Drugs That Require Prior Authorization (PA) Before Being Approved for Coverage

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1 Drugs That Require Prior Authorization (PA) Before Being Approved for Coverage You will need authorization by your Senior Blue HMO/HMO-POS or Forever Blue Medicare PPO plan before filling prescriptions for the drugs shown in the chart below. BlueCross BlueShield of WNY will only provide coverage after it determines that the drug is being prescribed according to the criteria specified in the chart. You, your appointed representative, or your prescriber can request prior authorization by calling Member Services at (TTY only, call ). We are open October 1 - February 14 8 a.m. to 8 p.m., 7 days a week and February 15 - September 30 8 a.m. to 8 p.m., Monday - Friday. Calls to these numbers are free. You can also visit our website, PRIOR AUTHORIZATION MEDICATIONS Covered Uses Covered Uses ACTEMRA All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Tocilizumab should not be given in combination with tumor necrosis factor (TNF) antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, anakinra, rituximab, or tofacitinib. For rheumatoid arthritis (RA), approve for adults. Prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. Adults with RA, approve for patients who have tried for at least 3 months or who were intolerant to adalimumab, or etanercept. Systemic-onset JIA, approve for patients who have tried a systemic corticosteroid or MTX, leflunomide, or sulfasalazine or another DMARD such as etanercept, adalimumab, infliximab, or anakinra OR have systemic arthritis with active systemic features and features of poor prognosis (eg, arthritis of the hip, radiographic damage). ACTEMRA SQ All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Concurrent use with another biologic therapy (e.g., certolizumab, etanercept, adalimumab, anakinra, abatacept, infliximab, rituximab, golimumab) or with tofacitinib. RA - adults Prescribed by or in consultation with a rheumatologist. 12 months Last Updated: March 2014 Page 1

2 RA - The pt had a 3 month trial with tofacitinib or one of the following biologic DMARDs, unless intolerant: Actemra (IV), abatacept, rituximab, or a tumor necrosis factor (TNF) antagonist (e.g., etanercept, adalimumab, certolizumab, infliximab, or golimumab Last Updated: March 2014 Page 2

3 ACTHAR Covered Uses All FDA-approved indications not otherwise excluded from Part D. Use in patients with multiple sclerosis (MS) as pulse therapy on a monthly basis. MS exacerbation, history of corticosteroid use. Infantile spasms, prescribed by or in consultation with a neurologist or an epileptologist. MS exacerbation, prescribed by or in consultation with a neurologist or physician that specializes in the treatment of MS. Infantile spasms, 12 months. MS exacerbation, approve 1 month. For MS exacerbation, approve if the patient cannot use high-dose IV corticosteroids because IV access is not possible or if the patient has tried high-dose corticosteroids administered IV for an acute MS exacerbation and has experienced a severe or limiting adverse effect. ADEMPAS Covered Uses All FDA-approved indications not otherwise excluded from Part D. PAH and CTEPH- must be precribed by or in consultation with a cardiologist or a pulmonologist. 12 months For PAH - must have PAH (WHO Group 1) and had a right heart catheterization to confirm the diagnosis of PAH (WHO Group 1). Right heart cathererization is not required in pts who are currently receiving Adempas or another agent indicated for WHO group 1. Last Updated: March 2014 Page 3

4 Covered Uses Covered Uses Covered Uses AFINITOR All FDA-approved indications not otherwise excluded from Part D. Plus patients already taking Afinitor for a Covered HER2 status. Advanced HER2-negative breast cancer, hormone receptor (HR) status. Authorization will be for 12 months. Advanced HER2-negative breast cancer, approve if the patient is a postmenopausal woman and has HR+ disease and Afinitor will be used in combination with exemestane or tamoxifen and the patient has tried letrozole or anastrozole. Advanced renal cell carcinoma (RCC), approve if patient has tried sunitinib (Sutent) or sorafenib (Nexavar). Tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA), approve if the patient requires therapeutic intervention but cannot be curatively resected. ALFA INTERFERONS All FDA approved indications not otherwise excluded from Part D. Additional off-label uses covered are Essential For chronic hepatitis C: contraindications such as decompensated liver disease or when used in combination with another interferon product For Hepatitis C: quantifiable hepatitis C viral level. For Kaposi sarcoma: T cell count is greater than or equal to 400/mm3 or in the absence of an opportunistic infection. 12 months For treatment of condylomata acuminata: at least ONE conventional therapy such as, (but not limited to) topical imiquimod (Aldara), podofilox (Condylox) or liquid nitrogen cryotherapy, has failed to treat the patient. AMPYRA All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on dalfampridine MS. If prescribed by, or in consultation with, a neurologist or MS specialist. Authorization will be for 12 mos. Last Updated: March 2014 Page 4

5 ANABOLIC STEROIDS Covered Uses All FDA-approved indications not otherwise excluded from Part D. Girls w/turner's Syndrome or Ullrich-Turner Authorization will be for 12 months, unless otherwise specified. ANDROGENS Covered Uses All FDA approved indications not otherwise excluded from Part D. Coverage is provided for females for the palliative treatment of breast cancer. Coverage is provided for males for delayed puberty or the treatment of hypogonadism in situations where the patient has symptoms suggestive of androgen deficiency AND either a baseline (pre-treatment) serum testosterone level of less than or equal to 300 ng/dl (less than 10.4 nmol/l) or a baseline serum free testosterone levels below the lower limit of normal for the reporting lab. All indications 5 years, except delayed puberty: 6 months Last Updated: March 2014 Page 5

6 Covered Uses Covered Uses ARANESP All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal Confirmation of adequate iron stores (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%).Anemia w/crf on and not on dialysis.a hemoglobin (Hb) of less than 10.0 g/dl for adults and less than or equal to 11 g/dl for children required for start,hb has to be less than or equal 11.5 g/dl adults or less than or equal to 12 g/dl in children if previously receiving epoetin alfa (EA) or Aranesp. Anemia due to myelosuppressive chemotx,hb is 10.0 g/dl or less to start.hb less than or equal to 12.0 g/dl if previously on epoetin alfa EA.MDS, approve tx if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start. If the pt has previously been receiving Aranesp or EA, approve only if Hb is 12.0 g/dl or less. All conds, deny if Hb exceeds 12.0 g/dl. MDS anemia = 18 years of age and older. MDS anemia, prescribed by or in consultation with, a hematologist or oncologist. Anemia w/myelosuppressive = 4 mos, Other=6 mos. Part B versus Part D determination will be made at time of prior authorization review per CMS guidance to establish if the drug prescribed is to be used for an end-stage renal disease (ESRD)-related condition. AVONEX All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Avonex for a Concurrent use of other disease-modifying agent used for multiple sclerosis (ie, interferon beta-1a, interferon beta-1b, glatiramer, natalizumab, fingolimod). Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 6

7 BETASERON/EXTAVIA Covered Uses All FDA-approved indications not otherwise excluded from Part D. Concurrent use of Avonex, Rebif, Copaxone, Tysabri, or fingolimod (Gilenya). Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months, unless otherwise specified. For patients requesting Betaseron, approve if the patient has previously tried Avonex or Rebif. Last Updated: March 2014 Page 7

8 Covered Uses Covered Uses BOSULIF All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Bosulif for a Diagnosis for which Bosulif is being used. For chronic myelogenous leukemia (CML), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For CML, prior therapies tried must be reported to confirm resistance or intolerance. Authorization will be for 12 months. For CML, patient must have Ph-positive CML and must have resistance or intolerance to prior therapy for approval. BOTOX All FDA-approved indications not otherwise excluded from Part D. Plus Achalasia. Anal Fissure. BPH. Chronic facial Use in the management of cosmetic uses (eg, facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platsymal bands, rejuvenation of the peri-orbital region), allergic rhinitis, gait freezing in Parkinsons disease, vaginismus, interstitial cystitis, trigeminal neuralgia, or Crocodile tears syndrome. Headache if prescribed by, or after consultation with, a neurologist or HA specialist. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 8

9 Covered Uses Primary axillary hyperhydrosis after trial with at least 1 topical agent (eg, aluminum chloride). BPH after trial with at least 2 other therapies (eg, alpha1-blocker, 5 alpha-reductase inhibitor, TURP, transurethral microwave heat treatment, TUNA, interstitial laser therapy, stents, various forms of surgery). Chronic low back pain after trial with at least 2 other pharmacologic therapies (eg, NSAID, antispasmodics, muscle relaxants, opioids, antidepressants) and if being used as part of a multimodal therapeutic pain management program. Headache (eg, migraine, chronic tension headache, whiplash, chronic daily headache) after a trial with at least 2 other pharmacologic therapies (eg, anticonvulsants, antidepressants, beta-blockers, calcium channel blockers, non-steroidal anti-inflammatory drugs). Palmar/plantar and facial hyperhidrosis after a trial with at least 1 topical agent (eg, aluminum chloride). Essential tremor after a trial with at least 1 other pharmacologic therapy (eg, primidone, propranolol, benzodiazepines, gabapentin, topiramate). Urinary incontinence after a trial with at least 1 other pharmacologic therapy (eg, oral antimuscarinic agents). Tourette s syndrome if after a trial with at least 1 more commonly used pharmacologic therapy (eg, neuroleptics, clonidine, SSRIs, psychostimulants). CELEBREX All medically accepted indications not otherwise excluded from Part D Coverage is not provided for the treatment/prevention of Alzheimer's disease or cancer. Coverage is provided when the pt has previously been unable to tolerate therapy with at least two other different NSAIDs OR is at high risk of NSAID induced adverse GI events evidenced by any of the following: 1. history of peptic ulcer disease, history of NSAID related ulcer, or history of clinically significant GI bleeding or 2. Concomitant therapy with anticoagulants (e.g. warfarin, heparin, or LMWH), chronic use of oral corticosteroids, or Non-aspirin anti-platelet agents (e.g. clopidogrel, ticagrelor, or prasugrel). Patients 65 years of age and older are exempt from the required medical information. For JRA, pt must be 2 years of age or older Lifetime for JRA/ 12 months for all other indications Last Updated: March 2014 Page 9

10 CHANTIX Covered Uses All FDA-approved indications not otherwise excluded from Part D. The patient must be enrolled in a behavioral support/ modification program (e.g., community program, manufacturer sponsored program, counseling by the physician, internet, or telephone quitline). The patient must be 18 years of age or older 6 months CHENODAL Covered Uses All FDA-approved indications not otherwise excluded from Part D. Authorization will be for 12 months. For the treatment of gallstones, approve if the patient has tried or is currently using an ursodiol product. Last Updated: March 2014 Page 10

11 Covered Uses CIMZIA All FDA-approved indications not otherwise excluded from Part D plus patients already started on certolizumab pegol Concurrent use with tumor necrosis factor (TNF) alpha antagonists (eg, adalimumab, etanercept, golimumab, and infliximab), or anakinra, rituximab, abatacept, natalizumab, tocilizumab. Covered Uses Adults. RA, prescribed by or in consultation with a rheumatologist. Crohn s disease, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months. Adult RA, approve if the patient has tried Enbrel or Humira for at least 3 months OR the patient is concurrently receiving MTX OR the patient has a contraindication or intolerance to MTX and leflunomide OR the patient has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation (eg, based on HAQ-DI score), extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. Adult CD, approve if patient has previously tried Humira OR the patient has tried or is currently taking corticosteroids, unless contraindicated. CINRYZE All FDA-approved indications not otherwise excluded from Part D. Plus for the acute treatment of Hereditary Must be prescribed by, or in consultation with, an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Last Updated: March 2014 Page 11

12 Authorization will be for 12 months. Last Updated: March 2014 Page 12

13 Covered Uses Covered Uses COLONY STIMULATING FACTORS All FDA-approved indications not otherwise excluded from Part D. Additional off-label coverage is provided for Combination therapy with Neulasta, Neupogen or Leukine. Patient has experienced neutropenia from previous chemotherapy OR for patient is considered to be at high risk for the development of neutropenia. High risk for neutropenia is define by pre-existing neutropenia due to disease, chemo regimen associated with a high incidence of febrile neutropenia, extensive prior chemotherapy, previous radiation to areas containing large amounts of bone marrow, pts at high risk for infection (such as advanced cancer, decreased immune function, open wounds, and active infection). Coverage is provided for: Myelodysplasia when ANC is less than or equal to 1000/mm3, Severe chronic neutropenia (i.e., Neutropenic disorder, cyclic neutropenia) when ANC is less than or equal to 1500/mm3, bone marrow transplant when ANC is less than or equal to 1000/mm3, Current or post peripheral blood progenitor cell (PBPC) mobilization/transplantation (i.e., harvesting of peripheral blood stem cells) when ANC is less than or equal to 1500/mm3 12 months COMETRIQ All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Diagnosis of progressive, metastatic medullary thyroid cancer. Authorization will be for 12 months. Last Updated: March 2014 Page 13

14 Last Updated: March 2014 Page 14

15 COPAXONE All FDA-approved indications not otherwise excluded from Part D. Covered Uses Concurrent use with other disease-modifying agent used for multiple scelorosis (ie, interferon beta-1a, interferon beta- 1b, natalizumab, fingolimod). Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 15

16 Covered Uses Covered Uses ENBREL All FDA-approved indications not otherwise excluded from Part D plus patient already on etanercept for a Covered Concurrent use with adalimumab, anakinra, abatacept, certolizumab pegol, ustekinumab, infliximab, rituximab, golimumab, or tocilizumab. For use in rheumatoid arthritis (RA), approve for adults. For juvenile idiopathic arthritis (JIA) approve for children aged 2 years and older. RA/Ankylosing spondylitis/jia/jra,prescribed by or in consult w/ rheumatologist. Psoriatic arthritis, prescribed by or in consultation w/ rheumatologist or dermatologist.plaque psoriasis (PP)/AMBD, prescribed by or in consult w/ dermatologist.gvhd,prescribed by or in consult w/ oncologist,hematologist,or physician affiliated w/ transplant center.behcet s disease,prescribed by or in consult w/ rheumatologist,dermatologist,ophthalmologist,gastroenterologist,or neurologist. Uveitis- ophthalmol Authorization will be for 12 months, unless otherwise specified. RA, Tried 1 DMARD for 3 mos or is also receiving MTX, has a contraindication or intolerance to MTX and leflunomide, or has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. JIA/JRA, approve if the pt has aggressive disease or the pt has tried one other agent for this condition (eg, MTX, sulfasalazine, leflunomide, NSAID, biologic DMARD or the pt will be started on Enbrel concurrently with MTX, sulfasalazine, or leflunomide or the pt has an absolute contraindication to MTX (eg, pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias), sulfasalazine, or leflunomide.plaque psoriasis (PP). Approve if the patient has tried at least one of the following agents for at least 3 months for plaque psoriasis: an oral therapy for psoriasis (eg, MTX, cyclosporine, Soriatane), oral methoxsalen plus PUVA, or a biologic agent OR the patient had intolerance to a trial of at least one oral or biologic therapy for plaque psoriasis OR the patient has a contraindication to one oral agent for psoriasis such as MTX. GVHD. Tried or currently is receiving with etanercept 1 conventional GVHD tx (high-dose SC, CSA, tacrolimus, MM, thalidomide, antithymocyte globulin, etc.). Behcet's. Have not responded to at least 1 conventional tx (eg, CS, immunosuppressant, interferon alfa, MM, etc) or adalimumab or infliximab. AMBD. Tried 2 conventional txs (eg, systemic corticosteroids, azathioprine, cyclophosphamide, dapsone, MTX, cyclosporine, mycophenolate mofetil). Uveitis, tried 1 of the following periocular, intraocular, or systemic CS, immunosuppressives, Humira or Remicade EPOETIN/PROCRIT All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal Last Updated: March 2014 Page 16

17 Covered Uses Confirmation of adequate iron stores (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%).CRF anemia in patients on dialysis.hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl for children to start.hb less than or equal to 11.5 g/dl for adults or 12 g/dl or less for children if previously on epoetin alfa or Aranesp.CRF anemia in patients not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl in children to start or Hb less than or equal to 11.5 g/dl in adults or 12 g/dl or less in children.anemia w/myelosuppressive chemotx.hb 10.0 g/dl or less to start.hb less than or equal to 12.0 g/dl if previously on epoetin alfa or Aranesp.MDS, approve if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start.previously receiving Aranesp or EA, approve if Hb is 12.0 g/dl or less. Anemia in HIV (with or without zidovudine), Hb is 10.0 g/dl or less or endogenous erythropoetin levels are 500 munits/ml or less at tx start.previously on EA approve if Hb is 12.0 g/dl or less.anemia due to ribavirin for Hep C, Hb is 10.0 g/dl or less at tx start. Previously on EA or Aranesp approve if Hb is 12.0 g/dl or less. MDS anemia/hepc anemia = 18 years of age and older MDS anemia, prescribed by or in consultation with, a hematologist or oncologist. Hep C anemia, prescribed by or in consultation with hepatologist, gastroenterologist or infectious disease physician who specializes in the management of hepatitis C. Anemia w/myelosuppressive = 4 mos.mds=6mo.transfus=1 mo.other=6mo. HIV + zidovudine = 4 mo Part B versus Part D determination will be made at time of prior authorization review per CMS guidance to establish if the drug prescribed is to be used for an end-stage renal disease (ESRD)-related condition. For all covered uses, if the request is for Epogen, then the patient is required to try Procrit or Aranesp first line. ERIVEDGE All FDA-approved indications not otherwise excluded from Part D. Plus, patient already started on Erivedge for a Last Updated: March 2014 Page 17

18 Authorization will be for 12 months Last Updated: March 2014 Page 18

19 Locally advanced basal cell carcinoma (LABCC), approve if the patient s BCC has recurred following surgery or the patient is not a candidate for surgery or radiation therapy. Last Updated: March 2014 Page 19

20 GILENYA Covered Uses All FDA-approved indications not otherwise excluded from Part D. Concurrent use of Gilenya with other disease-modifying agents used for multiple sclerosis (MS). For use in MS, patient has a relapsing form of MS. Prescribed by, or in consultation with, a neurologist or an MS specialist. Authorization will be for 12 months. For use in MS, patient has a relapsing form of MS and is not currently taking Gilenya, approve if the patient has tried interferon beta-1a intramuscular (Avonex), interferon beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone), teriflunomide (Aubagio), or natalizumab (Tysabri) or if the patient is unable to administer injections due to dexterity issues or visual impairment. Patient has a relapsing form of MS and is currently receiving Gilenya, approve without a trial of a disease modifying injectable for MS. Last Updated: March 2014 Page 20

21 GILOTRIF Covered Uses All FDA-approved indications not otherwise excluded from Part D. For NSCLC - EGFR exon deletions or mutations Authorization will be for 12 months. For the treatment of metastatic non small cell lung cancer (NSCLC) must be used in tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations GROWTH HORMONES Covered Uses All FDA-approved indications not otherwise excluded from Part D. Growth hormone (GH) deficiency (DF). Non-GH Use in the management of acute critical illness due to complications of surgery, trauma, or with acute respiratory failure, as antiaging therapy, to improve functional status in elderly, somatopause, enhancement of athletic ability, bone marrow transplant (BMT) without total body irradiation, bony dysplasias, burn injury, cardiac transplantation, central precocius puberty, chronic fatigue syndrome, congenital adrenal hyperplasia, constitutional delay of growth and puberty, corticosteroid-induced short stature including a variety of chronic glucocorticoid-dependent conditions, such as asthma, juvenile rheumatoid arthritis, after renal, heart, liver, or BMT, Crohn's disease, cystic fibrosis, dilated cardiomyopathy/heart failure, end-stage renal disease in adults undergoing hemodialysis, Down's syndrome, familial dysautonomia, fibromyalgia, HIV-infected patients with alterations in body fat distribution, infertility, kidney transplant patients (children) with a functional renal allograft, liver transplantation, multiple system atrophy, myelomeningocele, obesity, osteogenesis imperfecta, osteoporosis (postmenopausal, idiopathic in men, glucocorticoid-induced), thalassemia, and X-linked hypophosphatemic rickets (familial hypophosphatemia, hypophosphatemic rickets). Last Updated: March 2014 Page 21

22 Child/adol GH DF initial tx, eval by an endocrin, documented GH stim test w/gh response less than 10 ng/ml AND base Ht less than the 10th pct for gender/age + pretx Ht growth rate (GR) child less than 3 yrs of less than 7 cm/yr and child greater than or equal to 3 yrs of less than 4 cm/yr OR child/adol less than 18 yrs of age GR less than the 10th pct for age/gender based on min 6 mo data.child w/brain radiation does not have to meet bas Ht crit.congenital hypopituit does not have to meet Ht or GR crit.child w/hypophysectomy,approve.child/adol GH DF cont tx, GR increased by 4 cm/yr or more in most recent yr (MRY) + epiphyses open (between 12 and 18 yrs),both crit exclude adol w/hypopituit.review GR annually.adoles/yng adult w/completed linear growth (GR less than 2 cm/yr), review for adult GH DF.Greater than 18 yrs,gr increased by 4 cm/yr or more in MRY AND epiphyses open, auth not allowed if midparental ht attained.iss child w/open epiphyses,6 mo trial if base Ht less than 5th pct + pretx GR child greater than or equal to 7 yrs of less than 4 cm/yr and child 3 or more yrs of less than 4 cm/yr OR child any age GR less than the 10th pct for age/gender based on min 6 mo of data and has condition which GH effective + endocrinol certifies via bone-age x- ray, + the pt doesn t have constitutional delay of growth and puberty (CDGP).Auth after initial tx based on adequate clinical response (annualized GR doubles).cont tx, at least 7 yrs and received somatropin on 6 mo trial, if GR has doubled in comparison to previous yr. At least 7 and less than 12 yrs, GR increased by 4 cm/yr or more in MRY. At least 12 and less than or equal to 18 yrs), GR increased by 4 cm/yr or more in MRY AND epiphyses open).greater than 18 yrs, GR increased by 4 cm/yr or more in MRY,+ epiphyses open auth not allowed if midparental ht attained.adult GH DF or PW/trans adoles, eval by endocrinol (start and annually).ns/shox/child PW, eval by an endocrinol, CKD, eval by an endocrinol or nephrologist. Child/adolesc w/gh DF (initial tx), adolescent is less than or equal to 18 years of age.ts, children. SHOX/CRI/NS, children/adolescents.hiv infection w/wasting or cachexia, less than or equal to 18 years of age.sbs/hiv cachexia/wasting, adults. For adults, the endocrinologist must certify that the somatropin is not being prescribed for anti-aging therapy or to enhance athletic ability. GH DF 12 mos.sbs 4-8wks/yr.Non-GH DF ISS 6 mos.hiv wast/cach 24 wks. Last Updated: March 2014 Page 22

23 Adult GH DF (start), document diagnosis of GH DF due to adult-onset (GH alone or multiple hormone deficiencies/hypopituitarism from pituitary dz, hypothalamic dz, surgery, cranial radiation tx, tumor txment, traumatic brain injury, or subarachnoid hemorrhage) or due to childhood-onset (GH not rec in adults who had GH tx as child for uses not due to GH DF) AND negative response to 1 GH stim test (insulin tolerance [peak less than 5 mcg/l], or glucagon [peak less than 3 mcg/l]) [GHRH plus arginine may be used if available] (exclude stim test for childhoodonset due to mutations, lesions, congenital defects), transition adoles off somatropin 1 mo before retesting, OR 3 or more pituitary hormone deficiencies (TSH, ACTH, LH/FSH, or AVP) AND serum IGF-1 84 microg/l or less using the Esoterix ECB RIA or age/gender adjusted serum IGF-1 SDS below the lower limits of the normal reference range for the reporting laboratory.ts start, female and has short stature (SS).SHOX start, open epiphyses AND baseline Ht less than the 3rd percentile for gender/age.cri w/growth failure (GF), start, approve.child PW w/gf or adult PW, approve.ns start, baseline ht less than 5th percentile.ts/shox/ckd/child PW/NS, cont tx, GR increased by 2.5 cm/yr or more in most recent yr (MRY) AND epiphyses open.pw, Cont tx in Adult OR adolescent, GR increased by 2.5 cm/yr or more in most recent yr.hiv w/wasting or cachexia, HIV-positive AND have 1 of the following, documented unintentional wt loss of greater than or equal to 10% from baseline OR wt less than 90% of the lower limit of ideal body wt OR BMI less than or equal to 20 kg/m2 AND wasting or cachexia that is due to malabsorption, poor diet, opportunistic infection, depression, and other causes have been addressed prior to starting somatropin AND on antiretroviral tx greater than or equal to 30 days prior to beginning GH tx and will continue antiretroviral tx throughout GH txment. Repeat 12 or 24-wk courses of GH may be authorized after initial 12 or 24-wk GH course for HIV infection w/wasting or cachexia provided that they are off GH for at least 1 mo and meet all of previous HIV criteria.hiv-assoc failure to thrive.able to consume or be fed via parenteral or enteral feedings 75% or more of maintenance energy requirements based on current body wt AND on antiretroviral tx for greater than or equal to 30 days prior to beginning GH tx and will continue antiretroviral tx.sbs, receiving specialized nutritional support.sbs pts approve for a second 4-wk course if adult responded to somatropin therapy w/ a decrease in requirement for specialized nutritional support according to prescribing physician. Covered Uses HUMIRA All FDA-approved indications not otherwise excluded from Part D plus patients already started on adalimumab for a Concurrent use with anakinra, abatacept, rituximab, ustekinumab, certolizumab pegol, etanercept, infliximab, or golimumab. RA, adults. Crohn's disease (CD), 6 or older.ulcerative colitis (UC), adults. Last Updated: March 2014 Page 23

24 RA/JIA/JRA/Ankylosing spondylitis, prescribed by or in consultation with rheumatologist. Psoriatic arthritis (PsA), prescribed by or in consultation with a rheumatologist or dermatologist. Plaque psoriasis (PP), prescribed by or in consultation with a dermatologist. UC/ CD, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months. RA, Tried 1 DMARD (brand or generic, oral or injectable) for 3 mos (this includes patients who have tried other biologic DMARDs for 3 mos), or pt is concurrently receiving methotrexate (MTX), or pt has a contraindication or inolerance to MTX and leflunomide, as determined by prescribing physician, or pt has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anticyclic citrullinated protein antibodies, or bony erosions by radiograph. JIA/JRA. Tried another agent (e.g MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if pt has absolute contraindication to MTX, sulfasalazine, or leflunomide or if pt has aggressive disease. Plaque psoriasis (PP). Pt has tried a systemic therapy (eg, MTX, CSA, acritretin, etanercept, infliximab, or ustekinumab) for 3 mos or PUVA) for 3 months, or pt experienced an intolerance to a trial of at least one systemic therapy (oral or biologic therapy), or pt has a contraindication to one oral agent for psoriasis such as MTX, as determined by the prescribing physician. CD. Tried corticosteroids (CSs) or if CSs are contraindicated or if pt currently on CSs or patient has tried one other agent for CD (eg, azathioprine, 6-mercaptopurine, MTX, certolizumab, infliximab) OR pt had ilecolonic resection. UC. Pt has tried a systemic therapy (eg, 6-mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, or a corticosteroid such as prednisone or methylprednisolone) for 3 2 months or was intolerant to one of these agents, or the pt has pouchitis and has tried therapy with an antibiotic, probiotic, corticosteroid enema, or mesalamine (Rowasa) enema. Last Updated: March 2014 Page 24

25 Covered Uses ILARIS All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on canakinumab (Ilaris) When used in combination with tumor necrosis factor (TNF) blocking agents (e.g., etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept. Covered Uses CAPS/MWS/FCAS intial tx- Prescribed by or in consultation with a rheumatologist, geneticist, or dermatologist. SJIA initial tx - prescribed by or in consultation with a rheumatologist Initial approval for MWS or FCAS, one dose, subsequent auth 12 mo if response. SJIA, 12 mos. For initial approval for MWS or FCAS, authorize one dose. After up to 8 weeks of therapy if the patient has had a response to therapy as determined by prescribing physician an additional 12 months authorization is allowed. For treatment of SJIA, approve. INCIVEK All FDA-approved indications not otherwise excluded from Part D. Plus patients current taking Incivek for a Covered Patients who have failed therapy with Incivek or another NS3/4A protease inhibitor (e.g., Victrelis) for HCV. Adults. Must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease physician, or a liver transplant physician. Authorization will be for 3 months. Must be prescribed in combination with peginterferon alfa and ribavirin. INCRELEX Last Updated: March 2014 Page 25

26 All FDA-approved indications not otherwise excluded from Part D. Covered Uses For severe primary IGFD coverage is provided if patient s height standard deviation score must be less than or equal -3.0 AND the basal IGF-1 score must be below the lower limits of normal for the reporting lab AND the patient must have normal or elevated growth hormone AND epiphyses must be confirmed as open in patients greater than or equal 10 years of age. For GH gene deletion coverage is provided if presence of neutralizing antibodies to growth hormones and open epiphyses in patients older than 10 years old. A growth response of greater than or equal 4.5 cm/yr (pre-pubertal growth phase) or greater than or equal 2.5 cm/yr (post-pubertal) must occur for continuation of coverage. Last Updated: March 2014 Page 26

27 Coverage is provided in situations where the diagnosis of IGF-1 deficiency has been made by an endocrinologist. 12 months Last Updated: March 2014 Page 27

28 Covered Uses Covered Uses INLYTA All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Inlyta for a Covered Authorization will be for 12 months Advanced renal cell carcinoma, approve the patient has failed at least one prior systemic therapy (eg, Torisel, Avastin, Sutent, IFN-alpha, IL-2, Votrient, Nexavar). IVIG All FDA-approved indications not otherwise excluded from Part D. Idiopathic thrombocytopenic purpura (ITP) or ITP acute bleed, tried systemic corticosteroid (CS), or has a CI to tx w/ a CS according to prescribing physician or before surgery/procedure if PC less than 75,000 for majory surgery or less than 50,000 for other. Chronic ITP if patient (pt) tried a systemic CS, or has a CI to tx w/ a CS according to prescribing physician OR there is an urgent need to increase the plt count quickly AND IVIG will be started with a systemic CS. BMT/HSCT in previous yr, AND according to prescribing physician, pt has a significant risk of having frequent and/or severe bacterial infections despite antibiotic therapy, 6 mos if IgG is less than 500 mg/dl (not applicable to MM, malignant macroglobulinemia). HIV-infected kids PRB, on highly active antiretroviral therapy (HAART), IgG less than 400 mg/dl or functional antibody deficiency (2 or more serious bacterial infections (SBis) in 1 yr-period of HAART and antibiotic prophylaxis or absence of detectable antibody response). HIV-infected kids (PIV), 1 dose if VariZIG unavailable and no history of varicella infection, or seronegative for varicella-zoster virus, or has not received 2 varicella vaccine doses, or is immunized but is moderately/severely immunocompromised, and no IVIG dose within 2-3 wks of varicella exposure.evs, refer to ITP or AIHA criteria depending on predominant symptoms.gbs, approve if IVIG started within 2 wks and no longer than 4 wks of neuropathic symptoms onset or initial response to IVIG now having a relapse.hat, approve 1 mo if significant bleeding or on antiretroviral therapy (ART)/HAART. MM stable disease, recurrent SBis. LEMS - has paraneoplastic LEMS, tried one CS, AZA, or other immunosuppressive (CSA, MM), OR has contraind to BOTH CS AND AZA or immunosuppressive. HIV-infected infants and children less than 13 yrs old - prevention of recurrent bacterial infxns or passive immunization of varicella (chickenpox). Still's disease, adult. Retractable epilepsy, children. ITP acute bleed or chronic ITP less than 17 yrs old and adults greater than 17 yrs old. Last Updated: March 2014 Page 28

29 PID,allergist/immunol,immuno,otolaryng,pulmon,or ID.ITP/AIHA,hematol.KD,ped cardio or ped ID.B-cell CLL/ BMT/HSCT/CMV interstit pneumonia HCT/MM,oncol,hematol,or ID.CIDP/MMN/MG/SPS,neurol.HIV-kids/VPP,ID or immunol.hiv-infected,id.dap,neurol or rheuma.gbs,neurol or GBS special.hat,id or HIV special.ms exac,msppr,ms special/neuro.prca infxn/prca, ID,immunol, hematol, transplant MD.Scleromyxedema,dermatol or rheumatol.tcp,fetal alloimmune,hematol or OB.Vasculitic syndromes,rheum or nephrol. Acute or surgery ITP,1 mo.cmv/prca,2 mo.gbs,1 mo. Fetal allo thrombo,6 mo.preg ITP,3 mo.others 12 mo Part B versus D determination per CMS guidance to establish if drug used for PID in pt s home. KD, 2nd dose if failed to respond to initial therapy (tx). AIHA, tried systemic CS,or Rituxan (rituximab), OR has a CI to tx w/ a CS or Rituxan (rituximab) according to prescribing physician, or had splenectomy. AMBD, tried conventional txs (eg, systemic CS and immunosuppresive) OR has a CI to tx w/ a CS according to prescribing physician, or disease rapidly progressive/extensive/debilitating, or inadequate time for tx to have rapid effect. DaP, tried conventional tx of systemic CS and immunosuppressive, OR has a CI to tx w/ a CS or according to prescribing physician. Retractable epilepsy, tried an anticonvulsant and CS. MSase, 1 5-day course if not responded to or significant AE from 2 of following: oral/iv CS tx (if possible), plasma exchange, or adrencorticotropic hormone and continuing to deteriorate. MSppr, 6 mo in women not currently receiving disease-modifying tx. MG, 1 5-day course if MG exacerbation, requires stabilization before surgery, has been started on immunosuppressive drug or responded to previous IVIG course but weakens/relapses and no response to other drugs. PRCA from B19 infxn, 3 mos if chronic immunodeficient condition and clinically significant anemia or transfusion dependent. PRCA immunologic, tried prednisone and CPA or cyclosporine (CSA). VPP, 1 dose if VariZIG not available AND pt does not have evidence of immunity to varicella (i.e. pt has no history of the disease or age-appropriate vaccination) or pt immunocompromised, or pregnant woman. VSS, patient has anti-neutrophil antibodyassociated vasculitis, tried a systemic CS and either CPA, methotrexate (MTX), Rituxan, or AZA. Last Updated: March 2014 Page 29

30 Covered Uses JAKAFI All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Jakafi for a Covered Authorization will be for 12 months. KALYDECO Covered Uses All FDA-approved indications not otherwise excluded from Part D. Coverage is NOT provided in patients who are homozygous for F508 deletion or who have other mutations in the CFTR gene. Coverage is provided in the treatment of cystic fibrosis in patients who have a G551D mutation in the CFTR gene as detected by a FDA cleared CF mutation test. 12 months Coverage may be renewed in situations where the patient is continuing to derive benefit from treatment (for example, improved or stable lung function measured by FEV1) LETAIRIS/TRACLEER Covered Uses All FDA-approved indications not otherwise excluded from Part D. Patients currently on Letairis or Tracleer for a Pulmonary arterial hypertension (PAH) WHO Group 1patients not currently on Letairis or Tracleer or another agent indicated for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm the diagnosis of PAH to ensure appropriate medical assessment. PAH WHO Group 1 patients currently on Letairis or Tracleer or another agent indicated for WHO Group 1 PAH may continue therapy without confirmation of a right-heart catheterization. Last Updated: March 2014 Page 30

31 For treatment of pulmonary arterial hypertension, Letairis or Tracleer must be prescribed by or in consultation with a cardiologist or a pulmonologist. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 31

32 Covered Uses Covered Uses LIDODERM All FDA-approved indications not otherwise excluded from Part D. Plus diabetic neuropathic pain. Authorization will be for 12 months, unless otherwise specified. MEKINIST All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Mekinist for a Diagnosis for which Mekinist is being used. For unresectable or metastatic melanoma must have documentation of BRAF V600E or V600K mutations Authorization will be for 12 months. For unresectable or metastatic melanoma must be used in patients with BRAF V600E or V600K mutations Last Updated: March 2014 Page 32

33 Covered Uses NEULASTA All FDA-approved indications not otherwise excluded from Part D but worded more broadly as cancer patients receiving Cancer patients receiving chemotherapy, if prescribed by or in consultation with an oncologist or hematologist. Authorization will be for 6months. Cancer patients receiving chemotherapy, approve if the patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), OR the patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years]), history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status, OR the patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor and a reduced dose or frequency of chemotherapy may compromise treatment. Last Updated: March 2014 Page 33

34 NEUMEGA Covered Uses All FDA-approved indications not otherwise excluded from Part D. Patient has experienced severe thrombocytopenia (e.g., platelet count less than equal to 20,000/mcL) from previous chemotherapy OR for patient is considered to be at high risk for the development of severe thrombocytopenia. 12 months Covered Uses NEUPOGEN All FDA-approved indications not otherwise excluded from Part D worded more broadly as cancer patients receiving Cancer/AML, MDS, ALL, oncologist or a hematologist. Cancer patients receiving BMT and PBPC, prescribed by or in consultation with an oncologist, hematologist, or a physician who specializes in transplantation. SCN, AA- hematologist. HIV/AIDS neutropenia, infectious disease (ID) physician (MD), hematologist, or MD specializing in HIV/AIDS. chemo/scn/aml-6mo.hiv/aids/4mo.mds-3mo.pbpc,agranulocytosis,neutropenia,aa,all-1mo.all others=12mo Last Updated: March 2014 Page 34

35 Cancer patients receiving chemotherapy, approve if the patient meets one of the following conditions: patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years], history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status), patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor (eg, Leukine, Neulasta, Neupogen) and a reduced dose or frequency of chemotherapy may compromise treatment, patient has received chemotherapy has febrile neutropenia and has at least one risk factor (eg, sepsis syndrome, aged greater than 65 years, severe neutropenia [absolute neutrophil account less than 100 cells/mm3], neutropenia expected to be greater than 10 days in duration, invasive fungal infection). Last Updated: March 2014 Page 35

36 Covered Uses NEXAVAR All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Nexavar for a Authorization will be for 12 months. Osteosarcoma, approve if the patient has tried standard chemoterhapy and have relapsed/refractory or metastatic disease. GIST, approve if the patient has tried imatinib mesylate (Gleevec) and sunitinib (Sutent). Differentiated thyroid carcinoma, approve if the patient has clinically progressive or symptomatic metastatic disease and the patient has nonradioiodine-responsive tumors at sites other than the central nervous system. Medullary thyroid carcinoma, approve if the patient has disseminated symptomatic disease and the patient has tried vandetanib (Caprelsa) or cabozantinib (Cometriq). NUVIGIL/PROVIGIL Covered Uses All FDA-approved indications not otherwise excluded from Part D. Fatigue associated with multiple sclerosis (MS) - Patients must be greater than or equal to 17 years of age. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 36

37 Excessive sleepiness due to SWSD if the patient is working at least 5 overnight shifts per month. Adjunctive/augmentation treatment for depression in adults if the patient is concurrently receiving other medication therapy for depression. Idiopathic hypersomnolence is covered diagnosis is confirmed by a sleep specialist physician or at an institution that specializes in sleep disorders (i.e., sleep center). Last Updated: March 2014 Page 37

38 OLYSIO Covered Uses All FDA approved indications not otherwise excluded from Part D. 18 years or older Prescribed by or in consultation with a GI, hepatologist, ID, or a liver transplant MD 12 weeks Genotype 1 - prescribed in combination with PegINF and RBV. Not used in combination with Solvadi and has not failed therapy with Olysio or another NS3/4A Protease Inhibitor for HCV (i.e., Incivek or Victrelis). Pts with genotype 1a must NOT have the Q80K polymorphism (unknown Q80K status is not covered). OPSUMIT Covered Uses All FDA-approved indications not otherwise excluded from Part D. PAH WHO group, right heart catherization PAH - must be prescribed by or in consultation with a cardiologist or a pulmonologist. Authorization will be for 12 months Pulmonary arterial hypertension (PAH) WHO Group 1 patients not currently on Opsumit or another agent indicated for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm the diagnosis of PAH to ensure appropriate medical assessment. PAH WHO Group 1 patients currently on Opsumit or another agent indicated for WHO Group 1 PAH may continue therapy without confirmation of a right-heart catheterization. ORENCIA Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients who have already been started on Concurrent use with a tumor necrosis factor (TNF) alpha antagonist (e.g., etanercept, adalimumab, certolizumab pegol, golimumab, or infliximab) with anakinra, rituximab, or tocilizumab. Rheumatoid arthritis (RA), adults. RA and JIA/JRA prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months, unless otherwise specified. Last Updated: March 2014 Page 38

39 RA, approve if the patient has tried adalimumab, or etanercept for at least 3 months, or was intolerant to one of these therapies OR the patient has moderate or high disease activity or features of poor prognosis (ie, functional limitation [eg, based on HAQ-DI score], extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph), and the patient has tried one oral DMARD (eg, MTX, leflunomide, sulfasalazine, hyroxychloroquine) for at least 3 months. Juvenile idiopathic arthritis (JIA) [or Juvenile Rheumatoid Arthritis (JRA)], approve Orencia IV only if the patient has tried adalimumab or etanercept for at least 2 months or was intolerant to one of these therapies (Orencia SC is not FDA-approved for the treatment of JIA/JRA). Last Updated: March 2014 Page 39

40 Covered Uses PEGYLATED INTERFERONS All medically-accepted indications not otherwise excluded from Part D. Patient has been started on Pegasys for a CHC approve Pegasys if 5 years of age or older and PegIntron if 3 years of age or older. For pts with recurrent hep C after liver transplant and pts with CHC on waiting list for liver transplantation, must be prescribed by, or in consultation with, an infectious disease MD, gastroenterologist, hepatologist, or a transplant MD. For all other indications, must be prescribed by, or in consultation with, an infectious disease MD, gastroenterologist, or hepatologist. HepC.24,48,72 wks.acute hepc. 24 wks.chronic hepc waiting for lvr trnplnt 12 mo.non-hepc 12 mo Last Updated: March 2014 Page 40