Medicare Part D Drugs that Require Prior-Authorization Effective 12/01/2015

Transcription

1 Medicare Drugs that Require Prior- Effective 12/01/2015 Prior Actemra IV Actemra All FDAapproved Required Medical Information Age Prescriber 2. For Rheumatoid Arthritis: Patient must have tried and failed previous therapy with a TNF antagonist and provider must state which TNF antagonist and provide documentation. 1. Rheumatologist 12 Months Actemra SubQ Actemra All FDAapproved 1. Documentation of moderate to severe active rheumatoid arthritis. 2. For rheumatoid arthritis: patient must have tried and failed previous therapy with a TNF antagonist and provider must state which TNF antagonist and provide documentation. 1. Rheumatologist 12 Months Providers may call the Pharmacy Help Desk at for a copy of prior authorization criteria or print a copy from our website at Rocky Mountain Health Plans All rights reserved Updated December 2015

2 Adcirca Adcirca All FDAapproved Required Medical Information Age Prescriber 1. Documentation of approved diagnosis of PAH WHO 1 and NYHA Functional Class II-III. 1. Pulmonologist 2. Cardiologist 12 Months Adempas Adempas All FDAapproved prescribing physician. 1. Pulmonologist 2. Cardiologist 12 Months Afinitor Afinitor All FDAapproved prescribing physician. 2. For advanced renal cell carcinoma, documentation of failure of either sunitinib or sorafenib. 1. Oncologist 12 Months

3 Afinitor Disperz Afinitor Disperz All FDAapproved Required Medical Information Age Prescriber 1. Documentation of patient with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected. 1. Oncologist 12 Months Apokyn Apokyn All FDAapproved 12 Months Arzerra Arzerra All FDAapproved 2. For Refractory CLL - documented failure of both fludarabine and alemtuzumab. 3. For previously untreated CLL - documented use in combination with chlorambucil and documented reason why fludarabine is not an option in this patient. 1. Oncologist 12 Months

4 Avastin Avastin All medically accepted Required Medical Information Age Prescriber 12 Months Beleodaq Beleodaq All FDAapproved 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. For relapsed or refractory peripheral T-cell lymphoma: documentation from the medical record of diagnosis and prior therapy that the cancer was relapsed or refractory to, is required. 3. Prescribing provider must check two informative acknowledgements: the first regarding FDA approval only being based on tumor response rate and duration of response from a phase II trial and the second is regarding the metabolism of Beleodaq and need for dose reduction if patient has UGT1A1 28 allele. 1. Oncologist 12 Months Benlysta Benlysta All FDAapproved 1. Documentation of diagnosis of systemic lupus erythematosus that is autoantibody-positive. 2. Documentation of persistently active disease in spite of treatment with standard therapy or intolerance, contraindication, or failure of standard therapy. Standard therapy includes antimalarials (i.e. hydroxychloroquine or chloroquine) or immunosuppressants (i.e. azathioprine, methotrexate, or Cellcept). 3. Patient does not have severe active lupus nephritis or severe active CNS lupus. 1. Rheumatologist

5 Bosulif Bosulif All FDAapproved Required Medical Information Age Prescriber 2. Documentation of resistance to or intolerance of Gleevec. Alternatively, if Tasigna was used 1st line in newly diagnosed chronic phase CML, documentation of either resistance to or intolerance of Tasigna. 3. Patient does not have the T315I or V299L mutation. 1. Oncologist Botox Botox All FDAapproved 1. Cosmetic indications 2. For migraine prophylaxis, patient must be unresponsive to a 60 day trial of at least 2 different classes of prophylactic medications, e.g., beta-blockers, anticonvulsants. 3. For overactive bladder, patient must have tried and failed a minimum of 2 urinary anticholinergic medications -orif intolerant or use is contraindicated, patient must have tried and failed a beta-3 adrenergic agonist, e.g., Myrbetriq.

6 Caprelsa Caprelsa All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis of symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic disease. 2. Consideration will be given to patients with indolent, asymptomatic or slowly progressing disease due to treatment related risks with vandetanib. 3. Documented past medical history negative for congenital long QT syndrome -ANDbaseline QTCF less than 450ms -ANDbaseline labs including potassium, calcium, magnesium and TSH within normal limits. 1. Oncologist 2. Endocrinologist 3. Prescriber enrolled in Caprelsa REMS program. Carbaglu Carbaglu All FDAapproved 1. PA only required for maintenance therapy for chronic hyperammonemia in patients with n-acetylglutamate synthase deficiency. 2. Documentation of NAGS deficiency required. 3. PA is not required for acute hyperammonemia due to NAGS deficiency. 1. Physician experienced in metabolic disorders

7 Carisoprodol HRM AL Carisoprodol Carisoprodol Compound- Codeine Carisoprodol- Aspirin- All FDAapproved Required Medical Information Age Prescriber 2. If age 65 years or older, prescribing provider must attest that the benefit of use of carisoprodol medications outweighs the risk. 3. Prior authorization only applies when age 65 years or older. Cimzia Cimzia All FDAapproved 1. Rheumatologist 2. Gastroenterologist 3. Dermatologist

8 Cinryze Cinryze All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis of hereditary angioedema needing prophylaxis against angioedema attacks in adults and adolescents. 2. Documentation that patient has a history of at least 1 severe event per month. 3. Documentation that the patient has tried and failed or is intolerant to at least one other prior therapy, including 17-alpha-alkylated androgens (e.g. danazol, stanozolol) or an anti-fibrinolytic agent (e.g. tranexamic acid) for HAE prophylaxis. 1. Immunologist 2. Allergist Cometriq Cometriq All FDAapproved 2. Documentation of diagnosis and disease progression required. 3. It is noted that increasing tumor markers, in the absence of structural disease progression are not an indication for treatment with Cometriq. 1. Oncologist 2. Endocrinologist

9 Cyramza Cyramza All FDAapproved Required Medical Information Age Prescriber 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. For advanced gastric cancer or advanced gastro-esophageal junction adenocarcinoma, documentation that Cyramza will be used as a single agent or in combination with paclitaxel when there is disease progression on or after fluoropyrimidine - ORplatinum-containing chemotherapy is required. 3. For metastatic non-small cell lung cancer, documentation that Cyramza will be used in combination with docetaxel -ANDdocumentation of disease progression on or after platinum-based chemotherapy -ANDif patient has EGFR or ALK mutation, documentation of disease progression while on FDA approved EGFR or ALK targeted therapy - e.g. erlotinib, gefitinib, afatinib, crizotinib, ceritinib. 4. For the treatment of metastatic colorectal cancer, documentation that Cyramza will be used in combination with FOLFIRI when there is disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

10 Daliresp Daliresp All FDAapproved 1. Indication to improve FEV1 in patient with COPD or in patient without history of COPD exacerbation in the past year. Required Medical Information Age Prescriber 1. Documentation of diagnosis of severe or very severe COPD as defined by the GOLD initiatives. 2. Acknowledgement of the following: Daliresp is FDA approved to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp is not indicated for the improvement in FEV1 or for patients without history of COPD exacerbations 3. Documentation of at least one COPD exacerbation within the last year. Desoxyn Desoxyn Methamphetamine HCL All FDAapproved 1. Indications related to the treatment of obesity Dificid Dificid All FDAapproved 1. Documentation of diagnosis of clostridium difficle-associated diarrhea. 2. Documentation of failure, intolerance, or contraindication to standard therapy for CDAD including metronidazole, vancomycin, or Alinia. 10 days

11 Dysport Dysport All FDAapproved 1. Cosmetic Indications Required Medical Information Age Prescriber Enbrel Enbrel All FDAapproved 1. Rheumatologist 2. Dermatologist Erivedge Erivedge All FDAapproved 1. Documentation of diagnosis of metastatic basal cell carcinoma, -OR- 2. Documentation of locally advanced basal cell carcinoma that has recurred following surgery, -OR- 3. Documentation of locally advanced basal cell in patient who is not a candidate for surgery or radiation. 4. Females with reproduction potential require documentation of a negative pregnancy test within 7 days prior to start of therapy with Erivedge. 1. Oncologist

12 Esbriet Esbriet All FDAapproved Required Medical Information Age Prescriber 2. For Idiopathic Pulmonary Fibrosis, documentation showing that: a. The patient does not have other known causes of interstitial lung disease, e.g., connective tissue disease, drug toxicity, asbestos or beryllium exposure, hypersensitivity pneumonitis, systemic sclerosis, rheumatoid arthritis, radiation, sarcoidosis, bronchiolitis obliterans organizing pneumonia, HIV, viral hepatitis, or cancer. b. The patient has an unusual interstitial pneumonia (UIP) pattern as evidenced by highresolution computed tomography (HRCT) alone or by combination of surgical lung biopsy and HRCT. c. Forced vital capacity (FVC) is 50 percent or greater. 3. Renewal requests for interstitial lung disease require documented clinical benefit for the patient. 1. Pulmonologist Exjade Exjade All FDAapproved 2. For chronic iron overload: must have documentation of serum ferritin level that is greater than 1000mcg/L. 3. For thalassemia syndromes: must have documentation of liver iron concentrations of at least 5mg FE/g dry weight and serum ferritin levels greater than 300mcg/L. 2 years and older for chronic iron overload and 10 years and older for thalassemia syndromes

13 Farydak Farydak All FDAapproved Faslodex Faslodex All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis by prescribing provider. 2. For relapsed multiple myeloma a. Provider must provide documentation of relapsed multiple myeloma as evidenced by increase in M protein in the serum or urine, -orincrease in bone marrow plasma cell percentage, -orabnormal change in the FLC ratio, or new bone or soft tissue lesions -e.g. plasmacytomas -orincrease in size of previously existing lesions -- -oran unexplained serum calcium greater than 11.5mg/dl, b. Farydak must be used in combination with Velcade IV or SUBQ and dexamethasone, c. Provider must provide documentation indicating the patient has received at least 2 prior regimens which must include Velcade and an immunomodulatory derivative -e.g. Thalomid, Revlimid, Pomalyst. The regimen and dates of therapy must be provided for each prior regimen, d. The patient must have an ECOG performance status of 0, 1, or Documentation of disease progression following antiestrogen or aromatase inhibitor therapy. 1. Oncologist 1. Oncologist

14 Ferriprox Ferriprox All FDAapproved Required Medical Information Age Prescriber 1. Documentation supportive of transfusional iron overload due to thalassemia syndromes -AND- 2. Documentation supporting use as second line therapy due to failure or intolerance of other chelation therapy (e.g. deferoxamine). Failure is defined as serum ferritin concentration greater than 2500mcg/L. Firazyr Firazyr All FDAapproved 1. Documentation supporting diagnosis of either hereditary angioedema Type 1 or Type to meet the diagnosis of Type 1 HAE are C4 and C1-INH protein quantities are decreased and patient has family history of HAE 3. to meet the diagnosis of Type 2 HAE are C4 quantity is low but C1-INH protein is normal or elevated and C1-INH function is decreased. 4. Renewal requires documentation supporting symptom relief and history of at least 1 HAE attack in the previous month. 18 years of age and older 1. Immunologist 2. Allergist 3 months

15 Forteo Forteo All FDAapproved Required Medical Information Age Prescriber prescriber. 2. Documentation of treatment failure with oral osteoporosis therapy, to include: a. Evidence of oral therapy (e.g. raloxifene or bisphosphonate) with continued osteoporosis confirmed by DXA scan or other suitable diagnostic evaluation -orb. Evidence of contraindication or intolerance to oral therapy. 24 months Fusilev Fusilev levoleucovorin calcium All FDAapproved 2. Acknowledgement that leucovorin is not attainable due to short supply and is documented on the FDA drug shortage website. 1. Oncologist 6 months Gilenya Gilenya All FDAapproved 1. Documentation of diagnosis of relapsingremitting multiple sclerosis by physician. 2. Documentation of prior treatment with an injectable disease-modifying agent e.g., interferon, glatiramir, natalizumab. 3. Safety acknowledgements for first dose monitoring and if varicella antibody positive or has been vaccinated. 1. Neurologist

16 Required Medical Information Age Prescriber Gilotrif Gilotrif All FDAapproved Gleevec Gleevec All FDAapproved Grastek Grastek All FDAapproved 1. Individual with severe, unstable, or uncontrolled asthma. 2. Individual with a history of severe systemic allergic reactions. 3. Individual with a history of severe local reactions to sublingual allergen immunotherapy. 4. Individual with a history of eosinophilic esophagitis. 1. Documentation of adult patient with diagnosis of metastatic non-small cell lung cancer. 2. Documentation of tumors with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a US Food and Drug Administration-approved test. 3. Documentation of use for first-line treatment for NSCLC. 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. Individual has a prescription for an autoinjectable epinephrine product. 3. Documentation of positive skin test or positive in vitro testing for pollen-specific IGE antibodies for timothy grass or crossreactive grass pollens is required. 4. Treatment will be initiated at least 12 weeks before the expected grass pollen season and continued throughout the season. Provider is to indicate treatment start date. 5 years and older to 65 years and younger 1. Oncologist 1. Oncologist 1. Allergist 36 months

17 Growth Hormone Required Medical Information Age Prescriber Genotropin Humatrope Norditropin Flexpro Norditropin Nordiflex Nutropin AQ Nuspin Omnitrope Saizen Tev-tropin Zomacton All FDAapproved 1. Documentation of growth hormone deficiency. 2. Documentation of diagnosis by prescribing provider. Halaven Halaven All FDAapproved 2. Documentation supporting prior trial with at least two chemotherapeutic regimens for the treatment of metastatic disease either in the adjuvant or metastatic setting including an anthracycline and a taxane or documentation supporting reason patient is not a candidate for an anthracycline and/or taxane. 1. Oncologist

18 Harvoni Harvoni All FDAapproved - and - Indications for use of Harvoni when consistent with the AASLD/IDSA Hepatitis C guidelines. Required Medical Information Age Prescriber 1. Documentation of FDA approved diagnosis or AASLD/IDSA supported diagnosis by prescribing provider. 2. If treatment experienced, documentation of prior failed regimens required. 3. Provider must answer and provide documentation regarding whether or not the patient has hepatocellular carcinoma and is awaiting liver transplant, if the patient is a liver transplant recipient, and if the patient is HIV-1 co-infected - based on current AASLD/IDSA guidelines, if these are present and other criteria are met, we will approve. 4. Provider must provide documentation of the patient's most recent HCV RNA level - level must be drawn within the past 6 months - viral titers must be detectable. 5. Provider must attest that their patient is ready, willing, and able to comply with the chosen HCV treatment regimen and understands that nonadherence may result in denial of remaining therapy when therapy duration is greater than 12 weeks. 6. Provider must attest that a drug-druginteraction check has been conducted - e.g Approval is granted in 12 week increments for those whose condition requires treatment duration greater than 12 weeks. Total duration determined by recommended treatment duration in the prescribing information or in the HCV guidelines. Pharmacy claims must support adherence to the treatment for renewal. 18 years or older 1. Infectious disease specialist 2. Transplant specialist 3. Hepatologist 4. Gastroenterologist 5. A specially trained group such as ECHO - Extension for Community Healthcare Outcomes 12 weeks

19 Humira Humira Humira Crohn s All FDAapproved Required Medical Information Age Prescriber 2. For ulcerative colitis only, documentation of inadequate response to at least one other immunosuppressants, e.g. corticosteroids, azathioprine, and 6-mercaptopurine. 3. For ulcerative colitis only, initial approval will be given for 2 months at which time documentation supportive of clinical remission is required for renewal that is then granted in 12 month increments. 1. Rheumatologist 2. Dermatologist 3. Gastroenterologist Ibrance Ibrance All FDAapproved 2. For postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer, Ibrance must be used in combination with letrozole. 3. For postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer, Ibrance must be the first endocrine-based treatment of the patient's metastatic disease in patients who are endocrine therapy naive, in patients who progress greater than from the end of adjuvant endocrine therapy -e.g. Tamoxifen, anastrazole, letrozole, exemestane - or in patients who present with de novo metastatic breast cancer. 1. Oncologist

20 Iclusig Iclusig All FDAapproved Required Medical Information Age Prescriber 1. Documentation in medical record of approved diagnosis by prescribing provider required. 2. For adult patients with chronic phase, accelerated phase, or blast phase CML or PH+ all, documentation of resistance and/or intolerance to a prior TKI, e.g. Gleevec, Sprycel, Tasigna, Bosulif, is required -ORdocumentation indicating no other tyrosine kinase inhibitor therapy is indicated. 3. For acute lymphoblastic leukemia and chronic myeloid leukemia, documentation of T315I mutation status required. 4. If T315I-positive, prior TKI therapy not required. 5. For acute lymphoblastic leukemia, documentation that it is Philadelphia chromosome-positive is required. 1. Oncologist Ilaris Ilaris All FDAapproved 1. Age 2 years or older for systemic onset juvenile chronic arthritis 2. Age 4 years or older for all other FDA approved indications

21 Imbruvica Imbruvica All FDAapproved Increlex Increlex All FDAapproved Inlyta Inlyta All FDAapproved Istodax Istodax All FDAapproved Required Medical Information Age Prescriber 2. Documentation of at least one prior therapy for the treatment of Mantle Cell Lymphoma. 3. Documentation of at least one prior therapy for the treatment of Chronic Lymphocytic Leukemia. 2. Lab results supportive of diagnosis required. 1. Documentation of diagnosis of advanced renal cell carcinoma after failure of one prior systemic therapy e.g., sunitinib-based therapy, cytokinebased therapy, bevacizumab-based therapy, or temsirolimus-based therapy 2. List prior failed therapies 3. Documentation supporting predominant clear cell histology. 2. For CTCL - patient has failed at least one prior multi-agent chemotherapy regimen e.g. CHOP, CHOEP, EPOCH, HYPERCVAD. Documentation of prior regimen required. 3. For PTCL - patient has failed at least one prior systemic therapy, e.g. extracorporeal photopheresis, systemic retinoids, interferons, vorinostat. Documentation of prior therapy required. 1. Oncologist 2 years and older 1. Oncologist 1. Oncologist

22 Ixempra Ixempra All FDAapproved Required Medical Information Age Prescriber 1. Oncologist Jakafi Jakafi All FDAapproved 2. Documentation of 2 or more prognostic factors (intermediate-2 or high-risk) based on the international working group consensus criteria, e.g., leukocytosis, marked anemia, peripheral blood blast greater than or equal to 1 percent, positive for constitutional symptoms. 3. Documentation indicating palpable splenomegaly at least 5cm below the costal margin. 4. Documentation of starting platelet count of 50 x 10(9)/L or higher. 5. Continuation of therapy beyond 6 months requires 35% reduction in spleen size and decrease in symptoms compared to baseline. 1. Oncologist 6 months

23 Kalydeco Kalydeco All FDAapproved 1. Patients with CF who are homozygous for the F508del mutation in the CFTR gene. Required Medical Information Age Prescriber 2. Documentation of confirmed G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation in the Cystic Fibrosis Transmembrane Regulator gene. 6 years and older 1. Pulmonologist Kalydeco Granules Kalydeco All FDAapproved 1. Patients with CF who are homozygous for the F508del mutation in the CFTR gene. 2. Documentation of confirmed G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation in the Cystic Fibrosis Transmembrane Regulator gene. 2 years of age or older 1. Pulmonologist Keytruda Keytruda All FDAapproved 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. Documentation of disease progression while taking Yervoy or documentation of intolerance to Yervoy required. 3. Documentation of BRAF V600 mutation status. 4. If BRAF V600 mutation-positive, documentation of disease progression or intolerance to a BRAF inhibitor is required, e.g. Tafinlar, Zelboraf. 1. Oncologist Kineret Kineret All FDAapproved 2. For RA only: Patient must have tried and failed therapy with a DMARD. 3. Check which DMARD (from a list of DMARDs). 1. Rheumatologist 2. Physician experienced with Kineret therapy.

24 Kuvan Kuvan All FDAapproved Required Medical Information Age Prescriber 2. Documentation of BH4 responsiveness. 3. Documentation that patient is refractory to treatment with a PHE- restricted diet. 4. PHE level must be greater than 10mg/DL. 5. Documentation of a 30 percent or greater reduction in PHE level after the initial approval is required for renewal. 1. Metabolic disease specialist 2 months for initial request, subsequent renewals granted in 12 month increments Lazanda Lazanda All FDAapproved 1. Documentation indicating use in patient with cancer pain who is already receiving and who is tolerant to around-the-clock opioid therapy. 2. Documentation of trial and failure of fentanyl citrate lollipop or documentation indicating an oral formulation would be difficult or uncomfortable due to oral problems including mucositis or xerostomia. 3. Documentation that patient has signed a pain/opioid contract with their physician. 4. Documentation must be supplied showing physician visits for pain management no less often than every three months. 18 years and older 1. Oncologist 2. Pain specialist 3. Physician must have completed the REMS program for transmucosal immediate release fentanyl 3 months

25 Lenvima Lenvima All FDAapproved Required Medical Information Age Prescriber prescribing physician. 2. For differentiated thyroid cancer, documentation showing that it is locally recurrent or metastatic -and- progressive -and- radioactive iodine-refractory is required. 3. To verify radioactive iodine-refractoriness, the physician must check one or more of the following and provide supporting documentation. Options include:patient has iodine uptake with disease progression within of RAI therapy, - or- disease progression after a cumulative RAI dose of greater than 600 mci, - or- disease progression after a single RAI treatment greater or equal to 100 mci within the previous 16 months, - or- disease progression after more than 1 RAI treatment -the last greater than 16 months ago- with disease progression occurring after each of 2 RAI treatments greater or equal to 100 mci administered within 16 months of each other, - or- progression of lesions as determined by CT, MRI, or bone scan following therapeutic dosing of RAI, - orprogression of lesions detected by FDG-PET imaging/progressive increase in metabolic activity -standardized uptake value, - or- lack of I-131 uptake in 1 or more tumor lesions, as determined by whole-body scan following diagnostic or therapeutic dosing of RAI. 4. Physician attests to true refractoriness - e.g. RAI refractoriness is not due to excess iodine intake in the diet, iodine supplement use, or prior procedures involving the administration of iodinecontaining dye. 1. Oncologist

26 Letairis Letairis All FDAapproved Lidoderm Patch Lidocaine Lidoderm All FDAapproved - and - Pain associated with Diabetic Neuropathy Required Medical Information Age Prescriber 1. Documentation of diagnosis of PAH WHO group 1 and NYHA functional class II-III by 1. Documentation of diagnosis of pain associated with postherpetic neuralgia - OR - 2. Documentation of diagnosis of pain associated with diabetic neuropathy. 1. Pulmonologist 2. Cardiologist Lynparza Lynparza All FDAapproved 2. For advanced ovarian cancer, documentation of the following is required: Lynparza is being used as monotherapy, patient has BRCA mutation detected by an FDA approved test and patient has prior failure of 3 or more chemotherapy regimens for treatment of ovarian cancer. 1. Oncologist

27 Mekinist Mekinist All FDAapproved 1. Patients who have received prior BRAFinhibitor therapy. 2. Patients with wild-type BRAF melanoma Required Medical Information Age Prescriber prescribing physician. 2. Monotherapy -Documentation supporting diagnosis of unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. 3. Tafinlar in combination with Mekinist - Documentation of unresectable or metastatic melanoma with BRAF V600E or V600K mutation. 1. Oncologist 6 months Namenda AL Memantine HCl Namenda Namenda XR All FDAapproved 1. Autism Must be 27 years or older Nexavar Nexavar All FDAapproved 1. Oncologist

28 Northera Northera All FDAapproved Required Medical Information Age Prescriber 2. For neurogenic orthostatic hypotension -NOH-, the provider must indicate if NOH is caused by: a. Primary autonomic failure e.g., Parkinson s disease, multiple symptom atrophy, or pure autonomic failure, b. Dopamine beta-hydroxylase, or, c. Non-diabetic autonomic neuropathy. 3. For NOH, documentation must be provided indicating the patient's NOH is symptomatic e.g., dizziness, lightheadedness, or the feeling of blacking out. 4. When criteria are met, initial approval is granted for 3 months. Renewal requires documentation from the patient's medical record of continued efficacy of Northera as demonstrated by improvements in NOH symptoms e.g. decreased dizziness and lightheadedness. Nulojix Nulojix All FDAapproved 1. Documentation of use for prophylaxis of organ rejection in adult patients receiving a kidney transplant. 2. Documentation that patient is EBV seropositive. 3. Documentation that Nulojix will be used in combination with basiliximab induction, mycophenolate mofetil and corticosteroids. 4. Patient has been assessed for tuberculosis and tested for latent infections. 1. Physician experienced in immunosuppressive therapy and management of kidney transplant patients

29 Ofev Ofev All FDAapproved Required Medical Information Age Prescriber 2. For Idiopathic Pulmonary Fibrosis, documentation showing that: a. The patient does not have other known causes of interstitial lung disease, e.g., connective tissue disease, drug toxicity, asbestos or beryllium exposure, hypersensitivity pneumonitis, systemic sclerosis, rheumatoid arthritis, radiation, sarcoidosis, bronchiolitis obliterans organizing pneumonia, HIV, viral hepatitis, or cancer. b. The patient has an unusual interstitial pneumonia (UIP) pattern as evidenced by high-resolution computed tomography (HRCT) alone or by combination of surgical lung biopsy and HRCT. c. Forced vital capacity (FVC) is 50 percent or greater. 3. Renewal requests for interstitial lung disease requires documented clinical benefit for the patient. 1. Pulmonologist

30 Olysio Olysio All FDAapproved - and - Indications for use of Olysio plus Sovaldi when consistent with the AASLD/IDSA Hepatitis C guidelines. 1. Hepatitis C with NS3 Q80K polymorphism Required Medical Information Age Prescriber 1. Documentation of diagnosis of chronic Hepatitis C genotype 1 infection -AND- 2. Documentation of compensated liver disease 3. Documentation that Olysio will be used as a component of a combination antiviral treatment regimen according to FDA approved labeling. 4. For treatment with Olysio plus Sovaldi - must meet the AASLD/IDSA Hepatitis C guidelines for use of this combination, documentation of compensated liver disease is required and documentation of interferon ineligibility is required. IFN ineligible is defined as one or more of the following: intolerance to IFN, autoimmune hepatitis and other autoimmune disorders, hypersensitivity to PEG or any of its components, decompensated hepatic disease, history of depression, or clinical features consistent with depression, a baseline neutrophil count below 1500/microliter, a baseline platelet count below 90,000/microliter or baseline hemoglobin below 10 g/dl, or a history of preexisting cardiac disease years of age or older 1. Infectious disease specialist 2. Hepatologist 3. Gastroenterologist 3 months

31 Opdivo Opdivo All FDAapproved Required Medical Information Age Prescriber 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. For malignant melanoma that is unresectable or metastatic, we require documentation of disease progression following prior therapy with Yervoy (ipilimumab) and documentation of BRAF V600 mutation status. 3. If a patient is BRAF V600 mutation positive, we also require documentation of disease progression on a BRAF inhibitor (e.g. Zelboraf, Tafinlar) 1. Oncologist Opsumit Opsumit All FDAapproved. 1. Pulmonologist 2. Cardiologist Orencia Orencia All FDAapproved 2. For juvenile idiopathic arthritis - only the IV formulation is approved. Must be 18 years or older for the subcutaneous formulation 1. Rheumatologist

32 Orenitram ER Orenitram ER All FDAapproved Required Medical Information Age Prescriber 2. Patient was previously treated with injectable e.g. Remodulin, or inhalation e.g. Tyvaso, form of treprostinil, and this treatment has been poorly tolerated or has presented compliance problems. 1. Pulmonologist 2. Cardiologist Perjeta Perjeta All FDAapproved 2. Documentation indicating use of Perjeta will be in combination with trastuzumab and docetaxel. 3. Documented HER2 overexpression, defined as 3+ IHC or FISH amplification ratio 2.0 or greater. 4. Safety acknowledgement for provider to consider doing an echocardiogram. 1. Oncologist 6 months Pomalyst Pomalyst All FDAapproved 1. Documentation supporting diagnosis of multiple myeloma. 2. Documentation indicating the patient has received at least 2 prior therapies including lenalidomide and bortezomib. 3. Documentation indicating the patient has progressed on or within 60 days of last therapy. 4. Individual has an ECOG performance score of 0, 1, or Oncologist 6 months

33 Prolia Prolia All FDAapproved Required Medical Information Age Prescriber 2. For osteoporosis - documentation of diagnosis of osteoporosis on a bone densitometry report is required -ANDdocumentation indicating patient failed and/or is intolerant to bisphosphonate therapy, e.g. alendronate, ibandronate, is required. 3. For bone loss secondary to cancer treatment - documentation of bone loss on a bone densitometry report is required. Provigil Modafinil Provigil All FDAapproved 2. For Narcolepsy - polysomnogram and MSLT supportive of diagnosis required. 3. For Excessive Daytime Fatigue related to Obstructive Sleep Apnea: polysomnogram supportive of diagnosis is required -ANDdocumentation of use of Positive Airway Pressure therapy or oral appliance use required -ORdocumentation in the medical record of trial of PAP therapy or oral device that was not tolerated. 4. For Shift Worker's Sleep Disorder - documentation of shift work, excessive sleepiness at the time of the night shifts, and documented daytime insomnia required. 1. Sleep Specialist - or- 2. Neurologist 3. Primary Care Physician if a Sleep Specialist or Neurologist made the original diagnosis of Narcolepsy or Obstructive Sleep Apnea 4. Primary Care Physician if Shift Worker Sleep Disorder

34 Ragwitek Ragwitek All FDAapproved 1. Individual with severe, unstable, or uncontrolled asthma. 2. Individual with a history of severe systemic allergic reactions. 3. Individual with a history of severe local reactions to sublingual allergen immunotherapy. 4. Individual with a history of eosinophilic esophagitis. Required Medical Information Age Prescriber 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. Individual has a prescription for an autoinjectable epinephrine product. 3. Documentation of positive skin test or positive in vitro testing for pollen-specific IGE antibodies for short ragweed pollen is required. 4. Treatment will be initiated at least 12 weeks before the expected grass pollen season and continued throughout the season. Provider is to indicate treatment start date. 18 years and older to 65 years and younger 1. Allergist Remicade Remicade All FDAapproved 2. For moderate to severely active rheumatoid arthritis - documented use of Remicade in combination with methotrexate -ANDdocumentation of an inadequate response to at least one conventional therapy, e.g. disease modifying anti-rheumatic drug. For rheumatoid arthritis only, documentation of approved diagnosis by a Rheumatologist

35 Remodulin Remodulin All FDAapproved Revatio IV Revatio Sildenafil Citrate All FDAapproved Required Medical Information Age Prescriber 1. Documentation of approved diagnosis of PAH WHO group 1 AND NYHA functional class II- IV. 2. For the injectable formulation, rational must be provided explaining why an oral PDE5 inhibitor formulation would be inappropriate. 1. Pulmonologist 2. Cardiologist 1. Pulmonologist 2. Cardiologist Sancuso Sancuso All FDAapproved 1. Documentation of planned administration of moderate to severely emetogenic IV chemotherapy. 2. Attestation that a reasonable possibility exists that oral formulations will not sufficiently control patient's symptoms of nausea and vomiting. 1. Oncologist Serostim Serostim All FDAapproved Sildenafil Oral Sildenafil All FDAapproved 1. Documentation of diagnosis of PAH WHO group 1 and NYHA functional class II - III by 1. Pulmonologist 2. Cardiologist

36 Simponi Simponi All FDAapproved Required Medical Information Age Prescriber 2. For rheumatoid arthritis only - documentation indicating patient will receive concomitant therapy with methotrexate. 3. For ulcerative colitis only - documentation of corticosteroid dependence and documentation of an inadequate response or intolerance to oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. 1. Rheumatologist 2. Dermatologist 3. Gastroenterologist Simponi Aria Simponi Aria All FDAapproved 1. Documentation of moderate to severe active rheumatoid arthritis. 2. Documentation indicating patient will receive concomitant therapy with methotrexate. 1. Rheumatologist Somavert Somavert All FDAapproved 2. Documentation that patient has had an inadequate response to surgery, radiation therapy, or other medical therapies -ORthat therapies were not appropriate. 3. Documentation of serum IGF-1 levels. 1. Endocrinologist

37 Sovaldi Sovaldi All FDAapproved - and - Indications for use of Olysio plus Sovaldi when consistent with the AASLD/IDSA Hepatitis C guidelines. Sprycel Sprycel All FDAapproved Stelara Stelara All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis of chronic Hepatitis C (HCV) genotype 1, 2, 3 or 4 -AND- 2. Documentation that Sovaldi will be used as a component of a combination antiviral treatment regimen according to FDA approved labeling 3. For treatment with Olysio plus Sovaldi: must meet the AASLD/IDSA Hepatitis C guidelines for use of this combination, documentation of compensated liver disease is required and documentation of interferon ineligibility is required. IFN ineligible is defined as one or more of the following: intolerance to IFN, autoimmune hepatitis and other autoimmune disorders, hypersensitivity to PEG or any of its components, decompensated hepatic disease, history of depression, or clinical features consistent with depression, a baseline neutrophil count below 1500/microliter, a baseline platelet count below 90,000/microliter or baseline hemoglobin below 10 g/dl, or a history of preexisting cardiac disease. 2. For all indications except newly diagnosed chronic phase chronic myeloid leukemia, documentation of previous therapy with Gleevec. 3. Adult patient 2. If 90mg dose is being prescribed, documentation of weight 100kg or more and at least one other failed DMARD is required years of age or older 1. Infectious disease specialist 2. Hepatologist 3. Gastroenterologist 3 months to 12 months depending on genotype and diagnosis 1. Oncologist 1. Dermatologist

38 Stivarga Stivarga All FDAapproved Sutent Sutent All FDAapproved Sylvant Sylvant All FDAapproved Synagis Synagis All FDAapproved 1. Prevention of RSV infection in cancer patient 2. Use as monotherapy for the treatment of RSV in cancer patient Required Medical Information Age Prescriber 2. For MCRC only - documentation of prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy, and, if KRAS wild type, an anti-egfr therapy and documentation of KRAS mutation status if no prior treatment with an anti-egfr therapy. 3. For GIST only - documentation of prior treatment with imatinib with either intolerance or disease progression and documentation of disease progression on sunitinib. 2. For gastrointestinal stromal tumor only: documented intolerance to Gleevec therapy or disease progression despite previous therapy. 1. Documentation that the patient is HIV negative and HHV-8 negative. 1. Documentation of use for FDA approved indication by prescribing provider 1. Oncologist 1. Oncologist 1. Oncologist 1. No prescriber restriction for FDA approved use 5 months for FDA approved indication

39 Synribo Synribo All FDAapproved Tafinlar Tafinlar All FDAapproved Tarceva Tarceva All FDAapproved 1. Patients with wild-type BRAF melanoma. Required Medical Information Age Prescriber 2. Documentation of chronic phase or accelerated phase chronic myelogenous leukemia. 3. Documentation showing the patient tried and had resistance and/or intolerance to two or more tyrosine kinase inhibitors, e.g. Gleevec, Sprycel, Tasigna, Bosulif. 2. Monotherapy - documentation supporting diagnosis of unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. 3. Tafinlar in combination with Mekinist - documentation of unresectable or metastatic melanoma with BRAF V600E OR V600K mutation. 2. For pancreatic cancer only - documentation indicating chemotherapy regimen includes gemcitabine. 3. For locally advanced or metastatic NSCLC only - documentation of failed prior chemotherapy regimen or documentation indicating no disease progression following 4 cycles of platinum based chemotherapy for monotherapy maintenance with Tarceva. 4. For metastatic NSCLC as first-line treatment - documentation of EGFR EXON 19 deletions or EXON 21 (L858R) substitution mutations as detected by an FDA approved test. 1. Oncologist 1. Oncologist 6 months 1. Oncologist

40 Tasigna Tasigna All FDAapproved Torisel Torisel All FDAapproved Tracleer Tracleer All FDAapproved Transmucosal Fentanyl Citrate Fentanyl Citrate Fentora All FDAapproved Required Medical Information Age Prescriber 2. For all FDA approved indications except newly diagnosed chronic phase chronic myeloid leukemia, documentation that patient has attempted therapy with Gleevec. 3. Adult patient. 1. Documentation of diagnosis of PAH WHO group 1 and NYHA functional class III-IV by 1. Documentation indicating use in patient with cancer pain who is already receiving and who is tolerant to around-the-clock opioid therapy. 2. For Fentora only, documentation of trial and failure of fentanyl citrate lollipop. 3. Documentation that patient has signed a pain/opioid contract with their physician years and older for Fentora years and older for fentanyl citrate lollipop. 1. Oncologist 1. Oncologist 1. Pulmonologist 2. Cardiologist 1. Prescriber completed TIRF REMS Treanda Treanda All FDAapproved 1. Oncologist

41 Tretinoin AL Avita Tretinoin All FDAapproved 1. Cosmetic indications Required Medical Information Age Prescriber years and older Tykerb Tykerb All FDAapproved 2. For refractory HER2+ breast CA only: documentation indicating refractory to first-line treatment and that Tykerb will be used in combination with capecitabine treatment. 3. For hormone receptor positive cancer in postmenopausal women whom hormonal therapy is indicated, documentation indicating use of Tykerb in combination with an aromatase inhibitor. 4. Patient must be registered with the Tykerb Cares Program. 1. Oncologist 2. Physician must be registered with the Tykerb Cares Program Tysabri Tysabri All FDAapproved 1. In combination with other MS treatments or immunosuppress ive treatment 2. For MS only: documented disease progression despite therapy with Avonex, Betaseron, Copaxone, or Rebif and state duration of therapy with previous regimen. 3. For Crohn's disease only: documented inadequate response or intolerance to conventional therapy and TNF-alpha inhibitors. 4. Patient must be enrolled in Touch Program. 1. Neurologist 2. Gastroenterologist, 3. Physician must be enrolled in Touch Program.

42 Tyvaso Tyvaso All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis of PAH WHO group 1 and NYHA functional class III by 1. Pulmonologist 2. Cardiologist Uceris Uceris All FDAapproved 1. Documentation supporting diagnosis of mild to moderate ulcerative colitis with indication for use for the induction of remission in patients with active disease. 2. Documentation that patient had failure, incomplete response, or intolerance to one or more 5-ASA medications (e.g. topical 5-ASA or oral 5-ASA), -OR- 3. Documentation that patient is not a candidate for 5-ASA medication due to hypersensitivity to mesalamine, other salicylates (including aspirin) or aminosalicylates. 1. Gastroenterologist 6 months Valchlor Valchlor All FDAapproved 1. Palliative treatment of cutaneous lesions of mycosis fungoides. 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. For stage 1A or 1B mycosis fungoides-type cutaneous t-cell lymphoma, documentation supportive of at least one prior skin-directed therapy is required, e.g. topical corticosteroids, topical retinoids, local radiation, phototherapy, total skin electron beam therapy. 3. Provider must list prior skin-directed therapies. 1. Oncologist only

43 Ventavis Ventavis All FDAapproved Required Medical Information Age Prescriber 1. Documentation of diagnosis of PAH WHO group 1 and NYHA functional class III-IV by 1. Pulmonologist 2. Cardiologist Votrient Votrient All FDAapproved Adipocytic STS or gastrointestinal stromal tumors 2. For advanced renal cell carcinoma only - documentation of diagnosis of clear-cell histology. 3. For soft tissue sarcoma only - documentation of prior anthracycline-containing chemotherapy. 1. Oncologist Xalkori Xalkori All FDAapproved 2. Documented anaplastic lymphoma kinase positive cancer as detected by an FDA-approved test. 1. Oncologist Xeljanz Xeljanz All FDAapproved 2. Documentation of inadequate response or intolerance to methotrexate. 3. Documentation of inadequate response or intolerance to one or more biologic DMARD, e.g., Humira, Enbrel, Cimzia, Simponi, Orencia, etc. 1. Rheumatologist

44 Xenazine Xenazine All FDAapproved 1. Hepatic dysfunction 2. Depression, untreated or inadequatelytreated 3. Actively suicidal 4. Use of tetrabenazine within 20 days of reserpine discontinuation 5. Concomitant use of an MAOI. Required Medical Information Age Prescriber 2. Doses exceeding 50mg daily will be reviewed for medical necessity. 1. Neurologist Xeomin Xeomin All FDAapproved 1. Cosmetic indications Xgeva Xgeva All FDAapproved Documentation supporting - 1. Risk of skeletal-related events in patient with bone metastases from solid tumor AND patient does not have diagnosis of multiple myeloma. 2. Adult or skeletally mature adolescent with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. 3. Preexisting hypocalcemia corrected. 1. Oncologist

45 Xolair Xolair All FDAapproved Xtandi Xtandi All FDAapproved Required Medical Information Age Prescriber 2. For IGE-mediated allergic asthma, documentation of moderate to severe persistent asthma, documentation indicating asthma inadequately controlled despite use of high dose inhaled corticosteroids, documentation of pulmonary function testing that has confirmed reversible airway disease, documentation of positive skin test or blood test to confirm allergic sensitivity, and documentation of patient weight and IGE level. IGE must be between 30 IU/ML and 700 IU/ML. 3. For chronic idiopathic urticaria, documentation in medical record of h1 antihistamine tried and documentation of continued symptoms despite h1 antihistamine therapy. 4. For chronic idiopathic urticaria, initial approval will be for one month and if patient responds to therapy, re-approvals will be granted in 12 month increments. 5. For all approved diagnoses, documented medication success required for re-approvals. 2. Documentation of prior docetaxel-based therapy. 3. Safety consideration acknowledging that the patient does not have a history of seizure, is not taking medicines known to decrease the seizure threshold, or does not have other risk factors for seizures. 12 years old and older 1. Allergist 2. Pulmonologist 1. Oncologist 2. Urologist

46 Xyrem Xyrem All FDAapproved Required Medical Information Age Prescriber 2. Documentation of cataplexy or excessive daytime sleepiness in patient with confirmed narcolepsy. 3. Polysomnogram and MSLT required to confirm narcolepsy diagnosis. 1. Neurologist 2. Sleep disorder specialist Zavesca Zavesca All FDAapproved 1. Patient refractory or intolerant to enzyme replacement therapy. 2. Documentation of approved diagnosis by Zelboraf Zelboraf All FDAapproved 1. Documentation of diagnosis of unresectable or metastatic melanoma with BRAF V600E mutation detected by an FDA-approved test. 2. Documentation of completed baseline monitoring parameters including electrocardiogram, electrolytes, liver enzymes, and bilirubin. 3. Documentation of completion of baseline dermatologic evaluation. 1. Oncologist Zolinza Zolinza All FDAapproved 2. Documentation supporting trial of at least 2 prior systemic therapies e.g. Targretin, Ontak, Campath, Interferon alpha, various chemotherapy regimens. Please list therapies. 1. Oncologist

47 Zydelig Zydelig All FDAapproved Required Medical Information Age Prescriber 1. Documentation supportive of approved diagnosis by prescribing provider required. 2. For relapsed chronic lymphocytic leukemia, documentation indicating use will be in combination with rituximab is required. 3. For relapsed follicular B-cell Non-Hodgkin Lymphoma, documentation of treatment with at least two prior therapies is required. 4. For relapsed small lymphocytic lymphoma, documentation of treatment with at least two prior therapies is required. 5. Renewal requires documentation showing no disease progression. 1. Oncologist Zykadia Zykadia All FDAapproved 2. Patients previously treated with Xalkori, metastatic ALK-positive NSCLC. 1. Oncologist Zytiga Zytiga All FDAapproved 1. Documentation supporting diagnosis of metastatic castration-resistant prostate cancer. 2. Documentation supporting concurrent use with prednisone twice daily. 1. Oncologist