Medicare Part D Drugs Requiring Prior Authorization

(1)

Formulary ID 14068, Version 17 Last Updated 11/2014

Y0051_1622_508 Accepted 09/14/2012

Medicare Part D Drugs Requiring Prior Authorization

MVP Health Care requires you or your doctor to get prior authorization for certain drugs. This means that you will need to get approval from MVP before you fill your prescriptions. If you don’t get approval first, MVP may not cover the drug. You can ask MVP to make an exception to our coverage rules. For more information, refer to the MVP Health Care Medicare Part D Formulary (“How do I request an exception to MVP’s Medicare Part D

Formulary”).

Drugs that require prior authorization have the abbreviation “PA” in the Formulary under the Notes column next to the drug name or are listed in the chart below. Criteria are subject to change if required and approved by

Medicare.

(Note: A formulary exception request may be required for a brand name drug if the drug is not listed on the Formulary and there is a generic equivalent available.)

PRIOR AUTHORIZATION MEDICATIONS ACTEMRA

Covered Uses

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

Exclusion Criteria

• Patients with clinically important active infections or a history of chronic or recurrent infections

• Active tuberculosis

• Doses greater than those in FDA approved package labeling

• Liver enzymes 5X ULN

• ANC <500 cells per mm3

• Platelet count <50,000 cells per mm3

Required Medical Info

Documented moderate to severe active adult Rheumatoid Arthritis, or Juvenile Idiopathic Arthritis and chart notes identifying the following:

• Synovitis

• Number of swollen and/or tender joints

• Morning stiffness of significant duration

• PE findings

(2)

For continued therapy: Documentation of response to Actemra must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms

Age

Restrictions

Restricted to 18 years and older, except for juvenile arthritis which is restricted to 2 years and older Prescriber Restrictions Rheumatologist, immunologists Coverage Duration Up to 12 months Other Criteria

Subcutaneous Actemra will only be approved for the treatment of rheumatoid arthritis

Documentation must include failure or inadequate response to a 12-week trial each of Humira and Enbrel, OR

If chart notes identify intolerance, and/or clinical side effects, and/or contraindication to Enbrel and Humira, the following must be documented:

• Failed to respond to an adequate trial of maximally tolerated dose of methotrexate.

• If the member has a contraindication or significant intolerance to methotrexate, the member must have failed to respond for an adequate trial to at least one other nonbiologic DMARDs at a maximally tolerated dose

ACTHAR Covered

Uses

• Patients with medical contraindications for use identified in package label, including:

scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, presence or history of peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin

• Treatment of conditions for which Acthar is indicated when they are accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction

• For use in children under 2 years of age with congenital infections

• Administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar

Acute exacerbation of relapsing-remitting multiple sclerosis (RRMS):

• Neurology notes including all radiologic reports, supporting the diagnosis RRMS must be provided

(3)

IV corticosteroid therapy

• Patient is currently being treated with an immunomodulatory drug (i.e. Betaseron, Avonex, or Copaxone

Infantile spasms:

• Documentation supporting diagnosis of infantile spasms, including onset of age, symptom description, EEG results identifying hypsarryhthmia

• Treatment plan and goals submitted by prescriber, including dose, frequency, and number of vials per month being requested.

Induction of diuresis or proteinuria remission in nephrotic syndrome:

• Documentation of proteinuria ≥ 3.5 grams/24 hours

• Member has been complaint with ACE/ARB therapy

• Documentation of intolerable side effect or contraindication to corticosteroid therapy; OR

• Documented failure to achieve complete (<300 mg/24 hours) or partial remission (300-3500 mg/24 hours) of proteinuria with high dose corticosteroids (prednisone up to 80mg/day)

Rheumatic Disorders:

• Documentation of an acute episode or exacerbation of Psoriatic arthritis, Rheumatoid arthritis or Ankylosing spondylitis

• Patient is currently being treated with disease modifying antirheumatic drug (DMARD)

• Documentation of intolerable side or failure of high-dose oral and/or IV corticosteroid therapy

Documentation of one of the following diagnosis: systemic lupus erythematosus, systemic

dermatomyositis, severe erythema multiforme, Steven-Johnson syndrome, inflammatory ophthalmic disease, symptomatic sarcoidosis

• Documentation of all prior treatments

• Documentation of intolerable side and/or failure of high-dose oral and/or IV corticosteroid therapy Age Restrictions Prescriber Restrictions Coverage Duration Up to 3 months

(4)

Other Criteria

For continuation of therapy-Documentation must be provided indentifying anticipated length of therapy, treatment plan and improvement in clinical signs and symptoms

ACTIMMUNE Covered

Uses

All FDA-approved indications not otherwise excluded from Part D

• Not covered for idiopathic pulmonary fibrosis (IPF).

Target doses greater than or less than the recommended dose of 50mcg/m² are not covered except if severe reaction(s) occur. The dosage should be reduced by 50 percent or therapy interrupted if severe reaction(s) occur

Supporting documentation including prescription history with intravenous antibiotics, complete blood count (CBC) with differential identifying anemia or thrombocytopenia.

Documented diagnosis of Chronic Granulomatous Disease (CGD) and continued frequent serious infectious episodes while receiving prophylactic antibiotics,

OR

Diagnosis of severe, malignant osteopetrosis supported by radiological reports, documentation of previous therapy with intravenous antibiotics, and other relevant clinical findings that were used to diagnosis osteopetrosis and which will be monitored for outcomes such as:

• anemia,

• thrombocytopenia,

• splenomegaly,

• optic atrophy

• chronic osteomyelitis.

Continued therapy will be considered based on demonstrated response identified by reduction in serious infections requiring intravenous antibiotics (CGD), reduction in hospitalizations due to serious infections (CGD), increase in hemoglobin and platelet counts (osteopetrosis), no more than 50dB decrease in hearing and no evidence of progressive optic atrophy (osteopetrosis), no evidence of a serious bacterial infection requiring antibiotics (osteopetrosis).

Age

Restrictions Prescriber Restrictions

Restricted to a hematologist, oncologist, infectious disease specialist, or endocrinologist.

Coverage Duration

3 months initial approval. Remainder of calendar year for extension of therapy.

(5)

Criteria

ADAGEN Covered

Uses

Exclusion Criteria Required Medical Info

• Baseline plasma enzyme adenosine deaminase (ADA) activity confirming diagnosis of ADA deficiency, AND

• Baseline level of deoxyadenosine triphosphate (dATP) in erythrocytes confirming diagnosis of ADA deficiency, AND

• Documentation of severe combined immunodeficiency disease, AND

• Not a suitable candidate for BMT OR failure of BMT.

Extension of therapy will be considered if the plasma ADA activity is maintained between 15-35micromol/hr/Ml. Age Restrictions Prescriber Restrictions Immunologist or endocrinologist. Coverage Duration

Remainder of contract year.

ADCIRCA Covered

Uses

Coverage will not be provided if any of the following are true:

• Treatment of digital ulcers or erectile dysfunction.

• Combination therapy with other phosphodiesterase 5 (PDE5) inhibitors and/or nitrates.

• Combination therapy with other PAH agents will not be covered for initial therapy. Combination therapy requests will be reviewed when monotherapy in each appropriate drug class (e.g. PDE inhibitor, ERA, prostacyclin) has failed and when supporting clinical literature is provided and is consistent with the American College of Cardiology consensus statement.

(6)

• Doses greater than 40mg daily.

• Verification of WHO Group I pulmonary hypertension due to idiopathic (IPAH), familial (FPAH), or associated pulmonary hypertension (APAH) by right sided catheterization identifying:

resting mean pulmonary artery pressure (mPAP) greater than 25 mmHg, and pulmonary capillary wedge pressure (PCWP) less than 15 mmHg.

• NYHA Class II or III at baseline,

• Baseline and current 6-minute walk test result,

• Vasoreactive testing is recommended for all PAH patients.(Documentation with rationale must be provided for patients that have not been tested.) A limited number of patients with

idiopathic, familial, or anorexigen-induced PAH who are vasoreactive positive may respond favorably to calcium channel blockers.

• Previous and current therapies.

Extension of therapy is dependent upon documentation of clinical response including but not limited to:

• Improvement in exercise capacity (6-minute walk test) versus baseline,

• Improvement in NYHA class versus baseline,

Lack of deterioration (e.g. no hospitalizations due to worsening PAH, no addition of new PAH therapy, no worsening of the functional class).

Age

Restrictions

Restricted to members who are greater than 18 years old

Prescriber Restrictions

Ordered by or consult with pulmonologist or cardiologist

Initial authorization up to 3 months. Extended authorizations up to 6 months

ADEMPAS Covered

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

Criteria

Coverage will not be provided if any of the following are true:

• Use in pregnancy

• Co-administration of Adempas with a phosphodiesterase inhibitor, including specific PDE-5 inhibitors (i.e. sildenafil, tadalafil, vardenafil), nonspecific PDE inhibitors (i.e. theophylline or dipyridamole), nitrates or nitric oxide donors

(7)

• Treatment of WHO Group 2 or 3

• Total daily dose exceeds package labeling

• Combination therapy with other pulmonary arterial hypertension (PAH) medications for the treatment of CTEPH (Chronic Thromboembolic Pulmonary Hypertension)

• Presence of pulmonary veno-occlusive disease

• Severe hepatic impairment

• Combination therapy with other PAH agents for treatment of WHO Group 1 will not be covered for initial therapy

• If WHO Group 1, verification of pulmonary arterial hypertension [due to iodiopathic (IPAH), familial (FPAH), or associated with other conditions/disorders (APAH)] via right heart catheterization identifying:

i. Resting mean pulmonary arterial pressure (mPAP) > 25 mmHg AND

ii. Pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg

• If WHO Group 4, verification of CTEPH diagnosis via ventilation-perfusion scanning and confirmatory pulmonary angiograpy AND

Documentation of persistence/recurrence of CTEPH following surgical treatment OR Documentation that indicates patient is not considered a surgical candidate for the

treatment of CTEPH

• WHO Functional Class II or III at baseline

• Baseline and current 6-minute walk test results

• If WHO Group 1, vasoreactive testing is recommended for all PAH patients (documentation with rationale must be provided for patients for whom this testing is not performed). A limited number of patients with idiopathic, familial, or anorexigen-induced PAH who are vasoreactive positive may respond favorably to calcium channel blockers.

• Documentation of previous and current therapies identifying outcome

• Documentation of ClCr greater than or equal to15 mL/min

Extension of therapy will be dependent upon documentation of clinical response, including but not limited to:

i. Improvement in exercise capacity (6-minute walk test) compared to baseline ii. Improvement in WHO Functional Class compared to baseline

iii. Lack of deterioration (e.g. no hospitalizations due to worsening PAH or CTEPH, no addition of new PAH therapy, no worsening in Functional Class status)

Age

Restrictions

Adults age 18 and over.

(8)

Restrictions Coverage Duration

Initial authorization will be limited to 3 months. Extension up to 12 months

• Female patients of childbearing potential must be enrolled in the Adempas REMS program

• For WHO Group 1 (new starts only), documentation is required demonstrating failure or inadequate response to a trial of one of the following:

o Orally administered PDE-5 inhibitor approved for the treatment of PAH (i.e. Adcirca or sildenafil)

o Endothelin receptor antagonist-Letairis, Tracleer, or Opsumit

ALDURAZYME Covered

Uses

The use of Aldurazyme will not be considered medically necessary for the following situations: Dose and frequency outside of package labeling

• Diagnosis of Hurler or Hurler-Scheie forms of MPS 1 OR diagnosis of Scheie form with moderate to severe symptoms.

• Baseline forced vital capacity (FVC) less that 80% and ongoing FVC showing improvement with treatment.

• Distance walked in 6 minutes (6 minute walk test, 6MWT) at baseline and showing improvement with treatment.

• Documented deficiency in iduronate-2-sulfatase enzyme activity confirming diagnosis Mucopolysaccharidosis I.

• Extension of therapy: documentation supports continued benefit based upon improvement in FVC and 6MWT. Age Restrictions Prescriber Restrictions Coverage Duration

Remainder of contract year

ALPHA1-ANTITRPYSIN REPLACEMENT THERAPY Drugs: Aralast, Galssia, Prolastin-C, Zemaira Covered

Uses

(9)

Not covered if any of the following situations are true: 1. PiMZ or PiMS phenotypes

2. Members identified with selective IgA deficiencies (IgA level less than 15mg/dl) that have known antibodies against IgA, since they may experience severe reactions

3. Dosing exceeding package labeling

4. Frequency exceeding once weekly infusions 5. Member not compliant with therapy.

Coverage is not provided for doses exceeding package labeling

• Progressive clinically evident emphysema with a documented rate of decline in forced expiratory volume in 1 second (FEV1) post bronchodilation between 30 and 65% predicted except when:

1. Nearly normal pulmonary function if they experience a rapid decline in lung function (FEV1 greater than 120 ml/yr) OR

2. Poor lung function and currently receiving standard treatment.

• AAT serum level less than 11 µM or less than 80mg/dL.

• Rate of decline in forced expiratory volume in 1 second (FEV1) post bronchodilation between 30 and 65% predicted.

• Non-smoker OR evaluated for smoking cessation counseling.

• Phenotype is identified as PiZZ, PiZ(null) or Pi(null)(null)

• Continued therapy will be considered based on demonstrated response in slowing progression of lung function decline AND member compliance with all pharmacologic therapies

Age

Restrictions Prescriber Restrictions

Must be ordered or followed by a pulmonologist

3 months initial approval. Remainder of contract year for extension of therapy.

AMPYRA Covered

Uses

• Prior history of seizure.

• Moderate or severe renal impairment defined as a creatinine clearance (CrCl) of ≤50 mL/min.

(10)

• Not covered for prevention of symptoms.

• History of hypersensitivity to Ampyra or 4-aminopyridine

• Use with 4-aminopyridine or fampridine

• Neurology chart notes must be provided over the past 2 years including all radiologic reports supporting the diagnosis of multiple sclerosis.

• EDSS score between 5.0 - 6.0 (disability severe enough to impair full daily activities) OR documentation supporting the disability within that range.

• Prior to dalfampridine treatment, three timed 25-foot walk (T25FW) results (at least one week apart) and within the past 60 days and between 8 and 45 seconds. (Assistive devices must be consistently used across pre-treatment walk tests and identified in the chart notes.)

For continuation of therapy for second request:

• Two T25FW results at least 1 week between tests must be documented with at least a 30% improvement over the baseline average or a minimum of 10 seconds decrease with demonstrated improvement in disability

Continuation thereafter:

• Three T25FW results from 3 separate visits (at least one week apart) identifying a continued 30% improvement over the fastest baseline maximum speed.

• EDSS score remains 6.5 or below, and/or has not progressed to constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting which precludes full daily activities.

• Individuals must maintain initial 30% improvement in T25FW at each 6 month interval. Approval of Ampyra will be discontinued if the T25FW declines.

Age

Restrictions

Must be18 years or older

Restricted to neurologists

(11)

Other Criteria • Currently receiving a stable dose of disease-modifying therapy for RRMS (or on a stable dose of disease-modifying therapy for all other forms of MS if appropriate) for at least 60 days (e.g. no changes in therapy for 60 days prior to start of dalfampridine treatment).

ANTIDEPRESSANTS Drugs: Fetzima, Brintellix Covered

Uses

• Use in combination with MAOIs or linezolid

• Uncontrolled narrow-angle glaucoma for Fetzima only

• Documentation identifying diagnosis of major depressive disorder

• Previous therapies tried

Age

Restrictions

Restricted to 18 years and older

Prescriber Restrictions Coverage Duration Up to 12 months

Other Criteria Documentation must include failure or inadequate response to a minimum of a 6 week trial of two

of the following: o Citalopram o Escitalopram o Fluoxetine o Paroxetine o Sertraline o Trazodone o Venlafaxine o Duloxetine APTIOM Covered Uses

Exclusion

Criteria • Hypersensitivity or severe reaction (ie. Stevens-Johnson Syndrome or drug reaction with

eosinophilia and systemic symptoms) to Aptiom OR oxcarbazepine

(12)

• Diagnosis of partial-onset seizures

• Prior and current therapies

• Documentation that Aptiom will be used as an adjunctive treatment

Age

Restrictions

Restricted to 18 years of age and older.

Prescriber Restrictions Restricted to neurologists. Coverage Duration 12 months Other Criteria ARANESP Covered Uses

All FDA-approved indications not otherwise excluded from Part D and MDS.

Uncontrolled hypertension.

Hgb less than 10g/dL at start of therapy, transferrin saturation greater than 20 percent, ferritin greater than 100ng/ml, anemia not requiring immediate correction, anemia related to other conditions must be treated prior to therapy, and rule out the following causes of anemia:

-folate deficiency, -B-12 deficiency, -iron deficiency, -hemolysis,

-bleeding, or bone marrow fibrosis, acute or chronic blood loss

A. Anemia due to chronic renal failure (CRF): 1. serum creatinine greater than 3mg/dl,

2. crcl less than 60ml/min, or GFR less than 60 ml/min/1.73m2.

B. Current (not for prophylaxis) anemia due to current myelosuppressive noncurative chemotherapy:

1. Diagnosis of solid tumor, multiple myeloma, lymphoma or lymphocytic leukemia. 2. For continuation of therapy:

• Transfusion records identifying a reduction during ESA treatment.

(13)

within 8 weeks of final chemo dose. C. MDS requirement:

1. Myelodysplasia with less than 10% blasts, 2. Pretreatment epoetin level 500 or less, 3. Not transfusion dependent,

4. Anemia causing symptoms such as shortness of breath or tachycardia. 5. Continuation: significant increase in HGB/HCT or decrease in transfusions.

To continue therapy for anemia related to CRF and MDS: Hgb between 10 and 12 g/dL (average over 3 months) OR hgb is 1g/dL or greater then pre-treatment level but less than 12g/dL.

Continuation of therapy for all diagnoses, HGB must remain less than 12 grams/dL, no epo-type resistance due to neutralizing antibodies, doses follow package label, AND when iron stores are adequate, HGB must show an increase by 1-2gm/dl after 6 weeks at max doses to achieve HGB of 10-12 gm/dL OR for MDS or non-myeloid dx on the member has must demonstrate a 50% reduction in transfusion requirements OR if HGB has normalized at 10 gm/dL or greater.

Age

Restrictions

Restricted to 5 years and older for anemia due to chemo

Restricted to oncologists, hematologists, and nephrologists.

Initial 3 month approval, followed by approvals up to 6 months.

Other Criteria • Hct/Hgb have been stabilized on erythropoietin for at least 8 weeks.

• Must have bone marrow potentially responsive to erythropoietin therapy.

• Diagnosis of non-Hodgkins lymphoma, or chronic lymphocytic leukemia requires documentation of failure of prior adequate trial of high dose corticosteroids and or chemotherapy.

Aranesp may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Aranesp is not covered under Part D. Information may need to be

submitted describing the use and setting of the drug to make the determination.

ARCALYST Covered

Uses

• Dosing other than FDA approved dosing regimen;

• In combination with other interleukin-1 inhibitor;

(14)

• Genetic test identifying CIAS1 (Cold-Induced Autoinflammatory Syndrome 1) gene mutation (also known as NLRP3, NALP3 or PYPAF).

• Skin biopsy if performed.

• Serum amyloid.

• C-reactive protein.

• Documentation of symptoms affecting activities of daily living (ADLs) due to CAPS symptoms.

Extension of therapy will be medically necessary if documentation identifies symptom improvement or disease stability.

Age

Restrictions

Must be 12 years of age or older.

Rheumatologist or immunologist

Initial 6 month approval followed by an additional 6 months if medically necessary

Other Criteria

AUBAGIO Covered

Uses

• Liver Function Tests (LFTs) elevated greater than 3 times the upper limit of normal (ULN)

• Pregnancy

• Concurrent treatment with leflunomide

• Neurology notes must be provided over the past 2 years including all radiologic reports supporting the diagnosis of relapsing-remitting form of multiple sclerosis.

• EDSS score less than or equal to 6 (disability severe enough to impair full daily activities) OR documentation supporting the disability within that range.

• Documentation of two relapses within the previous 12 months.

• Normal CBC within 6 months prior to the start of therapy

• No clinically important infection or a history of chronic or recurrent infections.

• Transaminase and bilirubin levels within 6 months prior to initiation of Abagio

• Use of reliable contraception.

(15)

Documentation needed for evaluation of TB infection with skin test. For continuation of therapy:

• Chart notes identifying continued benefit with a decrease in number of relapses from baseline.

• EDSS score remains less than or equal to 6.

Age

Restrictions

Restricted to patients aged 18 years of age and older.

Prescriber Restrictions Restricted to neurologists. Coverage Duration Up to 6 months.

Other Criteria Treatment plan does not include Aubagio in combination with other disease-modifying multiple

sclerosis medications.

Documented failure or significant side effects to a trial of one interferon beta product and a trial of Copaxone. Documented failure is defined as having two of the following:

1. Two relapses within the previous 12 months,

2. MRI identifying lesion progression while on therapy, 3. Documented worsening disability while on therapy.

B VS D

Drugs Abelcet Inj Ipratropium/Albuterol Neb

Abilify Maintena Inj Irinotecan Inj

Abraxane Inj Isolyte Inj

Acetylcysteine Vial Istodax Inj

Acyclovir Inj Ixempra Inj

Adriamycin Inj Jevtana Inj

Albuterol Neb Leucovorin Inj

Alimta Inj Levalbuterol Neb

Amifostine Inj Levocarnitine Inj*

Amino acid Inj Levocarnitine Oral Soln*

Aminosyn Inj Levocarnitine Tabs*

Amphotericin B Inj Liposyn III Inj

Anzemet Tabs Lupron Depot Inj

Apokyn Inj Melphalan Inj

Arranon Inj Mesna Inj

(16)

Avastin Inj Miacalcin Inj*

Azasan Tabs Mitomycin Inj

Azathioprine Tabs Mitoxantrone Inj

Azathioprine Inj Mustargen Inj

Bicnu Inj Mycophenolate Mofetil Caps

Bleomycin Inj Mycophenolate Mofetil Tabs

Brovana Neb Myfortic Tabs

Budesonide Neb Nebupent Neb

Busulfex Inj Neoral Caps

Calcitriol Caps* Neoral Oral Soln

Calcitriol Inj* Nephramine Inj

Calcitriol Soln* Neulasta Inj

Nipent Inj

Carboplatin Inj Normosol-R Inj

Cellcept Susp Nulojix Inj

Cellcept Inj Ondansetron Oral Soln

Cisplatin Inj Ondansetron Tabs

Cladribine Inj Ondansetron Odt

Clinimix Inj Ontak Inj

Cromolyn Neb Oxaliplatin Inj

Cubicin Inj* Paclitaxel Inj

Cyclophosphamide Tabs Pentam 300 Inj

Cyclosporine Caps Pentostatin Inj

Cyclosporine Inj Perforomist Neb

Cyclosporine Modified Caps Plasma-Lyte Inj

Cyclosporine Modified

Oral

Soln Premasol Inj

Cytarabine Inj Procalamine Inj

Dacarbazine Inj Prograf Inj

Dacogen Inj Prosol Inj

Daunorubicin (&

cerubidine) Inj Pulmicort Amp

Dexrazoxane Inj Pulmozyme Amp

Docefrez Inj Rabavert Inj

(17)

Doxil Inj Rapamune Tabs

Rituxan Inj

Doxorubicin Inj Sandimmune Caps

Eligard Inj Sandimmune Inj

Elitek Inj Sandimmune Oral Soln

Ellence Inj Sandostatin Lar Depot Inj

Elspar Inj Simulect Inj

Emend Caps Tacrolimus Caps

Epirubicin Inj Thiotepa Inj

Erbitux Inj Thymoglobulin Inj

Etopophos Inj Tobi Neb

Etoposide Inj Tobramycin Inj

Faslodex IM Topotecan Inj

Firmagon Inj Torisel Inj

Fludarabine Inj Tranexamic Acid Inj

Fluorouracil Inj Travasol Inj

Freamine III Inj Treanda Inj

Ganciclovir Inj Trelstar Depot Inj

Gemcitabine Inj Trisenox Inj

Gengraf Caps Trophamine Inj

Gengraf

Oral

Soln Vancomycin Inj*

Geodon IM Vectibix Inj

Granisetron Tabs Velcade Inj

Granisol

Oral

Soln Vidaza Inj

Halaven Inj Vinblastine Inj

Hectorol Caps*

Hectorol Inj* Vincasar Pfs Inj

Heparin Inj* Vincristine Inj

Hepatamine Inj Vinorelbine Inj

Hepatasol Inj Vivitrol Inj

Herceptin Inj Xopenex Neb

Idarubicin Inj Zanosar Inj

(18)

Ifosfamide Inj Zemplar Inj*

Imovax Rabies Inj Zinecard Inj

Intralipid Inj Zortress Tabs

Invega Sustenna Inj

Ionosol Inj

Ipratropium Neb

These drugs 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(s) to make the determination.

*Subject to review for ESRD patients receiving dialysis to determine if drug should be obtained by the dialysis center. Exclusion Criteria Required Medical Info Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria BOSULIF

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

Criteria Required Medical Info

Documentation provided supporting the diagnosis of chronic, accelerated or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. The following documentation must be provided:

• Diagnosis of Philadelphia chromosome-positive CML by a bone marrow biopsy.

• ANC (Absolute Neutrophil Count) greater than or equal to 1000x106/L.

• Platelets greater than or equal to 50,000x106/L.

• No history of the T315I mutation.

• Liver transaminases less than or equal to 2.5 x ULN (upper limit of normal),

(19)

the following:

1. failure to achieve or maintain any hematologic improvement within four weeks. 2. failure to achieve a complete hematologic response (CHR) by 3 months,

cytogenetic response by 6 months or major cytogenetic response (MCyR) by 12 months.

3. progression of disease after a previous cytogenetic or hematologic response. 4. presence of a genetic mutation in the BCR-ABL gene associated with imatinib

resistance.

Age

Restrictions

Must be 18 years of age or older.

Oncologist

Remainder of the contract year

Other Criteria A dose escalation to 600 mg once daily with food may be considered in patients who do not

reach complete hematological response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week 12, who did not have Grade 3 or higher adverse reactions, and who are currently taking 500 mg daily.

CAPRELSA Covered

Uses

vandetanib will not be covered in the following situations:

• Uncorrected hypocalcemia, hypokalemia, or hypomagnesemia.

• History of congenital long QT Syndrome.

Imaging reports and biopsy confirming diagnosis of symptomatic or progressive medullary thyroid cancer that is non-operable locally advanced or metastatic disease

Age

Restrictions

Must be 18 years of age or older

Oncologists or endocrinologists required to be certified with the restricted distribution program called Caprelsa REMS Program

(20)

Drugs known to prolong the QT interval should be avoided.

Chronic Hepatitis C Treatment

Drugs: Infergen, Pegasys, Peg-Intron, Rebetol, Ribapak, Ribasphere, ribavirin Covered

Uses

a. contraindications for the use of ribavirin, including pregnancy, renal failure, hemoglobinopathies

b. contraindications for the use of pegylated interferon, including autoimmune hepatitis, decompensated liver disease (i.e. hepatic encephalopathy, acsites, portal

hypertension, jaundice, etc.

c. Investigation/experimental or indications not supported by the compendia are excluded from coverage.

Pegylated interferon (or interferon alfa-2B) in combo with ribavirin in treatment naïve patients may be medically necessary if the following criteria are met:

• Chronic, compensated hepatitis C as documented by a positive HCV antibody and quantitative HCV PCR level, AND

• elevated ALT levels (greater than 6 months), OR

• normal ALT levels in the presence of a liver biopsy consistent with chronic hepatitis C (at least moderate inflammation and/or fibrosis) i.e. Ishak stage greater than 3 or METAVIR stage greater than F2.

• No contraindications for the use of ribavirin or pegylated interferon.

• Enrolled and compliant with substance abuse or alcohol support programs if relevant.

Pegylated interferon monotherapy may be medically necessary if:

• member meets the appropriate above, AND

• member has a contraindication for use of ribavirin.

• Liver biopsy results identifying genotype of Hepatitis C.

For continuation of therapy at 12 weeks for genotypes 1 and 4 not co-infected with HIV: HCV RNA is undetectable or reduced by at least 2 log10.

In addition peginterferon alfa-2a (Pegasys) may be considered medically necessary in patients with chronic hepatitis B who have compensated liver disease if:

(21)

• HBsAg positive status for at least 6 months. AND

• Evidence of viral replication as documented by HBV DNA greater than 20,000 IU/ml. AND

• Evidence of liver inflammation as documented by 2 times the upper limit of normal of ALT. OR biopsy show moderate/severe necroinflammation or significant fibrosis.

Hepatitis B continuation of therapy will be considered medically necessary based on demonstrated response supported by all of the following:

• Member is compliant with therapy as determined by review of prescription drug history.

• Normalization of serum ALT.

• Decrease in serum HBV DNA level by 2 log.

• Loss of HBeAG with or without detection of anti-HBe.

• Stable or improvement in liver histology defined as > 2 point decrease in Knodell necro-inflammatory score with no worsening of the Knodell fibrosis score. (Using the Ishak Fibrosis Score – improvement is defined as > 1 point decrease).

Age

Restrictions

Restricted to 18 years of age or older except when medication is FDA approved for use in pediatrics

Prescriber Restrictions Coverage Duration

Initial approval 12-48 weeks depending on genotype. 48 weeks if approved for monotherapy. Complete therapy 24-48 weeks.

Other Criteria 1. Members with genotypes 2 and 3 who are not co-infected with HIV will be authorized for a

total of 24 weeks of therapy.

2. Members with genotypes 1 and 4 who are not co-infected with HIV: obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log10

• members who have not achieved a greater than or equal to 2 log10 reduction in HCV RNA level at week 12 are unlikely to achieve SVR and further therapy is not considered

medically necessary

• those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks

a. if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized

(22)

to achieve SVR and further therapy is not considered medically necessary 3. Members with genotypes 2 and 3 who are co-infected with HIV:

• members with detectable HCV RNA levels and CD4 count greater or equal to 200 cells/µL will be authorized for 48 weeks of therapy

• members with detectable HCV RNA levels and CD4 count 100 to 199 cells/µL and HIV RNA titer less than 5000 copies/mL will be authorized for 48 weeks of therapy

4. Members with genotypes 1 and 4 who are co-infected with HIV:

A. members with detectable HCV RNA levels and CD4 count greater or equal to 200 cells/µL will be authorized for an initial 12 weeks of therapy

B. members with detectable HCV RNA levels and CD4 count 100 to 199 cells/µL and HIV RNA titer less than 5000 copies/mL will be authorized for an initial 12 weeks of therapy. Obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log10

1. members who have not achieved a greater or equal to 2 log10 reduction in HCV RNA level at week 12 are unlikely to achieve SVR and further therapy is not considered medically necessary

2. those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks

a. if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized

b. members who have a detectable HCV RNA level at 24 weeks are unlikely to achieve SVR and further therapy is not considered medically necessary

5. Members with all genotypes who are not co-infected with HIV and have contraindication for use of ribavirin:

• obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log10

• those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks

• if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized

(23)

and further therapy is not considered medically necessary

CIALIS FOR BPH Covered

Uses

Exclusion

Criteria • Concomitant use of nitrate-based drugs (nitroglycerin) for heart conditions,

• Hypersensitivity reaction to Cialis® or Adcirca®,

• Creatinine clearance less than 30 mL/minute,

• Planned cataract surgery,

• Not covered solely for erectile dysfunction (ED) symptoms for standard plans,

• Status post radical prostatectomy,

• Cialis use solely to reduce PSA levels,

• Cialis strengths not FDA approved for use in BPH are not covered for standard plans,

• When Cialis is approved for BPH, no additional quantities are covered for ED,

• Use in combination therapy with other PDE-5 inhibitors,

• Quantities exceeding one tablet per day

Required

Medical Info Cialis

®

(tadalafil) 2.5mg or 5mg may be considered medically necessary when the following criteria are met:

• Enlarged prostate AND bothered by symptoms for at least 50 percent of the time over one month.

• Moderate to severe uncontrolled symptoms due to benign prostatic hyperplasia (BPH) with an American Urological Association Symptom Index (AUA-SI) > 8. (Symptoms include incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia.)

• Failure (defined less than 50% improvement of symptoms after 3 month trial), to two different combination therapies consisting of an alpha-blocker with

1. Anticholinergic, OR

(24)

3. has a contraindication or are intolerant to all appropriate drug classes used to treat BPH.

For continued therapy:

• At least a 50% reduction in symptoms, AND

• Prescription history identifies compliance for BPH use

Age

Restrictions

18 years old or older

To urologists (or urology consult identified).

Other Criteria

CICLOPIROX NAIL Covered

Uses

• Positive KOH test from a nail scraping or a positive pathogenic fungal culture documenting the presence of hyphae consistent with a susceptible dermatophyte (Trichophyton rubrum)

• No lunula involvement.

• Member is immunocompromised (e.g. HIV/AIDS, undergoing chemotherapy, transplant recipient) or has a history of peripheral vascular disease (e.g. diabetes), and/or ADLs are significantly compromised due to the infection.

Documented contraindication to terbinafine OR prescription history/chart notes identify a significant drug interaction with terbinafine.

Age

Restrictions

Restricted to 12 years and older

(25)

Remainder of the contract year.

Other Criteria

CIMZIA Covered

Uses

FDA-approved indications not otherwise excluded from Part D.

Documentation of evaluation for latent TB infection with a TB skin test. If TB infection is present, TB treatment started prior to therapy if indicated. Not at risk for an infection. Dosing does not exceed the FDA approved dosing schedule of 400mg every four weeks (for Crohn’s Disease/RA) or 200mg every other week for RA except for the initial one time induction period.

For Crohn’s Disease:

Significant clinical signs, symptoms, and radiologic reports documenting moderate to severely active disease such as frequent liquid stools greater than 4 times/day, presence of abdominal pain, presence of abdominal mass, extra-intestinal symptoms, need for opiates or

diphenoxylate/atropine for diarrhea, anemia, and weight loss greater than 10%. For Rheumatoid Arthritis:

Significant clinical signs, symptoms, and radiologic reports documenting moderate to severe active disease which includes documented synovitis and morning stiffness of significant duration to inhibit activities of daily living (ADLs), PE findings, number of swollen and/or tender joints. For RA and Crohn’s disease: Documentation of response to Cimzia must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms described. No signs of a serious infection.

Age

Restrictions

Restricted to gastroenterologists, rheumatologists, immunologists, and colorectal surgeons

Initial approval for 3 months with extensions of up to 6 months intervals.

Other Criteria For Crohn’s Disease:

Documentation must include failure or inadequate response to a 12-week trial of Humira.

OR if chart notes identify intolerance and/or clinical side effects and/or contraindication to Humira, a trial of one corticosteroid and one anti-inflammatory aminosalicylate is required.

(26)

For Rheumatoid Arthritis:

Documentation must include failure or inadequate response to a 12-week trial of Humira or Enbrel, OR

If chart notes identify intolerance, and/or clinical side effects, and/or contraindication to etanercept and adalimumab, the following must be documented;

• Failed to respond to an adequate trial of maximally tolerated dose of methotrexate. (Failure is defined as ACR response less than 20.)

If the member has a contraindication or significant intolerance to methotrexate, the member must have failed to respond for an adequate trial to at least one other nonbiologic DMARDs at a

maximally tolerated dose.

COMETRIQ Covered

Uses

Diagnosis of progressive, metastatic medullary thyroid cancer. Radiologic report with evidence of actively progressive disease. Evidence that surgery is inappropriate.

Baseline Liver Function Test (LFTs) levels are less than 3 times the upper limit of normal (ULN).

Normal blood pressure.

No invasive dental treatments 28 days prior to initiation.

Not pregnant and using effective contraception during and up to 4 months after completion of therapy.

Age

Restrictions

Restricted to patients aged 18 years and older.

Oncologist or endocrinologist

Other Criteria

CYPROHEPTADINE Covered

Uses

FDA-approved indications not otherwise excluded from part-D.

(27)

Criteria • narrow-angle glaucoma

• bladder neck obstruction

• pyloroduodenal obstruction

• symptomatic prostatic hyperplasia

• stenosing peptic ulcer

• concurrent use of MAO inhibitors

• use in debilitated elderly patients

• use in premature and term newborns

• breast-feeding

• use for appetite stimulation

Diagnosis of migraine and documented:

• interference with daily routine despite acute treatment

• contraindication/failure/overuse or adverse effects of acute therapies

• Frequency of migraine attacks over past 6 months Extension of therapy requires documentation of:

• reduced attack frequency, severity, improvement

• Reduction in functional impairment

Age

Restrictions

Other Criteria Failure of a 2 month trial of one of the following:

1. Divalproex sodium 2. Topiramate

Elderly patients with a history of falls or confusion may not be appropriate candidates for cyproheptadine.

CYSTARAN Covered

Uses

(28)

Medical Info Corneal cystine crystal score prior to start of therapy Age Restrictions Prescriber Restrictions Ophthalmologist Coverage Duration Up to 12 months

Other Criteria For continuation of therapy documentation must be provided identifying either a lack of increase

or reduction in the corneal cystine crystal score.

DIFICID Covered

Uses

Stool sample positive for clostridium difficile toxin

Age

Restrictions

Restricted to18 years of age and older

Infectious Disease Specialists and gastroenterologists

10 days

Other Criteria Failure of a 10-14 day course of treatment of metronidazole and oral vancomycin. (Recurrence of

c. difficile AFTER treatment with vancomycin or metronidazole does not meet the criteria for failure of vancomycin or metronidazole.)

ENBREL Covered

Uses

• No TB skin test result provided or TB infection has not been treated appropriately.

• Concomitant therapy with Rituxan and other DMARDs or biologic therapies other than methotrexate.

• Doses greater than 50mg/wk except for the initial 12 weeks for a diagnosis of psoriasis

(one induction per lifetime).

(29)

psoriasis).

• Members who have a clinically important infection or a history of chronic or recurrent infections.

• Members who have another form of psoriasis other than chronic plaque psoriasis (e.g. guttate, erythrodermic or pustular psoriasis as the sole or predominant form).

• Dose escalation beyond the initial 12-week period, including during psoriasis flares, is not

a covered benefit.

• For continuation of coverage: clinical failure or less than desired effect with Enbrel and no clinical rationale provided for continuation of therapy.

• For the diagnosis of RA: No prior trial with mtx unless documentation of acute, aggressive, very rapidly progressive intense inflammatory symmetrical arthritis dz.

• Members with contraindication to TNF use. Increase in dose without prior authorization

For a diagnosis of psoriatic arthritis: chart notes indicating at least 3 tender joints AND at least 3 swollen joints on 2 separate occasions at least one month apart.

For a diagnosis of rheumatoid arthritis: chart notes identifying persistent or recurrent symptoms with documented synovitis and morning stiffness of significant duration to inhibit activities of daily living.

For a diagnosis of ankylosing spondylitis (AS): Documented significant clinical symptoms such as those identified in the Bath ankylosing spondylitis disease activity index (BASDAI) greater than 4 (0-10).

For a diagnosis of psoriasis: For initial treatment, documentation of moderate to severe plaque psoriasis

Age

Restrictions

Polyarticular juvenile idiopathic arthritis covered for patients ages 2 and older. Over 18 years old for all other indications

Restricted to rheumatologists or immunologists for members with arthropathies, dermatologists.

Initial approval for 3 months with extensions of up to 6 months intervals.

Other Criteria Must be screened for immunologic and infectious diseases.

A. For the treatment of moderate to severe active adult rheumatoid arthritis with documented synovitis and morning stiffness of significant duration to inhibit activities of daily living (ADLs),

(30)

the following criteria must be met:

• Failed to respond to one or more nonbiologic DMARDs, one of which includes an adequate trial of a maximally tolerated dose of methotrexate (MTX) before Enbrel is covered.

• If the member has a contraindication or intolerance to methotrexate, the member must have failed to respond to an adequate trial of one other DMARD at a maximally tolerated dose.

B. For the treatment of moderate to severe polyarticular-course juvenile chronic rheumatoid

arthritis as indicated by 4 affected joints with limitation of motion, pain, tenderness or both, or

persistent symptoms in oligoarticular disease, the following criteria must be met: Failed to respond to an adequate trial of at least one DMARD.

C. For the treatment of moderate to severe psoriatic arthritis as indicated by three or more tender joints AND three or more swollen joints on two separate occasions at least one month apart, the following criteria must be met:

• Must have had an inadequate response to at least one NSAID, and

• Failed to respond to an adequate trial of at least 1 DMARD.

D. For the treatment of plaque psoriasis the following criteria must be met:

• Members with severe psoriasis or those with functional disability and/or intractable recalcitrant psoriasis which interferes with ADLs due to the affected areas (e.g. hands and/or feet).

• Severe chronic plaque psoriasis or involvement of the palms, soles of feet and scalp for at least 1 yr.

• An appropriate treatment trial of at least one of the following agents was not effective: MTX, oral retinoids, cyclosporine.

• Continuation of therapy will require documentation of improved patient status in the monitoring parameters of all of the following:

A significant improvement of clinical signs/symptoms of psoriasis (eg. itching, redness, scaling, psoriatic body surface area coverage) at three months. Quality of life assessments - improved per patient and/or physician.

E. For the treatment of active moderate to severe ankylosing spondylitis the following criteria must be met:

(31)

• Bath ankylosing spondylitis disease activity index (BASDAI) > 4 (0-10); AND

• Failure of a 4 month trial of sulfasalazine at maximum tolerated dose in patients with persistent peripheral arthritis; AND

• Patients with pure axial manifestations do not have to have a trial of DMARDs; AND Continued coverage will be based on significant symptom improvement and/or 2 units (on a 0-10 scale) of the BASDAI.

EPOETIN Covered

Uses

All FDA-approved indications not otherwise excluded from Part D and MDS.

• Uncontrolled hypertension

All diagnoses except surgical patients: Hgb less than 10g/dL at start of therapy, transferrin saturation more than 20%, ferritin more than 100ng/ml, anemia not requiring immediate

correction, anemia related to other conditions must be treated prior to therapy, and rule out the following causes of anemia:

-folate deficiency, -B-12 deficiency, -iron deficiency, -hemolysis,

-bleeding, or bone marrow fibrosis, acute or chronic blood loss.

A. Anemia due to chronic renal failure (CRF) criteria: 3. serum creatinine greater than 3mg/dl,

4. crcl less than 60ml/min, or GFR less than 60 ml/min/1.73m2.

B. Current (not for prophylaxis) anemia due to current myelosuppressive noncurative chemotherapy:

3. Diagnosis of solid tumor, multiple myeloma, lymphoma or lymphocytic leukemia. 4. For continuation of therapy:

• Transfusion records identifying a reduction during ESA treatment.

• HGB must be maintained at 10g/dL average over 2 months and currently receiving or within 8 weeks of final chemo dose.

C. Anemia related to AZT or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) therapy for HIV patients:

1. Epoetin level 500 or less,

(32)

D. MDS requirement:

1. Myelodysplasia with less than 10% blasts, 2. Pretreatment epoetin level 500 or less, 3. Not transfusion dependent,

4. Anemia causing symptoms such as shortness of breath or tachycardia. 5. Continuation: significant increase in HGB/HCT or decrease in transfusions. E. Pre-surgical, HGB less than 13 grams/dL

1. Surgical procedure and date of surgery, 2. Elective, noncardiac, nonvascular surgery, 3. Not able to donate autologous blood,

4. Must be at high risk for perioperative transfusions with anticipated blood loss greater than 2 units,

5. Hgb between 10 and 13 g/dL and evaluation identifying anemia due to chronic disease, To continue therapy for anemia related to CRF, AZT, and MDS: Hgb between 10 and 12 g/dL (average over 3 months) OR hgb is 1g/dL or greater then pre-treatment level but less than 12g/dL. HGB must remain less than 12 grams/dL, no epo-type resistance due to neutralizing antibodies, doses follow package label, AND when iron stores are adequate, HGB must show an increase by 1-2gm/dl after 6 weeks at max doses to achieve HGB of 10-12 gm/dL OR for MDS or non-myeloid dx on chemo the member must demonstrate a 50% reduction in transfusion

requirements OR the HGB has normalized at 10 gm/dL or greater.

Age

Restrictions

ESAs restricted to 5 years and older for anemia due to chemo.

Restricted to oncologists, hematologists, and nephrologists.

Chemo/CRF/AZT/MDS - Initial 3 month approval, followed by approvals up to 6 months. Presurgical limited to1 month.

Other Criteria Must have bone marrow potentially responsive to erythropoietin therapy.

Diagnosis of non-Hodgkins lymphoma, or chronic lymphocytic leukemia requires documentation of failure of prior adequate trial of high dose corticosteroids and or chemotherapy.

Epogen may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Epogen is not covered under Part D. Information may need to be

submitted describing the use and setting of the drug to make the determination.

(33)

Documentation supporting diagnosis of:

1. Metastatic basal cell carcinoma (mBCC), OR

2. Locally advanced BCC (laBCC) that has recurred following surgery and patient is not a candidate for radiation.

For continuation of therapy the following criteria must be met:

Absence of disease progression and for laBCC at least one of the following:

1. Greater than or equal to 30 percent reduction in lesion size from baseline by radiographic assessment,

2. Greater than or equal to 30 percent reduction in sum of the longest diameter from baseline in externally visible dimension of target lesions,

3. Complete resolution of ulceration in all target lesions,

4. Complete response with no residual basal cell carcinoma on sampling tumor biopsy. Absence of disease progression (for laBCC) as defined by the package label as any of the following:

1. Greater than or equal to 20 percent increase in the sum of the longest diameter from nadir in target lesions (either by radiography or by externally visible dimension).

2. New ulceration of target lesions persisting without evidence of healing for at least 2 weeks, 3. New lesions by radiographic assessment or physical examination,

Progression of non-target lesions by Response Evaluation Criteria in Solid Tumors (RECIST).

Age

Restrictions

Restricted to 18 years old and older.

Dermatologists, oncologists

Remainder of contract year.

Other Criteria

Other Criteria Exjade may be considered medically necessary if all of the following criteria are met:

• Chronic iron overload due to blood transfusions or non-transfusion dependent thalassemia syndromes .

(34)

treatment.

FYCOMPA Covered

Uses

• Diagnosis of partial-onset seizures.

• Documentation that Fycompa will be used as adjunctive therapy.

• Not adequately controlled on a combination of 2 antiepileptic drugs (AEDs).

• Creatinine clearance > 30 mL/min.

• Not on dialysis.

• Baseline Liver Function Test (LFTs) levels must be less than 3 times the upper limit of normal (ULN).

Age

Restrictions

Restricted to 12 years of age or older.

Restricted to neurologists.

Remainder of the contract year.

FABRY DISEASE Drug: Fabrazyme Covered

Uses

The use of Fabrazyme will not be considered medically necessary in the following situations:

• members who are carriers of the disease,

• doses or frequency exceeding FDA approved dosing regimen

Mainz Severity Score Index (MSSI) or FOS Mainz Severity Score Index and/or globotriaosylceramide level confirming diagnosis.

(35)

met:

• The diagnosis of α-galactosidase deficiency has been confirmed which is supported by at least one of the following:

1. pain in the extremities 2. hypohidrosis

3. corneal opacities 4. kidney dysfunction 5. cardiac dysfunction

6. cerebrovascular disorders.

Continued coverage criteria: appropriate doses and absence of disease progression.

Age

Restrictions

Restricted to members who are greater than 8 years old.

Other Criteria

FENTANYL Covered

Uses

• Increased strength and/or frequency other than approved dosing are excluded.

• Treatment of acute or postoperative pain.

• Combination use of short-acting fentanyl products.

• Monotherapy

• Diagnosis of cancer.

• Documentation identifies that use is for breakthrough cancer pain. For extension of therapy: documentation provided must identify:

1. continued benefit from therapy, AND

2. dosing of long-acting product has been evaluated and is at the maximum tolerated dose

Age

Restrictions

Transmucosal solid dosage form restricted to 16 and older. All other forms restricted to18 years and older.

(36)

Restricted to oncologists and pain management.

Initial 3 months approval followed by 6-month intervals.

Other Criteria Fentanyl oral transmucosal or buccal solid dosage forms require prior authorization (for all

quantities) and may be considered medically necessary when all of the following criteria are met: 1. Immediate-release (short-acting) opioid drugs are ineffective supported by documentation of

excessive rescue doses used.

2. Already receiving and compliant but tolerant to a chronic pain around-the-clock extended release formulation. (Opioid tolerant patients are those who are taking around-the-clock medicine consisting of at least 60mg oral morphine, 30mg oral oxycodone, 8mg of oral hydromorphone, or an equianalgesic dose of another opioid daily for one week or longer.)

FIRAZYR

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

Criteria Required Medical Info

Documentation of the following must be provided:

1. Laboratory data confirming diagnosis of hereditary angioedema (HAE):

• C1-INH activity and serum complement factor 4 level below the reference range, AND

• Serum C1q level within normal reference range, AND

• Family history of HAE, if any.

2. Medications that may trigger or worsen angioedema have been evaluated and discontinued if appropriate. (Examples of these are estrogen contraceptives, hormone replacement therapy, and ACE-Inhibitors.)

3. Prescribed for acute attacks (not for prophylaxis) and not for stock for future attacks (i.e. not stockpiling).

4. Member is not currently receiving medications that may trigger or worsen angioedema. For continued use, the following documentation must be identified following Firazyr use:

diminished symptoms, decreased severity of attack, reduced duration of attacks, and decreased hospitalizations when compared to previous therapies. Please provide date of last attack.

Age

Restrictions

Must be greater than 18 years of age.

(37)

Three month intervals

Other Criteria _•

Not to be used in combination with Kalbitor or Berinert.

• Triggers (e.g. surgery, major dental work, etc.) of attacks have been prophylactically treated appropriately and severe HAE attacks persist OR contraindication (such as pregnancy or lactatin) or severe intolerance to attenuated androgens (e.g. danazol).

• Member has been compliant with preventative therapy, therapy has been optimized, and severe HAE attacks persist.

• Note: Severe attacks are defined as attacks that compromise the airway, compromise activities of daily living for at least 5 days per month, or last more than 72 hours.

GAUCHERS DISEASE Drugs: Cerezyme, Vpriv, Zavesca Covered

Uses

The use of these agents will not be considered medically necessary in the following situations:

• members with Type 2 or Type 3 Gaucher's Disease.

• asymptomatic Type 1 disease.

• carriers of Gaucher's Disease.

• combination use of any of these agents.

• Miglustat is not covered for severe disease (severe disease defined as a hemoglobin concentration below 9 g/dL or a platelet count below 50 x 109/L or active bone disease).

• Miglustat is not covered for diagnosis other than Type 1 Gaucher Disease.

• Miglustat is not covered if there is no documented allergy, hypersensitivity, or poor venous access to enzyme replacement therapy.

• These agents are not covered for any diagnosis other than Gaucher's disease.

Required medical information for imiglucerase, velaglucerase alfa, and alglucerase is as follows:

• diagnosis of Gaucher's Disease Type 1 confirmed by biochemical assay AND

• member is experiencing symptomatic manifestations of the disease as evidenced by one of the following:

1. documented skeletal disease (osteopenia, avascular osteosclerosis, marrow infiltration, lytic lesions);

(38)

12.5gm/dL males or 1.0gm/dL below lower limit of normal for age and sex); 3. thrombocytopenia (platelet count less than or equal to 120,000/mm3) 4. hepatomegaly or splenomegaly.

Required medical information for miglustat is as follows:

• diagnosis of Gaucher's Disease Type 1 confirmed by biochemical assay AND

• member is experiencing symptomatic manifestations of the disease AND

• member has a contraindication for use of enzyme replacement therapy such as allergy, hypersensitivity reaction or poor venous access.

Age

Restrictions

Imiglucerase and alglucerase are restricted to greater than 2 years old. Miglustat is restricted to ages greater than 18 years and less than 65 years old. Velaglucerase alfa is restricted to 4 years of age and greater

Prescriber Restrictions Coverage Duration Other Criteria GILENYA Covered Uses

FDA-approved indications not otherwise excluded from Part D

• Mycocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure occurring within the last 6 months

• History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker

• Baseline QTc interval greater than or equal to 500ms

• Treatment with Class Ia or Class III anti-arrhythmic drugs

Required

Medical Info Diagnosis of relapsing-remitting form of multiple sclerosis and:

• Neurology chart notes must be provided over the past 2 years including all radiologic reports.

• EDSS (Expanded Disability Status Scale) 5.5 or less OR documentation supporting the disability is 5.5.or less.