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2017 Prior Authorization Criteria...كتغلب تامولع äلاو ةدعاسلا يقلت كل...

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2017 Prior Authorization Criteria Last Updated: 10/24/2017 HPMS Approved Formulary File Submission 00017455 Version Number 39
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Page 1: 2017 Prior Authorization Criteria...كتغلب تامولع äلاو ةدعاسلا يقلت كل قحي, Florida Health Care Plans[ لوح تاراسفتسا هدعاست يذلا

2017 Prior Authorization Criteria

Last Updated: 10/24/2017

HPMS Approved Formulary File Submission 00017455

Version Number 39

Page 2: 2017 Prior Authorization Criteria...كتغلب تامولع äلاو ةدعاسلا يقلت كل قحي, Florida Health Care Plans[ لوح تاراسفتسا هدعاست يذلا

If you or someone you’re helping has questions about Florida Health Care Plans, you have the right to

get help and information in your language at no cost. To talk to an interpreter, call 1-877-615-4022.

(TTY: TRS Relay 711)

Si usted o alguien a quien ayuda tienen preguntas sobre Florida Health Care Plans, tienen derecho a

obtener ayuda e información en su idioma de manera gratuita. Para hablar con un intérprete, llame al

1-877-615-4022. (TTY: TRS Relay 711)

Si ou menm, oswa yon moun w ap ede, gen kesyon sou Florida Health Care Plans ,ou gen dwa pou

jwenn enfòmasyon nan lang ou gratis. Pou ale ak yon entèprèt, rele 1-877-615-4022. (TTY: TRS Relay

711)

Nêu quy vi, hoăc ngươi nao đo ma quy vi đang giup đơ, co cac thăc măc vê Florida Health Care Plans,

quy vi co quyên đươc nhân trơ giup va thông tin băng ngôn ngư cua quy vi miên phi. Đê trao đôi vơi

phiên dich, hay goi theo sô 1-877-615-4022. (TTY: TRS Relay 711)

Se você, ou alguém que estiver a ajudar, tiver dúvidas sobre Florida Health Care Plans, tem o direito

de obter ajuda e informações na sua língua, sem nenhumas custas. Para falar com um intérprete, ligue

para 1-877-615-4022. (TTY: TRS Relay 711)

如果您或您正協助的某人對Florida Health Care Plans

有疑問,您有權免費以您的語言取得本協助及資訊。如欲與口譯員交談,請致電1-877-615-4022.

(TTY: TRS Relay 711)

Si vous ou une personne que vous aidez avez des questions au sujet de Florida Health Care Plans, vous

avez le droit d'obtenir gratuitement de l'aide et des informations dans votre langue. Pour parler à un

interprète, veuillez appeler le 1-877-615-4022. (TTY: TRS Relay 711)

Kung ikaw, o ang isang taong tinutulungan mo, ay may mga tanong tungkol sa Florida Health Care

Plans, mayroon kang karapatang humingi ng tulong at impormasyon sa iyong wika nang walang

bayad. Upang makipag-usap sa isang interpreter, tumawag sa 1-877-615-4022. (TTY: TRS Relay 711)

Если у Вас или у кого-то, кому Вы помогаете, есть вопросы о программе Florida Health Care Plans,

Вы имеет право бесплатно получить ответы в переводе на Ваш язык. Для того чтобы

воспользоваться помощью устного переводчика, позвоните по телефону 1-877-615-4022. (TTY:

TRS Relay 711)

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,يحق لك تلقي المساعدة والمعلومات بلغتك Florida Health Care Plansذا كان لديك أو الشخص الذي تساعده استفسارات حول ]

.(TTY: TRS Relay 711) .4022-615-877-1مجانا. تحدث إلى مترجم فوري، اتصل على الرقم ]

se voi, o una persona che state aiutando, avete domande relative al Florida Health Care Plans, avete

diritto a ottenere assistenza e informazioni gratuitamente nella vostra lingua. Per parlare con un

interprete, chiamare il numero 1-877-615-4022. (TTY: TRS Relay 711)

Falls Sie oder jemand, dem Sie helfen, irgendwelche Fragen über Florida Health Care Plans haben, so

haben Sie Anspruch auf kostenlose Unterstützung und Informationen in Ihrer eigenen Sprache. Bitte

rufen Sie uns unter der Nummer 1-877-615-4022. (TTY: TRS Relay 711) an, um mit einem

Dolmetscher/einer Dolmetscherin zu sprechen.

귀하 또는 귀하가 도와드리고 있는 분이Florida Health Care Plans에 관한 질문이 있을 경우,

귀하에게는 무료로 본인이 구사하는 언어로 도움과 정보를 받을 권리가 있습니다. 통역으로 전화

연결되려면1-877-615-4022. (TTY: TRS Relay 711) 번으로 전화해 주십시오.

Jeśli Ty lub ktoś, komu pomagasz macie pytania dotyczące Florida Health Care Plans, macie prawo

uzyskać pomoc i informacje w swoim języku, bez żadnych kosztow. Porozmawiaj z tłumaczem,

zadzwoń pod numer 1-877-615-4022. (TTY: TRS Relay 711)

જો તમન અથવા તમ જન મદદ કરી રહાા છો તમન Florida Health Care Plans વવશ કોઈ પરશનો હોય, તો તમન

તમારી ભાષામાા કોઇ પણ ખરચ વવના મદદ અન માહહતી મળવવાનો હક છ. દભાવષયા સાથ વાત કરવા માટ 1-

877-615-4022. (TTY: TRS Relay 711)

પર ફોન કરો.

หากคณ หรอคนทคณก าลงชวยเหลออยมค าถามเกยวกบ Florida Health Care Plans

คณจะไดรบการชวยเหลอและไดรบขอมลในภาษาของคณโดยทไมมคาใชจายใดๆ หากตองการพดคยกบลามแปลภาษา โทร.

1-877-615-4022. (TTY: TRS Relay 711)

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Discrimination is Against the Law

Florida Health Care Plans complies with applicable Federal civil rights laws and does not discriminate on the basis of

race, color, national origin, age, disability, or sex. Florida Health Care Plans does not exclude people or treat them

differently because of race, color, national origin, age, disability, or sex.

Florida Health Care Plans:

• Provides free aids and services to people with disabilities to communicate effectively with us, such as:

o Qualified sign language interpreters o Written information in other formats (large print, audio, accessible electronic formats, other

formats)

• Provides free language services to people whose primary language is not English, such as:

o Qualified Interpreters o Information written in other languages

If you need these services, contact Daria Siciliano, RN-BC, CCM.

If you believe that Florida Health Care Plans has failed to provide these services or discriminated in another way on

the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Daria Siciliano, RN-BC, CCM,

Manager of Member Services,

1340 Ridgewood Avenue,

Holly Hill, FL 32117.

1-844-219-6137, TTY: TRS Relay 711, 386-676-7149,

[email protected].

You can file grievance in person or by mail, fax, or email. If you need help filing a grievance, Daria Siciliano, RN-BC, CCM

Manager of Member Services is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights,

electronically through the Office for Civil Rights Complaint Portal, available at

https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services

200 Independence Avenue, SW

Room 509F, HHH Building

Washington, D.C. 20201

1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

H1035_A5228 CMS Accepted (08/11/2016)

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ABILIFY MAINTENA

DrugsAbilify Maintena Intramuscular SUSPENSION RECONSTITUTED 300 MG, 400 MG

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

Exclusion CriteriaPatient has a diagnosis of dementia-related psychosis.

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage DurationPlan Year

Other Criteria

5

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ACTIMMUNE

DrugsActimmune

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis, Bone biopsy if osteopetrosis, Antibiotic failure if chronic granulomatous disease

Age RestrictionAges approved in FDA labeling/compendia

Prescriber RestrictionInfectious Disease/Hematology-oncology/Orthopedist/rheumatologist

Coverage Duration12 months

Other CriteriaSulfamethoxazole/Trimethoprim and/or itraconazole failure for infections secondary to chronic granulomatous disease. Osteopetrosis must be severe malignant

6

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Adcirca Tabs

DrugsAdcirca

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

Exclusion Criteria

Required Medical InformationRight Heart catheterization, vasoreactivity test.

Age Restriction

Prescriber RestrictionPulmonology, Cardiology

Coverage Duration12 months

Other CriteriaFailure of Sildenafil for WHO group 1 PAH

7

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Adempas

DrugsAdempas

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionpulmonologist/cardiologist

Coverage Duration12 months

Other CriteriaFor PAH must have tried and failed bosentan and sildenafil, CTPH does not require failure of bosentan

8

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Alecensa

DrugsAlecensa

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaApproved for ALK+ Non Small Cell Lung Cancer after progression on crizotinib

9

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Alunbrig FHCP

DrugsAlunbrig

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until progression

Other Criteria

10

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AMITIZA

DrugsAmitiza

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindication

Required Medical InformationPrevious Treatment History

Age RestrictionAges in FDA label

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of Lactulose and polyethylele glycol 3350 (Miralax)

11

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Ampyra (s)

DrugsAmpyra

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

Exclusion CriteriaHistory of seizure. Moderate or severe renal impairment (creatinine clearance less than or equal to 50 mL/minute).

Required Medical InformationDiagnosis of multiple sclerosis AND patient is ambulatory (able to walk at least 25 feet) AND patient has walking impairment

Age Restriction

Prescriber Restriction

Coverage DurationInitial - 3 months. Renewal - 12 months

Other CriteriaFor renewal, walking speed has improved from baseline.

12

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Anti-thymocyte globulin

DrugsAtgam

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration1 month

Other CriteriaCoverage Criteria Based on current Medicare Part B LCD/NCD

13

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APOKYN

DrugsApokyn Subcutaneous Solution Cartridge

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling/compendia

Prescriber RestrictionNeurologist

Coverage Duration12 months

Other CriteriaPatient must have poorly controlled off time episodes and failed dopamine agonist and COMT inhibitor

14

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Aptiom

DrugsAptiom

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other CriteriaFailure of carbamazepine and Oxcarbazepine

15

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ARANESP

DrugsAranesp (Albumin Free) INJECTION SOLUTION 100 MCG/ML, 200 MCG/ML, 25 MCG/ML, 40 MCG/ML, 60 MCG/ML, Aranesp (Albumin Free) Injection Solution Prefilled Syringe 10 MCG/0.4ML, 100 MCG/0.5ML, 300 MCG/0.6ML, 40 MCG/0.4ML, 60 MCG/0.3ML

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes and Scr and HGB and T-sat and Ferritin

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration6 months

Other CriteriaFailure of Procrit. Hemoglobin required to be within FDA approved ranges for initiation and maintenance. Patient must have adequate iron stores to initiate and continue treatment. ESRD would be covered under part B benefit

16

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ARCALYST

DrugsArcalyst

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationCoverage will be based on a Diagnosis of CAPS, failure of 1 other treatment used for this condition such as cancakinumab, nsaids

Age Restriction

Prescriber RestrictionImmunologist,dermatologist,rheumatologist

Coverage Duration12 months

Other Criteria

17

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Aubagio Tabs

DrugsAubagio

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other CriteriaFailure of Glatopa, Gilenya

18

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AVASTIN

DrugsAvastin

Covered UsesAll medically accepted indications not otherwise excluded from part D OR Metastatic carcinoma of the colon or rectum when used in combination with intravenous 5-Fluorouracil based chemotherapy for first-line or second-line treatment OR Metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer when used in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer OR Nonsquamous non-small cell lung cancer in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable or locally advanced or recurrent or metastatic non-squamous cell disease OR Central nervous system (CNS) cancers OR Renal cell carcinoma (RCC) OR Ovarian cancer OR Cervical cancer OR wet AMD OR diabetic macular edema OR macular retinal edema

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes and previous treatment history and associated studies

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncologist, ophthalmologist

Coverage Duration12 months or until disease progression

Other Criteria

19

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Azilect

DrugsAzilect, Rasagiline Mesylate Oral

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of entacapone or a dopamine agonist

20

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BANZEL

DrugsBanzel

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other Criteria

21

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BOSULIF

DrugsBosulif

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration6 months or until disease progression

Other CriteriaRequires failure of another Tyrosine Kinase inhibitor for CML

22

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BOTOX

DrugsBotox Injection SOLUTION RECONSTITUTED 100 UNIT

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications OR cosmetic conditions

Required Medical InformationDiagnosis, supporting notes

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

23

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Briviact

DrugsBriviact ORAL

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other Criteriafailed trial or contraindication or intolerance of Levetiracetam

24

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BUDESONIDE EC

DrugsBudesonide ORAL

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionGastroenterologist

Coverage Duration3 months

Other CriteriaCovered for Short term use in mild to moderate Crohn's

25

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BUPRENORPHINE

DrugsBuprenorphine HCl Sublingual, Buprenorphine HCl-Naloxone HCl

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, Not covered for pain management

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

26

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BYDUREON

DrugsBydureon Subcutaneous Pen-injector

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPatient must be on maximal metformin unless contraindicated and failure of Tanzeum. Not covered for combination use outside of FDA label.

27

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BYETTA

DrugsByetta 10 MCG Pen Subcutaneous Solution Pen-injector, Byetta 5 MCG Pen Subcutaneous Solution Pen-injector

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, HA1c BG

Age RestrictionAges approved in FDA labeling

Prescriber Restrictionnone

Coverage Duration12 months

Other CriteriaPatient must be on maximal tolerated doses of sulfonylurea and Metformin and failure of Tanzeum, unless contraindicated

28

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Cabometyx

DrugsCabometyx

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaCovered until disease progression.

29

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CARBAGLU

DrugsCarbaglu

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other Criteria

30

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CEREZYME

DrugsCerezyme Intravenous SOLUTION RECONSTITUTED 400 UNIT

Covered UsesAll FDA-approved indications not otherwise excluded from Part D. Approved for treatment of type 1 Gauchers with a history of Thrombocytopenia OR splenomegaly OR bone disease OR hepatomegaly

Exclusion Criteria

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionMedical Geneticist, hematologist, metabolic specialist

Coverage Duration12 months

Other Criteria

31

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Cinryze

DrugsCinryze

Covered UsesAll Medically acceptable indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPatient must have two or more angioedema attacks per month and has failed danazol

32

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Cometriq

DrugsCometriq (100 mg Daily Dose), Cometriq (140 mg Daily Dose), Cometriq (60 mg Daily Dose)

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteriacombination use with other tyrosine Kinase inhibitors.

Required Medical InformationDiagnosis

Age Restriction

Prescriber Restrictiononcology/hematology

Coverage Duration6 months or until disease progression

Other CriteriaCovered for Metastatic Thyroid Medullary Cancer

33

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Cotellic

DrugsCotellic

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaCovered for BRAF+ metastatic melanoma for combination use in with Zelboraf

34

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Cuprimine

DrugsCuprimine ORAL CAPSULE 250 MG

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

Exclusion Criteria

Required Medical Informationserum ceruloplasmin if used for wilson's disease

Age Restriction

Prescriber Restrictionrheumatology/hepatology/neurology/urology

Coverage Duration12 months

Other CriteriaCoverage for RA requires failure of a TNF-Agent and JAK inhibitor or abatacept.

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DALIRESP

DrugsDaliresp

Covered UsesAll medically acceptable indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure or intolerance of combination inhaled corticosteroid/Long Acting Beta Agonist and long acting muscarinic antagonist.

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DRONABINOL

DrugsDronabinol

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious Treatment History

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionInfectious disease/oncologist/gastroenterologist

Coverage Durationup to 12 months

Other CriteriaFor HIV/Cancer related cachexia patient must fail megestrol, For Chemotherapy induced nausea, patient must fail Emend and Ondansetron.

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ELAPRASE

DrugsElaprase

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious Treatment History, medical notes supporting diagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionMedical Geneticist, Endocrinologist, metabolic specialist

Coverage Duration12 months

Other Criteria

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ELITEK

DrugsElitek Intravenous SOLUTION RECONSTITUTED 1.5 MG

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious Treatment History

Age RestrictionAges approved in FDA labeling

Prescriber Restrictiononcologist

Coverage Duration12 months

Other CriteriaPatient must fail xanthine oxidase inhibitor

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EMEND

DrugsAprepitant, Emend ORAL CAPSULE 40 MG, Emend Oral CAPSULE 80 MG, Emend ORAL SUSPENSION RECONSTITUTED, Emend Tri-Pack

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist/Surgeon

Coverage Duration12 months

Other CriteriaPatient must fail treatment with ondansetron (PA not applicable for PONV)

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EMSAM

DrugsEmsam Transdermal Patch 24 Hour 6 MG/24HR, 9 MG/24HR

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, prior medication failures

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPatient must fail 6 week trial with two formulary anti-depressants

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ENBREL

DrugsEnbrel Subcutaneous Solution Prefilled Syringe, Enbrel SureClick Subcutaneous Solution Auto-injector

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications combination with other biologic

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionRheumatology/Dermatology or Specialist trained in management of prescribed condition

Coverage Duration12 months

Other CriteriaFor RA Patient must fail adequate trial of MTX in combination with a DMARD If MTX contraindicated, must try combination of 2-nonbiologic DMARDS. For Ankylosing Spondylitis PT must fail 2 NSAIDS within past 6 months. For Plaque Psoriasis patient must fail MTX or Soriatane and Topical Therapy(ie. high potency steroids Vit D analogs). for Psoriatic Arthritis Patient must fail adequate trial of MTX or LEF in past 6 months.

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Esbriet

DrugsEsbriet

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaConfirmed Diagnosis of idiopathic pulmonary fibrosis (IPF) through exclusion of other fibrosing conditions/causes and definitive High resolution CT IPF pattern or Biopsy proven IPF. FVC of at least 50% of predicted value DLCO of at least 30%

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Exelon

DrugsExelon Transdermal

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of memantine and donepezil for Alzheimer's disease. no prequisite medications for dementia due to parkinson's disease

44

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EXJADE

DrugsExjade

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, iron indices

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist

Coverage Duration12 months

Other CriteriaPatient must fail or have contraindication to deferoximine

45

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FABRAZYME

DrugsFabrazyme Intravenous SOLUTION RECONSTITUTED 35 MG

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionMedical Geneticist, metabolic specialist

Coverage Duration12 months

Other CriteriaPatient must have a diagnosis of Fabry's disease with significant cardiac or renal manifestations.

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FANAPT

DrugsFanapt

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNeurology/Psychiatry

Coverage Duration12 months

Other Criteria

47

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Farydak

DrugsFarydak

Covered UsesAll FDA-approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematologist/oncologist

Coverage Duration12months

Other Criteria

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FENTANYL LOZENGE

DrugsFentaNYL Citrate Buccal

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPain management physician/oncologist

Coverage Duration12 months

Other CriteriaCovered for breakthrough pain in patients receiving long acting opioid treatment and are opioid tolerant. Patient must fail two immediate release C-II opioid such as hydromorphone, morphine, oxycodone.

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FENTANYL PATCH

DrugsFentaNYL Transdermal Patch 72 Hour 12 MCG/HR, 25 MCG/HR, 50 MCG/HR, 75 MCG/HR

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPain management physician/oncologist

Coverage Duration12 months

Other Criteria

50

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Ferriprox

DrugsFerriprox ORAL TABLET

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictiononcologist/hematologist

Coverage Duration12 months

Other CriteriaFailure of Exjade and Desferal

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Fetzima

DrugsFetzima

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaMust fail two generically available anti-depressants in past12 months

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FIRAZYR

DrugsFirazyr

Covered UsesAll FDA approved indications not otherwise excluded by part D.

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other Criteria

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FONDAPARINUX

DrugsFondaparinux Sodium

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical Information

Age RestrictionAges approved in FDA labeling/compendia

Prescriber Restrictionnone

Coverage Duration12 months

Other CriteriaCoverage will be based on allergy to Lovenox or other condition where Lovenox use is not appropriate

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FORTEO

DrugsForteo Subcutaneous SOLUTION 600 MCG/2.4ML

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications/ cumulative tx more than 24month

Required Medical InformationMedical notes, previous treatment history, BMD, PTH, VITD

Age RestrictionLate adolescents and Adults only

Prescriber Restrictionnone

Coverage Duration12 months

Other CriteriaPatient must fail or have contraindication to bisphosphonates, Vitamin D (25,OH), PTH must be WNL

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FOSRENOL

DrugsFosrenol ORAL PACKET, Fosrenol Oral TABLET CHEWABLE 1000 MG, 500 MG, 750 MG

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious treatment history, CA, PO4, IPTH

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNephrologist

Coverage Duration12 months

Other CriteriaPatient must fail or not be a candidate for calcium based phosphate binders based on KDOQI guidelines for use

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fycompa

DrugsFycompa

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other CriteriaCovered for use as an adjunctive agent for partial onset seizures

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GAMMAGARD

DrugsGammagard INJECTION SOLUTION 2.5 GM/25ML

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical InformationMedical notes, immunoglobulin studies

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

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Gattex

DrugsGattex

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionGastroenterologist

Coverage Duration6 months initially

Other CriteriaDiagnosis of Short Bowel Syndrome Dependent on Parenteral Support Baseline Records of parenteral hydration After 6 month trial of Gattex, patient must demonstrate clinical improvement and or reduction in weekly parenteral fluid volume for continuation.

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GEODON

DrugsGeodon Intramuscular

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling/compendia

Prescriber RestrictionPsychiatry/ Neurology

Coverage Duration12 months

Other Criteria

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Gilenya

DrugsGilenya

Covered UsesAll Medically Acceptable indications not otherwise covered by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other Criteria

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Gilotrif

DrugsGilotrif

Covered UsesAll medically accepted indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionOncology/Hematology

Coverage Duration12 months

Other CriteriaOff label use must be supported by NCCN criteria with evidence rating of 2a or 1

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Hetlioz

DrugsHetlioz

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaConfirmed Diagnosis of non-24 hour sleep-Wake disorder Sleep study to rule out Sleep/apnea or other contributory sleep disorders Patient must be totally Blind

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High Risk Medications in the Elderly

DrugsCyclobenzaprine HCl Oral TABLET 10 MG, GlyBURIDE Micronized Oral TABLET 3 MG, GlyBURIDE Oral

Covered UsesAll FDA-approved indications not otherwise excluded from part D

Exclusion CriteriaFDA Labeled contraindications

Required Medical Information

Age RestrictionNo authorization needed for patients less than 65 years old

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor patients 65 years of age or older prescriber attests that side effects related to the use of this medication in older adults: Will be monitored periodicallyOverall benefit outweighs riskPatient/caretaker has been informed of special considerations related to use in patients over 65 years of age For Nitrofurantoin, Zolpidem, Zaleplon no authorization is needed if patients will use less than 90 days of medication in a year.

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HUMIRA

DrugsHumira Pediatric Crohns Start Subcutaneous Prefilled Syringe Kit 40 MG/0.8ML, Humira Pen Subcutaneous Pen-injector Kit, Humira Subcutaneous Prefilled Syringe Kit 10 MG/0.2ML, 40 MG/0.8ML

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications combination with other biologic

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionDermatologist/rheumatologist/ Gastroenterologist/Ophthalmologist

Coverage Duration12 months

Other CriteriaFor RA Patient must fail adequate trial of MTX in combination with a DMARD If MTX contraindicated, must try combination of 2-nonbiologic DMARDS. For Ankylosing Spondylitis PT must fail 2 NSAIDS within past 6 months. For Plaque Psoriasis patient must fail MTX or Soriatane and Topical Therapy(ie. high potency steroids Vit D analogs). for Psoriatic Arthritis Patient must fail adequate trial of MTX or LEF in past 6 months. For Inflammatory Bowel disease patient must fail recent 3 month trial of immunosupressive (MTX, azathioprine, 6-mp) and anti-inflammatory (such as 5-ASA, olsalazine/balsalazide) in past 6 months

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Ibrance

DrugsIbrance

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

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Iclusig

DrugsIclusig

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical InformationDiagnosis

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

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IDHIFA FHCP

DrugsIDHIFA

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

Exclusion Criteria

Required Medical InformationEvidence of IDH-1 mutation

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until disease progression

Other Criteria

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Ilaris

DrugsIlaris (150mg Delivered)

Covered UsesAll FDA approved indications not otherwise excluded by partD

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor JRA patient must fail Enbrel and Humira

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Imbruvica

DrugsImbruvica

Covered UsesAll medically accepted indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaOff Label and combination use must be supported by NCCN guidelines with evidence rating of 2a or 1

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INCRELEX

DrugsIncrelex

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionEndocrinologist

Coverage Duration12 months

Other Criteria

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INVEGA SUSTENNA

DrugsInvega Sustenna

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

Exclusion CriteriaA. Diagnosis of dementia-related psychosis. B. Prior use of risperidone demonstrated a hypersensitivity reaction.

Required Medical Information Diagnosis of acute and maintenance treatment of schizophrenia AND The patient has received at least ONE of the following: a. three test doses of oral Risperdal (risperidone) b. three test doses of oral Invega c. previous use of Invega Sustenna.

Age RestrictionPatient must be 18 years old or older.

Prescriber Restriction

Coverage DurationAuthorization will be for 12 months

Other CriteriaPhysician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

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IRESSA

DrugsIressa

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion CriteriaIressa is contraindicated in patients with severe hypersensitivity to gefitinib or other components.

Required Medical InformationDiagnosis

Age RestrictionPatient must be at least 18 years old or older.

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaApproved for Non Small Cell Lung Cancer with Egfr exon 19 deletion or Exon 21 substitution.

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isotretinoin

DrugsClaravis ORAL CAPSULE 30 MG, Myorisan ORAL CAPSULE 10 MG, Zenatane ORAL CAPSULE 20 MG, 40 MG

Covered UsesAll medically acceptable indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration5 months

Other CriteriaFor cystic, nodular or scarring acne, must be refractory to oral antibiotics and topical retinoids. Trial of combination oral teracycline and topical retinoid most have been tried in most recent 6 months.

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ITRACONAZOLE

DrugsItraconazole Oral, Sporanox ORAL SOLUTION

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, fungal culture and sensitivity

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Durationminimum of 12 week up to 12 months

Other CriteriaFailure of terbinafine for onychomycosis

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IVIG

DrugsGamunex-C INJECTION SOLUTION 1 GM/10ML

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical InformationDiagnosis, immunoglobulin studies

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor ITP Must fail corticosteroids and Anti-D immunoglobulin (if indicated).

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JAKAFI

DrugsJakafi

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications, Low risk Disease

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematology-oncology

Coverage Duration3 months

Other CriteriaContinuation will be based on reduction in spleen size from baseline or symptomatic improvement. Not covered when used in combination with antiproliferative drugs (i.e lenalidomide), or other JAK or Tyrosine Kinase inhibitors.

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JANUVIA

DrugsJanuvia

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, Non FDA approved combinations

Required Medical InformationMedical notes, previous treatment history, HA1c BG

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPatient must be on maximal tolerated doses of sulfonylurea and Metformin unless contraindicated

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Juxtapid

DrugsJuxtapid

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration3 months initially, 12 months for continuation

Other CriteriaClinical confirmation that patient has HoFH and failure of Statin and PCSK-9 therapy. Continuation of Juxtapid after 3 month trial based on LDL reduction while on therapy.

79

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kalydeco

DrugsKalydeco ORAL TABLET

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaGenotyping supportive of mutation status in the FDA label

80

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KINERET

DrugsKineret Subcutaneous Solution Prefilled Syringe

Covered UsesAll medically accepted indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications combination with other biologic

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor RA failure of Enbrel and Humira

81

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Kisqali

DrugsKisqali 200 Dose, Kisqali 400 Dose, Kisqali 600 Dose

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

82

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Kisqali FHCP

DrugsKisqali Femara 200 Dose, Kisqali Femara 400 Dose, Kisqali Femara 600 Dose

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until progression

Other Criteria

83

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Korlym

DrugsKorlym

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionendocrinologist

Coverage Duration12 months

Other CriteriaDiagnosis of Cushings syndrome , Type 2 diabetes mellitus , Failed surgery OR not a candidate for surgery , Failure of ketoconazole

84

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KUVAN

DrugsKuvan ORAL PACKET 500 MG, Kuvan ORAL TABLET SOLUBLE

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionMedical Geneticist, neurologist, hepatologist,Metabolic specialist

Coverage Duration12 months

Other CriteriaCoverage will be based on medical history/status, response to previous treatments, and the consideration of other therapeutic options

85

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Kynamro

DrugsKynamro Subcutaneous Solution Prefilled Syringe

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration3 months initially, 12 months after response

Other CriteriaClinical confirmation that patient has HoFH AND failure of Statin AND PCSK-9 therapy. Continuation of Kynamro after 3 month trial based on LDL reduction.

86

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LATUDA

DrugsLatuda

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

87

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Lenvima

DrugsLenvima 10 MG Daily Dose, Lenvima 14 MG Daily Dose, Lenvima 20 MG Daily Dose, Lenvima 24 MG Daily Dose

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology Oncology

Coverage Duration12 months or until disease progression

Other Criteria

88

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LIDODERM

DrugsLidocaine EXTERNAL PATCH 5 %

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaCovered for PHN, patient must fail gabapentin

89

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linzess

DrugsLinzess

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionGastroenterology

Coverage Duration12 month

Other CriteriaFailure of Lactulose and polyethylele glycol 3350 (Miralax)

90

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Lonsurf

DrugsLonsurf

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

91

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Lynparza

DrugsLynparza

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

92

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Mavyret FHCP

DrugsMavyret

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

Exclusion Criteria

Required Medical InformationGenotype, Viral Load, stage of liver fibrosis, previous treatment history

Age Restriction

Prescriber Restriction

Coverage Duration8-16 weeks depending on patient characterstics

Other Criteria

93

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Mekinist

DrugsMekinist

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months or until disease progression

Other CriteriaMutation analysis showing BRAF V600E or V600K positive, not covered for combination use with other anti-neoplastics unless FDA indication or NCCN recommended with a class 2A or greater evidence rating.

94

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Menest

DrugsMenest ORAL TABLET 0.3 MG, 0.625 MG, 1.25 MG

Covered UsesAll FDA-labeled indications not otherwise excluded from Part D

Exclusion CriteriaFDA contraindications

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaCovered for palliative treatment of breast cancer. Coverage for Hormone replacement therapy would required failure of formulary estrogens which do not have utilization management (ie. premarin, estradiol, estropipate)

95

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MODAFINIL

DrugsArmodafinil, Modafinil

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, Sleep study or MSLT when appropriate

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNone

Coverage Duration12 months

Other Criteria

96

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Movantik

DrugsMovantik

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12months

Other CriteriaFailure of Lactulose and polyethylele glycol 3350 (Miralax)

97

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multaq

DrugsMultaq

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of sotalol and amiodarone

98

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Myrbetriq

DrugsMyrbetriq

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of Toviaz and Oxybutynin

99

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NAGLAZYME

DrugsNaglazyme

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber Restrictionmedical geneticist, endocrinologist, metabolic specialist.

Coverage Duration12 months

Other CriteriaMust demonstrate improvement in 3 minute stair climb or 12 minute walk distance for continuation at 24 weeks

100

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Natpara

DrugsNatpara

Covered UsesAll FDA approved uses not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionendocrinologist

Coverage Duration12 months

Other CriteriaUncontrolled hypocalcemia on adequate doses of calcium and vitamin D.

101

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Nerlynx FHCP

DrugsNerlynx

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematologist/Oncologist

Coverage Duration12 months or until disease progression

Other Criteria

102

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Neupro

DrugsNeupro

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of Ropinirole and Pramipexole

103

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Ninlaro

DrugsNinlaro

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaFailure of Velcade and Revlimid required for coverage

104

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Northera

DrugsNorthera

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaDocumented orthostatic hypotension, failure of midodrine or Fludrocortisone. No perquisite drugs required for Dopamine-Beta-Hydroxylase deficiency

105

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Noxafil

DrugsNoxafil ORAL

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration3 months

Other CriteriaFailure, resistance or contraindication to itraconazole,voriconazole

106

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Nuedexta

DrugsNuedexta

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical InformationDiagnosis

Age Restriction

Prescriber Restrictionneurology

Coverage Duration12 months

Other Criteria

107

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NULOJIX

DrugsNulojix

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaSeronegative for Epstein Barr-Virus exposure, Liver Transplantation

Required Medical InformationDiagnosis, previous treatment history, EBV titers

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionTransplant/nephrology

Coverage Duration12 months

Other CriteriaDocumentation of failure or intolerance to calcineurin inhibitor

108

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Nuplazid

DrugsNuplazid

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other CriteriaNotes supporting dementia with hallucinations or delusions secondary to parkinsons dementia.

109

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ODOMZO

DrugsOdomzo

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration3 - 12 months

Other CriteriaApproval will initially be for three months, if patient has a response to therapy will be renewed for 12 months

110

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Ofev

DrugsOfev

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionpulmonologist

Coverage Duration12 months

Other CriteriaConfirmed Diagnosis of idiopathic pulmonary fibrosis (IPF) through exclusion of other fibrosing conditions/causes and definitive High resolution CT IPF pattern or Biopsy proven IPF. FVC of at least 50% of predicted value DLCO of at least 30%

111

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OMNITROPE

DrugsOmnitrope

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, studies establishing diagnosis of indication.

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionEndocrinologist

Coverage Duration12 months

Other Criteria

112

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ONFI

DrugsOnfi ORAL SUSPENSION, Onfi ORAL TABLET 10 MG, 20 MG

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionFDA approved Ages

Prescriber RestrictionRestricted to Neurology

Coverage Duration12 Months

Other Criteria

113

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ONGLYZA

DrugsOnglyza ORAL TABLET 2.5 MG, 5 MG

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, Non FDA approved combinations

Required Medical InformationMedical notes, previous treatment history, HA1c BG

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPatient must be on maximal tolerated doses of sulfonylurea and Metformin unless contraindicated

114

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Opsumit

DrugsOpsumit

Covered UsesAll FDA approved uses not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionpulmonologist/cardiologist

Coverage Duration12 months

Other CriteriaFailure of sildenafil and Bosentan

115

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ORENCIA

DrugsOrencia Intravenous

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, combination therapy with other biologics

Required Medical InformationMedical notes, previous treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionRheumatologist

Coverage Duration12 months

Other CriteriaPatient must fail an ANTI-TNF, and xeljanz

116

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Orkambi

DrugsOrkambi ORAL TABLET 200-125 MG

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

Exclusion Criteria

Required Medical InformationCFTR mutation analysis, spirometry

Age RestrictionAges approved in FDA label

Prescriber Restrictionpulmonologist

Coverage Duration12 months

Other CriteriaCFTR mutation must be supported by FDA approved label such as homozygous F508-deletion

117

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OXANDROLONE

DrugsOxandrolone ORAL TABLET 2.5 MG

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other Criteria

118

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PEGASYS

DrugsPegasys Subcutaneous SOLUTION 180 MCG/0.5ML

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications, HCV Retreatment for Peg INF+RBV Non-responders

Required Medical InformationMedical notes, Viral Load

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionGastroenterologist/ Infectious Disease

Coverage Durationup to 12 months

Other CriteriaFor HCV patient must have allergy of contraindication to Peg-Intron. For HBV Patient must be Pegasys naive, with chronic HBV infection with chronically elevated transaminases.

119

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POMALYST

DrugsPomalyst

Covered UsesAll FDA approved indications not otherwise excluded by PartD

Exclusion CriteriaFDA contraindications

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaApprove for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy

120

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PROCRIT

DrugsProcrit

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, Scr, HGB, T-sat, Ferritin

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration6 months

Other CriteriaHemoglobin must be within FDA approved ranges for initiation and maintenance. Patient must have adequate iron stores to initiate and continue treatment. ESRD will be covered under Medicare Part B

121

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prolia

DrugsProlia

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaIntolerance or contraindication to injectable bisphosphonate required for coverage of prolia

122

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PROMACTA

DrugsPromacta

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical Notes, CBC ,Platelet count less than 50,000

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist, Hepatologist, Infectious Disease

Coverage Duration12 months

Other CriteriaChronic ITP Refractory to IVIG, corticosteroids or splenectomy as per FDA approval studies not applicable to HCV related thrombocytopenia

123

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PULMOZYME

DrugsPulmozyme

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, Spirometry

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPulmonologist

Coverage Duration12 months

Other CriteriaFor Patients with Cystic Fibrosis who have had recurrent pulmonary infections

124

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Quinine

DrugsQuiNINE Sulfate Oral

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaNotes supporting diagnosis of malaria

125

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RANEXA

DrugsRanexa

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationRecent Cardiology notes, previous treatment history for angina

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaPt must fail one agent in two of the three following medication classes used for angina- Long acting nitrates including isosorbide dinitrate or isosorbide mononitrate, CCB including amlodipine and nifedapine and a Beta blocker metoprolol, atenolol, carvedilol, propranolol, labetalol.

126

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Ravicti

DrugsRavicti

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionhepatologist or metabolic specialist such as a endocrinologist or geneticist

Coverage Duration12 months

Other CriteriaClinical Failure of Buphenyl

127

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RELISTOR

DrugsRelistor Subcutaneous SOLUTION 12 MG/0.6ML, 8 MG/0.4ML

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious treatment history

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPain management physician, gastroenterologist, oncologist

Coverage Duration12 months

Other CriteriaCovered for patients with advanced illness receiving palliative opioid treatment who fail Movantik, Lactulose, and metoclopramide

128

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REMICADE

DrugsRemicade

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, combination therapy with other biologics

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionRheumatology/Dermatology or Specialist trained in management of prescribed condition

Coverage Duration12 months

Other CriteriaFor RA, Plaque Psoriasis, or Psoriatic Arthritis patient must fail Humira. For Inflammatory Bowel Disease must have moderate to severe disease refractory to conventional therapies or steroid dependency despite use of adequate doses of immunosuppressive agents. Conventional therapies includes adequate doses of anti-inflammatories and immunosuppressive agents supported by current peer reviewed guidelines (American Gastroenterology Association).

129

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REMODULIN

DrugsRemodulin

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications, combination therapy with other PAH medications

Required Medical InformationMedical notes, previous treatment history, 6 min walk, diffusion studies,Rt Heart Cath

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPulmonologist/Cardiologist

Coverage Duration12 months

Other CriteriaPulmonary hypertension must be diagnosed by heart catheterization ,Evaluation, EKG, diffusion studies, catheterization results and an objective test of exercise ability (6 minute walk) must be submitted with referral, Patient must fail Tracleer.

130

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Repatha

DrugsRepatha, Repatha Pushtronex System, Repatha SureClick

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of rosuvastatin 40mg and ezetimibe 10mg in combination. Not currently approved for monotherapy or for patients who are not on maximally tolerated statin dose. Diagnosis of HeFH must be supported by Dutch Lipid Clinic Network criteria. Statin intolerant patients must have had myositis or elevated transaminases while on statin therapy which resolved after discontinuation of statin.

131

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REVATIO

DrugsSildenafil Citrate Oral

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, 6 min walk, diffusion studies,Rt Heart Cath

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPulmonologist/Cardiologist

Coverage Duration12 months

Other CriteriaPulmonary hypertension must be diagnosed by heart catheterization ,Evaluation, EKG, diffusion studies, catheterization results and an objective test of exercise ability (6 minute walk) must be submitted with referral ,Coverage will be based on medical history/status, vasoreactivity tests.

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REVLIMID

DrugsRevlimid

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, CBC, Bone Marrow Biopsy, Karyotype

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist

Coverage Duration12 months

Other CriteriaPatient must fail Thalidomide for Multiple Myeloma.

133

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Rexulti

DrugsRexulti

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12months

Other CriteriaFailure of aripiprazole and risperidone for schizophrenia or failure of combination SSRI and aripiprazole for major depressive disorder.

134

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RILUTEK

DrugsRiluzole

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, associated studies

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNeurologist

Coverage Duration12 months

Other CriteriaDiagnosis is definite or probable ALS by Neurology, symptoms present for less than 5 years, Vital Capacity is 60% or more of predicted, patient does not have a tracheotomy

135

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RITUXAN

DrugsRituxan Intravenous SOLUTION 500 MG/50ML

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, immunohistopathy

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist, rheumatologist

Coverage Duration12 months

Other CriteriaFor Rheumatoid Arthritis coverage patient must fail 2 TNF antagonists. Patient must also be on methotrexate unless contraindicated or intolerant.

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Rozerem

DrugsRozerem

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other Criteriafailure of Zolpidem and one other medication used for insomnia, such as temazepam, zaleplon, doxepin, trazodone.

137

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Rubraca

DrugsRubraca Oral TABLET 200 MG, 300 MG

Covered UsesAll medically accepted indications not otherwise excluded from Part D.

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionOncology/Hematology

Coverage Duration12 months or until disease progression

Other CriteriaNotes and labs supporting presences of BRCA mutation.

138

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Rydapt FHCP

DrugsRydapt

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until progression

Other CriteriaLabs supporting FLT3 mutation

139

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SABRIL

DrugsSabril, Vigabatrin

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNeurologist

Coverage Duration12 months

Other CriteriaPatient must fail treat with adjunctive treatment combination (applies to Refractory Partial Complex only)

140

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SAPHRIS

DrugsSaphris

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPsychiatry/ Neurology

Coverage Duration12 months

Other Criteria

141

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SENSIPAR

DrugsSensipar

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, associated studies

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNephrologist/endocrinologist/oncologist

Coverage Duration12 months

Other CriteriaFor secondary hyperparathyroidism related to CKD, patient must fail active vit-D therapy/phosphate binders, iPTH must be greater than 300 in ESRD

142

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Signifor

DrugsSignifor, Signifor LAR Intramuscular Suspension Reconstituted ER

Covered UsesAll FDA approved uses not excluded form part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionEndocrinologist

Coverage Duration12 months

Other CriteriaFor Cushings Disease Failed or poor surgical candidate for pituitary resection For Acromegaly Failed or poor surgical candidate for pituitary resection Failure of octreotide

143

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SOLARAZE

DrugsDiclofenac Sodium Transdermal GEL 3 %

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionDermatologist, oncologist

Coverage Duration12 months

Other Criteria

144

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Somatuline

DrugsSomatuline Depot Subcutaneous SOLUTION 120 MG/0.5ML, 60 MG/0.2ML, 90 MG/0.3ML

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionendocrinologist, oncologist , medical geneticist

Coverage Duration12 Months

Other CriteriaNeed clinical notes and labs supporting diagnosis of Acromegaly GH, IGF-1

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SOMAVERT

DrugsSomavert Subcutaneous SOLUTION RECONSTITUTED 10 MG

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionEndocrinologist

Coverage Duration12 months

Other Criteria

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Soriatane

DrugsAcitretin

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionDermatologist

Coverage Duration12 months

Other CriteriaMust have severe psoriasis and failed one other systemic therapy and one topical therapy.

147

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Sovaldi Tabs

DrugsSovaldi

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

Exclusion Criteria

Required Medical InformationGenotype, Viral Load, Liver Biopsy or Fibrosure/Fibroscan

Age Restriction

Prescriber RestrictionInfectious Disease, Gastroenterology/Hepatology

Coverage DurationDuration Supported by current AASLD based on patient characteristics

Other CriteriaZepatier will be the preferred and exclusive treatment for genotype 1 or 4 unless contraindicated or unsupported by current AASLD guidelines.

148

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SUBOXONE

DrugsSuboxone SUBLINGUAL FILM

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

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SYLATRON

DrugsSylatron Subcutaneous KIT 200 MCG, 300 MCG, 600 MCG

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical Information

Age RestrictionAges approved in FDA labeling

Prescriber Restrictiononcology

Coverage Duration12 months

Other CriteriaMust be used as adjuvant treatment within 84 days of surgical resection in patients with metastatic melanoma with nodal involvement

150

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Sylvant

DrugsSylvant Intravenous SOLUTION RECONSTITUTED 100 MG

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology Oncology

Coverage Duration12months

Other Criteria

151

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SYMLIN

DrugsSymlinPen 120 Subcutaneous Solution Pen-injector, SymlinPen 60 Subcutaneous Solution Pen-injector

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, HA1c BG

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionEndocrinologist, Internist

Coverage Duration12 months

Other CriteriaPatient BG must be non-controlled on optimal doses of insulin

152

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SYNAREL

DrugsSynarel

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis, Notes, Previous treatment history

Age RestrictionAges approved in FDA Label

Prescriber Restriction

Coverage Duration12 months

Other CriteriaCovered after patient fails treatment with Lupron for endometriosis or precocious puberty

153

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Tafinlar

DrugsTafinlar

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months or until disease progression

Other CriteriaMutation analysis showing BRAF V600E or V600K positive, not covered for combination use with other anti-neoplastics unless FDA indication or NCCN recommended with a class 2A or greater evidence rating.

154

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Tagrisso

DrugsTagrisso

Covered UsesAll FDA approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other CriteriaCoverage requires Diagnosis of Non Small Cell Lung cancer, progression on an EGRF TKI inhibitor, and confirmation of T790M mutation

155

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TASIGNA

DrugsTasigna

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist

Coverage Duration12 months

Other CriteriaCovered for failure or relapse of CML when previously treated with imatinib. Covered for newly diagnosed CML patients who are Philadelphia chromosome +. Will also be covered for intolerance or adverse reaction to imatinib. Combination therapy with other tyrosine kinase inhibitors or MTOR inhibitors for CML is not supported.

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TAZORAC

DrugsTazarotene External, Tazorac EXTERNAL CREAM, Tazorac EXTERNAL GEL 0.1 %

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationPrevious treatment history

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor Psoriasis patient must have failed medium to high potency topical corticosteroid, For acne patient must have failed Tretinoin and oral antibiotic

157

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Tecfidara

DrugsTecfidera

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionNeurology

Coverage Duration12 months

Other CriteriaFailure of Gilenya

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THALOMID

DrugsThalomid

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical Information

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist/infectious disease

Coverage Duration12 months

Other Criteria

159

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TRACLEER

DrugsTracleer

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, Right heart Catheterization, 6 Minute Walk time

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPulmonologist or cardiologist

Coverage Duration12 months

Other CriteriaPulmonary hypertension must be diagnosed by heart catheterization ,Evaluation, EKG, diffusion studies, catheterization results and an objective test of exercise ability (6 minute walk) must be submitted with referral ,Coverage will be based on medical history/status, vasoreactivity tests, failure of sildenafil

160

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Transderm-Scop

DrugsTransderm-Scop (1.5 MG)

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration4 weeks

Other CriteriaFailure of two oral anti-emetics

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TRETINOIN CAPSULE

DrugsTretinoin Oral

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematologist/oncologist

Coverage Duration12 months

Other Criteria

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TRETINOIN TOPICAL

DrugsTretinoin EXTERNAL CREAM, Tretinoin External GEL 0.01 %, 0.025 %

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications, treatment of photoaging, wrinkles

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

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Trintellix

DrugsTrintellix

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFailure of two generically available anti-depressants within past 6 months

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TYKERB

DrugsTykerb

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, associated studies

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncologist/hematologist

Coverage Duration12 months

Other CriteriaPatient is using in combination with capecitabine for HER/NEU + Metastatic breast CA, having failed an anthracycline, Herceptin and a taxane, or Patient must be using in combination with an aromatase inhibitor and have HER/NEU+ HR+ metastatic breast CA

165

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Tysabri

DrugsTysabri

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictionneurologist/Gastroenterologist

Coverage Duration12 months

Other CriteriaRequires failure of first line Multiple Sclerosis agent or Tumor Necrosis Factor inhibitor for Crohn's Disease, and a negative JC antibody test.

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Uptravi

DrugsUptravi

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

Exclusion Criteria

Required Medical InformationRight heart catheterization supporting diagnosis of PAH

Age Restriction

Prescriber RestrictionPulmonology or Cardiology

Coverage Duration12 months

Other Criteriadiagnosis of WHO group 1 PAH, failure of bosentan and sildenafil,

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Vancomycin Capsules

DrugsVancomycin HCl Oral

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical InformationDiagnostic confirmation of clostridium difficile diarrhea

Age Restriction

Prescriber RestrictionGastroenterology, infectious disease, oncology

Coverage Duration10 days

Other CriteriaFailure or contraindication to oral metronidazole

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Venclexta

DrugsVenclexta, Venclexta Starting Pack

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

Exclusion Criteria

Required Medical InformationNotes supporting Diagnosis and documentation of 17p deletion

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months

Other Criteria

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VIMPAT

DrugsVimpat ORAL

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age Restriction17 and older

Prescriber RestrictionNeurology

Coverage Duration12 months

Other Criteria

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Voriconazole

DrugsVoriconazole ORAL SUSPENSION RECONSTITUTED, Voriconazole Oral TABLET 200 MG

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration3 months

Other CriteriaCovered when two of the following medications have been tried, unless resistance or contraindication precludes use, Itraconazole, fluconazole, ketoconazole. Exclusions to prerequisite medications are Invasive pulmonary aspergillosis, Scedosporium apiospermum, Fusarium

171

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Vraylar

DrugsVraylar

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionPsychiatry or Neurology

Coverage Duration12 months

Other CriteriaRequires failure of aripiprazole and risperidone.

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Welchol

DrugsWelchol Oral TABLET

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration12 months

Other CriteriaFor diabetes must fail Metformin and DPP-IV inhibitor, For Hyperlipidemia must fail cholestyramine

173

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XALKORI

DrugsXalkori

Covered UsesAll FDA approved indications not otherwise excluded from part D, locally advanced or metastatic ALK+ NSCLC

Exclusion CriteriaFDA labeled contraindications, NCLC which is Anaplastic Lymphoma Kinase negative, combination therapy with other tyrosine kinase inhibitors or EGRf inhibitors.

Required Medical InformationDiagnosis, documentation support ALK+ NSLC

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematology-oncology

Coverage Duration6 months

Other CriteriaContinuation will be based on lack of disease progression

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XELJANZ

DrugsXeljanz, Xeljanz XR

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionRheumatology

Coverage Duration12 months

Other Criteria3 month trial of Combination DMARD therapy in past 6 months.

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XGEVA

DrugsXgeva

Covered UsesAll Medically Acceptable indications not otherwise excluded by PART D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restrictiononcology/endocrinology

Coverage Duration12 months

Other CriteriaFailure or contraindication to bisphosphonate for osteolytic cancer indications other than giant cell tumor of the bone.

176

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XOLAIR

DrugsXolair

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical Notes, Previous treatment history, For asthma please submit RAST, aeroallergens results, IgE values

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionPulmonologist, allergist, Dermatologist

Coverage Duration12 months

Other CriteriaFor Asthma patient Must Fail Combination LABA/ICS. For chronic ideopathic urticaria failure of hydroxyzine and H-2 antagonist.

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XTANDI

DrugsXtandi

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber Restriction

Coverage Duration6 months or until disease progression

Other CriteriaFailure of docetaxel and Abiraterone

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XYREM

DrugsXyrem

Covered UsesAll FDA approved indications not otherwise excluded by part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionPhysician Board certified in Sleep Medicine or neurologist

Coverage Duration12 months

Other CriteriaFailure of Modafanil and amphetamine/dextroamphetamine or failure of fluoxetine for narcolepsy with cataplexy

179

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YERVOY

DrugsYervoy Intravenous SOLUTION 50 MG/10ML

Covered UsesAll FDA approved indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis, medical notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionHematology-oncology

Coverage Duration6 months

Other CriteriaApproval will be for up to 4 doses at 3mg/kg. Not covered for combination therapy with BRAF inhibitors, MEK inhibitors, Adjuvant agents (Interferon), Interleukins subject to FDA approval changes or Listings within Medicare Approved compendia. Not covered for patients who previously experienced a severe immune mediated reaction related to ipilimumab.

180

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Zaltrap

DrugsZaltrap Intravenous SOLUTION 100 MG/4ML

Covered UsesAll FDA Approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/oncology

Coverage Duration6 months or until disease progression

Other CriteriaFailure Allergy or contraindication to Avastin.

181

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ZAVESCA

DrugsZavesca

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, associated studies

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncologist/Hematologist, Neurologist, Medical Geneticist, Metabolic Specialist.

Coverage Duration12 months

Other CriteriaCoverage will be based on medical history/status, response to previous treatments, and the consideration of other therapeutic options

182

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Zejula FHCP

DrugsZejula

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

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until progression

Other CriteriaSupporting BRCA results

183

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ZELBORAF

DrugsZelboraf

Covered UsesAll medically accepted indications not otherwise excluded from part D, Metastatic Melanoma Stage IIIC unresectable or Stage IV

Exclusion CriteriaAbsence of Braf V600E mutation, Combination therapy with other antineoplastic agents

Required Medical InformationDiagnosis, verification of a positive Braf V600e Mutation

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncology

Coverage Duration3 months

Other CriteriaAuthorization for continuation past 90 days will be based on absence of disease progression.

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ZEMPLAR

DrugsParicalcitol Oral

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical notes, previous treatment history, CA PO4, iPTH

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionNephrologist/endocrinologist

Coverage Duration12 months

Other CriteriaPatient must fail or have contraindication to Calcitriol or phosphate binder if appropriate

185

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Zepatier

DrugsZepatier

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

Exclusion Criteria

Required Medical InformationGentotype, Viral Load, Fibroscan/Fibrosure or liver biopsy, RAV NS5A panel

Age Restriction

Prescriber RestrictionInfectious disease, Gastroenterology/Hepatology

Coverage Duration12 or 16 weeks depending on RAV profile as supported by current AASLD guidelines

Other CriteriaZepatier is the exclusive treatment for indicated Genotype-1 and 4 patients with chronic HCV

186

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ZOLINZA

DrugsZolinza

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationMedical Notes

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncologist/hematologist/dermatologist

Coverage Duration12 months

Other CriteriaFailed minimum of two systemic treatments, one of which must be Targretin, unless contraindicated

187

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Zydelig

DrugsZydelig

Covered UsesAll FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until disease progression

Other Criteria

188

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ZYKADIA

DrugsZykadia

Covered UsesAll FDA approved indications not otherwise excluded by Part D

Exclusion Criteria

Required Medical Information

Age Restriction

Prescriber RestrictionHematology/Oncology

Coverage Duration12 months or until disease progression

Other CriteriaRestricted to use in ALK+ Non Small Cell Lung Cancer in patients who have failed crizotinib.

189

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ZYPREXA IM INJ

DrugsOLANZapine Intramuscular

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber Restriction

Coverage Duration12 months

Other Criteria

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ZYTIGA

DrugsZytiga

Covered UsesAll medically accepted indications not otherwise excluded from part D

Exclusion CriteriaFDA labeled contraindications

Required Medical InformationDiagnosis

Age RestrictionAges approved in FDA labeling

Prescriber RestrictionOncology/urology

Coverage Duration12 months

Other CriteriaPatient Must have castrate resistant metastatic prostate cancer and have failed docetaxel

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192

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Index

Index

Abilify Maintena Intramuscular SUSPENSION RECONSTITUTED 300 MG, 400 MG.........................................5Acitretin....................................147Actimmune................................... 6Adcirca......................................... 7Adempas.......................................8Alecensa....................................... 9Alunbrig......................................10Amitiza....................................... 11Ampyra.......................................12Apokyn Subcutaneous Solution Cartridge.....................................14Aprepitant...................................40Aptiom........................................15Aranesp (Albumin Free) INJECTION SOLUTION 100 MCG/ML, 200 MCG/ML, 25 MCG/ML, 40 MCG/ML, 60 MCG/ML....................................16Aranesp (Albumin Free) Injection Solution Prefilled Syringe 10 MCG/0.4ML, 100 MCG/0.5ML, 300 MCG/0.6ML, 40 MCG/0.4ML, 60 MCG/0.3ML...............................16Arcalyst.......................................17Armodafinil................................ 96Atgam......................................... 13Aubagio...................................... 18Avastin........................................19Azilect.........................................20Banzel.........................................21Bosulif........................................ 22Botox Injection SOLUTION RECONSTITUTED 100 UNIT..23Briviact ORAL........................... 24Budesonide ORAL..................... 25Buprenorphine HCl Sublingual.. 26Buprenorphine HCl-Naloxone HCl............................................. 26Bydureon Subcutaneous Pen-injector........................................27Byetta 10 MCG Pen Subcutaneous Solution Pen-injector........................................28Byetta 5 MCG Pen Subcutaneous Solution Pen-injector........................................28

Index

Cabometyx..................................29Carbaglu..................................... 30Cerezyme Intravenous SOLUTION RECONSTITUTED 400 UNIT..31Cinryze....................................... 32Claravis ORAL CAPSULE 30 MG..............................................74Cometriq (100 mg Daily Dose).. 33Cometriq (140 mg Daily Dose).. 33Cometriq (60 mg Daily Dose).... 33Cotellic....................................... 34Cuprimine ORAL CAPSULE 250 MG.......................................35Cyclobenzaprine HCl Oral TABLET 10 MG........................ 64Daliresp.......................................36Diclofenac Sodium Transdermal GEL 3 %...................................144Dronabinol..................................37Elaprase...................................... 38Elitek Intravenous SOLUTION RECONSTITUTED 1.5 MG......39Emend ORAL CAPSULE 40 MG..............................................40Emend Oral CAPSULE 80 MG. 40Emend ORAL SUSPENSION RECONSTITUTED................... 40Emend Tri-Pack..........................40Emsam Transdermal Patch 24 Hour 6 MG/24HR, 9 MG/24HR.41Enbrel Subcutaneous Solution Prefilled Syringe.........................42Enbrel SureClick Subcutaneous Solution Auto-injector................42Esbriet.........................................43Exelon Transdermal....................44Exjade.........................................45Fabrazyme Intravenous SOLUTION RECONSTITUTED 35 MG.......46Fanapt......................................... 47Farydak.......................................48FentaNYL Citrate Buccal........... 49FentaNYL Transdermal Patch 72 Hour 12 MCG/HR, 25 MCG/HR, 50 MCG/HR, 75 MCG/HR.................................... 50Ferriprox ORAL TABLET.........51Fetzima....................................... 52

Index

Firazyr.........................................53Fondaparinux Sodium................ 54Forteo Subcutaneous SOLUTION 600 MCG/2.4ML...55Fosrenol ORAL PACKET..........56Fosrenol Oral TABLET CHEWABLE 1000 MG, 500 MG, 750 MG.............................. 56Fycompa..................................... 57Gammagard INJECTION SOLUTION 2.5 GM/25ML........58Gamunex-C INJECTION SOLUTION 1 GM/10ML...........76Gattex......................................... 59Geodon Intramuscular................ 60Gilenya....................................... 61Gilotrif........................................ 62GlyBURIDE Micronized Oral TABLET 3 MG.......................... 64GlyBURIDE Oral....................... 64Hetlioz........................................ 63Humira Pediatric Crohns Start Subcutaneous Prefilled Syringe Kit 40 MG/0.8ML...................... 65Humira Pen Subcutaneous Pen-injector Kit..................................65Humira Subcutaneous Prefilled Syringe Kit 10 MG/0.2ML, 40 MG/0.8ML................................. 65Ibrance........................................ 66Iclusig......................................... 67IDHIFA.......................................68Ilaris (150mg Delivered)............ 69Imbruvica....................................70Increlex.......................................71Invega Sustenna..........................72Iressa...........................................73Itraconazole Oral........................ 75Jakafi...........................................77Januvia........................................78Juxtapid...................................... 79Kalydeco ORAL TABLET.........80Kineret Subcutaneous Solution Prefilled Syringe.........................81Kisqali 200 Dose........................ 82Kisqali 400 Dose........................ 82Kisqali 600 Dose........................ 82Kisqali Femara 200 Dose........... 83Kisqali Femara 400 Dose........... 83Kisqali Femara 600 Dose........... 83

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Index

Korlym........................................84Kuvan ORAL PACKET 500 MG..............................................85Kuvan ORAL TABLET SOLUBLE.................................. 85Kynamro Subcutaneous Solution Prefilled Syringe.........................86Latuda.........................................87Lenvima 10 MG Daily Dose...... 88Lenvima 14 MG Daily Dose...... 88Lenvima 20 MG Daily Dose...... 88Lenvima 24 MG Daily Dose...... 88Lidocaine EXTERNAL PATCH 5 %..............................................89Linzess........................................90Lonsurf....................................... 91Lynparza.....................................92Mavyret.......................................93Mekinist......................................94Menest ORAL TABLET 0.3 MG, 0.625 MG, 1.25 MG...........95Modafinil.................................... 96Movantik.................................... 97Multaq........................................ 98Myorisan ORAL CAPSULE 10 MG..............................................74Myrbetriq....................................99Naglazyme................................100Natpara..................................... 101Nerlynx.....................................102Neupro...................................... 103Ninlaro......................................104Northera....................................105Noxafil ORAL..........................106Nuedexta...................................107Nulojix......................................108Nuplazid................................... 109Odomzo.................................... 110Ofev.......................................... 111OLANZapine Intramuscular.....190Omnitrope.................................112Onfi ORAL SUSPENSION......113Onfi ORAL TABLET 10 MG, 20 MG.......................................113Onglyza ORAL TABLET 2.5 MG, 5 MG................................ 114Opsumit.................................... 115Orencia Intravenous..................116Orkambi ORAL TABLET 200-125 MG.....................................117Oxandrolone ORAL TABLET 2.5 MG......................................118

Index

Paricalcitol Oral........................185Pegasys Subcutaneous SOLUTION 180 MCG/0.5ML.119Pomalyst................................... 120Procrit ....................................... 121Prolia........................................ 122Promacta...................................123Pulmozyme...............................124QuiNINE Sulfate Oral.............. 125Ranexa...................................... 126Rasagiline Mesylate Oral........... 20Ravicti...................................... 127Relistor Subcutaneous SOLUTION 12 MG/0.6ML, 8 MG/0.4ML............................... 128Remicade.................................. 129Remodulin................................ 130Repatha.....................................131Repatha Pushtronex System..... 131Repatha SureClick....................131Revlimid................................... 133Rexulti...................................... 134Riluzole.................................... 135Rituxan Intravenous SOLUTION 500 MG/50ML.....136Rozerem....................................137Rubraca Oral TABLET 200 MG, 300 MG............................ 138Rydapt...................................... 139Sabril........................................ 140Saphris...................................... 141Sensipar.................................... 142Signifor.....................................143Signifor LAR Intramuscular Suspension Reconstituted ER...143Sildenafil Citrate Oral...............132Somatuline Depot Subcutaneous SOLUTION 120 MG/0.5ML, 60 MG/0.2ML, 90 MG/0.3ML......145Somavert Subcutaneous SOLUTION RECONSTITUTED 10 MG.....146Sovaldi......................................148Sporanox ORAL SOLUTION....75Suboxone SUBLINGUAL FILM........................................ 149Sylatron Subcutaneous KIT 200 MCG, 300 MCG, 600 MCG.....150Sylvant Intravenous SOLUTION RECONSTITUTED 100 MG...151

Index

SymlinPen 120 Subcutaneous Solution Pen-injector................152SymlinPen 60 Subcutaneous Solution Pen-injector................152Synarel......................................153Tafinlar..................................... 154Tagrisso.................................... 155Tasigna..................................... 156Tazarotene External..................157Tazorac EXTERNAL CREAM 157Tazorac EXTERNAL GEL 0.1 %...............................................157Tecfidera...................................158Thalomid.................................. 159Tracleer.....................................160Transderm-Scop (1.5 MG)....... 161Tretinoin EXTERNAL CREAM.................................................. 163Tretinoin External GEL 0.01 %, 0.025 %.....................................163Tretinoin Oral........................... 162Trintellix...................................164Tykerb.......................................165Tysabri......................................166Uptravi......................................167Vancomycin HCl Oral..............168Venclexta..................................169Venclexta Starting Pack........... 169Vigabatrin.................................140Vimpat ORAL.......................... 170Voriconazole ORAL SUSPENSION RECONSTITUTED................. 171Voriconazole Oral TABLET 200 MG.....................................171Vraylar......................................172Welchol Oral TABLET............ 173Xalkori......................................174Xeljanz......................................175Xeljanz XR............................... 175Xgeva........................................176Xolair........................................177Xtandi....................................... 178Xyrem.......................................179Yervoy Intravenous SOLUTION 50 MG/10ML........................... 180Zaltrap Intravenous SOLUTION 100 MG/4ML........................... 181Zavesca.....................................182Zejula........................................183Zelboraf.................................... 184

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Index

Zenatane ORAL CAPSULE 20 MG, 40 MG................................ 74Zepatier.....................................186Zolinza......................................187Zydelig......................................188Zykadia.....................................189Zytiga........................................191

195


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