prior authorization

98
1 ACUTE MIGRAINE AGENTS Products Affected NURTEC ODT REYVOW ORAL TABLET 100 MG, 50 MG UBRELVY PA Criteria Criteria Details Exclusion Criteria PA Criteria: Pending CMS Approval Required Medical Information PA Criteria: Pending CMS Approval Age Restrictions PA Criteria: Pending CMS Approval Prescriber Restrictions PA Criteria: Pending CMS Approval Coverage Duration PA Criteria: Pending CMS Approval Other Criteria PA Criteria: Pending CMS Approval Indications PA Criteria: Pending CMS Approval Off Label Uses PA Criteria: Pending CMS Approval Updated 10/18/2021 Y0117_MC-785-0417-C-10-21_C Prior Authorization Current as of Jan. 1, 2022

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Page 1: Prior Authorization

1

ACUTE MIGRAINE AGENTS

Products Affected NURTEC ODT

REYVOW ORAL TABLET 100 MG, 50

MG

UBRELVY

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Updated 10/18/2021 Y0117_MC-785-0417-C-10-21_C

Prior Authorization Current as of Jan. 1, 2022

Page 2: Prior Authorization

1

ACUTE MIGRAINE AGENTS

Products Affected NURTEC ODT

REYVOW ORAL TABLET 100 MG, 50

MG

UBRELVY

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 3: Prior Authorization

2

ANTIFUNGALS

Products Affected itraconazole oral capsule itraconazole oral solution

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis, past medication history, and recent culture

data.

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Onychomycosis 12wk. Systemic infection 1yr. Candidiasis (sol):

Oropharyngeal 2wk, Esophageal 6wk

Other Criteria For onychomycosis: documentation of diagnosis confirmed by fungal

diagnostic test (KOH preparation, fungal culture or nail biopsy) within the

past year and a documented trial, inadequate response or contraindication

to oral terbinafine. For systemic fungal infection: diagnosis of a systemic

fungal infection including, but not limited to blastomycosis,

histoplasmosis, or aspergillosis.

Indications All FDA-approved Indications.

Off Label Uses

Page 4: Prior Authorization

3

ANTI-HEPATITIS C AGENTS

Products Affected EPCLUSA

HARVONI ORAL PELLETS IN

PACKET 33.75-150 MG, 45-200 MG

HARVONI ORAL TABLET 45-200 MG,

90-400 MG

VOSEVI

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 5: Prior Authorization

4

ANTI-MIGRAINE AGENTS

Products Affected AIMOVIG AUTOINJECTOR

SUBCUTANEOUS AUTO-INJECTOR

140 MG/ML, 70 MG/ML

AJOVY AUTOINJECTOR

AJOVY SYRINGE

EMGALITY PEN

EMGALITY SYRINGE

SUBCUTANEOUS SYRINGE 120

MG/ML, 300 MG/3 ML (100 MG/ML X

3)

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria The patient has had a trial (4 weeks), inadequate response, or valid

contraindication, with one conventional products for migraine

prophylaxis: a) Antiepileptic b) Antidepressant c) Beta-blocker d)

Calcium-channel blocker or e) ACE/ARB. For episodic cluster headache

(Emgality only): the patient has had a trial (4 weeks), inadequate response,

or valid contraindication, with verapamil

Indications All FDA-approved Indications.

Off Label Uses

Page 6: Prior Authorization

5

ANTINEOPLASTICS

Products Affected abiraterone oral tablet 250 mg

AFINITOR DISPERZ

AFINITOR ORAL TABLET 10 MG

ALECENSA

ALUNBRIG ORAL TABLET 180 MG,

30 MG, 90 MG

ALUNBRIG ORAL TABLETS,DOSE

PACK

AYVAKIT

BALVERSA ORAL TABLET 3 MG, 4

MG, 5 MG

bexarotene

BOSULIF ORAL TABLET 100 MG, 400

MG, 500 MG

BRAFTOVI

BRUKINSA

CABOMETYX ORAL TABLET 20 MG,

40 MG, 60 MG

CALQUENCE

CAPRELSA ORAL TABLET 100 MG,

300 MG

COMETRIQ ORAL CAPSULE 100

MG/DAY(80 MG X1-20 MG X1), 140

MG/DAY(80 MG X1-20 MG X3), 60

MG/DAY (20 MG X 3/DAY)

COPIKTRA

COTELLIC

DAURISMO ORAL TABLET 100 MG,

25 MG

ERIVEDGE

ERLEADA

erlotinib oral tablet 100 mg, 150 mg, 25

mg

everolimus (antineoplastic)

FARYDAK

FOTIVDA

GAVRETO

GILOTRIF

HEMADY

IBRANCE

ICLUSIG ORAL TABLET 10 MG, 15

MG, 30 MG, 45 MG

IDHIFA

imatinib oral tablet 100 mg, 400 mg

IMBRUVICA

INLYTA ORAL TABLET 1 MG, 5 MG

INQOVI

INREBIC

INTRON A INJECTION

IRESSA

JAKAFI

KISQALI FEMARA CO-PACK ORAL

TABLET 200 MG/DAY(200 MG X 1)-2.5

MG, 400 MG/DAY(200 MG X 2)-2.5

MG, 600 MG/DAY(200 MG X 3)-2.5 MG

KISQALI ORAL TABLET 200 MG/DAY

(200 MG X 1), 400 MG/DAY (200 MG X

2), 600 MG/DAY (200 MG X 3)

KOSELUGO

lapatinib

LENVIMA ORAL CAPSULE 10

MG/DAY (10 MG X 1), 12 MG/DAY (4

MG X 3), 14 MG/DAY(10 MG X 1-4 MG

X 1), 18 MG/DAY (10 MG X 1-4 MG

X2), 20 MG/DAY (10 MG X 2), 24

MG/DAY(10 MG X 2-4 MG X 1), 4 MG,

8 MG/DAY (4 MG X 2)

LONSURF ORAL TABLET 15-6.14 MG,

20-8.19 MG

LORBRENA ORAL TABLET 100 MG,

25 MG

LUMAKRAS

LYNPARZA

MEKINIST ORAL TABLET 0.5 MG, 2

MG

MEKTOVI

NERLYNX

NEXAVAR

NINLARO

NUBEQA

ODOMZO

ONUREG

ORGOVYX

Page 7: Prior Authorization

6

PEGINTRON SUBCUTANEOUS KIT 50

MCG/0.5 ML

PEMAZYRE

PIQRAY ORAL TABLET 200 MG/DAY

(200 MG X 1), 250 MG/DAY (200 MG

X1-50 MG X1), 300 MG/DAY (150 MG

X 2)

POMALYST

QINLOCK

RETEVMO ORAL CAPSULE 40 MG, 80

MG

ROZLYTREK ORAL CAPSULE 100

MG, 200 MG

RUBRACA

RYDAPT

SPRYCEL ORAL TABLET 100 MG, 140

MG, 20 MG, 50 MG, 70 MG, 80 MG

STIVARGA

sunitinib oral capsule 12.5 mg, 25 mg,

37.5 mg, 50 mg

SYNRIBO

TABRECTA

TAFINLAR ORAL CAPSULE 50 MG,

75 MG

TAGRISSO

TALZENNA ORAL CAPSULE 0.25 MG,

1 MG

TARGRETIN TOPICAL

TASIGNA

TAZVERIK

TEPMETKO

THALOMID ORAL CAPSULE 100 MG,

150 MG, 200 MG, 50 MG

TIBSOVO

toremifene

TRUSELTIQ

TUKYSA

TURALIO

UKONIQ

VENCLEXTA ORAL TABLET 10 MG,

100 MG, 50 MG

VENCLEXTA STARTING PACK

VERZENIO

VITRAKVI ORAL CAPSULE 100 MG,

25 MG

VITRAKVI ORAL SOLUTION

VIZIMPRO

VOTRIENT

WELIREG

XALKORI

XOSPATA

XPOVIO ORAL TABLET 100

MG/WEEK (20 MG X 5), 100

MG/WEEK (50 MG X 2), 40 MG/WEEK

(20 MG X 2), 40 MG/WEEK (40 MG X

1), 40MG TWICE WEEK (40 MG X 2),

40MG TWICE WEEK (80 MG/WEEK),

60 MG/WEEK (20 MG X 3), 60

MG/WEEK (60 MG X 1), 60MG TWICE

WEEK (120 MG/WEEK), 80 MG/WEEK

(20 MG X 4), 80 MG/WEEK (40 MG X

2), 80MG TWICE WEEK (160

MG/WEEK)

XTANDI ORAL CAPSULE

XTANDI ORAL TABLET 40 MG, 80

MG

ZEJULA

ZELBORAF

ZOLINZA

ZYDELIG

ZYKADIA ORAL TABLET

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Page 8: Prior Authorization

7

PA Criteria Criteria Details

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 9: Prior Authorization

8

ARANESP

Products Affected ARANESP (IN POLYSORBATE)

INJECTION SYRINGE

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and lab values

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Non-ESRD members will have approval for 60 days. ESRD members will

have approval for 12 months.

Other Criteria INITIAL: Lab values obtained within 30 days of administration, adequate

iron stores as demonstrated by serum ferritin and transferrin saturation

prior to initiation of therapy, Hemoglobin less than 10 g/dL and/or

Hematocrit less than 30% and other causes of anemia have been ruled out.

CONTINUATION: Last dose less than 120 days ago, disease response,

absence of unacceptable toxicity from the drug, lab values obtained within

30 days of the date of administration, adequate iron stores as demonstrated

by serum ferritin and transferrin saturation within the previous 4 months

and other causes of anemia have been ruled out. Anemia secondary to

chemotherapy treatment (Hemoglobin less than 10 g/dL and/or

Hematocrit less than 30% and there is a minimum of two additional

months of planned chemotherapy). Anemia secondary to chronic kidney

disease (non-dialysis patients) (Pediatric patients: Hemoglobin less than

12 g/dL and/or Hematocrit less than 36%, Adults: Hemoglobin less than

11 g/dL and/or Hematocrit less than 33%). Anemia secondary to

myelodysplastic syndrome (Hemoglobin less than 12 g/dL and/or

Hematocrit less than 36%). Anemia secondary to myeloproliferative

neoplasms (Hemoglobin less than 10 g/dL and/or Hematocrit less than

30%).

Indications All FDA-approved Indications.

Off Label Uses

Page 10: Prior Authorization

9

CANNABIDIOL

Products Affected EPIDIOLEX

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 11: Prior Authorization

10

CARBAGLU

Products Affected CARBAGLU

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 12: Prior Authorization

11

CAYSTON

Products Affected CAYSTON

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, laboratory data and documentation of

previous treatments.

Age Restrictions 7 years or older

Prescriber

Restrictions

Pulmonologist, Infectious Disease Specialist or specialist in Cystic

Fibrosis

Coverage

Duration

Indefinite as long as member is eligible for coverage

Other Criteria Documentation that inhaled bronchodilator is administered prior to

Cayston. Member has had a trial, an inadequate response, or

contraindication to inhaled tobramycin solution.

Indications All FDA-approved Indications.

Off Label Uses

Page 13: Prior Authorization

12

COSENTYX

Products Affected COSENTYX (2 SYRINGES)

COSENTYX PEN (2 PENS)

COSENTYX SUBCUTANEOUS

SYRINGE 75 MG/0.5 ML

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Dermatologist or Rheumatologist.

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Ankylosing Spondylitis: Member has had a trial, inadequate response or

valid contraindication with at least two conventional treatments including:

NSAIDs or COX-2 inhibitors (e.g., celecoxib). Plaque Psoriasis: Member

has had a trial, inadequate response or valid contraindication to with

conventional treatments including topical therapies (e.g., steroids, vitamin

D analogs), systemic therapies (e.g., acitretin, cyclosporine, methotrexate)

or has had a trial of or is not a candidate for phototherapy. Psoriatic

Arthritis, peripheral disease: Member has had a trial, inadequate response

or valid contraindication to treatment with one DMARD (e.g.

sulfasalazine, hydroxychloroquine, methotrexate, azathioprine,

leflunomide). Psoriatic Arthritis, axial disease: Member has had a trial,

inadequate response or valid contraindication to treatment with at least

two NSAIDs.

Indications All FDA-approved Indications.

Off Label Uses

Page 14: Prior Authorization

13

CYSTIC FIBROSIS AGENT

Products Affected KALYDECO ORAL GRANULES IN

PACKET

KALYDECO ORAL TABLET

ORKAMBI ORAL GRANULES IN

PACKET

ORKAMBI ORAL TABLET

SYMDEKO

TRIKAFTA

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and confirmation of the mutation as detected

by a FDA-cleared test.

Age Restrictions

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria N/A

Indications All FDA-approved Indications.

Off Label Uses

Page 15: Prior Authorization

14

CYSTIC FIBROSIS PULMONARY FUNCTION

AGENTS

Products Affected BRONCHITOL PULMOZYME

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Pulmonologist, Infectious Disease specialist, or a specialist in Cystic

Fibrosis

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 16: Prior Authorization

15

DALFAMPRIDINE

Products Affected dalfampridine

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 17: Prior Authorization

16

DERMATOLOGICAL PRODUCTS (RETINOIDS

AND ACNE MEDS)

Products Affected adapalene topical cream

adapalene topical gel

avita

tazarotene topical cream

TAZORAC TOPICAL CREAM 0.05 %

TAZORAC TOPICAL GEL

tretinoin

tretinoin microspheres topical gel

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis, confirmation of non-cosmetic indication.

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria N/A

Indications All FDA-approved Indications.

Off Label Uses

Page 18: Prior Authorization

17

DIACOMIT

Products Affected DIACOMIT ORAL CAPSULE 250 MG,

500 MG

DIACOMIT ORAL POWDER IN

PACKET 250 MG, 500 MG

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 19: Prior Authorization

18

DICLOFENAC SODIUM TOPICAL GEL

Products Affected diclofenac sodium topical gel 3 %

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis.

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 20: Prior Authorization

19

DICLOFENAC TOPICAL PATCH

Products Affected diclofenac epolamine

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

90 days

Other Criteria Member had a documented, unsatisfactory response or intolerance to

diclofenac 1% gel or diclofenac 1.5% solution

Indications All FDA-approved Indications.

Off Label Uses

Page 21: Prior Authorization

20

DIFICID

Products Affected DIFICID ORAL SUSPENSION FOR

RECONSTITUTION

DIFICID ORAL TABLET

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis, medical records or pharmacy claims

documenting previous drug treatments.

Age Restrictions N/A

Prescriber

Restrictions

Coverage

Duration

10 days

Other Criteria Member must have a documented prior trial or contraindication with

vancomycin. Approval will be granted if member has been receiving

Dificid as an inpatient during hospitalization and needs to complete the

course of therapy as an outpatient.

Indications All FDA-approved Indications.

Off Label Uses

Page 22: Prior Authorization

21

DROXIDOPA

Products Affected droxidopa oral capsule 100 mg, 200 mg,

300 mg

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Initial: 3 months. Continuation: 1 year based on beneficial response to

therapy

Other Criteria The patient has had a trial (4 weeks), inadequate response, or valid

contraindication with midodrine and fludrocortisone

Indications All FDA-approved Indications.

Off Label Uses

Page 23: Prior Authorization

22

DUPIXENT

Products Affected DUPIXENT PEN SUBCUTANEOUS

PEN INJECTOR 200 MG/1.14 ML, 300

MG/2 ML

DUPIXENT SYRINGE

SUBCUTANEOUS SYRINGE 200

MG/1.14 ML, 300 MG/2 ML

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, previous drug treatments

Age Restrictions

Prescriber

Restrictions

Dermatologist, allergist, immunologist, pulmonologist, otolarynologist

Coverage

Duration

Initial requests approved for six months. Continuation requests approved

indefinitely

Other Criteria Initial: Atopic dermatitis 1) patient has one of the following a)

involvement of at least 10% of BSA b) incapacitation due to AD lesion

location 2) evidence of symptoms 3) previous 30-day trial, inadequate

response, or valid contraindication to at least TWO topical agents.

Asthma: 1) eosinophilic phenotype or oral corticosteroid dependent

asthma 2) previous therapy with medium to high dose inhaled

corticosteroid 3) current therapy with an additional controller medication

4) asthma exacerbation within past 12 months 5) being used as add-on

treatment 6) not used with other asthma biologics. Chronic Rhinosinusitis

with Nasal Polyposis (CRSwNP): 1) clinical documentation of nasal

polyps 2) inadequately controlled disease 3) being used as add-on

treatment. Continuation: 1) absence of unacceptable toxicity 2) disease

response as indicated by improvement in signs and symptoms.

Indications All FDA-approved Indications.

Off Label Uses

Page 24: Prior Authorization

23

ENBREL

Products Affected ENBREL MINI

ENBREL SUBCUTANEOUS RECON

SOLN

ENBREL SUBCUTANEOUS

SOLUTION

ENBREL SUBCUTANEOUS SYRINGE

25 MG/0.5 ML (0.5), 50 MG/ML (1 ML)

ENBREL SURECLICK

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 25: Prior Authorization

24

ERYTHROPOIESIS STIMULATING AGENTS -

EPOETIN ALFA

Products Affected RETACRIT

PA Criteria Criteria Details

Exclusion

Criteria

FDA labeled contraindication(s) to the requested agent

Required

Medical

Information

Documentation of diagnosis and lab results

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

ESRD: Approved for 12 months. Non-ESRD indications: Approved for

60 days.

Other Criteria INITIAL: Lab values obtained within 30 days of administration, adequate

iron stores as demonstrated by serum ferritin and transferrin saturation

prior to initiation of therapy and other causes of anemia (hemolysis,

bleeding, vitamin deficiency) have been ruled out. Anemia secondary to

chronic kidney disease (CKD), Zidovudine therapy, and myelosuppressive

chemotherapy require a hemoglobin level less then 10g/dL and/or

hematocrit less than 30%. Elective, non-cardiac or non-vascular surgery

requires a hemoglobin level between 10g/dL and 13g/dL and/or

hematocrit between 30% and 39%. CONTINUATION: Last dose less

than 120 days ago, disease response, absence of unacceptable toxicity

from the drug, lab values obtained within 30 days of the date of

administration, adequate iron stores as demonstrated by serum ferritin and

transferrin saturation within the previous 3 months and other causes of

anemia have been ruled out. Anemia secondary to Zidovudine

(Hemoglobin less than 12 g/dL and/or Hematocrit less than 36%). Anemia

secondary to myelosuppressive chemotherapy (Hemoglobin less than 10

g/dL and/or Hematocrit less than 30% and a minimum of two additional

months of planned chemotherapy). Elective, non-cardiac or non-vascular

surgery (hemoglobin level between 10g/dL and 13g/dL and/or hematocrit

between 30% and 39%). All other indications (Hemoglobin less than 11

g/dL and/or Hematocrit less than 33%). Coverage under Part D will be

denied if coverage is available under Part A or Part B as the medication is

Page 26: Prior Authorization

25

PA Criteria Criteria Details

prescribed and dispensed or administered for the individual (e.g., used for

treatment of anemia for a patient with chronic renal failure who is

undergoing dialysis, or furnished from physician's supply incident to a

physician service).

Indications All FDA-approved Indications.

Off Label Uses

Page 27: Prior Authorization

26

FASENRA

Products Affected FASENRA

PA Criteria Criteria Details

Exclusion

Criteria

In combination with another monoclonal antibody (e.g., omalizumab,

mepolizumab, reslizumab, etc.)

Required

Medical

Information

Documentation of diagnosis, lab tests, previous treatments and past

medical history

Age Restrictions 12 years of age or older

Prescriber

Restrictions

Coverage

Duration

Coverage will be provided for six months and may be renewed.

Other Criteria Initial: Must be used as add-on maintenance treatment in patients

regularly receiving both medium to high-dose inhaled corticosteroids and

additional controller medication (e.g., long-acting beta agonist,

leukotriene modifiers, etc.) and have two or more exacerbations in the

previous year requiring daily oral corticosteroids for at least 3 days (in

addition to the regular maintenance therapy defined above). Continuation:

1) Improvement in asthma symptoms or asthma exacerbations as

evidenced by decrease in one or more of the following: a) Use of systemic

corticosteroids b) Two-fold or greater decrease in inhaled corticosteroid

use for at least 3 days c) Hospitalizations d) ER visits e) Unscheduled

visits to healthcare provider OR 2) Improvement from baseline in forced

expiratory volume in 1 second (FEV1)

Indications All FDA-approved Indications.

Off Label Uses

Page 28: Prior Authorization

27

FINTEPLA

Products Affected FINTEPLA

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 29: Prior Authorization

28

GATTEX

Products Affected GATTEX 30-VIAL

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and medical records.

Age Restrictions N/A

Prescriber

Restrictions

Gastroenterologist

Coverage

Duration

1 year

Other Criteria Medical records are needed to confirm member dependence on total

parental/IV nutrition.

Indications All FDA-approved Indications.

Off Label Uses

Page 30: Prior Authorization

29

GRANULOCYTE COLONY STIMULATING

FACTORS

Products Affected GRANIX SUBCUTANEOUS SYRINGE ZARXIO

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 31: Prior Authorization

30

GROWTH HORMONE

Products Affected NORDITROPIN FLEXPRO

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 32: Prior Authorization

31

HEREDITARY ANGIOEDEMA, ACUTE

Products Affected BERINERT INTRAVENOUS KIT

icatibant

RUCONEST

PA Criteria Criteria Details

Exclusion

Criteria

Concurrent medication(s) known to trigger angioedema attacks

Required

Medical

Information

Documentation of diagnosis, lab values

Age Restrictions

Prescriber

Restrictions

Prescribed by, or in consultation with, a specialist in: allergy,

immunology, hematology, pulmonology, or medical genetics

Coverage

Duration

12 weeks and may be renewed based on clinical response

Other Criteria Initial: 1) patient has history of moderate to severe cutaneous or

abdominal attacks or mild to severe airway swelling attacks of HAE 2)

patient has clinical presentations consistent with HAE subtype as

confirmed by repeat blood testing. Continuation: 1) patient continues to

meet the initial criteria 2) significant improvement in severity and

duration of attacks has been achieved and sustained 3) absence of

unacceptable toxicity from the drug.

Indications All FDA-approved Indications.

Off Label Uses

Page 33: Prior Authorization

32

HEREDITARY ANGIOEDEMA, PREVENTIVE

Products Affected CINRYZE

HAEGARDA

ORLADEYO

TAKHZYRO

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 34: Prior Authorization

33

HETLIOZ

Products Affected HETLIOZ

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 35: Prior Authorization

34

HUMIRA

Products Affected HUMIRA PEN

HUMIRA PEN CROHNS-UC-HS

START

HUMIRA PEN PSOR-UVEITS-ADOL

HS

HUMIRA SUBCUTANEOUS SYRINGE

KIT 40 MG/0.8 ML

HUMIRA(CF) PEDI CROHNS

STARTER SUBCUTANEOUS SYRINGE

KIT 80 MG/0.8 ML, 80 MG/0.8 ML-40

MG/0.4 ML

HUMIRA(CF) PEN CROHNS-UC-HS

HUMIRA(CF) PEN PEDIATRIC UC

HUMIRA(CF) PEN PSOR-UV-ADOL

HS

HUMIRA(CF) PEN SUBCUTANEOUS

PEN INJECTOR KIT 40 MG/0.4 ML, 80

MG/0.8 ML

HUMIRA(CF) SUBCUTANEOUS

SYRINGE KIT 10 MG/0.1 ML, 20

MG/0.2 ML, 40 MG/0.4 ML

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and previous treatments.

Age Restrictions N/A

Prescriber

Restrictions

Dermatologist, Gastroenterologist, Ophthalmologist, or Rheumatologist.

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Coverage criteria: Ankylosing Spondylitis: documented failure,

contraindication or intolerance to two conventional treatments including:

NSAIDs or COX-2 inhibitors. Crohn's Disease: documented failure,

contraindication or intolerance to one conventional treatment including

immunosuppressants, corticosteroids or aminosalicylates. Pediatric

Crohn's Disease: documented failure, contraindication or intolerance to

one conventional treatment including corticosteroids or

immunosuppressants. Plaque Psoriasis: documented failure,

contraindication or intolerance to one conventional treatment including

topical therapies, systemic therapies or has had a trial of or is not a

candidate for phototherapy. Juvenile Idiopathic Arthritis: documented

failure, contraindication or intolerance to one conventional treatment

including NSAIDs, corticosteroids, methotrexate or leflunomide.

Psoriatic Arthritis, axial disease: documented failure, contraindication or

intolerance to at least two conventional treatments including NSAIDs and

Page 36: Prior Authorization

35

PA Criteria Criteria Details

COX-2 inhibitors. Psoriatic Arthritis, peripheral disease: documented

failure, contraindication or intolerance to one DMARD. Rheumatoid

Arthritis: documented failure, contraindication or intolerance to one

DMARD. Ulcerative Colitis documented failure, contraindication or

intolerance to one conventional treatment including immunosuppressants,

corticosteroids or aminosalicylates. Uveitis: documented failure,

contraindication or intolerance to one conventional treatment including

immunosuppressants, DMARDs, or corticosteroids.

Indications All FDA-approved Indications.

Off Label Uses

Page 37: Prior Authorization

36

ILARIS

Products Affected ILARIS (PF)

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis.

Age Restrictions

Prescriber

Restrictions

Prescribed by or in consultation with a Rheumatologist or Immunologist

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 38: Prior Authorization

37

IMMUNE THROMBOCYTOPENIA

Products Affected PROMACTA ORAL POWDER IN

PACKET 12.5 MG, 25 MG

PROMACTA ORAL TABLET 12.5 MG,

25 MG, 50 MG, 75 MG

TAVALISSE

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, lab results with current platelet count,

previous treatments.

Age Restrictions

Prescriber

Restrictions

Hematologist, Oncologist, Gastroenterologist or Infectious Disease

Specialist.

Coverage

Duration

Chronic ITP: 6 mo. Severe aplastic anemia: 4 mo. Hepatitis C associated

thrombocytopenia: 48 wks

Other Criteria Initial Criteria: Chronic ITP, initial: 1) platelet count less than 50,000/mcL

AND 2) documentation of trial with corticosteroids or immunoglobulin.

Chronic ITP, continuation: platelet count less than 50,000/mcL. Hepatitis

C associated thrombocytopenia: 1) platelet count less than 75,000/mcL

AND documentation of treatment with interferon for chronic hepatitis C.

Severe aplastic anemia, initial: 1) low platelet counts at

baseline/pretreatment (less than 30,000/mcl) AND will be using the

requested agent in combination with standard immunosuppressive therapy

(i.e., antithymocyte globulin (ATG) and cyclosporine) for the first-line

treatment of SAA OR has refractory (RSAA) defined as an insufficient

response or documented intolerance, or contraindication to

immunosuppressive therapy [i.e., failure to ATG and cyclosporine].

Severe aplastic anemia, continuation: documentation of positive clinical

response (platelet count of at least 50,000/mcL but less than 200,000/mcL.

If platelet count is greater than or equal to 200,000 but less than or equal

to 400,000 platelets per mcL, therapy will be adjusted to the minimum

platelet count needed to reduce the bleeding risk)

Indications All FDA-approved Indications.

Off Label Uses

Page 39: Prior Authorization

38

IMMUNOMODULATORS

Products Affected ACTEMRA ACTPEN

ACTEMRA SUBCUTANEOUS

CIMZIA

CIMZIA POWDER FOR RECONST

ILUMYA

ORENCIA CLICKJECT

ORENCIA SUBCUTANEOUS

SYRINGE 125 MG/ML, 50 MG/0.4 ML,

87.5 MG/0.7 ML

OTEZLA

OTEZLA STARTER ORAL

TABLETS,DOSE PACK 10 MG (4)-20

MG (4)-30 MG (47), 10 MG (4)-20 MG

(4)-30 MG(19)

SILIQ

SIMPONI SUBCUTANEOUS PEN

INJECTOR

SIMPONI SUBCUTANEOUS SYRINGE

100 MG/ML, 50 MG/0.5 ML

TALTZ AUTOINJECTOR

TALTZ SYRINGE

TALTZ SYRINGE (2 PACK)

TALTZ SYRINGE (3 PACK)

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments. Documentation of

recent (within previous year) negative tuberculin (TB) test.

Age Restrictions

Prescriber

Restrictions

Rheumatologist, Gastroenterologist or Dermatologist

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Coverage criteria: Active non-radiographic axial spondyloarthritis with

objective signs of inflammation: documented failure, contraindication or

intolerance to ONE of the preferred agents (Cosentyx). Ankylosing

Spondylitis: documented failure, contraindication or intolerance to TWO

of the preferred agents (Cosentyx, Enbrel, Humira,). Crohn's Disease:

documented failure, contraindication or intolerance to Humira AND

Stelara. Giant Cell Arteritis: documented failure, contraindication or

intolerance to high-dose systemic glucocorticoids or methotrexate. Plaque

Psoriasis: documented failure, contraindication or intolerance to TWO of

the preferred agents (Cosentyx, Enbrel, Humira, Stelara, Skyrizi,

Tremfya). Polyarticular Juvenile Idiopathic Arthritis: documented failure,

contraindication or intolerance to TWO of the preferred agents (Enbrel,

Humira, Xeljanz). Psoriatic Arthritis: documented failure,

contraindication or intolerance to TWO of the preferred agents (Cosentyx,

Page 40: Prior Authorization

39

PA Criteria Criteria Details

Enbrel, Humira, Stelara, Tremfya, Xeljanz/XR). Rheumatoid Arthritis:

documented failure, contraindication or intolerance to TWO of the

preferred agents (Enbrel, Humira, Rinvoq, Xeljanz/XR). Ulcerative

Colitis: documented failure, contraindication or intolerance to TWO of the

preferred agents (Humira, Stelara, Xeljanz/XR).

Indications All FDA-approved Indications.

Off Label Uses

Page 41: Prior Authorization

40

INBRIJA

Products Affected INBRIJA INHALATION CAPSULE,

W/INHALATION DEVICE

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Prescribed by, or in consultation with, a neurologist

Coverage

Duration

Initial requests 6 months. Continuation requests may be approved

indefinitely based on response.

Other Criteria Member has tried, had an inadequate response, or valid contraindication to

treatment with at least two (2) adjunctive anti-Parkinson's disease

pharmacotherapy classes (dopamine agonists, catechol-O-methyl

transferase (COMT) inhibitors, or monoamine oxidase (MAO) B

inhibitors)

Indications All FDA-approved Indications.

Off Label Uses

Page 42: Prior Authorization

41

INCRELEX

Products Affected INCRELEX

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 43: Prior Authorization

42

INHALED TOBRAMYCIN AGENTS

Products Affected TOBI PODHALER INHALATION

CAPSULE, W/INHALATION DEVICE

tobramycin in 0.225 % nacl

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, past medication history, and recent culture

data.

Age Restrictions 6 years of age or older

Prescriber

Restrictions

Pulmonologist, Infectious Disease Specialist or specialist in Cystic

Fibrosis

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Member has sputum cultures positive for or colonization history of

Pseudomonas aeruginosa. For TOBI Podhaler: member has had a trial, an

inadequate response, or contraindication to generic tobramycin

nebulization solution.

Indications All FDA-approved Indications.

Off Label Uses

Page 44: Prior Authorization

43

KINERET

Products Affected KINERET

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions N/A

Prescriber

Restrictions

Prescribed by or in consultation with a Rheumatologist or Immunologist

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Rheumatoid Arthritis: 1) Confirmation of diagnosis and 2) Documented

trial, inadequate response or valid contraindication with one or more

Disease Modifying Anti-rheumatic Drug (DMARDS) such as

hydroxychloroquine, leflunomide, methotrexate or sulfasalazine AND a

trial, contraindication, or intolerance to Humira or Enbrel. Cryopyrin-

Associated Periodic Syndrome (CAPS) and deficiency of IL-1 receptor

antagonist: 1) Confirmation of diagnosis.

Indications All FDA-approved Indications.

Off Label Uses

Page 45: Prior Authorization

44

LETERMOVIR (PREVYMIS)

Products Affected PREVYMIS ORAL

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Prescribed by or in consultation with a hematologist, oncologist,

infectious disease specialist, or transplant specialist

Coverage

Duration

Up to 100 days post transplant

Other Criteria Initiated within the first 28 days post-transplant and patient does not have

active CMV infection (CMV PCR level over 250 IU/mL) and is not

receiving preemptive treatment (ex. foscavir)

Indications All Medically-accepted Indications.

Off Label Uses

Page 46: Prior Authorization

45

LIDOCAINE PATCH

Products Affected lidocaine topical adhesive

patch,medicated 5 %

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis.

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications, Some Medically-accepted Indications.

Off Label Uses Diabetic neuropathy

Page 47: Prior Authorization

46

METYROSINE

Products Affected metyrosine

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions Patient must be 12 years old or older

Prescriber

Restrictions

Coverage

Duration

Initial request 1 year. Continuation requests will be approved annually

based on clinical response.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 48: Prior Authorization

47

MOZOBIL

Products Affected MOZOBIL

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Up to 4 consecutive days within a period of 3 months

Other Criteria Indications outside of FDA-approved indications must be consistent with

NCCN guidelines or primary literature references containing clinical

evidence supporting the treatment

Indications All FDA-approved Indications.

Off Label Uses

Page 49: Prior Authorization

48

MULTIPLE SCLEROSIS AGENTS

Products Affected AUBAGIO

AVONEX INTRAMUSCULAR PEN

INJECTOR KIT

AVONEX INTRAMUSCULAR

SYRINGE KIT

BETASERON SUBCUTANEOUS KIT

COPAXONE SUBCUTANEOUS

SYRINGE 20 MG/ML, 40 MG/ML

dimethyl fumarate oral capsule,delayed

release(dr/ec) 120 mg, 120 mg (14)- 240

mg (46), 240 mg

GILENYA

glatiramer subcutaneous syringe 20

mg/ml, 40 mg/ml

glatopa subcutaneous syringe 20 mg/ml,

40 mg/ml

KESIMPTA PEN

MAVENCLAD (10 TABLET PACK)

MAVENCLAD (4 TABLET PACK)

MAVENCLAD (5 TABLET PACK)

MAVENCLAD (6 TABLET PACK)

MAVENCLAD (7 TABLET PACK)

MAVENCLAD (8 TABLET PACK)

MAVENCLAD (9 TABLET PACK)

MAYZENT ORAL TABLET 0.25 MG, 2

MG

MAYZENT STARTER PACK

PLEGRIDY SUBCUTANEOUS PEN

INJECTOR 125 MCG/0.5 ML, 63

MCG/0.5 ML- 94 MCG/0.5 ML

PLEGRIDY SUBCUTANEOUS

SYRINGE 125 MCG/0.5 ML, 63

MCG/0.5 ML- 94 MCG/0.5 ML

VUMERITY

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Neurologist

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 50: Prior Authorization

49

NUCALA

Products Affected NUCALA SUBCUTANEOUS AUTO-

INJECTOR

NUCALA SUBCUTANEOUS SYRINGE

PA Criteria Criteria Details

Exclusion

Criteria

In combination with another monoclonal antibody (e.g., omalizumab,

mepolizumab, reslizumab, etc.)

Required

Medical

Information

Documentation of diagnosis, laboratory data, previous treatments and past

medical history

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Coverage will be provided for six months and may be renewed

Other Criteria Initial, Severe asthma: Must be used as add-on maintenance treatment in

patients regularly receiving both a medium to high-dose inhaled

corticosteroids and an additional controller medication and have two or

more exacerbations in the previous year requiring daily oral

corticosteroids for at least 3 days (in addition to the regular maintenance

therapy defined above). EGPA: blood eosinophils 150 cells/microL

within 6 weeks of dosing and been on stable doses of concomitant oral

corticosteroid therapy for at least 4 weeks. HES: blood eosinophils at least

1000 cells/microL within 4 weeks of dosing and used in combination with

stable doses of at least one other HES therapy. Continuation (all

indications): 1) member has absence of unacceptable toxicity from the

drug 2) treatment has resulted in clinical benefit

Indications All FDA-approved Indications.

Off Label Uses

Page 51: Prior Authorization

50

NUEDEXTA

Products Affected NUEDEXTA

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 52: Prior Authorization

51

NUPLAZID

Products Affected NUPLAZID ORAL CAPSULE NUPLAZID ORAL TABLET 10 MG

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Prescribed by or in consultation with a provider specializing in neurology,

geriatric medicine or behavioral health (such as psychiatrist)

Coverage

Duration

Initial: 12 months. Continuation: indefinite based on beneficial response

to therapy.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 53: Prior Authorization

52

OCTREOTIDE

Products Affected octreotide acetate

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, laboratory data, and previous treatments

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Approved for 6 months and may be renewed based on clinical response

Other Criteria

Indications All FDA-approved Indications, Some Medically-accepted Indications.

Off Label Uses Neuroendocrine tumors, Meningiomas, Malignant Bowel Obstruction,

Chemotherapy- and/or Radiation-Induced Diarrhea, HIV/AIDS-related

diarrhea, Bleeding Gastroesophageal Varices

Page 54: Prior Authorization

53

OCTREOTIDE ORAL (MYCAPSSA)

Products Affected MYCAPSSA

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, lab results and previous treatments

Age Restrictions

Prescriber

Restrictions

Prescribed by or in consultation with an endocrinologist

Coverage

Duration

Initial:3 months. Continuation: approved annually based on clinical

response.

Other Criteria Initial: responded to and is currently stable on an injectable sandostatin

analog therapy. Continuation: 1) reduction, normalization or maintenance

of IGF-1 levels based on age and gender 2) improvement or sustained

remission of clinical symptoms of acromegaly

Indications All FDA-approved Indications.

Off Label Uses

Page 55: Prior Authorization

54

OXANDROLONE

Products Affected oxandrolone oral tablet 10 mg, 2.5 mg

PA Criteria Criteria Details

Exclusion

Criteria

Muscle strength or muscle size to enhance performance.

Required

Medical

Information

Documentaion of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

1 year

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 56: Prior Authorization

55

PARATHYROID HORMONE

Products Affected FORTEO SUBCUTANEOUS PEN

INJECTOR 20 MCG/DOSE

(620MCG/2.48ML)

teriparatide

TYMLOS

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of a diagnosis, previous treatments, history of bone

fracture, and bone density status.

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

2 years

Other Criteria Coverage criteria: member had a documented, unsatisfactory response or

intolerance to oral bisphosphonate therapy OR has multiple risk factors or

history of osteoporotic fracture(s).

Indications All FDA-approved Indications.

Off Label Uses

Page 57: Prior Authorization

56

PEGFILGRASTIM

Products Affected FULPHILA

NYVEPRIA

UDENYCA

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, previous medications, lab values

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

BMT and PBPC related: 1 dose only. All other indications: 4 months and

may be renewed

Other Criteria Renewal based on clinical response and absence of unacceptable toxicity

Indications All Medically-accepted Indications.

Off Label Uses

Page 58: Prior Authorization

57

PENICILLAMINE

Products Affected d-penamine penicillamine oral tablet

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, laboratory data and documentation of

previous treatments

Age Restrictions

Prescriber

Restrictions

Physician who specializes in the treatment of inherited metabolic

disorders, Hepatologist, Nephrologist or Rheumatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Wilson Disease and Cystinuria: 1) documentation of diagnosis 2)

documentation of baseline urinalysis, complete blood count, platelet

count, and hemoglobin within the past 6 months. Rheumatoid Arthritis: 1)

documentation of diagnosis 2) documentation of baseline urinalysis,

complete blood count, platelet count, and hemoglobin within the past 6

months 3) previous 3 month trial of methotrexate, leflunomide,

hydroxychloroquine, minocycline, or sulfasalazine with an inadequate

response or valid contraindication.

Indications All FDA-approved Indications.

Off Label Uses

Page 59: Prior Authorization

58

PHOSPHATE BINDERS

Products Affected AURYXIA

PA Criteria Criteria Details

Exclusion

Criteria

Auryxia when used as iron replacement therapy to treat iron deficiency

anemia

Required

Medical

Information

Documentation of diagnosis, past medication history

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

12 months

Other Criteria Criteria for approval: 1) patient has a diagnosis of hyperphosphatemia in

chronic kidney disease on dialysis 2) documented failure, contraindication

or intolerance to two preferred agents: calcium acetate, lanthanum

carbonate, sevelamer carbonate, sevelamer hydrochloride.

Indications All FDA-approved Indications.

Off Label Uses

Page 60: Prior Authorization

59

POSACONAZOLE

Products Affected NOXAFIL ORAL SUSPENSION posaconazole oral tablet,delayed release

(dr/ec)

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 61: Prior Authorization

60

PROLIA

Products Affected PROLIA

PA Criteria Criteria Details

Exclusion

Criteria

Pregnancy, hypocalcemia

Required

Medical

Information

Documentation of a diagnosis, bone density status, history of bone

fracture and previous treatments.

Age Restrictions 18 years of age or older

Prescriber

Restrictions

Coverage

Duration

1 year. May be renewed based on clinical response and absence of toxicity

Other Criteria Osteoporosis and Glucocorticoid-induced Osteoporosis: documented

minimum twelve month trial on previous bisphosphonates (oral or IV) OR

documented contraindication or intolerance to BOTH oral

bisphosphonates AND IV bisphosphonates.

Indications All FDA-approved Indications.

Off Label Uses

Page 62: Prior Authorization

61

PULMONARY ARTERIAL HYPERTENSION

Products Affected ADEMPAS

epoprostenol (glycine)

OPSUMIT

ORENITRAM

UPTRAVI ORAL TABLET 1,000 MCG,

1,200 MCG, 1,400 MCG, 1,600 MCG,

200 MCG, 400 MCG, 600 MCG, 800

MCG

UPTRAVI ORAL TABLETS,DOSE

PACK

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Pulmonary arterial hypertension: must be in WHO Group 1. Chronic

thromboembolic pulmonary hypertension: must be in WHO Group 4.

Indications All FDA-approved Indications.

Off Label Uses

Page 63: Prior Authorization

62

PULMONARY FIBROSIS AGENTS

Products Affected ESBRIET ORAL CAPSULE

ESBRIET ORAL TABLET 267 MG, 801

MG

OFEV

PA Criteria Criteria Details

Exclusion

Criteria

Treatment of interstitial lung disease caused by domestic and occupational

environmental exposures or drug toxicity

Required

Medical

Information

Documentation of diagnosis.

Age Restrictions N/A

Prescriber

Restrictions

Prescribed by or in consultation with a Pulmonologist.

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 64: Prior Authorization

63

PYRIMETHAMINE

Products Affected pyrimethamine

PA Criteria Criteria Details

Exclusion

Criteria

Megaloblactic anemia due to folate deficiency.

Required

Medical

Information

Documentation of diagnosis and any concomitant therapy.

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

1 year

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 65: Prior Authorization

64

QUININE SULFATE

Products Affected quinine sulfate

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 66: Prior Authorization

65

RAVICTI

Products Affected RAVICTI

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions Patient is 2 months of age or older

Prescriber

Restrictions

Coverage

Duration

Initial approval 1 year. Continuation requests approved indefinite as long

as member is eligible.

Other Criteria Coverage criteria: Member has had a trial, inadequate response, or valid

contraindication to sodium phenylbutyrate therapy. Continuation criteria:

Member has had a documented positive clinical response to treatment.

Indications All FDA-approved Indications.

Off Label Uses

Page 67: Prior Authorization

66

REGRANEX

Products Affected REGRANEX

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, adequate blood supply to ulcer

Age Restrictions 16 years of age or older

Prescriber

Restrictions

Coverage

Duration

Initial approval 3 months. Continuation requests will be approved for 3

months.

Other Criteria Regranex gel is covered when the following conditions are met: 1)

Member has chronic lower extremity diabetic neuropathic ulcers

extending into the subcutaneous tissue (NPUAP stage III or IV) or

beyond, AND 2) Ulcer has adequate tissue blood supply (determined by a

transcutaneous oxygen pressure of TcpO2 greater than 30mm Hg or

verified with Doppler flow). Continuation criteria: Ulcer decreased in size

by 30%.

Indications All FDA-approved Indications.

Off Label Uses

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REVLIMID

Products Affected REVLIMID ORAL CAPSULE 10 MG, 15

MG, 2.5 MG, 20 MG, 25 MG, 5 MG

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Oncologist or hematologist

Coverage

Duration

Indefinite as long as the member is eligible

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

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REZUROCK

Products Affected REZUROCK

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 70: Prior Authorization

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RINVOQ

Products Affected RINVOQ

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Rheumatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Member has had a trial, inadequate response, or valid contraindication to

treatment with one conventional DMARD.

Indications All FDA-approved Indications.

Off Label Uses

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SAPROPTERIN

Products Affected sapropterin

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and lab values

Age Restrictions

Prescriber

Restrictions

Provider with knowledge and expertise in metabolic diseases or genetic

diseases

Coverage

Duration

Initial: 2 months. Continuation approved annually based on clinical

response

Other Criteria Initial criteria: Documentation of baseline blood Phe level measured

within 2 weeks of initiation of treatment. Continuation criteria: Patient

continues to be under the appropriate care and re-evaluations of a

specialist knowledgeable in the management of PKU AND member has

had a documented positive clinical response to treatment. Dosing is within

the range of 5 to 20 mg/kg/day.

Indications All FDA-approved Indications.

Off Label Uses

Page 72: Prior Authorization

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SILDENAFIL (PAH)

Products Affected sildenafil (pulm.hypertension) oral

suspension for reconstitution

sildenafil (pulm.hypertension) oral tablet

PA Criteria Criteria Details

Exclusion

Criteria

Erectile dysfunction

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Payment determination required

Indications All FDA-approved Indications.

Off Label Uses

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SKYRIZI

Products Affected SKYRIZI

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Dermatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Member has had a trial, inadequate response or valid contraindication to

one conventional treatment including topical therapies (e.g., steroids,

vitamin D analogs), systemic therapies (e.g., acitretin, cyclosporine,

methotrexate) or has had a trial of or is not a candidate for phototherapy

Indications All FDA-approved Indications.

Off Label Uses

Page 74: Prior Authorization

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STELARA

Products Affected STELARA SUBCUTANEOUS

SYRINGE

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments.

Age Restrictions

Prescriber

Restrictions

Dermatologist, Gastroenterologist or Rheumatologist.

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria Crohn's Disease: Member has had a trial, inadequate response or valid

contraindication to one conventional treatment including

immunosuppressants (e.g., methotrexate, azathioprine, 6-mercaptopurine),

corticosteroids (e.g., prednisone, hydrocortisone, budesonide) or

aminosalicylates (e.g., sulfasalazine). Plaque Psoriasis: Member has had a

trial, inadequate response or valid contraindication with one conventional

treatment including topical therapies (e.g., steroids, vitamin D analogs),

systemic therapies (e.g., acitretin, cyclosporine, methotrexate) or has had a

trial of or is not a candidate for phototherapy. Psoriatic Arthritis,

peripheral disease: Member has had a trial, inadequate response or valid

contraindication to treatment with one DMARD (e.g. sulfasalazine,

hydroxychloroquine, methotrexate, azathioprine, leflunomide). Psoriatic

Arthritis, axial disease: Member has had a trial, inadequate response or

valid contraindication to treatment with at least two NSAIDs. Ulcerative

Colitis: Member has had a trial, inadequate response or valid

contraindication to conventional treatments including

immunosuppressants (e.g. azathioprine, 6-mercaptopurine),

corticosteroids (e.g., prednisone, hydrocortisone, budesonide) or

aminosalicylates (e.g., sulfasalazine, mesalamine).

Indications All FDA-approved Indications.

Off Label Uses

Page 75: Prior Authorization

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TADALAFIL (BPH)

Products Affected tadalafil oral tablet 2.5 mg, 5 mg

PA Criteria Criteria Details

Exclusion

Criteria

Erectile dysfunction unrelated to BPH

Required

Medical

Information

Medical information to support the diagnosis of benign prostatic

hyperplasia (BPH)

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Payment determination required

Indications All FDA-approved Indications.

Off Label Uses

Page 76: Prior Authorization

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TADALAFIL (PAH)

Products Affected alyq tadalafil (pulm. hypertension)

PA Criteria Criteria Details

Exclusion

Criteria

Erectile dysfunction

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Payment determination required

Indications All FDA-approved Indications.

Off Label Uses

Page 77: Prior Authorization

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TAFAMIDIS (VYNDAQEL, VYNDAMAX)

Products Affected VYNDAMAX VYNDAQEL

PA Criteria Criteria Details

Exclusion

Criteria

New York Heart Association (NYHA) Class IV heart failure

Required

Medical

Information

Documentation of diagnosis

Age Restrictions 18 years or older

Prescriber

Restrictions

Prescribed by or in consultation with a cardiologist, transthyretin

amyloidosis (ATTR) specialist, or medical geneticist

Coverage

Duration

Initial and continuation: 12 months

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 78: Prior Authorization

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TELOTRISTAT (XERMELO)

Products Affected XERMELO

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis.

Age Restrictions

Prescriber

Restrictions

Prescribed by or given in consultation with an oncologist, endocrinologist

or gastroenterologist

Coverage

Duration

Indefinite

Other Criteria Symptomatic (greater than 4 bowel movements per day) despite treatment

with a somatostatin analog such as octreotide, lanreotide, pasireotide) for

at least 3 months. Medication will be used in combination with a

somatostatin analog.

Indications All Medically-accepted Indications.

Off Label Uses

Page 79: Prior Authorization

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TESTOSTERONE REPLACEMENT

Products Affected testosterone cypionate intramuscular oil

200 mg/ml, 200 mg/ml (1 ml)

testosterone enanthate

testosterone transdermal gel in metered-

dose pump 12.5 mg/ 1.25 gram (1 %),

20.25 mg/1.25 gram (1.62 %)

testosterone transdermal gel in packet 1 %

(25 mg/2.5gram), 1 % (50 mg/5 gram),

1.62 % (20.25 mg/1.25 gram), 1.62 %

(40.5 mg/2.5 gram)

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of primary or secondary hypogonadism (congenital or acquired)

or delayed puberty and documentation of serum testosterone level for

males. Diagnosis of metastatic (skeletal) mammary cancer for women.

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 80: Prior Authorization

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TOLVAPTAN

Products Affected tolvaptan oral tablet 15 mg, 30 mg

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

30 days

Other Criteria Therapy must be initiated in hospital setting

Indications All FDA-approved Indications.

Off Label Uses

Page 81: Prior Authorization

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TRANSMUCOSAL IMMEDIATE-RELEASE

FENTANYL (TIRF)

Products Affected fentanyl citrate buccal lozenge on a

handle

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite as long as member is eligible.

Other Criteria N/A

Indications All FDA-approved Indications.

Off Label Uses

Page 82: Prior Authorization

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TREMFYA

Products Affected TREMFYA

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Dermatologist or Rheumatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Plaque Psoriasis: documented failure, contraindication or intolerance to

one conventional treatment including topical therapies (e.g. steroids,

vitamin D analogs), systemic therapies (e.g. acitretin, cyclosporine,

methotrexate)or has had a trial of or is not a candidate for phototherapy

Indications All FDA-approved Indications.

Off Label Uses

Page 83: Prior Authorization

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TRIENTINE

Products Affected clovique trientine

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis by plasma copper-protein ceruloplasmin,

liver biopsy or genetic testing

Age Restrictions

Prescriber

Restrictions

Must be prescribed by or in consultation with a physician who specializes

in the treatment of inherited metabolic disorders or by a hepatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria

Indications All FDA-approved Indications.

Off Label Uses

Page 84: Prior Authorization

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VIGABATRIN

Products Affected vigabatrin

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments.

Age Restrictions

Prescriber

Restrictions

Prescribed by or in consultation with a neurologist

Coverage

Duration

For infantile spasms, 3 months. For seizures, indefinite as long as the

member is eligible.

Other Criteria For diagnosis of refractory complex partial seizures, documentation of

inadequate response to least two generic anticonvulsants

Indications All FDA-approved Indications.

Off Label Uses

Page 85: Prior Authorization

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VMAT 2 INHIBITORS

Products Affected AUSTEDO tetrabenazine oral tablet 12.5 mg, 25 mg

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Neurologist or behavioral health specialist

Coverage

Duration

1 year

Other Criteria Initial criteria: 1) diagnosis of chorea associated with Huntington's disease

2) diagnosis of Tardive Dyskinesia and patient has persistent symptoms

despite a trial of dose reduction, tapering, or discontinuation of the

offending medication or is not a candidate for a trial of dose reduction,

tapering, or discontinuation of the offending medication. Continuation

criteria: documented evidence of clinical beneficial response

Indications All FDA-approved Indications.

Off Label Uses

Page 86: Prior Authorization

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VORICONAZOLE

Products Affected voriconazole intravenous

voriconazole oral suspension for

reconstitution

voriconazole oral tablet

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and other first-line medications tried (as

appropriate) unless contraindicated.

Age Restrictions N/A

Prescriber

Restrictions

Infectious Disease Specialist, Oncologist or Pulmonologist.

Coverage

Duration

Esophageal candidiasis: 1 month. All other indications: 6 months.

Other Criteria Criteria: 1) treatment of Invasive Aspergillus OR 2) treatment of

infections caused by Scedosporium apiospermum or Fusarium spp

intolerant of, or refractory to other therapy OR 3) treatment of Systemic

Candida OR 4) prophylaxis in members at high risk of developing

Aspergillus or Candida due to being severely immunocompromised, such

as allogenic hematopoietic stem cell transplant recipient, hematologic

malignancy with prolonged neutropenia from chemotherapy, or a high risk

solid organ transplant OR 5) treatment of Blastomycosis for members who

have tried, had inadequate response, or a valid contraindication to

itraconazole or fluconazole OR 6) treatment of esophageal candidiasis for

members who have tried, had an inadequate response, or valid

contraindication to fluconazole, nystatin, or clotrimazole troche

Indications All FDA-approved Indications.

Off Label Uses

Page 87: Prior Authorization

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WAKEFULNESS PROMOTING AGENTS

Products Affected armodafinil oral tablet 150 mg, 200 mg,

250 mg, 50 mg

modafinil oral tablet 100 mg, 200 mg

PA Criteria Criteria Details

Exclusion

Criteria

N/A

Required

Medical

Information

Documentation of diagnosis and previous drug treatments

Age Restrictions N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Indefinite for narcolepsy and obstructive sleep apnea. Shift work sleep

disorder, 1 year.

Other Criteria Initial Criteria: 1) previous trial, inadequate response, or valid

contraindication to amphetamine salts, dextroamphetamine, or

methylphenidate AND 2) diagnosis of narcolepsy confirmed by sleep lab

evaluation OR 3) diagnosis of obstructive sleep apnea (OSA) confirmed

by polysomnography OR 4) diagnosis of shift work disorder (SWD) and a

letter from patient's employer is required stating that the patient is

working variable, alternating or 3rd shift. For continuation requests for

shift work disorder, requests are reviewed annually to review the

member's work schedule.

Indications All FDA-approved Indications.

Off Label Uses

Page 88: Prior Authorization

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XELJANZ / XELJANZ XR

Products Affected XELJANZ ORAL SOLUTION

XELJANZ ORAL TABLET

XELJANZ XR

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis and previous treatments

Age Restrictions

Prescriber

Restrictions

Gastroenterologist or Rheumatologist

Coverage

Duration

Indefinite as long as member is eligible

Other Criteria Coverage criteria: Psoriatic Arthritis, axial disease: documented failure,

contraindication or intolerance to at least two conventional treatments

including NSAIDs and COX-2 inhibitors. Psoriatic Arthritis, peripheral

disease: documented failure, contraindication or intolerance to one

DMARD. Rheumatoid Arthritis: documented failure, contraindication or

intolerance to one DMARD. Ulcerative Colitis documented failure,

contraindication or intolerance to one conventional treatment including

immunosuppressants, corticosteroids or aminosalicylates AND Humira.

Indications All FDA-approved Indications.

Off Label Uses

Page 89: Prior Authorization

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XGEVA

Products Affected XGEVA

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, lab values and previous drug treatments

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

1 year and may be renewed

Other Criteria Continuation: positive clinical response and absence of unacceptable

toxicity from the drug

Indications All Medically-accepted Indications.

Off Label Uses

Page 90: Prior Authorization

89

XIFAXAN

Products Affected XIFAXAN ORAL TABLET 200 MG, 550

MG

PA Criteria Criteria Details

Exclusion

Criteria

Required

Medical

Information

Documentation of diagnosis, lab values and previous treatments.

Age Restrictions

Prescriber

Restrictions

Coverage

Duration

Hepatic encephalitis: 6 mo. IBS-D: 14 days. Traveler's diarrhea: 3 days.

Other Criteria Hepatic encephalopathy, initial: previous trial, inadequate response, or

valid contraindication to lactulose. Continuation: patient has experienced a

clinical benefit from therapy for hepatic encephalopathy (decrease in

fasting serum ammonia levels from baseline and improvements in mental

status). IBS-D: previous one month trial, inadequate response, or valid

contraindication to increased dietary fiber, loperamide, or diphenoxylate

atropine. Continuation: patient has experienced recurrence of IBS-D after

a 14 day course of therapy and the patient had a treatment-free period

between courses of therapy. Traveler's diarrhea: previous trial, inadequate

response, or valid contraindication to azithromycin, ciprofloxacin,

levofloxacin or ofloxacin.

Indications All FDA-approved Indications.

Off Label Uses

Page 91: Prior Authorization

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XOLAIR

Products Affected XOLAIR SUBCUTANEOUS RECON

SOLN

XOLAIR SUBCUTANEOUS SYRINGE

150 MG/ML, 75 MG/0.5 ML

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 92: Prior Authorization

91

XYREM

Products Affected XYREM

PA Criteria Criteria Details

Exclusion

Criteria

PA Criteria: Pending CMS Approval

Required

Medical

Information

PA Criteria: Pending CMS Approval

Age Restrictions PA Criteria: Pending CMS Approval

Prescriber

Restrictions

PA Criteria: Pending CMS Approval

Coverage

Duration

PA Criteria: Pending CMS Approval

Other Criteria PA Criteria: Pending CMS Approval

Indications PA Criteria: Pending CMS Approval

Off Label Uses PA Criteria: Pending CMS Approval

Page 93: Prior Authorization

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INDEX

A abiraterone oral tablet 250 mg ............ 5, 6, 7

ACTEMRA ACTPEN ........................ 38, 39

ACTEMRA SUBCUTANEOUS ........ 38, 39

adapalene topical cream ............................ 16

adapalene topical gel ................................. 16

ADEMPAS ............................................... 61

AFINITOR DISPERZ ......................... 5, 6, 7

AFINITOR ORAL TABLET 10 MG . 5, 6, 7

AIMOVIG AUTOINJECTOR

SUBCUTANEOUS AUTO-INJECTOR

140 MG/ML, 70 MG/ML ....................... 4

AJOVY AUTOINJECTOR ........................ 4

AJOVY SYRINGE ..................................... 4

ALECENSA ........................................ 5, 6, 7

ALUNBRIG ORAL TABLET 180 MG, 30

MG, 90 MG ..................................... 5, 6, 7

ALUNBRIG ORAL TABLETS,DOSE

PACK .............................................. 5, 6, 7

alyq ............................................................ 75

ARANESP (IN POLYSORBATE)

INJECTION SYRINGE .......................... 8

armodafinil oral tablet 150 mg, 200 mg, 250

mg, 50 mg ............................................. 86

AUBAGIO ................................................ 48

AURYXIA ................................................ 58

AUSTEDO ................................................ 84

avita ........................................................... 16

AVONEX INTRAMUSCULAR PEN

INJECTOR KIT .................................... 48

AVONEX INTRAMUSCULAR SYRINGE

KIT ........................................................ 48

AYVAKIT .......................................... 5, 6, 7

B BALVERSA ORAL TABLET 3 MG, 4

MG, 5 MG ....................................... 5, 6, 7

BERINERT INTRAVENOUS KIT .......... 31

BETASERON SUBCUTANEOUS KIT .. 48

bexarotene ........................................... 5, 6, 7

BOSULIF ORAL TABLET 100 MG, 400

MG, 500 MG ................................... 5, 6, 7

BRAFTOVI......................................... 5, 6, 7

BRONCHITOL ......................................... 14

BRUKINSA ........................................ 5, 6, 7

C CABOMETYX ORAL TABLET 20 MG, 40

MG, 60 MG ..................................... 5, 6, 7

CALQUENCE .................................... 5, 6, 7

CAPRELSA ORAL TABLET 100 MG, 300

MG .................................................. 5, 6, 7

CARBAGLU............................................. 10

CAYSTON ................................................ 11

CIMZIA .............................................. 38, 39

CIMZIA POWDER FOR RECONST 38, 39

CINRYZE ................................................. 32

clovique ..................................................... 82

COMETRIQ ORAL CAPSULE 100

MG/DAY(80 MG X1-20 MG X1), 140

MG/DAY(80 MG X1-20 MG X3), 60

MG/DAY (20 MG X 3/DAY)......... 5, 6, 7

COPAXONE SUBCUTANEOUS

SYRINGE 20 MG/ML, 40 MG/ML ..... 48

COPIKTRA......................................... 5, 6, 7

COSENTYX (2 SYRINGES) ................... 12

COSENTYX PEN (2 PENS) .................... 12

COSENTYX SUBCUTANEOUS

SYRINGE 75 MG/0.5 ML .................... 12

COTELLIC ......................................... 5, 6, 7

D dalfampridine ............................................ 15

DAURISMO ORAL TABLET 100 MG, 25

MG .................................................. 5, 6, 7

DIACOMIT ORAL CAPSULE 250 MG,

500 MG ................................................. 17

DIACOMIT ORAL POWDER IN PACKET

250 MG, 500 MG .................................. 17

diclofenac epolamine ................................ 19

diclofenac sodium topical gel 3 % ............ 18

DIFICID ORAL SUSPENSION FOR

RECONSTITUTION ............................ 20

DIFICID ORAL TABLET ........................ 20

dimethyl fumarate oral capsule,delayed

release(dr/ec) 120 mg, 120 mg (14)- 240

mg (46), 240 mg .................................... 48

d-penamine ................................................ 57

droxidopa oral capsule 100 mg, 200 mg, 300

mg ......................................................... 21

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DUPIXENT PEN SUBCUTANEOUS PEN

INJECTOR 200 MG/1.14 ML, 300 MG/2

ML......................................................... 22

DUPIXENT SYRINGE SUBCUTANEOUS

SYRINGE 200 MG/1.14 ML, 300 MG/2

ML......................................................... 22

E EMGALITY PEN ....................................... 4

EMGALITY SYRINGE

SUBCUTANEOUS SYRINGE 120

MG/ML, 300 MG/3 ML (100 MG/ML X

3) ............................................................. 4

ENBREL MINI ......................................... 23

ENBREL SUBCUTANEOUS RECON

SOLN .................................................... 23

ENBREL SUBCUTANEOUS SOLUTION

............................................................... 23

ENBREL SUBCUTANEOUS SYRINGE 25

MG/0.5 ML (0.5), 50 MG/ML (1 ML) . 23

ENBREL SURECLICK ............................ 23

EPCLUSA ................................................... 3

EPIDIOLEX ................................................ 9

epoprostenol (glycine) .............................. 61

ERIVEDGE......................................... 5, 6, 7

ERLEADA .......................................... 5, 6, 7

erlotinib oral tablet 100 mg, 150 mg, 25 mg

......................................................... 5, 6, 7

ESBRIET ORAL CAPSULE .................... 62

ESBRIET ORAL TABLET 267 MG, 801

MG ........................................................ 62

everolimus (antineoplastic) ................. 5, 6, 7

F FARYDAK ......................................... 5, 6, 7

FASENRA ................................................ 26

fentanyl citrate buccal lozenge on a handle

............................................................... 80

FINTEPLA ................................................ 27

FORTEO SUBCUTANEOUS PEN

INJECTOR 20 MCG/DOSE

(620MCG/2.48ML) ............................... 55

FOTIVDA ........................................... 5, 6, 7

FULPHILA ............................................... 56

G GATTEX 30-VIAL ................................... 28

GAVRETO ......................................... 5, 6, 7

GILENYA ................................................. 48

GILOTRIF .......................................... 5, 6, 7

glatiramer subcutaneous syringe 20 mg/ml,

40 mg/ml ............................................... 48

glatopa subcutaneous syringe 20 mg/ml, 40

mg/ml .................................................... 48

GRANIX SUBCUTANEOUS SYRINGE 29

H HAEGARDA ............................................ 32

HARVONI ORAL PELLETS IN PACKET

33.75-150 MG, 45-200 MG .................... 3

HARVONI ORAL TABLET 45-200 MG,

90-400 MG .............................................. 3

HEMADY ........................................... 5, 6, 7

HETLIOZ .................................................. 33

HUMIRA PEN .................................... 34, 35

HUMIRA PEN CROHNS-UC-HS START

......................................................... 34, 35

HUMIRA PEN PSOR-UVEITS-ADOL HS

......................................................... 34, 35

HUMIRA SUBCUTANEOUS SYRINGE

KIT 40 MG/0.8 ML ........................ 34, 35

HUMIRA(CF) PEDI CROHNS STARTER

SUBCUTANEOUS SYRINGE KIT 80

MG/0.8 ML, 80 MG/0.8 ML-40 MG/0.4

ML................................................... 34, 35

HUMIRA(CF) PEN CROHNS-UC-HS ... 34,

35

HUMIRA(CF) PEN PEDIATRIC UC 34, 35

HUMIRA(CF) PEN PSOR-UV-ADOL HS

......................................................... 34, 35

HUMIRA(CF) PEN SUBCUTANEOUS

PEN INJECTOR KIT 40 MG/0.4 ML, 80

MG/0.8 ML ..................................... 34, 35

HUMIRA(CF) SUBCUTANEOUS

SYRINGE KIT 10 MG/0.1 ML, 20

MG/0.2 ML, 40 MG/0.4 ML .......... 34, 35

I IBRANCE ........................................... 5, 6, 7

icatibant ..................................................... 31

ICLUSIG ORAL TABLET 10 MG, 15 MG,

30 MG, 45 MG ................................ 5, 6, 7

IDHIFA ............................................... 5, 6, 7

ILARIS (PF).............................................. 36

ILUMYA............................................. 38, 39

imatinib oral tablet 100 mg, 400 mg ... 5, 6, 7

IMBRUVICA ...................................... 5, 6, 7

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INBRIJA INHALATION CAPSULE,

W/INHALATION DEVICE ................. 40

INCRELEX ............................................... 41

INLYTA ORAL TABLET 1 MG, 5 MG5, 6,

7

INQOVI .............................................. 5, 6, 7

INREBIC............................................. 5, 6, 7

INTRON A INJECTION .................... 5, 6, 7

IRESSA ............................................... 5, 6, 7

itraconazole oral capsule ............................. 2

itraconazole oral solution ............................ 2

J JAKAFI ............................................... 5, 6, 7

K KALYDECO ORAL GRANULES IN

PACKET ............................................... 13

KALYDECO ORAL TABLET ................ 13

KESIMPTA PEN ...................................... 48

KINERET ................................................. 43

KISQALI FEMARA CO-PACK ORAL

TABLET 200 MG/DAY(200 MG X 1)-

2.5 MG, 400 MG/DAY(200 MG X 2)-2.5

MG, 600 MG/DAY(200 MG X 3)-2.5

MG .................................................. 5, 6, 7

KISQALI ORAL TABLET 200 MG/DAY

(200 MG X 1), 400 MG/DAY (200 MG X

2), 600 MG/DAY (200 MG X 3) .... 5, 6, 7

KOSELUGO ....................................... 5, 6, 7

L lapatinib............................................... 5, 6, 7

LENVIMA ORAL CAPSULE 10 MG/DAY

(10 MG X 1), 12 MG/DAY (4 MG X 3),

14 MG/DAY(10 MG X 1-4 MG X 1), 18

MG/DAY (10 MG X 1-4 MG X2), 20

MG/DAY (10 MG X 2), 24 MG/DAY(10

MG X 2-4 MG X 1), 4 MG, 8 MG/DAY

(4 MG X 2)...................................... 5, 6, 7

lidocaine topical adhesive patch,medicated 5

% ........................................................... 45

LONSURF ORAL TABLET 15-6.14 MG,

20-8.19 MG ..................................... 5, 6, 7

LORBRENA ORAL TABLET 100 MG, 25

MG .................................................. 5, 6, 7

LUMAKRAS ...................................... 5, 6, 7

LYNPARZA ....................................... 5, 6, 7

M MAVENCLAD (10 TABLET PACK) ..... 48

MAVENCLAD (4 TABLET PACK) ....... 48

MAVENCLAD (5 TABLET PACK) ....... 48

MAVENCLAD (6 TABLET PACK) ....... 48

MAVENCLAD (7 TABLET PACK) ....... 48

MAVENCLAD (8 TABLET PACK) ....... 48

MAVENCLAD (9 TABLET PACK) ....... 48

MAYZENT ORAL TABLET 0.25 MG, 2

MG ........................................................ 48

MAYZENT STARTER PACK................. 48

MEKINIST ORAL TABLET 0.5 MG, 2

MG .................................................. 5, 6, 7

MEKTOVI .......................................... 5, 6, 7

metyrosine ................................................. 46

modafinil oral tablet 100 mg, 200 mg ....... 86

MOZOBIL ................................................ 47

MYCAPSSA ............................................. 53

N NERLYNX ......................................... 5, 6, 7

NEXAVAR ......................................... 5, 6, 7

NINLARO........................................... 5, 6, 7

NORDITROPIN FLEXPRO ..................... 30

NOXAFIL ORAL SUSPENSION ............ 59

NUBEQA ............................................ 5, 6, 7

NUCALA SUBCUTANEOUS AUTO-

INJECTOR ............................................ 49

NUCALA SUBCUTANEOUS SYRINGE

............................................................... 49

NUEDEXTA ............................................. 50

NUPLAZID ORAL CAPSULE ................ 51

NUPLAZID ORAL TABLET 10 MG ...... 51

NURTEC ODT ........................................... 1

NYVEPRIA .............................................. 56

O octreotide acetate ...................................... 52

ODOMZO ........................................... 5, 6, 7

OFEV ........................................................ 62

ONUREG ............................................ 5, 6, 7

OPSUMIT ................................................. 61

ORENCIA CLICKJECT ..................... 38, 39

ORENCIA SUBCUTANEOUS SYRINGE

125 MG/ML, 50 MG/0.4 ML, 87.5

MG/0.7 ML ..................................... 38, 39

ORENITRAM ........................................... 61

ORGOVYX......................................... 5, 6, 7

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ORKAMBI ORAL GRANULES IN

PACKET ............................................... 13

ORKAMBI ORAL TABLET ................... 13

ORLADEYO ............................................. 32

OTEZLA ............................................. 38, 39

OTEZLA STARTER ORAL

TABLETS,DOSE PACK 10 MG (4)-20

MG (4)-30 MG (47), 10 MG (4)-20 MG

(4)-30 MG(19) ................................ 38, 39

oxandrolone oral tablet 10 mg, 2.5 mg ..... 54

P PEGINTRON SUBCUTANEOUS KIT 50

MCG/0.5 ML ...................................... 6, 7

PEMAZYRE ........................................... 6, 7

penicillamine oral tablet ............................ 57

PIQRAY ORAL TABLET 200 MG/DAY

(200 MG X 1), 250 MG/DAY (200 MG

X1-50 MG X1), 300 MG/DAY (150 MG

X 2) ..................................................... 6, 7

PLEGRIDY SUBCUTANEOUS PEN

INJECTOR 125 MCG/0.5 ML, 63

MCG/0.5 ML- 94 MCG/0.5 ML ........... 48

PLEGRIDY SUBCUTANEOUS SYRINGE

125 MCG/0.5 ML, 63 MCG/0.5 ML- 94

MCG/0.5 ML ........................................ 48

POMALYST ........................................... 6, 7

posaconazole oral tablet,delayed release

(dr/ec) .................................................... 59

PREVYMIS ORAL .................................. 44

PROLIA .................................................... 60

PROMACTA ORAL POWDER IN

PACKET 12.5 MG, 25 MG .................. 37

PROMACTA ORAL TABLET 12.5 MG, 25

MG, 50 MG, 75 MG ............................. 37

PULMOZYME ......................................... 14

pyrimethamine .......................................... 63

Q QINLOCK............................................... 6, 7

quinine sulfate ........................................... 64

R RAVICTI .................................................. 65

REGRANEX ............................................. 66

RETACRIT ......................................... 24, 25

RETEVMO ORAL CAPSULE 40 MG, 80

MG ...................................................... 6, 7

REVLIMID ORAL CAPSULE 10 MG, 15

MG, 2.5 MG, 20 MG, 25 MG, 5 MG ... 67

REYVOW ORAL TABLET 100 MG, 50

MG .......................................................... 1

REZUROCK ............................................. 68

RINVOQ ................................................... 69

ROZLYTREK ORAL CAPSULE 100 MG,

200 MG ............................................... 6, 7

RUBRACA ............................................. 6, 7

RUCONEST ............................................. 31

RYDAPT................................................. 6, 7

S sapropterin................................................. 70

sildenafil (pulm.hypertension) oral

suspension for reconstitution ................ 71

sildenafil (pulm.hypertension) oral tablet . 71

SILIQ .................................................. 38, 39

SIMPONI SUBCUTANEOUS PEN

INJECTOR ...................................... 38, 39

SIMPONI SUBCUTANEOUS SYRINGE

100 MG/ML, 50 MG/0.5 ML ......... 38, 39

SKYRIZI ................................................... 72

SPRYCEL ORAL TABLET 100 MG, 140

MG, 20 MG, 50 MG, 70 MG, 80 MG 6, 7

STELARA SUBCUTANEOUS SYRINGE

............................................................... 73

STIVARGA ............................................ 6, 7

sunitinib oral capsule 12.5 mg, 25 mg, 37.5

mg, 50 mg ........................................... 6, 7

SYMDEKO ............................................... 13

SYNRIBO ............................................... 6, 7

T TABRECTA ........................................... 6, 7

tadalafil (pulm. hypertension) ................... 75

tadalafil oral tablet 2.5 mg, 5 mg .............. 74

TAFINLAR ORAL CAPSULE 50 MG, 75

MG ...................................................... 6, 7

TAGRISSO ............................................. 6, 7

TAKHZYRO ............................................. 32

TALTZ AUTOINJECTOR ................. 38, 39

TALTZ SYRINGE.............................. 38, 39

TALTZ SYRINGE (2 PACK) ............ 38, 39

TALTZ SYRINGE (3 PACK) ............ 38, 39

TALZENNA ORAL CAPSULE 0.25 MG, 1

MG ...................................................... 6, 7

TARGRETIN TOPICAL ........................ 6, 7

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TASIGNA ............................................... 6, 7

TAVALISSE ............................................. 37

tazarotene topical cream ........................... 16

TAZORAC TOPICAL CREAM 0.05 % .. 16

TAZORAC TOPICAL GEL ..................... 16

TAZVERIK............................................. 6, 7

TEPMETKO ........................................... 6, 7

teriparatide ................................................ 55

testosterone cypionate intramuscular oil 200

mg/ml, 200 mg/ml (1 ml) ...................... 78

testosterone enanthate ............................... 78

testosterone transdermal gel in metered-dose

pump 12.5 mg/ 1.25 gram (1 %), 20.25

mg/1.25 gram (1.62 %) ......................... 78

testosterone transdermal gel in packet 1 %

(25 mg/2.5gram), 1 % (50 mg/5 gram),

1.62 % (20.25 mg/1.25 gram), 1.62 %

(40.5 mg/2.5 gram) ............................... 78

tetrabenazine oral tablet 12.5 mg, 25 mg .. 84

THALOMID ORAL CAPSULE 100 MG,

150 MG, 200 MG, 50 MG .................. 6, 7

TIBSOVO ............................................... 6, 7

TOBI PODHALER INHALATION

CAPSULE, W/INHALATION DEVICE

............................................................... 42

tobramycin in 0.225 % nacl ...................... 42

tolvaptan oral tablet 15 mg, 30 mg ........... 79

toremifene ............................................... 6, 7

TREMFYA ............................................... 81

tretinoin ..................................................... 16

tretinoin microspheres topical gel ............. 16

trientine ..................................................... 82

TRIKAFTA ............................................... 13

TRUSELTIQ ........................................... 6, 7

TUKYSA ................................................ 6, 7

TURALIO ............................................... 6, 7

TYMLOS .................................................. 55

U UBRELVY .................................................. 1

UDENYCA ............................................... 56

UKONIQ ................................................. 6, 7

UPTRAVI ORAL TABLET 1,000 MCG,

1,200 MCG, 1,400 MCG, 1,600 MCG,

200 MCG, 400 MCG, 600 MCG, 800

MCG ..................................................... 61

UPTRAVI ORAL TABLETS,DOSE PACK

............................................................... 61

V VENCLEXTA ORAL TABLET 10 MG,

100 MG, 50 MG .................................. 6, 7

VENCLEXTA STARTING PACK ........ 6, 7

VERZENIO............................................. 6, 7

vigabatrin .................................................. 83

VITRAKVI ORAL CAPSULE 100 MG, 25

MG ...................................................... 6, 7

VITRAKVI ORAL SOLUTION ............ 6, 7

VIZIMPRO ............................................. 6, 7

voriconazole intravenous .......................... 85

voriconazole oral suspension for

reconstitution......................................... 85

voriconazole oral tablet ............................. 85

VOSEVI ...................................................... 3

VOTRIENT............................................. 6, 7

VUMERITY ............................................. 48

VYNDAMAX ........................................... 76

VYNDAQEL ............................................ 76

W WELIREG............................................... 6, 7

X XALKORI............................................... 6, 7

XELJANZ ORAL SOLUTION ................ 87

XELJANZ ORAL TABLET ..................... 87

XELJANZ XR .......................................... 87

XERMELO ............................................... 77

XGEVA..................................................... 88

XIFAXAN ORAL TABLET 200 MG, 550

MG ........................................................ 89

XOLAIR SUBCUTANEOUS RECON

SOLN .................................................... 90

XOLAIR SUBCUTANEOUS SYRINGE

150 MG/ML, 75 MG/0.5 ML ............... 90

XOSPATA .............................................. 6, 7

XPOVIO ORAL TABLET 100 MG/WEEK

(20 MG X 5), 100 MG/WEEK (50 MG X

2), 40 MG/WEEK (20 MG X 2), 40

MG/WEEK (40 MG X 1), 40MG TWICE

WEEK (40 MG X 2), 40MG TWICE

WEEK (80 MG/WEEK), 60 MG/WEEK

(20 MG X 3), 60 MG/WEEK (60 MG X

1), 60MG TWICE WEEK (120

MG/WEEK), 80 MG/WEEK (20 MG X

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4), 80 MG/WEEK (40 MG X 2), 80MG

TWICE WEEK (160 MG/WEEK) ...... 6, 7

XTANDI ORAL CAPSULE................... 6, 7

XTANDI ORAL TABLET 40 MG, 80 MG

............................................................. 6, 7

XYREM .................................................... 91

Z ZARXIO ................................................... 29

ZEJULA .................................................. 6, 7

ZELBORAF ............................................ 6, 7

ZOLINZA ............................................... 6, 7

ZYDELIG ............................................... 6, 7

ZYKADIA ORAL TABLET .................. 6, 7