prior authorization requirements - arizona advantage · 1 an independent licensee of the blue cross...
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1
An Independent Licensee
of the Blue Cross and
Blue Shield Association
Prior Authorization Requirements
Effective: 12/01/2018
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
ADASUVE
Products Affected • ADASUVE
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
ADMINISTRATION MUST BE AT AN ENROLLED HEALTHCARE
FACILITY IN COMPLIANCE WITH FDA APPROVED REMS
PROGRAM
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED.
Other Criteria
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ADEMPAS
Products Affected • ADEMPAS
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
AIMOVIG
Products Affected • AIMOVIG 70 MG/ML AUTOINJECTOR • AIMOVIG AUTOINJECTOR (2 PACK)
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES PREVIOUS TRIAL OF OR
CONTRAINDICATION TO TWO OF THE FOLLOWING
FORMULARY ALTERNATIVES FOR PREVENTIVE MIGRAINE
TREATMENT SUCH AS DIVALPROEX SODIUM, TOPIRAMATE,
PROPRANOLOL, OR TIMOLOL.
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ALECENSA
Products Affected • ALECENSA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
AMPYRA
Products Affected • AMPYRA • dalfampridine
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D. PLUS PATIENT ALREADY STARTED
ON DALFAMPRIDINE EXTENDED-RELEASE FOR MULTIPLE
SCLEROSIS (MS).
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
MS. IF PRESCRIBED BY, OR IN CONSULTATION WITH, A
NEUROLOGIST OR MS SPECIALIST.
Coverage
Duration
INITIAL APPROVAL FOR MS, 90 DAYS. SUBSEQUENT
AUTHORIZATION FOR 12 MOS IF PATIENT HAD A RESPONSE.
Other Criteria FOR INITIAL APPROVAL FOR MS, AUTHORIZE FOR 90 DAYS.
AFTER UP TO 90 DAYS OF DALFAMPRIDINE EXTENDED-
RELEASE THERAPY, IF MS PATIENT HAS HAD A RESPONSE TO
THERAPY AS DETERMINED BY PRESCRIBING PHYSICIAN (EG,
INCREASED WALKING DISTANCE, IMPROVED LEG/LIMB
STRENGTH, IMPROVEMENT IN ACTIVITIES OF DAILY LIVING),
THEN AN ADDITIONAL AUTHORIZATION IS ALLOWED.
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ARANESP
Products Affected • ARANESP (IN POLYSORBATE)
INJECTION SOLUTION 100 MCG/ML,
150 MCG/0.75 ML, 200 MCG/ML, 25
MCG/ML, 300 MCG/ML, 40 MCG/ML,
60 MCG/ML
• ARANESP (IN POLYSORBATE)
INJECTION SYRINGE
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
AUBAGIO
Products Affected • AUBAGIO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
PRESCRIBED BY, OR IN CONSULTATION WITH A
NEUROLOGIST OR A MS SPECIALIST
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
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Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
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AZATHIOPRINE
Products Affected • azathioprine sodium
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
BOSULIF
Products Affected • BOSULIF ORAL TABLET 100 MG, 500
MG
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES A TRIAL OF, OR A CONTRAINDICATION
TO, GLEEVEC, SPRYCEL, OR TASIGNA
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BOTOX
Products Affected • BOTOX
• DYSPORT
• XEOMIN
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D.
CHORIONIC GONADOTROPIN
Products Affected • CHORIONIC GONADOTROPIN,
HUMAN
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
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Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
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CIALIS
Products Affected • CIALIS ORAL TABLET 2.5 MG, 5 MG • tadalafil oral tablet 2.5 mg, 5 mg
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
INDICATION FOR WHICH TADALAFIL IS BEING PRESCRIBED.
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MOS.
Other Criteria BENIGN PROSTATIC HYPERPLASIA (BPH), AFTER
CONFIRMATION THAT TADALAFIL IS BEING PRESCRIBED TO
TREAT THE SIGNS AND SYMPTOMS OF BPH AND NOT FOR THE
TREATMENT OF ERECTILE DYSFUNCTION (ED) AND AFTER A
TRIAL OF AN ALPHA-1 BLOCKER (EG, DOXAZOSIN [CARDURA
XL], TERAZOSIN, TAMSULOSIN [FLOMAX], ALFUZOSIN
EXTENDED-RELEASE [UROXATRAL]) OR 5 ALPHA REDUCTASE
INHIBITOR (EG, FINASTERIDE, DUTASTERIDE [AVODART]).
CINRYZE
Products Affected • CINRYZE
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria
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CORLANOR
Products Affected • CORLANOR
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
PATIENT MUST HAVE A DIAGNOSIS OF STABLE
SYMPTOMATIC CHRONIC HEART FAILURE WITH LEFT
VENTRICULAR EJECTION FRACTION OF LESS THAN OR EQUAL
TO 35 PERCENT SINUS RHYTHM WITH RESTING HEART RATE
OF GREATER THAN OR EQUAL TO 70 BEATS PER MINUTE AND
EITHER ON MAXIMALLY TOLERATED DOSES OF BETA
BLOCKERS OR HAVE A CONTRAINDICATION TO BETA
BLOCKER USE.
Age Restrictions
Prescriber
Restrictions
TREATMENT MUST BE INITIATED BY OR AFTER
CONSULTATION WITH A CARDIOLOGIST.
Coverage
Duration
12 MONTHS
Other Criteria
COSENTYX
Products Affected • COSENTYX (2 SYRINGES) • COSENTYX PEN (2 PENS)
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES TRIAL OF ENBREL OR HUMIRA OR A
CONTRAINDICATION TO ENBREL AND HUMIRA
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CYCLOBENZAPRINE
Products Affected • cyclobenzaprine oral tablet
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS
Other Criteria
DAKLINZA
Products Affected • DAKLINZA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
MUST BE PRESCRIBED BY, OR AFTER CONSULTATION WITH A
GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST OR
HEPATOLOGIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 24 WEEKS.
Other Criteria
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DUPIXENT
Products Affected • DUPIXENT
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
ENBREL
Products Affected • ENBREL SUBCUTANEOUS RECON
SOLN • ENBREL SUBCUTANEOUS SYRINGE
25 MG/0.5ML (0.51), 50 MG/ML (0.98
ML)
• ENBREL SURECLICK
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D PLUS PATIENT ALREADY ON
ETANERCEPT FOR A COVERED USE. UVEITIS
(NONINFECTIOUS). GRAFT VERSUS HOST DISEASE (GVHD).
BEHCET'S SYNDROME. AUTOIMMUNE MUCOCUTANEOUS
BLISTERING DISEASES (PEMPHIGUS VULGARIS, MUCOUS
MEMBRANE PEMPHIGOID [CICATRICIAL PEMPHIGOID])
(AMBD). TUMOR NECROSIS FACTOR RECEPTOR-ASSOCIATED
PERIODIC SYNDROME (TRAPS).
Exclusion
Criteria
CONCURRENT USE WITH ADALIMUMAB, ANAKINRA,
ABATACEPT, CERTOLIZUMAB PEGOL, USTEKINUMAB,
INFLIXIMAB, RITUXIMAB, GOLIMUMAB, OR TOCILIZUMAB.
INTRA-ARTICULAR INJECTION OF ETANERCEPT.
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
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EPCLUSA
Products Affected • EPCLUSA
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST,
PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS
(HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS
ECHO (EXTENSION FOR COMMUNITY HEALTHCARE
OUTCOMES) MODEL.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria PATIENT NOT ELIGIBLE FOR 8 OR 12 WEEKS OF HARVONI IF
GENOTYPE 1, 4, 5 OR 6
EPOETIN/PROCRIT
Products Affected • PROCRIT
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
CRF ANEMIA.HEMOGLOBIN (HB) OF LESS THAN OR EQUAL TO
10.0 G/DL TO START.HB LESS THAN OR EQUAL TO 12.0 G/DL IF
PREVIOUSLY ON EPOETIN ALFA (EA) OR ARANESP.ANEMIA
W/MYELOSUPPRESSIVE CHEMOTX.HB IMMEDIATELY PRIOR
TO EA IS 10.0 G/DL OR LESS (OR HEMATOCRIT [HCT] IS 30% OR
LESS).EA MAINTENANCE IS STARTING DOSE IF HB LEVEL
REMAINS 10.0 G/DL OR LESS (OR HCT REMAINS 30% OR LESS) 4
WKS AFTER START AND HB RISE IS 1.0 G/DL OR MORE (HCT
RISE IS 3% OR MORE).PTS W/HB RISES LESS THAN 1.0 G/DL
(HCT RISE LESS THAN 3%) VS PRETX BASELINE OVER 4 WKS
OF TX AND HB IS LESS THAN 10.0 G/DL AFTER 4 WKS OF TX
(HCT IS LESS THAN 30%), THE RECOMMENDED FDA STARTING
DOSE MAY BE INCREASED ONCE BY 25%.CONTINUED USE IS
NOT REASONABLE/NECESSARY IF HB RISES LESS THAN 1.0
G/DL (HCT RISE LESS THAN 3%) VS PRETX BASELINE BY 8 WKS
OF TX.CONTINUED EA IS NOT REASONABLE/NECESSARY IF
THERE IS A RAPID HB RISE MORE THAN 1.0 G/DL (HCT MORE
THAN 3%) OVER 2 WKS OF TX UNLESS HB REMAINS BELOW OR
SUBSEQUENTLY FALLS TO LESS THAN 10.0 G/DL (OR HCT IS
LESS THAN 30%).CONTINUATION/REINSTITUTION OF EA MUST
HAVE DOSE REDUCTION OF 25% OF PREVIOUS DOSE. MDS,
APPROVE IF HB IS 12.0 G/DL OR LESS.PREVIOUSLY RECEIVING
ARANESP OR EA, APPROVE IF HB IS 12.0 G/DL OR LESS. AN
ADDITIONAL 6 MONTHS ALLOWED AFTER FIRST 6 MONTHS IF
HB IS 12.0 G/DL OR LESS. ANEMIA IN HIV (WITH OR WITHOUT
ZIDOVUDINE), HB IS 10.0 G/DL OR LESS OR ENDOGENOUS
ERYTHROPOETIN LEVELS ARE 500 MUNITS/ML OR LESS AT TX
START.PREVIOUSLY ON EA APPROVE IF HB IS 12.0 G/DL OR
LESS.ANEMIA DUE TO RIBAVIRIN FOR HEP C, HB IS 10.0 G/DL
OR LESS AT TX START. ALL CONDS, DENY IF HB EXCEEDS 12.0
G/DL.
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PA Criteria Criteria Details
Age Restrictions
Prescriber
Restrictions
PRESCRIBED BY A HEMATOLOGIST, INFECTIOUS DISEASE
SPECIALIST, HIV SPECIALIST, ONCOLOGIST OR SURGEON.
Coverage
Duration
CHEMO +8 WK LAST CHEMO
DOSE.MDS=6MO.TRANSFUS=3WK.START -HF
2MO.OTHER=12MO
Other Criteria PART B VERSUS PART D DETERMINATION WILL BE MADE AT
TIME OF PRIOR AUTHORIZATION REVIEW PER CMS GUIDANCE
TO ESTABLISH IF THE DRUG PRESCRIBED IS TO BE USED FOR
AN END-STAGE RENAL DISEASE (ESRD)-RELATED CONDITION.
FOR ALL COVERED USES, IF THE REQUEST IS FOR EPOGEN,
THEN THE PATIENT IS REQUIRED TO TRY PROCRIT OR
ARANESP FIRST LINE. ANEMIA SECONDARY TO
MYELOSUPPRESSIVE ANTICANCER CHEMOTHERAPY IN SOLID
TUMORS, MULTIPLE MYELOMA, LYMPHOMA, AND
LYMPHOCYTIC LEUKEMIA. PTS WITH HB RISE OF LESS THAN
1.0 G/DL (OR HCT 3% OR LESS) AND HB LEVELS IS LESS THAN
10.0 G/DL AFTER 4 WKS THERAPY, THE RECOMMENDED FDA
DOSE MAY BE INCREASED ONCE BY 25%. CONTINUED
EPOETIN ALFA USE IS NOT REASONABLE OR NECESSARY IF
THE HB RISE IS LESS THAN 1.0 G/DL (OR HCT IS LESS THAN 3%)
COMPARED TO PRETREATMENT BASELINE BY 8 WEEKS OF
TREATMENT. CONTINUED EPOETIN ALFA ADMINISTATION IS
NOT REASONABLE AND NECESSARY IF THERE IS A RAPID RISE
IN HB OR MORE THAN 1.0 G/DL (OR HCT MORE THAN 3%) OVER
2 WEEKS OF TREATMENT UNLESS THE HB REMAINS BELOW
OR SUBSEQUENTLY FALLS TO LESS THAN 10.0 G/DL (OR HCT
LESS THAN 30%). CONTINUATION AND REINSTITUTION OF
EPOETIN ALFA MUST INCLUDE A DOSE REDUCTION OF 25%
FROM THE PREVIOUSLY ADMINISTERED DOSE.
CONTINUATION AND REINSTITUTION OF ARANESP MUST
INCLUDE A DOSE REDUCTION OF 25% FROM THE PREVIOUSLY
ADMINISTERED DOSE. ANEMIA IN HF, APPROVE INITIAL TRIAL
OF UP TO 2 MONTHS FOR PATIENTS WITH MORE SEVERE HF,
HB OF 10.0 G/DL OR LESS, ANEMIA PERSISTS DESPITE
TRANSFUSIONS OR PT HAS CONTRAINDICATIONS TO
TRANSFUSIONS. DENY IF HB IS MORE THAN 12.0 G/DL.
FURTHER APPROVAL AFTER INITIAL COURSE WILL BE
DETERMINED ON A CASE-BY-CASE BASIS AFTER EVALUATION
BY A PHARMACIST AND/OR PHYSICIAN. ANEMIA OF CHRONIC
DISEASE, APPROVE INITIAL TRIAL OF 3 MONTHS FOR
PA Criteria Criteria Details
PATIENTS WITH SYMPTOMATIC ANEMIA OF 10.0 G/DL OR
LESS, ANEMIA PERSISTS DESPITE TRANSFUSIONS OR CANNOT
TOLERATE OR UNDERGO TRANSFUSIONS, AND/OR LOW
ERYTHROPOIETIN LEVELS OT FAILURE OF OTHER
TREATMENT MODALITIES. OTHER CAUSES OF ANEMIA HAVE
BEEN RULED OUT. DENY IF HB IS MORE THAN 12.0 G/DL.
FURTHER APPROVAL AFTER INITIAL COURSE WILL BE
DETERMINED ON A CASE-BY-CASE BASIS AFTER EVALUATION
BY A PHARMACIST AND/OR PHYSICIAN. TREATMENT OF AA,
APPROVE INITIAL TRIAL OF UP TO 1 MONTH FOR PATIENTS
WITH SYMPTOMATIC ANEMIA OF LESS THAN 11.0 G/DL. DENY
IF HB IS MORE THAN 12.0 G/DL. FURTHER APPROVAL AFTER
INITIAL COURSE WILL BE DETERMINED ON A CASE-BY-CASE
BASIS AFTER EVALUATION BY A PHARMACIST AND/OR
PHYSICIAN.
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FASENRA
Products Affected • FASENRA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
GATTEX
Products Affected • GATTEX 30-VIAL
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
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GILENYA
Products Affected • GILENYA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
CONCURRENT USE OF AVONEX, BETASERON, EXTAVIA, REBIF,
COPAXONE OR TYSABRI.
Required
Medical
Information
FOR USE IN MULTIPLE SCLEROSIS (MS), PATIENT HAS A
RELAPSING FORM OF MS.
Age Restrictions
Prescriber
Restrictions
PRESCRIBED BY A NEUROLOGIST OR AN MS SPECIALIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
HARVONI
Products Affected • HARVONI
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST,
PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS
(HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS
ECHO (EXTENSION FOR COMMUNITY HEALTHCARE
OUTCOMES) MODEL.
Coverage
Duration
AUTHORIZATION WILL BE FOR 24 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria PATIENT SHOULD NOT CONCURRENTLY TAKE ANY OF THE
FOLLOWING: CARBAMAZEPINE, PHENYTOIN,
PHENOBARBITAL, OXCARBAZEPINE, RIFAMPIN, RIFABUTIN,
RIFAPENTINE, ROSUVASTATIN, SIMEPREVIR, SOFOSBUVIR,
STRIBILD
(ELVITAGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR),
OR TIPRANAVIR/RITONAVIR.
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HETLIOZ
Products Affected • HETLIOZ
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria PATIENT MUST BE TOTALLY BLIND
HP ACTHAR
Products Affected • ACTHAR H.P.
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria
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IBRANCE
Products Affected • IBRANCE
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS
Other Criteria
JUXTAPID
Products Affected • JUXTAPID ORAL CAPSULE 10 MG, 20
MG, 5 MG
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
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KALYDECO
Products Affected • KALYDECO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL
MUTATION IN THE CFTR GENE.
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
KISQALI
Products Affected • KISQALI • KISQALI FEMARA CO-PACK
PA Criteria Criteria Details
Covered Uses ALL FDA INDICATIONS NOT OTHERWISE EXCLUDED FROM
PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
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35
KORLYM
Products Affected • KORLYM
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
KYNAMRO
Products Affected • KYNAMRO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
36
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37
LAZANDA
Products Affected • LAZANDA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D
LENVIMA
Products Affected • LENVIMA
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
LENVIMA MUST BE PRESCRIBED BY, OR AFTER
CONSULTATION WITH AN ONCOLOGIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
38
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
39
LIDOCAINE OINTMENT
Products Affected • lidocaine topical ointment
PA Criteria Criteria Details
Covered Uses ALL FDA INDICATIONS NOT OTHERWISE EXCLUDED FROM
PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 6 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D.
LIDODERM
Products Affected • lidocaine topical adhesive
patch,medicated
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D.
40
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
41
LONSURF
Products Affected • LONSURF
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
MAVYRET
Products Affected • MAVYRET
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST,
PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS
(HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS
ECHO (EXTENSION FOR COMMUNITY HEALTHCARE
OUTCOMES) MODEL.
Coverage
Duration
AUTHORIZATION WILL BE FOR 16 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria
42
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
43
METHAMPHETAMINE
Products Affected • methamphetamine
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
MODAFINIL
Products Affected • modafinil oral tablet 100 mg, 200 mg
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
44
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
45
NINLARO
Products Affected • NINLARO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
NORTHERA
Products Affected • NORTHERA
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR ONE MONTH.
Other Criteria
46
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
47
OCREVUS
Products Affected • OCREVUS
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
OLUMIANT
Products Affected • OLUMIANT
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES A TRIAL OF, OR A CONTRAINDICATION
TO HUMIRA AND ENBREL.
48
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
49
OLYSIO
Products Affected • OLYSIO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
OPSUMIT
Products Affected • OPSUMIT
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
50
ORKAMBI
Products Affected • ORKAMBI ORAL TABLET
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
51
PCSK9
Products Affected • PRALUENT PEN
• REPATHA PUSHTRONEX
• REPATHA SURECLICK
• REPATHA SYRINGE
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
52
PHOSPHODIESTERASE-5 INHIBITORS FOR PAH
Products Affected • ADCIRCA • tadalafil (antihypertensive)
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
FOR INITIAL APPROVAL FOR USE IN PULMONARY ARTERIAL
HYPERTENSION (PAH), APPROVE IF PATIENT HAS HAD A
RIGHT-HEART CATHETERIZATION TO CONFIRM DIAGNOSIS OF
PAH TO ENSURE APPROPRIATE MEDICAL ASSESSMENT. FOR
PATIENTS CURRENTLY RECEIVING SILDENAFIL OR
TADALAFIL, APPROVE IF PATIENT HAS A DIAGNOSIS OF PAH.
Age Restrictions
Prescriber
Restrictions
FOR PAH, IF PRESCRIBED BY, OR IN CONSULTATION WITH, A
CARDIOLOGIST OR A PULMONOLOGIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
53
PORTRAZZA
Products Affected • PORTRAZZA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
54
PYRIDINE ANALOGS
Products Affected • ESBRIET • OFEV
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
MUST BE PRESCRIBED BY, OR AFTER CONSULTATION WITH A
PULMONOLOGIST
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
55
SILDENAFIL
Products Affected • sildenafil (antihypertensive) oral
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D.
56
SILIQ
Products Affected • SILIQ
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
INITIAL APPROVAL FOR 12 WEEKS. SUBSEQUENT
AUTHORIZATION FOR 12 MONTHS IF PATIENT HAD A
RESPONSE.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
57
SIRTURO
Products Affected • SIRTURO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
MUST BE PRESCRIBED BY A INFECTIOUS DISEASE OR TB
SPECIALIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
58
SOMATROPIN
Products Affected • GENOTROPIN MINIQUICK
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
59
SOVALDI
Products Affected • SOVALDI
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D. PATIENT ALREADY STARTED ON
SOVALDI.
Exclusion
Criteria
Required
Medical
Information
ALL PATIENTS MUST BE GENOTYPED TO DETERMINE
APPROPRIATE THERAPY
Age Restrictions
Prescriber
Restrictions
SOVALDI MUST BE PRESCRIBED BY, OR AFTER
CONSULTATION WITH A GASTROENTEROLOGIST, INFECTIOUS
DISEASE SPECIALIST, HEPATOLOGIST OR TRANSPLANT
SPECIALIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 24 WEEKS
Other Criteria
60
SPRYCEL
Products Affected • SPRYCEL
PA Criteria Criteria Details
Covered Uses ALL MEDICALLY-ACCEPTED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D. PLUS PATIENTS ALREADY
STARTED ON SPRYCEL FOR A COVERED USE.
Exclusion
Criteria
Required
Medical
Information
DIAGNOSIS FOR WHICH SPRYCEL IS BEING USED. FOR
INDICATIONS OF CML AND ALL, THE PHILADELPHIA
CHROMOSOME (PH) STATUS OF THE LEUKEMIA MUST BE
REPORTED. NEW PATIENTS WITH CML AND ALL WHICH IS PH-
POSITIVE MAY RECEIVE AUTHORIZATION FOR SPRYCEL.
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria FOR CML, NEW PATIENT MUST HAVE PH-POSITIVE CML FOR
APPROVAL OF SPRYCEL. FOR ALL, NEW PATIENT MUST HAVE
PH-POSITIVE ALL FOR APPROVAL OF SPRYCEL.
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
61
STELARA
Products Affected • STELARA SUBCUTANEOUS
SOLUTION
• STELARA SUBCUTANEOUS
SYRINGE 45 MG/0.5 ML, 90 MG/ML
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
62
STIVARGA
Products Affected • STIVARGA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER..
Other Criteria APPROVAL REQUIRES A DIAGNOSIS OF METASTATIC
COLORECTAL CANCER AND A TRIAL OF AN ANTI-VEGF
THERAPY SUCH AS AVASTIN OR ZALTRAP AND A
FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-
BASED CHEMOTHERAPY SUCH AS: FOLFOX, FOLFIRI, CAPEOX,
INFUSIONAL 5-FU/LV OR CAPECITABINE, ALSO REQUIRES A
TRIAL OF AN ANTI-EGFR THERAPY SUCH AS ERBITUX OR
VECTIBIX. FOR GIST, A TRIAL OR CONTRAINDICATION TO
GLEEVEK AND SUTENT IS REQUIRED.
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
63
SUBSYS
Products Affected • SUBSYS
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria THIS DRUG ALSO REQUIRES PAYMENT DETERMINATION AND
MAY BE COVERED UNDER MEDICARE PART B OR D.
64
SYMDEKO
Products Affected • SYMDEKO
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
65
TAVALISSE
Products Affected • TAVALISSE
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
INITIAL APPROVAL FOR 6 MONTHS. SUBSEQUENT
AUTHORIZATION FOR 12 MONTHS IF PATIENT HAD A
RESPONSE.
Other Criteria
66
TREMFYA
Products Affected • TREMFYA
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
67
TYSABRI
Products Affected • TYSABRI
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
68
UPTRAVI
Products Affected • UPTRAVI
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
69
VELTASSA
Products Affected • VELTASSA
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
HYPERKALEMIA AS INDICATED BY A POTASSIUM LAB VALUE
OF AT LEAST 5.1 MEQ/L
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
12 MONTHS
Other Criteria
70
VIBERZI
Products Affected • VIBERZI
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 3 MONTHS.
Other Criteria MUST VERIFY POSITIVE RESPONSE FROM PHYSICIAN FOR
CONTINUED APPROVALS AND NO CONTRAINDICATION FOR
ITS USE.
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
71
VOSEVI
Products Affected • VOSEVI
PA Criteria Criteria Details
Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
GASTROENTEROLOGIST, INFECTIOUS DISEASE SPECIALIST,
PHYSICIAN SPECIALIZING IN THE TREATMENT OF HEPATITIS
(HEPATOLOGIST), OR A SPECIALLY TRAINED GROUP SUCH AS
ECHO (EXTENSION FOR COMMUNITY HEALTHCARE
OUTCOMES) MODEL.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 WEEKS UNLESS OTHERWISE
SPECIFIED BY PRESCRIBER.
Other Criteria
72
XELJANZ
Products Affected • XELJANZ • XELJANZ XR
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES A DIAGNOSIS OF RHEUMATOID
ARTHRITIS, A TRIAL OF ONE OF THE FOLLOWING DMARDS
(DISEASE-MODIFYING ANTIRHEUMATIC DRUG) SUCH AS
METHOTREXATE, LEFLUNOMIDE, HYDROXYCHLOROQUINE,
SULFASALAZINE AND A TRIAL OF A TNF INHIBITOR (SUCH AS
HUMIRA OR CIMZIA-WHICH MAY ALSO REQUIRE PRIOR
AUTHORIZATION).
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
73
XOLAIR
Products Affected • XOLAIR
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D. SEASONAL OR PERENNIAL
ALLERGIC RHINITIS (SAR OR PAR).
Exclusion
Criteria
Required
Medical
Information
MODERATE TO SEVERE PERSISTANT ASTHMA AND SAR/PAR,
BASELINE IGE LEVEL OF AT LEAST 30 IU/ML. FOR ASTHMA,
PATIENT HAS A POSITIVE SKIN TEST OR IN VITRO TESTING (IE,
A BLOOD TEST FOR ALLERGEN-SPECIFIC IGE ANTIBODIES
SUCH AS THE RAST) FOR 1 OR MORE PERENNIAL
AEROALLERGENS (EG, HOUSE DUST MITE, ANIMAL DANDER
[DOG, CAT], COCKROACH, FEATHERS, MOLD SPORES) AND/OR
FOR 1 OR MORE SEASONAL AEROALLERGENS (GRASS,
POLLEN, WEEDS). FOR SAR/PAR, PATIENT HAS POSITIVE SKIN
TESTING (EG, GRASS, TREE, OR WEED POLLEN, MOLD SPORES,
HOUSE DUST MITE, ANIMAL DANDER, COCKROACH) AND/OR
POSITIVE IN VITRO TESTING (IE, A BLOOD TEST FOR
ALLERGEN-SPECIFIC IGE ANTIBODIES) FOR ONE OR MORE
RELEVANT ALLERGENS (EG, GRASS, TREE, OR WEED POLLEN,
MOLD SPORES, HOUSE DUST MITE, ANIMAL DANDER,
COCKROACH).
Age Restrictions PATIENTS AGED 6 YEARS AND OLDER.
Prescriber
Restrictions
PRESCRIBED BY, OR IN CONSULTATION WITH AN ALLERGIST,
IMMUNOLOGIST, PULMONOLOGIST, GASTROENTEROLOGIST
OR DERMATOLOGIST.
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria MODERATE TO SEVERE PERSISTENT ASTHMA MUST MEET ALL
CRITERIA PATIENT'S ASTHMA SYMPTOMS HAVE NOT BEEN
ADEQUATELY CONTROLLED BY CONCOMITANT USE OF AT
LEAST 2 MONTHS OF INHALED CORTICOSTEROID AND A
LONG-ACTING BETA-AGONIST (LABA) OR LABA
ALTERNATIVE, IF LABA CONTRAINDICATED OR PT HAS
74
PA Criteria Criteria Details
INTOLERANCE THEN ALTERNATIVES INCLUDE SUSTAINED-
RELEASE THEOPHYLLINE OR A LEUKOTRIENE MODIFIER (EG,
MONTELUKAST), AND INADEQUATE CONTROL
DEMONSTRATED BY HOSPITALIZATION FOR ASTHMA,
REQUIREMENT FOR SYSTEMIC CORTICOSTEROIDS TO
CONTROL ASTHMA EXACERBATION(S), OR INCREASING NEED
(EG, MORE THAN 4 TIMES A DAY) FOR SHORT-ACTING
INHALED BETA2 AGONISTS FOR SYMPTOMS (EXCLUDING
PREVENTATIVE USE FOR EXERCISE-INDUCED ASTHMA).
SAR/PAR MUST MEET THE FOLLOWING CRITERIA - PT HAS
TRIED CONCURRENT THERAPY WITH AT LEAST ONE DRUG
FROM 2 OF THE FOLLOWING CLASSES, A NON-SEDATING OR
LOW-SEDATING ANTHISTAMINE/NASAL ANTIHISTAMINE, A
NASAL CORTICOSTEROID, OR MONTELUKAST OR PT HAS
TRIED AT LEAST ONE DRUG FROM ALL 3 OF THESE CLASSES
DURING ONE ALLERGY SEASON AND PT HAS HAD
IMMUNOTHERAPY, IS RECEIVING IMMUNOTHERAPY, OR WILL
BE RECEIVING IMMUNOTHERAPY. EOSINOPHILIC
GASTEROENTERITITS/EOSINOPHILIC
ESOPHAGITIS/EOSINOPHILIC COLITIS, PATIENT HAS TRIED
THERAPY WITH A SYSTEMIC OR ORALLY ADMINISTERED
TOPICAL CORTICOSTEROID.
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
75
XTANDI
Products Affected • XTANDI
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria APPROVAL REQUIRES A DIAGNOSIS OF METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER AND A TRIAL OF
DOCETAXEL AND ZYTIGA.
76
ZINBRYTA
Products Affected • ZINBRYTA
PA Criteria Criteria Details
Covered Uses ALL FDA-APPROVED INDICATIONS NOT OTHERWISE
EXCLUDED FROM PART D.
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
AUTHORIZATION WILL BE FOR 12 MONTHS, UNLESS
OTHERWISE SPECIFIED BY PRESCRIBER.
Other Criteria
Updated 11/2018 H0302_2_2014 CMS Accepted 05/05/2014
77
INDEX
A
ACTHAR H.P. ..........................................
.................................................
.................................................
.................................................
..
................................................
...................................................
...........................................
..........................
..................................................
....................................
..........................................................
.....................................................
...............................................
.................................................
.............................................
...................
....................
.......................
..............................................
..............................................
...............................................
................................................
....................................................
...............................................................
............................
.................................................
........................................................
.............................................
....................................................
.................................................
...................
...........................................
29
ADASUVE 1
ADCIRCA 52
ADEMPAS 2
AIMOVIG 70 MG/ML AUTOINJECTOR 3
AIMOVIG AUTOINJECTOR (2 PACK) 3
ALECENSA 4
AMPYRA 5
ARANESP (IN POLYSORBATE) INJECTION SOLUTION 100 MCG/ML,
150 MCG/0.75 ML, 200 MCG/ML, 25 MCG/ML, 300 MCG/ML, 40 MCG/ML, 60 MCG/ML 6
ARANESP (IN POLYSORBATE) INJECTION SYRINGE 6
AUBAGIO 7
azathioprine sodium 8
B BOSULIF ORAL TABLET 100 MG, 500
MG 9
BOTOX 10
C CHORIONIC GONADOTROPIN,
HUMAN 11
CIALIS ORAL TABLET 2.5 MG, 5 MG. 12
CINRYZE 13
CORLANOR 14
COSENTYX (2 SYRINGES) 15
COSENTYX PEN (2 PENS) 15
cyclobenzaprine oral tablet 16
D DAKLINZA 17
dalfampridine 5
DUPIXENT 18
DYSPORT 10
E ENBREL SUBCUTANEOUS RECON
SOLN 19
ENBREL SUBCUTANEOUS SYRINGE 25
MG/0.5ML (0.51), 50 MG/ML (0.98 ML)
19
ENBREL SURECLICK 19
EPCLUSA 20
ESBRIET ..................................................
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54
F FASENRA 24
G GATTEX 30-VIAL 25
GENOTROPIN MINIQUICK 58
GILENYA 26
H HARVONI 27
HETLIOZ 28
I
IBRANCE 30
J JUXTAPID ORAL CAPSULE 10 MG, 20
MG, 5 MG 31
K KALYDECO 32
KISQALI 33
KISQALI FEMARA CO-PACK 33
KORLYM 34
KYNAMRO 35
L LAZANDA 36
LENVIMA 37
lidocaine topical adhesive patch,medicated 39
lidocaine topical ointment 38
LONSURF 40
M MAVYRET 41
methamphetamine 42
modafinil oral tablet 100 mg, 200 mg 43
N NINLARO 44
NORTHERA 45
O
OCREVUS 46
OFEV 54
OLUMIANT 47
OLYSIO 48
OPSUMIT 49
ORKAMBI ORAL TABLET 50
P
PORTRAZZA 53
78
PRALUENT PEN .....................................
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51
PROCRIT 21, 22
R REPATHA PUSHTRONEX 51
REPATHA SURECLICK 51
REPATHA SYRINGE 51
S sildenafil (antihypertensive) oral 55
SILIQ 56
SIRTURO 57
SOVALDI 59
SPRYCEL 60
STELARA SUBCUTANEOUS SOLUTION 61
STELARA SUBCUTANEOUS SYRINGE 45 MG/0.5 ML, 90 MG/ML 61
STIVARGA 62
SUBSYS 63
SYMDEKO 64
T tadalafil (antihypertensive) 52
tadalafil oral tablet 2.5 mg, 5 mg 12
TAVALISSE 65
TREMFYA 66
TYSABRI 67
U UPTRAVI 68
V
VELTASSA 69
VIBERZI 70
VOSEVI 71
X
XELJANZ 72
XELJANZ XR 72
XEOMIN 10
XOLAIR 73
XTANDI 75
Z ZINBRYTA 76
79