR CONTRAINDICATION TO SODIUM PHENYLBUTYRATE (BUPHENYL).

57 GOLIMUMAB IV SIMPONI ARIA RHEUMATOID ARTHRITIS. RENEWAL: AT LEAST 20% IMPROVEMENT IN TENDER JOINT COUNT AND SWOLLEN JOINT COUNT. 18 YEARS OF AGE AND OLDER PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOLOGIST. INITIAL: 4 MOS RENEWAL: 12 MOS INITIAL: PREVIOUS TRIAL HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENT: ORENCIA, XELJANZ, OR CIMZIA. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH ORENCIA OR KINERET.

58 GOLIMUMAB SQ SIMPONI RENEWAL: ACTIVE RHEUMATOID ARTHRITIS/PSORIATIC ARTHRITIS: MAINTAINED OR EXPERIENCED GREATER THAN 20% IMPROVEMENT IN TENDER JOINT COUNT AND SWOLLEN JOINT COUNT. ANKYLOSING SPONDYLITIS: MAINTAINED OR EXPERIENCED GREATER THAN 20% IMPROVEMENT IN ANKYLOSING SPONDYLITIS (ASAS20) CRITERIA. 18 YEARS OR OLDER PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. ULCERATIVE COLITIS: GASTROENTEROLOGIST. INITIAL: RA /PSA/AS: 4 MONTHS. UC: RENEWAL: FOR ALL DIAGNOSES. INITIAL: RHEUMATOID ARTHRITIS (RA): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENTS: ORENCIA, XELJANZ, OR CIMZIA. PSORIATRIC ARTHRITIS (PSA):PREVIOUS TRIAL WITH

59 HUMIRA FOLLOWED BY ONE OF THE FOLLOWING PREFERRED AGENTS: CIMZIA OR OTEZLA. ANYKYLOSING SPONDYLITIS (AS): PREVIOUS TRIAL WITH HUMIRA ULCERATIVE COLITIS (UC): PREVIOUS TRIAL WITH HUMIRA AND ONE OF THE FOLLOWING CONVENTIONAL AGENTS SUCH AS CORTICOSTEROIDS (I.E., BUDESONIDE, METHYLPREDNISOLONE), AZATHIOPRINE, MERCAPTOPURINE, METHOTREXATE, OR MESALAMINE. NOT APPROVED FOR PATIENTS ON CONCURRENT THERAPY WITH ORENCIA OR KINERET.

60 HEPATITIS B VACCINE BVD DETERMINATION ENGERIX-B ADULT ENGERIX-B PEDIATRIC-ADOLESCENT RECOMBIVAX HB THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

61 HIGH RISK DRUGS IN THE ELDERLY - ANTI-INFECTIVE NITROFURANTOIN NITROFURANTOIN MONO-MACRO APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. TRIAL OF (UNLESS CONTRAINDICATED) OF SULFAMETHOXAZOLE/TRIMETHOPRIM (TMP-SMX) OR TRIMETHOPRIM.

62 HIGH RISK DRUGS IN THE ELDERLY - ANTICHOLINERGICS - BENZTROPINE_TRIHEXYPHENIDYL BENZTROPINE MESYLATE TRIHEXYPHENIDYL HCL APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER.

63 HIGH RISK DRUGS IN THE ELDERLY - ANTICHOLINERGICS - HYDROXYZINE HYDROXYZINE HCL HYDROXYZINE PAMOATE SEASONAL/PERENNIAL ALLERGIC RHINITIS. APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. PRURITUS/URTICARIA/SEASONAL/PERENNIAL ALLERGY: TRIAL OR CONTRAINDICATION TO A NON-SEDATING ANTIHISTAMINE SUCH AS LEVOCETIRIZINE. ANXIETY: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - BUSPIRONE, PAROXETINE, DULOXETINE, OR VENLAFAXINE.

64 HIGH RISK DRUGS IN THE ELDERLY - ANTICHOLINERGICS - PROMETHAZINE PHENADOZ PROMETHAZINE HCL PROMETHEGAN APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. PRURITUS/URTICARIA/SEASONAL/PERENNIAL ALLERGY: TRIAL OR CONTRAINDICATION TO A NON-SEDATING ANTIHISTAMINE SUCH AS LEVOCETIRIZINE. ANXIETY: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - BUSPIRONE, PAROXETINE, DULOXETINE, OR VENLAFAXINE. MOTION SICKNESS: TRIAL OR CONTRAINDICATION TO MECLIZINE.

65 HIGH RISK DRUGS IN THE ELDERLY - BARBITURATE COMBINATIONS ACETAMINOPHEN-BUTALBITAL ASCOMP WITH CODEINE BUTALB- ACETAMINOPH-CAFF-CODEIN BUTALB-CAFF-ACETAMINOPH-CODEIN BUTALBITAL-ACETAMINOPHEN-CAFFE BUTALBITAL-ASPIRIN-CAFFEINE APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. 6 MONTHS PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER.

66 HIGH RISK DRUGS IN THE ELDERLY - CARDIOVASCULAR GUANFACINE HCL APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. HYPERTENSION: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - BENAZEPRIL, BENAZEPRIL/HYDROCHLOROTHIAZIDE, CAPTOPRIL, CAPTOPRIL/HYDROCHLOROTHIAZIDE, ENALAPRIL, ENALAPRIL/HYDROCHLOROTHIAZIDE, FOSINOPRIL, FOSINOPRIL/HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL/HYDROCHLOROTHIAZIDE, QUINAPRIL, QUINALPRIL/HYDROCHLOROTHIAZIDE, RAMIPRIL, MOEXIPRIL, MOEXIPRIL/HYDROCHLOROTHIAZIDE, PERINDOPRIL ERBUMINE, QUNINAPRIL, QUINAPRIL/HYDROCHLOROTHIAZIDE, TRANDOLAPRIL, TRANDOLAPRIL/VERAPAMIL, LOSARTAN, LOSARTAN/HYDROCHLOROTHIAZIDE, IRBESARTAN, IRBESARTAN/HYDROCHLOROTHIAZIDE, OLMESARTAN, OLMESARTAN/HYDROCHLOROTHIAZIDE,

67 OLEMSARTAN/AMILODIPINE/HYDROCHLOROTHIAZIDE, VALSARTAN, VALSARTAN/HYDROCLOROTHIAZIDE, DILTIAZEM HCL, DILTIAZEM SUSTAINED RELEASE, VERAPAMIL, VERAPAMIL SUSTAINED RELEASE, ATENOLOL, ATENOLOL/HCLORTHALIDONE, BISOPROLOL, BISOPROLOL/HYDROCHLOROTHIAZIDE, CARVEDILOL, METOPROLOL TARTRATE, NADOLOL, ACEBUTOLOL, BETAXOLOL, LABETAOL, METOPROLOL SUCCINATE, METOPROLOL/HYDROCHLOROTHIAZIDE, PINDOLOL, PROPANOLOL, PROPRANOLOL/HYDROCHLOROTHIAZIDE, SOTALOL, TIMOLOL MALEATE.

68 HIGH RISK DRUGS IN THE ELDERLY - CENTRAL NERVOUS SYSTEM - THIORIDAZINE THIORIDAZINE HCL 65 YEARS AND OLDER: SCHIZOPHRENIA - PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER. PRIOR AUTHORIZTAION APPLIES TO NEW START ONLY

69 HIGH RISK DRUGS IN THE ELDERLY - DIGOXIN DIGITEK DIGOX DIGOXIN LANOXIN DIGOXIN LEVEL APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. APPROVAL FOR MEMBERS STABLE ON DOSES GREATER THAN 125 MCG PER DAY WITH DOCUMENTED THERAPEUTIC DIGOXIN LEVEL TAKEN WITHIN THE PAST YEAR.

70 HIGH RISK DRUGS IN THE ELDERLY - ENDOCRINE - ESTROGEN COMBIPATCH DUAVEE ESTRADIOL ESTRADIOL-NORETHINDRONE ACETAT ESTROPIPATE MENEST MIMVEY MIMVEY LO PREMARIN PREMPHASE PREMPRO APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. VULVAR/VAGINAL ATROPHY: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - ESTRACE VAGINAL CREAM, PREMARIN VAGINAL CREAM, OR VAGIFEM. OSTEOPOROSIS: TRIAL OR CONTRAINDICATION TO ONE OF THE FOLLOWING - ALENDRONATE, IBANDRONATE, OR RALOXIFENE. VASOMOTOR SYMPTOMS OF MENOPAUSE: PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER. ALL OTHER FDA APPROVED INDICATIONS, SUCH AS PALLIATION TREATMENT, NOT PREVIOUSLY MENTIONED IN THIS SECTION, ARE TO BE APPROVED WITHOUT A TRIAL OF FORMULARY ALTERNATIVES.

71 HIGH RISK DRUGS IN THE ELDERLY - ENDOCRINE - SULFONYLUREAS GLYBURIDE GLYBURIDE MICRONIZED GLYBURIDE-METFORMIN HCL APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. INITIAL: TRIAL OF ALTERNATIVES: 12 MOS. PRESCRIBER ACKNOWLEGEMENT OF HRM: 2 MOS. RENEWAL: 12 MOS INITIAL: TRIAL OF GLIIMEPIRIDE OR GLIPIZIDE QUALIFIED FOR 12 MONTH APPROVAL. PRESCRIBER ACKNOWLEDGEMENT/ AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER QUALIFIES FOR 2 MONTH APPROVAL RENEWAL: PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER OR TRIAL OF GLIMEPIRIDIE OR GLIPIZIDE.

72 HIGH RISK DRUGS IN THE ELDERLY - INDOMETHACIN INDOMETHACIN APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. TRIAL OF OR CONTRAINDICATION TO CELECOXIB OR A TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SUCH AS VOLTAREN GEL OR FLECTOR. PRESCRIPTIONS WRITTEN BY A RHEUMATOLOGIST DO NOT REQUIRE TRIAL OF FORMULARY ALTERNATIVES.

73 HIGH RISK DRUGS IN THE ELDERLY - NON-BENZODIAZEPINE ZALEPLON ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE ER APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. INITIAL: TRIAL OF SILENOR AND ROZERUM: 12 MOS. PRESCRIBER ACKNOWLEGE HRM: 2 MOS. RENEW: 12 MOS INITIAL: TRIAL OF SILENOR AND ROZEREM QUALIFIES FOR 12 MONTH APPROVAL. PRESCRIBER ACKNOWLEDGEMENT/ AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER QUALIFIES FOR 2 MONTH APPROVAL RENEWAL: PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER OR TRIAL OF SILENOR AND ROZEREM.

74 HIGH RISK DRUGS IN THE ELDERLY - SKELETAL MUSCLE RELAXANTS CARISOPRODOL CHLORZOXAZONE CYCLOBENZAPRINE HCL METAXALONE METHOCARBAMOL APPROPRIATE HIGH RISK MEDICATION USE: 65 YEARS OF AGE OR OLDER. PA NOT REQUIRED FOR AGE 0-64 YEARS. PRESCRIBER ACKNOWLEDGEMENT/AWARENESS DRUG IS LABELED AS HIGH RISK MEDICATION IN THE ELDERLY FOR PATIENTS 65 YEARS AND OLDER.

75 HIGH RISK DRUGS IN THE ELDERLY - TCA AMITRIPTYLINE HCL CLOMIPRAMINE HCL DOXEPIN HCL IMIPRAMINE HCL IMIPRAMINE PAMOATE PERPHENAZINE-AMITRIPTYLINE SURMONTIL MIGRAINE HEADACHE AND POST-HERPETIC NEURALGIA. APPLIES TO MEMBERS 65 YEARS AND OLDER FOR THE FOLLOWING: MIGRAINE PROPHYLAXIS: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - PROPRANOLOL, TIMOLOL, TOPIRAMATE, VALPROIC ACID, OR DIVALPROEX. DEPRESSION: TRIAL OR CONTRAINDICATION TO TWO (2) OF THE FOLLOWING - PAROXETINE, SERTRALINE, VENLAFAXINE, DULOXETINE, CITALOPRAM, ESCITALOPRAM, FLUOXETINE, OR TRAZODONE. POSTHERPERTIC NEURALGIA: TRIAL OR CONTRAINDICATION TO GABAPENTIN OR PREGABALIN. PRIOR AUTHORIZATION APPLIES TO NEW START ONLY.

76 IBRUTINIB IMBRUVICA

77 IDELALISIB ZYDELIG

78 IMATINIB MESYLATE GLEEVEC ALL DIAGNOSIS:. ADJUVANT GIST TREATMENT (TWICE DAILY DOSE): 36 MONTHS GASTROINTESTINAL STROMAL TUMOR (GIST) KIT (CD117) POSITIVE USE FOR GLEEVEC 400MG TWICE DAILY: TRIAL OF GLEEVEC 400MG ONCE DAILY OR GIST TUMOR EXPRESSING A KIT EXON 9 MUTATION. PREVIOUSLY TREATED CML REQUIRES MUTATIONAL ANALYSIS NEGATIVE FOR THE FOLLOWING MUTATIONS FOLLOWING BCR-ABL MUTATIONAL ANALYSIS - T315I, V299L, F317L/V/I/C, Y253H, E255K/V, F359V/C/I.

79 IMIQUIMOD - ALDARA IMIQUIMOD MOLLUSCUM CONTAGIOSUM, AND LETIGO MALIGNA. EXTERNAL GENITAL OR PERIANAL WARTS: GREATER THAN OR EQUAL TO 12 YEARS OF AGE. ACTINIC KERATOSIS: GREATER THAN OR EQUAL TO 18 YEARS OF AGE. PRESCRIBED BY OR IN CONSULTATION WITH: ACTINIC KERATOSIS, MOLLUSCUM CONTAGIOSIUM: DERMATOLOGIST ONLY. SUPERFICIAL BASAL CELL CARCINOMA/LETIGO MALIGNA: DERMATOLOGIST OR ONCOLOGIST ONLY. 4 MONTHS CRITERIA APPLIES TO NEW STARTS ONLY. EXTERNAL GENITAL WARTS: TRAIL OF OR CONTRAINDICATION TO PODOFILOX (CONDYLOX). ACTINIC KERATOSIS: TRIAL OF TOPICAL 5-FLUOROURACIL. ACTINIC KERATOSIS BRAND DRUG REQUEST: TRIAL/FAILURE OF GENERIC IMIQUIMOD 5%. SUPERFICIAL BASAL CELL CARCINOMA: LESS THAN 2CM IN SIZE AND NOT ON THE FACE. MOLLUSCUM CONTAGISOUM LIMITED TO THE FACE.

80 IMMUNE GLOBULIN BVD DETERMINATION CARIMUNE NF NANOFILTERED FLEBOGAMMA DIF GAMASTAN S-D GAMMAGARD LIQUID GAMMAPLEX OCTAGAM PRIVIGEN THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

81 IMMUNOSUPPRESSANT BVD DETERMINATION ASTAGRAF XL AZATHIOPRINE CELLCEPT CYCLOSPORINE CYCLOSPORINE MODIFIED GENGRAF MYCOPHENOLATE MOFETIL MYCOPHENOLIC ACID NULOJIX PROGRAF RAPAMUNE SIROLIMUS TACROLIMUS ZORTRESS THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

82 INFLIXIMAB REMICADE INITIAL: PLAQUE PSORIASIS: MODERATE TO SEVERE PLAQUE PSORIASIS INVOLVING GREATER THAN OR EQUAL TO 5 PERCENT BODY SURFACE AREA OR PSORIATIC LESIONS AFFECT THE HANDS, FEET, OR GENITAL AREA. RENEWAL: RHEUMATOID/PSORIATIC ARTHRITIS: MAINTAINED OR EXPERIENCED GREATER THAN 20% IN TENDER JOINT COUNT AND SWOLLEN JOINT COUNT. PLAQUE PSORIASIS: MAINTAINED OR EXPERIENCED PASI OF GREATER THAN 50% OR SIGNIFCANT IMPROVEMENT IN QUALITY OF LIFE OBSERVED BY PHYSICIAN AND PATIENT. ANKYLOSING SPONDYLITIS: MAINTAINED OR EXPERIENCED IMPROVEMENT OF AT LEAST 50%, OR 2 UNITS (SCALE OF 1-10), IN THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX (BASDAI) OR IMPROVEMENT OF AT LEAST 20% IN THE ASSESSMENT IN ANKYLOSING SPONDYLITIS (ASAS20) CRITERIA. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS: RHEUMATOLOGIST. PSORIATIC ARTHRITIS: DERMATOLOGIST OR RHEUMATOLOGIST. PSORIASIS: DERMATOLOGIST. CROHNS DISEASE/ULCERATIVE COLITIS: GASTROENTEROLOGIST. CD/UC: 8 MO. OTHER INDICATIONS INITIAL: 4 MO RENEWAL: 12 MO

83 INITIAL: RHEUMATOID ARTHRITIS (RA): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING: ORENCIA, XELJANZ, OR CIMZIA. PSORIATRIC ARTHRITIS (PSA): PREVIOUS TRIAL OF HUMIRA FOLLOWED BY ONE OF THE FOLLOWING: CIMZIA OR OTEZLA. ANKYLOSING SPONDYLITIS: HUMIRA FOLLOWED BY CIMZIA. PLAQUE PSORIASIS (PSO): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY ONE OF THE FOLLOWING: COSENTYX OR OTEZLA. CROHNS DISEASE (CD): PREVIOUS TRIAL OF HUMIRA FOLLOWED BY CIMZIA. ULCERATIVE COLITIS (UC): PREVIOUS TRIAL WITH HUMIRA FOLLOWED BY SIMPONI. NOT APPROVED FOR PATINETS ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), ORENCIA (ABATACEPT), ACTEMRA (TOCILIZUMAB) OR ANOTHER TNF (TUMOR NECROSIS FACTOR) INHIBITOR: HUMIRA, ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA.

84 INFUSIBLE DRUG BVD DETERMINATION ABELCET ACYCLOVIR SODIUM ADRUCIL AMBISOME AMPHOTERICIN B BLEOMYCIN SULFATE FLUOROURACIL FOSCARNET SODIUM GANCICLOVIR SODIUM IFOSFAMIDE METHOTREXATE REMODULIN THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

85 INTERFERON ALFA-2B INTRON A FOR HEPATITIS C INDICATION GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST, PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS (E.G. HEPATOLOGIST). FOR OTHER FDA APPROVED INDICATIONS, NO REQUIREMENT. INITIAL HEP C AND ALL OTHER DX: 6 MOS. RENEWAL HEP C AND ALL DX: 6 MOS. CRITERIA APPLIES TO NEW STARTS ONLY. DURATION LIMITATION OF 1 YEAR OF THERAPY EXCEPT 18 MONTHS FOR FOLLICULAR LYMPHOMA. FOR HEPATITIS C INDICATION REQUIRES A TRIAL OF PEGINTERFERON ALFA 2A OR PEGINTERFERON ALFA 2B. HEP C: DRUG MUST BE USED IN COMBINATION WITH RIBAVIRIN UNLESS CONTRAINDICATED. TRIAL OF OR CONTRAINDICATION TO PEGINTERFERON ALFA- 2A OR PEGINTERFERON ALFA-2B. GENOTYPE 1, 2, 3, 4, 5, OR 6.

86 IPILIMUMAB YERVOY 3 MONTHS

87 IVACAFTOR KALYDECO HOMOZYGOUS FOR F508DEL MUTATION IN CFTR GENE. CONFIRMED MUTATION IN CFTR GENE ACCEPTABLE FOR THE TREATMENT OF CYSTIC FIBROSIS. 6 YEARS OF AGE OR OLDER.

88 IVACAFTOR - GRANULE PACKETS KALYDECO F508DEL MUTATION IN CFTR GENE. CONFIRMED MUTATION IN CFTR GENE ACCEPTABLE FOR THE TREATMENT OF CYSTIC FIBROSIS. PATIENT WEIGHT. 2 YEARS OF AGE TO 5 YEARS OF AGE

89 LEDIPASVIR-SOFOSBUVIR HARVONI HCV RNA LEVEL. 18 YEARS OF AGE AND OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST, PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS (HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS ECHO (EXTENSION FOR COMMUNITY HEALTHCARE OUTCOMES) MODEL. DURATION BASED ON FDA APPROVED DOSING SEE FIELD FOR MORE INFORMATION. GUIDELINE CRITERIA ARE BASED ON AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES AND INFECTIOUS DISEASE SOCIETY OF AMERICA (AASLD/IDSA) TREATMENT GUIDELINES AND BEST AVAILABLE EVIDENCE. NO APPROVAL FOR REQUESTS WHERE PROVIDER ATTESTS THAT PATIENT HAS LIFE EXPECTANCY LESS THAN DUE TO NON-LIVER RELATED COMORBID CONDITIONS (PER AASLD/IDSA TREATMENT GUIDELINE RECOMMENDATION). APPROVAL REQUIRES PATIENT HAS EVIDENCE OF HEPATITIS C INFECTION (AT LEAST 2 DETECTABLE

90 HCV RNA LEVELS) OVER THE PAST 6 MONTHS OR PATIENT HAS AT LEAST ONE DETECTABLE HCV RNA LEVEL OVER THE PAST 6 MONTHS AND HAS PREVIOUS EVIDENCE OF INFECTION (E.G., PREVIOUS PRESCRIPTION FOR TREATMENT OF HEPATITIS C). GENOTYPE 1, TREATMENT NAIVE (WITH OR WITHOUT CIRRHOSIS): WILL BE APPROVED FOR FULL 12 WEEKS OF TREATMENT PER PRODUCT LABELING WITHOUT INTERRUPTION (NO RENEWAL). GENOTYPE 1 PATIENTS WITHOUT CIRRHOSIS WHO HAVE RECEIVED PRIOR TREATMENT (TREATMENT EXPERIENCED PATIENT) SUCH AS PEGINTERFERON AND RIBAVIRIN OR TRIPLE THERAPY WITH HCV PROTEASE INHIBITOR, PEGINTERFERON AND RIBAVIRIN FOR HEPATITIS C: APPROVE 12 WEEKS. PER PRODUCT LABELING WITHOUT INTERRUPTION (NO RENEWAL). GENOTYPE 1 PATIENTS WITH CIRRHOSIS WHO HAVE RECEIVED PRIOR TREATMENT (TREATMENT EXPERIENCED PATIENT) SUCH AS PEGINTERFERON AND RIBAVIRIN OR TRIPLE THERAPY WITH HCV PROTEASE INHIBITOR, PEGINTERFERON AND RIBAVIRIN FOR HEPATITIS C: APPROVE 24 WEEKS PER PRODUCT LABELING WITHOUT INTERRUPTION (NO RENEWAL). GENOTYPE 4,5, or 6: WILL BE APPROVED FOR FULL 12 WEEKS OF TREATMENT. PATIENT IS NOT CONCURRENTLY TAKING ANY OF THE FOLLOWING: CARBAMAZEPINE, PHENYTOIN, PHENOBARBITAL, OXCARBAZEPINE, RIFAMPIN, RIFABUTIN, RIFAPENTINE, ROSUVASTATIN, SIMEPREVIR, SOFOSBUVIR (AS A SINGLE AGENT), STRIBILD (ELVITAGRAVIR/COBICISTAT/EMTRICITABINE /TENOFOVIR), OR TIPRANAVIR/RITONAVIR.

91 LENALIDOMIDE REVLIMID

92 LENVATINIB MESYLATE LENVIMA

93 LIDOCAINE LIDOCAINE ADDITIONAL COVERAGE CONSIDERATION FOR DIABETIC NEUROPATHY OR CANCER PAIN.

94 LOMITAPIDE JUXTAPID USE IN COMBINATION WITH OTHER LIPID LOWERING TREATMENTS SUCH AS A STATIN (EXAMPLE: SIMVASTATIN, ATORVASTATIN), FENOFIBRATE, NIACIN, ETC.

95 METHOTREXATE BVD DETERMINATION METHOTREXATE TREXALL THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

96 METHYLNALTREXONE RELISTOR ADVANCED ILLNESS: CONSTIPATION DUE TO OPIOIDS CHRONIC NON-CANCER PAIN:HAS BEEN TAKING OPIOIDS FOR AT LEAST 4 WEEKS. 6 MONTHS FOR PATIENTS RECEIVING PALLATIVE CARE, FOR CHRONIC NON-CANCER PAIN. ADVANCED ILLNESS (OR TERMINAL ILLNESS):PATIENT IS RECEIVING PALLIATIVE CARE. CHRONIC NON-CANCER PAIN: HAS BEEN TAKING OPIOIDS FOR AT LEAST 4 WEEKS, PREVIOUS TRIAL (UNLESS CONTRAINDICATED) WITH MOVANTIK.

97 MIFEPRISTONE KORLYM

98 MIPOMERSEN KYNAMRO PATIENT IS CONCURRENTLY RECEIVING LDL APHERESIS. USE IN COMBINATION WITH A STATIN (EXAMPLE: SIMVASTATIN, ATORVASTATIN), BILE ACID SEQUESTRANT FENOFIBRATE OR NIACIN.

99 MODAFINIL AND ARMODAFINIL - NUVIGIL NUVIGIL NARCOLEPSY: TRIAL OF AT LEAST ONE OF THE FOLLOWING (UNLESS ALL ARE CONTRAINDICATED): AMPHETAMINE-DEXTROAMPHETAMINE IR, DEXTROAMPHETAMINE SULFATE IR, DEXTROAMPHETAMINE SULFATE ER, METHYLPHENIDATE IR OR METHYLPHENIDATE ER.

100 NATALIZUMAB TYSABRI CROHNS DISEASE: PRESCRIBED BY OR IN CONSULTATION WITH GASTROENTEROLOGIST. MULTIPLE SCLEROSIS:. CROHNS DISEASE: 6 MONTHS. RENEWAL: CROHNS:. MULTIPLE SCLEROSIS: TRIAL OF ONE OF THE FOLLOWING PREFERRED AGNETS FOR MULTIPLE SCLEROSIS: COPAXONE, REBIF, AVONEX, PLEGRIDY, TEDFIDERA, OR AUBAGIO. CROHNS DISEASE: TRIAL OF A HUMIRA FOLLOWED BY CIMZIA. NOT APPROVED FOR PATINETS ON CONCURRENT THERAPY WITH A TNF (TUMOR NECROSIS FACTOR) INHIBITOR: ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA.

101 NEBULIZER BVD DETERMINATION ACETYLCYSTEINE ALBUTEROL SULFATE BETHKIS CROMOLYN SODIUM NEBUPENT PULMOZYME TOBRAMYCIN TYVASO VIRAZOLE THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

102 NILOTINIB TASIGNA PREVIOUSLY TREATED CML REQUIRES MUTATIONAL ANALYSIS NEGATIVE FOR THE FOLLOWING MUTATIONS FOLLOWING BCR-ABL MUTATIONAL ANALYSIS - T315I, Y253H, E255K/V, F359V/C/I.

103 NINTEDANIB ESYLATE OFEV A USUAL INTERSTITIAL PNEUMONIA (UIP) PATTERN AS EVIDENCED BY HIGH- RESOLUTION COMPUTED TOMOGRAPHY (HRCT) ALONE OR VIA A COMBINATION OF SURGICAL LUNG BIOPSY AND HRCT. PRESCRIBED BY OR IN CONSULTATION WITH A PULMONOLOGIST. NOT APPROVED FOR PATIENTS WITH OTHER KNOWN CAUSES OF INTERSTITIAL LUNG DISEASE (E.G., CONNECTIVE TISSUE DISEASE, DRUG TOXICITY, ASBESTOS OR BERYLLIUM EXPOSURE, HYPERSENSITIVITY PNEUMONITIS, SYSTEMIC SCLEROSIS, RHEUMATOID ARTHRITIS, RADIATION, SARCOIDOSIS, BRONCHIOLITIS OBLITERANS ORGANIZING PNEUMONIA, HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION, VIRAL HEPATITIS, AND CANCER. NOT APPROVED IF PATIENT HAS NOT OBTAINED LIVER FUNCTION TESTS.

104 NIVOLUMAB OPDIVO MELANOMA: OPDIVO IS NOT APPROVED FOR COMBINATION THERAPY WITH YERVOY, TAFINLAR, OR ZELBORAF.

105 OLAPARIB LYNPARZA

106 OMACETAXINE SYNRIBO INDUCTION: 3 MONTHS. POST INDUCTION/RENEWAL: 3 TO CML INDUCTION THERAPY: TRIAL OF OR CONTRAINDICATION TO AT LEAST TWO OF THE FOLLOWING GLEEVEC, SPRYCEL, TASIGNA, BOSULIF, OR ICLUSIG. DETERMINATION FOR THERAPY LENGTH OF APPROVAL THAT IS NOT INDUCTION THERAPY WILL DEPEND ON THE PATIENTS HEMATOLOGIC RESPONSE (DEFINED AS ABSOLUTE NEUTROPHIL COUNT (ANC) GREATER THAN OR EQUAL TO 1.5 X 10^9/L AND PLATELETS GREATER THAN OR EQUAL TO 100 X 10^9/L AND NO BLOOD BLASTS OR BONE MARROW BLASTS LESS THAN 5%). IF MEETS HEMATOLOGIC RESPONSE CRITERIA APPROVAL WILL BE. IF HEMATOLOGIC RESPONSE CRITERIA IS NOT MET APPROVAL WILL BE FOR 3 MONTHS.

107 OMALIZUMAB XOLAIR INITIAL CRITERIA FOR ASTHMA: PATIENT MEETS THE CRITERIA OF MODERATE TO SEVERE ASTHMA, POSITIVE SKIN PRICK OR RAST TEST, FEV1 LESS THAN 80%, DEMONSTRATED INADEQUATELY CONTROLLED SYMPTOMS ON INHALED CORTICOSTEROIDS AND SECOND ASTHMA CONTROLLER, BASELINE IGE SERUM LEVEL GREATER THAN OR EQUAL TO 30 IU/ML. RENEWAL CRITERIA FOR ASTHMA: PATIENT REDUCED EXACERBATIONS BY AT LEAST 25% FROM BASELINE, REDUCTION IN ORAL OR INHALED CORTICOSTEROID USE FROM BASELINE. PATIENT 12 YEARS OF AGE OR OLDER SPECIALIST IN ALLERGY OR PULMONARY MEDICINE ONLY ASTHMA:. CIU: 6 MONTHS. FOR CIU:TRIAL OF A HIGH DOSE H1 ANTI-HISTAMINE (SUCH AS CLARINEX OR XYZAL) FOR AT LEAST 2 WEEKS AND STILL EXPERIENCES HIVES ON MOST DAYS OF THE WEEK.

108 OPIOID DEPENDENCY AGENTS BUPRENORPHINE HCL BUPRENORPHINE-NALOXONE ZUBSOLV PATIENT CURRENTLY TAKING OPIOID ANALGESICS. PSYCHOSOCIAL COUNSELING PRESCRIBING PHYSICIAN MUST BE CERTIFIED TO PRESCRIBE BUPRENORPHINE FOR OPIOID DEPENDENCE. BUPRENORPHINE: 1 WEEK. RENEWAL: 6 MOS. BUPRENOR/NALOX: 6 MOS CONTINUATION OF THERAPY WITH BUPRENORPHINE: CONTRAINDICATION OR UNABLE TO TOLERATE NALOXONE IN COMBINATION WITH BUPRENORPHINE.

109 PALBOCICLIB IBRANCE

110 PANOBINOSTAT FARYDAK

111 PARATHYROID HORMONE NATPARA

112 PAZOPANIB VOTRIENT

113 PDE5 INHIBITORS FOR PULMONARY ARTERIAL HYPERTENSION ADCIRCA SILDENAFIL SILDENAFIL CITRATE CARDIOLOGIST OR PULMONOLOGIST REQUEST FOR ADCIRCA REQUIRE TRIAL OR CONTRAINDICATION TO REVATIO.

114 PEG-INTERFERON ALFA-2A PEGASYS PEGASYS PROCLICK INITIAL: HEP C: PRETREATMENT HCV RNA LEVEL GREATER THAN OR EQUAL TO 25 IU/ML. RENEWAL: PRIOR TREATMENT STATUS (TX NAIVE, RELAPSER OR PRIOR NON-RESPONDER,) FOR THOSE USING PEGINTERFERON WITH OLYSIO. THERAPY WITH OLYSIO: HCV RNA LEVELS LESS THAN 25 IU/ML AT TREATMENT WEEK 4, 12, AND 24. DUAL THERAPY WITH PEGINTERFERON AND RIBAVIRIN: 2 LOG REDUCTION IN HCV RNA AT WEEK 12, UNDETECTABLE HCV RNA LEVELS AT WEEK YEARS OR OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST, PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS (E.G. HEPATOLOGIST). HEP B: 48 WEEKS. HEP C: DURATION BY GENOTYPE DIAGNOSIS SEE OTHER CRITERIA FIELD FOR MORE INFORMATION HEP C: TRIAL OR CONTRAINDICATION TO PEGINTRON. DRUG MUST BE USED IN COMBINATION WITH RIBAVIRIN UNLESS CONTRAINDICATED. INITIAL APPROVAL - GENOTYPE 1 WITH SOVALDI (SOFOSBUVIR): APPROVE 12 WEEKS. GENOTYPE 1

115 TRIPLE THERAPY WITH OLYSIO: APPROVE 6 MONTHS. GENOTYPE 1 PEGINTERFERON ALONE, OR AS DOUBLE THERAPY WITH RIBAVIRIN: 4 MONTHS. GENOTYPE 3: APPROVE 6 MONTHS. GENOTYPE 2: WITH SOVALDI: 3 MONTHS. GENOTYPE 2: AS DOUBLE THERAPY WITH RIBAVIRIN: 24 WEEKS. GENOTYPE 4 WITH SOVALDI: 12 WEEKS. GENOTYPE 4 AS PART OF REGIMEN WITH SOVALDI: 12 WEEKS. GENOTYPE 5 OR 6 ON SOVALDI TRIPLE THERAPY: 12 WEEKS. GENOTYPE 5 OR 6 ON PEGINTERFERON WITH RIBAVIRIN: APPROVE FOR 24 WEEKS. RENEWAL FOR HEP C: USED IN COMBINATION OR CONTRAINDICATION WITH RIBAVIRIN. RENEWAL, GENOTYPE 1, DOUBLE THERAPY WITH RIBAVIRIN, 12 OR 24 WEEKS BASED ON HCV RNA LEVELS (MAX TOTAL UP TO 48 WEEKS). RENEWAL, GENOTYPE 1: USE IN A TRIPLE THERAPY WITH OLYSIO AND IS A PREVIOUS NON-RESPONDER: APPROVE TOTAL MAX 48 WEEKS. USE IN A TRIPLE THERAPY WITH OLYSIO AND IS NOT A NON-RESPONDER, TREATMENT NAIVE OR PRIOR RELAPSER: APPROVE TOTAL MAX OF 24 WEEKS. GENOTYPE 1, 2, 3, 4, 5, OR 6 ON TRIPLE THERAPY WITH SOVALDI: APPROVE TOTAL MAX OF 12 WEEKS. FOR GENOTYPE 2 OR 3, DOUBLE THERAPY WITH RIBAVIRIN: 24 OR 48 WEEKS DEPENDENT UPON RNA LEVELS.

116 PEG-INTERFERON ALFA-2B PEGINTRON INITIAL: HEP C: PRETREATMENT HCV RNA LEVEL GREATER THAN OR EQUAL TO 25 IU/ML. RENEWAL: PRIOR TREATMENT STATUS (TX NAIVE, RELAPSER OR PRIOR NON-RESPONDER,) FOR THOSE USING PEGINTERFERON WITH OLYSIO. THERAPY WITH OLYSIO: HCV RNA LEVELS LESS THAN 25 IU/ML AT TREATMENT WEEK 4, 12, AND 24. DUAL THERAPY WITH PEGINTERFERON AND RIBAVIRIN: 2 LOG REDUCTION IN HCV RNA AT WEEK 12, UNDETECTABLE HCV RNA LEVELS AT WEEK YEARS OR OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST, PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS (E.G. HEPATOLOGIST). HEP C: DURATION BY GENOTYPE DIAGNOSIS. SEE FIELD FOR MORE INFORMATION. HEP C: TRIAL OR CONTRAINDICATION TO PEGASYS. DRUG MUST BE USED IN COMBINATION WITH RIBAVIRIN UNLESS CONTRAINDICATED. GENOTYPE 1 WITH SOVALDI (SOFOSBUVIR): APPROVE 12 WEEKS. GENOTYPE 1 TRIPLE THERAPY WITH

117 OLYSIO: APPROVE 6 MONTHS. GENOTYPE 1 PEGINTERFERON ALONE, OR AS DOUBLE THERAPY WITH RIBAVIRIN, 4 MONTHS. GENOTYPE 3: 24 WEEKS. GENOTYPE 2: WITH SOVALDI: 3 MONTHS. GENOTYPE 2: AS DOUBLE THERAPY WITH RIBAVIRIN: 24 WEEKS. GENOTYPE 4 WITH SOVALDI: 12 WEEKS. GENOTYPE 4, 5 OR 6 AS PART OF A REGIMEN WITH SOVALDI: 12 WEEKS. GENOTYPE 5 OR 6 ON PEGINTERFERON WITH RIBAVIRIN: APPROVE FOR 6 MONTHS. RENEWAL FOR HEP C: USED IN COMBINATION OR CONTRAINDICATION WITH RIBAVIRIN. RENEWAL, GENOTYPE 1, DOUBLE THERAPY WITH RIBAVIRIN, 12 OR 24 WEEKS BASED ON HCV RNA LEVELS (MAX TOTAL UP TO 48 WEEKS). RENEWAL, GENOTYPE 1: USE IN A TRIPLE THERAPY WITH OLYSIO AND IS A PREVIOUS NON-RESPONDER: APPROVE TOTAL MAX 48 WEEKS. USE IN A TRIPLE THERAPY WITH OLYSIO AND IS NOT A NON-RESPONDER, TREATMENT NAIVE OR PRIOR RELAPSER: APPROVE TOTAL MAX OF 24 WEEKS. GENOTYPE 1, 2, 3, 4, 5, OR 6 ON TRIPLE THERAPY WITH SOVALDI: APPROVE TOTAL MAX OF 12 WEEKS. DUAL THERAPY (PEGINTERFERON AN RIBAVIRIN) FOR GENOTYPE 2, 3, 24 OR 48 WEEKS DEPENDEDNT UPON RNA LEVELS.

118 PEG-INTERFERON ALFA-2B-SYLATRON SYLATRON CRITERIA APPLIES TO NEW STARTS ONLY. DURATION LIMITATION OF 5 YEARS OF THERAPY.

119 PEMBROLIZUMAB KEYTRUDA NO CONCURRENT REQUESTS FOR YERVOY, TAFINLAR, OR ZELBORAF.

120 PIRFENIDONE ESBRIET PATIENT WITH USUAL INTERSTITIAL PNEUMONIA (UIP) PATTERN AS EVIDENCED BY HIGH-RESOLUTION COMPUTED TOMOGRAPHY (HRCT) ALONE OR VIA A COMBINATION OF SURGICAL LUNG BIOPSY AND HRCT. PRESCRIBED BY OR IN CONSULTATION WITH A PULMONOLOGIST. NOT APPROVED FOR PATIENTS WITH KNOWN CAUSES OF INTERSTITIAL LUNG DISEASE (E.G., CONNECTIVE TISSUE DISEASE, DRUG TOXICITY, ASBESTOS OR BERYLLIUM EXPOSURE, HYPERSENSITIVITY PNEUMONITIS, SYSTEMIC SCLEROSIS, RHEUMATOID ARTHRITIS, RADIATION, SARCOIDOSIS, BRONCHIOLITIS OBLITERANS ORGANIZING PNEUMONIA, HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION, VIRAL HEPATITIS, AND CANCER). NOT APRPOVED IF THE PATIENT HAS NOT OBTAINED LIVER FUNCTION TESTS. NOT APPROVED IF THE PATIENT CURRENTLY SMOKE CIGARETTES.

121 POMALIDOMIDE POMALYST

122 PONATINIB ICLUSIG

123 PRAMLINTIDE SYMLINPEN 120 SYMLINPEN 60 TYPE I OR TYPE II DIABETES: REQUIRING INSULIN OR CONTINUOUS INSULIN INFUSION (INSULIN PUMP) FOR GLYCEMIC CONTROL

124 QUININE SULFATE QUININE SULFATE

125 RABIES VACCINE BVD DETERMINATION IMOVAX RABIES VACCINE RABAVERT THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR D DEPENDING UPON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE AND SETTING OF THE DRUG TO MAKE THE DETERMINATION.

126 REGORAFENIB STIVARGA FOR KRAS WILD TYPE COLORECTAL CANCER, TRIAL OR CONTRAINDICATION TO ANTI-EGFR THERAPY SUCH AS ERBITUX OR VECTIBIX. FOR COLORECTAL CANCER, TRIAL OR CONTRAINDICATION TO ANTI-VEGF THERAPY SUCH AS AVASTIN OR ZALTRAP AND A FLUOROPYRMIDE-, OXAPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY SUCH AS FOLFOX, FOLFIRI,CAPEOX, INFUSIONAL 5-FU/LV OR CAPECITABINE, AND FOLFOXIRI. FOR GIST, A TRIAL OR CONTRAINDICATION TO GLEEVEC AND SUTENT IS REQUIRED.

127 RIFAXIMIN XIFAXAN TRAVELERS DIARRHEA: 12 YEARS OR OLDER. TRAVELERS DIARRHEA: 1 FILL IN 1 MONTH. TRAVELERS DIARRHEA: TRIAL OF CIPROFLOXACIN OR AZITHROMYCIN.

128 RIOCIGUAT ADEMPAS PRESCRIBED BY OR IN CONSULTATION WITH A CARDIOLOGIST OR PULMONOLOGIST. TRIAL OF OR CONTRAINDICATION TO A PHOSPHODIESTERASE-5 (PDE-5) INHIBITOR SUCH AS REVATIO OR ADCIRCA.

129 RITUXIMAB RITUXAN RENEWAL: ACTIVE RHEUMATOID ARTHRITIS: GREATER THAN 20% IMPROVEMENT IN TENDER JOINT COUNT AND SWOLLEN JOINT COUNT. PRESCRIBED BY OR IN CONSULTATION WITH: RHEUMATOID ARTHRITIS: RHEUMATOLOGIST. FOR NHL OR CLL: ONCOLOGIST. RA: INITIAL: 4 MO. RENEWAL: 12 MO NHL: 1 YEAR. CLL: 6 MO. WG, MPA: 1 MO INITIAL: RHEUMATOID ARTHRITIS: PREVIOUS TRIAL OF HUMIRA FOLLOWED BY ONE OF THE FOLLOWING: ORENCIA, XELJANZ, OR CIMZIA. NON HODGKIN'S LYMPHOMA/CHRONIC LYMPHOCYTIC LEUKEMIA: USED IN COMBINATION WITH CHEMOTHERAPY. WEGNER'S GRANULOMATOSIS/MICROSCOPIC POLYANGIITIS: CONCURRENT GLUCOCORTICOID USE. NOT APPROVED FOR PATIENTS ON ON CONCURRENT THERAPY WITH KINERET (ANAKINRA), ORENCIA (ABATACEPT), ACTEMRA (TOCILIZUMAB) OR ANOTHER TNF BLOCKER (ENBREL, CIMZIA, REMICADE, SIMPONI, OR SIMPONI ARIA).

130 RUXOLITINIB JAKAFI RENEWAL: IMPROVEMENT OR MAINTENANCE OF SYMPTOM IMPROVEMENT SUCH AS A 50% OR GREATER REDUCTION IN TOTAL SYMPTOM SCORE ON THE MODIFIED MYELOFIBROSIS SYMPTOM ASSESSMENT FORM (MFSAF) V2.0 OR 50% OR GREATER REDUCTION IN PALPABLE SPLEEN LENGTH, OR REDUCTION OF 35% OR GREATER FROM BASELINE SPLEEN VOLUME AFTER 6 MONTHS OF THERAPY. INITIAL: 6 MONTHS. RENEWAL:

131 SECUKINUMAB COSENTYX (2 SYRINGES) COSENTYX PEN (2 PENS) PLAQUE PSORIASIS: MODERATE TO SEVERE PLAQUE PSORIASIS INVOLVING GREATER THAN OR EQUAL TO 5 PERCENT BODY SURFACE AREA OR PSORIATIC LESIONS AFFECT THE HANDS, FEET, OR GENITAL AREA. RENEWAL: PLAQUE PSORIASIS: ACHIEVED OR MAINTAINED CLEAR OR MINIMAL DISEASE OR A DECREASE IN PSORIASIS AREA AND SEVERITY INDEX (PASI) OF AT LEAST 50% OR MORE. PRESCRIBED BY OR IN CONSULTATION WITH A DERMATOLOGIST. INITIAL: 4 MONTHS. RENEWAL: FOR ALL DIAGNOSES. INITIAL: PREVIOUS TRIAL WITH HUMIRA AND ONE OF THE FOLLOWING CONVENTIONAL THERAPIES SUCH AS PUVA (PHOTOTHERAPY ULTRAVIOLET LIGHT A), UVB (ULTRAVIOLET LIGHT B), TOPICAL CORTICOSTEROIDS, CALCIPOTRIENE, ACITRETIN, METHOTREXATE, OR CYCLOSPORINE.

132 SILTUXIMAB SYLVANT

133 SIMEPREVIR OLYSIO HCV RNA LEVEL OR VIRAL LOAD. FOR ALL GENOTYPE 1A: NS3 80K POLYMORPHISM LAB TEST AT BASELINE. 18 YEARS OF AGE AND OLDER. PRESCRIBED BY OR IN CONSULTATION WITH: GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST, PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS (FOR EXAMPLE HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS ECHO (EXTENSION FOR COMMUNITY HEALTHCARE OUTCOMES) MODEL. 12 WEEKS. PT W/ CIRRHOSIS ON SOLVADI: 24 WEEKS. SEE FIELD FOR MORE INFORMATION. APPROVAL REQUIRES PATIENT HAS EVIDENCE OF HEPATITIS C INFECTION (AT LEAST 2 DETECTABLE HCV RNA LEVELS) OVER THE PAST 6 MONTHS OR PATIENT HAS AT LEAST ONE DETECTABLE HCV RNA LEVEL OVER THE PAST 6 MONTHS AND HAS PREVIOUS EVIDENCE OF INFECTION (E.G., PREVIOUS PRESCRIPTION FOR TREATMENT OF HEPATITIS C). NO APPROVAL FOR REQUESTS WHERE PROVIDER ATTESTS THAT PATIENT HAS LIFE EXPECTANCY LESS THAN DUE TO

134 NON-LIVER RELATED COMORBID CONDITIONS (PER AASLD/IDSA TREATMENT GUIDELINE RECOMMENDATION). NO APPROVAL FOR PATIENTS WITH DECOMPENSATED CIRRHOSIS. GENOTYPE 1A NOT POSITIVE FOR NS3 Q80K POLYMORPHISM OR 1B WITH USE IN COMBINATION WITH RIBAVIRIN AND PEG- INTERFERON ALFA: MAXIMUM DURATION OF 12 WEEKS. COMBINATION REGIMEN SOVALDI AND OLYSIO APPROVED IF THE PATIENT HAS TRIED HARVONI AS LONG AS PATIENT HAS NOT FAILED A PRIOR COURSE OF THERAPY WITH ANY HCV PROTEASE INHIBITOR (SUCH AS INCIVEK OLYSIO, OR VICTRELIS) (I.E., HAS NOT ACHIEVED A SUSTAINED VIROLOGIC RESPONSE). SOVALDI AND OLYISO APPROVAL IS FOR 24 WEEKS FOR PATIENTS WITH CIRRHOSIS OR 12 WEEKS FOR PATIENTS WITHOUT CIRRHOSIS. PATIENT MUST NOT BE TAKING ANY OF THE FOLLOWING INTERACTING MEDICATIONS: CARBAMAZEPINE, PHENYTOIN, PHENOBARBITAL, OXCARBAZEPINE, RIFAMPIN, RIFABUTIN, RIFAPENTINE, ERYTHROMYCIN (DOES NOT INCLUDE TOPICAL FORMULATIONS), CLARITHROMYCIN, TELITHROMYCIN, ITRACONAZOLE, KETOCONAZOLE, POSACONAZOLE, FLUCONAZOLE (DOES NOT INCLUDE TOPICAL FORMULATIONS), VORICONAZOLE, DEXAMETHASONE, CISAPRIDE, CYCLOSPORINE, ROSUVASTATIN DOSE ABOVE 10MG, ATORVASTATIN DOSE ABOVE 40MG, OR ANY OF THE FOLLOWING HIV MEDICATIONS: COBICISTAT- CONTAINING MEDS (E.G., STRIBILD), ANY HIV PROTEASE INHIBITOR (ATAZANAVIR, FOSAMPRENAVIR, LOPINAVIR, INDINAVIR, NELFINAVIR, SAQUINAVIR, OR TIPRANAVIR) RITONAVIR, DARUNAVIR/RITONAVIR, DELAVIRIDINE, ETRAVIRINE, NEVIRAPINE, EFAVIRENZ). PATIENT ALSO MUST NOT BE TAKING AMIODARONE IF ON COMBINATION REGIMEN OF SOLVADI AND OLYSIO.