Prior Authorization BCBS RI 5-Tier 2013 Last Updated: 09/2013 ABATACEPT Orencia PA Details Age Other Diagnosis of moderate to severe Rheumatoid Arthritis OR moderate to severe Juvenile Idiopathic Arthritis Member has had an inadequate response to one or more nonbiologic disease modifying antirheumatic drugs OR Member has had an inadequate response to one or more biologic disease modifying antirheumatic drugs. Patient is 18 years of age or older for RA. Patient is 6-17 years of age for juvenile idiopathic arthritis. Formulary ID 13460 1
ABIRATERONE Zytiga PA Details Age Other Patient is male Patient has a diagnosis of metastatic castration-resistant prostate cancer Patient has received prior chemotherapy containing docetaxel OR patient is medically unable to tolerate chemotherapy Patient is 18 years of age or older Abiraterone acetate 1,000 mg will be used in combination with prednisone 5 mg twice daily Formulary ID 13460 2
ADALIMUMAB Humira Humira Pen-crohns Diseasestarter PA Details Formulary ID 13460 3
Age Patient has a diagnosis of moderate to severe rheumatoid arthritis (RA) Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs for at least 3 consecutive months OR Patient has been diagnosed with RA for less than 6 months with high disease activity for 3 6 months or with high disease activity for less than 3 months but also with poor prognostic features Adalimumab will be used in combination with methotrexate OR Diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs for at least 3 consecutive months OR Patient has a diagnosis of psoriatic arthritis or ankylosing spondylitis Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic disease modifying anti-rheumatic drugs OR Patient has a diagnosis of moderate to severe Crohn s disease OR Patient has a diagnosis of moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months Patient is 4 years of age or older for polyarticular juvenile idiopathic arthritis, patient is 18 years of age or older for all other indications Formulary ID 13460 4
Other Formulary ID 13460 5
AGALSIDASE Fabrazyme INJ 35MG PA Details Age Other Diagnosis Lifetime Formulary ID 13460 6
ALGLUCOSIDASE ALFA Lumizyme Myozyme PA Details Age Other Diagnosis Lifetime Formulary ID 13460 7
AMBRISENTAN Letairis PA Details Age Other Diagnosis of PAH (WHO Group I) in Class II through III patients For female patients, pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception Prescription is written by or in consultation with a pulmonologist or cardiologist Formulary ID 13460 8
ANABOLIC STEROIDS (OXROLONE) Oxandrolone PA Details Age Other Patient is receiving treatment to counterbalance protein catabolism associated with chronic corticosteroid administration OR Patient is receiving treatment for relief of osteoporosis-related bone pain Formulary ID 13460 9
ANAKINRA Kineret PA Details Age Other Diagnosis of moderate to severe RA The patient must meet the following requirements: o Inadequate response to one or more non-biologic disease modifying antirheumatic drugs (DMARDS) [e.g., hydroxychloroquine, leflunomide, methotrexate, and sulfasalazine] OR o Inadequate response to one or more biologic DMARDS (e.g., adalimumab, infliximab, etanercept, etc.) Patient must be 18 years or older Formulary ID 13460 10
ANALGESICS (HIGH RISK MEDICATIONS) Meperidine Hcl INJ 25MG/ML, 50MG/ML Meperidine Hcl ORAL SOLN Meperitab Pentazocine/acetaminophen Pentazocine/naloxone Hcl Talwin PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication OR Patient has already tried and failed any ONE non-high risk formulary alternative OR has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally prescribed medication. Applies to patients 65 years or older Formulary ID 13460 11
RODERM Androderm PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D carcioma of the breast, known or suspected carcinoma of the prostate Patient is male, diagnosis of hypogonadism (primary or hypogonadotropic) serum testosterone level (free or total) value and laboratory reference value range reported by laboratory service has been provided diagnosis is confirmed by a low-for-age serum testosterone (total or free) level defined by the normal laboratory reference value For renewal, patient has experienced an objective response to therapy and has not developed any contraindication to therapy Formulary ID 13460 12
ROGENS (HIGH RISK MEDICATIONS) Android Methitest Testred PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication OR Patient has already tried and failed any ONE non-high risk formulary alternative OR has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally prescribed medication. Applies to patients 65 years or older Formulary ID 13460 13
ANTIDEPRESSANTS (HIGH RISK MEDICATIONS) Amitriptyline Hcl Chlordiazepoxide/amitriptyline Clomipramine Hcl Doxepin Hcl Imipramine Hcl Imipramine Pamoate Perphenazine/amitriptyline Trimipramine Maleate PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 14
ANTI-EMETICS (HIGH RISK MEDICATIONS) Diphenhydramine Hcl CAPS 50MG Diphenhydramine Hcl INJ Hydroxyzine Hcl Hydroxyzine Pamoate Metoclopramide Hcl Phenadoz Promethazine Hcl Promethegan RECTAL SUPP 25MG, 50MG Tigan Trimethobenzamide Hcl CAPS PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 15
ANTIHISTAMINES (HIGH RISK MEDICATIONS) Carbinoxamine Maleate Clemastine Fumarate SYRP Clemastine Fumarate TABS 2.68MG Cyproheptadine Hcl Palgic LIQD Promethazine Vc PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 16
ANTIHYPERTENSIVE (HIGH RISK MEDICATIONS) Guanfacine Hcl Reserpine TABS 0.25MG PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 17
ANTIPARKINSON (HIGH RISK MEDICATIONS) Benztropine Mesylate Trihexyphenidyl Hcl PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication OR Patient has already tried and failed any ONE non-high risk formulary alternative OR has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally prescribed medication. Applies to patients 65 years or older Formulary ID 13460 18
ANXIOLYTICS (HIGH RISK MEDICATIONS) Meprobamate PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 19
ATTENTION DEFICIT HYPERACTIVITY DISORDER AGENTS (HIGH RISK MEDICATIONS) Adderall Xr Amphetamine/dextroamphetamine Concerta Daytrana Desoxyn Dexmethylphenidate Hcl Dextroamphetamine Sulfate ORAL TABS Dextroamphetamine Sulfate Er Focalin Xr Metadate CD Metadate Er Methamphetamine Hcl Methylin Methylphenidate Hcl Methylphenidate Hcl CD ORAL CPCR 10MG, 50MG, 60MG Methylphenidate Hcl Er ORAL CP24 Methylphenidate Hcl Er ORAL TBCR 18MG, 20MG, 27MG, 36MG, 54MG Methylphenidate Hydrochloride Procentra Ritalin Ritalin La Ritalin Sr Vyvanse ORAL CAPS 30MG, 50MG, 70MG PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 20
AUBAGIO Aubagio PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. First clinical episode. Severe hepatic impairment, current treatment with leflunomide (Arava), pregnancy, or women of child-bearing potential who are not using reliable contraception Diagnosis of relapsing form of multiple sclerosis (relapsing-remitting multiple sclerosis and progressive-relapsing multiple sclerosis) and patient has an inadequate response, intolerance, or contraindication to interferon beta and Copaxone OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis and patient has an inadequate response, intolerance, or contraindication to interferon beta and Copaxone 18 years of age or older For renewal, confirm that the patient had an objective response to therapy (.ie. no or slowed progression of disease) Formulary ID 13460 21
AXITINIB Inlyta PA Details Age Other Patient has a diagnosis of advanced renal cell carcinoma Patient has failed one or more systemic therapy for renal cell carcinoma Patient is 18 years of age or older Renewal criteria: patient has not had disease progression based on Response Evaluation in Solid Tumors (RECIST). Formulary ID 13460 22
BARBITURATES Butisol Sodium PA Details Age Other not provided for contraindications to oral phenobarbital therapy: marked impairment of liver function (e.g., severe hepatic disease) OR pulmonary disease in which dyspnea or obstruction is evident. Diagnosis A message will be sent to the pharmacy to verify the diagnosis. After the pharmacist verifies that it's being used for an FDA approved diagnosis, the pharmacy can then submit a clarification code to override the PA restriction and the claim will pay. Formulary ID 13460 23
BECAPLERMIN Regranex PA Details Age Other Patient has lower extremity diabetic neuropathic ulcer(s) that extend into the subcutaneous tissue or beyond (Stages III and IV of the NPUAP/WOCN pressure ulcer staging) Patient s diabetic ulcer(s) has an adequate blood supply (defined as transcutaneous oxygen tension [TcpO2] of greater than 30 mm Hg on limb where ulcer is located) Patient is receiving a program of good ulcer care (consisting of initial complete sharp debridement, a non-weight-bearing regimen, systemic treatment for wound-related infection if present, moist saline dressings changed twice a day, and additional debridement as necessary) Patient is 16 years of age or older Formulary ID 13460 24
BENZODIAZEPINES Alprazolam Alprazolam Er Alprazolam Intensol Alprazolam Odt Chlordiazepoxide Hcl Clonazepam Clonazepam Odt Clorazepate Dipotassium Diazepam ORAL TABS Diazepam RECTAL GEL Diazepam SOLN Diazepam Intensol Estazolam Flurazepam Hcl Klonopin Lorazepam ORAL TABS Lorazepam Intensol Niravam Onfi ORAL TABS Oxazepam Temazepam Triazolam Xanax Xanax Xr PA Details Age Other not provided for contraindications to therapy: acute closed-angle glaucoma (with the exception of oxazepam) and for lorazepam injection only: sleep apnea syndrome or severe respiratory insufficiency except in those patients receiving lorazepam for amnestic effects while being mechanically ventilated. Diagnosis A message will be sent to the pharmacy to verify the diagnosis. After the pharmacist verifies that it's being used for an FDA approved diagnosis, the pharmacy can then submit a clarification code to override the PA restriction and the claim will pay. Formulary ID 13460 25
BEXAROTENE Targretin PA Details Age Other Diagnosis Formulary ID 13460 26
BOCEPREVIR Victrelis PA Details Age will not be provided if patient is pregnant or unwilling to comply with required contraception or coadministration with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihyroergotamine, ergonovine, ergotamine, methylergovovine, cisapride, St. John s Wort, lovastatin, simvastatin, drosperinone, REVATIO (sildenafil) or ADCIRCA (tadalafil) (pulmonary arterial hypertension use), pimozide, triazolam, and midazolam (orally administered). Patient has a documented diagnosis of Chronic Hepatitis C Virus Genotype 1 with compensated liver disease Patient is receiving concurrent therapy with ribavirin and PEG-INTRON (peginterferon alfa-2b) or PEGASYS (peginterferon alfa-2a) Patient is treatment naïve to peginterferon alfa and ribavirin therapy OR Patient has been previously treated with peginterferon and ribavirin and was considered a partial responder, defined as a greater than or equal to 2- log10 reduction in HCV-RNA at week 12, but with a detectable HCV- RNA level during the therapy period. OR Patient has been previously treated with peginterferon and ribavirin and was a null responder, defined as less than a 2-log10 HCV-RNA decline by treatment week 12. OR Patient has been previously treated with peginterferon and ribavirin and was considered a prior relapser, defined as HCV-RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV-RNA detectable during the follow-up period Patient has not previously failed a regimen with an HCV protease inhibitor (INCIVEK or VICTRELIS) Patient is 18 years of age or older Initial approval is 12 weeks. Formulary ID 13460 27
Other Additional approval of 12 to 32 weeks is dependent on genotype and HCV RNA response at specific timepoints based on FDA-approved labeling. Formulary ID 13460 28
BOSENTAN Tracleer PA Details Age Other Patient is not receiving concomitant cyclosporine-a or glyburide therapy. Diagnosis of PAH (WHO Group I) in Class II through IV patients Patient does not have moderate-to-severe hepatic impairment or appropriate baseline liver function tests have or will be performed prior to the start of therapy for patients with mild hepatic impairment For female patients, pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception Prescription is written by or in consultation with a pulmonologist or cardiologist Formulary ID 13460 29
BOSULIF Bosulif PA Details Age Other Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia disease is resistant or intolerant to prior therapy (such as Gleevec, Sprycel, or Tasigna) 18 years of age or older Formulary ID 13460 30
BUPRENORPHINE Buprenorphine Hcl SUBLINGUAL SUBL Buprenorphine Hcl/naloxone Hcl Suboxone SUBLINGUAL FILM 12MG; 3MG, 4MG; 1MG, 8MG; 2MG Suboxone SUBLINGUAL SUBL 8MG; 2MG PA Details Age Other Patient has a diagnosis of opioid dependence is certified through SAMHSA (Substance Abuse and Mental Health Services Administration) to prescribe Suboxone (buprenorphine) and provide registration number Prescription is part of an overall treatment program (e.g., self-help groups, counseling, provide ongoing care, vocational training) Up to 9 months Renewal criteria also requires: Patient is not receiving any other opioids is evaluating random urine drug screens and assessment of the patient s progress (e.g., relapse, progress/accomplishment of treatment goals) duration is as follows: 1 month for Subutex in non-pregnant patients, 3 months for Suboxone initial therapy or Subutex initial therapy in pregnancy, 9 months for Suboxone renewals and Subutex renewals in pregnancy Formulary ID 13460 31
BUPRENORPHINE PATCH Butrans TRANSDERMAL PTWK 10MCG/HR, 20MCG/HR, 5MCG/HR Suboxone SUBLINGUAL FILM 2MG; 0.5MG Suboxone SUBLINGUAL SUBL 2MG; 0.5MG PA Details Age Other is not provided for patients with any contraindications to therapy including: significant respiratory depression or severe bronchial asthma, known or suspected paralytic ileu, management of acute pain or in patients who require opioid analgesia for a short period of time, the management of post-operative pain, including use after out-patient or day surgeries, the management of mild pain the management of intermittent pain. Patient has diagnosis of moderate to severe pain requiring continuous, around-the-clock opioid analgesic for an extended period of time Patient has tried and failed, is unable to tolerate, or has contraindication(s) to at least one therapy from each of the following two drug categories: (1) non-steroidal antiinflammatory (NSAIDs) and (2) opioid (immediate and extended-release) and/or opioid combination products OR Patient has documented swallowing difficulties. Patient must be 18 years of age or older Formulary ID 13460 32
CALCIPOTRIENE BETAMETHASONE Taclonex PA Details Age Other Known or suspected disorders of calcium metabolism or erythrodermic, exfoliative and pustular psoriasis. Patient has a diagnosis of stable moderate to severe psoriasis vulgaris (plaque psoriasis) Patient has less than or equal to 30% body surface area affected Patient meets any of the following criteria: o Patient has tried adequate treatment (at least 2 weeks) with at least one medium to high potency topical steroid OR o Patient has contraindications to utilizing topical steroids in absence of calcipotriene OR o Patient has tried adequate treatment (at least 2 weeks) with vitamin D analogs (calcipotriene, calcitriol) OR o Patient has tried adequate treatment (at least 2 weeks) or is intolerant to tazarotene Patient is 18 years of age or older Formulary ID 13460 33
CALCIUM CHANNEL BLOCKERS, DIHYDROPYRIDINE (HIGH RISK MEDICATIONS) Nifedipine PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication Applies to patients 65 years or older Formulary ID 13460 34
CANNABINOIDS (DRONABINOL) Dronabinol Marinol PA Details Age Other Patient has a diagnosis of cancer with chemotherapy-induced nausea/vomiting Patient has failed to achieve desired outcome with at least two other antiemetic agents such as: aprepitant/fosaprepitant, dexamethasone, 5- hydroxytriptamine-3 (5-HT3) serotonin receptor antagonists (dolasetron, granisetron, ondansetron, palonosetron), butyrophenones (droperidol, haloperidol), phenothiazines (prochlorperazine, promethazine), metoclopramide OR Patient has a diagnosis of acquired immunodeficiency syndrome (AIDS) with anorexia associated with weight loss Formulary ID 13460 35
CANNABINOIDS (NABILONE) Cesamet PA Details Age Other Patient has cancer with chemotherapy-induced nausea/vomiting Patient has failed to achieve desired outcome with at least two other antiemetic agents such as: aprepitant/fosaprepitant, dexamethasone, 5- hydroxytriptamine-3 (5-HT3) serotonin receptor antagonists (dolasetron, granisetron, ondansetron, palonosetron), butyrophenones (droperidol, haloperidol), phenothiazines (prochlorperazine, promethazine), metoclopramide, or dronabinol Formulary ID 13460 36
CELECOXIB Celebrex PA Details Age Other Patient is 65 years of age or older OR Patient has had a trial of one of the following therapies: NSAIDS or salicylates OR Patient is currently receiving treatment with antiulcer agents (i.e. protonpump inhibitors [PPIs], histamine-2-receptor antagonists [H2RAs], and misoprostol), anticoagulants, platelet aggregation inhibitors, glucocorticosteroids, or methotrexate. OR Patient has a history of ulcer disease Claim will pay at point-of-service if patient is 65 years or older and meets the required medical information field Formulary ID 13460 37
CERTOLIZUMAB Cimzia PA Details Age Other Patient has a diagnosis of moderate to severe Crohn s disease Patient has failed to achieve symptom control after an adequate therapy with, is intolerant to, or is contraindicated to: adalimumab [HUMIRA ] OR infliximab [REMICADE ] OR Patient has a diagnosis of moderate to severe rheumatoid arthritis Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 3 consecutive months Patient has failed to achieve symptom control after an adequate therapy with, is intolerant to, or is contraindicated to both adalimumab [HUMIRA ] or etanercept [ENBREL ] Patient must be 18 years or older Formulary ID 13460 38
COMETRIQ Cometriq ORAL KIT 0, 0, 20MG PA Details Age Other Gastrointestinal perforation. Fistula. Severe hemorrhage. Diagnosis of progressive, metastatic medullary thyroid cancer Formulary ID 13460 39
CRIZOTINIB Xalkori PA Details Age Other Patient has diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) Patient has documented anaplastic lymphoma kinase (ALK)-positive NSCLC disease as detected by FDA approved diagnostic test or Clinical Laboratory Improvement Amendments-approved facility Patient will be using crizotinib as monotherapy Patient is 18 years of age or older Renewal criteria: Patient has experienced an objective response to therapy Patient has not experienced any occurrence of pneumonitis, Grade 4 QTc prolongation, recurrent Grade 3 QTc prolongation, or Grade 2, 3 or 4 ALT or AST/bilirubin elevation with concurrent Grade 2, 3 or 4 total bilirubin elevations. Formulary ID 13460 40
CYSTARAN Cystaran PA Details Age Other The member has a diagnosis of cystinosis and has corneal cystine crystal accumulation. Formulary ID 13460 41
CYSTIC FIBROSIS RESPIRATORY AGENTS Cayston Pulmozyme Tobi Tobi Podhaler PA Details Age Other Diagnosis Formulary ID 13460 42
DALFAMPRIDINE Ampyra PA Details Age Other is not provided for patients who have a history of seizures, moderate or severe renal impairment (CrCl less than 50 ml/min) or is currently using any other forms of 4-aminopyridine Patient has a documented diagnosis of one of the four types of multiple sclerosis (MS) (relapse-remitting, primary-progressive, secondaryprogressive, and progressive-relapsing) Patient is ambulatory (able to walk with or without an assistive device for at least 25 feet in 8 to 45 seconds) Patient must be 18 years of age or older 3 months Renewal review: patient has demonstrated documented improvement by maintaining a stable walking speed without worsening of ambulation at least a 20% improvement in the T25FW from baseline. Formulary ID 13460 43
DASATINIB Sprycel PA Details Age Other o Patient has newly diagnosed Philadelphia chromosome positive CML in the chronic phase OR o Patient has a diagnosis of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib OR o Patient has a diagnosis of Ph+positive ALL with resistance or intolerance to prior therapy including imatinib Patient is 18 years of age or older Formulary ID 13460 44
DEFERIPRONE Ferriprox PA Details Age Other Patient has a diagnosis of transfusional iron overload due to thalassemia syndromes Patient has failed prior chelation therapy with DESFERAL (deferoxamine) or EXJADE (deferasirox) [failure defined as serum ferritin greater than 2,500 mcg/l] OR Patient has a contraindication or intolerance to DESFERAL (deferoxamine) or EXJADE (deferasirox) Absolute neutrophil count (ANC) greater than 1.5 x 109/L Patient is 18 years of age or older Renewal criteria: Patient has experienced an objective response to therapy defined as a greater than or equal to 20% decline in serum ferritin Absolute neutrophil count (ANC) greater than 1.5 x 109/L Formulary ID 13460 45
DEGARELIX Firmagon PA Details Age Other Patient is male Patient has a diagnosis of advanced or metastatic prostate cancer Patient must be at least 18 years of age Formulary ID 13460 46
DENOSUMAB (PROLIA) Prolia PA Details Age Other Patient is female and is receiving adjuvant aromatase inhibitor therapy for breast cancer and is at high risk for fracture OR Patient is male and is receiving androgen deprivation therapy for nonmetastatic prostate cancer and is at high risk for fracture OR Patient is a postmenopausal female with a diagnosis of osteoporosis and at high risk of fracture defined as one of the following: history of osteoporotic fractures or multiple risk factors for fractures Patient has a documented trial and therapeutic failure with a bisphosphonate. Therapeutic failure is defined as new fractures in compliant patients on therapy for at least six months or significant loss of bone mineral density on follow-up scans after 12 to 24 months of therapy OR Patient has a documented contraindication, is intolerant to bisphosphonate therapy, or is unable to comply with appropriate administration recommendations for oral or injectable bisphosphonate therapy Patient is concomitantly taking calcium 1000 mg daily and at least 400 IU vitamin D daily Patient will have pre-existing hypocalcemia and vitamin D deficiency corrected prior to administration of PROLIA, and calcium, mineral, and vitamin D levels will be monitored periodically during treatment Patient is 18 years of age or older Approvable under Part D only if patient is in a long term care facility OR the medication is not being administered with an infusion pump. Formulary ID 13460 47
DENOSUMAB (XGEVA) Xgeva PA Details Age Other Patient has bone metastasis(es) from a solid tumor (due to breast cancer, castrate-resistant prostate cancer, thyroid carcinoma, or non-small cell lung cancer) and is using XGEVA for the prevention of skeletal-related events OR patient has a diagnosis of giant cell tumor of bone and the tumor is unresectable or surgical resection is likely to result in severe morbidity. Patient must be 18 years of age or older Approvable under Part D only if patient is in a long term care facility OR the medication is not being administered with an infusion pump. Formulary ID 13460 48
DICLOFENAC PATCH Flector PA Details Age Other not provided for the following contraindications to therapy: patient previously experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, use for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery, orapplication to non-intact or damaged skin resulting from any etiology (e.g. exudative dermatitis, eczema, infected lesion, burns or wounds). Patient is receiving treatment for acute pain due to minor strains, sprains and contusions Patient has experienced treatment failure with at least 1 prescription strength oral NSAIDs OR Patient has a documented swallowing disorder 1 month Formulary ID 13460 49
ELELYSO Elelyso PA Details Age Other Diagnosis of type 1 Gaucher disease 18 years of age or older Formulary ID 13460 50
ERLOTINIB Tarceva PA Details Age Other Patient has diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) Patient has failed at least one prior chemotherapy regimen OR Erlotinib will be used as maintenance therapy in patients with no evidence of disease progression after 4 cycles of standard first-line platinum-based chemotherapy The patient has documented known positive/activated EGFR mutation discovered prior to first-line therapy or during chemotherapy OR Patient has a diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer Erlotinib will be used in combination with gemcitabine (Gemzar) Patient must be at least 18 years of age Formulary ID 13460 51
ERYTHROPOIESIS-STIMULATING AGENTS (DARBEPOETIN) Aranesp Albumin Free INJ 100MCG/0.5ML, 100MCG/ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML PA Details Age Patient with uncontrolled hypertension or antibody-mediated pure red cell aplasia Patient has one of the following diagnoses: o Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy two additional months of chemotherapy is anticipated OR o Anemia of chronic kidney disease (CKD) OR o Anemia due to myelodysplastic syndrome with endogenous serum erythropoietin level less than or equal to 500 mu/ml Pretreatment hemoglobin level as follows: o Anemic patient at high risk for perioperative blood loss, Hgb: between 10 and 13 g/dl OR o All other indications, Hgb is less than 10 g/dl Patient must have adequate iron stores prior to initiation of therapy defined as ferritin greater than 100 mcg/l and serum transferrin saturation greater than 20% Other causes of anemia have been ruled out Prescribed by a hematologist or an oncologist if patient with non-myeloid malignancies or myelodysplastic syndrome or hematolgist or nephrologist if anemia in patients with CKD Formulary ID 13460 52
Other Initial authorization will be 3 months. Continued use shall be reviewed at least every 6 months for all indications and for CKD. Renewal criteria: Patient must have adequate iron stores defined as ferritin greater than 100 mcg/l and serum transferrin saturation greather than 20% For CKD: o If patient has end stage renal disease and is on dialysis, covered under Part B, otherwise covered under Part D. O Measurable response after 12 weeks defined as an increase in Hgb greater than 1 g/dl or a reduction in RBC transfusion requirements o For dialysis patients: Hgb less than 11g/dL OR Hgb greater than 11 and physician will decrease or interrupt dose OR for non-dialysis patients: Hgb less than 10 g/dl OR Hgb greater than 10 and physician will decrease or interrupt dose OR For Non-Myeloid Malignancies: o Measurable response after 8 weeks defined as an increase in Hgb of 1g/dL or a reduction of transfusion requirements concurrent myelosuppressive chemotherapy OR For other indications Hgb is less than or equal to 12 g/dl o Myelodysplastic syndrome: measurable response after 8 weeks defined as a 1.5 g/dl rise in Hgb or a decrease in RBC transfusion requirements OR o Concomitant trial of NEUPOGEN (G-CSF/filgrastrim) and a measurable response as defined above after 6-8 weeks of NEUPOGEN therapy OR For Hepatitis C: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements concurrent interferon/ribavirin or pegylated interferon/ribavirin therapy OR For Zidovudine-treated HIV: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements OR documented dose escalation (up to max of 300 U/kg every 4-8 weeks) Zidovudine doses less than or equal to 4200 mg/week Formulary ID 13460 53
ERYTHROPOIESIS-STIMULATING AGENTS (EPOETIN) Epogen Procrit PA Covered Uses Age Details All medically accepted indications not otherwise excluded from Part D Patient with uncontrolled hypertension or antibody-mediated pure red cell aplasia Patient has one of the following diagnoses: o Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy two additional months of chemotherapy is anticipated OR o Anemia of chronic kidney disease (CKD) OR o Anemia in zidovudine-treated HIV-infection with serum erythropoietin levels less than or equal to 500 mu/ml and zidovudine doses less than or equal to 4200 mg/week prescribed by an infectious disease specialist OR o Anemia secondary to treatment of hepatitis C infection with a combination of ribavirin and interferon/peginterferon prescribed by a hepatologist, infectious disease specialist, or gastroenterologist OR o Treatment of anemic patient at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusion prescribed by a surgeon Pretreatment hemoglobin level as follows: o Anemic patient at high risk for perioperative blood loss, Hgb between 10 and 13 g/dl OR o All other indications, Hgb less than 10 g/dl Patient must have adequate iron stores prior to initiation of therapy defined as ferritin greater than 100 mcg/l and serum transferrin saturation greater than 20% Other causes of anemia have been ruled out Prescribed by a hematologist or an oncologist if patient with non-myeloid malignancies or myelodysplastic syndrome, hematolgist or nephrologist if anemia in patients with CKD, neonatologist if anemia due to prematurity, surgeon if surgery patient Formulary ID 13460 54
Other Initial authorization will be 3 months. Renewal criteria: Patient must have adequate iron stores defined as ferritin greater than 100 mcg/l and serum transferrin saturation greater than 20% For Chronic Kidney Disease: o If patient has end stage renal disease and is on dialysis, covered under Part B, otherwise covered under Part D. O Measurable response after 12 weeks defined as an increase in Hgb greater than 1 g/dl or a reduction in RBC transfusion requirements o For dialysis patients: Hgb less than 11g/dL OR Hgb greater than 11 and physician will decrease or interrupt dose OR for non-dialysis patients: Hgb less than 10 g/dl OR Hgb greater than 10 and physician will decrease or interrupt dose OR For Non-Myeloid Malignancies: o Measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction of transfusion requirements concurrent myelosuppressive chemotherapy OR For other indications Hgb less than or equal to 12 g/dl OR For Hepatitis C: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements concurrent interferon/ribavirin or pegylated interferon/ribavirin therapy OR For Zidovudine-treated HIV: measurable response after 8 weeks defined as an increase in Hgb greater than 1g/dL or a reduction in RBC transfusion requirements OR documented dose escalation (up to max of 300 U/kg every 4-8 weeks) Zidovudine doses less than or equal to 4200 mg/week Formulary ID 13460 55
ETANERCEPT Enbrel PA Details Formulary ID 13460 56
Age Other Patient has a diagnosis of moderate to severe rheumatoid arthritis (RA) Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 3 consecutive months OR Patient has a diagnosis of moderate to severe RA Patient has had RA for less than 6 months with high disease activity for 3 6 months or with high disease activity for less than 3 months but also with poor prognostic features Etanercept will be used in combination with methotrexate OR Diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic DMARDs for at least 3 consecutive months OR Patient has a diagnosis of psoriatic arthritis OR ankylosing spondylitis Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic DMARDs OR Patient has a diagnosis of moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months. Patient must be at least 2 years of age for polyarticular juvenile idiopathic arthritis, patient must be at least 18 years of age for all other indications Formulary ID 13460 57
EVEROLIMUS Afinitor PA Details Age Other Patient has a diagnosis of advanced/metastatic renal cell carcinoma (RCC) Patient has failed therapy (disease progressed) with sunitinib [SUTENT] or sorafenib [NEXAVAR] OR Patient has a diagnosis of progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced, or metastatic OR Patient has Subependymal Giant Cell Astrocytoma associated with tuberous sclerosis (TS) that requires therapeutic intervention but is not a candidate for curative surgical resection OR Patient has a diagnosis of renal angiomyolipoma and tuberous sclerosis complex Patient does not require immediate surgerycurative surgical resection OR Patient is a postmenopausal woman Patient has a diagnosis of advanced hormone receptor-positive, HER2- negative breast cancer Patient has failed treatment with letrozole [Femara] or anastrozole [Arimidex] Afinitor will be used in combination with exemestane [Aromasin] Patient is greater than or equal to 18 years of age for Renal Cell Carcinoma and Progressive Neuroendocrine Tumors. Patient is greater than or equal to 3 years of age for Subependymal Giant Cell Astrocytoma Formulary ID 13460 58
Formulary ID 13460 59
FENTANYL, SHORT-ACTING Abstral Actiq Fentanyl Citrate Oral Transmucosal Fentora Onsolis Subsys SUBLINGUAL LIQD 100MCG, 1200MCG, 200MCG, 400MCG, 800MCG PA Details Age Other Fentanyl is not being used for the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room Patient has a diagnosis of cancer and use is for breakthrough cancer pain Patient is opioid tolerant and taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer Other formulary short-acting strong narcotic analgesic alternatives (other than fentanyl) have been ineffective, not tolerated, or contraindicated. Examples of short-acting strong narcotics include, but are not limited to, concentrated morphine oral solution, oxycodone or hydromorphone Patient must be at least 18 years of age for ABSTRAL, FENTORA and ONSOLIS. Patient must be at least 16 years of age for ACTIQ. Formulary ID 13460 60
FILGRASTIM Neupogen INJ 300MCG/0.5ML, 480MCG/0.8ML, 480MCG/1.6ML PA Details Age Other Patient has a diagnosis of cancer and is receiving myelosuppressive chemotherapy OR Patient has a diagnosis of acute myeloid leukemia and is receiving induction or consolidation chemotherapy OR Patient has a diagnosis of cancer and is receiving a bone marrow transplant OR Patient is undergoing peripheral blood progenitor cell collection and therapy OR Patient has a diagnosis of severe chronic neutropenia (congenital, cyclic, or idiopathic) Formulary ID 13460 61
FINGOLIMOD Gilenya PA Details Age Other Patient is diagnosed with a relapsing form of MS Patient will be observed in a controlled setting, for signs and symptoms of bradycardia for 6 hours after the first dose Patient is 18 years of age or older Formulary ID 13460 62
GABAPENTIN (GRALISE) Gralise PA Details Age Other Patient has a diagnosis of post-herpetic neuralgia Patient has tried and failed a dose of at least 1800 mg of generic gabapentin OR Patient had experienced intolerance to generic gabapentin. Formulary ID 13460 63
GABAPENTIN ENACARBIL Horizant PA Details Age Other Patient has a diagnosis of moderate to severe primary restless legs syndrome Formulary ID 13460 64
GALSULFASE Naglazyme PA Details Age Other Diagnosis Formulary ID 13460 65
GASTROINTESTINAL AGENTS (HIGH RISK MEDICATIONS) Dicyclomine Hcl Diphenoxylate/atropine Motofen Propantheline Bromide PA Details Age Other Diagnosis The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication OR Patient has already tried and failed any ONE non-high risk formulary alternative OR has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally prescribed medication. Applies to patients 65 years or older Formulary ID 13460 66
GATTEX Gattex PA Details Age Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer Diagnosis of short bowel syndrome patient is receiving specialized nutritional support (i.e. parenteral nutrition) 18 years of age or older Other For renewal, patient has a reduced need for parenteral support (20% reduction) after at least 6 months of therapy. Formulary ID 13460 67
GLATIRAMER Copaxone PA Details Age Other Patient has a diagnosis of relapsing-remitting multiple sclerosis OR Patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis Formulary ID 13460 68
GOLIMUMAB Simponi INJ 50MG/0.5ML PA Details Age Other Patient has a diagnosis of moderate to severe rheumatoid arthritis Patient will be on concomitant methotrexate therapy Patient has had inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs (DMARD) for at least 3 consecutive months OR Patient has a diagnosis of psoriatic arthritis OR ankylosing spondylitis Patient has had inadequate response to, intolerance to, or contraindication to: o One or more non-steroidal anti-inflammatory drugs (NSAIDs) OR o One or more non-biologic DMARDs Patient is 18 years of age or older Formulary ID 13460 69
GROWTH HORMONE - GHD & GROWTH FAILURE Genotropin Genotropin Miniquick Humatrope INJ 12MG, 24MG, 6MG Humatrope Combo Pack Norditropin Flexpro Norditropin Nordiflex Pen Nutropin Nutropin Aq Pen Omnitrope INJ 5MG/1.5ML Saizen INJ 5MG Saizen Click.easy Tev-tropin PA Details Age Other Diagnosis Prescription is written by an endocrinologist Formulary ID 13460 70
GROWTH HORMONE (SEROSTIM) Serostim PA Details Age Other Diagnosis of AIDs-wasting syndrome or cachexia (define as unintentional weight loss greater than or equal to 10% of baseline weight) Treatment failure with or intolerance to dronabinol or megestrol Patient is currently receiving treatment with antiretrovirals 12 weeks Renewal criteria: Patient has experienced an increase in body weight and/or body cell mass Wasting is still evident Formulary ID 13460 71
GROWTH HORMONE (ZORBTIVE) Zorbtive PA Details Age Other Patient has a diagnosis of short bowel syndrome Patient is receiving specialized nutritional support (i.e. parenteral nutrition) of approval is limited to 4 weeks. Additional authorizations not provided. Formulary ID 13460 72
H.P. ACTHAR GEL Acthar Hp PA Details Age Other Diagnosis of infantile spasms (IS) OR use after failure of corticosteroid therapy for the following conditions: multiple sclerosis (MS), adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, including juvenile idiopathic arthritis, ankylosing spondylitis, for exacerbations or as maintenance therapy of systemic lupus erythematous, systemic dermatomyositis (polymyositis), severe erythema multiforme, Stevens- Johnson Syndrome, serum sickness, severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation, symptomatic sarcoidosis, to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 2 years of age or younger for diagnosis of IS, 18 years of age or older in MS IS - plan year. Collagen diseases - 6 months. Others - 1 month Formulary ID 13460 73
HEPATITIS B AGENTS Baraclude Hepsera Tyzeka PA Details Age Other Diagonsis Formulary ID 13460 74
HYDROMORPHONE Exalgo ORAL TB24 12MG, 16MG, 8MG PA Details Age Other is not provided for patients with any contraindications to therapy including: significant respiratory depression and acute or severe bronchial asthma or hypercarbia, known or suspected paralytic ileus, patients who have had surgical procedures or known allergy to sulfitecontaining medications Patient has diagnosis of moderate to severe pain requiring continuous, around-the-clock opioid analgesia for an extended period of time Patient is opioid tolerant. Opioid tolerant patients are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer Documentation of a trial of at least one generic extended-release opioid product Patient is 18 years of age or older Formulary ID 13460 75
IBRONATE Boniva INJ PA Details Age Other Patient has any of the following diagnoses: o Osteoporosis in a postmenopausal female o Primary or hypogonadal osteoporosis in a male Documented trial and therapeutic failure of an oral bisphosphonate for six months. Therapeutic failure is defined as new fractures in compliant patients on therapy for at least six months or significant loss of bone mineral density on follow-up scans after 12 to 24 months of therapy OR Patient has a documented contraindication, is intolerant to oral bisphosphonate therapy or is unable to comply with appropriate administration recommendations for oral bisphosphonate therapy Approvable under Part D only if patient is in a long term care facility OR the medication is not being administered with an infusion pump. Formulary ID 13460 76
ICLUSIG Iclusig PA Details Chronic myelogenous leukemia in patients with the T315I mutation. Age Other Diagnosis of chronic myelogenous leukemia (CML) and patient has tried and failed or has an intolerance to two first-line tyrosine kinase inhibitors OR Diagnosis of CML and the patient has a known T315I mutation OR Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia and the patient has tried and failed or had an intolerance to two previous tyrosine kinase inhibitors. 18 years of age or older Formulary ID 13460 77
ILOPROST Ventavis PA Details Age Other Patient has a diagnosis of PAH (WHO Group I) WHO/NYHA Class IV patients OR Patient has a diagnosis of PAH (WHO Group I) WHO/NYHA Class II- III patients who do not respond adequately to, are unable to tolerate, or are not candidates for endothelin receptor antagonists (e.g. TRACLEER [bosentan] or LETAIRIS [ambrisentan]) and phosphodiesterase-5 (PDE- 5) inhibitors (e.g. REVATIO [sildenafil], ADCIRCA [tadalafil]). Pulmonologist or cardiologist or documentation of consultation with pulmonologist or cardiologist Formulary ID 13460 78
IMATINIB Gleevec PA Details Patient has a diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia that is newly diagnosed in the chronic phase (CP), accelerated phase (AP) or blast crisis (BC), or in chronic phase after failure of interferon alpha therapy OR Patient has a diagnosis of Philadelphia chromosome positive acute lymphoblastic leukemia that is relapsed or refractory OR Patient has documented c-kit (CD117) positive unresectable or metastatic malignant gastrointestinal stromal tumor (GIST) OR Patient had resection of c-kit (CD117) positive GIST and imatinib will be used as an adjuvant therapy OR Patient has a diagnosis of dermatofibrosarcoma protuberans that is unresectable, recurrent, or metastatic OR Patient has a diagnosis of hypereosinophilic syndrome (HES) or chronic eosinophilic leukemia (CEL) with documentation of FIP1L1-PDGFR-a fusion kinase [mutational analysis or FISH demonstration of CHIC2 allele deletion] OR Patient has a diagnosis of HES or CEL and is FIP1L1-PDGFR-a fusion kinase negative or unknown OR Patient has a diagnosis of myelodysplastic syndrome or myeloproliferative disease associated with PDGFR gene rearrangements OR Patient has a diagnosis of systemic mastocytosis without the D816V c- KIT mutation or with c-kit mutational status unknown OR Patient has a diagnosis of Ph+ CML that is newly diagnosed in the CP Formulary ID 13460 79
Age Other Patients at least 18 years of age for FDA approved indications in adults. Patients at least 2 years of age and older for Philadelphia chromosome positive chronic myelogenous leukemia Formulary ID 13460 80
IMIGLUCERASE Cerezyme INJ 200UNIT PA Details Age Other Diagnosis Formulary ID 13460 81
IMMUNE GLOBULIN Carimune Nanofiltered INJ 3GM Gammagard Liquid Gamunex-c INJ 1GM/10ML Privigen INJ 20GM/200ML PA Details Age Other is not provided in patients with selective IgA deficiency, history of anaphylactic reaction or hypersensitivity to immune globulin preparations. For the IM formulation only, coverage not provided for patients with severe thrombocytopenia or coagulation disorders where IM injections are contraindicated. Diagnosis Formulary ID 13460 82