All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Covered Use.

(1)

Prior Authorization Criteria

Paramount Medicare Formulary 2014

Formulary ID: 14170. Version 22. CMS approved 10/28/2014. Last Updated: 10/31/2014

1

A

CTEMRA

Products Affected

• Actemra INJ 162MG/0.9ML,

200MG/10ML

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Covered Use.

Exclusion Criteria

Tocilizumab should not be given in combination with tumor necrosis factor (TNF) antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, anakinra, rituximab, or tofacitinib. Required

Medical Information

N/A

Age Restrictions For rheumatoid arthritis (RA), approve for adults. Prescriber

Restrictions

Prescribed by or in consultation with a rheumatologist.

Coverage Duration

Authorization will be for 12 months.

Other Criteria 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).

(2)

A

FINITOR

Products Affected

• Afinitor

• Afinitor Disperz

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already taking Afinitor for a Covered Use. Advanced,

unresectable neuroendocrine tumors. Exclusion Criteria N/A Required Medical Information

HER2 status. Advanced HER2-negative breast cancer, hormone receptor (HR) status.

Age Restrictions N/A Prescriber

Restrictions

N/A

Other Criteria 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.

(3)

3

A

LPHA

-1

P

ROTEINASE

I

NHIBITORS

Products Affected

• Aralast Np INJ 400MG • Glassia

• Prolastin-c • Zemaira

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Alpha-1 antitrypsin (AAT) deficiency-associated panniculitis. Exclusion Criteria N/A Required Medical Information

For AAT deficiency with emphysema (or COPD), approve in patients with baseline (pretreatment) alpha1-antitrypsin serum concentration less than 11 microM (11 micromol/L) or 80 mg/dL.

Restrictions

N/A

Authorization will be for 12 months, unless otherwise specified.

Other Criteria For all covered uses, the patient is required to try Aralast NP first line. For AAT deficiency with emphysema (or COPD), approve in patients with baseline (pretreatment) alpha1-antitrypsin serum concentration less than 11 microM (11 micromol/L) or 80 mg/dL.

(4)

A

MPYRA

Products Affected

• Ampyra

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on dalfampridine extended-release for Multiple Sclerosis (MS). Exclusion Criteria N/A Required Medical Information

Coverage not recommended for patients with CrCl less than or equal to 50 ml/min or patients with a history of seizure disorder.

Restrictions

MS. If prescribed by, or in consultation with, a neurologist or MS specialist.

Initial approval for MS, 90 days. Subsequent authorization for 12 mos if patient had a response.

Other Criteria For initial approval for MS, authorize for 90 days. After up to 90 days of dalfampridine extended-release therapy, if MS patient has had a response to therapy as determined by prescribing physician (eg, increased walking distance, improved leg/limb strength, improvement in activities of daily living), then an additional authorization is allowed.

(5)

5

A

NABOLIC

S

TEROIDS

Products Affected

• Oxandrolone ORAL TABS

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Duchenne muscular dystrophy, constitutional delay of growth or growth and puberty in prepubertal boys with psychosocial difficulties or

psychological distress due to their condition, girls w/Turner's Syndrome or Ullrich-Turner Syndrome, management of protein catabolism w/burns or burn injury, AIDS wasting and cachexia due to a chronic disease, cachexia due to cancer (except oxandrolone), and prevention/prophylaxis of hereditary angioedema (except oxandrolone). Oxymetholone for prevention/prophylaxis of hereditary angioedema, and AIDS wasting and cachexia due to a chronic disease.

Exclusion Criteria N/A Required Medical Information N/A

Restrictions

N/A

Other Criteria Oxandrolone for the management of protein catabolism associated with burns/burn injury. approve for patients who have tried a beta-blocker or who have a contraindication to beta-blocker use. Oxymetholone for the prevention/prophylaxis of hereditary angioedema, approve if the patient has tried danazol.

(6)

A

RANESP

Products Affected

• Aranesp Albumin Free INJ

100MCG/0.5ML, 100MCG/ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Anemia due to myelodysplastic syndrome (MDS). Exclusion Criteria N/A Required Medical Information

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 dialysis.A hemoglobin (Hb) of less than 10.0 g/dL required for start,Hb has to be less than or equal 11.0 g/dL if previously receiving epoetin alfa (EA) or Aranesp.CRF anemia in patients not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dL.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. Anemia due to ribavirin for Hep C, Hb is 10.0 g/dL or less at tx start. Previously on EA approve if Hb is 12.0 g/dL or less.All conds, deny if Hb exceeds 12.0 g/dL.

Age Restrictions MDS anemia= 18 years of age and older. Prescriber

Restrictions

MDS anemia, prescribed by or in consultation with, a hematologist or oncologist.

(7)

7 Other Criteria 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.

(8)

A

RCALYST

Products Affected

• Arcalyst

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on rilonacept for Muckle Wells Syndrome (MWS) or Familial Cold Autoinflammatory Syndrome (FCAS).

Rilonacept should not be given in combination with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), anakinra, or canakinumab.

Required Medical Information

N/A

Age Restrictions Greater than or equal to 12 years of age. Prescriber

Restrictions

Prescribed by, or in consultation with, a rheumatologist, geneticist, or dermatologist.

Initial approval of MWS/FCAS, 2 mos. Subsequent authorization for 12 mos if patient had a response.

Other Criteria Patients already started on rilonacept for MWS/FCAS may receive authorization if they have had a response and are continuing therapy to maintain response/remission.

(9)

9

A

UBAGIO

Products Affected

• Aubagio

PA Criteria

Criteria Details

Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Aubagio for a Covered Use.

Concurrent use of Aubagio with other disease-modifying agents used for multiple sclerosis (MS) [eg, Avonex, Rebif, Betaseron, Extavia,

Copaxone, Tysabri, or Gilenya]. Required

MS, patient has a relapsing form of MS. MS, previous MS therapies tried.

Restrictions

Prescribed by or in consultation with a neurologist or MS specialist.

Other Criteria For use in MS, patient must have a relapsing form of MS (includes relapsing-remitting MS, secondary-progressive MS with relapses, and progressive-relapsing MS) AND patient must have tried interferon beta-1a intramuscular (Avonex), interferon beta-beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone), Gilenya, or Tysabri unless the patient is unable to administer injections due to dexterity issues or visual impairment.

(10)

A

VONEX

Products Affected

• Avonex

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Avonex for a Covered Use.

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.

Restrictions

Prescribed by or after consultation with a neurologist or an MS specialist.

(11)

11

B

ETASERON

/

EXTAVIA

Products Affected

• Betaseron

• Extavia

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion

Criteria

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.

Restrictions

Other Criteria For patients requesting Extavia or Betaseron, approve if the patient has previously tried Avonex or Rebif.

(12)

B

ONIVA

I

NJECTION

Products Affected

• Boniva INJ

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Hypercalcemia of malignancy. Treatment of bone metastases in patients with solid tumor (eg, breast cancer, prostate cancer). Osteoporosis disorder related to organ transplantation.

Restrictions

N/A

Other Criteria 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. Treatment of postmenopausal osteoporosis, approve if pt has tried one oral bisphosphonate or patient had an inadequate response after a trial duration of 12 months (eg, ongoing and significant loss of BMD, lack of BMD increase) or patient had an osteoporotic fracture while receiving therapy or patient experienced intolerability (eg, severe GI-related adverse effects, severe musculoskeletal-related side effects, a femoral fracture), OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI

medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying

[stricture, achalasia]), OR pt has tried an IV bisphosphonate (ibandronate or zoledronic acid).

(13)

13

B

OSULIF

Products Affected

• Bosulif

PA Criteria

Criteria Details

Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Bosulif for a Covered Use.

Exclusion Criteria N/A Required Medical Information

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.

Restrictions

N/A

Other Criteria For CML, patient must have Ph-positive CML and must have resistance or intolerance to prior therapy for approval.

(14)

B

OTOX

Products Affected

• Botox INJ 100UNIT

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus Achalasia. Anal Fissure. BPH. Chronic facial pain/pain associated with TMJ dysfunction. Chronic low back pain. Headache (migraine, chronic tension HA, whiplash, chronic daily HA). Palmar/plantar and facial hyperhidrosis. Myofascial pain. Salivary hypersecretion. Spasticity (eg, due to cerebral palsy, stroke, brain injury, spinal cord injury, MS, hemifacial spasm). Essential tremor. Dystonia other than cervical (eg, focal dystonias, tardive dystonia, anismus). Frey's syndrome (gustatory sweating). Ophthalmic disorders (eg, esotropia, exotropia, nystagmus, facial nerve paresis). Speech/voice disorders (eg, dysphonias). Tourette's syndrome. Additional indications will be evaluated by a pharmacist and/or a physician on a case-by-case basis.

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. Required

N/A

Restrictions

Headache if prescribed by, or after consultation with, a neurologist or HA specialist.

(15)

15 Other Criteria 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).

(16)

C

APRELSA

Products Affected

• Caprelsa

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A

Restrictions

Oncologist.

Other Criteria Use must be in accordance with the Risk Evaluation and Mitigation Strategy (REMS) program for vandetanib.

(17)

17

C

EREZYME

Products Affected

• Cerezyme INJ 200UNIT

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information

Type I Gaucher's Disease

Restrictions

N/A

(18)

C

HENODAL

Products Affected

• Chenodal

PA Criteria

Criteria Details

Restrictions

N/A

Other Criteria For the treatment of gallstones, approve if the patient has tried or is currently using an ursodiol product.

(19)

19

C

HORIONIC

G

ONADOTROPINS

(

HCG

)

Products Affected

• Chorionic Gonadotropin INJ

• Pregnyl W/diluent Benzyl Alcohol/nacl

PA Criteria

Criteria Details

Age Restrictions Prepubertal cryptorchidism, 4 years or older. Prescriber

Restrictions

N/A

Authorization will be for 12 months, unless noted otherwise.

(20)

C

IALIS

Products Affected

• Cialis ORAL TABS 2.5MG, 5MG

PA Criteria

Criteria Details

Indication for which tadalafil is being prescribed.

Restrictions

N/A

Other Criteria Benign prostatic hyperplasia (BPH), after confirmation that tadalafil is being prescribed to treat the signs and symptoms of BPH and not for the treatment of erectile dysfunction (ED) and after a trial of an alpha-1 blocker (eg, doxazosin [Cardura XL], terazosin, tamsulosin [Flomax], alfuzosin extended-release [UroXatral]) or 5 alpha reductase inhibitor (eg, finasteride, dutasteride [Avodart]).

(21)

21

C

IMZIA

Products Affected

• Cimzia

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D plus patients already started on certolizumab pegol for Covered use.

Concurrent use with tumor necrosis factor (TNF) alpha antagonists (eg, adalimumab, etanercept, golimumab, and infliximab), or anakinra, rituximab, abatacept, natalizumab, tocilizumab.

N/A

Age Restrictions Adults. Prescriber

Restrictions

RA, prescribed by or in consultation with a rheumatologist. Crohn’s disease, prescribed by or in consultation with a gastroenterologist. Coverage

Duration

Other Criteria 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.

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.

(22)

C

INRYZE

Products Affected

• Cinryze

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus for the acute treatment of Hereditary Angioedema (HAE).

Restrictions

Must be prescribed by, or in consultation with, an allergist/immunologist or a physician that specializes in the treatment of HAE or related

disorders. Coverage

Duration

(23)

23

C

OMETRIQ

Products Affected

• Cometriq

PA Criteria

Criteria Details

Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Covered Use.

Diagnosis of progressive, metastatic medullary thyroid cancer.

Restrictions

N/A

(24)

C

OPAXONE

Products Affected

• Copaxone

PA Criteria

Criteria Details

Criteria

Concurrent use of Avonex, Betaseron, Extavia, Rebif, Tysabri, or fingolimod (Gilenya).

N/A

Restrictions

(25)

25

C

YMBALTA

Products Affected

• Cymbalta

PA Criteria

Criteria Details

Covered Uses All medically accepted indications not otherwise excluded from Part D. Plus, patients currently taking Cymbalta for a Covered Use.

Restrictions

N/A

Other Criteria Authorize use of Cymbalta if the patient has tried a generic selective serotonin reuptake inhibitor (SSRI) or generic serotonin norepinephrine reuptake inhibitor (SNRI). For patients who have taken Cymbalta at any time in the past and discontinued its use, authorize use without a trial of a generic SSRI or generic SNRI. For patients with symptoms of suicidal ideation, authorize use of Cymbalta without a trial of a generic SSRI or generic SNRI. For patients with symptoms of stress urinary incontinence (men or women), fibromyalgia, chronic musculoskeletal pain (e.g., chronic low back pain or chronic pain due to osteoarthritis), or diabetic peripheral neuropathy (DPN), authorize use of Cymbalta without a trial of a generic SSRI or generic SNRI.

(26)

E

LELYSO

Products Affected

• Elelyso

PA Criteria

Criteria Details

Type 1 Gaucher's disease

Restrictions

N/A

(27)

27

E

NBREL

Products Affected

• Enbrel

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D plus patient already on etanercept for a Covered Use. Graft versus host disease (GVHD). Behcet's disease. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris, mucous membrane pemphigoid [cicatricial pemphigoid]) (AMBD) .

Concurrent use with adalimumab, anakinra, abatacept, certolizumab pegol, ustekinumab, infliximab, rituximab, golimumab, or tocilizumab. Required

N/A

Age Restrictions For use in rheumatoid arthritis (RA), approve for adults. For juvenile idiopathic arthritis (JIA) approve for children aged 2 years and older. Prescriber

Restrictions

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.

(28)

Other Criteria 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).

(29)

29

E

POETIN

/

PROCRIT

Products Affected

• Epogen

• Procrit

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Plus anemia in patients with HIV who are receiving zidovudine. Anemic patients (Hb of 13.0 g/dL or less) at high risk for perioperative transfusions (secondary to significant, anticipated blood loss and are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions). Anemia due to myelodysplastic syndrome (MDS). Anemia associated with use of ribavirin therapy for hepatitis C (in combination with interferon or pegylated interferon alfa 2a/2b products with or without the direct-acting antiviral agents Victrelis or Incivek). Anemia in HIV-infected patients. Exclusion Criteria N/A Required Medical Information

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 to start.Hb less than or equal to 11.0 g/dL if previously on epoetin alfa or Aranesp.CRF anemia in patients not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dL.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.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 approve if Hb is 12.0 g/dL or less.All conds, deny if Hb exceeds 12.0 g/dL.

(30)

Prescriber Restrictions

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

Other Criteria 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.

(31)

31

E

RIVEDGE

Products Affected

• Erivedge

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patient already started on Erivedge for a covered use.

Restrictions

N/A

Other Criteria 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.

(32)

F

ABRAZYME

Products Affected

• Fabrazyme INJ 35MG

PA Criteria

Criteria Details

Fabry disease in male patients based on clinical symptoms or by genetic testing. Fabry disease in female patients based on family history and/or genetic testing.

Restrictions

N/A

(33)

33

F

IRAZYR

Products Affected

• Firazyr

PA Criteria

Criteria Details

Restrictions

Prescribed by, or in consultation with, an allergist/immunologist or a physican that specializes in the treatment of HAE or related disorders. Coverage

Duration

(34)

F

ORTEO

Products Affected

• Forteo

PA Criteria

Criteria Details

Criteria

Concomitant use with other medications for osteoporosis (eg, denosumab [Prolia], bisphosphonates, raloxifene, calcitonin nasal spray [Miacalcin, Fortical]), except calcium and Vitamin D.

N/A

Restrictions

N/A

Authorization will be for up to 2 years in a patient’s lifetime.

Other Criteria Treatment of PMO, approve if pt has tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried an IV bisphosphonate (ibandronate or

zoledronic acid), OR pt has severe renal impairment (creatinine clearance less than 35 mL/min) or CKD or pt has had multiple osteoporotic

fractures. Increase bone mass in men with primary or hypogondal

osteoporosis/Treatment of men and women with GIO, approve if pt tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the patient cannot swallow or has difficulty swallowing or the patient cannot remain in an upright position post oral bisphosphonate administration or has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried zoledronic acid (Reclast), OR pt has severe renal impairment (CrCL less than 35 mL/min) or has CKD or has had multiple osteoporotic fractures.

(35)

35

G

ILENYA

Products Affected

• Gilenya

PA Criteria

Criteria Details

Criteria

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.

Restrictions

Prescribed by, or in consultation with, a neurologist or an MS specialist.

Other Criteria 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.

(36)

G

ILOTRIF

Products Affected

• Gilotrif

PA Criteria

Criteria Details

For NSCLC - EGFR exon deletions or mutations

Restrictions

Oncologist.

Other Criteria 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

(37)

37

G

LEEVEC

Products Affected

• Gleevec

PA Criteria

Criteria Details

Covered Uses All medically-accepted indications not otherwise excluded from Part D. Plus patients already started on Gleevec for a Covered Use.

Diagnosis for which Gleevec is being used. For indications of CML and ALL, the Philadelphia chromosome (Ph) status of the leukemia must be reported. New patients with CML and ALL which is Ph-positive may receive authorization for Gleevec.

Restrictions

N/A

Other Criteria For CML, new patient must have Ph-positive CML for approval of Gleevec. For ALL, new patient must have Ph-positive ALL for approval of Gleevec.

(38)

G

LUCAGON

-

LIKE

P

EPTIDE

-1

A

GONISTS

Products Affected

• Bydureon

• Byetta • Victoza

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already on GLP-1 agonist therapy for a Covered Use.

Restrictions

N/A

(39)

39

G

ROWTH

H

ORMONES

A

ND

R

ELATED

D

RUGS

Products Affected

• Genotropin

• Genotropin Miniquick

• Humatrope INJ 12MG, 24MG, 6MG • Humatrope Combo Pack

• Norditropin Flexpro

• Norditropin Nordiflex Pen INJ 30MG/3ML

• Nutropin INJ 10MG

• Nutropin Aq Nuspin 5

• Nutropin Aq Pen INJ 20MG/2ML • Omnitrope • Saizen INJ 5MG • Saizen Click.easy • Serostim • Tev-tropin • Zorbtive

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Growth hormone (GH) deficiency (DF) (except Serostim and Zorbtive). Non-GH deficient short stature (idiopathic short stature, ISS) (except Serostim and Zorbtiv). Turner’s syndrome (TS) (except Serostim and Zorbtive). SHOX (short stature homeobox-containing gene) deficiency (except Serostim and Zorbtive). Chronic kidney disease (CKD) (except Serostim and Zorbtive). Prader-Willi syndrome (PW) (except Serostim and Zorbtive). Noonan syndrome (NS) (except Serostim and Zorbtive). Short bowel syndrome (SBS) (except Serostim). Human

Immunodeficiency Virus (HIV) infection with wasting or cachexia (Serostim only). HIV-associated failure to thrive (Serostim only).

(40)

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).

(41)

41 Required

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.

Age Restrictions 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. Coverage

Duration

GH DF 12 mos.SBS 4-8wks/yr.Non-GH DF ISS 6 mos.HIV wast/cach 24 wks.

(42)

Other Criteria 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 childhood-onset 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.

(43)

43

H

EPATITIS

C

D

RUGS

Products Affected

• Pegasys

• Pegasys Proclick INJ 135MCG/0.5ML • Peg-intron • Peg-intron Redipen • Rebetol SOLN • Ribasphere • Ribavirin CAPS • Ribavirin TABS

PA Criteria

Criteria Details

Covered Uses All medically accepted indications being supported by FDA label or compendia and not otherwise excluded from Part D. Treatment naïve pediatric patients. Hep B (except Rebetol, Ribasphere, Ribavirin). Acute hep C. Retreatment of hep C. Recurrent Hep C. Chronic hep C. Patient has been started on Pegasys for a Covered use. Patient has been started on PegIntron for a Covered use. Patient has been started on Rebetol,

Ribasphere, or Ribavirin for a Covered use. Exclusion Criteria N/A Required Medical Information N/A

Restrictions

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

(44)

Other Criteria Genotype (gtype)1,4,5,or6 chronic hep C (CHC) - Tx- naïve pts, authorize 48 wks if peginterfreron is prescribed in combination with ribavirin unless there is a contraindication (CI) or intolerance to ribavirin AND the pt is not on a waiting list for liver transplantation AND the pt does not have recurrent hepC after liver transplantation.Gtype 2or3 CHC-Tx-naïve pts, w/o hep B or HIV co-infection, auth 24 wks if peginterferon prescribed in comb w/ ribavirin unless CI or intolerance AND pt does not have gtype 3 CHC and high viral titer or adv fibrosis AND the pt is not on a waiting list for liver transplant AND the pt does not have recurrent hepC after liver transplant.Gtype 2or3 CHC-Tx-naïve pts, w/ HIV or hepB co-infection, auth 48 wks if peginterferon prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND pt does not have recurrent hepC after liver transplant.Gtype 2or3 CHC-Tx-naïve pts, pediatric pt with high iron load at baseline,auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND the pt does not have recurrent hepC after liver transplant. Gtype 3 CHC-Tx-naïve pts and high level of HCV RNA or advanced fibrosis, auth 48 wks if

peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND pt does not have recurrent hepC after liver transplant.CHC (any viral gtype).Retx pts,auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt has previously received tx w/ or w/o ribavirin for tx of hepC AND its been at least 3 mo since completion of the prior

interferon/peginterferon tx course AND the pt is not on a waiting list for liver transplant AND pt does not have recurrent hepC after liver

transplant. Acute hepC,auth 24 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance to ribavirin AND its been at least 8 wks after acute onset. Extend tx to 72 wks in slow responders.Tx naïve pts (gtype 1,4,5,or6), auth 24 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND the pt does not have HIV co-infection AND is not on a waiting list for liver transplant AND the pt does not have recurrent hepC after liver transplantat AND the viral titer has decreased by at least 2 log 10, but the virus was still detectable at wk 12, AND the virus was undetectable at wk 24.Pts with recurrent hepC after liver transplant, auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt has grade 2 fibrosis or greater.CHC, on a waiting list for liver transplantat, auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance to ribavirin.

(45)

45

H

IGH

R

ISK

M

EDICATIONS

-

B

ARBITURATES

Products Affected

• Phenobarbital ELIX

• Phenobarbital ORAL TABS

PA Criteria

Criteria Details

Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A

Restrictions

N/A

Other Criteria Prescriber will be notified this is a high risk medication, and the

prescriber still wishes to prescribe medication. Treatment is for epilepsy, cancer, or chronic mental health disorder, approve. Insomnia, patient has tried zaleplon, zolpidem, zolpidem ER, trazodone, Rozerem, or

(46)

H

IGH

R

ISK

M

EDICATIONS

-

B

ENZODIAZEPINES

Products Affected

• Clorazepate Dipotassium • Diazepam ORAL TABS • Diazepam RECTAL GEL • Diazepam SOLN

• Diazepam Intensol • Lorazepam ORAL TABS • Lorazepam Intensol

• Onfi ORAL TABS 10MG, 20MG • Onfi SUSP

PA Criteria

Criteria Details

Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A

Age Restrictions Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply.

N/A

Procedure-related sedation = 1mo. All other conditions = 12 months.

Other Criteria All medically accepted indications other than Restless Leg Syndrome and insomnia, authorize use. Restless Leg Syndrome, approve clonazepam or temazepam if the patient has tried one other agent for this condition (eg, ropinirole, pramipexole, carbidopa-levodopa [immediate-release or extended-release]). Insomnia, approve lorazepam, oxazepam, or temazepam if the patient has had a trial with two of the following: ramelteon, trazodone, doxepin 3mg or 6 mg, eszopiclone, zolpidem, or zaleplon.

(47)

47

H

IGH

R

ISK

M

EDICATIONS

-

F

IRST

G

ENERATION

A

NTIHISTAMINES

Products Affected

• Cyproheptadine Hcl SYRP • Cyproheptadine Hcl TABS • Hydroxyzine Hcl ORAL SOLN

• Promethazine Hcl ORAL TABS • Promethazine Hcl SYRP

• Promethazine Vc Plain

PA Criteria

Criteria Details

N/A

Other Criteria For promethazine tablets/syrup, authorize use without a previous drug trial for all FDA-approved indications other than emesis, including cancer/chemo-related emesis. For diphenhydramine capsules/elixir, authorize use without a previous drug trial for all FDA-approved indications other than insomnia. For hydroxyzine hydrochloride tablets/syrup, authorize use without a previous drug trial for all FDA-approved indications other than anxiety. For the treatment of

non-cancer/chemo related emesis, approve promethazine hydrochloride tablets or syrup if the patient has tried a prescription oral anti-emetic agent (ondansetron, granisetron, dolasetron, palonosetron, aprepitant) for the current condition. Approve diphenhydramine (capsules or elixir) if the patient has tried at least two other FDA-approved products for the management of insomnia. Approve hydroxyzine hydrochloride (tablets and syrup) or hydroxyzine pamoate (capsules) if the patient has tried at least two other FDA-approved products for the management of anxiety.

(48)

H

IGH

R

ISK

M

EDICATIONS

-

S

EDATIVE

/

HYPNOTICS

Products Affected

• Rozerem • Zaleplon • Zolpidem Tartrate • Zolpidem Tartrate Er

PA Criteria

Criteria Details

N/A

Age 65 or greater, approve 90 days. See Other Criteria. Otherwise, approve for 12 months.

Other Criteria In the elderly, not recommended for chronic use. See American Geriatrics Society 2012 Beers Criteria Update Expert Panel, American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, J Am Geriatr Soc, 2012, 60(4). 616-31. Ninety days is defined as at least two prescription fills for zaleplon, zolpidem, or eszopiclone and the cumulative days supply for any product is greater than 90 days during the calendar year. For example, if a patient received a 30 day supply for zolpidem, a second 30 day supply fill for zolpidem, and then a 30 day supply fill for eszopiclone (all during the same calendar year), this would reach the maximum allowable under these approval criteria.

(49)

49

H

UMIRA

Products Affected

• Humira INJ 20MG/0.4ML, 40MG/0.8ML

• Humira Pen-crohns Diseasestarter

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D plus patients already started on adalimumab for a Covered Use.

Concurrent use with anakinra, abatacept, rituximab, ustekinumab, certolizumab pegol, etanercept, infliximab, or golimumab.

N/A

Age Restrictions RA, adults. Crohn's disease (CD), adults.Ulcerative colitis (UC), adults. Prescriber

Restrictions

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.

(50)

Other Criteria 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 anti-cyclic citrullinated protein antibodies, or bony erosions by

radiograph. JIA/JRA. Tried MTX, sulfasalazine, leflunomide 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. 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). UC. Pt has tried a systemic therapy (eg, 6-mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, or a corticosteroid such as prednisone or

methylprednisolone) for 3 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.

(51)

51

I

LARIS

Products Affected

• Ilaris

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on canakinumab (Ilaris) for a Covered Use. Exclusion

Criteria

When used in combination with tumor necrosis factor (TNF) blocking agents (e.g., etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept.

N/A

Restrictions

Prescribed by or in consultation with a rheumatologist, geneticist, or dermatologist.

Initial approval for MWS or FCAS, one dose, subsequent auth 12 mo if response. SJIA, 12 mos.

Other Criteria 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.

(52)

I

MBRUVICA

Products Affected

• Imbruvica

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded frrom Part D. Exclusion Criteria N/A Required Medical Information N/A

Restrictions

Oncologist.

Authorization will be for 12 monts

(53)

53

I

NCIVEK

Products Affected

• Incivek

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients current taking Incivek for a Covered Use.

Patients with recurrent hepatitis C after liver (or other organ)

transplantation. Patients who have failed therapy with Incivek or another NS3/4A protease inhibitor (e.g., Victrelis) for HCV.

N/A

Restrictions

Must be prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease physician.

(54)

I

VIG

Products Affected

• Carimune Nanofiltered INJ 6GM • Gammagard Liquid

• Gammaplex INJ 10GM/200ML • Gamunex-c INJ 1GM/10ML • Privigen INJ 20GM/200ML

PA Criteria

Criteria Details

Covered Uses All FDA-approved indications not otherwise excluded from Part D. Idiopathic thrombocytopenic purpura (ITP) or immune thrombocytopenia, acute and chronic treatment. Kawasaki disease (KD). B-cell CLL in patients with hypogammaglobulinemia and previous history of a serious bacterial infection. Chronic inflammatory demyelinating polyneuropathy (CIDP). Allogeneic bone marrow transplant (BMT) or hematopoietic stem cell transplantation (HSCT). HIV-infected infants and children less than 13 yrs old - prevention of recurrent bacterial infections (PRB) or passive immunization of varicella (chickenpox) [PIV]. Autoimmune hemolytic anemia (AIHA). Autoimmune mucocutaneous blistering diseases (AMBD). CMV interstitial pneumonia in allogeneic BMT or HSCT patients. Dermatomyositis and polymyositis (DaP). End stage heart failure, ESRD, end stage liver or lung disease, or small bowel transplant awaiting transplant or post-transplant, to lower allosensitization.

Desensitization therapy prior to and immediately after solid organ (kidney, heart, lung, liver, intestinal) transplantation. Evans syndrome (EvS). Guillan-Barre syndrome (GBS). HIV-associated thrombocytopenia (HAT). Multifocal acquired demyelinating sensory and motor neuropathy or Lewis-Sumner syndrome. Multifocal motor neuropathy (MMN),

treatment. Multiple myeloma (MM). Multiple sclerosis (MS), acute severe exacerbations (MSase). MS, post-partum to prevent relapses (MSppr). Myasthenia gravis (MG). Pure red blood cell aplasia (PRCA) secondary to chronic parvovirus B19 infection (infxn). PRCA, immunologic subtype. Stiff-person syndrome (SPS). Thrombocytopenia, fetal

alloimmune (TFA). Varicella, postexposure prophylaxis (VPP). Vasculitic syndromes, systemic (VSS).