Prior Authorization Criteria 2014

Transcription

1 Prior Authorization Criteria 2014 For information on obtaining an updated coverage determination or an exception to a coverage determination please contact Easy Choice Health Plan of New York s Member Services at or, for TTY/TDD users Our hours of operation are Monday through Friday from 8:00 AM to 8:00 PM from February 15, 2013 to September 30, 2013; 7 days a week from 8:00 AM to 8:00 PM from October 1, 2013 to February 14, 2014; Monday through Friday from 8:00 AM to 8:00 PM from February 15, 2014 to September 30, 2014 or visit No changes made since 05/01/2014 1

2 Table of contents Actemra... 5 Actimmune... 5 Adcirca, Sildenafil... 6 Aldurazyme... 6 Ampyra... 6 Analgesics (High Risk Medications)... 7 Androgens (High Risk Medications)... 7 Apokyn... 8 Aralast, Zemaira... 8 Aranesp... 9 Arcalyst... 9 Arixtra Attention Deficit Hyperactivity Disorder Agents (High Risk Medications) Aubagio Avonex Benlysta Benzodiazepines Betaseron Botox Butrans Cayston Cerezyme Cesamet Chorionic gonadotropin, Pregnyl Cialis Cimzia Cinryze Copaxone Dementia Agents (High Risk Medications) Effient Elaprase Eleyso Eligard, leuprolide Emsam Enbrel Epogen Fabrazyme Fentora Ferriprox Firazyr Flector Forteo

3 Gastrointestinal Agents (High Risk Medications) Gattex Gilenya Glassia Gleevec Humira Ilaris Incivek Increlex Infergen Intron-A Itraconazole Juxtapid Kalydeco Kineret Kuvan Kynamro Letairis Leukine Linzess Lumizyme, Myozyme Lyrica Mozobil Neulasta Neumega Neupogen Octreotide, Sandostatin, Zorbtive Oral Estrogens (High Risk Medications) Orencia Pegasys Peg-Intron Prolastin-C Promacta Qualaquin Relistor Remicade Revlimid Sabril Somatropin Somavert Sulfonylureas (High Risk Medications) Tarceva Testosterone Tetrahydrocannabinol Tracleer Trelstar

4 Tretinoin (topical) UTI Antibacterials (High Risk Medications) Vasodilators (High Risk Medications) Ventavis, Remodulin Victrelis Vimpat Vpriv Xenazine Xgeva Xolair Xyrem Zoledronic Acid Zyvox

5 Actemra Diagnosis. Labs: ANC and Platelet Count.The patient must have had an inadequate response to conventional treatment including methotrexate with or without one or more disease modifying anti- rheumatic drugs (DMARDs) +/- NSAIDs for at least 3 consecutive months within the last 12 months, unless contraindicated or intolerant. The patient has had an inadequate response to one the TNF antagonist therapy Remicade, Humira, or Enbrel. An inadequate response can be defined as therapy was ineffective, not tolerated, or other clinical circumstance Required_Medical_Information exists that precludes use. Licensed Practioner highly familiar with the use and monitoring of special biologic response modifiers Actimmune Hypersensitivity to interferon gamma, E. coli derived proteins, or any component of the formulation. Treatment of IPF (not FDA approved) Medical documentation of FDA approved diagnosis of chronic granulomatous disease or severe malignant Required_Medical_Information osteopetrosis. Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. ONLY APPLIES to NEW STARTS 5

6 Adcirca, Sildenafil Coverage not provided for patients currently receiving nitrate therapy Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) WHO Group I with NYHA functional class II or III OR Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) (WHO Group I) WHO/NYHA functional class IV and documentation that the patient refuses IV therapy, is not capable of managing the complex delivery system, or is intolerant to or has contraindications to IV prostanoid Required_Medical_Information therapy (i.e. epoprostenol, treprostinil). Prescription is written by a pulmonologist or cardiologist or documentation of consultation with pulmonologist or cardiologist Aldurazyme Required_Medical_Information Diagnosis Patients must be greater than 5 years old Ampyra Coverage 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 4-6

7 aminopyridine. Required_Medical_Information Patient has a documented diagnosis of one of the four types of multiple sclerosis (MS) AND, Patient is ambulatory (able to walk with or without an assistive device, 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 AND, at least a 20% improvement in the T25FW from baseline. Analgesics (High Risk Medications) Diagnosis: AND, 1.) 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, 2.) Patient has already tried and failed any TWO nonhigh risk formulary drug alternatives (narcotic analgesics) Required_Medical_Information Applies to patients 65 years or older Androgens (High Risk Medications) 7

8 Required_Medical_Information Diagnosis: AND, 1.) 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 Apokyn Patient that has not been previously treated with standard dopaminergic therapy Advanced Parkinson s Disease: 1. Confirmed diagnosis of advanced Parkinson's disease, AND 2. inability to control 'off' symptom s with any TWO of the following drugs: levodopa/carbidopa AND a dopamine agonist (bromocriptine, pramipexole, or ropinirole) or COMT inhibitor (tolcapone or entacapone) AND 3. Used in combination with a non-5-ht3 antagonist antiemetic for initial therapy, AND 4. Not used in combination with 5-HT3 antagonists Required_Medical_Information Aralast, Zemaira 8

9 Required_Medical_Information Patients with IgA deficiency who have known antibodies against IgA, anaphylaxis or hypersensitivity to IgA products or components or a history of severe systemic response to A1-PI products. Diagnosis Aranesp Uncontrolled hypertension, known hypersensitivity to the active substance or any excipients, iron stores are inadequate, pre-treatment Hgb greater than 12 g/dl. Required_Medical_Information Diagnosis and the following Labs: Hgb, Ferritin, and Tstats 3 months Arcalyst Rilonacept is not considered medically necessary when members have the following concomitant conditions: Active Tuberculosis, HIV, Hepatitis B, Hepatitis C, Neonatal- Onset Multisystem inflammatory disease, or currently utilizing tumor necrosis factor inhibitors or interleukinn-1 blockers. Diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome Required_Medical_Information (FCAS) and Muckle-Wells syndrome (MWS) The patient must be 12 years and older 9

10 Arixtra Required_Medical_Information Diagnosis Attention Deficit Hyperactivity Disorder Agents (High Risk Medications) Required_Medical_Information ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Diagnosis: AND, 1.) 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, 2.) Patient has already tried and failed any ONE nonhigh risk formulary alternative (Strattera) Applies to patients 65 years or older Aubagio Severe hepatic impairment. Current treatment with leflunomide. Patients who are pregnant or women of childbearing potential not using reliable contraception. 10

11 Required_Medical_Information Diagnosis of relapsing forms of multiple sclerosis (relapsing-remitting MS or progressive-relapsing MS) OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis. 18 years of age or older Avonex Required_Medical_Information Hypersensitivity to human albumin (Avonex(R) lyophilized powder vials and Rebif(R) prefilled syringes), hypersensitivity to natural or recombinant interferon Diagnosis from neurologist of definite or probable relapsing remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Statement may include a first MS attack with documented MRI scan abnormalities characteristic of MS, OR evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal neurological deficit which has resolved, and documentation of an MRI suggestive of MS. Prescribing physician must be a neurologist 1 year, only extend for 3 months at a time beyond this duration Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Benlysta Receiving other biologic therapy or intravenous cyclophosphamide 11

12 Required_Medical_Information Diagnosis of active, autoantibody-positive (acceptable assays include ANA, anti-ds-dna, anti-sm, etc.) systemic lupus erythematosus AND patient is currently receiving one or more of the following standard therapies: corticosteroids, antimalarials, NSAIDs, immunosuppressants. 18 years of age or older Benzodiazepines Coverage 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: AND, 1.) 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, 2.) Patient has already tried and failed any ONE nonhigh risk formulary alternative, OR, 3.) Prescriber has been made aware that the requested drug is a high risk medication and wishes to proceed with the originally Required_Medical_Information prescribed medication. Applies to patients 65 years or older Betaseron Hypersensitivity to E. coli-derived products, natural or recombinant interferon beta, albumin human or any other component of the formulation Required_Medical_Information Approvable for treatment of with a diagnosis of MS. 12

13 Prescribing physician must be a nuerologist Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Botox ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Infection at the proposed injection site. Cosmetic use (e.g., wrinkles). Diagnosis of one of the following: A) strabismus, OR B) blepharospasm associated with dystonia, OR C) Urinary incontinence and condition is associated with a neurologic condition and Patient tried and had an inadequate response to at least one antimuscarinic agent, unless contraindicated or intolerant to antimuscarinics (e.g., narrow angle glaucoma) and patient does not have a urinary tract infection and patient is routinely performing clean intermittent self-catheterization (CIC) or is willing/able to perform CIC, OR D) Chronic migraine and medication will be used as prophylaxis and experiences headaches on 15 or more days per month lasting four hours or longer and patient has tried and had an inadequate response with at least two first-line therapies from two different therapeutic classes (i.e. antiepileptics, beta-blockers, triptans, and tricyclic antidepressants) OR E) Cervical dystonia (including spasmodic torticollis) F) Overactive bladder and has symptoms (e.g., urge urinary incontinence, urgency, and frequency) and patient has tried and had an inadequate response to at least one antimuscarinic agent, unless contraindicated or intolerant to anti-muscarinics (e.g., narrow angle glaucoma) OR F) Axillary hyperhidrosis and patient s condition significantly interferes with patient's daily activities and condition is refractory after 30 days of Required_Medical_Information treatment with topical aluminum chloride OR G) Upper limb 13

14 spasticity. 12 years of age or older - strabismus or blepharospasm Urinary incontinence - prescribed by or in consultation with an urologist Butrans Significant respiratory depression or severe bronchial asthma. Known or suspected paralytic ileus. The medication will not be used for one of the following: management of acute pain or requires opioid analgesia for a short period of time (management of post-operative pain, including use after outpatient or day surgeries), management of mild pain, or management of intermittent pain (e.g., use on an as needed basis). Patient is in hospice care (age restriction does not apply) OR Patient has a diagnosis of moderate to severe chronic pain requiring continuous, around-the-clock opioid analgesic for an extended period of time AND patient tried and failed, is unable to tolerate, or has a contraindication to at least one therapy from each of the following two drug categories: NSAIDs and generic extended-release opioid product and/or opioid combination product, unless the Required_Medical_Information patient has documented swallowing difficulties. 18 years of age or older (does not apply to hospice patients) Cayston 14

15 Required_Medical_Information Diagnosis of cystic fibrosis AND patient has evidence of P. aeruginosa in the lungs 7 years of age or older Cerezyme Diagnosis of non-neuropathic Gaucher s disease with one of the following: anemia, thrombocytopenia, bone disease, hepatomegaly or splenomegaly, it has been designated an orphan product for use in the treatment of types I and III Required_Medical_Information Gaucher's disease. Patient must be at least 2 years of age Cesamet Diagnosis of chemotherapy-induced nausea and vomiting AND patient has tried and failed conventional antiemetic treatments (e.g., aprepitant/fosaprepitant, dexamethasone, t-hydroxytriptamine-3 serotonin receptor antagonists, butyrophenones, phenothiazines, metoclopramide) AND Required_Medical_Information patient has tried and failed dronabinol. 6 months 15

16 Chorionic gonadotropin, Pregnyl Pregnancy or suspected pregnancy. Use for infertility or sexual dysfunction. Required_Medical_Information Diagnosis required Must be at least 4 years of age Cialis Coverage is not provided for erectile dysfunction without signs and symptoms of BPH or concurrent use with nitrates. Patient has a diagnosis of benign prostatic hyperplasia (BPH) AND 1.) Tadalafil 2.5 mg or 5 mg is being requested AND 2.) Patient has experienced intolerance to or treatment failure with an alpha-blocker (e.g. doxazosin, prazosin, tamsulosin) and a 5-alpha reductase inhibitors Required_Medical_Information (e.g. dutasteride, finasteride) Cimzia Active serious infection (including tuberculosis) 16

17 Required_Medical_Information Diagnosis of moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs for at least 3 consecutive months OR Diagnosis of moderate to severe Crohn's disease and patient has an inadequate response to, is intolerant to, or a contraindication exists to conventional therapy with one of the following: corticosteroids (i.e. Entocort EC, prednisone, methylprednisolone). 18 years of age or older Patient has been tested for TB and latent TB has been ruled out or is being treated. Cinryze History of life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product. Diagnosis of hereditary angioedema AND Medicaton will be Required_Medical_Information used for routine prophylaxis against angioedema. Copaxone Diagnosis of relapsing-remitting multiple sclerosis OR diagnosis of first clinical episode with MRI features Required_Medical_Information consistent with multiple sclerosis 17

18 18 years of age or older Dementia Agents (High Risk Medications) Diagnosis: AND, 1.) 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, 2.) Patient has already tried and failed any ONE nonhigh risk formulary alternative (donepezil or galantamine) Required_Medical_Information Applies to patients 65 years or older Effient Patients with active pathological bleeding or history of TIA or stroke. Patients over 75 years of age who do not have high risk situations such as diabetes or a history of prior MI. Required_Medical_Information Documented treatment failure or intolerance to Plavix. Elaprase 18

19 Required_Medical_Information Diagnosis of Hunter syndrome (Mucopolysaccaridosis II or MPS II) Eleyso Required_Medical_Information Diagnosis of type 1 Gaucher disease 18 years of age or older Eligard, leuprolide Required_Medical_Information Must have a dx of at least one: Prostatic Carcinoma, Endometroisis, Uterine Leiomyomata (Fibroids), Central Precocious Puberty, Amenorrhea. Patient must be at least 18 years of age for all diagnoses, except for central precocious puberty 3 mo - 2 yrs (diagnosis dependent) Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Applies to new starts only for Prostatic Carcinoma. Emsam 19

20 Required_Medical_Information Failure of two (2) preferred antidepressants which should be from different classes of antidepressants, one of which should be Mirtazapine orally disintegrating tablets for patients unable to swallow tablets/capsules Patient must have tried at least 2 of the following Preferred agents, one which should be mirtazapine ODT: Fluoxetine capsules, Paroxetine, Citalopram, Bupropion, Mirtazapine/ Mirtazapine ODT, Trazodone, Amitriptyline, or Venlafaxine. Recommended treatment dose of Emsam is 6mg/24hr, maximum dose is 12mg/24hr. ONLY APPLIES TO NEW STARTS. Enbrel Patients with sepsis or active infection Rheumatoid Arthritis(RA): diagnosis of moderate to severe, active RA and documented failure of adequate trial, defined by the ACR, of one DMARD (Methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine) and one NSAID (ibuprofen, naproxen, ketoprofen, meloxicam). Ankylosing Spondylitis: documented failure of maximum doses of at least 2 nonsteroidal anti-inflammatory drugs (NSAIDS) OR a cyclo-oxygenase (COX)-2-selective inhibitor. Psoriatic arthritis: diagnosis of moderate to severe disease with documented intolerance to at least 2 different preferred drugs. Preferred drugs include: DMARD s methotrexate, sulfasalazine, hydroychloroquine, azathioprine, lefludomide AND/OR NSAIDs ibuprofen, naproxen, ketoprofen, meloxicam. Plaque Psoriasis: Failure of two oral agents including methotrexate and a steroid OR Puva therapy. One of the treatments listed below: The use of topical steroids. The use of either Tazorac (tazorotene), Methotrexate Cyclosporine, UVB Required_Medical_Information phototherapy and/or PUVA therapy. 20

21 Epogen Pre-treatment Hct greater than 36%, patients not receiving iron supplementation if iron stores are inadequate, unspecified diagnosis of anemia, uncontrolled hypertension. Patients with an allergy to albumin, or any component of epoetin or allergy to mammalian cell-derived products Diagnosis with corresponding criteria outlined below, no active gastrointestinal bleed and lab data within 30 days prior to request. Anemia associated with one of the following: Chronic renal failure patients on dialysis with hgb less than 11g/dL (prior to treatment) or non dialiysis patients with hgb less than 10g/dL AND transferrin saturation should be at least 20% AND ferritin at least 100ng/mL. Zidovudine-treated HIV-infected patients with zidovudine dose less than 4,200 mg/week. Hgb below 10g/dL for initiation, serum erythropoietin levels 500mUnits/mL or less, Serum ferritin greater than100ng/ml, and transferrin sat.greater than 20%. Continuation of therapy is approved for hgb level less than 12g/dL. Anemia due to chemotherapy treatment of non-myeloid malignancies (where anemia is not caused by other factors) and hgb prior to therapy initation is less than 10g/dL (or Hct is less than 30%), continuation of therapy during concomitant chemotherapy requires Hgb less than 12 g/dl. Reduction of allogenic blood transfusion for patients scheduled to undergo elective, non-cardiac, nonvascular surgery with anemia and hemoglobin greater Required_Medical_Information than10 g/dl but less than 12 g/dl. For patients with cancer: prescribers must be under the ESA APPRISE Oncology program 3 months Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 21

22 Fabrazyme Required_Medical_Information Diagnosis Fentora Coverage not provided in the management of acute or postoperative pain, opiod non-tolerant patients, patients with known intolerance or hypersensitivity to the drug or fentanyl Diagnosis of cancer and use is for breakthrough cancer pain AND other formulary short acting narcotics have been ineffective, not tolerated, or contraindicated AND patient is opioid tolerant and taking at least 60 mg morphine/day or an equianalgesic dose of another opioid for a week or Required_Medical_Information longer Patient must be at least 18 years of age 6 months Patient must have tried and failed or not responded to the following formulary short acting narcotics, Oxycodone and morphine. Ferriprox 22

23 Required_Medical_Information Diagnosis of transfusional iron overload due to thalassemia syndromes AND patient has failed prior chelation therapy with Desferal or Exjade (failure is defined as a serum ferritin level greater than 2,500 mcg/l) or patient has a contraindication or intolerance to Desferal or Exjade AND Patient has an absolute neutrophil count greater than 1.5 x 109/L. For renewal, patient has experienced at least a 20% reduction in serum ferritin levels and has an absolute neutrophil count greater than 0.5 x 109/L Firazyr Diagnosis of hereditary angioedema AND medication will Required_Medical_Information be used for the treatment of acute attacks. 18 years of age or older Flector Known hypersensitivity to diclofenac. Previously experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Use for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Application 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 AND patient had experienced treatment failure with at least 2 prescription strength oral NSAIDs or patient has a documented Required_Medical_Information swallowing disorder. 23

24 14 days Forteo BMD scan with a T score of -2.5 or less AND High risk of fracture or those with a history of a previous fracture who have failed treatment with bisphosphonates. Member has had at least one fracture or has multiple risk factors for fracture OR member has BMD screening results of -2.5 or below AND member has had a 3 month trial, failure or adverse reaction to 1 oral bisphosphonate (alendronate Required_Medical_Information and ibandronic acid) and Boniva Inj. Preferred bisphosphonate agents include: Alendronate,Ibandronic Acid, and Boniva. Gastrointestinal Agents (High Risk Medications) Required_Medical_Information Diagnosis: AND, 1.) 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 24

25 Gattex Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer Diagnosis of short bowel syndrome AND patient is receiving specialized nutritional support (i.e. parenteral Required_Medical_Information nutrition) 18 years of age or older For renewal, patient has a reduced need for parenteral support (20% reduction) after at least 6 months of therapy. Gilenya Required_Medical_Information Patient is diagnosed with a relapsing form of MS. AND, Has had a trial and failure or intolerance to one of the following preferred therapies: Avonex or Betaseron Patient is 18 years of age or older Patient should be monitored following the first dose for signs and symptoms of bradycardia. Glassia IgA deficiency with known anti-iga antibody, current smoker 25

26 Required_Medical_Information Diagnosis of emphysema AND patient has alpha-1 proteinase inhibitor deficiency AND patient has a high-risk phenotype (PiZZ, PiZ(null), Pi(null) (null), or other phenotype associated with serum alpha-1 antitrypsin concentrations of less than 11 um/l (80 mg/dl). Gleevec Required_Medical_Information Diagnosis Prescribing physician must be a hematology/oncology specialist or have consulted with one ONLY APPLIES to NEW STARTS Humira Patients with mild rheumatoid arthritis, patients with mild Crohn s disease, patients with an active, serious infection, patients with a latent tuberculosis infection, concurrent use of anakinra 26

27 Required_Medical_Information Rheumatoid and Psoriatic arthritis: Patient has had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDS): Methotrexate, Sulfasalazine, hydroxychloroquine, injectable gold, azathioprine, or penicillamine.(humira can be used in combination with methotrexate for patients who do not respond adequately to methotrexate alone.) Juvenile rheumatoid arthritis: diagnosis of moderate to severe, active polyarticular JIA and documented failure of methotrexate, following an appropriate treatment period, and one (preferably ibuprofen, naproxen or meloxicam). Moderate to Severe Active Crohn's disease: Patient has had inadequate response to one or more of the following: Sulfasalazine or azathioprine only, oral 5-ASA products (mesalamine, Asacol, Pentasa, Apriso, etc.), corticosteroids (Entocort EC, prednisone, etc.). Ankylosing Spondylitis: Non-therapeutic response to the maximum tolerated dose of at least two nonsteroidal antiinflammatory drugs (NSAIDS: sulindac, naproxen, diclofenac) or including a cyclo-oxygenase (COX)-2- selective inhibitor Celebrex. Plaque Psoriasis - At least 2 of the following treatment:: The use of topical steroids, the use of either Tazorac (tazorotene), Methotrexate, Oxsoralen, UVB phototherapy and/or PUVA treatment. Ilaris Diagnosis of cryopyrin-associated period syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and/or Muckle-Wells Syndrome (MWS), or Systemic Juvenile Idiopathic Arthritis (SJIA). Required_Medical_Information 2 years of age or older for SJIA 27

28 Prescribed by or in consultation with or recommendation of, an immunologist, allergist, dermatologist, rheumatologist, neurologist, or other medical specialist Approve doses based on FDA labeling Incivek Pregnant. Unwilling to comply with required contraception methods. Co-administration with alfuzosin, cisapride, dihydroergotamine, drosperinone, ergonovine, ergotamine, lovastatin, methylergonovine, midazolam (oral), pimozide, rifampin, sildenafil (Revatio), simvastatin, St. John's wort, tadalafil (Adcirca), triazolam Diagnosis of chronic hepatitis C genotype 1 with compensated liver disease AND medication will be used with ribavirin and peginterferon alfa AND Has not previously failed a treatment regimen with a hepatitis C Required_Medical_Information protease inhibitor. Patient is 18 years of age or older Initial - 8 weeks. Renewal - 4 weeks for a total of 12 weeks. For renewal, patient continue to receive concurrent therapy with ribavirin and peginterferon alfa AND viral load at week 4 is 1,000 IU/mL or less, the patient has not experienced a serious skin reaction while on therapy. Increlex Insulin-like growth factor therapy is considered NOT medically necessary when any of the following criteria are met: Final adult height has been reached as determined by the 5th percentile of adult height OR the bone epiphyses are closed OR the patient is older than 18 years of age. Required_Medical_Information Diagnosis, Labs (IGF-1, GH) 28

29 The patient is between 2 years -18 years old for Increlex therapy Licensed Practioner Infergen Uncontrolled depression. Autoimmune hepatitis or other autoimmune condition known to be exacerbated by interferon and ribavirin. Excluded from use with protease inhibitors as triple therapy. Required_Medical_Information For Hepatitis C: positive hepatitis C viral load. Prescribing physician must be gastroenterologist, hepatologist or infectious disease specialist Intron-A Uncontrolled depression. Solid organ transplant other than liver. Autoimmune hepatitis or other autoimmune condition known to be exacerbated by interferon and ribavirin. Excluded from use as triple therapy with protease inhibitors. 29

30 Required_Medical_Information Diagnosis of hairy cell leukemia OR Diagnosis of Condylomata acuminata OR Diagnosis of AIDS-related Kaposi's sarcoma OR Clinically aggressive follicular lymphoma and the medication will be used concurrently with anthracycline-containing chemotherapy or is not a candidate for anthracycline-containing chemotherapy OR Malignant melanoma and the request for coverage is within 56 days of surgery and the patient is at high risk of disease recurrence OR Diagnosis of chronic hepatitis B with compensated liver disease and patient has evidence of hepatitis B viral replication and patient has been serum hepatitis B surface antigen-positive for at least 6 months OR DIagnosis of chronic hepatitis C with compensated liver disease and is receiving combination therapy with ribavirin, unless ribavirin is contraindicated. 1 yr chronic Hep C, 6 mo-1yr Hep B, All other approved indications - plan year ONLY APPLIES to NEW STARTS for Cancer Patients. Itraconazole Coadministration with cisapride, dofetilide, oral midazolam, pimozide, levacetylmethadol, quinidine, lovastatin, simvastatin, triazolam, ergot alkaloids metabolized by CYP3A4 (such as dihydroergotamine, ergometrine, ergotamine and methylergometrine), congestive heart failure or history of (capsules for treatment of onychomycosis), pregnant women or women contemplating pregnancy (capsules for treatment of onychomycosis), hypersensitivity to itraconazole. Onychomycosis: documented positive KOH test or other lab documenting diagnosis AND trial/failure or contraindication to terbinafine and topical ciclopirox. For Required_Medical_Information Aspergillosis, histoplasmosis, or blastomycosis: Approve. 30

31 Juxtapid Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests. Pregnancy. Concomitant use with strong or moderate CYP3A4 inhibitors. Diagnosis of homozygous familial hypercholesterolemia AND Medication will be used as adjunct to a low-fat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response or intolerance to statins AND Patient has tried and had an inadequate response or Required_Medical_Information intolerance to the following: lipid apheresis. Initial - 6 months. Renewal - For renewal, patient has responded to therapy with a decrease in LDL levels. Kalydeco Diagnosis of cystic fibrosis AND Patient has a known G551D mutation on at least one allele in the cystic fibrosis transmembrane conductance regulator gene documented by an FDA-cleared cystic fibrosis-mutation test that Required_Medical_Information includes measurement of the G551D mutation. 6 years of age or older Kineret 31

32 Diagnosis of moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs)for at least 3 consecutive months OR Diagnosis of cryopyrin-associated periodic syndrome (CAPS) with neonatal-onset multisystem Required_Medical_Information inflammatory disease (NOMID). 18 years of age or older for rheumatoid arthritis For CAPS, diagnosed by, or upon consultation with or recommendation of, an immunologist, allergist, dermatologist, rheumatologist, neurologist or other medical specialist. 6 mo-refractory chronic infantile neurological, cutaneous and articular syndrome, 1 yr-all others Patient has been tested for TB and latent TB has been ruled out or is being treated. Dosing as per the FDA labeling for rheumatoid arthritis. Kuvan Diagnosis of phenylketonuria (PKU) and patient is and will Required_Medical_Information be maintained on a phenylalanine-restricted diet 2 months to determine response, if response is positive, then approve for remainder of plan year. Response is defined as a 20% or greater reduction of blood Phe level from baseline during treatment for 1 2 months Kynamro 32

33 Required_Medical_Information Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests. Diagnosis of homozygous familial hypercholesterolemia AND Medication will be used as adjunct to a low-fat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response or intolerance to statins AND Patient has tried and had an inadequate response or intolerance to at least one of the following: ezetimibe, cholestyramine, or lipid apheresis. Initial - 6 months. Renewal - For renewal, patient has responded to therapy with a decrease in LDL levels. Letairis Letairis: known or suspected pregnancy Diagnosis of PAH with WHO class II or III symptoms, a negative response to the acute vasoreactivity test, and documented trial/failure to sildenafil or Adcirca. The dose/quantity requested must be supported by one of the three CMS accepted compendia (DrugDex, USP or AHFS) or a published, peer reviewed article found on Medline with the supporting documentation in such literature being Required_Medical_Information specific to that indication. Must be a provider enrolled in the Letairis Education Access Program (LEAP) Leukine 33

34 Required_Medical_Information Diagnosis of one of the following: A) Patient has undergone allogeneic or autologous bone marrow transplant (BMT) and engraftment is delayed or failed and Patient does not have excessive leukemic myeloid blasts in bone marrow/peripheral blood (more than 10%) OR B) Patient is undergoing autologous peripheral-blood progenitor cell transplant to mobilize progenitor cells for collection by leukapheresis OR C) Medication will be used for myeloid reconstitution after an autologous or allogeneic BMT OR D) Patient has acute myeloid leukemia and administration will be after completion of induction chemotherapy. Linzess Mechanical gastrointestinal obstruction. Diagnosis of irritable bowel syndrome-constipation for at least 12 non-consecutive weeks and patient has tried and failed increasing fluid and fiber intake and patient has tried and failed or has an intolerance to osmotic laxatives, stimulant laxatives or probiotics OR Diagnosis of chronic idiopathic constipation for at least 3 months and patient has tried and failed increasing fluid and fiber intake and patient has tried and failed or has an intolerance to osmotic Required_Medical_Information laxatives, stimulant laxatives and stool softeners. 18 years of age or older Initial - 4 months. Renewal - Lumizyme, Myozyme 34

35 Required_Medical_Information Diagnosis: 1) Lumizyme used for late (non-infantile) onset Pompe disease (GAA) deficiency and the patient does not have evidence of cardiac hypertrophy. 2) Myozyme used for patients with infantile-onset Pompe disease (GAA deficiency). Lyrica Approve for the diagnosis of seizure disorder. For post herpetic neuralgia, trial and failure of preferred alternative, gabapentin is required. For Fibromyalgia: trial and failure or intolerance to Cymbalta is required. For Diabetic Peripheral Neuroathy trial and failure or intolerance to Cymbalta is Required_Medical_Information required. ONLY APPLIES TO NEW STARTS for Seizure Disorders. Mozobil Pregnant. Breast feeding. Patient is to undergo autologous stem cell transplantation for the treatment of non-hodgkin's lymphoma or multiple myeloma AND Patient will concomitantly receive a daily dose of a granulocyte colony-stimulating factor (G-CSF) for 4 days prior to the first evening dose of Mozobil and on Required_Medical_Information each day prior to apheresis while using Mozobil. 4 days 35

36 Neulasta Required_Medical_Information Diagnosis, chemo regimen, patient history when applicable. Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Forward to clinical pharmacist to review. Neumega Documented diagnosis of Chemo-induced thrombocytopenia AND Platelet count less than 50,000 Required_Medical_Information cells/microliter. Certified hematologist and/or oncologist Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Neupogen 36

37 Required_Medical_Information Diagnosis of the any of the indications and the following information must be obtained before approval is authorized: patient s weight, most recent (within the past week) CBC with differential or absolute neutrophil count (ANC) (for chemotherapeutic regimens where patient has had history of significant neutropenia while on chemotherapy, provide CBC with diff. or ANC of last chemo cycle where patient experienced neutropenia), dose to administer, duration of therapy, target ANC or target WBC. Clinical trial data shows no clinical benefit seen once an ANC is greater than 10,000/mm3. Home or LTC administration covered under Medicare Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Octreotide, Sandostatin, Zorbtive Diagnosis of acromegaly OR Diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea and flushing episodes OR Diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse Required_Medical_Information watery diarrhea. Labs, IGF-1, Glucose. Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Oral Estrogens (High Risk Medications) 37

38 Required_Medical_Information Diagnosis: AND, 1.) 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 Orencia Moderate to severe rheumatoid arthritis. The patient must have had an inadequate response to conventional treatment including methotrexate with or without one or more disease modifying anti- rheumatic drugs (DMARDs) +/- NSAIDs unless contraindicated or intolerant.the patient has had an inadequate response to one TNF antagonist therapy Remicade, Humira, or Enbrel. Moderate to severe polyarticular juvenile idiopathic arthritis and patient had an inadequate response, intolerance or contraindication to one or more non-biologic DMARDs for at least 3 consecutive months and patient had an inadequate response to one or more tumor necrosis factor inhibitors. An inadequate response can be defined as therapy was ineffective, not tolerated, or other clinical circumstance exists that Required_Medical_Information precludes use. Licensed Practioner highly familiar with the use and monitoring of special biologic response modifiers Pegasys 38

39 Required_Medical_Information Hepatitis C: positive hepatitis C viral load, with compensated liver disease AND no signs or symptoms of jaundice, ascites, active gastrointestinal bleeding, and encephalopathy. Required information for HCV:Baseline serunm HCV RNA and Statement indicating Hep C genotype. For Hepatitis B with compensated liver disease and evidence of viral replication and live inflammation. Peg-Intron Approved for the following diagnosis.hepatitis C AND the following labs are provided: HCV RNA levels, AST/ALT Required_Medical_Information levels, genotype, with or without results of liver biopsy. Prolastin-C IgA deficiency with known anti-iga antibody Required_Medical_Information Diagnosis of emphysema AND patient has alpha-1 proteinase inhibitor deficiency AND patient has a high-risk phenotype (PiZZ, PiZ(null), Pi(null) (null), or other phenotype associated with serum alpha-1 antitrypsin concentrations of less than 11 um/l (80 mg/dl) 39

40 Promacta Diagnosis of one of the following: A) Relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months AND Baseline platelet count is less than 50,000/mcL AND Degree of thrombocytopenia and clinical condition increase the risk of bleeding AND Patient had an insufficient response, intolerance, contraindication to corticosteroids or immune globulin or inadequate response or contraindication to splenectomy, B)Chronic hepatitis C and patient has thrombocytopenia defined as platelets less than 90,000/mcL for initiation (pre-treatment) of interferon Required_Medical_Information therapy. Qualaquin Coverage is not provided for patients with any of the following contraindications to therapy: prolongation of QT interval, glucose-6-phosphate dehydrogenase (G6PD) deficiency, myasthenia gravis, Known hypersensitivity to quinine, mefloquine, or quinidine, or optic neuritis. Patient is being treated for uncomplicated Plasmodium Required_Medical_Information falciparum malaria Patient is 16 years of age or older 1 month 40

41 Relistor Coverage is not provided for use nausea, vomiting, pruritis, or urinary retention related to morphine or other opioids. Diagnosis of opioid-induced constipation AND Patient has used opioid medication for a minimum of 2 weeks AND Patient is experiencing fewer than 3 bowel movements in a week or no bowel movement for longer than 2 days AND Patient is diagnosed with an advanced illness (e.g., incurable cancer, end-stage chronic obstructive pulmonary disease/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, etc.) AND Patient is receiving palliative care AND Patient has tried and had an insufficient response to at least 2 formulary agents: lactulose, PEG 3350 or Amitiza. Required_Medical_Information 4 Months Remicade Diagnosis, AND documentation of trial and failure or intolerance with the following: Rheumatoid Arthritis: Either Methotrexate OR generic leflunomide (Arava). Ankylosing Spondylitis: One nonsteroidal anti-inflammatory drugs (NSAIDS) OR a cyclo-oxygenase (COX)-2-selective inhibitor. Chronic Plaque Psoriasis: Member must have tried a DMARD in the past year. Psoriatic Arthritis: The member must have used two corticosteroids. Moderately to severely active ulcerative colitis. The member must have an inadequate response to conventional therapy including: Required_Medical_Information 5-aminosalicylic acids (5-ASAs) OR Corticosteroids. 41

42 Moderately active Crohn's disease: Inadequate response to Entocort EC. Revlimid Diagnosis of multiple myeloma: LABS, Platelet count, ANC, pregnancy test if female. Diagnosis of transfusiondependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Diagnosis of mantle cell lymphoma (MCL): documentated treatment with at least 1 prior agent, either Velcare or Rituxan, AND Labs including ANC and platelet count, pregnancy test if female. Required_Medical_Information 6 months Patient is enrolled in the RevAssist Program. ONLY APPLIES to NEW STARTS Sabril 42

43 Required_Medical_Information Diagnosis and treatment failure or intolerence with one or more of lower tier AED drugs: carbamazepine, phenytoin, lamotrigine, valproic acid, levetiracetam. Neurologist ONLY APPLIES TO NEW STARTS Somatropin Growth promotion in pediatric patients with closed epiphyses, evidence of active malignancy, progression of any underlying intracranial lesion or actively growing intracranial tumor, acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure, active proliferative or severe nonproliferative diabetic retinopathy, or in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. 43

44 Required_Medical_Information NEW THERAPY: Children: Criteria 1, 2 or 3 are required PLUS one below for approval x 1 year. 1. Child has hypopituitarism. 2. Child has failed two provocative growth hormone tests. 3. Child is to be treated for short stature associated with Turner Syndrome. PLUS ONE OF THESE A) A height of greater than 2.5 standard deviations below the median for age. B) A yearly growth rate of less than 4.5 cm/yr. C) A bone age of 2 standard deviations below chronological age. D) For Turner's Syndrome only - must supply height information- 1. Present height below 5th percentile 2. A height of greater than 2.0 standard deviations below the median for age. If none of the information above is provided send to Clinical Pharmacist. Adults (new therapy) MD must provide one of the following diagnosis: 1. Adult growth hormone deficiency 2. Cachexia or 3. HIV / AIDS wasting, or 4. Short bowel syndrome. If diagnosis is growth hormone deficiency, MD must document failure of two growth hormone tests. If diagnosis is cachexia or HIV / AIDS wasting, must answer YES to patient receiving concomitant antiretroviral therapy. If answer is yes approve for Serostim only. If diagnosis is short bowel syndrome, must answer YES to patient receiving specialized nutritional support. If answer is yes approve for Zorbitive 8mg/day x 4 weeks only. 4 weeks (adults with short bowel syndrome), (all other diagnoses) Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Somavert Hypersensitivity to pegvisomant, polyethylene glycol, or any component of the formulation Diagnosis of acromegaly AND Inadequate response to surgery and/or radiation therapy and/or other medical therapies (such as dopamine agonists and/or somatostatin analogues) or patient is not a candidate for any of those Required_Medical_Information treatment options. 44

45 Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Sulfonylureas (High Risk Medications) Diagnosis: AND, 1.) 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, 2.) Patient has tried and failed ONE non-high risk formulary alternative (glipizide) Required_Medical_Information Applies to patients 65 years or older Tarceva Diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer and Tarceva will be used in combination with gemcitabine OR Diagnosis of locally advanced or metastatic (stage III or IV) non-small cell lung cancer with one of the following: A) failure with at least one prior chemotherapy regimen and Tarceva will be used as monotherapy, or B) no evidence of disease progression after four cycles of first-line platinum-based chemotherapy and Tarceva will be used as maintenance treatment and Tarceva will be used as monotherapy, or C) Patient has Required_Medical_Information known active epidermal growth factor receptor (EGFR) 45

46 mutation or gene amplification and Tarceva will be used first-line. Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. ONLY APPLIES to NEW STARTS Testosterone Male patients with normal or above normal testosterone levels (normal equal to ng/dl or mmol), breast cancer in males, hypersensitivity to testosterone or any component of the product, pregnancy, known or suspected prostate cancer, use of the gel or patch in women Diagnosis of hypogonadism (primary or hypogonadotropic) AND patient is male AND patient's serum testosterone (total or free) value and the laboratory reference value range reported by laboratory service AND diagnosis has been confirmed by a low-for-age serum testosterone (total or free) level defined by the normal laboratory reference Required_Medical_Information value Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 46

47 Tetrahydrocannabinol Nausea and Vomiting Associated with Cancer Chemotherapy (CINV): Patient is receiving cancer chemotherapy, AND Failure to 5HT-3 receptor antagonist, AND Failure to one of the following agents: Antihistamine, Corticosteroid, Prokinetic agent, Antipsychotic. AIDS Anorexia: Diagnosis of anorexia with weight loss in patients Required_Medical_Information with AIDS. CINV: 6 months, AIDS anorexia: Through benefit year CINV: tetrahydrocannabinol will be approved for continuation covered under Part B when patient is receiving chemotherapy Tracleer Receiving concomitant cyclosporine A or glyburide therapy. Aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin at least 2 times the upper limit of normal. Diagnosis of pulmonary arterial hypertension that was confirmed by right heart catheterization or Doppler echocardiogram if patient is unable to undergo a right heart catheterization (e.g., patient is frail, elderly, etc.) AND Patient has WHO Group I PAH AND Patient has New York Heart Association (NYHA) Functional Class II-IV AND pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception Required_Medical_Information in female patients of reproductive potential. Prescription is written by or in consultation with a pulmonologist or cardiologist 47