Prior Auth Protocol

FDA Approved Indications:

For the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older

Health Net Approved Indications and Usage Guidelines:

Failure or clinically significant adverse effects to generic balsalazide

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

With adjustment for multiplicity, statistically significant differences were seen in the male patients for Clinical Remission (35% with Giazo vs.13% for placebo) and for Mucosal Healing (52% with Giazo vs. 20% for placebo). Effectiveness of Giazo was not demonstrated in the female subpopulation in the clinical trial.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
balsalazide (Colazal^R)	Three 750 mg capsules taken PO TID for up to 12 weeks	6.75 g per day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Giazo (balsalazide disodium)	Three 1.1 g tablets PO BID (6.6 g/day) with or without food for up to 8 weeks.	Length of Benefit

Product Availability:

Tablets: 1.1 g

References:

1. Giazo [Prescribing Information] Raleigh, NC: Salix Pharmaceuticals, Inc.. February 2012.

2. Colazal [Prescribing Information] Morrisville, NC: Salix Pharmaceuticals, Inc. . May 2008.

3. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/. Acessed June 21, 2015
4. Giazo. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 21, 2015
5. DRUGDEX^R System [Internet database]. Greenwood Village, Colo; Thomson Healthcare.Updated periodically. Accessed June 21, 2015.