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Update: July 14, 2004
Prior Authorization (PA) Drugs and Categories
Prior authorization requirements apply to an entire therapeutic drug class, unless specifically stated
otherwise. All new drugs to the market are subject to existing PA criteria. The generic version of the
drugs listed below will be dispensed unless the Provider has obtained a PA for the brand product.
This document has been updated to incorporate the drugs that will require a PA as a result of the
Preferred Drug List (PDL) initiative. Please refer to the drug and/or drug category below to determine if
the “PDL Criteria” is applicable. Otherwise, the drug/drug category-specific criteria described below
apply.
PDL Criteria
Two or more of the following criteria (within the same therapeutic class) must be met before a drug is
approved:
1.
2.
3.
4.
5.
6.
Failed at least two generically available medications*
Failed at least two preferred drugs that can treat the same condition
Serious side effects have occurred or are likely to develop on a preferred drug
Serious side effects have occurred or are likely to develop with available generic agents
There are no similar generic product(s) available in the marketplace
Changing a patient’s medication from a drug on the PDL list to a drug on the Preferred Drug List
(PDL) would cause the patient undue clinical harm.
*When two or more generic products are available, otherwise, only one generic medication failure is
required.
ABILIFY (aripiprazole)
See Atypical Antipsychotic
ACE Inhibitors – See PDL Criteria
Drugs:
ACCUPRIL (quinapril)
ACEON (perindopril)
ALTACE (ramipril)
LOTENSIN (benazepril)
MONOPRIL (fosinopril)
ACE Inhibitors with Diuretics – See PDL Criteria
Drugs:
ACCURETIC (quinapril/HCTZ)
LOTENSIN HCT (benazepril/HCTZ)
MONOPRIL HCT (fosinopril/HCTZ)
ACE Inhibitors / Calcium Channel Blocker (CCB) Combinations – See PDL Criteria
Drug:
LOTREL (benazepril/amlodipine)
ACIPHEX (rabeprazole)
See Proton Pump Inhibitors
ACCUPRIL (quinapril) – See PDL Criteria
ACEON (perindopril) – See PDL Criteria
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ACCURETIC (quinapril/HCTZ) – See PDL Criteria
Acne Drugs
Drugs:
Criteria:
ALTINAC (tretinoin)
AVITA (tretinoin)
RETIN-A (tretinoin)
Diagnosis of a medically indicated skin condition, including acne and other
dermatoses.
ACTIQ (Implementation TBD)
Cancer Criteria:
1. For systemic cancer
2. For breakthrough pain
3. Physical examination within year
4. Concurrent treatment with a longer-acting narcotic analgesic
5. Opioid tolerant
Non-Cancer Criteria:
1. For non-cancer diagnosis that causes significant pain
2. For breakthrough pain
3. Physical examination within year
4. Failed or experienced side effects to at least 2 short-acting narcotic analgesics
5. Concurrent treatment with a longer-acting narcotic analgesic
6. Opioid tolerant
ADDERALL & ADDERALL XR (D-amphetamine)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
ADIPEX-P (phentermine)
See Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
ADVICOR – See PDL Criteria
ALLEGRA & ALLEGRA-D (fexofenadine)
See Antihistamines & Antihistamine Combinations
Alpha/Beta-Blockers – See PDL Criteria
Drugs:
COREG (carvedilol) for non-CHF indications
ALTACE(ramipril) – See PDL Criteria
ALTINAC (tretinein)
See Acne Drugs
AMERGE (naratriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
Anabolic Steroids
Drugs:
ANADROL-50 (oxymetholone)
DECA-DURABOLIN (nandrolone decanoate)
OXANDRIN (oxandrolone)
WINSTROL (stanozolol)
Criteria:
FDA indications only
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Angiotensin Receptor Blockers (ARBs) & ARBs with Diuretics – See PDL Criteria
Drugs:
AVAPRO (irbesartan)
DIOVAN (valsartan)
TEVETEN (eprosartan)
AVALIDE (irbesartan/HCTZ)
DIOVAN HCT (valsartan/HCTZ)
TEVETEN HCT (eprosartan/HCTZ)
ANADROL-50
See Anabolic Steroids
ANDRODERM
See Androgens
Androgens
Drug:
Criteria:
ANDRODERM (testosterone)
DEPO-TESTOSTERONE (testosterone)
TESTRED/ANDROID (methyltestosterone)
Males only
Anti-Cancer/Immunosuppressives
Medicare will cover designated medications in certain instances for those Recipients who have dual
coverage (i.e., Medicare and Medicaid) and a summary follows:
1. Cancer. Medicare will pay for these oral anti-cancer agents when they are used to treat cancer
and Medicare must be billed first in these cases. The diagnosis code range for Cancer is 239.0239.9. Medicaid Fee-For-Service (FFS) claims for anti-cancer agents for Medicare-Medicaid
Recipients will be denied without a diagnosis code.
2. Off label use for immunosuppressive therapy. Self-administered oral chemotherapy (anti-cancer)
drugs methotrexate and cyclophosphamide have been identified by CMS/HCFA as drugs that
may also be used for patients who have had organ transplants to prevent rejection. If the patient
is dual-eligible, Medicare will pay for these anti-cancer agents when they are used for
immunosuppressive treatment. Medicare must be billed first. Include on Medicaid claims for
transplant Recipients the diagnosis code for transplants: V42.0 – V42.9. If claims are submitted
to the Medicaid FFS Pharmacy Program without a diagnosis code, they will be rejected to bill
Medicare first.
For those indications that are not covered by Medicare, claims submitted to the Medicaid FFS
Pharmacy Program must have a diagnosis included (such as Arthritis – diagnosis code = 716.9 for
prednisone) or the claim will be denied to bill Medicare first.
Anti-Epileptics
Although some anti-epileptics are included on the Federal Upper Limit (FUL), the Medicaid FFS
Pharmacy Program does not currently require prior authorization for the brand. However, based
on State regulations, the automatic substitution of therapeutically equivalent generics is only
prohibited if the drug is being prescribed for epilepsy. If the drug is being used for any other
indication, an appropriate generic can be automatically provided unless the prescriber has noted
that the brand is medically necessary. The Provider should have the diagnosis documented.
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Antihistamines & Antihistamine Combinations
Drugs:
ALLEGRA fexofenadine) for conditions other than chronic urticaria and angioedema
ALLEGRA-D (fexofenadine with decongestant)
CLARITIN and CLARITIN-D (loratadine Federal Legend)
CLARINEX (desloratidine)
CLARITIN/ALEVERT OTC (loratadine OTC) for ages 21 through 60
ZYRTEC (cetirizine) for conditions other than chronic urticaria and angioedema
ZYRTEC-D (cetirizine with decongestant)
Criteria (prior to July 29, 2004):
For single-source prescription oral antihistamines
1. At least 2 generically available products have shown to be ineffective
2. Serious side effects have developed or are likely to develop with other agents. These side
effects are included in the prior authorization form
3. Diagnosis is allergic rhinitis or chronic urticaria
For single-source prescription oral non-sedating anti-histamines
1. At least 2 generically available products have shown to be ineffective
2. Serious side effects have developed or are likely to develop with other agents. These side
effects are included in the prior authorization form;
3. Diagnosis is allergic rhinitis or chronic urticaria
4. Patient’s age is…
6 months or older for ZYRTEC
2 years old or older for CLARITIN
6 years old or older for ALLEGRA
12 years old or older for ALLEGRA-D, CLARINEX, CLARITIN-D, ZYRTEC-D
Note: Once a prior authorization has been approved for one of the drugs in this class, another
agent may be tried if it was listed on the prior authorization form originally as an alternative.
Criteria (on or after July 29, 2004):
For single-source prescription oral antihistamines
1. At least 2 generically available products have shown to be ineffective
2. Serious side effects have developed or are likely to develop with other agents. These side
effects are included in the prior authorization form
3. Diagnosis is allergic rhinitis or chronic urticaria
For single-source prescription oral non-sedating anti-histamines
1. Patient has failed to respond to at least a one-week trial of Loratadine OTC or serious side
effects have developed or are likely to develop
2. Diagnosis is allergic rhinitis or chronic urticaria
3. Patient’s age is…
6 months or older for ZYRTEC
2 years old or older for CLARITIN
6 years old or older for ALLEGRA
12 years old or older for ALLEGRA-D, CLARINEX, CLARITIN-D, ZYRTEC-D
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Anti-Leprotic
Drugs:
DAPSONE (dapsone)
LAMPRENE (clofazimin)
THALOMID (thalidomide)
Criteria:
Medications prescribed for the treatment of leprosy are not covered by the Medicaid FFS
Pharmacy Program. The Hansen’s Disease Program, which is part of the Department of Health,
provides these medications free-of-charge to Recipients. Prescribers should refer their patients
to the Hansen’s Disease Program for follow-up and medications.
Note: If these medications are being used to treat other conditions other than for Hansen’s
Disease, a valid diagnosis code, will be required for the pharmacy claim to be processed. If no
diagnosis code is provided, the claim will reject.
Anti-Migraine Preps
Drugs:
AMERGE (naratriptan)
AXERT (almotriptan)
FROVA (frovatriptan)
IMITREX (sumatriptan)
MAXALT (rizatriptan)
RELPAX (eletriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
Drugs:
ADIPEX-P (phentermine)
FASTIN (phentermine)
IONAMIN (phentermine)
MERIDIA* (sibutramine)
TENUATE (diethylproprion)
XENICAL* (orlistat)
Criteria:
1. Patient’s weight and height (or Body Mass Index)
2. Patient’s program for weight loss
*Additional criteria for MERIDIA and XENICAL: refer to specific drug name.
ARAVA (leflunomide)
Criteria:
1. Diagnosis of active rheumatoid arthritis (Diagnosis Code 714.0)
2. Treatment with methotrexate and at least one (1) other disease modifying anti-rheumatic drug
(DMARD) including antimalarials, gold, D-penicillamine, and azathioprine is not adequate,
effective or medically appropriate.
3. Provide the following information on the Request for Medical Authorization (1144B Form):
A. State treatment with methotrexate has not been adequate, effective, or is not
medically appropriate. If not medically appropriate, explain.
B. Provide the name of at least one (1) other DMARD that has not been effective.
ARTHROTEC (diclofenac/misoprostol) – See NSAID Criteria
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Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD)/Narcolepsy
Drugs:
ADDERALL and ADDERALL XR (D-amphetamine)
CONCERTA (methylphenidate)
CYLERT (pemoline)
DEXEDRINE (D-amphetamine)
FOCALIN (demethylphenidate)
PROVIGIL (modafinil)
RITALIN and RITALIN LA (methylphenidate)
STRATTERA (atomoxetine)
Criteria:
1. Indication:
a. Attention deficit disorder
b. Hyperkinesis
c. Narcolepsy
2. If CONCERTA, patient must be between 6 and 12 years old
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Atypical Anti-Psychotics
Drugs:
ABILIFY (aripiprazole)
CLOZAPINE (generic clozaril)
GEODON (ziprasidone)
RISPERDAL and RISPERDAL-M (risperidone)
SEROQUEL (quetiapine)
ZYPREXA and ZYPREXA ZYDIS (olanzapine)
Restrictions:
 Providers recognized by Medicaid FFS Pharmacy Program as Psychiatrists may prescribe
ABILIFY, CLOZAPINE (generic CLOZARIL), RISPERDAL, RISPERDAL-M, ZYPREXA/ZYPREXA
ZYDIS, SEROQUEL, and GEODON without a prior authorization (PA)
 Psychiatrists must submit PA requests for the brand product CLOZARIL
 Non-Psychiatrist Providers must submit a PA request prior to prescribing this class of medication
Criteria:
1. For the initial request of CLOZAPINE (generic CLOZARIL), RISPERDAL/RISPERDAL-M,
ZYPREXA/ ZYPREXA ZYDIS, SEROQUEL, or GEODON
A. DHS Form 1162 – Use of Clozapine (generic Clozaril, Risperdal, Zyprexa, Seroquel, or
Geodon – must be attached to the prior authorization request. Indicate the drug being
requested;
B. Brief Psychiatric Rating Scale (BPRS) report must be attached to the PA request
C. PA request is submitted prior to prescribing this class of medication
2. After the initial approval for two (2) months, subsequent requests may be made for six (6) month
periods. The submission of BPRS must be submitted with the prior authorization request on each
subsequent request. Semi-annual narrative reports are required as well.
3. If there is no improvement after three (3) months of using Risperdal, Zyprexa, Seroquel,or
Geodon, or if the patient cannot tolerate it due to severe side effects, Clozpine (geric Clozaril)
may be approved. Seek initial request of Clozapine (generic Clozaril) as outlined in above in
Prior Authorization Criteria 1. A., 1. B., and 1. C. Indicate Clozapine (generic Clozaril) on DHS
Form 1162 – Use of Clozapine (generic Clozaril), Risperdal, Zyprexa, Seroquel, or Geodon.
Document the lack of improvement, on the specific drug, for the time period of use, and/or the
severe side effects experienced on the specific drug.
ABILIFY (aripiprazole)
Indications:
 Management of severely ill schizophrenic patients who fail to respond adequately to standard
anti-psychotic drug treatment
 Refractory or non-refractory schizophrenics
Clozapine (generic CLOZARIL)
Indication: Psychotic disorders. Management of severely ill schizophrenic patients who fail to
respond adequately to standard anti-psychotic drug treatment
GEODON (ziprasidone)
Indication: Treatment of schizophrenia
RISPERDAL (risperidone), RISPERDAL-M (risperidone), & SEROQUEL (quetiapine)
Indication: Bipolar disorder and Psychotic disorder (management of the manifestations of
psychotic disorders)
ZYPREXA (Olanzapine)
Indications:
1. Schizophrenia: Management of the manifestations of psychotic disorders;
2. Bipolar disorder and short-term treatment of acute manic episodes associated with Bipolar I
disorder
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Atypical Anti-Psychotics (continued)
Criteria used for low dose atypical antipsychotics in elderly patients with specific behavioral
symptoms:
1. Patient age 65 years or older
2. Patient has symptoms consistent with the following ICD 9 codes:
780.09
Delirium, NOS
780.1
Hallucination, NOS
297.1
Paranoia
294.11, 331.0
Alzheimer’s Dementia w/Behavioral Disturbance
290.40, 437.0
Arteriosclerotic Dementia w/Psychosis, NOS
290.12
Presenile Dementia with Delusions
290.20
Senile Dementia w/Delusions, paranoid type
3. Proposed use of one of the following Atypical Antipsychotics, not exceeding the
maximum daily doses listed below. (General guidelines for suggested starting doses
are also noted below).
Atypical Antipsychotic
Risperidone (Risperdal)
Olanzapine (Zyprexa)
Quetiapine (Seroquel)
Maximum Daily Dose
1.0 mg/day
5.0 mg/day
100 mg/day
Suggested Starting Dose
0.25 – 0.5 mg/d
2.5 mg/d
12.5 mg/d
AVALIDE – See PDL Criteria
AVAPRO – See PDL Criteria
AVITA (tretinoin)
See Acne Drugs
AVONEX (Interferon Beta-1)
See Multiple Sclerosis Products
AXERT (almotriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
AXID (nizatidine)
See H2-Antagonists
AZELEX (azelaic acid)
Criteria:
1. Diagnosis for mild to moderate acne
2. Documentation noting other less costly alternatives has been ineffective or inappropriate and
these are included in the prior authorization form.
BACLOFEN INTRATHECAL
Indication:
Management of severe spasticity of spinal cord origin in patients who are unresponsive to oral
Baclofen therapy or who experience intolerable central nervous system (CNS) side effects at effective
oral doses.
Criteria:
1. For the above indications only
2. Documentation of a response in a screening trial prior to implantable pump for the intrathecal
administration of Baclofen
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Beta-Blockers – See PDL Criteria
Drugs: CARTROL (carteolol)
INDERAL LA (propranolol)
INNOPRAN XL (propranolol)
LEVATOL (penbutolol)
Beta-Blockers with Diuretics – See PDL Criteria
Drugs:
INDERIDE LA (propranolol/HCTZ)
BETASERON (Interferon Beta)
Criteria: Relapsing, remitting multiple sclerosis for ambulatory patients only
BEXTRA (valdecoxib)
Criteria:
1. Patient has failed a two-week trial of Vioxx or the Prescriber has a cardiovascular concern that
would preclude him/her from prescribing Vioxx first.
2. Patient has one of the following diagnosis:
 Osteoarthritis (OA)
 Degenerative Joint Disease (DJD)
 Rheumatoid Arthritis (RA)
 Primary Dysmenorrhea (PD)
3. Documentation of at least one of the following situations:
 history of GI bleed or gastric/ duodenal ulcer
 history of symptoms of peptic ulcer disease, gastritis, or GERD while on conventional
NSAIDs
 concurrent use of corticosteroids
 concurrent use of warfarin or heparin
 history of platelet dysfunction or coagulopathy
BEXXAR (tostumomab)
Billing is restricted to ACS/Fiscal Agent using the Medicare HCPCS code for this specific drug
BOTOX (botulinum toxin type A)
Indications:
1. Eye muscle disorders limited to blepharospasm and strabisumus
2. Cervical dystonia to reduce the severity of abnormal head position and neck pain associated with
moderate to severe cervical dystonia.
Criteria: FDA approved indications only
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CAMPTOSAR (trinotecan)
Criteria:
 Patient must have one of the following diagnosis:
 Malignant neoplasm of colon
 Malignant neoplasm of rectum, rectosigmoid junction, and/or anus
 Malignant neoplasm of brain
OR
 Treatment of colorectal cancer in patients whose disease has recurred or progressed
following 5-FU based therapy
OR
 First-line therapy in combination with the standard treatment, 5-Fluorouracil and leucovorin
(5-FU/LV), for metastatic colorectal cancer.
OR
 Patient must be on Cisplatin and have one of the following diagnosis:
 Lung cancer
 Malignant neoplasm of trachea
 Malignant neoplasm of bronchus
 Malignant neoplasm of lung
CARRASYN GEL
Physician must submit documentation of medical necessity in order for the product to be approved.
CARTROL (carteolol) – See PDL Criteria
CAVERJECT (alprostadil) – Effective July 15, 2004
See Impotence, Drugs to Treat
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CELEBREX (celecoxib)
Criteria:
1. Patient has diagnosis of Familial Adematous Polyposis [FAP] (Diagnosis Code 211.3)
OR
1. Patient has failed a two-week trial of Vioxx or the Prescriber has a cardiovascular concern that
would preclude him/her form prescribing Vioxx first.
2. Patient must one of the following diagnosis:
 Osteoarthritis (OA)
 Degenerative Joint Disease (DJD)
 Rheumatoid Arthritis (RA)
 Primary Dysmenorrhea (PD)
 Acute Pain
3. Documentation of at least one of the following situations:
 history of GI bleed or gastric/ duodenal ulcer
 history of symptoms of peptic ulcer disease, gastritis, or GERD while on conventional
NSAIDs
 concurrent use of corticosteroids
 concurrent use of warfarin or heparin
 history of platelet dysfunction or coagulopathy
Cholestyramine (QUESTRAN)
All forms except bulk powder or granular dosage forms were removed from the Formulary. Bars,
chewable forms or pre-measured packets were excluded based on the comparable high cost per
dose.
CIALIS (tadalafil) – Effective July 15, 2004
See Impotence, Drugs to Treat
CLARITIN & CLARITIN-D (loratadine)
See Antihistamines & Antihistamine Combinations
CLARINEX (desloratadine)
See Antihistamines & Antihistamine Combinations
CLOZARIL (clozapine)
See Atypical Antipsychotics
COLESTID – See PDL Criteria
CONCERTA (methylphenidate)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
COPAXONE (glatiramer)
See Multiple Sclerosis Products
COREG
Criteria: Congestive Heart Failure [CHF] (Diagnosis Code 428.0 – 428.9) diagnosis should be
included on claim.
CYLERT (pemoline)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
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CYTOXAN (cyclophosphamide)
See Anti-Cancer/Immunosuppresives and Immunosuppressants
DAPSONE (dapsone)
See Anti-Leprotic
DAUNOXOME (daunorubicin liposome)
Criteria:
First-line cytotoxic therapy for Advanced HIV-related Kaposis’s sarcoma. It is not recommended for
any patient with less than an advanced case.
DECA-DURABOLIN (nandrolene decandate)
See Anabolic Steroids
DEPO-TESTOSTERONE
See Androgens
DEXEDRINE (D-amphetamine)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
DIFLUCAN (fluconazole)
Prior Authorization required if Maximum Standard Dose exceeded
See Maximum Standard Dose
DIOVAN (valsartan) – See PDL Criteria
DIOVAN HCT (valsartan/HCTZ) – See PDL Criteria
DURACT (bromfenac)
See Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
DYNACIRC (Isradapine) – See PDL Criteria
ELIDEL CREAM
Criteria:
Mild to moderate atopic dermatitis in nonimmunocompromised patients in whom alternative,
conventional therapy is deemed inadvisable, for short term and intermittent long-term therapy.
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ELOXATIN (oxalipaltin)
Indication:
In combination with infusional 5-fluorouracil (5-FUL)/leucovorin (LV) for the treatment of patients
with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed
during or within six months of completion of the first-line therapy with the combination of bolus 5FU/LV and irinotecan (Camptosar).
Criteria:
 Documentation of the diagnosis and medical necessity
 Must be used with 5-FUL/LV and irinotecan (Camptosar)
 Documented disease has recurred or progressed during or within six months of
completion of the first-line therapy with the combination of bolus 5-FU/LV and irinotecan
EMEND (aprepitant) – Effective July 15, 2004
Indication:
In combination with other antiemetic agents for the prevention of acute and delayed nausea and
vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy,
including high-dose cisplatin.
Criteria:
 Patient must be 18 years old and greater
 Patient is receiving concurrent course of a highly emetogenic cancer chemotherapy, which may
include high-does cisplatin or carboplatin
 Patient is receiving a 5HT3 antagonist (e.g., dolasetron, granisetron, or ondansetron) AND a
corticosteroid (e.g., dexamethasone, methylprednisolone, or prednisone) concurrently
ENBREL (etanercept)
Indications:
1. Moderate to severe active rheumatoid arthritis (Diagnosis Code 714.0)
2. Psoriatic arthritis
3. Reduction of signs and symptoms in patients with active ankylosing spondylitis.
Restriction:
Available without a PA when prescribed by a Rheumatologist for the diagnosis of Rheumatoid
Arthritis
Criteria:
1. Diagnosis of moderate to severe active rheumatoid arthritis
2. Treatment with methotrexate and at least one (1) other disease modifying anti-rheumatic drug
(DMARD) including antimalarials, gold, D-penicillamine, and azathioprine is not adequate,
effective or medically appropriate.
3. Provide the following information on the Request for Medical Authorization (Form 1144):
a. State treatment with methotrexate has not been adequate or effective or is not
medically appropriate. If not medically appropriate, explain.
b. Provide the name of at least one (1) other DMARD that has not been effective.
4. The diagnosis of psoriatic arthritis may be approved without documented failure of
methotrexate or a DMARD.
EPOGEN
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
Estrogens
Criteria: Females only
ETHAMBUTOL
See Tuberculosis Meds
FASTIN (phentermine)
See Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
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FLOLAN (epoprostenol)
Indication/Criteria:
Long term IV treatment of primary pulmonary hypertension in patients with Congestive Heart Failure
(CHF) rated New York Heart Association NYHA) Class III) patient only comfortable at rest) or Class
IV (continuous symptoms of CHF).
FLUMIST NASAL VACCINE (influenza vaccine, tri2003 live) – Not Covered
FOCALIN (dexmethylphenidate)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
FROVA (frovatriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
FUZEON (enfuvirtide) – Effective July 15, 2004
Indication: In combination with other antiretroviral agents for the treatment of HIV-1 infection in
treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral
therapy.
Criteria:
 Recipient must be 6 years old and greater
 Recipient must has a diagnosis of HIV infection
 Recipient must have tried any form of antiretroviral therapy for at least 180 days:
Agenerase
Fortovase
Rescriptor
Viread
Combivir
Hivid
Retrovir
Viracept
Crixivan
Invirase
Sustiva
Viramune
Epivir
Kaletra
Trizivir
Zerit
Norvir
Videx / Videx EC
Ziagen
 Documentation of combination therapy, which must include Fuzeon plus an antiretroviral agent
 CD4 count must be < 100 cells/mm3 while on antiretroviral therapy (latest available measurement
must be within the past 90 days)
 HIV viral load is > 10,000 copies/mL while on antiretroviral therapy (latest available measurement
must be within the past 90 days)
GEMZAR (gemcitabine)
Indications:
 First-line treatment for locally advanced (non-resectable Stage ii or iii) or Metastatic (Stage IV)
adenocarcinoma of the pancreas
 Combination therapy with cisplatin for Stage IIIA, IIIB, IV non-small cell lung cancer.
Criteria: Documentation of one of the above indications
GENOTROPIN (somatropin)
See Growth Hormones
GEODON (ziprasidone)
See Atypical Anti-psychotics
GLEEVEC (imatinib mesylate)
Indication:
Chronic myeloid leukemia (CML) as first line treatment, gastrointestinal stromal tumor.
If a diagnosis code of CML (205.0-205.9, 207.0-207.2, or 288.8) is not submitted on the claim or no
diagnosis code is entered, the claim will deny for “Prior Authorization Required”. A diagnosis on the
1144B Form of CML or gastrointestinal stromal tumor (GIST) will be approved.
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Gonadotropin-Releasing Hormone Analog
Drugs:
LUPRON (leuprolide)
`
VIADUR (leuprolide)
ZOLADEX (goserelin)
Indications:
1. Prostate Cancer (VIADUR only)
2. Endometriosis
Restrictions:
 ZOLADEX is available without prior authorization for any of the above indications
 ZOLADEX is also indicated for the diagnosis of advanced breast cancer without a PA
 LUPRON for pediatric use and LUPRON DEPOT-PED are indicated for diagnosis of central
precocious puberty (CPP) for children (recipients age, 21) without a PA
Criteria:
A. For LUPRON approval:
1. Documented failure of ZOLADEX
2. Documented side effects of significant nature with use of ZOLADEX
3. Diagnosis of uterine leiomyomata fibroids (for women
B. For VIADUR approval:
1. Diagnosis of advanced prostate cancer
2. Documented successful trial with LUPRON Depot or ZOLADEX.
Growth Hormones
Drugs:
GENOTROPIN (somatropin)
HUMATROPE (somatropin) – See Humatrope Criteria for normal short stature
NORDITROPIN (somatropin)
NUTROPIN (somatropin)
PROTROPIN (sonatrem)
SAIZEN (somatropin)
SEROSTIM – See Serostim Criteria
TEV-TROPIN (somatropin)
Adult Criteria:
1. Biochemical diagnosis of somatropin deficiency by means of a negative response to a standard
growth hormone stimulation test.
2. This deficiency either alone or with multiple hormone deficiencies as a result of pituitary disease,
hypothalamic disease, surgery, radiation therapy or trauma.
Pediatric Criteria:
1. Diagnosis of neurosecretory growth hormone dysfunction or lack of adequate endogenous growth
hormone
2. Diminished peak serum growth hormone response of less than seven (7) mg/ml to, at least two
(2) provocative stimuli
3. Growth rate less than 4.5cm per year between ages of 0-12
4. For ongoing therapy, there must be evidence of growth of 1-2’ per year to continue therapy
5. Chronic renal insufficiency resulting in reduced growth hormone and provocative stimuli is not
required for this condition.
- - 15
H2-Antagonists/Legend
Drugs:
AXID (nizatidine)
PEPCID (famotidine)
ZANTAC (ranitidine)
Criteria:
1. OTC H2-antagonists should be considered first with documented failure before Legend H2antagonists are considered.
2. Generics should be used before Brand, unless medical necessity is documented due to failure of
the generic or serious side effects have developed or are likely to develop.
3. Recipient has one of the following diagnosis:
 Peptic Ulcer Disease (PUD)
 Gastritis,
 Duodenitis,
 Zollinger-Ellison Syndrome (ZE)
 Gastroesophageal Reflux Disease (GERD)
4a. Failure of cimetidine or ranitidine at adequate doses after at least two weeks
OR
4b. Serious side effects have developed to cimetidine/ranitidine or have the potential to develop
OR
4c. Recipient is seriously ill and on medications with a low therapeutic ratio
OR
4d. Recipient was discharged from hospital on acute therapy.
Single Source Prescription Histamine H2 Antagonist:
 Will be considered if cimetidine has been tried at adequate doses for at least 2 weeks unless
serious side effects have developed or have a true potential of developing. On the Prior
Authorization form, please specify what the side effects were or are projected to be. If cimetidine
was ineffective, please note the dose and the period of time it was used..
 Consideration shall be given to those patients who are seriously ill and on medications that have
a low therapeutic ratio. Some exceptions may be made for school age children.
 If a patient has just been released from the hospital on acute therapy, please note this on the
form to expedite authorization.
Cimetidine is not totally contraindicated for patients who are also taking other medications which are
metabolized via the cytochrome P-450 pathway but dose adjustments of these agents may be
necessary.
Note: Once prior authorization has been approved for one of the products in this category, the drug
may be changed to another product in this class within the approved time period without a new
request. However, the alternative(s) must be listed on the original Prior Authorization form.
- - 16
HERCEPTIN (trastuzumb)
Indications:
1. Treatment as a single agent for metastatic breast cancer in patients whose tumors over-express
the HER2 protein and who have received one or more chemotherapy regimens for their disease.
2. Treatment in combination with paclitaxel for metastatic breast cancer in patients whose tumors
over express HER2 and who have not received any chemotherapy for their disease.
Criteria:
1. Significant HER2 protein over-expression must be present. The HER2 overexpression test
results must be included on the prior authorization form
2. Documentation of one of the above indications
HUMATROPE (somatropin)
Criteria:
1. Medical causes of short stature are not present (chronic renal insufficiency, prematurity with
persisting respiratory problems, Turner Syndrome, etc.)
2. Child is 2.25 standard deviations below the mean height for age and sex
3. Child has low growth velocity (2 standard deviations below the mean). Height must be followed
serially over a period of one (1) year and at least six (6) months apart by one physician. The
physician must have a standardize procedure for measuring height. It is highly recommended that
measurements be preformed by an Endocrinologist.
4. The bone age must be a minimum of one (1) year delayed from chronological age. The growth
plates must be open.
5. At a minimum, the child must be three (3) years of age
HUMIRA (adalimumab)
Indication:
Moderate to severe active rheumatoid arthritis (Diagnosis Code 714.0)
Restriction:
Providers recognized by Medicaid FFS Pharmacy Program as Rheumatologists may prescribe
Humira without a PA for the diagnosis of rheumatoid arthritis. The diagnosis code must be submitted
with the claim.
Criteria:
 Diagnosis of moderate to severe active rheumatoid arthritis
 Treatment with methotrexate and at least one other disease modifying anti-rheumatic drug
(DMARD) including antimalarials, gold, D-penicillamine, and azathiaoprine is not adequate,
effective or medically appropriate.
 Provide the following information on the Request for Medical Authorization (Form 1144B):
1. State treatment with methotrexate has not been adequate or effective or is not medically
appropriate. If not medically appropriate, explain.
2. Provide the name of at least one other DMARD that has not been effective.
HYCAMTIN (topotecan)
Indication/Criteria:
Treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
This is not first-line therapy.
IMITREX
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
- - 17
Immunosuppressants
Drugs:
CELLCEPT (mycophenolate mofetil)
CYTOXAN (cyclophosphomide)
GENGRAF (cyclosporin)
IMURAN (azathioprine)
LYMPHOCYTE IMMUNE GLOBULIN
METHOTREXATE
METHYLPREDNISOLONE
For more drugs and criteria, please refer to your Medicare manual
Criteria:
1. FDA approved indications other than to prevent transplant rejections:
 A diagnosis code must be on the claim to prevent unnecessary rejection of Medicaid
Fee-For-Service claim processing;
 Two (2) examples are as follows:
1. Diagnosis code for Arthritis is 716.9;
2. Diagnosis code for Asthma is 493.9.
 All strengths of these agents are included (i.e., Prednisone 1mg, 5mg, 10mg, 20mg,
etc.)
2. For Medicare-covered organ transplants for eligible Medicare beneficiaries that are dual
eligible for Medicaid:
 Medicare will pay for immunosuppressants (all strengths) if used to prevent
transplant rejection and Medicare must be billed first;
 Medicaid will deny claims for immunosuppressant drugs unless an appropriate
rejection from Medicare is attached with the claim;
 Include on Medicaid claims for transplant recipients the diagnosis code for
transplants: V42.0 – V42.9;
 If claims are submitted to the Medicaid program without a diagnosis code, they will be
rejected to bill Medicare first.
Impotence, Drugs To Treat – Effective July 15, 2004
Drugs:
CAVERJECT (alprostadil)
CIALIS (tadalafil)
LEVITRA (vardenafil hcl)
MUSE (alprostadil)
VIAGRA (sildenafil)
Indications:
 Treatment of erectile dysfunction caused by neurogenic, vasculogenic, psychogenic, or mixed
etiology.
 Intracavernosal alprostadil may be useful adjunct to other diagnostic tests in the diagnosis of
erectile dysfuntion (Caverject only).
Criteria:
 Recipient must be 21 years old and greater
 Recipient must be male
 Physical exam once a year
 Documented history of impotence due to psychogenic or organic causes
 Recipient cannot be on concurrent Nitrate (e.g., Isosorbide dinitrate, Nitroglycerin) or Alphaadrenergic blocker (e.g., Doxazoxin, Terazosin) therapy
Approval Limit: 1 tablet, injection, or pellet per month. Recipient cannot receive any combination of
dosage forms nor strengths per month.
Approval Period: 1 month
Other Limitations: A new prescription and a new PA# must be obtained on each drug fill. Drugs do
not qualify for refill-to-soon overrides/PAs or emergency supply PAs.
Note: Yohimbine continues to be not covered, because there are no FDA sanctioned indications.
- - 18
INDERAL LA (propranolol long-acting) – See PDL Criteria
INDERIDE LA (propranolol/HCTZ long acting – See PDL Criteria
INNOPRAN XL – See PDL Criteria
IONAMIN
See Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
ISONIAZID (INH)
Indication:
For chemoprophylasis of tuberculosis for children (Diagnosis Code 795.5)
Criteria:
Under the following circumstances only:
1. Under 19 years of age or if in Plan 200 – can exceed 19 years,
2. At least one positive tuberculin skin test within the past year;
3. A negative chest x-ray;
4. Claims for Isoniazid must be for products of manufacturers who participate in the Federal Drug
Rebate Program;
5. The diagnosis code 795.5 (tuberculin skin test converter) must be included on the claim for
payment to be considered.
Note: Recipients who have active tuberculosis must continue to be treated at Lanakila Health
Center, Leahi Hospital or Local Health Department Tuberculosis Clinics on the Outer Islands. Followup of contacts of tuberculin positive individuals is also considered to be the responsibility of the
Department of Health.
KINERET (anakinra)
Indication:
Moderate to severe active rheumatoid arthritis
Criteria:
Moderately to severely active rheumatoid arthritis;
1. At least 18 years of age; and
2. Failed one or more disease modifying antirheumatic drugs (DMARDS)
Restriction:
Providers recognized by the Medicaid FFS Pharmacy Program as a Rheumatologist may prescribe
Kineret without a PA for the diagnosis of rheumatoid arthritis (Diagnosis Code 714.0). The diagnosis
code must be submitted with the claim.
KLONOPIN WAFERS (clonazepam) – Effective July 15, 2004
Indications:
 Used alone or as adjunctive treatment of the Lennox-Gastaut syndrome (petit mal variant),
akinetic and myoclonic seizures. It may be useful in patients with absence (pet mal) seizures
who have failed to respond to succinimides.
 Treatment of panic disorder, with or without agoraphobia
Criteria:
 Recipient must have one of the following diagnosis:
 Lennox-Gastaut syndrome (petit mal variant), akinetic, or myoclonic seizures
 Panic disorder, with or without agoraphobia
 Recipient is unable to swallow any other solid oral dosage form
LAC-HYDRIN (ammonium lactate)
Indication/Criteria:
Dermatological conditions other than simple dry skin
Restriction:
Providers who are registered with the Medicaid FFS Pharmacy Program for the subspecialty of
Dermatology will not need a prior authorization.
- - 19
LAMPRENE (clofazimin)
See Anti-Leprotic
LEVATOL (penbutolol) – See PDL Criteria
LEVITRA (vardenafil hcl) – Effective July 15, 2004
See Impotence, Drugs to Treat
LIPITOR (atorvastatin)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
LOTENSIN (benazepril) & LOTENSIN HCT (benazepril/HCTZ) – See PDL Criteria
LOTREL (benazepril/amlodipine) – See PDL Criteria
LOTRISONE (Clotrimazole and betamethasone)
Restriction:
1. Providers who are registered with the Medicaid FFS Pharmacy Program with the subspecialty of
Dermatology will not need a prior authorization.
2. The individual ingredients in this combination will be available for compounding in the generic or
OTC forms only without prior authorization.
3. If the pharmacist receives approval from the physician to dispense the two (2) single ingredients
instead of the Lotrisone, the two (2) products must be compounded together and billed as a
single compounded prescription. The pharmacy must supply the NDC numbers and the
quantities used, etc., and may bill Medicaid for one dispensing fee plus one compounding fee of
$1.50 for mixing the two (2) agents together.
Criteria:
Documentation of failure or side effects from the compound of the two (2) single ingredients.
LOTRONEX (alosetron hydrocholoride)
Indication:
Treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS), who have
failed to respond to conventional therapy, whose IBS symptoms are chronic (generally lasting six
months or longer), and who have had other gastrointestional medical conditions ruled out, which
could have explained their symptoms.
Criteria:
 Female patients only.
 At least 18 years of age.
 A documented diagnosis of IBS with predominant severe diarrhea and have the following:
a. Failed to respond to conventional therapy; and
b. IBS symptoms (diarrhea predominant) are chronic (generally lasting six months or longer).
If approved, the following will apply:
 Maximum allowable quantity is 30 tablets for the first month and up to 60 tablets per
month thereafter.
 Initial approval is for up to three months only.
 Continued coverage requires documentation that the patient is responding to therapy.
The authorization period will be up to an additional three months.
LUPRON (leuprolide acetate)
See Gonadotropin-Releasing Hormone Analog
- - 20
MARINOL (dronabinol) – Effective July 15, 2004
Indications:
 Treatment of nausea and vomiting associated with cancer chemotherapy in patients not
responding adequately to conventional antiemetic treatment
 Treatment of anorexia associated with weight loss in AIDS patients
PA Criteria: Recipient must meet one of the following –
 Recipient is diagnosed with AIDS-related anorexia AND failed Megace (mesgestrol acetate)
therapy. Megace failure may include undesirable side effects or weight desired not achieved.
 Recipient has or is experiencing nausea and vomiting secondary to current cancer
chemotherapy AND has failed to respond or been intolerant to at least 2 classes of conventional
antiemetic treatments: metoclopromide
MAXALT (rizatriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
MERIDIA (sibutramine)
Indication:
1. Weight loss in patients with an initial Body Mass Index (BMI) greater than or equal to 30kg/m² in
the presence of at least one other risk factor such as hypertension, sleep apnea, diabetes,
dyslipidemia, coronary heart disease or other artherosclerotic diseases
2. Maintenance of weight loss
Criteria:
1. Must be for one of the indications noted above;
2. Used in conjunction with a reduced calorie diet.
3. Provide the following information on the Request for Medical Authorization (1144B Form):
A. For initial weight loss, state the recipient’s BMI or provide the height and weight. If the BMI is
equal to or greater than 27kg/m². State at least one risk factor;
B. For subsequent weight loss or for maintenance of weight loss, provide the initial and current
BMI; and
C. State recipient is on a reduced calorie diet.
Note: Initial approval will be for a maximum of 3 months. If there is weight loss or the recipient
has been able to maintain prior weight loss during this initial period, subsequent prior
authorization requests may be approved up to a maximum of 6 months.
METHOTREXATE
PA required for Medicare-Eligible Recipients
METHYLTESTOSTERONE
See Androgens
MIFEPREX (mifepristone; RU-486)
Criteria: Termination of intrauterine pregnancy through day 49 will be approved
MOBIC (meloxicam)
See Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
MONOPRIL & MONOPRIL HCT – See PDL Criteria
Multiple Sclerosis Drugs
Drugs:
AVONEX (Interferon Beta-1A/Albumin)
BETASERONE (Interferon Beta-1B)
COPAXONE (glatiramer)
REBIF (Interferon Beta-1A/ Albumin)
Criteria: Relapsing and remitting multiple sclerosis only
- - 21
Multiple Vitamins
See Vitamins
MUSE (alprostadil) – Effective July 15, 2004
See Impotence, Drugs to Treat
MYAMBUTOL (ethambutol)
See Tuberculosis Medications
MYLOBLOC (botulinum toxin type B)
Indication/Criteria:
Cervical dystonia in adults to decrease the abnormal head position and neck pain associated with
cervical dystonia
NEO-CALGLUCON (liquid calcium)
Criteria:
1. Replacement of calcium in documented calcium deficient patients that require enteral tube
feedings of calcium, etc.
NEPHRO-VITE & NEPHRO-VITE + FE
See Vitamins, Multi
NEXIUM (esomprazole)
See Proton Pump Inhibitors
NIMOTOP (nimodipine) – See PDL Criteria
- - 22
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)/Non-CoxIIs
Drugs:
DURACT (Bromfenac)
MOBIC (meloxicam)
RELAFEN (nabumetone)
Restrictions:
1. Over-the-counter products listed on the OTC Formulary are available without prior authorization
for FDA approved indications
2. Generic products are available without prior authorization for FDA approved indications
3. Based on diagnosis codes and/or age, selective COX-2 inhibitors are available without prior
authorization
Criteria:
1. For single source prescription nonsteroidal anti-inflammatory drugs
a. At least two (2) generically available products have been given adequate trials and
have proven ineffective;
b. Documentation of the Drug, the dose and the length of time for each generic tried is
included ion the prior authorization form;
c. If serious side effects developed or have a real potential of developing, document
them on the prior authorization form.
Note: Once Prior Authorization has been approved for a single source product in this class, the drug
may be changed to another single source product within the approved time period without a new
request. However, the alternative(s) must be listed on the original prior authorization form.
Exception: TORADOL (Ketorolac tromethamine) is not included in this category since it is generally
used for pain and is authorized for a 5 day supply.
Examples of oral products that were single source, but have generics available today are:
Daypro (Oxaprozin)
EC-Naprosyn (Naproxen delayed release)
Lodine (Etodolac)
Oruvail (Ketoprofen SR)
Voltaren (Diclofenac)
Examples of oral products that are single source prescription nonsteroidal anti-inflammatory agents
are:
Duract (Bromfenac)
Mobic (Meloxicam)
Relafen (Nabumetone)
NORDITROPIN (somatropin)
See Growth Hormones
NORMODYNE – See PDL Criteria
NORVASC (amlodipine)
Criteria:
1. Angina
2. May be considered for hypertension if Adalat CC or other calcium channel blockers have proven
to be ineffective after at least a 2-week trial
3. If Adalat or other calcium channel blocker was discontinued due to significant side effects, note
these on the 1144B Form. If these were ineffective, please not the dose and the length of time
used.
Note: Once prior authorization has been approved for one of the products in this category, the drug
may be changed to another product in this class within the approved time period without a new
request. However, the alternative(s) must be listed on the original Prior Authorization form. Over-thecounter products which are listed on the OTC Formulary are available without prior authorization.
- - 23
NUTROPIN (somatropin)
See Growth Hormones
ONTAK (denileukin diftitox)
Indication:
Persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25
component of the IL-2 receptor.
Criteria:
1. Documentation of malignant cells testing positive for CD25 expression
2. Significant reduction in tumor size should be seen prior to the fourth (4 th) course of treatment.
Three (3) treatment cycles (of 5 days each) will be approved initially.
OXANDRIN (oxandrolone)
See Anabolic Steroids
- - 24
OXYCONTIN (Oxycodone)
Authorization requests for use in chronic non-cancer pain for daily dosage exceeding 160mg:
1. Patient must be at least 18 years old.
2. Patient must not be pregnant.
3. Diagnosis must be provided.
4. Strength and total daily dosage must be provided.
5. Documentation of the failure or non-tolerance of at least one other long acting opioid
analgesic.
6. Acceptable reasons for a dosage greater than 160mg per day include:
 Patient has severe, chronic pain and has been referred to a pain specialist. The
name of the pain specialist must be attached. If being seen by a pain specialist, the
name of the pain specialist and the plan of care must be attached.
 The patient is currently physically dependent. A plan of care for the treatment must
be attached.
7. No early refills will be allowed.
Authorization requests for patients with pain related to systemic cancer for total daily doses
exceeding 160mg prescribed by non-oncologists:
1. Diagnosis must be provided.
2. Strength and total daily dosage must be provided.
3. Prior Authorization is required for early refills for dose adjustments, lost or stolen medications.
No authorization requirement for over 160mg per day:
1. Authorization for patients with pain related to systemic cancer will NOT be required if:
 The physician is a Medicaid provider with a specialty in oncology; and
 The patient has systemic cancer; and
 His/her pain is directly related to the cancer
2. Oncologist must provide the pharmacy with the ICD-9 diagnosis.
3. Prior authorization is required for early refills due to dose adjustments, lost or stolen
medications.
Approval Period:
1. For chronic non=cancer pain
 The initial authorization period will be a maximum of three (3) months.
 For subsequent requests for the same or greater dosages, justification and a plan of
care must be submitted.
2. For pain related to cancer, the authorization period will be a maximum of six (6) months.
Pharmacy Requirements:
The pharmacy must provide:
 The NDC numbers of the OxyContin strength(s) requested by the physician on the
authorization form.
 The pharmacy must include the ICD-9 Diagnosis code provided by the physician on
submitted claims.
- - 25
PANCRETIN (alitretinoin)
Indication:
Topical treatment of cutaneous lesions due to AIDS-related Kaposi’s Sarcoma (KS)
Criteria:
1. Systemic anti-KS treatment is not needed. Note on the prior authorization form that no systemic
KS treatment is indicated.
2. Systemic treatment would be indicated in such instances of more than ten (10) new KS lesions in
the prior month, symptomatic lymphedema, symptomatic pulmonary KS or symptomatic visceral
involvement.
Note: Approval period = 14 weeks. Maximum quantity for the approval period = 3 tubes. Submit
another 1144B Form with justification if therapy is needed for longer.
PEPCID (famotidine)
See H2-antagonists
PHOTOFRIN (porfimer sodium)
Indications:
 Palliation of patients with partially or completely obstructing esophageal cancer who cannot
be satisfactorily treated with Nd:YAG laser therapy
 Treatment of microinvasive endobronchial non-small cell lung cancer in patients for whom
surgery and radiotherapy are not indicated.
Criteria: Documentation of one of the above indications
PONSTEL (mefanamic acid) – See PDL Criteria
PRAVIGARD PAC (pravastatin/buffered ASA) – See PDL Criteria
PREVACID (lansoprazole)
See Proton Pump Inhibitors
PRILOSEC (omeprazole)
See Proton Pump Inhibitors
PROCARDIA XL (nifedipine XL)
Criteria:
 Diagnosis of angina
 Considered for hypertension if Adalat CC has proven to be ineffective after a trial of at least 2
weeks
 If Adalat CC was discontinued due to side effects, note these side effects on the 1144B Form. If
Adalat CC was ineffective, please note the dose and the length of time used.
PROCRIT
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
- - 26
Proton Pump Inhibitors
Drugs:
ACIPHEX
NEXIUM
PREVACID
PRILOSEC
PROTONIX (preferred prescription/legend PPI)*
*PRILOSEC OTC is the preferred PPI that does not require prior authorization (listed in OTC Formulary).
Protonix is the preferred PPI after PRILOSEC OTC has been tried/failed within the context of the
information in this section.
Restrictions:
1. A 14-day supply of Protonix may be provided without a prior authorization if a diagnosis of
H.Pylori is noted on the prescription and claim. ICD-9 codes 008.43 or 041.86 are acceptable
diagnosis codes. Any other diagnosis or for a greater length of therapy, prior authorization
approval is required.
2. Internists or pediatricians with a subspecialty of Gastroenterology may prescribe Protonix without
prior authorization if a diagnosis of gastroesophageal reflux disease (GERD) ICD-9 code =
530.81, is noted on the prescription, and the claim. The Prescriber’s specialty must be registered
with the Medicaid program. Other PPIs (except for Protonix) prescribed for any other diagnosis
regardless of prescriber specialty requires prior authorization approval.
Note:
1. H2 blockers do not have to be tried first for prior authorization of Protonix to be approved for
erosive esophagitis, GERD, GERD associated with erosive esophagitis, or Zollinger-Ellison
syndrome.
2. If a PPI is prescribed concurrently with a histamine H2-receptor antagonist (Zantac, Pepcid,
Axid or Tagamet), or sucralfate (Carafate), it will be considered duplicative therapy and will
not be reimbursed if both medications are dispensed by the same provider.
3. Failure of a two-week trial of Protonix and the diagnosis is erosive esophagitis, GERD, GERD
associated with erosive esophagitis, or Zollinger-Ellison syndrome is required before another
PPI can be approved.
4. In a pregnancy situation, Prilosec will not be approved due to a pregnancy C status. Other
PPIs, including Protonix, have a pregnancy B status.
Criteria:
1. The patient must have one of the following diagnosis:
 duodenal ulcer
 gastric ulcer
 erosive esophagitis
 Gatroesophageal Reflux Disease (GERD)
 GERD associated with erosive esophagitis
 hypersecretory conditions (Zollinger-Ellison/ZE syndrome)
2. One of the following situations exists and the diagnosis is duodenal ulcer and/or gastric ulcer:
 failed one or more H2-antagonists (cimetidine, famotidine, or nizatidine, or ranitidine) after at
least a two week course of therapy
 failed or experienced side-effects on Prilosec OTC
 experienced side-effects with two H2-antagonists or Prilosec OTC
Special Situation (Pregnancy):
1. The patient must have one of the following diagnosis:
 erosive esophagitis
 Gatroesophageal Reflux Disease (GERD)
 GERD associated with erosive esophagitis
 hypersecretory conditions (Zollinger-Ellison/ZE syndrome)
PROTONIX (pantoprazole)
See Proton Pump Inhibitors
- - 27
PROTROPIN (somatropin)
See Growth Hormones
PROVIGIL (modafinil)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
PULMILCORT TURBUHALER
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
PYRAZINAMIDE
See Tuberculosis Drugs
QUESTRAN (cholestyramine)
All forms except bulk powder or granular dosage forms were removed from the Formulary. Bars,
chewable forms or pre-measured packets were excluded based on the comparable high cost per
dose.
REBETRON (rebetol [ribavirin] with Intron A)
Indication:
Treatment of chronic hepatitis C in patients with compensated liver disease previously untreated
with alfa interferon or who have relapsed following alpha interon therapy.
Criteria:
1. Compensated Chronic Hepatitis C
2. HCV Antibody Positive
3. Elevated ALT level
REBIF (interferon Beta-1a)
See Multiple Sclerosis Drugs
REGRANEX (becaplerium)
Indication:
Lower extremity diabetic neuropathic ulcers
Criteria:
Diagnosis of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue and
beyond and have an adequate blood supply.
RELAFEN (nabumetone)
See Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
RELENZA (zanamivir)
Restriction: Five (5) day maximum supply.
RELPAX (eletriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
- - 28
REMICADE (infliximab)
Indications:
1. Moderate to severe and fistulating Crohn’s Disease
2. Rheumatoid Arthritis (Diagnosis Code 714.0).
Restriction:
Available without prior authorization if prescribed by a Rheumatologist for the diagnosis of rheumatoid
arthritis.
Criteria:
1. For Crohn’s Disease
A. Diagnosis of moderate to severe or fistulating Crohn’s Disease
B. Other conventional agents such as sulfasalazine, mesalamine derivatives, steroids,
azathioprine, 6-mercaptopure, or metronidazole are ineffective or are not medically
appropriate.
C. Provide the following information on the Request for Medical Authorization (1144B
Form):
1) State treatment with methotrexate has not been adequate or effective or is
not medically appropriate. If not medically appropriate, explain.
2) Provide the name of at least one (1) other DMARD that has not been
effective.
Note: If the infusion is to be done in the home setting, home pharmacy services and supplies
related to the infusion of Remicade must be prior authorized.
RESPIRDAL (respiridone)
See Atypical Antipsychotics
- - 29
RespiGam (human respiratory syncitial virus [RSV] immune globulin)
Indication:
Prevention of Serious Lower Respiratory Tract Infections caused by Respiratory Syncytial Virus
(RSV).
The following guideline for the prevention of RSV and coverage of this agent by Hawaii QUEST
medical plans and the Fee-For-Service Medicaid Program have been developed by the medical
directors in consultation with the University of Hawaii School of Medicine’s Pediatric Infectious
Disease Group.
Guideline:
Patients who should be considered for RSV prophylaxis should be in one or more of the following
groups:
 Premature infants with BPD and who are on supplemental oxygen and less than eight (8) months
chronological age [corrected age of less than six (6) months] as of December of the year of their
birth.
 Infants born at less than 32 weeks gestation with a history of one or more respiratory tract
infections which required hospitalization who are under eight (8) months age [corrected age of
less than six (6) months] as of December of the year of their birth.
 Infants 28 weeks gestation or less and who are less than twelve (12) months of age at the start of
the RSV season.
 Infants and children less than two (2) years of age at the start of the RSV season with chronic ling
disease (CLD) who were receiving long term medical therapy for treatment of their CLD within six
(6) months before the anticipated RSV season.
Recommended Treatment:
 Maximum of four (4) monthly doses to start as early as late October and to end no later than
March.
 RespiGam is indicated for the PREVENTION of RSV and should NOT be used in patients who
have RSV infections.
Additional Consideration:
 The physician must weigh the side effects of this agent against the benefit gained from preventing
RSV infections.
 RespiGam should not be administered at the same time as routine childhood immunizations and
may interfere with response to immunizations.
 RespiGam is not approved by the Food and Drug Administration (FDA) for use in patients with
congenital heart disease (CHD). RespiGam is contraindicated in cyanotic CHD.
RETIN-A (tretinoin)
See Acne Drugs
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RETUXIN (retuximab)
Criteria:
Diagnosis of relapsed or refractory low-grad or follicular, CD20+, B-cell Non-Hodgkin’s Lymphoma
RIFADIN (rifampin)
See Tuberculosis Drugs
RIFAMATE (rifampin/isoniazid)
See Tuberculosis Drugs
RIFAMPIN
See Tuberculosis Drugs
RISPERDAL (risperidone)
See Atypical Antipsychotics
RITALIN & RITALIN LA (methylphenidate)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
SAIZEN (somatropin)
See Growth Hormones
SECTROL (acebutolol) – See PDL Criteria
SEROQUEL (quetiapine)
See Atypical Antipsychotics.
SEROSTIM (somatropin)
Indication/Criteria:
Treatment of AIDS wasting syndrome and cachexia
SPORANOX (itraconazole)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
STRATTERA (atomoxetine)
See Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) /Narcolepsy
SULAR (nisoldipine) – See PDL Criteria
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SYNAGIS (palvizumab)
Indication:
Prevention of serious lower respiratory tract infections caused by Respiratory Syncytial Virus (RSV).
The following guidelines for the coverage of this agent by the Fee-For-Service Medicaid Program
have been by the medical directors in consultation with the University of Hawaii School of Medicine’s
Pediatric Infectious Disease Group.
Guideline:
Patients who should be considered for RSV prophylaxis should be in one or more of the following
groups:
 Premature infants with BPD and who are on supplemental oxygen and less than eight (8) months
chronological age [corrected age of less than six (6) months] as of December of the year of their
birth.
 Infants born at less than 32 weeks gestation with a history of one or more respiratory tract
infections which required hospitalization who are under eight (8) months age [corrected age of
less than six (6) months] as of December of the year of their birth.
 Infants 28 weeks gestation or less and who are less than twelve (12) months of age at the start of
the RSV season.
 Infants and children less than two (2) years of age at the start of the RSV season with chronic
lung disease (CLD) who were receiving long term medical therapy for treatment of their CLD
within six (6) months before the anticipated RSV season.
 All children 2 years or younger at the beginning of the season with hemodynamically significant
Congenital Heart Disease (CHD) requiring medical management such as medication to control
congestive heart failure, infants with cyanotic heart disease, or infants with moderate to severe
pulmonary hypertension.
Recommended Treatment:
 Maximum of five (5) doses to start as early as late October and to end no later than February.
 Please note that the beginning of the season this year for Hawaii will be considered to be October
15.
 Synagis is indicated for the PREVENTION of RSV and should NOT be used in patients who have
RSV infections.
Additional Consideration:
 The physician must weigh the side effects of this agent against the benefit gained from preventing
RSV infections.
 Synagis is not approved by the Food and Drug Administration (FDA) for use in patients with
congenital heart disease (CHD).
 As Synagis is given intramuscularly, it must be used with caution in patients with
thrombocytopenia and coagulation disorders.
 A second (2nd) course of Synagis therapy in the following season is rarely indicated.
SYNVISC
Billing is restricted to ACS/Fiscal Agent using the Medicare HCPCS code for this specific agent.
TAGAMET (cimetidine)
See H2-antagonists
TAMIFLU (oseltamivir phosphate)
Restriction: Five (5) day supply only
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TAXOTERE (docetaxel)
Indication:
1. Anthrycline resistant breast cancer.
2. Unresectable locally advanced or metastatic non-small cell lung cancer in patients who have not
received prior chemotherapy, as first-line treatment in combination with cisplatin.
3. Treatment of locally advanced or metastatic non-small cell lung cancer after failure of prior
platinum-based chemotherapy.
Criteria: Documentation of one of the above indications
TENUATE (diethylpropion)
See Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
TEVETEN (eprosartan) – See PDL Criteria
TEVETEN HCT (eprosartan/HCTZ) – See PDL Criteria
TEV-TROPIN (somatropin)
See Growth Hormones
THALOMIDE (thalidomide)
See Anti-Leprotic
TORADOL (ketorolac tromethamine)
Restriction: Five (5) day supply only
TRITEC (ranitidine bismuth citrate)
Indication:
Treatment of active duodenal ulcer associated with H. Pylori infection and used in conjunction with an
antibiotic (like Biaxin or other antibiotic deemed necessary by the prescriber.) This is not intended to
be prescribed alone.
Restrictions:
Tritec is available without prior authorization when both of the following apply and included in the
claim:
1. Diagnosis for H. Pylori (Diagnosis Code 041.86 or 008.43)
2. Days supply does not exceed 28 days.
Criteria:
 H. Pylori diagnosis
 Treatment longer than 28 days, will require a PA and justification for the extended therapy must
be documented.
Note: In cases of multiple treatments, pharmacists are encouraged to use appropriate drug utilization
review considerations.
Tuberculosis Drugs
Drugs:
ETHAMBUTOL
ISONIAZID
MYAMBUTOL (ethambutol)
PYRAZINAMIDE
RIFAMATE (rifampin/isoniazid)
RIFADIN (rifampin)
Criteria:
 Diagnosis other than pulmonary TB with the exception of INH use in children for
chemoprophylaxis (see Isoniazid-specific Criteria)
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UNASYN PIGGYBACK (ampicillin sodium/sulbactam)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
VALSTAR (valrubicin)
Indication/Criteria:
Bladder Cancer – for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary
bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity
or mortality.
VESANOID (tretinoin)
Indication/Criteria:
Acute Promyeloytic Leukemia (APL) for a maximum of 90 days.
VIADUR (leuprolide acetate)
See Gonadotropin-Releasing Hormone Analog
VIAGRA (sildenafil citrate) – Effective July 15, 2004
See Impotence, Drugs to Treat
VICON FORTE & VICON PLUS
See Vitamins
VICOPROFEN (hydrocodone w/ibuprofen)
Indication:
Analgesia
Criteria:
Documentation of trial and failure on other similar combination products, which are much less
expensive.
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VIOXX (rofecoxib)
Indication:
1. Osteoarthritis
2. Rheumatoid Arthritis
3. Degenerative joint disease
4. Primary Dysmenorrhea
5. Acute Pain
Restriction:
Vioxx is available without prior authorization when both of the following exists and included on the
claim:
1. Recipient is over age 60
2. Diagnosis of osteoarthritis or degenerative joint disease (Diagnosis Code 715.9).
Criteria for Recipients 60 years of age and under:
1. Diagnosis of osteoarthritis, rheumatoid arthritis, degenerative joint disease, primary
dysmenorrhea, or acute pain
2. At least one of the following documented under “justification” on the Request for Medical
Authorization (1144B Form):
 History of gastrointestinal bleed or gastric or duodenal ulcer
 History of symptoms of peptic ulcer disease, gastritis, or gastroesophageal reflux disease
while on conventional NSAID(s)
 Concurrent use of corticosteroids
 Concurrent use of warfarin or heparin
 History of platelet dysfunction or coagulopathy
Note: For Recipients with a diagnosis of acute pain, Vioxx will only be prior authorized for a
MAXIMUM of three (3) months. After this time period, the pain will be considered chronic and other
management strategies should be considered.
VITAMINS, Multi
Vitamins are covered, without prior authorization, under the following circumstances:
 Multivitamins covered for Recipients with End-Stage Renal Disease (ESRD)
 Multivitamin 1 tablet/capsule or 5 mls liquid covered for Nursing Home Recipients
 Pediatric multivitamins covered for Recipients age 12 and younger
 Prenatal multivitamins covered for Recipients with a diagnosis of pregnancy or lactation
VITAMINS, Multiple with or without Fluoride
Criteria:
1. Patient must have a demonstrated vitamin deficiency
2. Patient must meet one of the following diagnosis/ conditions:
 Age 12 and younger
 Mental retardation
 Spastic quadriplegia with gastrointestinal (GI) problems
 Tube feeding
 Low body weight
 Osteoporosis
 Recipient with compromised physical condition such as the elderly with poor nutrition,
alcoholism with cirrhosis
 Recipient with electrolyte imbalance
 Recipient is in a skilled nursing facility on a long-term basis
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VITAMIN B12
Restriction:
No prior authorization is required if one of the following diagnosis applies and included in the claim:
Malabsorption syndrome of Vitamin B12 due to gastrectomy
579.3
Pernicious anemia
281.0
Other Vitamin B12 anemias
281.1
Vitamin B12 and Folate anemia
281.3
Vitamin B12 deficiency
266.2
Criteria: Document one diagnosis listed and medical necessity.
VITAMIN C
Indications:
1. Scurvy – prevention and treatment
2. Acidify the urine
Restriction:
No prior authorization is required if the diagnosis is Urinary Tract Infection. Use one of the following
ICD-9 codes: 582.0-582.9; 590.0-590.01; 595.1; 595.2 must be included on the claim.
Criteria: Document one diagnosis listed and medical necessity.
WELCHOL (colesevelam) – See PDL Criteria
WINSTROL (stanozolol)
See Anabolic Steroids
XANAX XR (alprazolam, extended release) – Effective July 15, 2004
Indication: Treatment of panic disorder, with or without agoraphobia
Criteria:
 Recipient must have a diagnosis of panic disorder (300.1) or panic disorder with agoraphobia
(300.21)
 Recipient has a documented failure on immediate-release alprazolam
XENICAL (orlistat)
Indications:
1. For patients with an initial Body Mass Index (BMI) greater than or equal to 30kg/m² in the
presence of at least one other risk factor such as hypertension, sleep apnea, diabetes,
dyslipidemia, coronary heart disease or other artherosclerotic diseases
2. Maintenance of weight loss
Criteria:
1. Must be for one of the indications noted above
2. Used in conjunction with a reduced calorie diet.
Note: A daily multivitamin is recommended while taking Xenical, but is not a requirement for prior
authorization. A multivitamin will be approved if used in conjunction with Xenical. If a multivitamin is
not included on the prior authorization with Xenical and a separate request is submitted, please state
it is being used in conjunction with Xenical to expedite approval.
Provide all of the following information on the Request for Medical Authorization (1144B
Form):
1. For initial weight loss, state the recipient’s BMI or provide the height and weight. If the BMI is
equal to or greater than 27kg/m² but less than 30kg/m², state at least one risk factor
2. For subsequent weight loss or for maintenance of weight loss, provide the initial and current BMI
3. State Recipient is on a reduced calorie diet
Note: Initial approval will be for a maximum of 3 months. If there is weight loss or the recipient has
been able to maintain prior weight loss during this initial period, subsequent prior authorization
requests may be approved up to a maximum of 6 months.
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XOLAIR (omalizumab) – Effective July 15, 2004
Indication: For adults and adolescents 12 years of age and older with moderate to severe persistent
asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and those
symptoms are inadequately controlled with inhaled corticosteroids.
Criteria:
 Recipient is 12 years old and greater
 Recipient has a diagnosis of moderate to severe persistent asthma
 Recipient continues to experience asthma symptoms on an inhaled corticosteroids, long-acting
beta-agonists, theophylline, leuketriene modifiers, and/or long-term oral corticosteroid treatment
 Recipient has shown evidence of a specific allergy sensitivity by a positive skin test or in vitro
reactivity for a specific IgE
 Recipient has an IgE level between 30 IU/ml – 700 IU/ml
XYREM (oxybate)
Indication:
Cataplexy associated with narcolepsy
Criteria:
 Documentation of the diagnosis of cataplexy associated with narcolepsy (Diagnosis Code is 347)
and the medical necessity.
 Documentation of treatment failures for this diagnosis (by primary physician or specialist
evaluation).
 Evaluation by a Prescriber with a specialty in Neurology at least once a year. Name of
neurologist an date of evaluation must be stated on the PA request. The treatment plan must
also be attached.
Note:
 Initial approval is for up to three (3) months only
 Recommended starting daily dose is 9 milliliters/day (4.5 grams/day). Maximum daily dose is 18
milliliters/day (9 grams/day)
 Continued coverage requires documentation from the Provider that the patient is responding to
therapy; therefore, subsequent three (3) months of therapy can be considered.
ZANTAC (ranitidine)
See H2-Antagonists
ZELNORM (tegaserod)
Indication:
Short-term treatment of women with Irritable Bowel Syndrome (IBS) whose primary bowel symptom is
constipation.
Criteria
 Female patients only
 Documented diagnosis of IBS with primary bowel symptom of constipation
Note:
 Maximum allowable quantity is 60 tablets per month
 Initial approval is for up to two months only
 Continued coverage requires documentation that the patient is responding to therapy. The
authorization period will be up to an additional two months.
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ZETIA (ezetimibe)
Indication:
1. Primary hypercholesterolemia
2. Homozygous familial hypercholesterolemia
3. Homozygous sitosterolemia
Criteria:
 Documented diagnosis and medical necessity for treatment of primary hypercholesterolemia,
homozygous familial hypercholesterolemia or homozygous sitosterolemia.
 Treatment failure with at least two (2) other cholesterol-reducing compounds documented as
inadequate, ineffective, or not medically appropriate. If not medically appropriate, explain.
Note:
 Initial approval for three (3) months (maximum of one (1) tablet/day).
 Subsequent approvals up to three (3) moths (maximum of one (1) tablet/day) with documented
initial and subsequent lab values of LDL cholesterol and total cholesterol.
ZEVALIN (ibritumomab tiuxetan)
Billing is restricted to ACS/Fiscal Agent using the Medicare HCPCS code for this specific agent.
ZOFRAN (ondansetron)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
ZOMIG (zolmitriptan)
Prior Authorization required if Maximum Standard Dose exceeded. See Maximum Standard Dose.
ZYPREXA & ZYPREXA ZYDIS® (olanzapine)
See Atypical Antipsychotics
ZYRTEC & ZYRTEC-D (cetirizine)
See Antihistamines & Antihistamine Combinations
ZYVOX (linezolid)
Indications:
1. Vancomycin-resistant Enterococcus faecium
2. Nosocomial pneumonia
3. Complicated skin and akin structure infections
4. Uncomplicated skin and skin structure infections
5. Community acquired pneumonia
Note:
A diagnosis code must be submitted on the claim or the claim will reject for “PA Required”.
Restriction: Fourteen (14) day supply per dispensing
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