2016 Medicaid Preapproval Criteria

Transcription

1 2016 Medicaid Preapproval Criteria ABILIFY MAINTENA ACTIMMUNE ADAGEN ADCETRIS ADCIRCA ADEMPAS AFINITOR ALDURAZYME ALFERON-N ALGLUCOSIDASE ALFA ALIMTA ALPHA-1 PROTEINASE INHIBITORS ALPROLIX AMPYRA ANTIHEMOPHILIC FACTORS ARCALYST ARZERRA AUBAGIO AVASTIN AVONEX AVYCAZ BANZEL BELEODAQ BENLYSTA BETASERON BLINCYTO BOSULIF

2 BOTOX BUPHENYL CALPRESA C1 INHIBITOR CARBAGLU CAYSTON CERDELGA CEREZYME CHOLBAM CIMZIA COMPOUNDED MEDICATIONS COPAXONE CORLANOR COMETRIQ CRESEMBA CYRAMZA CYSTADANE DALIRESP DESMOPRESSIN DIABETIC TEST STRIPS DICLEGIS DUOPA ELAPRASE ELELYSO ELIQUIS ELOCTATE ENBREL ENTERAL NUTRITION ENTRESTO

3 ENTYVIO EPOPROSTENOL ERBITUX ERIVEDGE ERWINAZE, ONCASPAR EXJADE, JADENU EXTAVIA FABRAZYME FARYDAK FERRIPROX FORTEO GAZYVA GILENYA GILFOTRIF GLUCAGON-LIKE PEPTIDE-1 AGONISTS GROWTH HORMONES HARVONI HERCEPTIN HETLIOZ HIZENTRA HUMIRA HYALURONIC ACID DERIVATIVES IBRANCE ICLUSIG ILARIS IMBRUVICA IMATINIB INCRELEX INFERGEN

4 INLYTA INTRAVITREAL ANTI-VEGF THERAPY INTRON-A INVEGA SUSTENNA INVEGA TRINZA INVOKANA & INVOKAMET IMMUNE GLOBULIN ILUVIEN IRESSA JAKAFI JEVTANA KADCYLA KALBITOR KALYDECO KEYTRUDA KINERET KRYSTEXXA KUVAN KYNAMRO LEMTRADA LENVIMA LETAIRIS LEUKINE LEUKOTRIENE MODIFIERS LEUPROLIDE LIDOCAINE PATCH LONSURF LYNPARZA LYRICA

5 MAKENA MEKINIST MOZOBIL MYELOID GROWTH FACTORS NAGLAZYME NATPARA NEXAVAR NUEDEXTA OCTREOTIDE ODOMZO ONFI OPDIVO OPIOID QUANTITY ABOVE 120 MORPHINE EQUIVALENT DOSE (MED) ORAL-INTRANASAL FENTANYL ORENCIA ORENITRAM ORFADIN ORKAMBI OTEZLA OZURDEX PEGASYS PEGINTRON PERJETA PLEGRIDY POMALYST PROLIA PROMACTA PROVENGE REBIF

6 REMICADE REMODULIN REVATIO REVLIMID RIBAVIRIN RIBAVIRIN INHALATION RITUXAN SABRIL SAMSCA SANDOSTATIN LAR SEROSTIM SIGNIFOR SIGNIFOR LAR SIMPONI SIRTURO SOLIRIS SOVALDI SOMATULINE DEPOT SORIATANE (acitretin) SPRYCEL STELARA STIMULANTS STIVARGA SUTENT SYLVANT SYMLIN SYNAGIS SYNRIBO TAFINLAR

7 TARCEVA TARGRETIN TASIGNA TECFIDERA THALOMID THYMOGLOBULIN TOBRAMYCIN INHALATION TESTOPEL AND TRANSDERMAL TESTOSTERONE TRACLEER TREANDA TRELSTAR TYKERB TYSABRI TYVASO UNITUXIN VAGINAL PROGESTERONE VALCHLOR VARIZIG VECTIBIX VELCADE VENTAVIS VFEND VIBATIV VIDAZA VIMIZIM VIVITROL VOTRIENT VPRIV XALKORI

8 XELJANZ XENAZINE XEOMIN and MYOBLOC XGEVA XIFAXAN XOFIGO XOLAIR XTANDI XYREM YERVOY ZALTRAP ZAVESCA ZELBORAF ZONTIVITY ZORBTIVE ZYDELIG ZYKADIA ZYTIGA

9 ACTEMRA Affected Medications: ACTEMRA (tocilizumab) Effective Date: 01/01/2015 Last Review Date: 04/08/2015 Covered Uses: Required Medical All FDA-approved indications not otherwise excluded by plan design. Documentation of complete & current treatment course required. Rheumatoid Arthritis: laboratory test confirming diagnosis of RA (anti-ccp, RF) Documented latent TB screening with either a TB skin test or an interferon gamma release assay (e.g, QFT-GIT, T-SPOT.TB) with a negative result. Must be receiving or have completed treatment for positive latent TB prior to initiation. Negative HBV or treat prior to therapy with positive results Patient weight Regimen & Other Rheumatoid arthritis Has failed individually both: 12 weeks on Humira AND 12 weeks Enbrel QL 40 ml IV per 28 day supply QL 3.6 ml SQ per 28 day supply Exclusion Age Restriction: Polyarticular juvenile idiopathic arthritis Has failed individually both: 12 weeks on Humira AND 12 weeks Enbrel QL 12 mg/kg IV once per 14 day supply Systemic juvenile idiopathic arthritis Has failed individually both: 12 weeks on Humira AND 12 weeks Enbrel QL 12 mg/kg IV once per 14 day supply Subsequent approval: documentation of treatment success ANC < 2,000/mm 3, platelets < 100,000/mm 3, or ALT or AST 1.5 times above the upper limit of normal History of GI perforation or diverticulitis Prior intolerance or allergic reaction to Actemra Concurrent use of biologic DMARDs such as Orencia (abatacept), Rituxan (rituximab), Humira (adalimumab), Remicade (infliximab), Cimzia (certolizumab), Simponi (golimumab), Kineret (anakinra), Xeljanz (tofacitinib) HZV, positive tuberculosis, HBV Severely uncontrolled hyperlipidemia Rheumatoid arthritis: 18 years of age Polyarticular JIA or systemic JIA: Ages 2 to 16 years Prescribed by or in consultation with a rheumatologist 9

10 Coverage Duration: Approve 12 months unless otherwise specified 10

11 ABILIFY MAINTENA Affected Medications: ABILIFY MAINTENA (aripiprazole suspension, reconstituted) (J0401) (**Medical benefit only) Effective Date: 01/01/2014 Last Review Date: 02/12/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Diagnosis of schizophrenia and on maintenance treatment AND The patient has a history of non-compliance and/or refuses to utilize oral medication AND The patient has received at least ONE of the following: Oral apiprazole (Abilify) Previous use of Abilify Maintena or Abilify Solution Exclusion Diagnosis of dementia-related psychosis Prior use of aripiprazole demonstrated a hypersensitivity reaction. Psychiatrist or receiving input from a psychiatry practice Coverage Duration: Approval: 12 months, unless otherwise specified 11

12 ACTIMMUNE Affected Medications: ACTIMMUNE (Interferon Gamma 1 b) Effective Date: 01/01/2014 Last Review Date: 02/12/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. FDA approved indication must be documented in the member's chart notes within the most recent 12 months Patient's BSA must be documented along with the prescribed dose. Recent CBC with differential and platelet counts, liver function test Chronic granulomatous disease Patient is on prophylaxis regimine: antibacterial and antifungal Exclusion Coverage under Part D will be denied if coverage is available under Part A or Part B as the medication is prescribed and dispensed or administered for the individual. Labs outside of normal limits must have documentation of benefit of thearpy outweighing risk (bone marrow toxicity and hepatotoxicity) Chronic granulomatous disease: prescribed by or in consultation with a rheumatologist or an infectious disease specialist Severe, malignant osteopetrosis: prescribed by or in consultation with an oncologist Coverage Duration: Approval = 12 months, unless otherwise specified. 12

13 ADAGEN Affected Medications: ADAGEN (pegademase bovine) (J2504) Effective Date: 09/01/2014 Last Review Date: 07/08/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Diagnosis of combined immunodeficiency disease (SCID) with a deficiency of adenosine deaminase (ADA) Documentation of trial and failure or unsuitable for bone marrow transplantation Children and infants may receive therapy at time of diagnosis Documentation of appropriate treatment regimen for disease management as indicated (e.g., antibiotics, nutrition, oxygen, etc) Dose: Every 7 days maximum 30 U/kg per dose Reauthorization requires documentation of treatment success and ADA levels regularly monitored within normal levels Exclusion Not approved as preparatory or support therapy for bone marrow transplantation Not approved if diagnosis with severe thrombocytopenia (caution with mild moderate) Coverage Duration: Initial approval: 3 months Reauthorization: 12 months 13

14 ADCETRIS Affected Medications: ADCETRIS (brentuximab vodotin) (J9042) Effective Date: 01/01/2015 Last Review Date: 10/14/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design NCCN indications with evidence level of 2 or higher Documentation of disease staging, all prior therapies used, and anticipated treatment course AND Recent complete blood count (CBC) Systemic Anaplastic Large Cell Lymphoma (excluding cutaneous ALCL) Documentation of failure of at least one prior multi-agent chemotherapy regimen and for CD 30+ peripheral T-cell lymphoma Hodgkin Lymphoma Documentation of failure of autologous stem cell transplant (ASCT) OR Documentation of failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates Documentation of avoidance or appropriate dose monitoring with concomitant CYP3A4 inhibitors (ex. ketoconazole), inducers (ex. rifampin), P-gp inhibitors Documentation of CBC that are within normal limits Reauthorization: documentation of disease responsiveness to therapy Exclusion Concomitant use with bleomycin Creatinine Clearance of less than 30 ml/min Moderate to severe hepatic impairment (Child-Pugh B & C) Coverage Duration: Initial approval: 3 months, unless otherwise specified Reauthorization: 12 months, unless otherwise specified 14

15 ADCIRCA Affected Medications: ADCIRCA (tadalafil) Effective Date: 01/01/2014 Last Review Date: 02/11/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. NYHA/WHO Functional Class II or III symptoms Pulmonary arterial hypertension (PAH) (WHO Group 1) confirmed by right heart catheterization OR by Doppler echocardiography Etiology of PAH (idiopathic, heritable, or associated with connective tissue disease) For new starts only: patient has had an inadequate response or intolerance to sildenafil citrate tablets (Revatio) Subsequent approvals require documentation of treatment success such as improved walking distance or improvements in functional class. Exclusion Patient requires nitrate therapy on a regular or intermittent basis. Coverage Duration: Approval = 12 months, unless otherwise specified. 15

16 ADEMPAS Affected Medications: ADEMPAS (riociguat) Effective Date: 03/01/2014 Last Review Date: 02/11/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Chronic thromboembolic pulmonary hypertension (CTEPH) WHO Group 4 with documented thromboembolic occlusion of proximal or distal pulmonary vasculature and mean pulmonary arterial pressure of at least 25 mmhg at rest in the absence of elevated pulmonary capillary wedge pressure (i.e. PCWP not more than 15 mmhg) Pulmonary arterial hypertension (PAH) WHO Group 1 confirmed by right heart catheterization Etiology of PAH (idiopathic, heritable, or associated with connective tissue disease) NYHA/WHO Functional Class II to III symptoms CTEPH Documentation of failure of or inability to receive pulmonary endarterectomy surgery Current therapy with anticoagulants PAH The following supportive care should be considered: anticoagulants, diuretics oxygen, digoxin Failure/Contraindication to the following therapy classes: PDE5 inhibitors AND endothelin receptor antagonists Subsequent approval requires documentation of treatment success as described by: Exercise endurance Echocardiographic testing Hemodynamic testing BNP, functional class Exclusion Pregnancy Creatinine clearance 15 ml/min Severe hepatic impairment Concomitant use with nitrates (such as amyl nitrite) Concomitant use with PDE inhibitors (such as sidenafil, tadalafil, or vardenafil) 18 years or older Prescribed by or in consultation with a Cardiologist or a Pulmonologist 16

17 Coverage Duration: Initial approval = 3 months unless otherwise specified Subsequent approval = 12 months unless otherwise specified 17

18 AFINITOR Affected Medications: AFINITOR (everolimus) Effective Date: 10/15/2015 Last Review Date: 05/13/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. NCCN indications with evidence level of 2A or higher. Documentation of performance status, all prior therapies used, and prescribed treatment regimen Documentation that Afinitor is being used as a NCCN 2A level of evidence regimen Documentation of medication review and / or avoidance with strong CYP3A4 inhibitors, CYP3A4 induces, PgP inhibitors Exclusion Hypersensitivity to rapamycin derivatives Karnofsky Performance Status 50% or ECOG performance score 3 Oncologist Coverage Duration: Initial approval: 3 months Reauthorization: 12 months 18

19 ALDURAZYME Affected Medications: ALDURAZYME (laronidase) Effective Date: 09/01/2014 Last Review Date: 07/08/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Exclusion Diagnosis of MPS I Diagnosis confirmed by either an enzyme assay showing deficiency of alpha-liduronidase enzyme activity or by DNA testing If the patient has Scheie syndrome, the patient has moderate-to-severe disease In case of anaphylaxis or severe allergic reaction, there will be appropriate medical support readily available when Aldurazyme is administered Coverage Duration: Initial approval = 3 months, unless otherwise specified Subsequent approval = 12 months, unless otherwise specified 19

20 ALFERON-N Affected Medications: ALFERON-N (interferon alfa-n3) (J9215) Effective Date: 01/01/2014 Last Review Date: 03/12/2014 Covered Uses: Condylomata acuminate (genital warts) Referral for Alferon N Diagnosis of Condylomata acuminate Failed at least one of the following conventional therapies: podofilox, imiquimod, sinecatechins, podophyllin or podophyllum resin, trichloroacetic acid, bichloroacetic acid, cryotherapy, surgery Exclusion Known anaphylactic sensitivity to mouse immunoglobulin, egg protein, or neomycin Age 18 years Coverage Duration: Approval = 4 months 20

21 ALGLUCOSIDASE ALFA Affected Medications: LUMIZYME (alglucosidase alfa), MYOZYME (alglucosidase alfa) (J0220, J0221, J1458) Effective Date: 01/01/2014 Last Review Date: 07/08/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Exclusion 8 years of age Diagnosis of Pompe disease was confirmed by an enzyme assay demonstrating a deficiency of GAA enzyme activity or by DNA testing that identifies mutations in the GAA gene. Lumizyme: patient has late-onset (non-infantile) Pompe disease with no evidence of cardiac hypertrophy. Myozyme: patient has infantile-onset Pompe disease medical support is readily available when Lumizyme is administered in the event of anaphylaxis, severe allergic reaction, or acute cardiorespiratory failure. Coverage Duration: Approval = 12 months, unless otherwise specified. 21

22 ALIMTA Affected Medications: ALIMTA (pemetrexed disodium) (J9305) Effective Date: 01/01/2015 Last Review Date: 10/14/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2A or higher Documentation of performance status, disease staging, all prior therapies used, and prescribed treatment regimen Documentation of one of the following: Malignant pleural mesothelioma Non-squamous, Non-Small Cell Lung Cancer Epithelial Ovarian cancer / Fallopian tube Cancer / Primary Peritoneal Cancer- Single agent therapy for persistent disease or recurrence Cervical cancer - second line therapy as a single agent for metastatic disease Bladder cancer - second-line therapy as a single agent for metastatic disease Malignant neoplasm of renal pelvis or ureter - second-line therapy as a single agent for metastatic disease Malignant neoplasm of the prostatic urethra - second line therapy as a single agent for metastatic disease Thymic malignancies - second line therapy as a single agent Primary CNS Lymphoma - progression after Methotrexate or radiation therapy Ensure appropriate supplementation with folic acid and IM vitamin B12 Reauthorization requires documentation of disease responsiveness to therapy Exclusion Consider holding therapy if Karnofsky Performance Status 50% or ECOG performance score 3 Coverage Duration: Initial approval: 3 months unless otherwise specified Reauthorization: 12 months unless otherwise specified 22

23 ALPHA-1 PROTEINASE INHIBITORS Affected Medications: ARALAST NP, GLASSIA, PROLASTIN-C, ZEMAIRA (J0256, J0257) Effective Date: 01/01/2014 Last Review Date: 09/23/2012 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Exclusion Alpha-1 antitrypsin (AAT) deficiency-associated panniculitis. For AAT deficiency with emphysema (or COPD), approve in patients with baseline (pretreatment) alpha1-antitrypsin serum concentration 11 microm (11 micromol/l) or 80 mg/dl AND FEV1 65% OR FEV1 reduction of 120mL/year For all covered uses, the patient is required to try Aralast NP first line. Use in the management of cystic fibrosis, COPD without alpha1-antitrypsin deficiency, alpha1-antitrypsin deficiency without lung disease (even if deficiency-induced hepatic disease is present), OR bronchiectasis (without alpha1-antitrypsin deficiency), patients with IgA deficiency ( 15mg/dL) or IgA antibody deficiency Coverage Duration: Approval = 12 months, unless otherwise specified. 23

24 ALPROLIX Affected Medications: ALPROLIX (Coagulation factor IX (recombinant),fc Fusion Protein)(J7199) Effective Date: 10/08/2014 Last Review Date: 10/08/2014 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Hemophilia B Primary Prophylaxis Factor IX levels <1% of normal (age 2+) Circulating factor IX activity required (% of normal or [units/dl]) Hemophilia B Secondary Prophylaxis History of intracranial hemorrhage Factor Levels <1% and one or more joint bleeds Circulating factor IX activity required (% of normal or [units/dl]) Hemophilia B - Perioperative management For minor and major non-elective surgical procedures Factor IX levels <1% of normal (age 2+) Circulating factor IX activity required (% of normal or [units/dl]) Primary and Secondary Prophylaxis: All trough level monitoring must be recorded in chart notes Perioperative management in patients with hemophilia B Must use or have contraindication to Rixibus Exclusion History of anaphylaxis, or severe hypersensitivity to any component of the chosen concentrate Acute thrombosis, embolism or symptoms of DIC Hematologist Coverage Duration: Primary and Secondary Prophylaxis Approval = 12 months, unless otherwise specified Perioperative management = 1 month, unless otherwise specified 24

25 AMPYRA Affected Medications: AMPYRA (dalfampridine) Effective Date: 01/01/2014 Last Review Date: 04/03/2015 Covered Uses: All FDA approved indications not otherwise excluded from plan design. Exclusion Documentation of dosing and patient renal function (height / weight and serum creatinine OR egfr OR CrCl). If dosage > 20mg per day, then documentation supporting using greater than maximum recommended FDA dose. For initial approval for MS: Authorize for 90 days After up to 90 days of dalfampridine extended release therapy, if MS patient has had a response to therapy as determined by prescribing physician (eg, increased walking distance, improved leg/limb strength, improvement in activities of daily living), then an additional authorization is allowed. History of seizures Dose > 10 mg twice daily OR Creatinine clearance 50 ml/min. Coverage Duration: Prescribed by or after consultation with a neurologist or an MS specialist. Initial approval: 3 months Reauthorization: 12 months, based on treatment response 25

26 ANTIHEMOPHILIC FACTORS Affected Medications: Advate, Corifact, Helixate FS, Hemofil M, Kogenate FS, Konyne-80, Monoclate-P, Recombinate, Xyntha, Hemofil M, Benefix, Alphanine SD, Mononine, Novoseven RT,NovoEight, Koate DVI, Alphanate, Humate P, Wilate, Feiba NF, Alprolix, Eloctate, Obizur, Tretten (J7180-J7199) Effective Date: 06/08/2015 Last Review Date: 05/12/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. For NovoEight: Must have documentation of failure or contraindication to Advate or Hemofil. Documentation of dose, diagnosis, and rationale for use AND Documentation of rationale for dosing based on reasonable projections of the patients current utilization and the recommended packaging instructions OR Documentation of treatment of acute bleeding in patients with severe hemophilia, and maintenance therapy as needed to maintain factor levels greater than 1% of normal OR Documentation of treatment and management of acute bleeding episodes in patients with mild hemophilia (factor levels greater than 5 and less than 30%) OR actual levels for mild hemophilia is 5-49% Moderate hemophilia (factor levels 1% to 5%) OR Documentation of the management of acute bleeding in clinical situations in patients with von Willebrands disease that are at an increased risk of bleeding. Reauthorization requires documentation of past treatment history and titer inhibitor level to factor VIII, and IX. Exclusion Obizur will not be approved for the treatment of congenital hemophilia A or von Willebrands disease. History of anaphylaxis or severe hypersensitivity to any component of the chosen agent. Tretten will not be approved for the diagnosis of congenital factor XIII B-subunit deficiency. Acute thrombosis, embolism or symptoms of DIC. Coverage Duration: Initial approval= 3 months Reauthorization= 12 months, unless otherwise specified. Approval based on necessity and laboratory titer levels. 26

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28 ARCALYST Affected Medications: ARCALYST (Rilonacept) (J2793) Effective Date: 04/01/2014 Last Review Date: 02/12/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Patient has a diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) Patient has failed or has contrainidcations to Anakinra Negative TB test prior to initiation Exclusion Active or chronic infection, concurrent therapy with other biologics TB latent or active 12 years of age and older Prescribed by or in consultation with a rheumatologist Coverage Duration: Intial approval = 3 months Additional approvals require documentation of treatment success = 12 months, unless otherwise noted. 28

29 ARZERRA Affected Medications: ARZERRA (Ofatumumab)(J9302) Effective Date: 09/01/2014 Last Review Date: 02/17/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design NCCN indications with evidence level of 2A or higher Documentation of disease staging and all prior therapies used Hepatitis B screening If hepatitis B positive, documentation of consultation with physician with expertise in management (examples: GI, ID, or hepatologist) Chronic Lymphocytic Leukemia (CLL) First-line treatment in combination with chlorambucil if fludarabin-based therapy is medically inappropriate OR Documentation of relapsed CLL use as single agent Lymphoplasmacytic lymphoma or Waldenstrom s Macroglobulinemia Documentation of rituximab intolerance and disease progression/relapse on primary therapy Use as single agent Reauthorization requires documentation of disease responsiveness to therapy Maximum duration: 12 cycles Exclusion Karnofsky Performance Status 50% or ECOG performance score 3 Oncologist Coverage Duration: Initial approval: 3 months, unless otherwise specified Reauthorization: 9 months, unless otherwise specified 29

30 AUBAGIO Affected Medications: AUBAGIO (Teriflunomide) Effective Date: 06/01/2013 Last Review Date: 05/13/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Has relapsing form of MS (eg. Relapsing-remitted MS, Progressive-relapsing MS, or secondary progressive MS with relapses) Transaminase, bilirubin, and CBC within 6 mo before initiation of Aubagio. Transaminase levels at least monthly for 6 mo thereafter. For use in MS, patient has a relapsing form of MS and patient has failed at least one preferred product (Avonex, Copaxone, Extavia, Gilenya, Tecfidera) Exclusion Patients with known liver disease should not begin treatment with teriflunomide. Concurrent use of Avonex, Betaseron, Extavia, Rebif, Copaxone,mitoxantrone, Tysabri, or fingolimod (Gilenya). Prescribed by or after consultation with a neurologist or an MS specialist. Coverage Duration: Approval = 12 months, unless otherwise specified. 30

31 AVASTIN Affected Medications: AVASTIN (bevacizumab) (J9035) Effective Date: 01/01/2015 Last Review Date: 10/14/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2 or higher Exclusion Coverage Duration: Documentation of disease staging, all prior therapies used, and anticipated treatment course AND As indicated per NCCN, documentation of performance status 0-1 AND If patient is at risk of thrombocytopenia: Documentation that risks (DVT, intraabdominal thrombosis, gastrointestinal perforations, hemorrhage) have been reviewed and that benefit of therapy outweighs risks Reauthorization: documentation of disease responsiveness to therapy Initial approval: 3 months, unless otherwise specified Reauthorization: 12 months, unless otherwise specified 31

32 AVONEX Affected Medications: AVONEX (Interferon beta-1a) Effective Date: 01/01/2014 Last Review Date: 04/08/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Has relapsing form of MS (eg. relapsing-remitting MS, progressive-relapsing MS, or secondary progressive MS with relapses) OR First clinical episode of MS with MRI scan that demonstrated features consistent with a diagnosis of MS (i.e., multifocal white matter disease). Exclusion Titrate weekly to recommended dose of 30 mcg once weekly. Concurrent use of any of the following medications: interferon-beta therapy (Betaseron, Extavia, or Rebif), Copaxone, mitoxantrone, Tysabri, or fingolimod (Gilenya). Neurologist Coverage Duration: Approval = 12 months, unless otherwise specified. 32

33 AVYCAZ Affected Medications: AVYCAZ (ceftazidime/avibactam sodium) Effective Date: 07/08/2015 Last Review Date: 06/10/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. Complicated Intra-Abdominal Infections: Proven or strongly suspected to be caused by susceptible microorganisms: Enterobacter cloacae Escherichia coli Klebsiella oxytoca, Klebsiella pneumoniae Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Complicated Urinary Tract Infections or Pyelonephritis Proven or strongly suspected to be caused by susceptible microorganisms: Citrobacter freundii, Citrobacter koseri Enterobacter aerogenes, Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus spp. Pseudomonas aeruginosa Proven to be caused by susceptible microorganisms not listed above Complicated Intra-Abdominal Infections: To be used in combination with metronidazole Complicated Urinary Tract Infections or Pyelonephritis Used as monotherapy Exclusion Reserve for use in patients who have limited or no alternative treatment options Coverage Duration: 1 month 33

34 BANZEL Affected Medications: BANZEL (rufinamide) Effective Date: 04/08/2015 Last Review Date: 04/08/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. Diagnosis regimen Exclusion Neurologist or affiliated with a neurology practice Coverage Duration: Approval = 12 months, unless otherwise specified. 34

35 BELEODAQ Affected Medications: BELEODAQ (belinostat)(j9999) Effective Date: 09/01/2014 Last Review Date: 10/14/2015 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Diagnosis of relapsed or refractory peripheral T-cell lymphoma (PTCL) Prior therapies tried and failed CBC with differential, creatinine clearance (CrCl), liver function tests Documentation of UGT1A1*28 allele status Karnofsky Performance Status OR ECOG performance status Disease progression on two or more of the following equal placement therapies per NCCN guidelines (DHAP, ESHAP, GDP, GemOx, ICE, MINE, EPOCH, Gemcitabine) OR significant clinical contraindication to all equal placement therapies Documentation of trial/failure/contraindication of transplant therapy Documentation of benefit outweighing risk for CrCl less than 40 ml/min OR total bilirubin 1.5 times upper normal limit dose reduction based on absolute neutrophil count (ANC) OR homozygous UGT1a1*28 allele Reauthorization: documentation of disease responsiveness to therapy Documentation of ECOG performance status of 1 or 2 OR Karnofsky performance score greater than 50% Exclusion Age 18 years Coverage Duration: Prescribed by an Oncologist Approval = 3 months, unless otherwise specified. 35

36 BENLYSTA Affected Medications: Benlysta (Belimumab) (J0490) Effective Date: 01/01/2012 Last Review Date: 07/13/2011 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Active, autoantibody-positive Negative, baseline testing: Hepatitis B Heptatitis C PPD Initial approval requires documented failure, intolerance, or clinical rationale for avoidance to ALL of the following: Corticosteroids Immunosuppressants Antimalarials NSAIDs DMARDs Authorization will only be granted when used in an FDA approved or NCCN guideline supported regimen. Exclusion Patients on other biologic therapy or IV cyclophosphamide for SLE Patients with severe active lupus nephritis or severe active central nervous system lupus Adults 18 years of age Rheumatologists Coverage Duration: Authorization will be for 12 months, unless otherwise specified 36

37 BETASERON Affected Medications: BETASERON (Interferon beta-1b) Effective Date: 01/01/2014 Last Review Date: 04/11/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Has relapsing form of MS (eg. relapsing-remitting MS, progressive-relapsing MS, or secondary progressive MS with relapses) OR First clinical episode of MS with MRI scan that demonstrated features consistent with a diagnosis of MS (i.e., multifocal white matter disease). CBC, BMP testing one, three, and six months following introduction of Betaseron therapy and then periodically thereafter. Must fail at least one preferred product (Avonex, Copaxone, Extavia, Gilenya, Tecfidera) Exclusion Concurrent use of any of the following medications: interferon-beta therapy (Avonex, Extavia, or Rebif), Copaxone, mitoxantrone, Tysabri, or fingolimod (Gilenya). Prescribed by or after consultation with a neurologist or an MS specialist. Coverage Duration: Approval = 12 months, unless otherwise specified. 37

38 BLINCYTO Affected Medications: BLINCYTO (blinatumomab)(j9999,c9399) Effective Date: 02/11/2015 Last Review Date: 02/11/2015 Covered Uses: All FDA approved indications not otherwise excluded by plan design. Exclusion Documentation of disease staging, all prior therapies used, and anticipated treatment course AND Documentation of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia AND Philadelphia chromosome status AND Documentation of progression on 2 or more prior therapies AND Documentation that Black Box Warnings (cytokine release syndrome and neurological toxicities) have been fully reviewed and patient understands and accepts risks AND Documentation of ECOG performance status of 1 or 2 OR Karnofsky performance score greater than 50% Blincyto should permanently be discontinued for the following adverse reactions: grade 4 cytokine release syndrome, grade 4 neurological toxicity, or two Blincyto induced seizures Reauthorization: documentation of successful disease consolidation Maximum approval: 5 cycles Oncologist Coverage Duration: Initial approval: 3 months, unless otherwise specified Reauthorization: 5 months, unless otherwise specified 38

39 BOSULIF Affected Medications: BOSULIF (bosutinib) Effective Date: 10/15/2015 Last Review Date: 05/13/2015 Covered Uses: All FDA approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2A or higher. Documentation of performance status, all prior therapies used, and prescribed treatment regimen Documentation that Bosulif is being used as a NCCN 2A level of evidence regimen If applicable, test results demonstrating Philadelphia chromosome-positive status If applicable, BCR-ABL1 transcript levels Should not be used in combination with strong or moderate CYP3A4 or Pgp inducers or inhibitors Reauthorization requires documentation of treatment success (based on applicable markers examples BCR-ABL1 transcript levels, cytogenetic response, molecular relapse) Exclusion Karnofsky Performance Status 50% or ECOG performance score 3 Oncologist Coverage Duration: Initial approval: 3 months, unless otherwise stated Reauthorization: 12 months, unless otherwise stated 39

40 BOTOX Affected Medications: BOTOX (onabotulinumtoxina)(j0585) Effective Date: 09/01/2014 Last Review Date: 03/11/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Pertinent medical records and diagnostic testing Complete description of the site(s) of injection Strength and dosage of botulinum toxin used Prior therapies tried/failed for indicated diagnosis Approved first-line for: focal dystonia, hemifacial spasm, orofacial dyskinesia, blepharospasm, laryngeal spasm or dysphonia, upper limb spasticity or other conditions of central focal spasticity botulinum toxin is the preferred mode of therapy. Overactive Bladder (OAB): Inadequate response or intolerance to at least 2 anticholinergic medications Urinary incontinence associated with neurologic condition: Documentation of neurologic condition (e.g. spinal cord injury, multiple sclerosis) AND inadequate response or intolerance to at least 2 anticholinergic medications. Chronic migraine: Documentation of symptoms greater than 15 days per month with headache lasting at least 4 hours/day AND inadequate response (8 week trial) or intolerance to at least 2 oral migraine prophylactic treatments (beta blocker, anticonvulsant, tricyclic antidepressant, etc.) Achalasia and cardiospasm (must meet 1 of the following): o Failed conventional therapy, myotomy, or dilatation o high risk of complications from pneumatic dilation or surgical myotomy o Epiphrenic diverticulum or hiatal hernia Number of treatments must not exceed the following: OAB: 2 treatments/12 months Urinary incontinence associated with neurologic condition: 1 treatment/12 months Chronic migraine: initial approval 2 treatments/6 months, subsequent treatment approvals 4 treatments/12 months All other indications maximum of 4 treatments/12 months unless otherwise specified Reauthorization: Documentation of improvement and clinically significant response to therapy; Chronic migraine continuation of treatment: minimum 50% reduction in headache frequency and/or 15% decrease in number of migraines per month after initial injection(s) Exclusion Cosmetic procedures 40

41 For intradetrusor injections: documented current/recent urinary tract infection or urinary retention Current aminoglycoside use (or current use of other agents interfering with neuromuscular transmission) Coverage Duration: Blepharospasm, strabismus: ophthalmologist or optometrist Chronic migraine: neurologist or HEENT specialist OAB or urinary incontinence due to neurologic condition: urologist or neurologist Documentation of consultation with any of the above specialists mentioned Chronic migraine: Initial approval: 6 months Reauthorization: 12 months, unless otherwise specified All other indications Approval 12 months, unless otherwise specified 41

42 BUPHENYL Affected Medications: BUPHENYL (sodium phenylbutyrate) Effective Date: 09/01/2014 Last Review Date: 7/09/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design Exclusion Coverage Duration: Diagnosis of Urea Cycle Disorder (UCD) Diagnosis confirmed by enzymatic, biochemical, or genetic testing The prescribed medication will be used for chronic management of UCD The patient has UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone The prescribed medication will be used in combination with dietary protein restriction. Initial approval = 2 weeks Subsequent approval = 3 months, unless otherwise specified. Subsequent approval = 12 months, unless otherwise specified. 42

43 CALPRESA Affected Medications: CALPRESA (vandetanib) Effective Date: 06/08/2015 Last Review Date: 05/08/2015 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2A or higher Documentation of performance status, disease staging, all prior therapies used, and prescribed treatment regimen Documentation that Caprelsa is being used as a NCCN 2A level of evidence regimen Avoid administration with anti-arrhythmic drugs and strong CYP3A4 inducers Reauthorization requires documentation of treatment success Exclusion Congenital long QT syndrome Karnofsky Performance Status 50% or ECOG performance score 3 Oncologist Coverage Duration: Initial approval: 3 months Reauthorization: 12 months 43

44 C1 INHIBITOR Affected Medications: BERINERT, CINRYZE, RUCONEST (J0597, J0598, J3590), FIRAZYR *COVERED UNDER MEDICAL BENEFITS ONLY (J1744) Effective Date: 01/01/2015 Last Review Date: 12/10/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. FDA approved Indication must be documented in the member s chart notes within the most recent 6 months. Documentation of complete & current treatment course required. Number of HAE attacks per month must be 2. Laboratory confirmation of diagnosis: (the following levels must be documented) C4 antigenic level C1-inhibitor antigenic level C1-inhibitior functional level Initial approval : Requires documented failure, intolerance, or clinical rationale for avoidance to the following: Androgens: danazol, stanozolol, oxandrolone, oxymetholone, tibolone, or methyltestosterone. Subsequent approval: Requires documentation of treatment success. Exclusion Coverage Duration: Initial approvals = 3 months. Must be prescribed by, or in consultation with, an Allergist/Immunologist or a physician that specializes in the treatment of HAE or related disorders. Subsequent approvals = 12 months, unless otherwise specified 44

45 CARBAGLU Affected Medications: CARBAGLU (carblumic acid) Effective Date: 09/01/2014 Last Review Date: 06/10/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Diagnosis of N-acetyl glutamate synthase (NAGS) deficiency with hyperammonemia (plasma ammonia levels > 70 mcg/dl) For patients with acute hyperammonemia, Carbaglu should always be used in combination with other methods to lowering plasma ammonia levels such as hemodialysis, other pharmacologic therapy (Sodium phenylacetate and sodium benzoate), and dietary protein restriction. Exclusion Carbaglu should not be used to treat hyperammonemia due to disorders other than urea cycle disorder (UCD) specifically caused by NAGS dificency Carbaglu should not be used in patients with UCD caused by other enzyme deficiencies that lead to hyperammonemia. This includes: Carbamyl phosphate synthetase I (CPSI) deficiency Ornithine transcarbamylase (OTC) deficiency Argininosuccinate synthetase (ASS) deficiency Argininosuccinate lyase (ASL) deficiency Arginase deficiency Carbaglu treatment should be initiated by a physician experienced in the treatment of metabolic disorders. Coverage Duration: 12 months, unless otherwise specified 45

46 CAYSTON Affected Medications: CAYSTON (aztreonam inhalation) Effective Date: 09/15/2015 Last Review Date: 08/12/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Diagnosis of cystic fibrosis Culture and sensitivity report confirming presence of pseudomonas aeruginosa in the lungs Baseline FEV1 greater than 25% but less than 75% predicted Documented failure, contraindication, or resistance to inhaled tobramycin Anticipated treatment duration Reauthorization requires documentation of improved respiratory symptoms including improved FEV1, reduced bacterial density in sputum, and need for long-term use such as history of frequent exacerbations resulting in hospitalizations due to pseudomonas aeruginosa infection Exclusion Baseline FEV1 less than 25% or greater than 75% predicted Age 6 years or older Coverage Duration: Initial approval: 1 month Reauthorization: 12 months, unless otherwise specified 46

47 CERDELGA Affected Medications: CERDELGA (eliglustat) Effective Date: 02/08/2015 Last Review Date: 07/08/2015 Covered Uses: All FDA approved indications not otherwise excluded. FDA approved diagnosis must be documented in the member s chart notes within the past 6 months. Documentation of complete and current treatment course required. Enzyme Assay documenting Gaucher Disease Documentation of CY2D6 Genotype by a FDA approved test Initial approval requires documentation of failure, intolerance, or clinical rationale for the avoidance of combination therapy with Cerezyme, and failure with Cerezyme monotherapy. For patients that are extensive or immediate metabolizers of CYP2D6: Cerdelga 84 mg twice daily will be approved for the treatment of Gaucher disease. For patients that are poor metabolizers of CYP2D6: Cerdelga 84 mg daily will be approved for the treatment of Gaucher disease. Further approval requires documentation of treatment success. Exclusion Patient must not be a CYP2D6 ultra-rapid metabolizer, OR an indeterminate metabolizer. Patients on concomitant medication that inhibit CYP2D6 and CYP3A4 isoenzymes. Pre-existing Cardiac disease (CHF, MI, Bradycardia, heart block, arrhythmias, and long QT syndrome). with Class 1A (quinidine, procainaminde) and Class III (amiodarone, sotalol) antiarrhythmic medications. Presence of moderate to severe renal impairment or end stage renal disease. Patient must be 18 years of age or older Metabolic disease specialist Coverage Duration: Initial approval will be for 12 months. 47

48 CEREZYME Affected Medications: CEREZYME (imiglucerase) Effective Date: 09/01/2014 Last Review Date: 07/08/2014 Covered Uses: All FDA approved indications not otherwise excluded by plan design. Diagnosis of Type 1 Gaucher disease that has resulted in 1 or more of the following conditions: anemia, bone disease, hepatomegaly or splenomegaly, and thrombocytopenia Exclusion Coverage Duration: Initial approval 3 months, unless otherwise specified Subsequent approval 12 months unless otherwise specified 48

49 CHOLBAM Affected Medications: CHOLBAM (cholic acid) Effective Date: 07/08/2015 Last Review Date: 06/10/2015 Covered Uses: All FDA approved indications not otherwise excluded by plan design. Required Patient weight Medical Baseline liver function tests (AST, ALT, GGT, ALP, total bilirubin, INR) Diagnosis confirmed by assessment of serum or urinary bile acid levels using mass spectrometry (Fast Atom Bombardment ionization - Mass Spectrometry (FAB-MS) analysis) Dose: 10 to 15 mg/kg orally once daily, or in two divided doses Dose if concomitant familial hypertriglyceridemia: 11 to 17 mg/kg orally once daily, or in Regimen & two divided doses Other Reauthorization requires documentation of clinically significant improvement in liver function as determined by meeting TWO of the following criteria: ALT or AST values reduced to less than 50 U/L, or baseline levels reduced by 80%; total bilirubin values reduced to less than or equal to 1 mg/dl; no evidence of cholestasis on liver biopsy; body weight increased by 10% or stable at greater than the 50 th percentile should be discontinued if liver function does not improve after 3 months of start of treatment Exclusion of extrahepatic manifestations (such as neurologic symptoms) of bile acid synthesis disorders due to single enzyme defects or peroxisomal disorders including Zellweger spectrum disorders 3 weeks and older Prescribed by or in consultation with hepatologist or gastroenterologist Coverage Initial: 3 months Duration: Reauthorization: 12 months 49

50 CIMZIA Affected Medications: CIMZIA (certolizumab) (J0717) Effective Date: 12/10/2014 Last Review Date: 12/10/2014 Covered Uses: All FDA-approved indications not otherwise excluded by plan design. Indication must be documented in chart notes within the last 6 months Documentation of complete and current treatment course Rheumatoid Arthritis: laboratory test confirming diagnosis of RA (anti-ccp, RF) Documented latent TB screening with either a TB skin test or an interferon gamma release assay (e.g, QFT-GIT, T-SPOT.TB) with a negative result. Must be receiving or have completed treatment for latent TB prior to initiation. Negative HBV or treat prior to therapy with positive results Rheumatoid Arthritis (RA) Has failed 12 weeks on Humira AND 12 weeks Enbrel QL Initial (one time only) 6 ml per 28 day supply QL Continuation 2 ml per 28 day supply Psoriatic Arthritis (PsA) Has failed 12 weeks on Humira AND 12 weeks Enbrel QL Initial (one time only) 6 ml per 28 day supply QL Continuation 2 ml per 28 day supply Ankylosing Spondylitis (AS) Has failed 12 weeks on Humira AND 12 weeks Enbrel QL Initial (one time only) 6 ml per 28 day supply QL Continuation 2 ml per 28 day supply Crohn s Disease Has failed 12 weeks on Humira QL Initial (one time only) 6 ml per 28 day supply QL Continuation 2 ml per 28 day supply Exclusion Concurrent use of biologic DMARDs: Orencia (abatacept), Rituxan (rituximab), Actemra (tocilizumab), Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra), Simponi (golimumab), Xeljanz (tofacitinib) Positive test for TB; active HZV, HCV, or HBV Use for the management of plaque psoriasis 18 years of age CD: prescribed by or in consultation with a GI specialist RA/PsA/AS: prescribed by or in consultation with a rheumatologist Coverage Duration: Approval for 12 months, unless otherwise specified 50

51 COMPOUNDED MEDICATIONS Affected Medications: ALL COMPOUNDED MEDICATIONS Effective Date: 10/01/2014 Last Review Date: 07/07/2014 Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. All compound ingredients must be submitted on the pharmacy claim Compounded medications will only be payable after ALL commercially available or formulary products have been exhausted. In the case of a payable claim, only compound ingredients that are covered on the applicable formulary will be reimbursed under this policy. Compounds above a certain dollar threshold will be stopped by the claim adjudication system. Exclusion Compounds for experimental or investigational uses will not be covered. Non-FDA approved, compounded medications will not be covered when an FDA approved, commercially available medication is on the market. Coverage Duration: Approval = 3 months, unless otherwise specified. 51

52 COPAXONE Affected Medications: COPAXONE 20mg/mL and 40mg/mL (glatiramer acetate) Effective Date: 01/01/2014 Last Review Date: 02/11/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Relapsing-remitting MS OR First clinical episode of MS with MRI scan that demonstrated features consistent with a diagnosis of MS (i.e., multifocal white matter disease). Exclusion Concurrent use of any of the following medications: interferon-beta therapy (Avonex, Betaseron, Extavia, or Rebif) or mitoxantrone. Prescribed by or after consultation with a Neurologist or MS specialist. Coverage Duration: Approval = 12 months, unless otherwise specified. 52

53 CORLANOR Affected Medications: CORLANOR (ivabradine) Effective Date: 07/08/2015 Last Review Date: 06/10/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Chronic Heart Failure with ejection fraction 35% or less Resting heart rate of at least 70 beats per minute Contraindication to beta-blockers, or on maximum tolerated dose Exclusion Acute, decompensated heart failure Blood pressure less than 90/50 mm Hg Sick sinus syndrome, sinoatrial block, third-degree atrioventricular block (unless stable with demand pacemaker) Severe hepatic impairment Heart rate maintained exclusively by pacemaker Concomitant use with strong CYP3A4 inhibitors Coverage Duration: Initial approval: 12 months, unless otherwise specified Reauthorization: 12 months, unless otherwise specified 53

54 COMETRIQ Affected Medications: COMETRIQ (cabozantinib) Effective Date: 10/14/2015 Last Review Date: 05/08/2015 Covered Uses: All FDA approved indications not otherwise excluded by benefit design. NCCN indications with evidence level of 2A or higher Documentation of performance status, disease staging, all prior therapies used, and prescribed treatment regimen Documentation that Cometriq is being used as a NCCN 2A level of evidence regimen Cometriq should be discontinued with severe hypertension that cannot be controlled with antihypertensive therapy Avoid administration with strong CYP3A4 inducers or inhibitors Reauthorization requires documentation of treatment success Exclusion Congenital long QT syndrome Karnofsky Performance Status 50% or ECOG performance score 3 Oncologist Coverage Duration: Initial approval: 3 months Reauthorization: 12 months 54

55 CRESEMBA Affected Medications: CRESEMBA (isavuconazonium sulfate) Effective Date: 07/08/2015 Last Review Date: 11/11/2015 Covered Uses: All FDA-approved indications not otherwise excluded [from part D] [by plan design]. All FDA, National Coverage Determination, or Local Coverage Determination approved uses not otherwise excluded by Medicare Diagnosis of Invasive Aspergillosis Diagnosis of Invasive Mucormycosis Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. Exclusion Concurrent use of Cresemba and St. John s Wort (Hypericum perforatum) Coverage Duration: Initial approval: 3 months Reauthorization: 3 months 55