ABRAXANE

1. Recipient must have a diagnosis of metastatic breast cancer
2. Recipient must have failed a taxane (Taxol or Taxotere) or anthracycline (Doxorubicin, Daunorubicin) containing chemotherapy regimen in previous 6 months.

Restriction:
· Maximum of 8 vials per month.

Acne Drugs

Criteria:

• Diagnosis of a medically indicated skin condition, including acne and other dermatoses.
• For Retin-A, Altinac and Avita 0.025% gel, if diagnosis code = 701.8 or blank on the claim for recipients age 31 and older, the claim will DENY

ACTIQ

Actiq claims with DOS' prior to 10/27/04 will not require a PA but those after will.

Cancer Diagnosis
All criteria must be met for Actiq approval:

1. Patient must have a diagnosis of systemic cancer.
2. Patient must be using Actiq only for break-through pain.
3. Patient must have had a physical examination within one year of PA request. Date of examination required on 1144B form.
4. Patient must be concomitantly treated with one of the following narcotic analgesic drugs for one week or longer:
   • Avinza 
   • Codeine sulfate or phosphate
   • Darvon 
   • Demerol 
   • Dilaudid 
   • Duragesic 
   • Levo-dromoran 
   • Methadone HCL
   • Morphine sulfate, IR, ER, & SR
   • MS Contin 
   • Numorphan 
   • Oxycodone IR
   • Oxycontin

Patient must be opioid tolerant (i.e., able to tolerate the drugs listed in #2 above). An example of opioid tolerant patients are those who are taking > 60mg morphine per day or 50 mcg transdermal fentanyl per hour for greater than one week.

Non-Cancer Diagnosis
All criteria must be met for Actiq approval:

1. Patient must have a diagnosis other than cancer that causes a significant amount of pain.
2. Patient must be using Actiq only for break-through pain.
3. Patient must have had a physical examination within one year of PA request. Date of examination required on 1144B form.
4. Patient must be failed or experienced side effects to at least two of the following short-acting narcotic analgesic:
- Codeine sulfate or phosphate
- Darvon
- Demerol
- Dilaudid
- Methadone HCL
- Morphine sulfate, IR
- Numorphan
- Oxycodone, IR
5. Patient must be on a long-acting narcotic analgesic:
- Avinza
- Duragesic
- Levo-dromoran
- Morphine sulfate, ER, & SR
- MS Contin
- Numorphan
- Oxycodone IR
- Oxycontin

Patient must be opioid tolerant (i.e., able to tolerate the drugs listed in #2 above). An example of opioid tolerant patients are those who are taking > 60mg morphine per day or 50 mcg transdermal fentanyl per hour for greater than one week.

ACTONEL
Restriction: For 35mg tablet, 4 tablets per month.

ALTACE
An Altace® claim will process without PA if it is submitted with one of the following ICD-9 codes after the recipient’s diagnosis has been confirmed to be one of the following: 402.90 or 402.91 (Unspecified Hypertensive Heart Disease), 436.00 (Acute, But ill-defined, Cerebrovascular Disease), 250.00 through 250.93 (Diabetes Mellitus), or 272.0 through 272.9 (disorders of lipid metabolism).

AMERGE
Restriction: 9 tablets per month

AMITIZA
Approval criteria requires the following:
A diagnosis of Chronic Idiopathic Constipation*; AND
Failure of conventioal therapy**; AND
At least 18 years of age: AND
No history of mechanical gastointentinal obstruction.

* Diagnosis of Chronic Idiopathic Constiation is defined as constipation lasting for longer than six months with more than three complete spontaneous bowel movements per week that involves straining, incomplete evacuation and/or hard stools. Patients with chronic constipation should not have any form of Irritable Bowel Syndrome (IBS) ( diarrhea-predominant, constipation-predominant or mixed-type IBS) or loose stools at amy time.

**Conventional therapy includes the followin:
Bulk Laxatives: (at least two): fiber, psyllium, polyearbophil, methylcellulose.
Stimulants (at least two): bisacodyl, senna, castor oil.
Osmotic (at least one): Lactulose, Polyethylene glycol (Miralax®), Polyethylene glycol w/ electrolytes, sorbitol.
Stool Softeners: docusate (with or without sasathranol), glycerin suppository, mineral oil.
A trial of at least five from the list above (with or without stool softeners) must be documented on the PA request form.

NOTE:

The maximum allowable quantity is 60 tablets per month.
The initial approval is for up to three months only.
Continued coverage requires documentation that the patient is responding to therapy.
Up to three additional authorizations for a maximum of three months per each will be allowed.

Anabolic Steroids
Criteria: FDA indications 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 239.0-239.9. 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.

Antihistamines & Antihistamine Combinations
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, CLARINEX-D, 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
Allegra® oral tablets
An Allegra® claim will process without PA if the recipient has one of the following diagnoses and the ICD-9 code is submitted on the claim: 708.0 through 708.9 (chronic urticaria) or 277.6 and/or 995.1 (angioedema).

Loratadine and loratadine D OTC
A loratadine OTC and loratadine D OTC will process with out a PA if the recipient is less than 21 years of age or over 60 years of age.

Zyrtec® oral formulations
A Zyrtec® claim will process without PA is the recipient has one of the following diagnoses and the appropriate ICD 9 code is submitted with the claim: 708.0 through 708.9 (chronic urticaria) or 277.6 and/or 995.1 (angioedema).

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, CLARINEX-D, CLARITIN-D, ZYRTEC-D

Anti-Leprotic
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: Claim will deny if one of these diagnosis codes is present. Claim will require PA if diagnosis code is missing. Claim will continue adjudication if any other diagnosis code is present.

Antisera
Restriction:
PA required for the following ICD-9 codes
· 635.0 - 635.9

Appetite Suppressants/Anorexiants/Fat Absorption Decreasing
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
Criteria:
1. PA not required if prescribed by a Rheumatologist and ICD-9 =714.0 (rheumatoid arthritis or psoriatic 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 (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.

ARICEPT ODT
Criteria: Patient must have a diagnosis of dysphagia
ATACAND
*Atacand® oral tablets
An Atacand® claim will process without PA if the recipient has heart failure and an ICD-9 code of 428.0 through 428.9 (heart failure) is submitted with the claim and if the recipient is concurrently on ACE Inhibitor therapy within the last six months.
ATROVENT/ATROVENT HFA
Restriction: Atrovent, 29.4 grams per month
Atrovent HFA, 25.8 grams per month

Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder
(ADHD)/Narcolepsy

Criteria (for all drugs in this class):
Indication:
a. Attention deficit disorder
b. Hyperkinesis
c. Narcolepsy

Restriction (for all drugs in this class):
A prior authorization is not required if one of the following diagnosis codes is entered on the claim:
· 314, 314.0, 347, 347.0

ATYPICAL ANTI-PSYCHOTICS

Abilify
Indications:
· Management of severely ill schizophrenic patients who fail to respond adequately to standard anti-psychotic drug treatment
· Refractory or non-refractory schizophrenics

Clozapine
Indication: Psychotic disorders. Management of severely ill schizophrenic patients who fail to respond adequately to standard anti-psychotic drug treatment

Geodon
Indication: Treatment of schizophrenia

Risperdal, Risperdal-M, & Seroquel
Indication: Bipolar disorder and Psychotic disorder (management of the manifestations of psychotic disorders)

Zyprexa
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

AVONEX
Criteria: Relapsing, remitting multiple sclerosis for ambulatory patients only; ICD-9 = 340.0


AXERT
Restriction: 6 tablets per month

AZELEX
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


BETASERON
Criteria: Relapsing, remitting multiple sclerosis for ambulatory patients only; ICD-9 = 340.0

BEXXAR
The following Criteria must be met and documented on the PA request (Form 1144B) for PA approval:

A. Diagnosis of CD20 antigen-expressing relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin's lymphoma AND
B. Provider must be participating in the certification program or have been certified in the preparation and administration of Bexxar® therapeutic regimen prior to requesting a PA approval.
Exclusion: Bexxar® is NOT indicated for the initial treatment of patients with CD20 positive non-Hodgkin's lymphoma.

A single course of treatment includes both the dosimetic and therapeutic steps of which tositumomab and iodine I 131 tositumomab are utilized in each step. The specific drug is billable by its unique NDC number to the PBM for unites in milliliters (ml).

NOTE: The medical service of administration continues to be billed to the Medical FA without change.

BONIVA
Restriction: 150mg tablet - 1 tablet per 30 days.

BOTOX
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
Recipients must have one of the following approved FDA indications:
1. Eye muscle disorders limited to blepharospasm and strabismus
Or
2. Cervical dystonia to reduce the severity of abnormal head position and neck pain associated with moderate to severe cervical dystonia
Or
3. Spasmotic dysphonia

CAMPTOSAR
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 colon or rectal 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
Restriction:
· Maximum quantity is 60mls per month.

CARISOPRODOL

Restriction: 120 tablets per month

CARRASYN GEL
Physician must submit documentation of medical necessity in order for the product to be approved.

CELEBREX
Existing clinical criteria for Celebrex will be applied through the SmartPA program.

Claims for Celebrex will process for the following current clinical criteria:

1. Recipients with a diagnosis (submitted at the point-of-sale or in the two-year medical history) of familial adenomatous polyposis (FAP – ICD9 211.3).

2. Recipients with a diagnosis (submitted at the POS or in the two-year medical history) of ankylosing spondylitis, degenerative joint disease (DJD), osteoarthritis (OA), or rheumatoid arthritis (RA) AND with one of the following risk factors:

a. Age greater than 60 years.
b. Diagnosis of a GI bleed, GI perforation, gastric or duodenal ulcer, or peptic ulcer disease in two-year medical history.
c. Currently receiving (in previous 45 days) an oral or parenteral steroid, an anticoagulant, or methotrexate.
d. Diagnosis of a platelet dysfunction or coagulopathy in two-year medical history.
e. Failure of a 14-day trial of two different non-selective NSAIDs in the previous 60 days.

· Providers may call into the ACS PBM Call Center at 1-877-439-0803 for assistance if the recipient has one of the diagnoses listed in number 2 above AND had symptoms of peptic ulcer disease, gastritis, or GERD while taking conventional NSAIDs. The prescriber or pharmacist must specify the symptoms/side effects experienced, specify the medication tried and provide his/her name, as intervention provider.

· For the treatment of primary dysmenorrhea, acute pain, or any other indication not listed above, a submission of an 1144B form is still required. The form must be completed citing appropriate references and faxed to ACS PBM at 1-888-335-8474.

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.

Cholinesterase Inhibitors – See PDL Criteria
Drugs: Reminyl – Effective 3/2/05
· If a recipient has a previous claim history of therapy with a different cholinesterase inhibitor within the last 12 months then a claim for Reminyl® will not require PA.
· If previous treatment with another cholinesterase Inhibitor occurred more than 12 months ago then the prescriber and pharmacy will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk.

Aricept – Effective 3/2/05
· If a recipient has a previous claim history of therapy with a different Cholinesterase Inhibitor within the last 12 months then a claim for Aricept® will not require PA.
· If previous treatment with another Cholinesterase Inhibitor occurred more than 12 months ago then the prescriber and pharmacy will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk.
· A claim for a recipient currently on Aricept® prior to March 2, 2005 will automatically (via the system) be given a one year (from April 6, 2005 to April 5, 2006) extension. In this one year extension period, prescribers will need to either change to a preferred agent or have a prior authorization approved. Claims for recipients just starting on Aricept® processed on or after March 2, 2005 will be subject to PA.

COMBIVENT
Restriction: 29.4 grams per month

COMBUNOX
Criteria:
· Recipient must have had a documented trial and failure on oxycodone/APAP or ASA products.

Restrictions:
· For Acute pain only
· 4 tabs/24 hours

COPAXONE
Criteria: Relapsing, remitting multiple sclerosis for ambulatory patients only; ICD-9 = 340.0

CUBICIN
Criteria:
· Recipient must have severe skin infection.
· Physician must submit appropriate documentation showing that the cultures are sensitive to Cubicin and no other antibiotic can be used
DAUNOXOME
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.
· If diagnosis code=176.9, PA not required.


DETROL
· Detrol 1mg and 2 mg, brand is preferred and generic is non-preferred.

DIFLUCAN
Restriction: Diflucan 50 mg, 100 mg, 200 mg - 60 tablets per month
Diflucan 150 mg - 2 tablets per month

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:
a. metoclopromide
b. phenothiazine.
c. 5-HT3 antagonists
i. Anzemet (dolasetron)
ii. Kytril (granisetron)
iii. Zofran(ondansetron)
d. corticosteroids
i. dexamethasone
ii. methylprednisolone
iii. prednisone

ELIDEL CREAM – Preferred Effective 03/02/05
Criteria:
· Reserved for mild to moderate atopic dermatitis in nonimmunocompromised patients in whom alternative, conventional therapy is deemed inadvisable, for short term and intermittent long-term therapy. Recommended use of Elidel is for short periods of time, not continuously using the minimum amount to control the patient’s symptoms.
· Recipient is 2 years of age and older.

ELOXATIN
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 5-FU/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 – 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
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.
4. Moderate to severe plaque psoriasis

Restriction:
PA not required if prescribed by a Rheumatologist and ICD-9 =714.0 (rheumatoid arthritis or psoriatic 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.
5. Diagnosis of moderate to severe plaque psoriasis
a. Patient must be 18 years of age or older
b. Patient must have a diagnosis of moderate to severe plaque psoriasis
c. Patient must try and fail at least 2 other topical anti-psoriatic agents in the previous 6 months

EPOGEN
Restriction: 33 ml total per month

FENTANYL PATCH PRIOR AUTHORIZATION (PA) CRITERIA
For Oncologists:
No PA Required.

For Non-Oncologists :
Existing PAs will be grandfathered, such that approval periods will be allowed to expire.

An ICD-9 is required for all claims to process.
The pharmacy must provide the NDC for all strengths required on the PA form and include the ICD-9 diagnosis code provided by the prescriber on submitted claims.

Changes are as follows in Table 2.

Table 2: Fentanyl Patch PA Criteria for Non-Oncologists

ICD-9*

Quantity per 30 days

PA Criteria Generic

Approval Period

PA Criteria

Brand
Approval Period

Cancer related pain =

140 - 239

< or = 11

Required for early refills

Specific for one date of service

Required for early refills on dose adjustment, lost or stolen medication

Up to twelve (12) months

> 11
1. Strength and dose (mcg per 3 days) AND2. Quantity;

3. Required for early refills

Up to twelve (12) months
Document:

1. Generic tried and failed OR

2. Not medically appropriate PLUS

3. Strength and dose (mcg per 3 days) AND

4. Quantity OR

5. Early refills on dose adjustment, lost or stolen medication

Up to twelve (12) months
Pain NOT telated to Cancer 001-230.0, 280-289.9, 320-359,9, 390-629, 680-759.9, 800-999.9
< or = 11

Required for early refills

Specific for one date of service

Document:
1. Generic tried and failed OR

2. Not medically appropriate OR

3. Early refill on dose adjustment, lost or stolen medication

Up to three (3) months
> 11
1. Strength and dose (mcg per 3 days) AND

2. Quantity;

3. PA required for early refills

Up to three (3) months
Document:

1. Generic tried and failed OR

2. Not medically appropriate PLUS

3. Strength and dose (mcg per 3 days) AND

4. Quantity OR

5. Early refills on dose adjustment, lost or stolen medication

Up to three (3) months
* For all other ICD-9, justification must be documented on the PA request
FLOLAN
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 – Not Covered

FOSAMAX
Restriction:
For all tablets (including the Fosamax + D formulation), 4 tablets per month.
Fosamax Oral Solution, 300 ml/month

FROVA
Restriction: 9 tablets per month

GARDASIL
Restriction:
· Ages 19 to 26

GEMZAR
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.
· Pancreatic cancer previously treated with 5-FU (Fluorouracil)
· Combination therapy with paclitaxel as first-line treatment of metastatic breast cancer after failure of anthracycline-containing chemotherapy (unless anthracyclines were contraindicated)
· Ovarian Cancer - Gezmar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 onths after completion of platinum-based therapy.

Criteria: Documentation of one of the above indications

GLEEVEC
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.

Gonadotropin-Releasing Hormone Analog
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) (ICD-9 = 259.1) for children (recipients age, 21) without a PA

Criteria:
A. For LUPRON approval:
1. Documented failure or significant side-effects to Zoladex, Trelstar, or Eligard
2. One of the following diagnosis:
· Central Precocious Puberty (CCP) for children (Lupron does not require PA for Recipients less than 21 years old with a CCP diagnosis.)
· Endometriosis
· Prostrate Cancer (CA)
· Uterine leiomyomata (fibroids)
B. For VIADUR approval:
1. Diagnosis of advanced prostate cancer.
2. Recipient must have a documented successful trial of Zoladex, Trelstar, Eligard and/or Lupron Depot.
C. For VANTAS approval:
1. Need diagnosis of advanced prostate cancer
2. Documented failure or significant side effects to Zoladex, Trelstar or Eligard.

Growth Hormones
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.

H-2 Receptor Antagonists (H2RAs)

Existing clinical criteria for the H2 receptor antagonists (H2RAs) will be applied through the SmartPA program with a change in diagnosis and dosing requirements and intervention documentation via phone to ACS PBM Call Center.

· NOTE: NEW – A diagnosis code will no longer be required for OTC H2RAs.

· NOTE: NEW – All claims, except those for the treatment of hypersecretory conditions, are subject to dosing limits. Generic prescription H2RAs with a federal upper limit (FUL) or state maximum allowable cost (SMAC) will process if dosing guidelines are met. If the recipient has a hypersecretory condition but the diagnosis is not in the recipient’s two-year medical history, the prescriber or pharmacist may call the ACS PBM Call Center at 1-877-439-0803 to document the recipient’s diagnosis and provide his/her name as intervention provider.

· NOTE: Claims will reject for duplicative therapy if there is an active prescription for another antiulcer drug [e.g., a proton pump inhibitor (PPI), a PPI-containing product, sucralfate, or another H2RA] that was dispensed by the same pharmacy. If the initial agent has been discontinued, the prescriber or pharmacist may call the ACS PBM Call Center at 1-877-439-0803 to document the reason the initial agent was discontinued and provide his/her name as intervention provider.
Claims for brand prescription H2RAs will process for the following current clinical criteria:

1. Recipients with a diagnosis of peptic ulcer disease, gastritis, duodenitis, Zollinger-Ellison syndrome or other hypersecretory conditions, gastroesophageal reflux disease (GERD), or heartburn [submitted at the point-of-sale (POS) or in the two-year medical history] AND with at least a 14-day trial with a generic prescription product in the previous 60 days.
2. Ranitidine syrup for recipients younger than 21 years of age with a diagnosis of GERD (submitted at the POS or in the two-year medical history) OR who have a gastrostomy (in the two-year medical history)

· Prescribers or pharmacists may call into the ACS PBM Call Center at 1-877-439-0803 for assistance if the brand product is needed AND the recipient has one of the conditions listed in number 1 above AND either developed or has the potential to develop serious side effects to generic products. The prescriber or pharmacist must specify the symptoms/side effects of concern and provide his/her name as intervention provider.
· Prescriber, pharmacist or technician may call into the ACS PBM Call Center at 1-877-439-0803 for assistance if the brand product is needed AND the recipient has one of the conditions listed in number 1 above AND was discharged from the hospital in the previous 60 days on acute therapy. The prescriber or pharmacist or technician must provide the date the recipient was discharged from the hospital and his/her name as intervention provider. Smart PA will verify clinical criteria every six months.
Maximum Standard Doses
HEPSERA
Restriction: 1 tablet per day

HERCEPTIN
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

Restriction:
3 vials/month

Herpetic Antivirals
Drugs: Valtrex – Effective 3-2-05
§ Criteria: When a recipient needs Valtrex® and is immunocompromised (i.e., HIV positive, transplant recipient, etc),the pharmacist and prescriber will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk for expedited review.
.
Zovirax – Effective 3-2-05

HMG CoA Reductase Inhibitors
Drugs: Effective 1/5/05
Lipitor
A claim for Lipitor® 80 mg will be processed without a prior authorization.
A Lipitor claim will process without a prior authorization if a recipient has previous history of therapy with Lipitor within the last six months.
If a recipient has a previous history of therapy with a different HMG-CoA Reductase Inhibitor within the last 6 months then a claim for Lipitor® will not require prior authorization.
If previous treatment with another HMG-CoA reductase inhibitor occurred more than six months ago then the prescriber and pharmacy will need to work together to complete an 1144B form to submit to the ACS PBM PA Desk.

Mevacor - Effective 1/5/05
Pravachol - Effective 1/5/05
Criteria:
a. a. If a patient has a recent prescription (within the last 3 months) for a protease inhibitor or chronic therapy with an oral “azole” antifungal (itraconazole, fluconazole, ketoconazole).
b. b. If a patient has a recent prescription (within the last 3 months) for cyclosporine.
c. c. A patient is contraindicated or intolerant to alternatives for the interacting agents of CYP3A4.
Pravigard PAC - Effective 1/5/05

HUMATROPE
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

Indication:
Moderate to severe active rheumatoid arthritis (Diagnosis Code 714.0)
Moderate to severe Chron's Disease (Diagnosis Code 555.9)

Restriction:
PA not required if prescribed by a Rheumatologist and ICD-9 =714.0 (rheumatoid arthritis or psoriatic arthritis).

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
Indication/Criteria:
· Treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. This is not first-line therapy.
or
· Recipient must have indication for treatment of small cell lung cancer after failure of first-line chemotherapy.

Restriction: 8 vials per month.

IMITREX
No PA needed, when dispensed at or below restricted quantities.
Restriction: Tablets: 9 tablets per month
Kits: 2 kits per month (4 syringes)
Vials: 2 vials per month
Nasal Spray: 6 nasal spray devices per month

Immunosuppressants
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:
· Diagnosis code for Arthritis is 716.9;
· 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.

INSULINS
Criteria:
Exubera Combination Pack or Exubera Kit will require a PA. Patients must be intolerant or unable to use injectable insulin.

IRESSA
Criteria:
1. Diagnosis of locally advanced or metastatic non-small cell lung cancer.
2. Must have failed both platinum- and docetaxel-based chemotherapies.

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. Follow-up of contacts of tuberculin positive individuals is also considered to be the responsibility of the Department of Health.

Note: Drug not covered if diagnosis code=10.0 or 10.8 or 10.9 or 11.0 or 11.1 or 11.2 or 11.4 or 11.8 or 11.9 on claim. PA required if diagnosis code is not present on claim


KINERET
Criteria:
1. Moderately to severely active rheumatoid arthritis;
2. At least 18 years of age; and
3. Failed one or more disease modifying antirheumatic drugs (DMARDS)

Restriction:
PA not required if prescribed by a Rheumatologist and ICD-9 =714.0 (rheumatoid arthritis or psoriatic arthritis).

LAC-HYDRIN

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.

LEVAQUIN
PA is not required for claims submitted with a diagnosis code for cystitis (590.0 - 590.9) or pyelonephritis (595.0 - 595.9)

LIPITOR
A claim for Lipitor® 80 mg will be processed without a prior authorization.
If a recipient has a previous history of therapy with a different HMG-CoA Reductase Inhibitor within the last 6 months then a claim for Lipitor® will not require prior authorization.
If previous treatment with another HMG-CoA reductase inhibitor occurred more than six months ago then the prescriber and pharmacy will need to work together to complete an 1144B form to submit to the ACS PBM PA Desk.

Restriction: 30 tablets per month

LOTRONEX

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. Failure of conventional therapy: Laxatives, Anticholinergics, Antidepressants; and
b. IBS symptoms (diarrhea predominant) are chronic (generally lasting six months or longer).
If approved, the following restrictions 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.


MAXALT
No PA needed, when dispensed at or below restricted quantities.
Restriction: Regular and MLT - 6 tablets per month

MERREM
Restriction: 500 mg is restricted to 360 vials or bottles/month
1 gm is restricted to 180 vials or bottles/month

MERIDIA

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.

MIFEPREX
Criteria: Termination of intrauterine pregnancy through day 49 will be approved

MYOBLOC
Indication/Criteria:
Cervical dystonia in adults to decrease the abnormal head position and neck pain associated with cervical dystonia

NASAL Corticosteroids
Restriction: For adults (³12): 8.6 grams per 30 days.
For Children: 8.6 grams per 60 days.


NEO-CALGLUCON
Criteria:
1. Replacement of calcium in documented calcium deficient patients that require enteral tube feedings of calcium, etc.

NEPHRO-VITE & NEPHRO-VITE + FE
· A PA is not required for the following ICD-9 Codes:
o V22.0, V22.1, V22.2, 611.6, 675.2, 676.4, 676.5, 676.6, 676.8, 676.9, 585.0

Restriction: For Plan 200 patients, no diagnosis code is required. Limit 1 tablet/day.

NEURONTIN

Effective 10/6/04 all Neurontin claims require the recipient's diagnosis (ICD-9 format) be submitted on the claims (POS, batch or paper). If a diagnosis is not on the claim, it will be denied.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)/Non-Cox IIs
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
EC-Naprosyn
Lodine
Oruvail
Voltaren

Examples of oral products that are single source prescription nonsteroidal anti-inflammatory agents are:
Duract
Mobic
Relafen

ONTAK

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 (4th) course of treatment. Three (3) treatment cycles (of 5 days each) will be approved initially.

Restriction: 8 vials per month.

Opiates (Long acting)
Drugs: Duragesic – Effective 3/2/05

Note: When the provider is an Oncologist, a prior authorization is not required.
Fentanyl TD Patch

Note: When the provider is an Oncologist, a prior authorization is not required.
MS Contin – Effective 3/2/05
Palladone – Effective 3/2/05

OXYCONTIN
Oxycodone Long Acting (Oxycontin®) Additional International Classification of Diseases, 9th Revision Restriction
Effective April 10, 2007 the International Classification of Diseases, 9th Revision (ICD-9) 360-389.9 for disease of eye and ear will no longer be allowed for payment of Oxycodone Long Acting (Oxycontin®) claims without prior authorization (PA) documentation and approval. Utilizatoin review over calendar years 2005 and 2006 indicated inappropriate use of ICD-9 in this range.

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. Prior Authorization not required for the following diagnosis if dose is less than 160mg/day
· 001 - 239.9, 280 - 289.9, 320 - 629.9, 680 - 759.9, 800 - 999.9
4. No prior authorization needed if the physician is a Medicaid provider with a specialty in oncology
5. Strength and total daily dosage must be provided.
6. Documentation of the failure or non-tolerance of at least one other long acting opioid analgesic.
7. 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.
8. 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.

OXANDRIN
Restriction: 20 mg/day

PANCRETIN
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.

PHOTOFRIN
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

PLENAXIS
Criteria:
1. Physician must be enrolled in the Plenaxis Plus Program (Plenaxis User Safety Program – 1-800-278-1630)

2. Patient must have advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following:
a. Risk of neurological compromise due to metastases.
b. Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease.
c. Severe bone pain from skeletal metastases persisting on narcotic analgesia.
PROCRIT
Restriction: 33 ml per month

Proton Pump Inhibitors (PPIs)

Existing clinical criteria for the proton pump inhibitors (PPIs) shall be applied through the SmartPA program including new dosing limits and over-the-counter (OTC) diagnosis requirements.

· NOTE: Prior authorization (PA) criteria apply to oral and injectable formulations.

· NOTE: Duplicative therapy with an active prescription for another antiulcer drug (e.g., another PPI, a PPI-containing product, sucralfate, or an H2 receptor antagonists (H2RA) that was dispensed by the same pharmacy is a clinical edit that will stop the claim. If the initial agent has been discontinued, the prescriber or pharmacist may call the ACS PBM Call Center at 1-877-439-0803 to document the reason the initial agent was discontinued and provide his/her name as intervention provider.

· NOTE: For female recipients of child-bearing age/potential, claims for prescription omeprazole will be denied if there is a pregnancy code in the previous nine (9) months of medical history with no delivery or pregnancy termination code. If the delivery/termination code is not in the nine-month medical history but the recipient has delivered or terminated the pregnancy, prescribers, pharmacists or technicians may call the ACS PBM Call Center at 1-877-439-0803 to provide the name of the prescriber, the date of delivery/termination and his/her name as intervention provider.

· NOTE: NEW - All claims, except those for the treatment of hypersecretory conditions, are subject to dosing limits. If the recipient has a hypersecretory condition but the diagnosis is not in the recipient’s two-year medical history, the prescriber or pharmacist may call the ACS PBM Call Center at 1-877-439-0803 to provide the recipient’s diagnosis and his/her name as intervention provider.

Claims for PPIs will process in the following instances:

1. NEW - Criteria Required for Prilosec OTC/Omeprazole OTC – Diagnosis [d1]of peptic ulcer disease, gastritis, duodenitis, Zollinger-Ellison syndrome or other hypersecretory conditions, or GERD (submitted at the point-of-sale or in the two-year medical history).

2. NEW - Criteria Required for Prilosec OTC/Omeprazole OTC – Diagnosis of heartburn in the previous 90 days AND at least a 14-day trial of an H2RA (OTC or prescription) in the previous 90 days. Quantities for the treatment of heartburn are limited to one (1) tablet per day. SmartPA will verify clinical criteria every three (3) months.

3. Prevacid (lansoprazole) and Nexium (esomeprazole) shall process for the following:

a. Diagnosis of H. pylori infection (submitted at the point-of-sale (POS) or in the two-year medical history) in the past 60 days. Claims are processed for a maximum of 14 days.
b. Diagnosis of erosive esophagitis, Zollinger-Ellison or other hypersecretory conditions, or GERD (submitted at the POS or in the two-year medical history).
c. Diagnosis of duodenal ulcer, gastric ulcer, or NSAID-induced ulcer (submitted at the POS or in the two-year medical history) AND at least a 14-day trial with an H2RA in the previous 60 days. The prescriber or pharmacist may call into the ACS PBM Call Center at 1-877-439-0803 for assistance if Prevacid or Nexium are needed AND the recipient has one of the conditions listed above AND either developed or has the potential to develop serious side effects to H2RAs to document the specific symptoms/side effects of concern and provide his/her name as intervention provider.
4. Prescription Omeprazole – Recipients younger than 21 years of age with a nasogastric (NG) tube (in two-year medical history).
5. Aciphex, omeprazole, Prevacid NapraPAC, Prilosec, Protonix, Zegerid require diagnosis of erosive esophagitis, Zollinger-Ellison syndrome or other hypersecretory conditions, GERD, duodenal ulcer, gastric ulcer, or NSAID-induced ulcer (submitted at the POS or in the two-year medical history) AND at least a 14-day trial with Prevacid or Nexium. The prescriber or pharmacist may call into the ACS PBM Call Center at 1-877-439-0803 for assistance of a non-preferred PPI if the recipient has one of the conditions listed above AND either developed or has the potential to develop serious side effects to Prevacid or Nexium to document the specific symptoms/side effects of concern and provide his/her name as intervention provider.
· For treatment of a condition other than one listed above, a submission of an 1144B form is required. The form must be completed citing appropriate references and faxed to ACS PBM at 1-888-335-8474.

Maximum Standard Doses

PROTOPIC – Preferred Effective 3/2/05
Criteria:
· Reserved for short term and intermittent therapy of moderate to severe atopic dermatitis when alternative, conventional therapies are deemed unadvisable or in the treatment of patients who are not adequately responsive to or are intolerant of alternative conventional therapies. Recommended use of Protopic is for short periods of time, not continuously using the minimum amount to control the patient’s symptoms.

· Recipient is 2 years of age and older.

PULMICORT TURBUHALER
Restriction: 2 canisters/month

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.

RAZADYNE/RAZADYNE ER
*Razadyne® oral tablets

If a recipient has a previous claim history of therapy with another cholinesterase Inhibitor then the prescriber and pharmacy will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk.
If a recipient has been stable on Razadyne® therapy and, in the prescriber’s opinion, a change in therapy will disrupt the recipient’s care, then an 1144B form may be completed and submitted to the ACS PBM PA Desk for review.


REBIF
Criteria: Relapsing, remitting multiple sclerosis for ambulatory patients only; ICD-9 = 340.0

REGRANEX
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.


RELENZA
Restriction: Five (5) day maximum supply.

RELPAX
Restriction: 6 tablets per month

REMICADE
Indications:
1. Moderate to severe and fistulating Crohn’s Disease
2. Rheumatoid Arthritis (ICD-9 Code = 714.0).
3. Ankylosing Spondylitis (IDC-9 = 720.0)
4. Psoriatic Arthritis (ICD-9 = 696.0)
5. Ulcerative Colotis - moderate to severe (ICD-9 = 556.0)
6. Plaque Posriasis - chronic and severe (ICD-9 = 696.1)

Restrictions:
· Available without prior authorization if prescribed by a Rheumatologist for the diagnosis of rheumatoid arthritis.
· Maximum of 20 vials per month

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.

REMINYL
· If a recipient has a previous claim history of therapy with a different cholinesterase inhibitor within the last 12 months then a claim for Reminyl® will not require PA.
· If previous treatment with another cholinesterase Inhibitor occurred more than 12 months ago then the prescriber and pharmacy will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk.


RHINOCORT AQ
Restriction:
· For adults (³12): 8.6 grams per 30 days.
· For Children: 8.6 grams per 60 days.

RITUXAN
Criteria:
· Diagnosis of relapsed or refractory low-grad or follicular, CD20+, B-cell Non-Hodgkin’s Lymphoma
· Moderate to severe rheumatoid arthritis
Restriction: Maximum of 400mls per month.

Sedative-Hypnotics
Generic temazepam 15mg and 30mg, and generic estazolam shall be tried first.
Claims for Ambien CR will process if there is at least a 14-day trial with generic temazepam 15mg or 30mg or generic estazolam in the previous six (6) months then proceed to clinical criteria edits.
Providers may call into the ACS PBM Call Center at 1-877-439-0803 for assistance with Ambien CR if the recipient has either developed or has the potential to develop serious side effects to generic temazepam 15mg or 30mg or generic estazolam. The prescriber or pharmacist must specify the symptoms/side effects of concern and provide his/her name as intervention provider. Clinical criteria edits will then process.
Claims for brand and generic Dalmane and Halcion, Sonata, Doral, Lunesta, Prosom, Restoril require at least a 14-day trial of Ambien CR in order for authorization to be granted; then proceed to clinical criteria edits.
Providers may call into the ACS PBM Call Center at 1-877-439-0803 for assistance if the recipient has either developed or has the potential to develop serious side effects to Ambien CR. The prescriber or pharmacist must specify the symptoms/side effects of concern and provide his/her name as intervention provider.
Rozerem allowed without a trial of temazepam or estazolam for the following populations:

Age 62 years or older
History of controlled substance abuse or diversion in the past year
Clinical Criteria – NEW – Duration of Use Limitations

The clinical criteria are applied to all sedative-hypnotics – preferred and non-preferred products.

NOTE: NEW - Prescription quantities for all sedative hypnotics are limited to one (1) tablet/capsule per day.
NOTE: NEW - Duration of use criteria apply once the recipient has received 30 or more days of sedative-hypnotic therapy (all medications combined) in the previous 45 days.
Claims for sedative-hypnotics will continue to process in the following instances:

Recipients aged 18 years or older with a diagnosis of a chronic sleep disorder in the six-month medical history. SmartPA will verify clinical criteria every six (6) months.
Recipients younger than 18 years with a diagnosis of persistent insomnia, insomnia due to a medical condition, or insomnia due to a mental disorder in the six-month medical history. SmartPA will verify clinical criteria every two (2) months.
For any of the following reasons, a PA 1144B form is required for

Greater than six (6) months of cumulative sedative-hypnotic therapy in the previous 200 days for recipients 18 years or older;
Greater than two (2) months of cumulative sedative-hypnotic therapy in the previous 90 days for recipients younger than 18 years;
Quantities greater than one (1) tablet/capsule per day; and
The treatment of conditions other than the ones listed above.
The form must be completed citing appropriate references and faxed to ACS PBM at 1-888-335-8474.

Maximum Standard Doses

SEROSTIM
Indication/Criteria:
Treatment of AIDS wasting syndrome and cachexia
SMOKING CESSATION AGENTS
Smoking Cessation Agents

SPORANOX® (capsules and solution)
A claim for oral Sporanox® will process without PA if the recipient has one of the following diagnoses and the ICD 9 code is submitted with the claim:
Aspergillosis (for Sporanox ®capsules): 117.1, 117.2, 117.3, 117.5
Blastomycosis (for Sporanox ® capsules): 116.0 and 116.1
Febrile neutropenia, empiric (for Sporanox® oral solution): 228.0, 228.8, 228.9, and 776.7
Histoplasmosis (for Sporanox® capsules): 115.0 through 115.9
Oropharyngeal/esophageal candidiasis (for Sporanox® oral solution): 112.0 through 112.9
Restriction: Capsules - 120 capsules per month

SUBOXONE
Claims with dates of service starting January 12, 2005, or later for Suboxone will require prior authorization. The following criteria must be met:

1. Prescriber must be authorized to prescribe these medications (see note below).
2. Prescriber must possess a unique identification number issued by the Drug Enforcement Administration (DEA) indicating that he or she is a qualifying physician. Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA strongly encourage physicians to include their DATA 2000 waiver identification number (ID) on prescriptions for opioid addiction treatment medications. The DEA has issued a Notice of Proposed Rule Making (NPRM) that will require this ID number on all such prescriptions.

(This is not an adverse action and does not need clarification in a provider memo.)
Diagnosis: Opiate Dependence
Indication: Detoxification or treatment of opiate dependence; maintenance treatment of opiate dependence

SUBUTEX
Claims with dates of service starting January 12, 2005, or later Subutex will require prior authorization. The following criteria must be met:

1. Prescriber must be authorized to prescribe these medications (see note below).
2. Prescriber must possess a unique identification number issued by the Drug Enforcement Administration (DEA) indicating that he or she is a qualifying physician. Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA strongly encourage physicians to include their DATA 2000 waiver identification number (ID) on prescriptions for opioid addiction treatment medications. The DEA has issued a Notice of Proposed Rule Making (NPRM) that will require this ID number on all such prescriptions.
3. Recipient must be at least 16 years of age.
4. If Subutex is to used for longer than 28 days, the PA must state the reason why Suboxone is not appropriate for maintenance therapy.

Restrictions:
Quantity will be limited to 14 days supply at a time with one refill only.
Note:
According to the federal law, pharmacists and prescribers jointly share the legal responsibility for the legitimacy of a prescription. To verify that the physicians are authorized to prescribe Subutex, contact the following:
· Website http://[email protected] under physician locator;
· Toll free number 1-866-BUP-CSAT or 1-866-287-2728; Monday through Friday, 8:30 a.m. to 5 p.m. Eastern Standard Time; or
· Email [email protected].

(This is not an adverse action and does not need clarification in a provider memo.)
Diagnosis: Opiate Dependence.
(This must be clearly stated on the 1144 request and no other diagnosis is to be considered by the PA desk.)
Indication: Induction of detoxification or treatment of opiate dependence;
(Treatment for maintenance of opiate dependence ONLY if unsupervised administration to those patients who cannot tolerate Suboxone with hypersensitivity to naloxone documentation)

SUTENT
Approval criteria will include the following:
A diagnosis advanced renal cell carcinoma OR
Treatment of a gastrointestinal stromal tumor (GIST) after disease progression of intolerance to Gleevac® (imatinib mesylate), within the last six months for previous trial of Gleevac®, un less documented intolerance to Gleevac®.
NOTE: The maximum standard dose of one 50-mg oral dose taken once daily, on a schedule of four weeks on treatment followed by two weeks off treatment for both indications listed above.

SYNAGIS
General Prevention

Parents and caregivers of former premature infants, infants with bronchopulmonary dysplasia, and infants with congenital heart disease should receive education in the following:

Strict hand washing techniques;
Avoidance of unnecessary exposure of their infants to crowds;
Avoidance of exposure to their infants to smoke and dust especially passive smoke exposure in presence of smokers in the family; and
Avoidance of exposure of their infants to all sick persons especially those with respiratory symptoms.
Patient Population

Patients who should be considered for RSV prophylaxis should be in one or more of the following groups:

Infants and children younger than two (2) years of age at the start of the RSV season with Chronic Lung Disease (CLD) requiring significant medical therapy, such as oxygen for treatment of their CLD, within six (6) months before the anticipated RSV season (born on or after September 15, 2006; continuing medical treatment after March 15, 2008).
Infants and children younger than two (2) years of age at the start of the RSV season with hemodynamically significant Congenital Heart Disease (CHD) requiring medical management within six (6) months before the anticipated RSV season (born on or after September 15, 2006; continuing medical treatment after March 15, 2008). Infants younger than 12 months with CHD who are most likely to benefit from immunoprophylaxis include:
Infants who are receiving medication to control congestive heart failure;
Infants with moderate to severe pulmonary hypertension; and
Infants with cyanotic heart disease.
Infants born prematurely at 28 weeks gestation or earlier and who are less than 12 months chronological age at the start of the RSV season (born on or after September 15, 2007).
Infants born prematurely between 29 and 32 weeks gestation and who are less than six (6) months chronologic age at the start of the RSV season (born on or after March 15, 2008). The definition of 32 weeks is an infant born on or before the 32nd week of gestation (i.e., 32 + 0 weeks).
Infants born prematurely between 33 and 35 weeks gestation requiring significant respiratory support in the neonatal period (positive pressure support) and having at least one (1) of the following additional risk factors -- day care attendance, school-aged siblings, congenital abnormalities of the airways, or wevere neuromuscular disease -- and who are less than six (6) months chronological age at the start of the RSV season (born on or after March 15, 2008).
There are several children with other illnesses in the Pediatric age group who may be considered for prophylaxis. Pediatricians should evaluate these children on a case-by-case basis and, if necessary, in consultation with an appropriate sub-specialist.
All children after cardiopulmonary bypass and with indication for use of Synagis® should be considered for additional prophylzxis after discharge, Children with cardiac disease undergoing cardiopulmonary bypass during the season and currrently receiving prophylaxis should receive an additional dose of prophylaxis within a few days after bypass and should continue to receive subsequent prophylaxiz until the end of the season.
RSV Season

RSV infections occur in the community all year round. Based on available epidemiological data, the incidence is significantly higher from September to February. There, the season for late 2008 to early 2009 this year for Hawaii will be from September 15, 2008 to February 28, 2008. The Consensus Committee will meet again in late January 2009 to evaluate, utilizing available data, whether or not the RSV season needs to be extended.

Recommended Prophylaxis

Prophylaxis should start no earlier than September 15, 2008 and end no later than February 15, 2009. A maximum of five (5) doses will be covered for the identified regular season, Coverage for Synagis® for an additional dose per month will be allowed after February 28, 209 only if the RSV season is extended by the Consensus Committee.
The interval between the first and second dose should be no less than and as close as possible to 28 days. All subsequent dose intervals should be as close as possible to 30 days with the range being 28-35 days.
When children meet criteria for prophylaxis based on their age, prophylaxis should be continued for the duration of the RSV season.
Should a child develop RSV during the course of the season, prophylaxis should resume after recovery until the end of the season.
Additional Considerations

The MQD requires authorization for Synagis ®. For FFS providers, authorization must be obtained from Affiliatede Computer Services (ACS), the MQD's pharmacy fiscal agent. Requests for prior authorization should be faxed on the 1144B (Attachment 1) to 1-888-335-8474. ( For QUEST providers, authorization for Synagis ® must be obtained from the child's QUEST medical plan ).
Prior authorization will cover Synagis® doses in intervals of 28-35 days during the RSV season from September 15, 2008 to February 28, 2009. IF the season is extended by the Consensus Committee, the end date on the prior authorization will be changed to reflect the end date specified by the committee, and additional dises will then be covered up to the revised end date. A second prior authorization will not be required.
Families should be educated that although prophylaxis is not 100% effective, it may lead to a decrease in severity of subsequent illness. Consideration should be given to obtaining an informed consent prior to drug administration.
Vulnerable children meeting criteria for RSV prophylaxis shouls also be considered for influenza vaccine in addition to RSV prophylaxis if they are over the age of six (6) months.

SYNVISC
Billing is restricted to ACS/Fiscal Agent using the Medicare HCPCS code for this specific agent.

TAMIFLU
Restriction: 2 capsules per day or 3 bottles per 5 days

TARCEVA
Criteria
Diagnosis of locally-advanced or metastatic non-small cell lung cancer.
Must have failed at least one prior chemotherapy regimen.

Note: Tarceva in combination with gemcitabine can be used for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

TAXOTERE
Indication:
1. Recipient must have a diagnosis of locally advanced or metastatic breast cancer, either in conjunction with or after failure of an anthracycline (doxorubicin, daunorubicin)
· Up to 1 year
OR
2. Recipient must have a diagnosis of unresectable locally advanced or metastatic non-small cell lung cancer, either in conjunction with or after failure of platinum (cisplatin [Platinol], carboplatin [Paraplatin])
· Maximum of 8mls per month
OR
3. Recipient must have a diagnosis of androgen independent (hormone refractory) metastatic prostate cancer (AIPC), in conjunction with prednisone (Hormone therapies include Eulexin, Casodex, or Nilandron, coupled with Lupron or Zoladex.)
OR
4. Recipient must have a diagnosis of advanced gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction in combination with cisplatin and fluorauracil and have not received prior chemotherapy for advanced disease.


Criteria: Documentation of one of the above indications

TORADOL
Restriction: Tablets – 20 tablets per month
All other formulations – 5 days supply

TRICOR CAPSULES
For Tricor 54mg, 67mg, 134mg, and 200 mg the brand is preferred and generic is non-preferred.

TYSABRI
Criteria:
· Limited to Neurologists only
and
· Relapsing and remitting multiple sclerosis only

Tuberculosis Drugs
Criteria:
· Diagnosis other than pulmonary TB with the exception of INH use in children for chemoprophylaxis (see Isoniazid-specific Criteria)
· Drug not covered if diagnosis code=10.0 or 10.8 or 10.9 or 11.0 or 11.1 or 11.2 or 11.4 or 11.8 or 11.9 on claim. PA required if diagnosis code is not present on claim

UNASYN PIGGYBACK
Restriction: 8 piggyback vials per day.

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.

VALTREX
Criteria:
§ When a recipient needs Valtrex® and is immunocompromised (i.e., HIV positive, transplant recipient, etc),the pharmacist and prescriber will need to work together to complete an 1144B form and submit it to the ACS PBM PA Desk for expedited review.

VELCADE
Criteria:
1. Diagnosis of multiple myeloma.
2. Diagnosis of mantle cell lymphoma with at least one prior therapy

VESANOID
Indication/Criteria:
Acute Promyeloytic Leukemia (APL)

VICON FORTE & VICON PLUS
· PA not required for diagnosis of 585

Restriction: Covered for LTC; limit 1 capsule/day

VICOPROFEN

Indication:
Analgesia

Criteria:
Documentation of trial and failure on other similar combination products, which are much less expensive.

VIOXX - has been withdrawn from the US market

VITAMINS, Multi
Vitamins are covered, without prior authorization, under the following circumstances:
Patient must have a demonstrated vitamin deficiency
Multivitamins covered for Recipients with End-Stage Renal Disease (ESRD)
Multivitamin 1 tablet/capsule per day or 5 mls liquid covered for Nursing Home Recipients (LTC recipients)
Pediatric multivitamins covered for Recipients age 12 and younger
Prenatal multivitamins covered for Recipients with a diagnosis of pregnancy or lactation
PA not required if diagnosis code is one of the following:
v22.0 – v22.2, v23, 585, 611.6, 675.2, 676.4 – 676.6, 676.8, 676.9

VITAMIN B12
Restriction:
No prior authorization is required if one of the following diagnosis applies and included on the claim:
· 281.0 - 281.1, 281.3, 266.2, 579.3
Criteria: Document one diagnosis listed and medical necessity.

VITAMIN C

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.
XENICAL
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.

XOLAIR – 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

XOPENEX and XOPENEX HFA – See PDL Criteria – Effective 2/2/05
Xopenex® nebules

A Xopenex® claim will process without a PA if the recipient is 16 years of age or younger


XYREM
Indication:
Cataplexy associated with narcolepsy

Criteria:
· Documentation of the diagnosis of cataplexy associated with narcolepsy (Diagnosis Code is 347.0) 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.
· Prescribers must be enrolled in the Xyrem Success Program (1-866-XYREM88). Xyrem is made available to prescribers through a single, centralized pharmacy.

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.

ZEVALIN
Billing is restricted to ACS/Fiscal Agent using the Medicare HCPCS code for this specific agent.

ZOFRAN
Restrictions: 4mg and 8 mg tablets (and ODT) – 12 tablets per month
24 mg tablet – 2 tablets per month
4mg/5ml solution – 150 mls per month

ZOMIG
Restriction: 6 tablets or nasal sprays per month

ZYVOX
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
[d1] if the diagnosis is on the claim will it process?