prior authorization
Post on 11-Nov-2021
19 Views
Preview:
TRANSCRIPT
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
67
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
68
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
69
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
70
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
71
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
72
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
73
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
74
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
75
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
76
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
77
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
78
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
79
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
80
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
81
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
82
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
83
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
84
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
85
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
86
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
87
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
88
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
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
90
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
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
92
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
93
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
94
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
95
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
96
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
97
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
top related