acne topical - simply healthcare plans

Prior Authorization Criteria

Simply Health Care Plans 2013

Last Updated: 11/19/2012

ACNE-TOPICAL

Products Affected

Aczone

Adapalene

Tretinoin EXTERNAL CREA

Tretinoin EXTERNAL GEL

Details

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

Exclusion

Criteria

Cosmetic uses

Required

Medical

Information

Diagnosis

Age Restrictions Greater than or equal to 12 years old

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

2

ACTEMRA

Products Affected

Actemra INJ 200MG/10ML

Details

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

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of moderate to severe, active adult rheumatoid arthritis. 2)

Inadequate response to at least ONE of the following medications (Sub-Q

TNFinhibitors) OR does the patient have a contraindication to ALL of

the following medications: Humira, Cimzia, Enbrel, Simponi.

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria None

3

ADHD/NARCOLEPSY

Products Affected

Adderall Xr

Amphetamine/dextroamphetamine ORAL

TABS

Daytrana

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate Er

Focalin Xr ORAL CP24 10MG, 15MG,

20MG

Metadate CD ORAL CPCR 10MG,

20MG, 60MG

Metadate Er

Methamphetamine Hcl

Methylphenidate Hcl

Methylphenidate Hcl Er TBCR 20MG

Methylphenidate Hydrochloride

Strattera

Details


Exclusion

Criteria

N/A

Required

Medical

Information

ADHD: Diagnosis, drugs tried and failed: patient must try generic ADHD

drug first. Narcolepsy: Submission of sleep study confirming the

diagnosis of narcolepsy.

Age Restrictions Greater than or equal to 3 years old (amphetamines), greater than or equal

to 6 years old (methylphenidates, strattera)

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

4

AFINITOR

Products Affected

Afinitor

Details


Exclusion

Criteria

N/A

Required

Medical

Information

N/A


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Failure of treatment with sunitinib or sorafenib.

5

AMPYRA

Products Affected

Ampyra

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1. Diagnosis of MS 2. Moderate walking disability associated with MS,

but mantains the ability to walk. 3.Trial and failure to physical therapy.


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria None

6

ANTIFUNGAL

Products Affected

Cancidas INJ 70MG

Ciclopirox Nail Lacquer

Itraconazole

Noxafil

Terbinafine Hcl TABS

Vfend IV

Voriconazole ORAL TABS

Details

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

Exclusion

Criteria

N/A

Required

Medical

Information

Confirmation by positive fungal culture or positive KOH test AND at

least one of the following must apply: diabetic patient,

immunocompromised status - AIDS/immunosuppressive

therapy/chemotherapy, onychomycosis of fingernails, significant

impairment of mobility or significant pain. Diagnosis of onychomycosis.


Prescriber

Restrictions

N/A

Coverage

Duration

twelve weeks

Other Criteria None

7

ANTINEOPLASTIC

Products Affected

Ixempra Kit INJ 45MG Votrient

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Ixempra: In combination with capecitabine for the treatment of patients

with metastatic or locally advanced breast cancer resistant to treatment

with an anthracycline and a taxane, or in patients whose cancer is taxane-

resistant and for whom further anthracycline therapy is contraindicated, as

monotherapy for the treatment of metastatic or locally advanced breast

cancer in patients whose tumors are resistant or refractory to

anthracyclines, taxanes, and capecitabine. Torisel/Votrient: For the

treatment of advanced renal cell carcinoma.


Prescriber

Restrictions

oncologist, hematologist

Coverage

Duration

1 year

Other Criteria None

8

APOKYN

Products Affected

Apokyn

Details


Exclusion

Criteria

Contraindicated with concurrent use of apomorphine with drugs of the

5HT antagonist class (e.g. ondansetron, granisetron, dolasetron,

palonosetron,and alosetron).

Required

Medical

Information

Approved for the acute, intermittent treatment of hypomobility, off-

episodes (end-of-dose wearing off and unpredictable on/off episodes)

associated with advanced Parkinson disease.

Age Restrictions Greater than or equal to 18 years old

Prescriber

Restrictions

None

Coverage

Duration

1 year

Other Criteria None

9

ARALASP

Products Affected

Aralast Np INJ 400MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year

Other Criteria Subject to Part B vs D review

10

ARANESP

Products Affected

Aranesp Albumin Free INJ 100MCG/ML,

200MCG/ML, 25MCG/ML,

300MCG/0.6ML, 40MCG/ML,

500MCG/ML, 60MCG/ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Anemia Due to Chronic Renal Failure (Initial): Hct less than 33% or Hgb

less than 11 gm/dl. Verification of iron evaluation for adequate iron

stores. CRF (Reauthorization): Verification that average Hct was below

36% over a 3-month period. Verification of iron evaluation for adequate

iron stores. One of the following: Hct reached target range (30% to 36%),

decrease in blood transfusion, or Hgb is 1 g/dL or greater from pre-

treatment level. Anemia in cancer patients on chemotherapy (Initial):

Verification that other causes of anemia have been ruled out. Verification

of iron evaluation for adequate iron stores. Hct less than 30% or Hgb less

than 10 gm/dl. Verification that the cancer is a non-myeloid malignancy.

Verification that the patient is concurrently on chemotherapy, will be on

concomitant chemotherapy for 2 months, or that the anemia is caused by

cancer chemotherapy. Chemotherapy (Reauthorization): Hct less than

36% or Hgb less than 12 gm/dl. Hct reached target range (30% to 36%),

decrease in blood transfusion, or Hgb is 1 g/dL or greater from pre-

treatment level. Verification that the patient is concurrently on

chemotherapy, will be on concomitant chemotherapy for 2 months, or that

the anemia is caused by cancer chemotherapy. Refractory anemia in

Myelodysplastic Syndrome (Initial): Hct less than 33% or Hgb less than

11 g/dL.Serum erythropoietin of 500 mU/mL or less, or diagnosis of

transfusion-dependent MDS. Verification of adequate iron stores. MDS

(Reauthorization): Verification that average Hct was below 36% over a 3

month period. One of the following: verification that Hct reached target

(30% to 36%), or decrease in blood transfusion, or Hgb increase 1 g/dL

or more from pre-treatment level. Chemotherapy-Induced Anemia:

Hb/Hct levels collected within prior two weeks of request. All other uses

Hb/Hct levels collected within prior 30 days of request.


11

Prescriber

Restrictions

N/A

Coverage

Duration

Chemo, MDS (Initial): 3 mo. CRF (Initial): 6 mo. CRF (Reauth), MDS

(Reauth):12 mo.

Other Criteria 1) Trial of procrit (Preferred Agent First), and 2) Subject to Part B vs D

coverage review for Always Considered ESRD Related Drug

12

ARZERRA

Products Affected

Arzerra INJ 100MG/5ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis

Age Restrictions FDA approved age

Prescriber

Restrictions

oncologist, hematologist

Coverage

Duration

12 months

Other Criteria none

13

AVASTIN

Products Affected

Avastin INJ 100MG/4ML

Details


Exclusion

Criteria

Non-Small Cell Lung Cancer: Squamous cell histology. History of

hemoptysis. CNS metastases.

Required

Medical

Information

Colorectal Cancer: Diagnosis of metastatic colorectal cancer. Used in

combination with 5-FU, or oxaliplatin plus capecitabine, or capecitabine.

Non-Small Cell Lung Cancer: Diagnosis of unresectable locally advanced

recurrent or metastatic NSCLC. Used in combination with paclitaxel and

carboplatin. Renal Cell Cancer: Diagnosis of metastatic renal cell cancer.

Used in combination with interferon-alpha or refractory to either

interferon alpha or interleukin-2. Breast Cancer: Diagnosis of metastatic

breast cancer. Used in combination with paclitaxel. Age-related Macular

Degeneration: Failure to FDA-approved therapies or likely to have greater

benefit from the use of intravitreal bevacizumab.


Prescriber

Restrictions

Renal Cell Cancer, Breast Cancer: Prescribed by or in consultation with

an oncologist. ARMD: Prescribed or recommended by retina specialist

Coverage

Duration

Lifetime

Other Criteria Subject to Part B vs. Part D review (not limited to new starts only). If the

drug is determined to be Part D, the Prior Authorization criteria applies to

new starts only. Approve for continuation of prior therapy.

14

BARBITURATE

Products Affected

Phenobarbital ELIX Phenobarbital ORAL TABS 16.2MG,

30MG, 32.4MG, 64.8MG, 97.2MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of epilepsy AND failure/intolerance/contraindication to at least

one non-barbiturate/non-benzodiazepine medication (non-high risk

alternative)


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Considered a ?high risk medication? in patients 65 years of age and older.

Approval requires a failure/intolerance/contraindication to at least one

non-barbiturate/non-benzodiazepine alternative.

15

BENZODIAZEPINE

Products Affected

Clonazepam

Clonazepam Odt

Clorazepate Dipotassium

Diazepam GEL 10MG

Diazepam ORAL TABS

Diazepam SOLN

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of epilepsy AND failure/intolerance/contraindication to at least

one non-barbiturate/non-benzodiazepine medication (non-high risk

alternative)


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Considered a ?high risk medication? in patients 65 years of age and older.

Approval requires a failure/intolerance/contraindication to at least one

non-barbiturate/non-benzodiazepine alternative.

16

BOTOX

Products Affected

Botox INJ 100UNIT

Details


Exclusion

Criteria

Cosmetic use.

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year

Other Criteria N/A

17

CALCIUM RECEPTOR ANTAGONISTS

Products Affected

Sensipar

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis, calcium, iPTH, PTH


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

18

CARBAGLU

Products Affected

Carbaglu

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of acute hyperammonemia and/or maintenance of chronic

hyperammonemia due to deficiency of hepatic N-acetyl glutamate

(NAGS).


Prescriber

Restrictions

Health care provider experienced in the treatment of metabolic disorders.

Coverage

Duration

Initial approvals will be for 6 months. Subsequent approvals will be

approved 12 months.

Other Criteria None

19

CAYSTON

Products Affected

Cayston

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of Cystic Fibrosis, documented infection with Pseudomonas

aeruginosa, and patient also taking a bronchodilator.

Age Restrictions 7 years of age or older

Prescriber

Restrictions

N/A

Coverage

Duration

6 months

Other Criteria None

20

CELLCEPT (ORAL)

Products Affected

Cellcept SUSR Mycophenolate Mofetil

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Transplant: Patient received a renal (kidney), cardiac (heart), or hepatic

(liver) transplant. Patient received a bone marrow/stem cell transplant.

Lupus nephritis: Diagnosis of lupus nephritis. Failure to combination

therapy with corticosteroids and cyclophosphamide. Obliterative

Bronchiolitis: Diagnosis of obliterative bronchiolitis following lung

transplantation.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year



new starts only.

21

CHANTIX

Products Affected

Chantix Chantix Starting Month Pak

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Approved as an aid to smoking cessation treatment, patient enrolled in

any smoking cessation support program


Prescriber

Restrictions

N/A

Coverage

Duration

3 months initially

Other Criteria None

22

CHORIONIC GONADOTROPIN

Products Affected

Pregnyl W/diluent Benzyl Alcohol/nacl

Details


Exclusion

Criteria

N/A

Required

Medical

Information

N/A


Prescriber

Restrictions

N/A

Coverage

Duration

6 months

Other Criteria None

23

CIMZIA

Products Affected

Cimzia INJ 200MG/ML

Details


Exclusion

Criteria

Patients are excluded if they have an active infection or are on concurrent

biologic response modifier.

Required

Medical

Information

Diagnosis: Chron's Ds / Rheumatoid arthritis, moderately to severe.

Patient must demonstrate inadequate response to at least 1 conventional

therapy for Crohn's disease (i.e., prednisone, budesonide, sulfasalazine,

azathioprine, mesalamine, infliximab or adalimumab). Patient must

demonstrate inadequate response to Enbrel and Humira therapy for

Rheumatoid arthritis. Patient must be evaluated for latent TB with a PPD

test and be treated if positive. Patient must also be assessed for the risk of

hepatitis B and if appropriate, be tested.

Age Restrictions Approve for those 18 years of age or older

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria N/A

24

CINRYZE

Products Affected

Cinryze

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Prophylaxis against angioedema attacks in patients with Hereditary

Angioedema (HAE).

Age Restrictions Equal or older than 9 years of age

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria The requested dose cannot exceed 2 vials (1000 units) every 3 days

25

DEGARELIX

Products Affected

Firmagon INJ 120MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Failure to an LHRH agonist


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Subject to part B vs. Part D review.

26

DIFICID

Products Affected

Dificid

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosed with severe Clostridium difficile-associated diarrhea with a

positive results of a C.difficile toxin study in adult patients who have

failed oral vancomycin therapy.

Age Restrictions Greater or equal to 18 years of age

Prescriber

Restrictions

N/A

Coverage

Duration

10 days initially, continuation of therapy up to another 10 days

Other Criteria None

27

ENBREL

Products Affected

Enbrel

Details


Exclusion

Criteria

Concurrent use of anakinra.

Required

Medical

Information

Rheumatoid Arthritis: Dx of mod-to-sev RA. Failed MTX or 2 DMARDs

for 3 mo. Juvenile Idiopathic Arthritis: Dx of mod-to-sev polyarticular-

course JIA. Failed NSAID or steroid and methotrexate for three months.

PsA: Dx of active PsA. Failed MTX or 2 DMARDs for 3 mo. Ankylosing

Spondylitis: Dx of AS. Failed 2 NSAIDs for 3 mo. Plaque Psoriasis: Dx

mod-to-sev chronic (greater than 6 months) plaque psorisis. Failed

systemic therapy with one of the following: MTX, cyclosporine, acitretin,

hydroxyurea, sulfasalazine, 6-thioguanine, or mycophenolate.

Reauthorization: demonstration of clinical response to therapy.

Age Restrictions RA, PsA, AS, Plaque Psoriasis: 18 years and older. JIA: 2 years and

older.

Prescriber

Restrictions

RA (Initial), JIA (Initial), PsA (Initial), AS (Initial): Prescribed or

recommended by a rheumatologist. Plaque Psoriasis (Initial): Prescribed

or recommended by a dermatologist.

Coverage

Duration

Initial Auth: 12 months for all except Plaque Psoriasis: 3 mo. Reauth: All

uses: 12 mo.

Other Criteria Plaque Psoriasis (Reauth) Enbrel dosage is 50 mg or less per week or less.

All diagnoses: Verification that the pt has been evaluated for TB and

treated accordingly.

28

ENZYME REPLACEMENT

Products Affected

Aldurazyme

Fabrazyme INJ 35MG

Naglazyme

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis

Age Restrictions Greater than or equal to 18yo (or FDA approved age)

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

29

EPOETIN ALFA

Products Affected

Procrit

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Anemia Due to Chronic Renal Failure: Hct less than 33% or Hgb less than

11 gm/dl. CRF (Reauth): Avg Hct was below 36% over 3-mo. 1 of the

following: Hct reached target (30% to 36%), decr in blood transfusion, or

Hgb is 1 g/dL or greater from pre-tx level. HIV: Anemia is d/t zidovudine

tx or d/t HIV infection. Hgb less than 12 g/dL or Hct less than 36%. PtD-

HIV (Reauth): Hct was below 36% over 3 mo. 1 of the following: Hct

reached target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dL

or greater from pre-tx level. Chemo: Verify other causes of anemia have

been ruled out. Hct less than 30% or Hgb less than 10 gm/dl. Cancer is a

non-myeloid malignancy. Concurrently on chemo, will be on concomitant

chemo for 2 mo or anemia is caused by cancer chemo. Chemo (Reauth):

Hct less than 36% or Hgb less than 12 gm/dl. Hct reached target (30% to

36%), decr in blood transfusion, or Hgb is 1 g/dL or greater from pre-tx

level. Concurrently on chemo will be on concomitant chemo for 2 mo or

anemia is caused by cancer chemo. Pre-op: Hgb greater than 10 to less

than 13 g/dL scheduled to undergo elective, non-cardiac/vascular surgery

to reduce blood transfusions or at high risk for perioperative transfusions

with expected blood loss of 2 units or greater. MDS: Hct less than 33% or

Hgb less than 11 g/dL. Serum erythropoietin of 500 mU/mL or less, or dx

of transfusion-dependent MDS. MDS (Reauth): Avg Hct was below 36%

over a 3 mo. 1 of the following: Hct reached target (30% to 36%), or decr

in blood transfusion, or Hgb incr 1 g/dL or more from pre-tx level. HCV:

Hgb less than 11 g/dL or Hct less than 33%. Is concurrently on ribavirin

and interferon or peg-interferon alfa for the tx of HCV and the anemia is

d/t tx. HCV (Reauth): Avg Hct was below 36% over a 3 mo. Hct reached

target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dL or

greater from pre-tx level. All uses: Verify Fe evaluation for adequate Fe

stores.


Prescriber N/A

30

Restrictions

Coverage

Duration

Pre-op: 1 mo. Chemo, HCV, MDS: 3 mo. HCV (Reauth): 3 mo CRF,

HIV: 6 mo. Other reauth: 12 mo.

Other Criteria Subject to Part B vs. D review (not limited to new starts only. CRF:

Patient is on dialysis (covered under Part B).

31

ERBITUX

Products Affected

Erbitux INJ 100MG/50ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Head and Neck Cancer: Confirmed diagnosis of locally or regionally

advanced squamous cell carcinoma of the head and neck or recurrent or

metastatic squamous cell head and neck cancer. Used in combination

with radiation therapy, or after failure of platinum-based chemotherapy.

Colorectal Cancer: Confirmed diagnosis of metastatic carcinoma of the

colon or rectum. Used in combination with irinotecan-based

chemotherapy or intolerance to irinotecan-based chemotherapy or failure

of irinotecan or oxaliplatin-based chemotherapy regimens. Tumor

expresses wild-type KRAS gene.


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria Approve for continuation of prior therapy.

32

ERIVEDGE

Products Affected

Erivedge

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1. Diagnosis of metastatic basal cell carcinoma, or with locally advanced

basal cell carcinoma that has recurred following surgery or who are not

candidates for surgery, and who are not candidates for radiation 2.

Gender, If female, evidence of negative pregnancy test provided


Prescriber

Restrictions

Oncologist

Coverage

Duration

12 months

Other Criteria N/A

33

EXJADE

Products Affected

Exjade ORAL TBSO 250MG, 500MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis, Sr Cr, LFTs, Ferritin

Age Restrictions Greater than or equal to 2 yo

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

34

FENTANYL

Products Affected

Abstral SUBLINGUAL SUBL 100MCG,

200MCG, 800MCG

Fentanyl Citrate Oral Transmucosal

Fentora BUCCAL TABS 200MCG,

400MCG, 800MCG

Onsolis BUCCAL FILM 200MCG,

400MCG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Cancer Pain: Confirmed diagnosis of malignant pain. Failure or

contraindication to an immediate-release opioid. Demonstrated tolerance

to opioids.


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria N/A

35

FORTEO

Products Affected

Forteo

Details


Exclusion

Criteria

Osteoporosis: History of Paget's disease, bone metastases of skeletal

malignancies, radiation therapy, metabolic bone disease other than

osteoporosis. Concurrent use of bisphosphonate.

Required

Medical

Information

Osteoporosis: BMD T score of -3.0 or less and a previous fracture

resulting from minimal trauma, or both of the following: failure to a

formulary bisphosphonate and patient has a history of fracture resulting

from minimal trauma or BMD T score of -2.5 or less.


Prescriber

Restrictions

N/A

Coverage

Duration

Osteoporosis: 2 years.

Other Criteria Subject to Part B vs. Part D review. Remove. Not on BvD global list.

36

GILENYA

Products Affected

Gilenya

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS). Trial and

failure OR contraindication to one of the following medications: Avonex,

Betaseron, Copaxone, Extavia, Rebif


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

37

GLEEVEC

Products Affected

Gleevec

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Chronic Myeloid Leukemia (Adults): Diagnosis of Philadelphia

chromosome positive CML. CML (Children): Diagnosis of Philadelphia

chromosome positive (Ph+) chronic phase CML. Acute Lymphoblastic

Leukemia: Adult patients with Philadelphia chromosome positive ALL.

Myelodysplastic/myeloproliferative diseases: Adults diagnosed with

MDS/MPD diseases associated with platelet-derived growth factor

receptor gene rearrangements. Aggressive systemic mastocytosis: Adults

diagnosed with aggressive systemic mastocytosis. Patient is without the

D816V c-Kit mutation or c-Kit mutation status unknown.

Hypereosinophilic syndrome and chronic eosinophilic leukemia: Adults

diagnosed with HES or CEL. Dermatofibrosarcoma protuberans: Adults

with unresectable, recurrent and/or metastatic DFSP. Gastrointestinal

Stromal Tumors: Patients with a confirmed diagnosis of unresectable

and/or metastatic GIST.


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime


38

GROWTH HORMONES

Products Affected

Genotropin

Genotropin Miniquick INJ 0.2MG,

0.4MG, 0.8MG, 1MG

Humatrope INJ 6MG

Increlex

Norditropin Flexpro

Norditropin Nordiflex Pen

Nutropin Aq Pen INJ 10MG/2ML

Omnitrope INJ 5MG/1.5ML

Saizen Click.easy

Tev-tropin

Details

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

Growth Hormone Deficiency (GHD) in Children, Prader-Willi Syndrome

(PWS) or Small for Gestational Age (SGA), Turner Syndrome (TS) or

Noonan Syndrome (NS).

Exclusion

Criteria

COGHDA: Males with bone age greater than 17 yrs or females with bone

age greater than 15 years, closed epiphyses on bone radiograph, growth

velocity less than 2 cm/year during previous year of treatment unless

COGHD criteria are met.

Required

Medical

Information

GHD (Child): Dx GH deficiency based on 2 GH stimulation tests or low

IGF-1 levels. Demonstrate growth failure based on growth velocity or ht

shorter than 2 SD below the mean ht for age. PWS, SGA: Dx of PWS

confirmed by genetic testing or Dx of SGA confirmed by birth wt of less

than 2500g at gestation of more than 37 wks or at birth wt or length below

the 3rd percentile for gestational age who failed to catch up by 2 yrs of

age. TS, NS: Tx of short stature in females w/bone age less than 15 yrs

associated w/TS or NS or for tx of short stature in males w/bone age less

than 17 yrs associated w/NS. GRCRF: Dx of chronic renal insufficiency.

Ht shorter than or equal to 2 SD below the median age for children or

where growth velocity falls to below 4.5 cm/yr. GHD (Child), PWS,

SGA, TS, NS, GRCRF (Reauth): Incr in growth velocity of at least 2

cm/yr during previous yr of tx. Males w/bone age less than 17 yrs or

females w/bone age less than 15 yrs. ISS: Ht less than or equal to 2.25 SD

below the mean ht for age. Growth velocity less than the 25th percentile

for bone age. Verify open epiphyses on last bone age radiograph. Absence

of comorbid conditions that should be observed or treated by other means.

ISS (Reauth): Incr in growth velocity of at least 4.5 cm/yr during previous

yr of tx. Males w/bone age less than 17 yrs or females w/bone age less

than 15 yrs. AOGHD: Pts who have GHD alone or multiple hormone

deficiencies b/c of pituitary disease/insult, hypothalamic disease, surgery,

39

or radiation tx. IGF-1 level less than 77 mcg/L or 2 SD below the mean

value, matched by age and gender. COGHDA: Childhood onset in pts

who were GH deficient during childhood who have GH deficiency

confirmed as an adult before replacement tx w/GH is started. Persistent

deficiency of GH documented by GH stimulation tests. IGHDA:

Documented deficiency of GH documented by 2 GH stimulation tests.


Prescriber

Restrictions

GH Deficiency (Child), Turner Syndrome or Noonan Syndrome (Initial),

GRCRF, ISS (Initial), AOGH, Childhood Onset GH Deficiency in Adults,

Isolated GH Deficiency in Adults: Prescribed by an endocrinologist.

Coverage

Duration

All uses: 1 year.

Other Criteria None

40

HEPATITIS C PROTEASE INHIBITORS

Products Affected

Incivek Victrelis

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1)Diagnosis of chronic hepatitis c 2)viral genotype 1a or 1b 3)Child

plough score 4)Concurrent peginterferon alpha therapy 5)Concurrent

ribavirin therapy

Age Restrictions Greater or equal to 18 yo

Prescriber

Restrictions

Infectious disease physician, gastroenterologist, hepatologist, or transplant

physician

Coverage

Duration

1 year

Other Criteria None

41

HEXALEN

Products Affected

Hexalen

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of ovarian cancer, cancer has progressed or recurred following

first-line tx with a cisplatin or alkylating agent-based combination


Prescriber

Restrictions

Oncologist

Coverage

Duration

1 year


42

HIGH RISK MEDICATIONS

Products Affected

Carisoprodol TABS 350MG

Carisoprodol/aspirin

Carisoprodol/aspirin/codeine

Cenestin

Chlordiazepoxide/amitriptyline

Chlorpropamide

Chlorzoxazone

Cyclobenzaprine Hcl ORAL TABS

10MG, 5MG

Cyclobenzaprine Hcl Er

Cyproheptadine Hcl

Dicyclomine Hcl

Diphenhydramine Hcl CAPS 50MG

Diphenoxylate/atropine

Dipyridamole ORAL TABS

Estropipate

Hydroxyzine Hcl

Hydroxyzine Pamoate

Ketorolac Tromethamine INJ 15MG/ML,

30MG/ML

Ketorolac Tromethamine TABS

Macrodantin CAPS 25MG

Menest

Meperidine Hcl INJ 100MG/ML,

25MG/ML, 50MG/ML

Meperidine Hcl ORAL TABS

Meprobamate

Methocarbamol

Nifedipine

Nitrofurantoin Macrocrystalline CAPS

50MG

Nitrofurantoin Monohydrate

Orphenadrine Citrate

Orphenadrine Citrate Er

Orphenadrine/asa/caffeine

Pentazocine/acetaminophen

Phenadoz

Premarin ORAL TABS

Premphase

Prempro

Promethazine Hcl

Promethazine Vc

Promethegan RECTAL SUPP 25MG,

50MG

Thioridazine Hcl

Trimethobenzamide Hcl CAPS

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Prescriber or patient provides a reason why any ONE unrestricted

formulary alternative (listed on ""Other Criteria"" section)can not be tried,

OR pt has already tried and failed any ONE alternative medication, OR

MD has been made aware that the incoming drugs is a high risk

medications and wishes to proceed with originally prescribed medication.

Age Restrictions None

Prescriber None

43

Restrictions

Coverage

Duration

1 year

Other Criteria Formulary Alternative Medications per class include but are NOT limited

to: ANALGESICS: (Mild Pain) ibuprofen, naproxen, or meloxicam.

(Moderate/severe Pain) tramadol, morphine sulfate , hydrocodone/apap,

oxycodone, oxycodone/apap, Oxycontin, Avinza. NSAIDs: ibuprofen,

naproxen, nabumetone, meclofenamate, sulindac. ANTI-EMETICS:

ondansetron, granisetron. ANXIOLYTICS: buspirone.

ANTIHISTAMINES: fexofenadine, Clarinex, levocetirizine.

ANTIPSYCHOTICS: risperidone, Abilify, Fanapt , Geodon, Invega,

Latuda, Seroquel, Zyprexa. DIHYDROPYRIDINES: nifedipine

extended-release. ORAL ESTROGENS: estradiol patch. ADHD

AMPHETAMINES: Strattera, Vyvanse. ANTIDIARRHEAL:

loperamide. SKELETAL MUSCLE RELAXANTS: tizanidine, baclofen.

Zanaflex. UTI ANTIBACTERIALS: sulfamethoxazole/trimethoprim,

ciprofloxacin. VASODILATORS: Aggrenox, Plavix.

SULFONYLUREAS: glimepiride, glyburide, Glycron, glipizide

44

HORMONAL AGENTS

Products Affected

Eligard

Emcyt

Lupron Depot INJ 22.5MG, 3.75MG,

30MG, 45MG, 7.5MG

Lupron Depot-ped INJ 11.25MG, 15MG

Synarel

Trelstar Depot Mixject

Trelstar La Mixject

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

gynecologist, or endocrinologist, or oncologist

Coverage

Duration

1 year

Other Criteria Subject to Part B vs. Part D review.

45

HUMIRA

Products Affected

Humira

Details


Exclusion

Criteria

Concurrent use of anakinra

Required

Medical

Information

Moderate to severe active RA: Dx of mod-to-sev RA. Failed MTX or 2

DMARDs for 3 mo. Juvenile Idiopathic Arthritis: Dx of mod-to-sev

polyarticular-course JIA. Failed NSAID or steroid and methotrexate for

three months. Psoriatic Arthritis: Dx of active PsA. Failed MTX or 2

DMARDs for 3 mo. Ankylosing Spondylitis: Dx of AS. Failed 2 NSAIDs

for 3 mo. Plaque Psoriasis: Dx mod-to-sev plaque psorisis. Failed

systemic therapy. Crohn's disease: Dx of mod-to-sev CD. Failed one

conventional therapy. Reauthorization: demonstration of clinical response

to therapy.

Age Restrictions RA, PsA, CD, AS, Plaque Psoriasis: 18 years and older. JIA: 4 years and

older.

Prescriber

Restrictions

RA, PsA, AS, JIA: Prescribed or recommended by a rheumatologist.

Plaque Psoriasis: Prescribed or recommended by a dermatologist. CD:

Prescribed or recommended by a gastroenterologist.

Coverage

Duration

Initial Auth: 12 months for all except Plaque Psoriasis: 4 mo. Reauth for

all 12 mo.

Other Criteria RA: Authorization is for 40 mg every other week unless documented

treatment failure to Humira every other week dosing, then Humira may be

approved for every week dosing if other criteria met. Plaque Psoriasis:

Humira dosage is 80mg (initial dose) then 40 mg every other week

starting 1 week after the initial dose. All diagnoses: Verification that the

patient has been evaluated for TB and treated accordingly.

46

INLYTA

Products Affected

Inlyta

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1. Diagnosis of advanced renal cell carcinoma (RCC) 2. Tried and failed

one other systemic therapy for RCC


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial - 6 months, Continuation - Lifetime

Other Criteria Alternatives-Nexavar, Sutent, Afinitor, Gleevec, or Votrient

47

INTERFERON

Products Affected

Actimmune

Details


Exclusion

Criteria

N/A

Required

Medical

Information

CBC, LFTs, TSH, HCV RNA viral load, HepBAg, HBV DNA, CT, MRI,

or biopsy.


Prescriber

Restrictions

N/A

Coverage

Duration

initially up to 3 months, continuation of therapy up to 1 year

Other Criteria For Actimmune: Chronic granulomatous disease, OR Malignant

osteopetrosis

48

INTRON-A

Products Affected

Intron-a INJ 6000000UNIT/ML Intron-a W/diluent INJ 10MU

Details

Covered

Uses

All FDA-approved indications not otherwise excluded from Part D

Exclusion

Criteria

N/A

Required

Medical

Information

Hep B - HBeAg positive: HBsAg positive for at least 6 months. HBV DNA

level greater than 100,000 copies/mL. Compensated liver disease. One of the

following: persistent ALT 2 times ULN or moderate to severe hepatitis or

fibrosis on biopsy. Hep B - HBeAg negative: HBsAg positive for at least 6

months. HBV DNA level of 2000 IU/mL or more or 11,200 copies/mL.

Compensated liver disease. One of the following: persistent ALT 2 times

ULN or moderate to severe hepatitis or fibrosis on biopsy. Hep C - Treatment

Naive Patients (monotherapy): For patients with Chronic Hepatitis C with

compensated liver disease with positive HCV antibody and HCV RNA. Hep C

- Treatment Naive Patients (in combination with ribavirin): For patients with

Chronic Hepatitis C with compensated liver disease with positive HCV

antibody and HCV RNA. Hep C - Continuation of Therapy: For genotypes

2,3,5, or 6: loss of detectable HCV RNA from serum or 100 fold drop or more

in HCV RNA level. Non-Hepatitis Diagnoses: Diagnosis of one of the

following: Malignant Melanoma, Hairy cell leukemia, Stage III or IV

follicular Non-Hodgkin's Lymphoma, condylomata acuminata, AIDS-related

Kaposi's sarcoma, Multiple Myeloma. Acute Hep C: Patients with acute

hepatitis C.

Age

Restrictions

Hep B - HBeAg positive, Hep B - HBeAg negative: 1 year of age or older.

Hep C - Treatment Naive Patients, Non-Hepatitis Diagnoses, Acute Hep C: 18

years old and older. Hep C - Treatment Naive Patients (in combination with

ribavirin): 3 years of age and older.

Prescriber

Restrictions

N/A

Coverage

Duration

HepB+:: 6mo.(-):1yr.HepC:(2,3,5,6)

6mo(1,4,HIV/HCV):12mo.AcuteHepC,HCL,Kaposi:6mo.warts:3wk.Other:1yr

Other Approve for continuation of prior therapy for neoplastic diseases.

49

Criteria

50

JAKAFI

Products Affected

Jakafi

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1) Diagnosis of intermediate or high-risk myelofibrosis, including primary

myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential.

2)For continuation of therapy - respond to Jakafi therapy with spleen

reduction or symptom improvement


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial - 6month: continuation 6 months

Other Criteria None

51

JEVTANA

Products Affected

Jevtana

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Patient has been previously treated with a Taxotere (docetaxel) containing

treatment regimen AND is being treated with prednisone in combination

with Jevtana


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Subject to Part B vs. Part D review. Remove. Not on BvD global list.

52

KALYDECO

Products Affected

Kalydeco

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1. Diagnosis of cystic fibrosis, 2. Results of a CF mutation test to detect

the presence of the G551D mutation


Prescriber

Restrictions

Pulmonologist

Coverage

Duration

Initial - 6 months, Continuation - Lifetime

Other Criteria N/A

53

KINERET

Products Affected

Kineret

Details


Exclusion

Criteria

Concurrent use of TNF-blockers or Orencia

Required

Medical

Information

RA (Initial): Diagnosis of moderate to severe active RA. Treatment and

failure with Enbrel and Humira. RA (Reauthorization): Submission of

chart documentation demonstrating positive clinical response.

Age Restrictions RA: 18 years or older

Prescriber

Restrictions

RA: Prescribed or recommended by a rheumatologist.

Coverage

Duration

RA (Initial): 12 months. RA (Reauth): 1 year.

Other Criteria None

54

KUVAN

Products Affected

Kuvan

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis, phenylalanine levels


Prescriber

Restrictions

N/A

Coverage

Duration

3 months initially

Other Criteria none

55

LEUKINE

Products Affected

Leukine INJ 250MCG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

BMSCT: For patients with non-myeloid malignancies undergoing

myeloablative chemotherapy followed by autologous or allogeneic BMT,

or for mobilization of hematopoietic progenitor cells into the peripheral

blood for collection by leukapheresis, or for peripheral stem cell

transplant patients who have received myeloablative chemotherapy.

AML: For patients with AML following induction or consolidation

chemotherapy. NDDC: Patient is receiving NCI's Breast Intergroup, INT

C9741 dose dense chemotherapy protocol for primary breast cancer or a

dose-dense regimen for which the incidence of febrile neutropenia is

unknown.CFN: Patient is receiving a chemotherapy regimen associated

with more than 20% incidence of febrile neutropenia, or patient is

receiving chemotherapy regimen associated with 10-20% incidence of

febrile neutropenia and has risk factors associated with chemotherapy-

induced infection, febrile neutropenia or neutropenia. FN: For patients

receiving myelosuppressive anticancer drugs associated with neutropenia.

Patient has febrile neutropenia at high risk for infection-associated

complications or has a history of febrile neutropenia during a previous

course of chemotherapy. HIVN: HIV-infected patients with an ANC less

than or equal to 1,000 cells/mm3 with or without one or more risk factors

for developing chronic neutropenia.

Age Restrictions AML: greater than or equal to 55 years old.

Prescriber

Restrictions

N/A

Coverage

Duration

BMSCT,NDDC,CFN,FN,AML: 3 mo. HIVN: 6 mo

Other Criteria None

56

LOTRONEX

Products Affected

Lotronex

Details


Exclusion

Criteria

IBS (Initial): Male gender.

Required

Medical

Information

IBS (Initial): Confirmed diagnosis of (IBS) with diarrhea predominant

symptoms for at least 6 months. Failure to an antispasmodic and an anti-

diarrheal agent. IBS (Reauth): Recurrence of diarrhea-predominant IBS.

Documentation of positive clinical response while on Lotronex.

Age Restrictions IBS (Initial): 18 years and older.

Prescriber

Restrictions

IBS (Initial): Verification that physician has enrolled in the

GlaxoSmithKline Prescribing Program.

Coverage

Duration

IBS (Initial): 12 weeks IBS (Reauthorization): 6 months.

Other Criteria None

57

LUMIGAN

Products Affected

Lumigan SOLN 0.01%

Details


Exclusion

Criteria

Cosmetic uses

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

58

LUMIZYME / MYOZYME

Products Affected

Myozyme

Details


Exclusion

Criteria

N/A

Required

Medical

Information

N/A


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

59

MS AGENTS

Products Affected

Avonex

Betaseron

Copaxone

Extavia

Rebif

Rebif Titration Pack

Tysabri

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of a relapsing form of multiple sclerosis (MS), Crohn disease

(Tysabri only)


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime, except Tysabri ( 2 years). For Tysabri: Restricted Distribution

Program (TOUCH)

Other Criteria Betaseron: Trial of Rebif (Preferred Agent First)

60

NEULASTA

Products Affected

Neulasta

Details


Exclusion

Criteria

N/A

Required

Medical

Information

For patients receiving myelosuppressive anticancer drugs associated with

neutropenia.


Prescriber

Restrictions

N/A

Coverage

Duration

3 months

Other Criteria None

61

NEUMEGA

Products Affected

Neumega

Details


Exclusion

Criteria

Allergic or hypersensitivity reaction.

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year

Other Criteria N/A

62

NEUPOGEN

Products Affected

Neupogen INJ 300MCG/0.5ML,

480MCG/0.8ML, 480MCG/1.6ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

BMSCT: To decrease the incidence of infection, as manifested by febrile

neutropenia for pts with non-myeloid malignancies undergoing

myeloablative chemo followed by autologous or allogeneic BMT, or for

mobilization of hematopoietic progenitor cells into the peripheral blood

for collection by leukapheresis. AML: For pts with AML following

induction or consolidation chemotherapy for reducing the time to

neutrophil recovery and the duration of fever. FN: For patients receiving

myelosuppressive anticancer drugs associated with neutropenia. SCN: For

chronic administration to reduce the incidence and duration of sequelae of

neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic

patients with congenital neutropenia, cyclic neutropenia, or idiopathic

neutropenia.


Prescriber

Restrictions

N/A

Coverage

Duration

SCN 12 months, all others 3 months

Other Criteria None

63

NEXAVAR

Products Affected

Nexavar

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of renal cell carcinoma with relapse following surgical

excision, or diagnosis of renal cell carcinoma with medically or surgically

unresectable tumor, or diagnosis of Stage IV renal cell carcinoma, or

diagnosis of unresectable hepatocellular carcinoma.


Prescriber

Restrictions

Oncologist

Coverage

Duration

6 months


64

ORENCIA

Products Affected

Orencia

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis

Age Restrictions 6 years of age and older.

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Treatment and failure with Enbrel and Humira

65

OXANDRIN

Products Affected

Oxandrolone

Details


Exclusion

Criteria

Cosmetic use, drug abuse and dependence

Required

Medical

Information

Diagnosis of weight gain associated with AIDS wasting and cachexia due

to a chronic disease, to offset the protein catabolism associated with

prolonged administration of corticosteroids, or for the relief of the bone

pain frequently accompanying osteoporosis.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

66

PANRETIN

Products Affected

Panretin

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of AIDS-related Kaposi's sarcoma, Cutaneous


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year

Other Criteria N/A

67

PEGASYS

Products Affected

Pegasys Pegasys Proclick INJ 135MCG/0.5ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Hep B - HBeAg positive: HBsAg positive for at least 6 months. HBV

DNA level greater than 100,000 copies/mL. Compensated liver disease

and one of the following: ALT 2 times ULN or moderate-to-severe

hepatitis or fibrosis on biopsy. Hep B - HBeAg negative: HBsAg positive

for at least 6 months. HBV DNA level of 2000 IU/mL or more or 11,200

copies/mL. Compensated liver disease and one of the following: ALT 2

times ULN or moderate-to-severe hepatitis or fibrosis on biopsy. Hep C -

Treatment Naive Patients: Chronic Hepatitis C with compensated liver

disease. Positive HCV antibody HCV RNA. HCV RNA level

measurement. Genotype test result. For patients who have not previously

been treated with interferon. Hep C - Continuation of Therapy: For

genotypes 5 or 6: loss of detectable HCV RNA from serum or 100 fold

drop or more in HCV RNA level. For genotype 1: undetectable HCV

RNA after 24 weeks of therapy and one of the following: HCV RNA

more than 50 IU/mL at 4 weeks into treatment or less than 100 fold drop

or detectable HCV RNA 12 weeks into therapy. For genotype 3: baseline

HCV RNA more than 600,000 IU/mL and steatosis or advanced fibrosis

on liver biopsy. Hep C Retreatment: Retreatment in patients who have

failed or relapsed following standard or pegylated interferon

monotherapy, or for nonresponders or relapsers who have significant

fibrosis or cirrhosis who have undergone previous regimens of treatment

using non-pegylated interferon, or retreatment in patients with genotype 2

or 3 who have relapsed following 6 month treatment of pegylated

interferon plus ribavirin combination therapy. Used in combination with

ribavirin.

Age Restrictions Hep B - HBeAg positive, Hep B - HBeAg negative, Hep C - Treatment

Naive Patients: 18 years and older

Prescriber

Restrictions

N/A

68

Coverage

Duration

HepB:1yr. HepC(5,6):12 wk, (2,3): 24wk,

(1,4,HIV/HCV):48wk.con't(1,3):24wk, (5,6):36wk.Retreat:1yr

Other Criteria None

69

PEG-INTRON

Products Affected

Peg-intron INJ 50MCG/0.5ML

Peg-intron Redipen

Sylatron

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Hepatitis C - Treatment Naive Patients: Chronic Hepatitis C with

compensated liver disease. Positive HCV antibody HCV RNA. HCV

RNA level measurement. Genotype test result. For patients who have not

previously been treated with interferon. Hep C (Continuation): For

genotypes 5 or 6: loss of detectable HCV RNA from serum or 100 fold

drop or more in HCV RNA level. For genotype 1: undetectable HCV

RNA after 24 weeks of therapy and one of the following: HCV RNA

more than 50 IU/mL at 4 weeks into treatment or less than 100 fold drop

or detectable HCV RNA 12 weeks into therapy. For genotype 3: baseline

HCV RNA more than 600,000 IU/mL and steatosis or advanced fibrosis

on liver biopsy. Hep C (Retreatment): Retreatment in patients who have

failed or relapsed following standard or pegylated interferon

monotherapy, or for nonresponders or relapsers who have significant

fibrosis or cirrhosis who have undergone previous regimens of treatment

using non-pegylated interferon, or retreatment in patients with genotype 2

or 3 who have relapsed following 6 month treatment of pegylated

interferon plus ribavirin combination therapy. Used in combination with

ribavirin.

Age Restrictions Hepatitis C - Treatment Naive Patients: 3 years and older.

Prescriber

Restrictions

N/A

Coverage

Duration

Type5,6: 12 wk, type2,3: 24wk, type1,4,HIV/HCV: 48wk.Con't: type1,3:

24wk type5,6: 36wk.Retreat: 1yr

Other Criteria None

70

POTIGA

Products Affected

Potiga

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of partial-onset seizures,member currently taking a first-line

antiepileptic (e.g., carbamazepine, valproate, lamotrigine, topiramate, etc.)


Prescriber

Restrictions

Neurologist

Coverage

Duration

12 months

Other Criteria N/A

71

PROGRAF (ORAL)

Products Affected

Tacrolimus ORAL CAPS 1MG, 5MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Severe uveitis: Failure to one corticosteroid. Transplant: Patient received

a renal (kidney), cardiac (heart), lung, pancreas, small bowel, hepatic

(liver) transplant, or bone marrow/stem cell transplant.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Subject to Part B vs. Part D review (not limited to new starts only).

Approve for continuation of prior therapy if Part D.

72

PROLASTIN

Products Affected

Prolastin-c

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year


73

PROLEUKIN

Products Affected

Proleukin

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Metastatic Renal Cell Carcinoma or Metastatic Melanoma: Measurable,

histologically confirmed metastatic renal cell carcinoma or metastatic

melanoma. Good neurologic or ambulatory performance status. Adequate

organ function: normal cardiac stress test results, FEV1 greater than 2 L

on pulmonary function tests, creatinine concentration 1.5 mg/dL or less or

calculated creatinine clearance of greater than 60 ml/min, bilirubin

concentration of 1.5 mg/dL or less, SGOT/AST less than 150 IU or 4x

upper limit of normal. Platelet count greater than or equal to 100,000 /

mcL. Hemoglobin greater than or equal to 10 g/dL. WBC greater than or

equal to 3,500 / mcL. At least 7 weeks since prior therapy and complete

recovery from therapy-related side effects.

Age Restrictions Metastatic Renal Cell Carcinoma or Metastatic Melanoma: 18 years and

older

Prescriber

Restrictions

N/A

Coverage

Duration

Metastatic Renal Cell Carcinoma or Metastatic Melanoma: three months

Other Criteria All uses: For continuation of prior therapy. Metastatic Renal Cell

Carcinoma or Metastatic Melanoma: Administered in a hospital setting.

Additional courses of treatment should be given to patients only if there is

some tumor shrinkage following the last course and if retreatment is not

contraindicated.

74

PROLIA

Products Affected

Prolia

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis. Initial therapy: Bone mineral density (DXA or DEXA) T score

of negative 2.5 or less AND Patient is at high risk for osteoporotic

fracture (Personal history of fracture as an adult, history of osteoporotic

fracture in a first degree relative, concurrent use of systemic

corticosteroids for at least three months duration, concurrent cigarette

smoking, or body weight less than 127 pounds) AND treatment failure to

at least one of the following: risendronate, alendronate, ibandronate, or

raloxifene. Approved for continuation of therapy.


Prescriber

Restrictions

N/A

Coverage

Duration

Initial and continuation 1 year

Other Criteria Subject to Part B vs. Part D review

75

PROMACTA

Products Affected

Promacta

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of chronic ITP, platelet count less than 30 x 109/L.

Age Restrictions Greater than or equal to 18 yo (or FDA approved age)

Prescriber

Restrictions

Must be registered in Promacta CARES Prescribing Program

Coverage

Duration

6 months

Other Criteria None

76

PROVIGIL/NUVIGIL

Products Affected

Nuvigil

Details


Exclusion

Criteria

SWSD (Initial): Symptoms do not meet criteria for any other sleep

disorder producing insomnia or excessive sleepiness.

Required

Medical

Information

Documented Diagnosis of one of the Following: Narcolepsy, Idopathic

Hypersonia, Obstructive Sleep Apnea with Failure of CPAP, Shift work

sleep disorder (SWSD) excessive sleepiness , Multiple Sclerosis and

myotonic dystrophy.

Age Restrictions Greater than or equal to 17 yo (Nuvigil), greater than or equal to 16 yo

(Provigil)

Prescriber

Restrictions

N/A

Coverage

Duration

OSAHS, SWSD: 3 months, Reauthorization: Lifetime

Other Criteria NUVIGIL: plan restricts Nuvigil 50 mg to a dose of two tablets per day.

For higher doses, please use Nuvigil 150 mg or Nuvigil 250 mg tablets.

PROVIGIL: plan restricts Provigil 100 mg to a dose of one tablet per

day. For higher doses, please use the Provigil 200 mg tablet.

77

PULMONARY ARTERY HYPERTENSION

Products Affected

Adcirca

Letairis

Revatio TABS

Tracleer

Ventavis SOLN 10MCG/ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

PAH: Patients with a confirmed diagnosis of pulmonary arterial

hypertension (modified WHO Group I) which is symptomatic.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Ventavis only: Subject to Part B vs. Part D review. Tracleer only: Trial of

Letairis First.

78

PULMOZYME

Products Affected

Pulmozyme

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year


79

RANEXA

Products Affected

Ranexa

Details


Exclusion

Criteria

Patients taking strong inhibitors of CYP3A, patients taking inducers of

CYP3A, and those with clinically significant hepatic impairment.

Required

Medical

Information

Requires concurrent use with at least one medication of the following:

amlodipine, beta blockers, or long-acting nitrates


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

80

REGRANEX

Products Affected

Regranex

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diabetic Neuropathic Ulcers: Diabetic patient with ulcer wound.

Debridement being performed as needed. At least two of the following

are present: Stage III or IV wound, wound at least 1 cm x 1 cm, long-

standing wound that does not heal with standard care, or patients at high

risk for amputation (peripheral neuropathy, peripheral vascular disease,

skin or nail abnormalities, previous foot ulcer amputation).


Prescriber

Restrictions

N/A

Coverage

Duration

Diabetic Neuropathic Ulcers: Maximum 6 months.

Other Criteria None

81

RELISTOR

Products Affected

Relistor INJ 12MG/0.6ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of opioid induced constipation with life expectancy less than 6

months. Patient must not have had laxation for at least 48 hours. Patient

failed at least 1 laxative at the maximum recommended dose.


Prescriber

Restrictions

N/A

Coverage

Duration

4 months

Other Criteria None

82

REMICADE

Products Affected

Remicade

Details


Exclusion

Criteria

RA, PsA: Used in combination with anakinra.

Required

Medical

Information

Diagnosis of Rheumatoid Arthritis, Crohns, Ankylosing Spondylitis,

Psoriatic Arthritis, Plaque Psoriasis, Ulcerative Colitis. Liver function

tests, CBC, tuberculin test. Information regarding concomitant

immunosuppressants (e.g. methotrexate or corticosteroids).

Age Restrictions RA, PsA, AS, Plaque Psoriasis, FCD, UC: 18 years and older. Crohn's

Disease: 6 years and older.

Prescriber

Restrictions

RA ,AS, PsA: Prescribed or recommended by a rheumatologist. Crohn's

Disease, Fistulizing Crohn's Disease, UC: Prescribed by a

gastroenterologist or by gastroenterologist consult. Plaque Psoriasis:

Prescribed or recommended by a dermatologist. Sarcoidosis: Prescribed

or recommended by a pulmonologist.

Coverage

Duration

1 year

Other Criteria None

83

REVLIMID

Products Affected

Revlimid ORAL CAPS 10MG, 15MG,

25MG, 5MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

MDS: Diagnosis of myelodysplastic syndrome associated with a deletion

5q cytogenic abnormality and patient is transfusion dependent. OR

Diagnosis of myelodysplastic syndrome without deletion 5q cytogenic

abnormality and failure of initial treatment with epoetin alfa or

darbopoetin alfa, hypomethylating agents (e.g., Vidaza, Dacogen), or

immunosuppressive therapy (e.g., antithymocyte golbulin, cyclosporine).

Multiple Myeloma: Used in combination with dexamethasone. Chronic

Lymphocytic Leukemia: Relapsed or refractory to one prior therapy for

CLL.


Prescriber

Restrictions

MDS, Multiple Myeloma, CLL: Prescribed by an oncologist or

hematologist or by oncology or hemoatology consult.

Coverage

Duration

MDS, Multiple Myeloma: 6 months.


84

RIBAVIRIN

Products Affected

Ribapak TABS 400MG

Ribasphere

Ribavirin

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Hepatitis C: Adults with a diagnosis of Hepatitis C with compensated

liver disease, and verification of concurrent use with an alfa interferon

product.


Prescriber

Restrictions

N/A

Coverage

Duration

48 weeks

Other Criteria None

85

RILUTEK

Products Affected

Rilutek

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of amyotrophic lateral sclerosis (ALS), LFTs

Age Restrictions Greater than or equal to 18 years

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

86

RITUXAN

Products Affected

Rituxan

Details


Chronic Lymphocytic Leukemia, Immune or idiopathic thrombocytopenic

purpura, Waldenstroms macroglobulinemia

Exclusion

Criteria

N/A

Required

Medical

Information

Non-Hodgkin's Lymphoma: As first-line treatment of diffuse large B-cell,

CD20-positive, non-Hodgkins lymphoma in combination with CHOP or

other anthracycline-based chemotherapy regimens, or as first-line

treatment of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in

combination with CVP chemotherapy, or for the treatment of low-grade,

CD20-positive, B-cell non-Hodgkin's lymphoma in patients with stable

disease or who achieve a partial or complete response following first-line

treatment with CVP chemotherapy, or confirmed diagnosis of relapsed or

refractory, low grade or follicular CD20-positive, B-cell non-Hodgkins

lymphoma. RA (Initial): Diagnosis of moderate-to-severe active RA.

Used in combination with methotrexate. Failure to a TNF antagonist. RA

(Reauthorization): Documented positive clinical response.

Age Restrictions RA: 18 years and older.

Prescriber

Restrictions

RA: Prescribed by a rheumatologist.

Coverage

Duration

All uses except RA: 1 year. RA: One month

Other Criteria None

87

SAMSCA

Products Affected

Samsca TABS 15MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of Hyponatremia, hypervolemic or euvolemic.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

88

SANDOSTATIN

Products Affected

Octreotide Acetate Sandostatin Lar Depot

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Acromegaly: Inadequate response to surgery and/or radiotherapy, or who

are not a surgical and/or radiotherapy candidate. Diagnosis of acromegaly

by one of the following: serum GH level greater than 1 ng/mL after a 2-

hour oral glucose tolerance test, or elevated serum IGF-1 levels as

compared to normal reference values by age and gender. Carcinoid

tumors: diagnosis of metastatic carcinoid tumor, for symptomatic

treatment of severe diarrhea or flushing. Vasoactive Intestinal Peptide

Tumors: Diagnosis of metastatic vasoactive intestinal peptide tumor, for

symptomatic treatment of diarrhea associated with vasoactive intestinal

peptide tumor. Cancer Chemotherapy Induced Diarrhea.


Prescriber

Restrictions

N/A

Coverage

Duration

Acromegaly: long-term approval. Tumors: 6 mo. Chemo-induced

diarrhea, AIDS-related Diarrhea: 3 mo.

Other Criteria None

89

SIMPONI

Products Affected

Simponi

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis. Ankylosing spondylitis: For the treatment of adults with active

ankylosing spondylitis. Psoriatic arthritis: For the treatment of adults with

active psoriatic arthritis, used alone or in combination with methotrexate.

Rheumatoid arthritis: For the treatment of adults with moderately to

severely active rheumatoid arthritis (RA), in combination with

methotrexate.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Treatment and failure with Enbrel and Humira

90

SIMVASTATIN 80MG

Products Affected

Simvastatin TABS 80MG Vytorin TABS 10MG; 80MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1)Documented History of use of the simvastatin 80mg containing product

for a period longer than 12 months. 2) Confiramtion that member has not

experienced myopathy or rhabdomyolysis related symptoms


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria None

91

SOMATULINE

Products Affected

Somatuline Depot INJ 120MG/0.5ML,

60MG/0.2ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Acromegaly: Patients who require long-term treatment due to inadequate

response to surgery and/or radiotherapy, or who are not a surgical and/or

radiotherapy candidate. Diagnosis of acromegaly by one of the following:

serum GH level greater than 1 ng/mL after a 2-hour oral glucose tolerance

test, or elevated serum IGF-1 levels as compared to normal reference

values by age and gender.


Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite, long term therapy (open-ended)

Other Criteria None

92

SOMAVERT

Products Affected

Somavert

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Acromegaly (Initial): Inadequate response to surgery and/or radiation

therapy or not a candidate for surgery or radiation. Inadequate response or

intolerance to octreotide, or lanreotide, or IGF-1 value greater than 900

ng/mL. Acromegaly (Reauth): Serum IGF-1 level within the age-adjusted

normal range.


Prescriber

Restrictions

N/A

Coverage

Duration

Acromegaly (Initial): 12 weeks. Acromegaly (Reauth): indefinite

Other Criteria None

93

SORIATANE

Products Affected

Soriatane

Details


Exclusion

Criteria

Acitretin must not be used by females who are pregnant, or who intend to

become pregnant during therapy or at any time for at least 3 years

following discontinuation of therapy. Ethanol must not be ingested by

female patients either during treatment or for 2 months after cessation of

therapy.

Required

Medical

Information

Diagnosis. Contraception-Acitretin must not be used by females who are

pregnant, or who intend to become pregnant during therapy or at any time

for at least 3 years following discontinuation of therapy. Ethanol must not

be ingested by female patients either during treatment or for 2 months

after cessation of therapy.

Age Restrictions Must be greater than or equal to 18 yo (or FDA approved age).

Prescriber

Restrictions

Must be dermatologist

Coverage

Duration

Approve up to 1 year.

Other Criteria None

94

SPORANOX (SOLUTION)

Products Affected

Sporanox SOLN

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of oropharyngeal or esophageal candidiasis.


Prescriber

Restrictions

N/A

Coverage

Duration

12 weeks

Other Criteria None

95

SPRYCEL

Products Affected

Sprycel

Details


Exclusion

Criteria

N/A

Required

Medical

Information

CML: Diagnosis of Philadelphia chromosome positive or BCR-ABL

positive chronic, accelerated, or myeloid or lymphoid blast phase chronic

myeloid leukemia. Failure to Gleevec. ALL: Diagnosis of Philadelphia

chromosome-positive acute lymphoblastic leukemia. Failure to Gleevec

requirement does not apply to newly diagnosed Philadelphia

chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic

phase.


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime


96

STELARA

Products Affected

Stelara

Details


Exclusion

Criteria

N/A

Required

Medical

Information

For the treatment of moderate to severe plaque psoriasis who are

candidates for phototherapy or systemic therapy. Treatment and failure

with Enbrel and Humira

Age Restrictions Approve for those patients 18 years of age or older

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Subject to Part B vs. Part D review

97

SUTENT

Products Affected

Sutent

Details


Exclusion

Criteria

N/A

Required

Medical

Information

GIST: Disease progression on or intolerance to Gleevec. Renal Cell

Carcinoma: Diagnosis of renal cell carcinoma with relapse following

surgical excision, or diagnosis of renal cell carcinoma with medically or

surgically unresectable tumor, or diagnosis of Stage IV renal cell

carcinoma.


Prescriber

Restrictions

Oncologist

Coverage

Duration

1 year


98

TARCEVA

Products Affected

Tarceva

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Patients diagnosed with locally advanced or metastatic non-small cell

lung cancer (NSCLC) after failure of at least one prior chemotherapy

regimen. Pancreatic Cancer: Patient diagnosed with locally advanced,

unresectable or metastatic pancreatic cancer. Used in combination with

gemcitabine. Reauthorization: Patient has not experienced disease

progression.


Prescriber

Restrictions

Oncologist

Coverage

Duration

6 months


99

TARGRETIN

Products Affected

Targretin

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Definitive diagnosis of cutaneous T-cell lymphoma (CTCL)


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year

Other Criteria Approve for continuation of therapy

100

TASIGNA

Products Affected

Tasigna

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Chronic Myelogenous Leukemia: Diagnosis of Philadelphia chromosome

positive chronic or accelerated phase chronic myeloid leukemia and

failure to Gleevec. Failure to Gleevec requirement does not apply to

newly diagnosed CM


Prescriber

Restrictions

N/A

Coverage

Duration

1 year


101

TAXOTERE

Products Affected

Taxotere INJ 80MG/4ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

Lifetime

Other Criteria N/A

102

TESTOSTERONE (INJECTABLE)

Products Affected

Testosterone Cypionate Testosterone Enanthate

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of male hypogonadism with a pre-treatment total testosterone

level below normal physiological value (less than 280 ng/dl), or pre-

treatment free testosterone below normal reference value. Diagnosis of

delayed puberty in males. Diagnosis of Metastatic breast cancer, Female

(testosterone enanthate)


Prescriber

Restrictions

N/A

Coverage

Duration

Hypogonadism: 1 year. Delayed puberty: 6 months

Other Criteria None

103

TESTOSTERONE (ORAL)

Products Affected

Striant Testred

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Male: 1-Diagnosis of male hypogonadism with a pre-treatment total

testosterone level below normal physiological value (less than 280 ng/dl),

or pre-treatment free testosterone below normal reference value. OR 2-

Diagnosis of delayed puberty in males. Female: Diagnosis of Metastatic

breast cancer - (Methyltestosterone)


Prescriber

Restrictions

N/A

Coverage

Duration

Hypogonadism: 1 year. Delayed puberty: 6 months

Other Criteria None

104

TESTOSTERONE (TOPICAL)

Products Affected

Androgel GEL 50MG/5GM Androgel Pump GEL 1.62%

Details


Exclusion

Criteria

Female, prostate cancer

Required

Medical

Information

Hypogonadism: Diagnosis of hypogonadism in men with a pre-treatment

testosterone level below normal physiological value of 280 ng/dL or

below normal reference level provided by the physician laboratory.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

105

THALOMID

Products Affected

Thalomid

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Erythema nodosum leprosum: Confirmed diagnosis of moderate to severe

ENL. Multiple Myeloma: For newly diagnosed multiple myeloma in

combination with dexamethasone or conventional dose chemotherapy, or

in combination with high dose chemotherapy with stem cell rescue, or

salvage therapy in refractory or relapsed multiple myeloma after primary

therapy, or in combination with dexamethasone, doxorubicin,

cyclophosphamide, and etoposide as part of induction regimen prior to

autologous transplant. Waldenstroms Macroglobulinemia: Disease

progression on an alkylating agent, nucleoside analog, or rituximab.

Aphthous stomatitis or ulcers: Diagnosis of HIV-associated aphthous

ulcers, or recurrent aphthous stomatitis in immunocompromised patients.

Refractory to alternative therapies. Crohns Disease: Patient is refractory

to all of the following standard treatment regimens: corticosteroids, 5-

aminosalicylic acid, immunodulators, Remicade. GVHD: Diagnosis of

chronic or refractory GVHD in patient unresponsive to all of the

following: corticosteroids, azathioprine, tacrolimus, cyclosporine,

antithymocyte globulin. Primary Brain Tumors: As adjuvant therapy to

current cytotoxic therapies, or previous failure to cytotoxic therapies

and/or tumor resection. AIDS-related wasting (Initial): Diagnosis of AIDS

wasting or cachexia defined as chronic unremitting weight loss of more

than 10% body weight in the previous 4 months. Nutritional evaluation

since onset of wasting first occurred. Screened for hypogonadism. Failure

to respond to hormone replacement therapy in patients with

hypogonadism. Failure, contraindication or intolerance to standard

treatments. AIDS-related wasting (Reauthorization): Weight has

stabilized or improved but not at goal weight. Advanced Renal Cell

Carcinoma: Confirmed diagnosis of metastatic renal cell carcinoma.

Patient is refractory to, or an unsuitable of the following: interferon-alfa-

2b, interleukin-2, sorafenib, sunitanib.


106

Prescriber

Restrictions

N/A

Coverage

Duration

All uses: 3 mo. Except AS: 1 mo. ENL, MM: 1 year. WM: GVHD:

Primary Brain Tumors: 6 mo.


107

TYKERB

Products Affected

Tykerb

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Breast Cancer: Diagnosis of HER2-positive advanced or metastatic breast

cancer. Confirmation of normal left ventricular ejection fraction.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year


108

ULORIC

Products Affected

Uloric

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis, drugs tried and failed, or documented allergy or intolerable

side effect. Failure of either allopurinol or probenecid.

Age Restrictions Greater than or equal to 18 yo

Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

109

VANDETANIB

Products Affected

Caprelsa

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis: metastatic or unresectable medullary thyroid cancer


Prescriber

Restrictions

Endocrinologist or Oncologist

Coverage

Duration

Lifetime

Other Criteria None

110

VECTIBIX

Products Affected

Vectibix INJ 100MG/5ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Colorectal Cancer: Diagnosis of metastatic colorectal cancer. Relapsed,

refractory, or disease progression on one standard chemotherapy regimen

containing a fluoropyrmidine, oxaliplatin, or irinotecan. Tumor expresses

wild-type KRAS gene.


Prescriber

Restrictions

N/A

Coverage

Duration

Colorectal Cancer: 6 months



new starts only. Approve for continuation of prior therapy.

111

XALKORI

Products Affected

Xalkori

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1) Diagnosis of locally advanced or metastatic non-small cell lung cancer

(NSCLC). 2) Patient tried and failed at least one platinum-based or

taxane-based chemotherapy regimen or has a contraindication to these

medications. 3) prescriber provided the results of the genetic test, Vysis

ALK Break Apart FISH Probe Kit, indicating that the member is

anaplastic lymphoma kinase (ALK)-positive.


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial - 6month, continuation 6 months

Other Criteria None

112

XARELTO

Products Affected

Xarelto TABS 10MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1)Diagnosis Hip or Knee replacement. 2)Amount of tablets filled in the

past 365 days


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria None

113

XENAZINE

Products Affected

Xenazine

Details


Exclusion

Criteria

Hepatic function impairment, patients who are actively suicidal or who

have untreated or inadequately treated depression, patients taking

monoamine oxidase inhibitors (MAOIs) or reserpine.

Required

Medical

Information

Diagnosis, concommitant therapies, dose, Genotype CYP2D6

Age Restrictions Greater than or equal to 18 yo (or FDA approved age)

Prescriber

Restrictions

none

Coverage

Duration

6 months

Other Criteria None

114

XEOMIN

Products Affected

Xeomin INJ 50UNIT

Details


Exclusion

Criteria

Cosmetic use.

Required

Medical

Information

Diagnosis of Cervical Dystonia, Glabellar Lines or Blepharospasm.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria History of Treatment with Botox.

115

XGEVA

Products Affected

Xgeva

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Initial approval requires documented failure, intolerance, or clinical

rationale for avoidance to Zometa AND Recent oral exam to assess

osteonecrosis risk AND Concurrent treatment with Calcium and Vitamin

D. Subsequent approval requires documentation of treatment success.


Prescriber

Restrictions

N/A

Coverage

Duration

Initial approvals will be for 6 months. Subsequent approvals will be

approved 12 months

Other Criteria None

116

XOLAIR

Products Affected

Xolair

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Asthma (Initial): Diagnosis of moderate-to-severe persistent allergic

asthma, defined by daily asthmatic symptoms, daily use of inhaled short-

acting beta agonists, exacerbations affect/limit activity, exacerbations 2 or

more times per week, nocturnal symptoms once a week or more, forced

expiratory volume in one second or peak expiratory flow less than or

equal to 80% of predicted, or PEF variability greater than 30%. Baseline

IgE level greater than or equal to 30 IU/mL. Documented failure to

combination therapy with an inhaled corticosteroid at the maximum

dosage and a long-acting beta-agonist. Asthma (Reauthorization):

Documented reduction in the frequency of asthma exacerbations while

treated with Xolair. Documented reduction in the use of rescue

medications or inhaled corticosteroids while treated with Xolair.

Age Restrictions Asthma (Initial): 12 years and older.

Prescriber

Restrictions

Asthma (Initial): Prescribed by a pulmonologist or allergist/immunologist.

Coverage

Duration

Asthma (Initial): 16 weeks. Asthma (Reauthorization): 1 year.

Other Criteria None

117

XYREM

Products Affected

Xyrem

Details


Exclusion

Criteria

N/A

Required

Medical

Information

N/A


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Limited distribution only through the Xyrem Success program

118

YERVOY

Products Affected

Yervoy INJ 50MG/10ML

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1) Diagnosis of metastatic melanoma or unresectable melanoma


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial-4months

Other Criteria None

119

ZELBORAF

Products Affected

Zelboraf

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1) Diagnosis of metastatic melanoma or unresectable melanoma. 2)

Results of the cobas 4800 BRAF V600 Mutation Test showing that the

members tumor expresses the BRAF V600 gene mutation


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial - 6 months, continuation 6 months

Other Criteria None

120

ZEMAIRA

Products Affected

Zemaira

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis


Prescriber

Restrictions

N/A

Coverage

Duration

1 Year


121

ZOLINZA

Products Affected

Zolinza

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Definitive diagnosis of cutaneous T-cell lymphoma (CTCL)


Prescriber

Restrictions

N/A

Coverage

Duration

1 year


122

ZORTRESS

Products Affected

Zortress ORAL TABS 0.5MG, 0.75MG

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Renal transplant rejection prophylaxis. Concomitant medications being

used.


Prescriber

Restrictions

N/A

Coverage

Duration

1 year

Other Criteria Subject to Part B vs. Part D review.

123

ZYTIGA

Products Affected

Zytiga

Details


Exclusion

Criteria

N/A

Required

Medical

Information

1) diagnosis of metastatic castrate-resistant prostate cancer. 2) Member

tried and failed Taxotere (docetaxel) therapy


Prescriber

Restrictions

Oncologist

Coverage

Duration

Initial approval 6 months

Other Criteria None

124

ZYVOX

Products Affected

Zyvox

Details


Exclusion

Criteria

N/A

Required

Medical

Information

Infections: One of the following: Infections caused by vancomycin-

resistant enterococci (VRE) documented by culture and sensitivity report.

Nosocomial pneumonia caused by methicillin-resistant Staphylococcus

aureus (MRSA) documented by culture and sensitivity report.

Complicated skin and skin structure infections (including diabetic foot

infections) without osteomyelitis caused by methicillin-resistant

Staphylococcus aureus (MRSA) documented by culture and sensitivity

report. Empirical treatment of patients with community-acquired

complicated skin and skin structure infections without osteomyelitis

where MRSA infection is likely, in patients who have failed one of the

following: trimethoprim-sulfamethoxazole, tetracycline, doxycycline,

minocycline. As continuation of therapy when transitioning from

intravenous daptomycin, intravenous vancomycin, or intravenous Zyvox

therapy.


Prescriber

Restrictions

N/A

Coverage

Duration

Infections: 28 days.

Other Criteria None

125

PART B VERSUS PART D

Products Affected

Abelcet

Acetylcysteine INHALATION SOLN

Albuterol Sulfate INHALATION NEBU

Ambisome

Aminosyn II INJ 50.3MEQ/L;

695MG/100ML; 713MG/100ML;

490MG/100ML; 517MG/100ML;

350MG/100ML; 210MG/100ML;

462MG/100ML; 700MG/100ML;

735MG/100ML; 120MG/100ML;

209MG/100ML; 505MG/100ML;

371MG/100ML; 31.3MEQ/L;

280MG/100ML; 140MG/100ML;

189MG/100ML; 350MG/100ML,

61.1MEQ/L; 844MG/100ML;

865MG/100ML; 595MG/100ML;

627MG/100ML; 425MG/100ML;

255MG/100ML; 561MG/100ML;

850MG/100ML; 893MG/100ML;

146MG/100ML; 253MG/100ML;

614MG/100ML; 450MG/100ML;

33.3MEQ/L; 340MG/100ML;

170MG/100ML; 230MG/100ML;

425MG/100ML

Aminosyn M

Aminosyn-hbc

Aminosyn-pf

Aminosyn-pf 7%

Amphotec INJ 50MG

Amphotericin B

Brovana

Budesonide INHALATION SUSP

Calcitriol ORAL CAPS

Carimune Nanofiltered INJ 3GM

Clinimix 2.75%/dextrose 5%





Clinimix 5%/dextrose 15%

Gammagard Liquid

Ganciclovir INJ

Gengraf

Granisetron Hcl INJ 1MG/ML

Granisetron Hcl TABS

Hectorol ORAL CAPS

Heparin Sodium INJ 10000UNIT/ML,

1000UNIT/ML, 20000UNIT/ML,

5000UNIT/ML

Heparin Sodium/nacl 0.45% INJ

100UNIT/ML; 0.45%

Hepatasol

Hizentra INJ 1GM/5ML

Intralipid INJ 2.25%; 20%

Ipratropium Bromide INHALATION

SOLN 0.02%

Ipratropium Bromide/albuterol Sulfate

Levalbuterol

Levocarnitine SOLN

Levocarnitine TABS

Lidocaine OINT

Lidocaine/prilocaine CREA

Myfortic

Nebupent

Nephramine

Ondansetron Hcl ORAL TABS

Ondansetron Hcl SOLN

Ondansetron Odt

Pamidronate Disodium INJ 6MG/ML

Perforomist

Premasol INJ 52MEQ/L;

1760MG/100ML; 880MG/100ML;

34MEQ/L; 1760MG/100ML;

372MG/100ML; 406MG/100ML;

526MG/100ML; 492MG/100ML;

492MG/100ML; 526MG/100ML;

356MG/100ML; 356MG/100ML;

390MG/100ML; 34MG/100ML;

152MG/100ML

Procalamine

126



Clinimix E 2.75%/dextrose 10%




Clinimix E 5%/dextrose 15%



Clinisol Sf 15%

Colistimethate Sodium

Cromolyn Sodium NEBU

Cyclophosphamide ORAL TABS

Cyclosporine ORAL CAPS

Cyclosporine Modified CAPS 50MG

Cyclosporine Modified SOLN

Dronabinol

Emend ORAL CAPS

Engerix-b

Freamine III 3%

Prosol

Rapamune

Reclast

Recombivax Hb INJ 10MCG/ML,

40MCG/ML

Sancuso

Tacrolimus ORAL CAPS 0.5MG

Teflaro INJ 400MG

Travasol

Vancomycin Hcl INJ 1000MG, 10GM,

500MG

Zemplar INJ 2MCG/ML

Zemplar ORAL CAPS 1MCG, 2MCG

Zometa INJ 4MG/5ML

Details

This drug may be covered under Medicare Part B or D depending upon the circumstances.

Information may need to be submitted describing the use and setting of the drug to make the

determination.

127

INDEX

A

Abelcet .............................................................. 125

Abstral ................................................................. 34

Acetylcysteine ................................................... 125

ACNE-TOPICAL...................................................... 1

ACTEMRA .............................................................. 2

Actimmune .......................................................... 47

Aczone ................................................................... 1

Adapalene .............................................................. 1

Adcirca ................................................................ 77

Adderall Xr ............................................................ 3

ADHD/NARCOLEPSY .............................................. 3

AFINITOR .............................................................. 4

Albuterol Sulfate ............................................... 125

Aldurazyme ......................................................... 28

Ambisome ......................................................... 125

Aminosyn II....................................................... 125

Aminosyn M ...................................................... 125

Aminosyn-hbc ................................................... 125

Aminosyn-pf...................................................... 125

Aminosyn-pf 7% ............................................... 125

Amphetamine/dextroamphetamine ....................... 3

Amphotec .......................................................... 125

Amphotericin B ................................................. 125

AMPYRA ................................................................ 5

Androgel ............................................................ 104

Androgel Pump ................................................. 104

ANTIFUNGAL ......................................................... 6

ANTINEOPLASTIC .................................................. 7

APOKYN................................................................. 8

ARALASP ............................................................... 9

Aralast Np ............................................................. 9

ARANESP ............................................................. 10

Aranesp Albumin Free ........................................ 10

ARZERRA ............................................................. 12

AVASTIN .............................................................. 13

Avonex ................................................................ 59

B

BARBITURATE ...................................................... 14

BENZODIAZEPINE ................................................ 15

Betaseron.............................................................. 59

BOTOX.................................................................. 16

Brovana .............................................................. 125

Budesonide ......................................................... 125

C

Calcitriol ............................................................ 125

CALCIUM RECEPTOR ANTAGONISTS .................. 17

Cancidas ................................................................. 6

Caprelsa.............................................................. 109

CARBAGLU ........................................................... 18

Carimune Nanofiltered....................................... 125

Carisoprodol ......................................................... 42

Carisoprodol/aspirin ............................................. 42

Carisoprodol/aspirin/codeine ............................... 42

CAYSTON ............................................................. 19

Cellcept ................................................................ 20

CELLCEPT (ORAL) ............................................... 20

Cenestin................................................................ 42

CHANTIX .............................................................. 21

Chantix Starting Month Pak................................. 21

Chlordiazepoxide/amitriptyline ........................... 42

Chlorpropamide ................................................... 42

Chlorzoxazone ..................................................... 42

CHORIONIC GONADOTROPIN .............................. 22

Ciclopirox Nail Lacquer ........................................ 6

CIMZIA ................................................................. 23

CINRYZE .............................................................. 24

Clinimix 2.75%/dextrose 5% ............................. 125

Clinimix 4.25%/dextrose 10% ........................... 125



Clinimix 4.25%/dextrose 5% ............................. 125

Clinimix 5%/dextrose 15% ................................ 125

128

Clinimix 5%/dextrose 20% ............................... 125

Clinimix 5%/dextrose 25% ............................... 125

Clinimix E 2.75%/dextrose 10% ....................... 125

Clinimix E 2.75%/dextrose 5% ......................... 125

Clinimix E 4.25%/dextrose 25% ....................... 125

Clinimix E 4.25%/dextrose 5% ......................... 125

Clinimix E 5%/dextrose 15% ............................ 125



Clinisol Sf 15% ................................................. 125

Clonazepam ......................................................... 15

Clonazepam Odt .................................................. 15

Clorazepate Dipotassium..................................... 15

Colistimethate Sodium ...................................... 125

Copaxone ............................................................. 59

Cromolyn Sodium ............................................. 125

Cyclobenzaprine Hcl ........................................... 42

Cyclobenzaprine Hcl Er ...................................... 42

Cyclophosphamide ............................................ 125

Cyclosporine...................................................... 125

Cyclosporine Modified ...................................... 125

Cyproheptadine Hcl............................................. 42

D

Daytrana ................................................................ 3

DEGARELIX ......................................................... 25

Dextroamphetamine Sulfate .................................. 3

Dextroamphetamine Sulfate Er ............................. 3

Diazepam ............................................................. 15

Dicyclomine Hcl ................................................. 42

DIFICID ................................................................ 26

Diphenhydramine Hcl ......................................... 42

Diphenoxylate/atropine ....................................... 42

Dipyridamole ....................................................... 42

Dronabinol ......................................................... 125

E

Eligard ................................................................. 44

Emcyt .................................................................. 44

Emend................................................................ 125

ENBREL ............................................................... 27

Engerix-b ........................................................... 125

ENZYME REPLACEMENT ..................................... 28

EPOETIN ALFA ..................................................... 29

ERBITUX............................................................... 31

ERIVEDGE ............................................................ 32

Estropipate ........................................................... 42

EXJADE ................................................................ 33

Extavia ................................................................. 59

F

Fabrazyme ............................................................ 28

FENTANYL ............................................................ 34

Fentanyl Citrate Oral Transmucosal .................... 34

Fentora ................................................................. 34

Firmagon .............................................................. 25

Focalin Xr .............................................................. 3

FORTEO ................................................................ 35

Freamine III 3% ................................................. 125

G

Gammagard Liquid ............................................ 125

Ganciclovir ......................................................... 125

Gengraf .............................................................. 125

Genotropin ........................................................... 38

Genotropin Miniquick .......................................... 38

GILENYA .............................................................. 36

GLEEVEC ............................................................. 37

Granisetron Hcl .................................................. 125

GROWTH HORMONES .......................................... 38

H

Hectorol.............................................................. 125

Heparin Sodium ................................................. 125

Heparin Sodium/nacl 0.45% .............................. 125

Hepatasol............................................................ 125

HEPATITIS C PROTEASE INHIBITORS ................. 40

HEXALEN ............................................................. 41

HIGH RISK MEDICATIONS .................................. 42

Hizentra .............................................................. 125

HORMONAL AGENTS ........................................... 44

Humatrope............................................................ 38

HUMIRA ............................................................... 45

Hydroxyzine Hcl .................................................. 42

129

Hydroxyzine Pamoate ......................................... 42

I

Incivek ................................................................. 40

Increlex ................................................................ 38

INLYTA ................................................................ 46

INTERFERON ....................................................... 47

Intralipid ............................................................ 125

INTRON-A ............................................................ 48

Intron-a W/diluent ............................................... 48

Ipratropium Bromide ......................................... 125

Ipratropium Bromide/albuterol Sulfate ............. 125

Itraconazole ........................................................... 6

Ixempra Kit ........................................................... 7

J

JAKAFI ................................................................. 50

JEVTANA ............................................................. 51

K

KALYDECO .......................................................... 52

Ketorolac Tromethamine..................................... 42

KINERET .............................................................. 53

KUVAN ................................................................. 54

L

Letairis ................................................................. 77

LEUKINE .............................................................. 55

Levalbuterol ...................................................... 125

Levocarnitine ..................................................... 125

Lidocaine ........................................................... 125

Lidocaine/prilocaine .......................................... 125

LOTRONEX .......................................................... 56

LUMIGAN ............................................................. 57

LUMIZYME / MYOZYME ..................................... 58

Lupron Depot ...................................................... 44

Lupron Depot-ped ............................................... 44

M

Macrodantin ........................................................ 42

Menest ................................................................. 42

Meperidine Hcl .................................................... 42

Meprobamate ....................................................... 42

Metadate CD .......................................................... 3

Metadate Er ............................................................ 3

Methamphetamine Hcl ........................................... 3

Methocarbamol .................................................... 42

Methylphenidate Hcl .............................................. 3

Methylphenidate Hcl Er ......................................... 3

Methylphenidate Hydrochloride ............................ 3

MS AGENTS .......................................................... 59

Mycophenolate Mofetil ........................................ 20

Myfortic ............................................................. 125

Myozyme ............................................................. 58

N

Naglazyme ........................................................... 28

Nebupent ............................................................ 125

Nephramine ........................................................ 125

NEULASTA ............................................................ 60

NEUMEGA ............................................................ 61

NEUPOGEN ........................................................... 62

NEXAVAR ............................................................. 63

Nifedipine ............................................................ 42

Nitrofurantoin Macrocrystalline .......................... 42

Nitrofurantoin Monohydrate ................................ 42

Norditropin Flexpro ............................................. 38

Norditropin Nordiflex Pen ................................... 38

Noxafil ................................................................... 6

Nutropin Aq Pen .................................................. 38

Nuvigil ................................................................. 76

O

Octreotide Acetate ............................................... 88

Omnitrope ............................................................ 38

Ondansetron Hcl ................................................ 125

Ondansetron Odt ................................................ 125

Onsolis ................................................................. 34

ORENCIA .............................................................. 64

Orphenadrine Citrate ............................................ 42

Orphenadrine Citrate Er ....................................... 42

Orphenadrine/asa/caffeine ................................... 42

OXANDRIN ........................................................... 65

Oxandrolone ......................................................... 65

130

P

Pamidronate Disodium ...................................... 125

PANRETIN ............................................................ 66

PART B VERSUS PART D ................................... 125

PEGASYS .............................................................. 67

Pegasys Proclick .................................................. 67

PEG-INTRON ........................................................ 69

Peg-intron Redipen .............................................. 69

Pentazocine/acetaminophen ................................ 42

Perforomist ........................................................ 125

Phenadoz ............................................................. 42

Phenobarbital ....................................................... 14

POTIGA ................................................................ 70

Pregnyl W/diluent Benzyl Alcohol/nacl ............. 22

Premarin .............................................................. 42

Premasol ............................................................ 125

Premphase ........................................................... 42

Prempro ............................................................... 42

Procalamine ....................................................... 125

Procrit .................................................................. 29

PROGRAF (ORAL) ................................................ 71

PROLASTIN .......................................................... 72

Prolastin-c............................................................ 72

PROLEUKIN ......................................................... 73

PROLIA ................................................................ 74

PROMACTA .......................................................... 75

Promethazine Hcl ................................................ 42

Promethazine Vc ................................................. 42

Promethegan ........................................................ 42

Prosol ................................................................. 125

PROVIGIL/NUVIGIL ............................................. 76

PULMONARY ARTERY HYPERTENSION .............. 77

PULMOZYME ....................................................... 78

R

RANEXA ............................................................... 79

Rapamune .......................................................... 125

Rebif .................................................................... 59

Rebif Titration Pack ............................................ 59

Reclast ............................................................... 125

Recombivax Hb ................................................. 125

REGRANEX ........................................................... 80

RELISTOR ............................................................. 81

REMICADE ........................................................... 82

Revatio ................................................................. 77

REVLIMID ............................................................ 83

Ribapak ................................................................ 84

Ribasphere............................................................ 84

RIBAVIRIN ............................................................ 84

RILUTEK .............................................................. 85

RITUXAN .............................................................. 86

S

Saizen Click.easy ................................................. 38

SAMSCA ................................................................ 87

Sancuso .............................................................. 125

SANDOSTATIN ...................................................... 88

Sandostatin Lar Depot.......................................... 88

Sensipar ................................................................ 17

SIMPONI ............................................................... 89

Simvastatin ........................................................... 90

SIMVASTATIN 80MG ............................................ 90

SOMATULINE ....................................................... 91

Somatuline Depot................................................. 91

SOMAVERT ........................................................... 92

SORIATANE .......................................................... 93

Sporanox .............................................................. 94

SPORANOX (SOLUTION) ....................................... 94

SPRYCEL .............................................................. 95

STELARA .............................................................. 96

Strattera .................................................................. 3

Striant ................................................................. 103

SUTENT ................................................................ 97

Sylatron ................................................................ 69

Synarel ................................................................. 44

T

Tacrolimus ................................................... 71, 125

TARCEVA ............................................................. 98

TARGRETIN .......................................................... 99

TASIGNA............................................................. 100

TAXOTERE ......................................................... 101

Teflaro ................................................................ 125

131

Terbinafine Hcl ..................................................... 6

TESTOSTERONE (INJECTABLE) ......................... 102

TESTOSTERONE (ORAL) .................................... 103

TESTOSTERONE (TOPICAL) ............................... 104

Testosterone Cypionate ..................................... 102

Testosterone Enanthate ..................................... 102

Testred ............................................................... 103

Tev-tropin ............................................................ 38

THALOMID ........................................................ 105

Thioridazine Hcl .................................................. 42

Tracleer................................................................ 77

Travasol ............................................................. 125

Trelstar Depot Mixject ........................................ 44

Trelstar La Mixject .............................................. 44

Tretinoin ................................................................ 1

Trimethobenzamide Hcl ...................................... 42

TYKERB ............................................................. 107

Tysabri ................................................................. 59

U

ULORIC .............................................................. 108

V

Vancomycin Hcl ................................................ 125

VANDETANIB ..................................................... 109

VECTIBIX ........................................................... 110

Ventavis ............................................................... 77

Vfend IV ................................................................ 6

Victrelis ................................................................ 40

Voriconazole .......................................................... 6

Votrient .................................................................. 7

Vytorin ................................................................. 90

X

XALKORI ............................................................ 111

XARELTO ........................................................... 112

XENAZINE .......................................................... 113

XEOMIN .............................................................. 114

XGEVA ............................................................... 115

XOLAIR .............................................................. 116

XYREM ............................................................... 117

Y

YERVOY ............................................................. 118

Z

ZELBORAF .......................................................... 119

ZEMAIRA ............................................................ 120

Zemplar .............................................................. 125

ZOLINZA ............................................................ 121

Zometa ............................................................... 125

ZORTRESS .......................................................... 122

ZYTIGA .............................................................. 123

ZYVOX................................................................ 124

acne topical - simply healthcare plans

Documents