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ABATACEPT - MetroPlus Health Plan

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

<strong>ABATACEPT</strong><br />

Products Affected<br />

Orencia<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for juvenile rheumatoid arthritis, treatment or<br />

prophylaxis of systemic lupus erythematous.<br />

Diagnosis of moderate to severe Rheumatoid Arthritis OR moderate to<br />

severe Juvenile Idiopathic Arthritis AND member must have a negative<br />

tuberculin skin test, or if positive, have initiated treatment for latent TB<br />

prior to treatment with Orencia, AND member does not have an active<br />

infection that would put the patient at risk if receiving Orencia AND<br />

treatment will not be prescribed along with another biologic DMARD<br />

(i.e., Enbrel, Rituxan, Humira, Remicade, etc.) AND member has had an<br />

inadequate response to one or more nonbiologic disease modifying<br />

antirheumatic drugs OR member has had an inadequate response to one or<br />

more biologic disease modifying antirheumatic drugs.<br />

Patient is 18 years of age or older for RA. Patient is 6-17 years of age for<br />

juvenile idiopathic arthritis.<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 1


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ADALIMUMAB<br />

Products Affected<br />

Humira INJ 40MG/0.8ML<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for use of Humira in combination with other<br />

biologics e.g., Enbrel, Kineret or Remicade.<br />

Diagnosis<br />

N/A<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 2


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ANABOLIC STEROIDS<br />

Products Affected<br />

Anadrol-50<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Known or suspected carcinoma of the prostate or male breast, carcinoma<br />

of the breast in females with hypercalcemia, pregnancy, nephrosis,<br />

hypercalcemia, severe hepatic impairment<br />

Approve if treatment is for: anemia caused by deficient red cell<br />

production (documented hematocrit less than 33 or hemoglobin less than<br />

12), hereditary angioedema, involuntary weight loss following extensive<br />

surgery, chronic infections, or severe trauma, failure to gain or maintain at<br />

least 90% of ideal body weight without definite pathophysiologic reasons,<br />

chronic corticosteroid administration, osteoporosis related bone pain<br />

N/A<br />

N/A<br />

6 months<br />

N/A<br />

Version 10, Last updated 8/18/10 3


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ANAKINRA<br />

Products Affected<br />

Kineret<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Diagnosis of moderate to severe Rheumatoid Arthritis AND patient must<br />

have neutrophil counts assessed prior to beginning therapy, monthly for 3<br />

months and then quarterly thereafter for up to a year AND patient does<br />

not have an active infection AND treatment will not be prescribed with<br />

another biologic DMARD. Patient must also have had an inadequate<br />

response to at least one biologic and nonbiologic DMARD<br />

Patient must be 18 years or older<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 4


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

CERTOLIZUMAB<br />

Products Affected<br />

Cimzia<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Approve for FDA approved indications AND patient does not have a<br />

documented active infection, patient has been evaluated for tuberculosis<br />

risk factors and tested for latent infection prior to initiation of therapy and<br />

will be assessed periodically during therapy AND patient has failed to<br />

achieve symptom control after an adherent trial to conventional therapy<br />

AND patient has failed Remicade or Humira for Crohn's disease or Enbrel<br />

and Humira for rheumatoid arthritis<br />

Patient must be 18 years or older<br />

N/A<br />

3 months, then reassess for extension of PA x 1 yr.<br />

N/A<br />

Version 10, Last updated 8/18/10 5


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

DEGARELIX<br />

Products Affected<br />

Firmagon<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided for females<br />

Diagnosis of advanced or metastatic prostate cancer OR patient has as an<br />

intermediate to high risk of disease recurrence AND orchiectomy is not<br />

indicated or not acceptable to the patient AND estrogen therapy is not<br />

indicated or not acceptable to the patient<br />

Patient must be at least 18 years of age<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 6


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

DICLOFENAC PATCH<br />

Products Affected<br />

Flector<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Approve if used for the topical treatment of acute pain due to minor<br />

strains, sprains, and contusions AND documented trial and failure of an<br />

oral NSAID or documented swallowing disorder<br />

N/A<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 7


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ELTROMBOPAG<br />

Products Affected<br />

Promacta TABS 25MG, 50MG<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Concomitant use with other platelet-stimulating agents such as<br />

romiplostim or oprelvekin, Patient has failed to respond to therapy with<br />

eltrombopag following at least 4 weeks at the maximum dose,<br />

Eltrombopag is being used to normalize platelet count rather than to<br />

reduce the risk of bleeding in patients with chronic ITP,<br />

Chemotherapy/drug-induced thrombocytopenia, Treatment of<br />

thrombocytopenia due to causes other than chronic ITP, Patients who<br />

have previously failed therapy with eltrombopag<br />

Patient has a diagnosis of relapsed/refractory chronic ITP (greater than 6<br />

months) AND Prescriber and patient are enrolled in the Promacta Cares<br />

program (1-877-9-PROMACTA) AND Patient’s baseline platelet count is<br />

less than 50,000/mcL AND Patient’s degree of thrombocytopenia and<br />

clinical condition increases the risk for bleeding AND Patient is intolerant<br />

to splenectomy, and has had an insufficient response or is intolerant to<br />

corticosteroids and immune globulin OR Patient had a splenectomy with<br />

an inadequate response and had an insufficient response or is intolerant to<br />

corticosteroids and immune globulin.<br />

Patient is 18 years of age or older.<br />

N/A<br />

3 months<br />

N/A<br />

Version 10, Last updated 8/18/10 8


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ERYTHROPOIETINS<br />

Products Affected<br />

Aranesp Albumin Free<br />

Epogen<br />

Procrit<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided for prophylactic use to prevent chemotherapyinduced<br />

anemia or tumor hypoxia, sickle cell anemia, anemia associated<br />

only with radiotherapy or treatment of acute or chronic myelogenous<br />

leukemias or erythroid cancers, anemia of cancer not related to cancer<br />

treatment, anemia associated with iron deficiency, folate deficiency, B-12<br />

deficiency, hemolysis, or bone marrow fibrosis<br />

Pretreatment hemoglobin (Hgb) level must be less than 13 in anemic<br />

patients at high risk for perioperative blood loss and less than 10 for all<br />

other indications AND patient must have adequate iron stores prior to<br />

therapy AND patient must not have uncontrolled hypertension AND<br />

patient has not been diagnosed with antibody-mediated pure red cell<br />

aplasia AND other causes of anemia have been ruled out<br />

N/A<br />

N/A<br />

12 months<br />

Part B vs D Determination - if patient has end stage renal disease and is<br />

on dialysis, covered under Part B. Otherwise covered under Part D.<br />

Version 10, Last updated 8/18/10 9


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

FENTANYL CITRATE BUCCAL<br />

Products Affected<br />

Fentora<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided in the management of acute or postoperative pain,<br />

opiod non-tolerant patients, patients with known intolerance or<br />

hypersensitivity to the drug or fentanyl<br />

Diagnosis of cancer and use is for breakthrough cancer pain AND other<br />

formulary short acting narcotics have been ineffective, not tolerated, or<br />

contraindicated AND patient is opioid tolerant and taking at least 60 mg<br />

morphine/day or an equianalgesic dose of another opioid for a week or<br />

longer<br />

Patient must be at least 18 years of age<br />

N/A<br />

6 months<br />

N/A<br />

Version 10, Last updated 8/18/10 10


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

GOSERELIN<br />

Products Affected<br />

«TableStart:Rx1»«Tradename»<br />

«DosageForm»<br />

«Strength»«TableEnd:Rx1»<br />

«TableStart:Rx2»«Tradename»<br />

«DosageForm»<br />

«Strength»«TableEnd:Rx2»<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Coverage is not provided for carcinoma of pancreas, chronic pelvic pain<br />

of female, In vitro fertilization, ovarian cancer, precocious puberty,<br />

uterine leiomyoma, females who are pregnant or lactating,the 10.8 mg<br />

dose is not indicated for use in women, continued therapy or restarted<br />

after malignant disease progression constituting treatment failure,<br />

concomitant use with other LHRH agents, experimental/investigational<br />

uses including indications not supported by CMS recognized compendia<br />

Diagnosis of advanced or metastatic prostate cancer OR patient has as an<br />

intermediate to high risk of disease recurrence AND orchiectomy is not<br />

indicated or not acceptable to the patient AND estrogen therapy is not<br />

indicated or not acceptable to the patient. Diagnosis of hormone receptor<br />

(ER and/or PR +) positive advanced breast cancer in pre- or<br />

perimenopausal female or male patient, only the 3.6 mg dosage form is<br />

approved for advanced breast cancer. Diagnosis of endometriosis AND<br />

patient has had an inadequate pain control response or intolerance to:<br />

Danazol (six month trial) OR Combination [estrogen/progesterone] Oral<br />

Contraceptives (six month trial) OR Progestins (six month trial), only the<br />

3.6 mg dosage form is approved for endometriosis.Diagnosis of<br />

dysfunctional uterine bleeding AND Patient is scheduled for endometrial<br />

ablation, only the 3.6 mg is approved for Endometrial<br />

Thinning/Endometrial Hypoplasia for Dysfunctional Uterine Bleeding<br />

Patient must be 18 years or older.<br />

For oncology uses only, prescriber is an oncologist or an individual highly<br />

familiar with prescribing and monitoring of oncology related medications<br />

Adv Prostate Cancer, Invasive Breast Cancer 12 mth. Endometriosis 6<br />

mth. Endometrial thinning 2 mth<br />

Version 10, Last updated 8/18/10 11


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

Other Criteria<br />

N/A<br />

Version 10, Last updated 8/18/10 12


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

GROWTH HORMONES<br />

Products Affected<br />

Genotropin<br />

Genotropin Miniquick<br />

Humatrope<br />

Humatrope Combo Pack<br />

Norditropin Cartridge<br />

Norditropin Nordiflex Pen INJ<br />

10MG/1.5ML<br />

Nutropin<br />

Nutropin Aq<br />

Nutropin Aq Pen<br />

Omnitrope INJ 5.8MG<br />

Saizen INJ 5MG<br />

Saizen Click.easy<br />

Serostim<br />

Tev-tropin<br />

Zorbtive<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for constitutional delayed growth<br />

Diagnosis<br />

N/A<br />

N/A<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 13


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

IMMUNE GLOBULIN<br />

Products Affected<br />

Carimune Nanofiltered INJ 3GM<br />

Gamastan S/d<br />

Gammagard Liquid<br />

Gamunex<br />

Octagam<br />

Vivaglobin<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided in patients with selective IgA deficiency, history<br />

of anaphylactic reaction or hypersensitivity to immune globulin<br />

preparations<br />

Diagnosis<br />

N/A<br />

N/A<br />

6 months<br />

N/A<br />

Version 10, Last updated 8/18/10 14


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

MECASERMIN<br />

Products Affected<br />

Increlex<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided in the presence of: Concurrent treatment with<br />

growth hormone or Pharmacologic doses of corticosteroids, Allergy to<br />

mecasermin (ICF-1) or any component of the formulation, growth<br />

promotion in patients with closed epiphyses, active or suspected<br />

neoplasia, diagnosis of growth failure in adults<br />

1) diagnosis of growth failure due to severe primary IGFD with (a)height<br />

standard deviation less than-3.0, (b) basal IGF-1 standard deviation<br />

scoreless than-3.0 and (c) normal or elevated growth hormone levels OR<br />

(2) diagnosis of growth failure due to growth hormone deletion with<br />

neutralizing antibodies to growth hormone AND (3) treating physician is<br />

an endocrinologist or has consulted with an endocrinologist AND (4)<br />

patient does NOT have any of the following conditions: growth hormone<br />

deficiency, malnutrition, hypothyroidism or chronic treatmetn with<br />

pharmacologic doses of anti-inflammatory steroids.<br />

Patient must be a pediatric patient that is at least 2 years of age<br />

Prescribing physician must be an endocrinologist<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 15


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

METHYLNALTREXONE<br />

Products Affected<br />

Relistor<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for use nausea, vomiting, pruritis, or urinary<br />

retention related to morphine or other opioids.<br />

Diagnosis of opioid-induced constipation in patients with advanced illness<br />

AND patient is receiving palliative care AND documented trial and<br />

insufficient response to laxative therapy AND no known or suspected<br />

mechanical gastrointestinal obstruction (contraindication) AND no severe<br />

or persistent diarrhea (therapy should be discontinued in cases of severe<br />

or persistent diarrhea)<br />

N/A<br />

N/A<br />

4 months<br />

Use of methylnaltrexone in this diagnosis has not been studied beyond<br />

four months.<br />

Version 10, Last updated 8/18/10 16


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

NABILONE<br />

Products Affected<br />

Cesamet<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Diagnosis of cancer with chemotherapy-induced nausea/vomitting AND<br />

failure to reach desired outcomes with use of two conventional<br />

antiemetics<br />

Patient must be at least 18 years of age<br />

N/A<br />

6 months<br />

N/A<br />

Version 10, Last updated 8/18/10 17


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

PAZOPANIB<br />

Products Affected<br />

Votrient<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for Patients on concomitant tyrosine kinase<br />

inhibitors, Patients who have experienced significant disease progression<br />

while on pazopanib, Indications not supported by CMS-recognized<br />

compendia.<br />

Diagnosis of advanced renal cell carcinoma<br />

Patient is 18 years of age or older<br />

Prescriber is an oncologist or a healthcare provider highly familiar with<br />

prescribing and monitoring of oncology medications<br />

6 months<br />

N/A<br />

Version 10, Last updated 8/18/10 18


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

PEGFILGRASTIM<br />

Products Affected<br />

Neulasta<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Approve if anticipated that patient will require at least 10 days of white<br />

blood cell CSF therapy AND drug will be used as primary prophylaxis of<br />

febrile neutropenia associated with myelosuppresive chemotherapy OR<br />

patient's risk of febrile neutropenia is as least 20% or has risk factors if<br />

less than 20%, OR patient is receiving a dose density chemotherapy<br />

regimen OR patient had neutropenic complication from a prior cycle of<br />

chemotherapy OR patient had an autologous BMT or PBPC OR patient<br />

has diffuse aggressive lymphoma, is at least 65 years old, and being<br />

treated with curative chemotherapy OR patient is receiving radiation<br />

therapy, not on chemotherapy, and expected to have prolonged delays in<br />

treatment secondary to neutropenia<br />

N/A<br />

Patient is under the care of a physician with experience in prescribing<br />

pegfilgrastim<br />

4 months<br />

N/A<br />

Version 10, Last updated 8/18/10 19


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

PEGVISOMANT<br />

Products Affected<br />

Somavert<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided for Cancer, Insulin resistance, McCune-Albright<br />

syndrome, Turner syndrome<br />

Patient has a diagnosis of acromegaly AND Patient has had inadequate<br />

response to surgery and/or radiation therapy and/or other medical<br />

therapies, or these therapies are not appropriate.<br />

Patient is 18 years of age or older<br />

Prescriber is an endocrinologist or an individual familiar with prescribing<br />

and monitoring acromegaly related medications<br />

12 months<br />

N/A<br />

Version 10, Last updated 8/18/10 20


METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

RILONACEPT<br />

Products Affected<br />

Arcalyst<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also<br />

referred to as Chronic Infantile Neurologic Cutaneous Articular<br />

Syndrome (CINCA), Familial Mediterranean Fever (FMF), TNF<br />

Receptor-Associated Periodic Syndromes (TRAPS),<br />

Hyperimmunoglobulinemia D with periodic fever syndrome [HIDS] (also<br />

known as Hyper-IgD syndrome with periodic fever), Pyogenic arthritis,<br />

pyoderma gangrenosum, and acne syndrome [PAPA], Pediatric<br />

granulomatous arthritis (which encompasses familial Blau syndrome and<br />

the sporadic early-onset sarcoidosis), Deficiency of IL-1 receptor<br />

antagonist (DIRA), Pseudogout, Schnitzler syndrome, Systemic Juvenile<br />

Idiopathic Arthritis (SJIA), Gout (acute, chronic), Majeed syndrome,<br />

Cherubism, Adult-onset Still disease, Asthma, Chronic obstructive<br />

pulmonary disorder (COPD), Diabetes (type 1 or type 2), Prediabetes,<br />

Atherosclerosis, Rheumatoid arthritis, Wet age-related macular<br />

degeneration<br />

Patient has diagnosis of Familial Cold Autoinflammatory Syndrome<br />

(FCAS) OR Muckle-Wells Syndrome (MWS) diagnosed by, or upon<br />

consultation with or recommendation of, an immunologist, allergist,<br />

dermatologist, rheumatologist, neurologist or other medical specialist<br />

(medical specialty should be indicated by prescriber) AND Patient has<br />

been screened for latent tuberculosis (TB) infection and is negative or if<br />

positive, has been treated by standard medical practice for TB AND<br />

Patient has received all recommended vaccinations AND Patient is not<br />

receiving concomitant therapy with TNF inhibitors (i.e., certolizumab<br />

[CIMZIA], etanercept [ENBREL], adalimumab [HUMIRA], infliximab<br />

[REMICADE]) or other IL-1 blockers (i.e. anakinra [KINERET],<br />

canakinumab [ILARIS])<br />

Patient must be at least 12 year of age<br />

Diagnosed by, or upon consultation with or recommendation of, an<br />

immunologist, allergist, dermatologist, rheumatologist, neurologist or<br />

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2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

other medical specialist (medical specialty should be indicated by<br />

prescriber)<br />

Coverage<br />

Duration<br />

Other Criteria<br />

12 months<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

SARGRAMOSTIM<br />

Products Affected<br />

Leukine<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Diagnosis<br />

N/A<br />

Physician with experience in prescribing sargramostim<br />

4 months<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

SILDENAFIL<br />

Products Affected<br />

Revatio<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided for Sexual dysfunction as a result of<br />

antidepressant drug adverse reaction, Depression - Erectile Dysfunction,<br />

Diabetes mellitus - Erectile dysfunction, Dialysis procedure - Erectile<br />

dysfunction, Drug-induced impotence, Erectile dysfunction - Generalized<br />

atherosclerosis, Erectile dysfunction - Lower urinary tract symptoms, In<br />

combination with alfuzosin, Erectile dysfunction - Parkinson's disease,<br />

Erectile dysfunction - Peyronie's disease, Erectile dysfunction -<br />

Prostatectomy, Erectile dysfunction - Radiation therapy, Erectile<br />

dysfunction - Resection of rectum, Erectile dysfunction - Spina bifida,<br />

Erectile dysfunction - Spinal cord injury, Female sexual arousal disorder,<br />

Secondary Raynaud's phenomenon, Sexual dysfunction - Spinal cord<br />

injury.<br />

Diagnosis of Pulmonary Arterial Hypertension [PAH] (WHO Group I,<br />

WHO/NYHA functional class II, III or IV) AND Patient has undergone<br />

acute vasoreactivity testing and had a negative response or an initial<br />

positive response with subsequent failure of therapy with an oral calcium<br />

channel blocker (CCB) or the patient is unstable or has severe right-heart<br />

failure or a contraindication to CCB therapy AND Patient is not taking<br />

any of the following drugs concomitantly: organic nitrates in any form,<br />

ritonavir or other potent CYP3A4 inhibitors, Viagra or any other PDE5<br />

inhibitors AND Patients with hypoxia should receive concomitant oxygen<br />

therapy.<br />

N/A<br />

Prescription is written by a pulmonologist or cardiologist or<br />

documentation of consultation with pulmonologist or cardiologist<br />

Initial approval in new patients 6 months. Renewals annually thereafter.<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

SODIUM OXYBATE<br />

Products Affected<br />

Xyrem<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage is not provided for patients being treated with sedative hypnotic<br />

agents, patients with succinic semialdehyde dehydrogenase deficiency, a<br />

rare disorder is an inborn error of metabolism variably characterized by<br />

mental retardation, hypotonia, and ataxia.<br />

Documented (i.e., multiple sleep latency test) diagnosis of narcolepsy<br />

with excessive daytime sleepiness, cataplexy, or both. For a diagnosis of<br />

fibromyalgia, patients must try/fail two FDA approved drugs used for the<br />

treatment of fibromyalgia.<br />

Patients greater than 16 years of age.<br />

N/A<br />

Approval given for up to 3 years<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

TERIPARATIDE<br />

Products Affected<br />

Forteo<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

N/A<br />

Postmenopausal female with a diagnosis of osteoporosis OR male with<br />

diagnosis of hypogonadal osteoporosis with one of the following: history<br />

of osteoporotic fracture, multiple risk factors for fracture, trial and failure<br />

of oral bisphophonate, documented contraindication or intolerance to oral<br />

bisphophonate therapy<br />

Patient must be 18 years or older.<br />

N/A<br />

12 months<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

TREPROSTINIL-INJ<br />

Products Affected<br />

Remodulin<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not provided for Heart failure and Peripheral ischemia (Severe).<br />

Diagnosis of Pulmonary Arterial Hypertension [PAH] (WHO Group I) in<br />

Class III - IV patients OR Diagnosis of PAH (WHO Group I) in Class II<br />

patients who do not respond adequately to or are unable to tolerate<br />

conventional therapy, such as REVATIO (sildenafil), ADCIRCA<br />

(tadalafil), TRACLEER (bosentan) or LETAIRIS (ambrisentan) AND<br />

Patient has undergone acute vasoreactivity testing and had a negative<br />

response or an initial positive response with subsequent failure of therapy<br />

with an oral calcium channel blocker (CCB) or the patient is unstable or<br />

has severe right-heart failure or a contraindication to CCB therapy AND<br />

Patients with hypoxia should receive concomitant oxygen therapy.<br />

N/A<br />

Prescription is written by a pulmonologist or cardiologist or<br />

documentation of consultation with pulmonologist or cardiologist<br />

Initial approval in new patients 6 months. Renewals annually thereafter.<br />

N/A<br />

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METROPLUS MEDICARE ADVANTAGE PLAN<br />

2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

ZICONOTIDE<br />

Products Affected<br />

«TableStart:Rx1»«Tradename»<br />

«DosageForm»<br />

«Strength»«TableEnd:Rx1»<br />

«TableStart:Rx2»«Tradename»<br />

«DosageForm»<br />

«Strength»«TableEnd:Rx2»<br />

Details<br />

Covered Uses All FDA-approved indications not otherwise excluded from Part D.<br />

Exclusion<br />

Criteria<br />

Required<br />

Medical<br />

Information<br />

Age Restrictions<br />

Prescriber<br />

Restrictions<br />

Coverage<br />

Duration<br />

Other Criteria<br />

Coverage not included for chronic cancer pain, ischemia, post-operative<br />

pain history of psychosis, known hypersensitivity to ziconotide or any of<br />

its formulation components, OR Patients with concomitant treatment or<br />

medical conditions that would render IT administration hazardous such as<br />

the presence of infection at the microinfusion injection site, uncontrolled<br />

bleeding diathesis, or spinal canal obstruction that impairs circulation of<br />

cerebrospinal fluid.<br />

Diagnosis of severe chronic, intractable pain related or unrelated to<br />

cancer, AND The patient has documented inadequate response,<br />

intolerable adverse events, or contraindications to IT morphine or IT<br />

hydromorphone (see Note). AND The patient with non-cancer pain has<br />

documented failure or intolerance (over a 6-month period) of other<br />

conservative treatment modalities such as: pharmacologic, surgical,<br />

psychological, physical. AND The patient with non-cancer pain has had a<br />

documented psychological evaluation both to rule-out that the pain is not<br />

psychological in nature and that the patient will benefit and be able to<br />

cope with the demands of an IDDS and IT drug therapy AND Ziconotide<br />

will be infused via an implanted Medtronic SynchroMed® EL,<br />

SynchroMed® II infusion system, or Smiths Medical MD CADD-Micro®<br />

ambulatory infusion pump.<br />

The patient is 18 years of age or older.<br />

Prescribed by a pain specialist or anesthesiologist who has experience<br />

with the use of IT pain medications.<br />

6 months<br />

Note: According to the American Academy of Pain Medicine proposed<br />

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2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

guidelines for the management of chronic pain, IT therapy should be<br />

administered through a permanently implanted drug-delivery system<br />

(IDDS). An IDDS for the administration of IT pain medications is<br />

considered medically necessary in the following types of patients<br />

experiencing pain: Cancer-pain patients who: Have documented failure or<br />

intolerance of opioids or other analgesics, AND Have a life expectancy of<br />

greater than 3 months, AND Do not have tumor encroachment on the<br />

thecal sac, AND Have no contraindications to implantation of the device<br />

Non-cancer patients who: Have documented failure or intolerance (over a<br />

6-month period) of other conservative treatment modalities such as:<br />

pharmacologic, surgical, psychological, physical, AND Had a<br />

psychological evaluation performed to determine that the pain is not<br />

psychological in origin and that benefit would occur with implantation of<br />

a device, AND Have no contraindications to the implantation of the<br />

device.<br />

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2011 PRIOR AUTHORIZATION CRITERIA<br />

EFFECTIVE 1/1/11<br />

30

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