Prior Authorization Guidelines

Prior Authorization Guidelines

GENERIC	BRAND
ACYCLOVIR TOPICAL OINTMENT	ZOVIRAX ® 5%
ACYCLOVIR ORAL	ZOVIRAX ®
ALENDRONATE	FOSAMAX ®
ANTIHEMOPHILIC FACTORS	ALPHANATE®, HYATE-C®, BIOCLATE®, AUTOPLEX-T®, THROMBAT III®
CALCITONIN-SALMON/HUMAN	MIACALCIN ®
CIPROFLOXACIN	CIPRO ®
CLOPIDOGREL	PLAVIX ®
CYANOCOBALAMIN (HYDROXYCOBALAMIN)	VITAMIN B-12
DANTROLENE	DANTRIUM ®
DORZOLAMIDE	TRUSOPT ®
ERYTHROPOIETIN	PROCRIT ®
FELBAMATE	FELBATOL ®
FILGRASTIM	NEUPOGEN ®
FLUCONAZOLE (oral only)	DIFLUCAN ®
INTERFERON ALPHA	ROFERON-A ® and INTRON-A ®
INTERFERON BETA	AVONEX ® and BETASERON ®
KETOCONAZOLE (oral)	NIZORAL ®
LATANOPROST	XALATAN ®
LEUPROLIDE	LUPRON ®
LOMEFLOXACIN	MAXAQUIN ®
METFORMIN	GLUCOPHAGE ®
NAFARELIN	SYNAREL ®
OCTREOTIDE	SANDOSTATIN ®
PANCREATIC ENZYMES (MICROENCAPSULATED)	CREON ®
PENTOXIFYLLINE	TRENTAL ®
PPIs: OMEPRAZOLE and LANSOPRAZOLE	PRILOSEC ® and PREVACID ®
RILUZOLE	RILUTEK ®
SALMETEROL	SEREVENT ®
SOMATROPIN	HUMATROPE ®
SUCRALFATE	CARAFATE ®
THIAZOLIDINEDIONES	AVANDIA ®
TICLOPIDINE	TICLID ®
ZOLMITRIPTAN	ZOMIG ®

GENERIC: ACYCLOVIR TOPICAL OINTMENT

BRAND: ZOVIRAX ® 5%

INDICATIONS:

(1) Herpes genitalis

(2) Oral herpes infection

Criteria:

(a) Herpes genitalis – for initial episode only.

(b) Oral herpes infection – for immunocompromised patients only.

GENERIC: ACYCLOVIR ORAL

BRAND: ZOVIRAX ®

INDICATIONS:

(1) Herpes zoster

(2) Varicella zoster

(3) Herpes simplex

Criteria:

Restricted in patients £ 14 years of age except for:

(a) Patients £ 14 years of age, immunocompromised and exposed to chicken pox; or

(b) Patients £ 14 years of age with an episode of genital or oral herpes infection.

GENERIC: ALENDRONATE

BRAND: FOSAMAX ®

INDICATIONS:

(1) Treatment of Paget's disease

(2) Osteoporosis

(3) Prevention of osteoporosis (5mg tablet)

(4) Treatment of glucocorticoid-induced osteoporosis

Criteria:

(a) Diagnosis of Paget’s disease

(b) For the diagnosis of osteoporosis:

§ Bone density measurement > 2 standard deviations below

premenopausal mean; or

§ Documented osteoporosis as evidenced by one of the

following:

- atraumatic fractures

- loss of height due to vertebral compression

- x-ray evidence of osteopenia; or

§ Long-term glucocorticoid treatment; or

§ Continued loss of bone density despite estrogen therapy (documented); or

(c) For prevention or treatment of osteoporosis in postmenopausal women in whom estrogen therapy is contraindicated (e.g., ER-positive cancers, recurrent DVT, etc).

* Patients must be ambulatory and be instructed to, and be able to, either stand or sit upright for 30 minutes post dose.

* Patients must not have erosive esophagitis or any diagnosis indicative of a delayed gastric emptying disorder.

* If documentation of osteoporosis is available, please submit with PA request.

GENERIC: ANTIHEMOPHILIC FACTORS

BRAND: ALPHANATE®, HYATE-C®, BIOCLATE®,

AUTOPLEX-T®, THROMBAT III®

INDICATION:

(1) Hemophilia A

Criteria:

(a) Diagnosis of Hemophilia A.

GENERIC: CALCITONIN-SALMON/HUMAN

BRAND: MIACALCIN ®

INDICATIONS:

(1) Mild to moderate Paget's disease

(2) Osteoporosis

Criteria:

(a) Documented osteoporosis as evidenced by one of the following:

- atraumatic fractures

- loss of height due to vertebral compression

- x-ray evidence of osteopenia; or

(b) Established osteopenia (> 2 standard deviations) but no demonstrated fractures; or

(d) Primary hyperparathyroidism and contraindications to surgical treatment; or

(e) Contraindications to estrogen therapy; or

(f) Diagnosis of Paget’s disease.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary. If documentation of osteoporosis is available, please submit with PA request.

GENERIC: CIPROFLOXACIN

BRAND: CIPRO ®

INDICATIONS:

(1) Lower respiratory tract infections

(2) Skin and skin structure infections

(3) Urinary tract infections

(4) Bone infections

(5) Infectious diarrhea

(6) Typhoid fever

(7) STDs and chronic bacterial prostatitis

(8) Complicated intra-abdominal infections

Criteria:

(a) Diagnosis of one of the following infections:

- Pseudomonas aeruginosa infection

- Osteomyelitis

- Typhoid fever

- Cystic fibrosis

- Gonorrhea; or

(b) For other infections, the patient has failed a recent treatment trial (within 30 days) with at least one standard first-line formulary agent; or

(d) Diagnosis of chronic prostatitis in males > 35 years of age who have failed, or are intolerant to, SMX / TMP therapy; or

(e) Treatment of MAI infection in patients intolerant to rifampin, and ciprofloxacin is part of “triple therapy”; or

(f) Culture sensitivity to fluoroquinolones only.

GENERIC: CLOPIDOGREL

BRAND: PLAVIX ®

INDICATIONS:

(1) To reduce risk of atherosclerotic events (myocardial infarction, stroke and vascular death) in patients with atherosclerosis documented by recent stroke, recent MI, or established peripheral artery disease.

(2) STENT implantation

Criteria:

(a) Failure of, or intolerance to, aspirin therapy; or

(b) STENT implantation (One month authorization only).

GENERIC: CYANOCOBALAMIN (HYDROXYCOBALAMIN)

BRAND: VITAMIN B-12

INDICATION:

(1) Vitamin B-12 deficiency

Criteria:

(a) Patients who lack intrinsic factor; or

(b) Patients who are on long-term omeprazole or lansoprazole therapy; or

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: DANTROLENE

BRAND: DANTRIUM ®

INDICATION:

(1) Spasticity resulting from upper motor neuron disorders

Criteria:

(a) Failure of, or intolerance to, baclofen (Lioresol â ).

GENERIC: DORZOLAMIDE

BRAND: TRUSOPT ®

INDICATIONS:

(1) Elevated IOP

(2) Glaucoma (open angle, neovascular, congenital)

Criteria:

(a) Open angle glaucoma – treatment failure of two formulary agents of different classes.

(b) Neovascular or congenital glaucoma – treatment failure of a topical beta-blocker.

GENERIC: ERYTHROPOIETIN

BRAND: PROCRIT ®

INDICATIONS:

(1) Anemia associated with chronic renal failure

(hematocrit < 30)

(2) Anemia associated with HIV infection and therapy

(3) Chemotherapy-induced anemia in patients with non-myeloid malignancy

Criteria:

(a) Diagnosis of CRF; or

(b) Anemia due to chemotherapy in patients with non-myeloid malignancy; or

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

* Medicare is the primary payer for Method II Home Dialysis.

GENERIC: FELBAMATE

BRAND: FELBATOL ®

INDICATIONS:

(1) Lennox-Gastaut syndrome

(2) Partial seizures

Criteria:

(a) Failure of, or contraindication to, at least two formulary anticonvulsants; or

(b) Patient has been stabilized on felbamate therapy.

GENERIC: FILGRASTIM

BRAND: NEUPOGEN ®

INDICATION:

(1) Prevention of neutropenia in patients receiving myelosuppressive chemotherapy for non-myeloid malignancies.

Criteria:

(a) Absolute neutrophil count (ANC) nadir of < 1,000 neutrophils to previous chemotherapy. Once this has been documented, approval will be given to prophylax for all future chemotherapy cycles; or

(b) To prevent infection in patients with documented ANC of < 1,000.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

* Please indicate estimated duration of therapy.

GENERIC: FLUCONAZOLE (oral only)

BRAND: DIFLUCAN ®

INDICATIONS:

(1) Vaginal candidiasis

(2) Cryptococcal meningitis

(3) Serious systemic candidial infections

(4) Oropharyngeal candidiasis

(5) Esophageal candidiasis

Criteria:

(a) Any of the above diagnoses; or

(b) For the diagnosis of oropharyngeal candidiasis, failure of nystatin therapy.

GENERIC: INTERFERON ALPHA

BRAND: ROFERON-A ® and INTRON-A ®

INDICATIONS:

(1) Hairy cell leukemia

(2) AIDS-related Kaposi’s sarcoma

(3) Chronic hepatitis B or C

(4) FDA-labeled cancer indications

Criteria:

(a) Any of the above diagnoses.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: INTERFERON BETA

BRAND: AVONEX ® and BETASERON ®

INDICATIONS:

(1) Relapsing-remitting multiple sclerosis

(2) Relapsing-progressive multiple sclerosis

Criteria:

(a) Diagnosis of multiple sclerosis.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: KETOCONAZOLE (oral)

BRAND: NIZORAL ®

INDICATIONS:

(1) Serious systemic candidal infections

(2) Oropharyngeal candidiasis

(3) Esophageal candidiasis

(4) Blastomycosis

(5) Coccidiodomycosis

(6) Histoplasmosis

(7) Chromomycosis

(8) Paracoccidiomycosis

Criteria:

(a) Any of the above diagnoses; or

(b) For the diagnosis of oropharyngeal candidiasis, failure of nystatin therapy.

GENERIC: LATANOPROST

BRAND: XALATAN ®

INDICATIONS:

(1) Reduction of elevated IOP

(2) Open-angle glaucoma

Criteria:

(a) Failure of two formulary IOP lowering agents from different therapeutic classes.

GENERIC: LEUPROLIDE

BRAND: LUPRON ®

INDICATIONS:

(1) Advanced prostate cancer

(2) Central precocious puberty

(3) Endometriosis

(4) Uterine leiomyomata (fibroids)

Criteria:

(a) Diagnosis of advanced prostate cancer or precocious puberty; or

(b) For the diagnosis of endometriosis, failure of NSAIDs and oral contraceptives, or endometriosis diagnosed by laporoscopy.

* Note: This agent is ordinarily administered at the physician’s office. MIM Health Plans, Inc. does not provide coverage for agents administered by a health care professional. Please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: LOMEFLOXACIN

BRAND: MAXAQUIN ®

INDICATIONS:

(1) Lower respiratory tract infections

(2) Genitourinary infections

Criteria:

(a) The patient has failed a recent treatment trial (within 30 days) with at least one standard first-line formulary antibiotic; or

(b) Patient has multiple drug allergies to appropriate first-line formulary antibiotics; or

GENERIC: METFORMIN

BRAND: GLUCOPHAGE ®

INDICATION:

(1) Treatment of Type-2 diabetes mellitus

Criteria:

(a) Failure of maximal doses of one oral sulfonylurea (e.g., glyburide 20mg daily or equivalent). Failure is defined as: Hemoglobin A_1C > 7.2; or

(b) The patient is morbidly obese (BMI > 27kg/m²); or

(d) Patient's serum creatinine is:

£ 1.5 mg/dl in males

£ 1.4 mg/dl in females.

GENERIC: NAFARELIN

BRAND: SYNAREL ®

INDICATIONS:

(1) Central precocious puberty

(2) Endometriosis

Criteria:

(a) Diagnosis of central precocious puberty; or

(b) For the diagnosis of endometriosis in patients > 18 years of age, failure of NSAIDs and oral contraceptives, or endometriosis diagnosed by laporoscopy.

GENERIC: OCTREOTIDE

BRAND: SANDOSTATIN ®

INDICATIONS:

(1) Symptomatic treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors

(2) Profuse, watery diarrhea associated with vasoactive intestinal peptide (VIP) secreting tumors

(3) To reduce the blood levels of growth hormone and IGF-I associated with acromegaly

Criteria:

(a) Any of the above diagnoses; and

(b) For the diagnosis of acromegaly, the patient has had an inadequate response to, or can not be treated with surgical resection, pituitary irradiation and bromocriptine at maximally tolerated doses.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: PANCREATIC ENZYMES (MICROENCAPSULATED)

BRAND: CREON ®

INDICATION:

(1) Pancreatic insufficiency disorders (i.e., cystic fibrosis, etc.)

Criteria:

(a) Diagnosis of cystic fibrosis; or

(b) Failure of formulary enzyme replacement therapy.

GENERIC: PENTOXIFYLLINE

BRAND: TRENTAL ®

INDICATION:

(1) Intermittent claudication

Criteria:

(a) Pain on walking or ABI < 0.8.

GENERIC: PPIs: OMEPRAZOLE and LANSOPRAZOLE

BRAND: PRILOSEC ® and PREVACID ®

INDICATIONS:

(1) GERD

(2) Duodenal or gastric ulcers

(3) Pathological hypersecretory conditions

(4) Treatment of H. pylori

Criteria:

(a) GERD: (Savary-Miller classification)

Grade 0-1: failure of an adequate H2R-antagonist trial (e.g., cimetidine 1600mg/day or ranitidine 600mg/day)

Grade 2-3: no H2R-antagonist failure required

Grade 4-5: Barrett’s esophagitis or strictures

* Re-approvals for GERD (Grade 0-3) require the retrial of a H2RA +/- prokinetic agent

(b) PUD:

Failure of a formulary H2RA at adequate doses ( e.g., cimetidine 800mg/day or ranitidine 300mg/day) and documentation of H. pylori test results.

As part of standard treatment regimen: i.e., Pepto Bismol 525mg qid for 1 week, metronidazole 250mg qid for 1 week, tetracycline 500mg qid for 1 week, and a PPI for 1 week.

* Submission of objective evidence (i.e., EGD results, if available) along with the PA request is encouraged and will accelerate the decision making process.

GENERIC: RILUZOLE

BRAND: RILUTEK ®

INDICATION:

(1) Amytrophic lateral sclerosis (ALS)

Criteria:

(a) Diagnosis of ALS.

GENERIC: SALMETEROL

BRAND: SEREVENT ®

INDICATIONS:

(1) Asthma or bronchospasm

(2) Exercise-induced bronchospasm

(3) COPD

Criteria:

(a) Asthma which is not controlled with regular release b -agonist therapy and an inhaled anti-inflammatory agent; or

(b) COPD which is not controlled with regular release b -agonist therapy and ipratropium therapy; or

GENERIC: SOMATROPIN

BRAND: HUMATROPE ®

INDICATION:

(1) Long-term treatment in children who have growth failure due to a lack of adequate, endogenous growth hormone secretion

Criteria:

(a) Height is > 2.5 SD below the mean for age; and

(b) Growth velocity is subnormal (age specific growth rate at less than the 25^th percentile); and

(d) A subnormal GH response to a provocative stimulation test.

* To continue therapy, requests will be reviewed every six months.

* For injectable medications administered by a healthcare professional, please refer to the “Policy for Injectable Drugs” on page I-4 of this formulary.

GENERIC: SUCRALFATE

BRAND: CARAFATE ®

INDICATIONS:

(1) Gastric ulcers

(2) Duodenal ulcers

(3) Gastritis

(4) GERD

Criteria:

(a) Failure of or intolerance to a formulary H2RA at an adequate dose; or

(b) Diagnosis of bile reflux; and

GENERIC: THIAZOLIDINEDIONES

BRAND: AVANDIA ®

INDICATION:

(1) Type-2 diabetes mellitus

Criteria:

(a) Failure of maximal doses of one oral sulfonylurea (e.g., glyburide 20mg daily or equivalent). Failure, is defined as: Hemoglobin A_1C > 7.2; and

(b) Failure of metformin therapy, unless contraindicated; and

GENERIC: TICLOPIDINE

BRAND: TICLID ®

INDICATIONS:

(1) To reduce the risk of thrombotic stroke in patients who have experienced stroke precursors or have had a complete thrombotic stroke

(2) CABG

(3) Coronary angioplasty

(4) Post myocardial infarction

(5) STENT implantation

Criteria:

(a) Failure of, or intolerance to, aspirin therapy; or

(b) STENT implantation (One month authorization only).

GENERIC: ZOLMITRIPTAN

BRAND: ZOMIG ®

INDICATION:

(1) Acute treatment of migraine headache

Criteria:

(a) Failure of, or intolerance to, at least two traditional formulary agents (e.g., narcotics, ergotamine, NSAIDs); or

(b) Unsuccessful concurrent or previous use of migraine prophylaxis medications (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants or anticonvulsants) if a patient experiences more than two migraines per month.

Introduction Therapeutic Formulary Prior Authorization Guidelines