Somavert ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D.

Transcription

1 ACROMEGALY THERAPY Somatuline Depot subcutaneous syringe 120 mg/0.5 ml, 60 mg/0.2 ml, 90 mg/0.3 ml Somavert Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (FOR SOMAVERT, IGF-1 LEVELS AND LIVER TESTS SHOULD BE MONITORED AND SOMAVERT SHOULD BE DISCONTINUED IF LFTS ARE GREATER THAN 5 TIMES THE UPPER LIMIT OF NORMAL), AND DOCUMENTATION OF PREVIOUS THERAPIES (FOR ACROMEGALY- DOCUMENTATION OF FAILURE OF SURGERY, RADIATION, AND MEDICAL TREATMENT IS REQUIRED- EXAMPLES OF MEDICAL TREATMENT IS OCTREOTIDE.) FOR ACROMEGALY, SOMATULINE DEPOT OR SOMAVERT MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST. FOR GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS, SOMATULINE DEPOT MUST BE PRESCRIBED BY AN ONCOLOGIST. COVERED FOR THE TREATMENT OF ACROMEGALY IN PATIENTS WHO HAVE HAD FAILURE OF SURGERY, RADIATION AND MEDICAL RX (EXAMPLE:OCTREOTIDE). SOMAVERT SPECIFIC- IGF-1 LEVELS AND LIVER TESTS SHOULD BE MONITORED AND SOMAVERT SHOULD BE DISCONTINUED IF LFT'S ARE GREATER THAN 5 TIMES UPPER LIMIT OF NORMAL. REQUESTS WILL ALSO BE EVALUATED FOR OFF-LABEL USE. 1

2 ACTEMRA Actemra intravenous solution 200 mg/10 ml (20 mg/ml) Actemra subcutaneous USE OF ACTEMRA IN COMBINATION WITH TNF INHIBITORS WILL NOT BE COVERED DIAGNOSIS, DOCUMENTATION OF CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS Age FOR DX OF RHEUMATOID ARTHRITIS, PATIENT MUST BE 18 YEARS OF AGE OR OLDER. FOR DX OF JUVENILE IDIOPATHIC ARTHRITIS (SYSTEMIC OR POLYARTICULAR), PATIENT MUST BE 2 YEARS OF AGE OR OLDER. Other MUST BE PRESCRIBED BY A RHEUMATOLOGIST ACTEMRA WILL BE COVERED FOR A DIAGNOSIS OF MODERATE TO SEVERE RHEUMATOID ARTHRITIS. IN ADDITION, THERE MUST BE DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE OF AN APPROVED DMARD (SUCH AS METHOTREXATE, AZATHIOPRINE, SULFASALAZINE, OR HYDROXYCHLOROQUINE) EITHER ALONE OR IN COMBINATION FOR A 3-MONTH PERIOD. IF APPROVED FOR INITIAL THERAPY, INITIAL DOSING WILL BE LIMITED TO 4MG/KG EVERY 4 WEEKS. BASED ON CLINICAL RESPONSE, DOSE CAN BE INCREASED TO 8MG/KG BUT THE TOTAL DOSE CANNOT EXCEED 800MG. ACTEMRA WILL BE APPROVED FOR JUVENILE IDIOPATHIC ARTHRITIS (SYSTEMIC OR POLYARTICULAR) FOR PATIENTS AT LEAST TWO YEARS OF AGE. THERE MUST BE DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE OF GLUCOCORTICOIDS OR METHOTREXATE. IF APPROVED FOR INITIAL THERAPY, INITIAL DOSING WILL BE LIMITED TO 2

3 10MG/KG EVERY 4 WEEKS FOR PATIENTS UNDER 30KG, AND 8MG/KG EVERY 4 WEEKS FOR PATIENTS 30KG AND OVER. FOR SJRI DOSING IS EVERY TWO WEEKS AT 12MG/KG FOR PATIENTS LESS THAN 30KG AND 8MG/KG FOR PATIENTS GREATER THAN 30KG. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 3

4 ACTHAR Acthar H.P. Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF ANY PREVIOUS THERAPIES FOR ALL FDA-APPROVED INDICATIONS IN ADULTS, DOCUMENTATION OF SIGNIFICANT SIDE EFFECTS FROM ORAL OR INJECTABLE CORTICOSTEROIDS IS REQUIRED. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 4

5 ACZONE Aczone topical gel Age Other EXCLUDED WHEN USED FOR COSMETIC PURPOSES PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF ANY PREVIOUS THERAPIES ACZONE WILL BE COVERED FOR THE DIAGNOSIS OF ACNE VULGARIS. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 5

6 ADEMPAS Adempas Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE FOR THE DIAGNOSIS OF PULMONARY HYPERTENSION, PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND PERTINENT LAB/DIAGNOSTIC TEST RESULTS (RIGHT HEART CATHETERIZATION WHICH SHOWS MEAN PULMONARY ARTERY PRESSURE (PAP) OF GREATER THAN OR EQUAL TO 25 MMHG AT REST. IN ADDITION, THE PATIENT MUST HAVE A PULMONARY CAPILLARY WEDGE PRESSURE LESS THAN OR EQUAL TO 15 MMHG AT REST. FOR THE DIAGNOSIS OF CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), THERE MUST BE DOCUMENTATION OF RECURRENT OR PERSISTENT DISEASE AFTER SURGICAL TREATMENT OR DOCUMENTATION OF INOPERABLE DISEASE (RIGHT HEART CATH IS NOT REQUIRED FOR THE DIAGNOSIS OF CTEPH). MUST BE PRESCRIBED BY A PULMONOLOGIST OR CARDIOLOGIST COVERED FOR THE TREATMENT OF PULMONARY HYPERTENSION WHEN THE PATIENT HAS HAD A RIGHT HEART CATHETERIZATION WITH RESULTS AS LISTED IN THE REQUIRED MEDICAL INFORMATION SECTION. THERE MUST ALSO BE DOCUMENTATON OF CLINICAL FAILURE OR SEVERE INTOLERANCE TO GENERIC SILDENAFIL OR ADCIRCA AND ONE OTHER AGENT WITH A DIFFERENT MECHANISM OF ACTION, SUCH AS A PROSTACYCLIN OR AN ENDOTHELIN RECEPTOR ANTAGONIST. COVERED FOR THE TREATMENT OF CHRONIC 6

7 THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH) WHEN THE PATIENT HAS DOCUMENTATION OF RECURRENT OR PERSISTANT DISEASE AFTER SURGICAL TREATMENT OR DOCUMENTATION OF INOPERABLE DISEASE. 7

8 AFINITOR Afinitor Disperz oral tablet for suspension 2 mg, 3 mg, 5 mg Afinitor oral tablet 10 mg, 2.5 mg, 5 mg, 7.5 mg Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 8

9 ALDURAZYME Aldurazyme Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS ENZYME ANALYSIS, URINARY TESTS, SKELETAL RADIOGRAPHS, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES ALDURAZYME IS COVERED IN PATIENTS WITH MUCOPOLYSACCHARIDOSIS DIAGNOSED WITH HURLER OR HURLER-SCHEIE FORM OF MPS I WITH BIOCHEMICAL ENZYME ANALYSIS FOR ALPHA-IDURONIDASE ENZYME DEFICIENCY IN WBCS OR CULTURED SKIN FIBROBLASTS AND WITH SYMPTOMS WHICH INCLUDE: VALVULAR HEART DISEASE, CARDIOMYOPATHY, SLEEP APNEA, RESTRICTIVE LUNG DISEASE, REACTIVE AIRWAY DISEASE, JOINT STIFFNESS, JOINT CONTRACTURES, JOINT PAIN, SPINAL DEFORMITIES, CORNEAL CLOUDING, GLAUCOMA, DEVELOPMENTAL DELAY, MENTAL RETARDATION, COMMUNICATING HYDROCEPHALUS, HEARING LOSS, HEPATOMEGALY, INGUINAL/UMBILICAL HERNIA AND CHRONIC INFECTION OR WHO HAVE A FIRST DEGREE RELATIVE AFFECTED. 9

10 ALECENSA Alecensa Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS, AND DOCUMENTATION OF PREVIOUS THERAPIES. PATIENT MUST BE 18 YEARS OF AGE OR OLDER. MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 10

11 ALPHA-1 ANTITRYPSIN THERAPY Aralast NP intravenous recon soln 500 mg Glassia Prolastin-C Zemaira Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS AAT SERUM LEVELS, GENOTYPE TESTING, AND PULMONARY FUNCTION TESTING, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES MUST BE PRESCRIBED BY A PULMONOLOGIST, ONLY AS WEEKLY INFUSIONS COVERAGE WILL NOT PROVIDED FOR ALPHA ANTITRYPSIN DEFICIES OTHER THAN THE ONES DEFINED HERE: PATIENTS WITH ALPHA 1 ANTITRYPSIN (AAT) LEVELS BELOW 11MMOL/L (80MG/DL OR APPROXIMATELY 57MG/DL BY NEPHELOMETRY) WHO ARE PIZZ, PISZ, PIZ(NULL), PI(NULL)(NULL), OR HAVE DYSFUNCTIONAL AAT PROTEIN (SUCH AS PIF OR PI PITTSBURG GENOTYPES) AND HAVE EVIDENCE OF EMPHYSEMA AS FEV1 LESS THAN 80% OF PREDICTED VALUE. ADDITIONALLY, PATIENT MUST ALSO DEMONSTRATE 1 OR MORE OF THE FOLLOWING: SIGNS OF SIGNIFICANT LUNG DISEASE SUCH AS CHRONIC PRODUCTIVE COUGH OR UNUSUAL FREQUENCY OF LOWER RESPIRATORY INFECTION, AIRFLOW OBSTRUCTION, ACCELERATED DECLINE OF FEV1 OR CHEST RADIOGRAPH OR CT SCAN EVIDENCE OF EMPHYSEMA, ESPECIALLY IN THE ABSENCE OF A RECOGNIZED RISK FACTOR (SMOKING, 11

12 OCCUPATIONAL DUST EXPOSURE, ETC) AND PATIENTS WITH EMPHYSEMA DUE TO AAT DEFICIENCY MUST BE MAINTAINED ON REGIMENS SIMILAR TO THOSE PATIENTS WITH EMPHYSEMA NOT ASSOCIATED WITH AAT DEFICIENCY, INCLUDING: MAXIMUM DOSES OF BETA-ADRENERGIC BRONCHODILATORS, ANTICHOLINERGICS AND ANTIBIOTICS, WHEN APPROPRIATE. PATIENTS MUST ALSO HAVE VACCINATIONS AGAINST INFLUENZA AND PNEUMOCOCCUS AND SUPPLEMENTAL OXYGEN THERAPY WHEN INDICATED. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 12

13 ALUNBRIG Alunbrig Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY AN ONCOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 13

14 AMPYRA Ampyra Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, DOCUMENTATION OF CRCL, DOCUMENTATION OF ABILITY TO WALK WITH OR WITHOUT A WALKING DEVICE. PRESCRIBER MUST BE A NEUROLOGIST, THEN EVERY YEAR THEREAFTER PATIENT MUST HAVE A DIAGNOSIS OF MULTIPLE SCLEROSIS. INITIAL APPROVAL WILL BE FOR. AT THE END OF, CONTINUED APPROVAL WILL REQUIRE THAT THE INDIVIDUAL DEMONSTRATES IMPROVEMENT (INCREASED WALKING SPEED, REDUCED SPASTICITY) WHILE ON THE MEDICATION AND CONTINUES TO BE AMBULATORY. IF THIS CRITERIA IS MET, THEN APPROVAL WILL BE GRANTED FOR. RECERTIFICATION REQUIRING THIS SAME CRITERIA WILL BE REQUIRED EVERY THEREAFTER. 14

15 ANDRODERM Androderm Age Other DIAGNOSIS, TESTOSTERONE LEVELS (WITH LABORATORY REFERENCE RANGES), CURRENT AND PREVIOUS THERAPIES TO TREAT STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER TO CONFIRM A DIAGNOSIS OF TESTOSTERONE DEFICIENCY, THERE MUST BE DOCUMENTATION OF A TESTOSTERONE LABORATORY VALUE BELOW THE NORMAL REFERENCE RANGE PRIOR TO THE INITIATION OF TESTOSTERONE THERAPY. IN ADDITION, THE PATIENT MUST HAVE SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY (SUCH AS DECREASED SEX DRIVE, LOSS OF MUSCLE MASS, INABILITY TO MAINTAIN AN ERECTION). AT RECERTIFICATION, SUBMISSION OF A NORMAL TESTOSTERONE LEVEL (WITH LABORATORY REFERENCE RANGES), AND/OR DOCUMENTATION OF IMPROVEMENT IN THE SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY OBTAINED WHILE THE PATIENT WAS RECEIVING THE APPROVED TESTOSTERONE THERAPY IS REQUIRED. IF THE TESTOSTERONE LEVEL IS NORMAL COMPARED TO THE PROVIDED REFERENCE RANGE AND/OR THERE IS AN IMPROVEMENT OVER BASELINE IN THE SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY, THEN COVERAGE WILL CONTINUE TO BE REVIEWED AT ONE-YEAR INTERVALS. 15

16 WHILE ON THE APPROVED THERAPY, IF THE TESTOSTERONE LEVEL IS NOT WITHIN NORMAL LIMITS OR SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY HAVE NOT IMPROVED OVER BASELINE, THEN COVERAGE WILL NOT BE EXTENDED AT RECERTIFICATION. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 16

17 ANDROGEL AndroGel transdermal gel in metered-dose pump mg/1.25 gram (1.62 %) AndroGel transdermal gel in packet 1 % (25 mg/2.5gram), 1 % (50 mg/5 gram), 1.62 % (20.25 mg/1.25 gram), 1.62 % (40.5 mg/2.5 gram) Age Other DIAGNOSIS, TESTOSTERONE LEVELS (WITH LABORATORY REFERENCE RANGES), CURRENT AND PREVIOUS THERAPIES TO TREAT STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER TO CONFIRM A DIAGNOSIS OF TESTOSTERONE DEFICIENCY, THERE MUST BE DOCUMENTATION OF A TESTOSTERONE LABORATORY VALUE BELOW THE NORMAL REFERENCE RANGE PRIOR TO THE INITIATION OF TESTOSTERONE THERAPY. IN ADDITION, THE PATIENT MUST HAVE SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY (SUCH AS DECREASED SEX DRIVE, LOSS OF MUSCLE MASS, INABILITY TO MAINTAIN AN ERECTION). AT RECERTIFICATION, SUBMISSION OF A NORMAL TESTOSTERONE LEVEL (WITH LABORATORY REFERENCE RANGES), AND/OR DOCUMENTATION OF IMPROVEMENT IN THE SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY OBTAINED WHILE THE PATIENT WAS RECEIVING THE APPROVED TESTOSTERONE THERAPY IS REQUIRED. IF THE TESTOSTERONE LEVEL IS NORMAL COMPARED TO THE PROVIDED REFERENCE RANGE AND/OR THERE IS AN IMPROVEMENT OVER BASELINE IN THE SIGNS AND SYMPTOMS 17

18 OF ANDROGEN DEFICIENCY, THEN COVERAGE WILL CONTINUE TO BE REVIEWED AT ONE-YEAR INTERVALS. WHILE ON THE APPROVED THERAPY, IF THE TESTOSTERONE LEVEL IS NOT WITHIN NORMAL LIMITS OR SIGNS AND SYMPTOMS OF ANDROGEN DEFICIENCY HAVE NOT IMPROVED OVER BASELINE, THEN COVERAGE WILL NOT BE EXTENDED AT RECERTIFICATION. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 18

19 ARCALYST Arcalyst Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 19

20 AUSTEDO Austedo oral tablet 12 mg, 6 mg, 9 mg Age Other WILL NOT BE COVERED IN COMBINATION WITH TETRABENAZINE (XENAZINE) DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A NEUROLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 20

21 AVASTIN Avastin Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 21

22 BAVENCIO Bavencio Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 12 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 22

23 BEERS LIST SAFETY EDIT guanfacine oral tablet methyldopa methyldopa-hydrochlorothiazide Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF PREVIOUS THERAPIES, AND MEDICAL JUSTIFICATION FOR USING A DRUG THAT IS LISTED BY BEERS AS A MEDICATION THAT SHOULD BE AVOIDED IN THE ELDERLY PA APPLIES FOR PATIENTS AGE 65 AND OLDER. PA DOES NOT APPLY FOR PATIENTS AGE 64 AND YOUNGER THE AMERICAN GERIATRICS SOCIETY PUBLISHES THE BEERS CRITERIA FOR POTENTIALLY INAPPROPRIATE MEDICATIONS USED IN THE ELDERLY. THE MEDICATIONS IN THIS PRIOR AUTHORIZATION GROUP ARE LISTED AS DRUGS THAT SHOULD ALMOST ALWAYS BE AVOIDED IN PATIENTS AGED 65 AND OLDER. IN ORDER FOR ONE OF THESE MEDICATIONS TO BE APPROVED FOR COVERAGE, DOCUMENTATION WILL NEED TO BE PROVIDED STATING THAT THE PRESCRIBER IS AWARE OF THE RISK AND WISHES TO PRESCRIBE REGARDLESS. 23

24 BEERS SAFETY EDIT--NEW STARTS ONLY phenobarbital Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF PREVIOUS THERAPIES, AND MEDICAL JUSTIFICATION FOR USING A DRUG THAT IS LISTED BY BEERS AS A MEDICATION THAT SHOULD BE AVOIDED IN THE ELDERLY PA APPLIES FOR PATIENTS AGE 65 AND OLDER. PA DOES NOT APPLY FOR PATIENTS AGE 64 AND YOUNGER THE AMERICAN GERIATRICS SOCIETY PUBLISHES THE BEERS CRITERIA FOR POTENTIALLY INAPPROPRIATE MEDICATIONS USED IN THE ELDERLY. THE MEDICATIONS IN THIS PRIOR AUTHORIZATION GROUP ARE LISTED AS DRUGS THAT SHOULD ALMOST ALWAYS BE AVOIDED IN PATIENTS AGED 65 AND OLDER. IN ORDER FOR ONE OF THESE MEDICATIONS TO BE APPROVED FOR COVERAGE, DOCUMENTATION WILL NEED TO BE PROVIDED STATING THAT THE PRESCRIBER IS AWARE OF THE RISK AND WISHES TO PRESCRIBE REGARDLESS. 24

25 BELEODAQ Beleodaq Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF ANY PREVIOUS THERAPIES MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 25

26 BENLYSTA Benlysta intravenous Benlysta subcutaneous Age Other DOCUMENTATION OF DIAGNOSIS (MUST HAVE ACTIVE SLE), DOCUMENTATION THAT PATIENT IS SEROPOSITIVE (ANA =1:80 AND/OR ANTI-DSDNA =30 IU/ML), AND DOCUMENTATION OF OTHER AGENTS THE PATIENT IS CURRENTLY TAKING (MUST BE TAKING AT LEAST ONE AGENT USED TO MANAGE SLE, SUCH AS CORTICOSTEROIDS, IMMUNOSUPPRESSANTS, OR ANTIMALARIALS) MUST BE FOLLOWED BY A RHEUMATOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. WHILE NOT TRUE CONTRAINDICATIONS, USE OF BENLYSTA IN THE FOLLOWING SITUATIONS IS NOT RECOMMENDED: 1) PROGRESSION OF SLE IN THE CNS, WITH SYMPTOMS SUCH AS SEIZURES, PSYCHOSIS ORGANIC BRAIN SYNDROME, CVA, CEREBRITIS OR CNS VASCULITIS 2) SEVERE RENAL DISEASE OR LUPUS NEPHRITIS (PROTEINURIA ABOVE 6G/24 HR OR SERUM CREATININE ABOVE 2.5 MG/DL) 3) PREGNANT OR NURSING 4) CURRENTLY RECEIVING TREATMENT WITH ANY B CELL TARGETED THERAPY OR BIOLOGIC (INCLUDING HUMIRA, REMICADE, RITUXAN, ENBREL, CIMZIA, ORENCIA, STELARA, KINERET, ACTEMRA, SIMPONI) 5) HAVE RECEIVED IV CYCLOPHOSPHAMIDE WITHIN THE PAST 180 DAYS 6) HAVE 26

27 REQUIRED MANAGEMENT OF ACUTE OR CHRONIC INFECTIONS WITHIN THE PAST 60 DAYS (NOT CURRENTLY TREATED FOR INFECTION) 7) HAVE A HISTORICALLY POSITIVE TEST OR TEST POSITIVE AT SCREENING FOR HIV, HEPATITIS B OR HEPATITIS C. 27

28 BERINERT Berinert intravenous kit Age Other EXCLUDED FOR THE PROPHYLAXIS OF HEREDITARY ANGIOEDEMA ATTACKS. PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND LABORATORY TESTS USED TO CONFIRM DIAGNOSIS, AND DOCUMENTATION OF ANY PREVIOUS THERAPIES. MUST BE PRESCRIBED BY ALLERGIST, IMMUNOLOGIST, HEMATOLOGIST, OR DERMATOLOGIST COVERED FOR A CONFIRMED DIAGNOSIS OF HAE TYPE 1, TYPE II, OR TYPE III FOR THE TREATMENT OF ACUTE HEREDITARY ANGIOEDEMA ATTACKS. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 28

29 BOSULIF Bosulif oral tablet 100 mg, 500 mg Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS (MUST BE CHRONIC MYELOGENOUS LEUKEMIA--CML), PERTINENT LAB/DIAGNOSTIC TEST RESULTS (PATIENT MUST BE PHILADELPHIA CHROMOSOME POSITIVE, AND IF OTHER TESTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS, PROVIDING PATIENT MUST BE AT LEAST 18 YEARS OLD 6 MONTHS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 29

30 BOTOX Botox Age Other EXCLUDED FOR COSMETIC PURPOSES PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF ANY PREVIOUS THERAPIES REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 30

31 CABOMETYX Cabometyx Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY AN ONCOLOGIST 6 MONTHS INITIAL COVERAGE DURATION IS 6 MONTHS. AT RECERTIFICATION, COVERAGE WILL BE EXTENDED AT 6- MONTH INTERVALS WITH ONGOING EVIDENCE OF STABLE OR IMPROVED DISEASE. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 31

32 CAPRELSA Caprelsa oral tablet 100 mg, 300 mg Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS PATIENT MUST BE AGE 18 OR OLDER PRESCRIBER MUST BE AN ONCOLOGIST OR ENDOCRINOLOGIST REGISTERED WITH THE CAPRELSA REMS PROGRAM 6 MONTHS THE FOLLOWING WARNINGS/PRECAUTIONS SHOULD BE OBSERVED WHEN PRESCRIBING CAPRELSA: 1) HYPOCALCEMIA, HYPOKALEMIA, AND/OR HYPOMAGNESEMIA SHOULD BE CORRECTED PRIOR TO INITIATING THERAPY. 2) DRUGS KNOWN TO PROLONG THE QT INTERVAL SHOULD BE AVOIDED. 3) GIVEN THE HALF-LIFE OF 19 DAYS, ECGS SHOULD BE OBTAINED TO MONITOR QT INTERVAL AT BASELINE, AT 2-4 WEEKS AFTER INITIATING THERAPY, AND EVERY 3 MONTHS THEREAFTER. 4) USE OF CAPRELSA IN PATIENTS WITH INDOLENT, ASYMPTOMATIC, OR SLOWLY PROGRESSING DISEASE SHOULD BE CAREFULLY CONSIDERED BECAUSE OF THE TREATMENT RISKS OF THIS PRODUCT. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 32

33 CARBAGLU Carbaglu Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS PATIENT MUST HAVE A DIAGNOSIS OF ACUTE OR CHRONIC HYPERAMMONEMIA DUE TO THE DEFICIENCY OF THE HEPATIC ENZYME N-ACETYLGLUTAMATE SYNTHASE (NAGS). 33

34 CERDELGA Cerdelga Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE COMBINATION THERAPY WITH CERDELGA AND ENZYME REPLACEMENT THERAPY (SUCH AS ELEYSO, CEREZYME) IS EXCLUDED. CONCOMITANT USE OF A MODERATE OR STRONG CYP2D6 INHIBITOR WITH A MODERATE OR STRONG CYP3A INHIBITOR IN EXTENSIVE METABOLIZERS OR INTERMEDIATE METABOLIZERS IS EXCLUDED. CONCOMITANT USE OF A STRONG CYP3A INHIBITOR IN POOR METABOLIZERS OR INTERMEDIATE METABOLIZERS IS EXCLUDED. CERDELGA IS EXCLUDED IN PATIENTS WITH PRE-EXISTING CARDIAC DISEASE, LONG Q-T SYNDROME, AND FOR THOSE WHO TAKE CLASS 1A OR CLASS III ANTIARRHYTHMIC. PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS ENZYME ANALYSIS, MUTATION ANALYSIS, OR BONE MARROW STUDIES, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES PATIENT MUST BE 18 YEARS OF AGE OR OLDER CERDELGA IS COVERED FOR TYPE 1 GAUCHER DISEASE IN PATIENTS WHO ARE CYP2D6 EXTENSIVE METABOLIZERS, INTERMEDIATE METABOLIZERS OR POOR METABOLIZERS. 34

35 CEREZYME AND CEREDASE Cerezyme intravenous recon soln 400 unit Age ALL FDA-APPROVED INDICATIONS NOT OTHERWISE COMBINATION THERAPY OF ZAVESCA AND CEREZYME/CEREDASE IS EXCLUDED PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS ENZYME ANALYSIS, MUTATION ANALYSIS, OR BONE MARROW STUDIES, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES Other COVERED IN ADULT PATIENTS DIAGNOSED WITH TYPE 1 GAUCHER DISEASE CONFIRMED BY BIOCHEMICAL ASSAY OF GLUCOCEREBROSIDASE ACTIVITY IN WHITE BLOOD CELLS OR SKIN FIBROBLASTS LESS THAN OR EQUAL TO 30% OR GENOTYPE MUTATION OF TWO MUTANT ALLELES OF THE GLUCOCEREBROSIDASE GENE WHEN THE PATIENT HAS SYMPTOMATIC MANIFESTATIONS OF DISEASE (SKELETAL DISEASE AS DEMONSTRATED BY EVIDENCE OF JOINT DETERIORATION, PATHOLOGICAL FRACTURE, OSTEOPENIA, AVASCULAR NECROSIS, OSTEOSCLEROSIS, MARROW INFILTRATION, LYTIC LESIONS, OR ERLENMEYER FLASK DEFORMITY OR HGB LESS THAN 11.5 FOR FEMALES AND LESS THAN 12.5 FOR MALES [OR 1.0 G/DL BELOW THE LOWER LIMIT OF NORMAL FOR AGE AND SEX], PLATELET COUNT LESS THAN 120,000 MM3, CLINICALLY SIGNIFICANT SPLENOMEGALY OR HEPATOSPLENOMEGALY). COVERED IN PEDIATRIC PATIENTS 35

36 DIAGNOSED WITH TYPE 1 GAUCHER DISEASE MEETING THE SAME CRITERIA BUT WHO HAVE THE FOLLOWING SYMPTOMATIC MANIFESTATIONS (ABDOMINAL OR BONE PAIN, DELAYED GROWTH, FATIGUE, EXERTIONAL LIMITATIONS, MARROW INFILTRATION, ORGANOMEGALY, WEAKNESS AND CACHEXIA). 36

37 CESAMET Cesamet Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER 6 MONTHS COVERED FOR THE PROPHYLAXIS OF NAUSEA AND VOMITING ASSOCIATED WITH CANCER CHEMOTHERAPY WITH DOCUMENTED LACK OF RESPONSE OR SEVERE INTOLERANCE TO ONE 5HT-3 RECEPTOR ANTAGONIST. REQUESTS FOR NON- FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 37

38 CHOLBAM Cholbam Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS GAS CHROMATOGRAPHY-MASS SPECTROMETRY URINE ANALYSIS, LIVER FUNCTION TESTS AND OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS). PATIENT MUST BE 3 WEEKS OF AGE OR OLDER MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST, GASTROENTEROLOGIST, GENETICIST, HEPATOLOGIST, OR METABOLIC SPECIALIST. INITIAL APPROVAL 3 MONTHS. FOR SUBSEQUENT REVIEWS FOR ITS FDA-APPROVED INDICATIONS, THERE MUST BE A DIAGNOSIS MADE BY GAS CHROMATOGRAPHY-MASS SPECTROMETRY ANALYSIS OF THE URINE WITH A POSITIVE IDENTIFICATION OF ELEVATED BILE ACIDS. IN ADDITION, LIVER FUNCTION TESTS MUST IDENTIFY ELEVATED SERUM AMINOTRANSFERASES WITH NORMAL SERUM GAMMA GLUTAMYLTRANSFERASE. THE INITIAL APPROVAL WILL BE FOR THREE MONTHS. AFTER THE INITIAL THREE MONTH AUTHORIZATION, APPROVAL WILL BE GRANTED IN INCREMENTS WITH DOCUMENTATION OF IMPROVED LIVER FUNCTION VIA AMINOTRANSFERASE LOWERING. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 38

39 CHORIONIC GONADOTROPIN chorionic gonadotropin, human Novarel intramuscular recon soln 10,000 unit Pregnyl Age Other EXCLUDED WHEN USED TO PROMOTE FERTILITY DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES USED FOR THE TREATMENT OF THE STATED DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 39

40 CIALIS FOR DAILY USE Cialis oral tablet 2.5 mg, 5 mg Age Other CIALIS FOR DAILY USE WILL NOT BE COVERED FOR THE INDEPENDENT DIAGNOSIS OF ERECTILE DYSFUNCTION. CIALIS IS EXCLUDED FOR OFF-LABEL INDICATIONS EVEN IF SUPPORTED BY AHFS OR DRUGDEX COMPENDIUM. DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS COVERED FOR A DIAGNOSIS OF BENIGN PROSTATIC HYPERPLASIA (BPH). 40

41 CIMZIA Cimzia Cimzia Powder for Reconst Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES. PATIENT MUST BE AT LEAST 18 YEARS OF AGE AS SAFETY AND EFFICACY HAS NOT BEEN ESTABLISHED IN PEDIATRIC POPULATIONS. MUST BE PRESCRIBED BY A GASTROENTEROLOGIST FOR CROHN'S DISEASE DIAGNOSIS. RHEUMATOLOGIST FOR RHEUMATOID ARTHRITIS OR ANKYLOSING SPONDYLOSIS DIAGNOSES. RHEUMATOLOGIST OR DERMATOLOGIST FOR PSORIATIC ARTHRITIS DIAGNOSIS CIMZIA WILL BE COVERED FOR A DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE. IN ADDITION, THE PATIENT MUST MEET ONE OF THE FOLLOWING CRITERIA: 1) PATIENT CONTINUES TO EXPERIENCE DISEASE FLARE DESPITE COMPLETE AND ADEQUATE THERAPY WITH A CORTICOSTEROID. 2) TREATMENT WITH AN IMMUNOMODULATOR (SUCH AS AZATHIOPRINE OR 6-MP) FAILS TO MAINTAIN REMISSION IN A CASE OF STEROID DEPENDENT OR STEROID REFRACTORY DISEASE. 3) DOCUMENTATION IS PROVIDED THAT AZATHIOPRINE, 6-MP, OR METHOTREXATE IS NOT EFFECTIVE, CONTRAINDICATED, OR NOT TOLERATED. 4) THE PATIENT HAS HAD SEVERE INTOLERANCE OR THERAPEUTIC FAILURE OF HUMIRA. CIMZIA WILL BE COVERED FOR A DIAGNOSIS OF MODERATE TO 41

42 SEVERE RHEUMATOID ARTHRITIS. IN ADDITION, THERE MUST BE DOCUMENTATION OF CLINICALFAILURE OR SEVERE INTOLERANCE OF AN APPROVED DMARD (SUCH AS METHOTREXATE, AZATHIOPRINE, SULFASALAZINE, OR HYDROXYCHLOROQUINE) EITHER ALONE OR IN COMBINATION FOR A 3 MONTH PERIOD AND THERE MUST BE DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE OF EITHER HUMIRA OR ENBREL. CIMZIA WILL BE COVERED FOR A DIAGNOSIS OF ANKYLOSING SPONDYLITIS IN PATIENTS WITH REFRACTORY DISEASE DEFINED BY FAILURE OF AT LEAST ONE NSAID FOR AT LEAST A ONE MONTH DURATION. IN ADDITION, THERE MUST BE DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE TO EITHER HUMIRA OR ENBREL. CIMZIA WILL BE COVERED FOR A DIAGNOSIS OF PSORIATIC ARTHRITIS IN PATIENTS WITH DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE TO ENBREL, HUMIRA OR STELARA. 42

43 CINRYZE Cinryze Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FOR ACUTE HEREDITARYANGIOEDEMA ATTACKS PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND LABORATORY TESTS USED TO CONFIRM DIAGNOSIS, AND DOCUMENTATION OF ANY PREVIOUS THERAPIES MUST BE PRESCRIBED BY ALLERGIST, IMMUNOLOGIST, HEMATOLOGIST, OR DERMATOLOGIST COVERED FOR A CONFIRMED DIAGNOSIS OF HAE TYPE 1, TYPE II, OR TYPE III. PROPHYLACTIC THERAPY WITH CINRYZE WILL BE COVERED IN INDIVIDUALS WITH AT LEAST ONE SEVERE EPISODE OF ANGIOEDEMA PER MONTH. IN ADDITION, THE PATIENT MUST DOCUMENTATION OF SEVERE INTOLERANCE OR CLINICAL FAILURE OF STEROIDS, DANAZOL, OR ANTIFIBRINOLYTIC THERAPY. 43

44 COMETRIQ Cometriq Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (NO SPECIFIC TESTS ARE REQUIRED, BUT IF TESTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS, PROVIDING THE RESULTS WILL REDUCE THE LIKELIHOOD THAT ADDITIONAL INFORMATION WILL BE NEEDED TO PROCESS THE REQUEST), AND DOCUMENTATION OF PREVIOUS THERAPIES REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 44

45 COPAXONE Copaxone subcutaneous syringe 20 mg/ml Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A NEUROLOGIST COVERED FOR THE DIAGNOSIS OF MULTIPLE SCLEROSIS. DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE TO GLATOPA IS REQUIRED. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 45

46 COSENTYX Cosentyx Cosentyx Pen Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A DERMATOLOGIST OR RHEUMATOLOGIST COVERED FOR THE DIAGNOSIS OF MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS WITH PSORIASIS THAT INVOLVES AT LEAST 5% BODY SURFACE AREA (BSA). COVERED FOR THE DIAGNOSIS OF MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS IN PATIENTS WITH PSORIASIS THAT INVOLVES LESS THAN 5% BSA IF THE AFFECTED AREA INVOLVES THE HANDS, FEET, FACIAL OR GENITAL REGIONS. PATIENTS ALSO MUST MEET ONE OF THE FOLLOWING CRITERIA: 1) HAD A 3-MONTH TRIAL OF ACITRETIN, METHOTREXATE, OR CYCLOSPORINE THERAPY RESULTING IN INTOLERANCE OR CLINICAL FAILURE OR 2) HAVE TRIED UVB/COAL TAR OR PUVA/TOPICALCORTICOSTEROIDS FOR AT LEAST 3 MONTHS OR 3) HAVE TRIED AND FAILED AT LEAST TWO OF THE FOLLOWING FOR 3 MONTHS: TREATMENT WITH MEDIUM AND/OR HIGH POTENCY TOPICAL CORTICOSTEROIDS OR ANTHRALIN, CALCIPOTRIENE, TAZAROTENE, OR INTRALESIONAL CORTICOSTEROID INJECTIONS. COVERED FOR THE DIAGNOSIS OF ANKYLOSING SPONDYLITIS IN PATIENTS WITH REFRACTORY DISEASE DEFINED BY FAILURE OF AT 46

47 LEAST ONE NSAID TAKEN FOR A MINIMUM ONE-MONTH DURATION. COVERED FOR A DIAGNOSIS OF PSORIATIC ARTHRITIS. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 47

48 COTELLIC Cotellic Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS, AND DOCUMENTATION OF PREVIOUS THERAPIES. PATIENT MUST BE 18 YEARS OF AGE OR OLDER. MUST BE PRESCRIBED BY AN ONCOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 48

49 CYRAMZA Cyramza Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 49

50 DAKLINZA Daklinza Age Other DAKLINZA WILL NOT BE COVERED IN COMBINATION WITH DRUGS THAT STRONGLY INDUCE CYP3A. DAKLINZA WILL NOT BE COVERED FOR GENOTYPES THAT ARE NOT SUPPORTED BY ITS FDA APPROVED INDICATION, COMPENDIA, OR AASLD GUIDELINES. DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS INCLUDING BASELINE HCV RNA RESULTS AND HCV GENOTYPE, AND DOCUMENTATION OF CURRENT AND PREVIOUS THERAPIES (IF APPLICABLE). PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A GASTROENTEROLOGIST, HEPATOLOGIST, INFECTIOUS DISEASE SPECIALIST, OR HCV/HIV SPECIALIST 12 TO 24 WEEKS (DEPENDING ON DIAGNOSIS, FDA-APPROVED LABELING, AND AASLD/IDSA GUIDANCE) IF AASLD/IDSA GUIDELINES RECOMMENDS THE USE OF HARVONI TO TREAT A GIVEN GENOTYPE, THEN PATIENT MUST HAVE DOCUMENTATION OF A SEVERE INTOLERANCE (THAT PREVENTS COMPLETION OF THERAPY) OR A CONTRAINDICATION TO HARVONI. FOR OFF- LABEL DAKLINZA REVIEWS, CRITERIA WILL BE APPLIED CONSISTENT WITH COMPENDIA AND CURRENT AASLD/IDSA GUIDANCE. 50

51 DARZALEX Darzalex Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS, AND DOCUMENTATION OF PREVIOUS THERAPIES. PATIENT MUST BE 18 YEARS OF AGE OR OLDER. MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST 6 MONTHS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 51

52 DUPIXENT Dupixent Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY AN ALLERGIST, IMMUNOLOGIST, OR DERMATOLOGIST COVERED FOR THE DIAGNOSIS OF MODERATE TO SEVERE ATOPIC DERMATITIS IN PATIENTS AT LEAST 18 YEARS OLD WITH ATOPIC DERMATITIS THAT INVOLVES AT LEAST 10% BODY SURFACE AREA (BSA). IN ADDITION, THE PATIENT MUST HAVE RECEIVED TREATMENT WITH TWO OF THE FOLLOWING THREE TREATMENT OPTIONS DURING THE SIX MONTHS PRECEEDING THE REQUEST FOR DUXIPENT. 1) TREATMENT WITH A POTENT TOPICAL CORTICOSTEROID FOR A MINIMUM 14-DAY DURATION OR TREATMENT WITH A MEDIUM POTENCY TOPICAL CORTICOSTEROID FOR A MINIMUM 28-DAY DURATION. 2) TREATMENT WITH TOPICAL TACROLIMUS. 3) TREATMENT WITH AN ORAL OR INJECTABLE IMMUNOSUPPRESSANT, SUCH AS A CORTICOSTEROID, INDICATED OR COMPENDIA-SUPPORTED FOR THE TREATMENT OF ATOPIC DERMATITIS. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 52

53 EGRIFTA Egrifta subcutaneous recon soln 1 mg Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS (REQUIRED DIAGNOSIS OF HIV-POSITIVE LIPODYSTROPHY), AND DOCUMENTATION OF CURRENT MEDICATION USE (REQUIRED THAT PATIENT BE CURRENTLY ON ANTIRETROVIRAL THERAPY). 6 MONTHS THERE MUST BE A MINIMUM OF 3 CM REDUCTION IN WAIST CIRCUMFERENCE AFTER THE FIRST 6 MONTHS OF THERAPY. MAINTENANCE OF 3 CM REDUCTION IN WAIST CIRCUMFERENCE WILL BE REQUIRED FOR FURTHER THERAPY. 53

54 ELAPRASE Elaprase Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS ENZYME ANALYSIS, URINARY TESTS, SKELETAL RADIOGRAPHS, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES ELAPRASE IS COVERED FOR MEMBERS DIAGNOSED WITH HUNTER SYNDROME (MUCOPOLYSACCHARIDOSIS II) WHO MEET THE FOLLOWING: BIOCHEMICAL ENZYME ANALYSIS FOR IDURONATE SULFATASE DEFICIENCY IN WHITE BLOOD CELLS OR CULTURED SKIN FIBROBLASTS AND AFFECTED FIRST DEGREE RELATIVE OR SYMPTOMS WHICH INCLUDE: PROGRESSIVE COARSENING OF FACIAL FEATURES, SHORT STATURE, JOINT STIFFNESS, HEPATOSPLENOMEGALY, HERNIAS, IVORY COLORED PAPULAR SKIN LESIONS LOCATED ON THE UPPER BACK AND/OR LATERAL UPPER ARMS AND THIGHS, MENTAL RETARDATION, DEAFNESS, CEREBRAL VENTRICULAR DILATION, MILD DYSOSTOSIS MULTIPLEX OF BONE, HYPERTRICHOSIS, THICKENED SKIN OR MONGOLIAN SPOTS. 54

55 ELELYSO Elelyso Age ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS ENZYME ANALYSIS, MUTATION ANALYSIS, OR BONE MARROW STUDIES, OR OTHER TESTS PERFORMED TO CONFIRM THE DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES Other COVERED IN ADULT PATIENTS DIAGNOSED WITH TYPE 1 GAUCHER DISEASE CONFIRMED BY BIOCHEMICAL ASSAY OF GLUCOCEREBROSIDASE ACTIVITY IN WHITE BLOOD CELLS OR SKIN FIBROBLASTS LESS THAN OR EQUAL TO 30% OR GENOTYPE MUTATION OF TWO MUTANT ALLELES OF THE GLUCOCEREBROSIDASE GENE WHEN THE PATIENT HAS SYMPTOMATIC MANIFESTATIONS OF DISEASE (SKELETAL DISEASE AS DEMONSTRATED BY EVIDENCE OF JOINT DETERIORATION, PATHOLOGICAL FRACTURE, OSTEOPENIA, AVASCULAR NECROSIS, OSTEOSCLEROSIS, MARROW INFILTRATION, LYTIC LESIONS, OR ERLENMEYER FLASK DEFORMITY OR HGB LESS THAN 11.5 FOR FEMALES AND LESS THAN 12.5 FOR MALES [OR 1.0 G/DL BELOW THE LOWER LIMIT OF NORMAL FOR AGE AND SEX], PLATELET COUNT LESS THAN 120,000 MM3, CLINICALLY SIGNIFICANT SPLENOMEGALY OR HEPATOSPLENOMEGALY). COVERED IN PEDIATRIC PATIENTS 55

56 DIAGNOSED WITH TYPE 1 GAUCHER DISEASE MEETING THE SAME CRITERIA BUT WHO HAVE THE FOLLOWING SYMPTOMATIC MANIFESTATIONS (ABDOMINAL OR BONE PAIN, DELAYED GROWTH, FATIGUE, EXERTIONAL LIMITATIONS, MARROW INFILTRATION, ORGANOMEGALY, WEAKNESS AND CACHEXIA). 56

57 EMFLAZA Emflaza oral suspension Emflaza oral tablet 18 mg, 30 mg, 36 mg, 6 mg Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS, RESULTS OF DUCHENNE MUSCULAR DYSTROPHY (DMD) GENE MUTATION STUDY PATIENT MUST BE 5 YEARS OF AGE OR OLDER MUST BE A SPECIALIST IN THE TREATMENT OF NEUROMUSCULAR DISORDERS COVERED FOR ALL FDA-APPROVED INDICATIONS WITH REQUIRED DOCUMENTATION OF SIGNIFICANT SIDE EFFECTS RESULTING FROM A MINIMUM 3-MONTH TRIAL OF ORAL PREDNISONE. EXAMPLES OF SIGNIFICANT PREDNISONE SIDE EFFECTS INCLUDE CUSHINGOID APPEARANCE, CENTRAL (TRUNCAL) OBESITY, UNDESIRABLE WEIGHT GAIN, INABILITY TO MANAGE DIABETES OR HYPERTENSION, STEROID-INDUCED MANIA, OR SEPSIS. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 57

58 EMPLICITI Empliciti Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS, AND DOCUMENTATION OF PREVIOUS THERAPIES PATIENT MUST BE 18 YEARS OF AGE OR OLDER. MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 58

59 ENBREL Enbrel subcutaneous recon soln Enbrel subcutaneous syringe Enbrel SureClick Age Other PATIENT MUST NOT HAVE A CONTRAINDICATION TO TNF THERAPY PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES FOR TREATMENT OF PSORIASIS, PATIENTS MUST BE 4 YEARS OF AGE OR OLDER. FOR THE TREATMENT OF ARTHRITIS, THE PATIENT MUST BE AT LEAST 2 YEARS OLD. PRESCRIBER MUST BE A RHEUMATOLOGIST (FOR A DIAGNOSIS OF PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, RHEUMATOID ARTHRITIS, OR JUVENILE IDIOPATHIC ARTHRITIS) OR DERMATOLOGIST (FOR A DIAGNOSIS OF PSORIASIS). ENBREL IS COVERED FOR PATIENTS WITH A DIAGNOSIS OF PSORIATIC ARTHRITIS. PSORIASIS- IN ADULT PTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS THAT INVOLVES AT LEAST 5% BODY SURFACE AREA. COVERED FOR THE DIAGNOSIS OF MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS IN PATIENTS WITH LESS THAN 5% BSA IF THE AFFECTED AREA INVOLVES THE HANDS, FEET, FACIAL OR GENITAL REGIONS. PATIENT ALSO MUST MEET ONE OF THE FOLLOWING CRITERIA (REQMT BYPASSED IF PT HAS TRIED UVB AND COAL TAR OR PUVA AND TOPICAL CORTICOSTEROIDS--A NON-PART-D SERVICE): 1) HAD A 3 MONTH TRIAL OF ACITRETIN, METHOTREXATE, OR CYCLOSPORINE THERAPY RESULTING IN INTOLERANCE OR 59

60 CLINICAL FAILURE OR 2) HAVE TRIED AND FAILED AT LEAST 2 OF THE FOLLOWING FOR 3 MONTHS: TREATMENT WITH MEDIUM AND/OR HIGH POTENCY TOPICAL CORTICOSTEROIDS OR ANTHRALIN, CALCIPOTRIENE, TAZAROTENE, OR INTRALESIONAL CORTICOSTEROID INJECTIONS AFTER AT LEAST 3 MONTHS OF USE. ANKYLOSING SPONDYLITIS- IN PTS WITH REFRACTORY DISEASE DEFINED BY FAILURE OF AT LEAST TWO NSAIDS FOR AT LEAST 1 MONTH EACH. RHEUMATOID ARTHRITIS- IN PTS WITH ACTIVE MODERATE TO SEVERE RA WHO HAVE FAILED TO RESPOND TO AND/OR IS INTOLERANT TO ONE APPROVED DISEASE-MODIFYING ANTI- RHEUMATIC DRUG (DMARD) AGENTS, SUCH AS METHOTREXATE, AZATHIOPRINE, SULFASALAZINE, OR HYDROXYCHLOROQUINE, EITHER ALONE OR IN COMBINATION FOR A 3 MONTH PERIOD. COVERED FOR THE DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE JUVENILE IDIOPATHIC ARTHRITIS IN PATIENTS AT LEAST 2 YEARS OLD. THE PATIENT MUST HAVE FAILED TO RESPOND TO AND/OR IS INTOLERANT TO APPROVED DMARD AGENTS, SUCH AS METHOTREXATE, NSAIDS, ANALGESICS OR CORTICOSTEROIDS, EITHER ALONE OR IN COMBINATION. REQUESTS WILL ALSO BE EVALUATED FOR OFF-LABEL USE. 60

61 EPCLUSA Epclusa Age Other EPCLUSA WILL NOT BE COVERED FOR GENOTYPES THAT ARE NOT SUPPORTED BY ITS FDA-APPROVED INDICATION, COMPENDIA, OR AASLD/IDSA GUIDELINES. DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS TO INCLUDE BASELINE HCV RNA RESULTS AND HCV GENOTYPE, AND DOCUMENTATION OF CURRENT AND PREVIOUS THERAPIES (IF APPLICABLE). PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A GASTROENTEROLOGIST, HEPATOLOGIST, INFECTIOUS DISEASE SPECIALIST, OR HCV/HIV SPECIALIST 12 TO 24 WEEKS (DEPENDING ON DIAGNOSIS, FDA-APPROVED LABELING, AND AASLD/IDSA GUIDANCE) FOR GENOTYPE 1 PATIENTS, IF AASLD/IDSA GUIDELINES RECOMMEND THE USE OF HARVONI, THEN THE PATIENT MUST HAVE DOCUMENTATION OF A SEVERE INTOLERANCE (THAT PREVENTS COMPLETION OF THERAPY) OR A CONTRAINDICATION TO HARVONI. IF THE GENOTYPE AND PATIENT PRESENTATION WOULD REQUIRE THE USE OF HARVONI FOR 24 WEEKS, THEN PREREQUISITE USE OF HARVONI IS NOT REQUIRED. FOR OFF- LABEL EPCLUSA REVIEWS, CRITERIA WILL BE APPLIED CONSISTENT WITH COMPENDIA AND CURRENT AASLD/IDSA GUIDANCE. 61

62 ERBITUX Erbitux intravenous solution 100 mg/50 ml Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 62

63 ERIVEDGE Erivedge Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (NO SPECIFIC TESTS ARE REQUIRED, BUT IF TESTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS, PROVIDING THE RESULTS WILL REDUCE THE LIKELIHOOD THAT ADDITIONAL INFORMATION WILL BE NEEDED TO PROCESS THE REQUEST), AND DOCUMENTATION OF PREVIOUS THERAPIES REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 63

64 ERWINAZE Erwinaze Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS, AND DOCUMENTATION OF PREVIOUS THERAPIES REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 64

65 ESBRIET Esbriet oral capsule Esbriet oral tablet 267 mg, 801 mg Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS TO CONFIRM DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER MUST BE PRESCRIBED BY A PULMONOLOGIST ESBRIET WILL BE COVERED FOR A DOCUMENTED DIAGNOSIS OF IDIOPATHIC PULMONARY FIBROSIS. 65

66 EXONDYS 51 Exondys 51 Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS, RESULTS OF DUCHENNE MUSCULAR DYSTROPHY (DMD) GENE MUTATION STUDY MUST BE A SPECIALIST IN THE TREATMENT OF NEUROMUSCULAR DISORDERS 6 MONTHS INITIAL COVERAGE DURATION IS 6 MONTHS. AT RECERTIFICATION, COVERAGE WILL BE EXTENDED AT 6- MONTH INTERVALS WITH ONGOING EVIDENCE OF STABLE OR IMPROVED DISEASE. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 66

67 FABRAZYME Fabrazyme intravenous recon soln 35 mg Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (SUCH AS UNIRINARY TESTS ALPHA-GAL A ACTIVITY, GENERIC ANALYSIS, BIOPSY, OR OTHER TESTS PERFORMED TO CONFIRM DIAGNOSIS), AND DOCUMENTATION OF PREVIOUS THERAPIES FABRAZYME IS COVERED IN PATIENTS DIAGNOSED WITH FABRY DISEASE WHO HAVE AT LEAST ONE OF THE FOLLOWING DOCUMENTED SYMPTOMS: CHARACTERISTIC LYSOSOMAL DISEASE SKIN RASHES, DECREASED SWEATING, CHRONIC FATIGUE, DEPRESSION, NEUROPATHIC PAIN IN THE HANDS AND FEET, GASTROINTESTINAL ISSUES, STROKES, CARDIAC DISEASE (INCLUDING LEFT VENTRICULAR HYPERTROPHY), OR PROGRESSING RENAL DISEASE (PROTEINURIA TO END STAGE RENAL DISEASE). 67

68 FANAPT/LATUDA/SAPHRIS Fanapt Latuda Saphris (black cherry) Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES. FOR FANAPT AND LATUDA, THE PATIENT MUST BE 18 YEARS OF AGE OR OLDER. FOR SAPHRIS, THE PATIENT MUST BE 10 YEARS OF AGE OR OLDER. COVERAGE OF LATUDA FOR A DIAGNOSIS OF BIPOLAR DEPRESSION REQUIRES DOCUMENTATION OF SIGNIFICANT INTOLERANCE OR THERAPEUTIC FAILURE OF ONE FIRST LINE TREATMENT (SUCH AS LITHIUM, VALPROATE, LAMOTRIGINE, OLANZAPINE, QUETIAPINE). COVERAGE OF SAPHRIS, LATUDA, OR FANAPT FOR THE DIAGNOSIS OF SCHIZOPHRENIA OR SAPHRIS FOR THE DIAGNOSIS OF BIPOLAR DISORDER REQUIRES DOCUMENTATION OF SIGNIFICANT INTOLERANCE OR THERAPEUTIC FAILURE OF ONE FIRST LINE TREATMENT (SUCH AS RISPERIDONE, OLANZAPINE, ZIPRASIDONE, QUETIAPINE). REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 68

69 FARYDAK Farydak Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS VIA PERTINENT LAB/DIAGNOSTIC TEST RESULTS, DOCUMENTATION OF ANY PREVIOUS THERAPIES AND CONCURRENT THERAPIES. FOR THE DIAGNOSIS OF MULTIPLE MYELOMA, THERE MUST BE DOCUMENTATION OF PRIOR TREATMENT WITH VELCADE (BORTEZOMIB) AND AN IMMUNOMODULATORY AGENT (SUCH AS REVLIMID, POMALYST OR THALIDOMIDE). PATIENT MUST BE AT LEAST 18 YEARS OF AGE MUST BE PRESCRIBED BY AN ONCOLOGIST 24 WEEKS INITIALLY. MAXIMUM COVERAGE 48 WEEKS. FARYDAK IS COVERED FOR THE DIAGNOSIS OF MULTIPLE MYELOMA IF THERE IS DOCUMENTATION THAT THE PREREQUISITE THERAPIES (LISTED UNDER REQUIRED MEDICAL INFORMATION) HAVE FAILED. IN ADDITION, FOR THE DIAGNOSIS OF MULTIPLE MYELOMA, FARYDAK WILL ONLY BE COVERED ONLY IF USED IN COMBINATION WITH VELCADE (BORTEZOMIB) AND DEXAMETHASONE. IF APPROVED FOR THE DIAGNOSIS OF MULTIPLE MYELOMA, INITIAL COVERAGE WITH BE FOR 24 WEEKS. TO RECEIVE AN ADDITIONAL 24 WEEKS OF COVERAGE, THERE MUST BE NO EVIDENCE OF DISEASE PROGRESSION. REQUESTS FOR NON- FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE 69

70 REQUIREMENTS. 70

71 FIRAZYR Firazyr Age Other EXCLUDED FOR PROPHYLAXIS OF HEREDITARYANGIOEDEMA ATTACKS PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, PERTINENT LAB/DIAGNOSTIC TEST RESULTS (NO SPECIFIC TESTS ARE REQUIRED, BUT IF TESTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS, PROVIDING THE RESULTS WILL REDUCE THE LIKELIHOOD THAT ADDITIONAL INFORMATION WILL BE NEEDED TO PROCESS THE REQUEST), AND DOCUMENTATION OF PREVIOUS THERAPIES EXCLUDED IN PATIENTS UNDER 18 YEARS OF AGE MUST BE PRESCRIBED BY ALLERGIST, IMMUNOLOGIST, HEMATOLOGIST, OR DERMATOLOGIST ACUTE THERAPY WITH FIRAZYR WILL BE COVERED IN INDIVIDUALS WITH A CONFIRMED DIAGNOSIS OF HAE TYPE 1, TYPE II, OR TYPE III. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 71

72 FLECTOR Flector Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS, AND DOCUMENTATION OF PREVIOUS THERAPIES THREE MONTHS FLECTOR WILL BE COVERED FOR THE TREATMENT OF ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS. ACUTE PAIN IS DEFINED AS SHORT-TERM PAIN NOT LASTING LONGER THAN A THREE MONTH PERIOD. CHRONIC PAIN IS DEFINED AS A CONDITION THAT REQUIRES PAIN MANAGEMENT THAT EXCEEDS A THREE MONTH PERIOD, SUCH AS RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND PERIPHERAL NEUROPATHY. 72

73 FOLOTYN Folotyn intravenous solution 40 mg/2 ml (20 mg/ml) Age Other ALL FDA-APPROVED INDICATIONS NOT OTHERWISE PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF ANY PREVIOUS THERAPIES MUST BE PRESCRIBED BY AN ONCOLOGIST OR HEMATOLOGIST. FOR THE DIAGNOSIS OF RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA, THERE MUST BE A DOCUMENTED CLINICAL FAILURE OF AT LEAST ONE ANTHRACYCLINE BASED SYSTEMIC THERAPY (DAUNORUBICIN, DOXORUBICIN, EPIRUBICIN, IDARUBICIN, VALRUBICIN, MITOXANTRONE). IF ANTHRACYCLINES ARE CONTRAINDICATED, DOCUMENTED CLINICAL FAILURE OF ONE NON-ANTHRACYCLINE BASED CHEMOTHERAPY REGIMEN. 73

74 GATTEX Gattex One-Vial Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS (AND DEPENDENCY ON PARENTERAL NUTRITION SUPPORT), PERTINENT LAB/DIAGNOSTIC TEST RESULTS (NO SPECIFIC TESTS ARE REQUIRED, BUT IF TESTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS, PROVIDING THE RESULTS WILL REDUCE THE LIKELIHOOD THAT ADDITIONAL INFORMATION WILL BE NEEDED TO PROCESS THE REQUEST), AND DOCUMENTATION OF PREVIOUS THERAPIES SIX MONTHS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 74

75 GILOTRIF Gilotrif Age Other EXCLUDED FOR USE IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC AND TARGETED THERAPIES. DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS, EGFR-MUTATION TESTING (IF APPROPRIATE FOR DIAGNOSIS) MUST BE PRESCRIBED BY AN ONCOLOGIST REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 75

76 GLEEVEC Gleevec oral tablet 100 mg, 400 mg imatinib oral tablet 100 mg, 400 mg Age Other PATIENT PROGRESS NOTES AND DOCUMENTATION OF DIAGNOSIS REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF- LABEL USE REQUIREMENTS. 76

77 GLUMETZA Glumetza oral tablet,er gast.retention 24 hr 1,000 mg, 500 mg Age Other DIAGNOSIS, CURRENT AND PREVIOUS THERAPIES FOR STATED DIAGNOSIS PATIENT MUST BE 18 YEARS OF AGE OR OLDER COVERED FOR THE DIAGNOSIS OF TYPE-2 DIABETES. DOCUMENTATION OF CLINICAL FAILURE OR SEVERE INTOLERANCE OF BOTH GENERIC IMMEDIATE-RELEASE METFORMIN (EQUIVALENT OF GLUCOPHAGE) AND GENERIC EXTENDED-RELEASE METFORMIN (GENERIC EQUIVALENT OF GLUCOPHAGE XR OR FORTAMET) IS REQUIRED. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABEL USE REQUIREMENTS. 77

78 GONADOTROPIN RELEASING HORMONE ANALOGS Eligard Eligard (3 month) Eligard (4 month) Eligard (6 month) leuprolide subcutaneous kit Lupron Depot Lupron Depot (3 month) Lupron Depot (4 month) Lupron Depot (6 Month) Lupron Depot-Ped intramuscular kit mg, 15 mg Trelstar intramuscular syringe Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS INITIAL AUTHORIZATION IS 3 MONTHS TO 1 YEAR, AS INDICATED IN THE OTHER CRITERIA SECTION. LUPRON/LEUPROLIDE IS COVERED FOR MANAGEMENT OF ENDOMETRIOSIS, INCLUDING PAIN RELIEF AND REDUCTION OF ENDOMETRIOTIC LESIONS. AUTHORIZATION WILL BE FOR UP TO 6 MONTHS, BECAUSE OF A LACK OF SAFETY DATA WITH LONG TERM USE, AND CONCERNS REGARDING EFFECTS ON BONE DENSITY. LUPRON/LEUPROLIDE IS COVERED FOR TREATMENT OF ADVANCED PROSTATIC CANCER, DEFINED AS STAGE III OR STAGE IV. LUPRON/LEUPROLIDE IS COVERED FOR TREATMENT OF PRECOCIOUS PUBERTY. LUPRON/LEUPROLIDE IS COVERED AS ADJUNCT THERAPY FOR PREOPERATIVE HEMATOLOGIC IMPROVEMENTS OF PATIENTS WITH ANEMIA (HEMATOCRIT LESS THAN OR EQUAL TO 30% AND OR HEMOGLOBIN LESS THAN OR EQUAL TO 10.2 G/DL) CAUSED BY 78

79 UTERINE LEIOMYOMATA.TRELSTAR IS COVERED FOR PALLIATIVE TREATMENT OF ADVANCED PROSTATE CANCER. REQUESTS WILL ALSO BE EVALUATED FOR OFF-LABEL USE. 79

80 GRALISE Gralise 30-Day Starter Pack Gralise oral tablet extended release 24 hr 300 mg, 600 mg Age Other PATIENT PROGRESS NOTES, DOCUMENTATION OF DIAGNOSIS AND DOCUMENTATION OF ANY PREVIOUS THERAPIES FOR THE TREATMENT OF POST-HERPETIC NEURALGIA, THERE MUST BE DOCUMENTATION OF SEVERE INTOLERANCE OR CLINICAL FAILURE TO GENERIC GABAPENTIN. REQUESTS FOR NON-FDA APPROVED INDICATIONS WILL BE EVALUATED ACCORDING TO THE MEDICARE STATUTORY OFF-LABELUSE REQUIREMENTS. 80