Prior Auth Protocol

FDA Approved Indications:

C. difficile-associated diarrhea
Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
Important Limitations: Orally administered VANCOCIN is not effective for other types of infections.

Health Net Approved Indications and Usage Guidelines:

OR

AND

Prescribed by or in consultation with a gastroenterologist or infectious disease specialist

OR

One of the following:
- Failure or clinically significant adverse effects to oral metronidazole (failure may be declared in as little as 48 hours in patients with severe disease who fail to improve)

OR

Patient cannot take metronidazole secondary to interaction with concomitant warfarin therapy

OR

Coverage is Not Authorized For:

Systemic infections
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:

The parenteral product can be given orally for these infections.
Oral vancomycin is not absorbed systemically and is not effective for other types of infection.
2010 IDSA Clinical Practice Guidelines define Clostridium difficile associated diarrhea as "severe" when any one of the following is met: leukocytosis with a white blood cell count greater than or equal to 15,000 cells/uL, a serum creatinine level greater than or equal to 1.5 times the baseline level, hypotension, shock, ileus, or megacolon.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
metronidazole (Flagyl^R)	*C. difficile* colitis** 500 mg PO TID or 250 mg PO QID	10 to 14 days

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
C. difficile-associated diarrhea	125-500 mg PO QID	Up to 14 days
Staphylococcal enterocolitis	500 mg to 2 gm PO in 3-4 divided doses/day for 7-10 days	Up to 10 days
For recurrent treatment tapering and pulsed therapy	Various Regimens 125 mg PO QID for 10 to 14 days, then 125 mg PO BID for 7 days, then 125 mg PO QD for 7 days, then 125 mg PO QOD for 7 days, then 125 mg PO every 3 days for 14 - 21 days.	Up to 8 weeks

Product Availability:

Oral capsule: 125 mg, 250 mg
Powder for oral solution: 500 mg, 750 mg, 1 gm, 5 gm, 10 gm

Intravenous solution (to be taken orally): 500 mg/100 mL, 750 mg/150 mL, 1 gm/200 mL

References:

The Sanford Guide to Antimicrobial Therapy, 2011.
Vancocin. Prescribing information, ViroPharma Inc., December 2011.
Pelaez T, Alcala L, Rodriguez-Creixems M, et al. Reassessment of Clostridium difficile susceptibility to metronidazole and vancomycin. Antimicob Agents Chemother. 2002;46:1647-1650.
Joyce AM, Burns, DL. Recurrent Clostridium difficile colitis: Tackling a tenacious nosocomial infection. Postgradmed. 2002:112(5):53-54, 57-58, 65.
Musher DM, Logan N, Hamill RJ et al. Nitazoxanide for the treatment of Clostridium difficile colitis. Clin Infec Dis. 2006;43(4):421-427.
Kelly CP, LaMont JT. Clostridium difficile in adults: Treatment. Version 28.0 last amended March 2013. www.uptodate.com. Accessed June 2013.
Thomson MICROMEDEX [Internet database]. Greenwood Village, Colo: Thomson Healthcare, Inc. Accessed June 2015.
Cohen SH, Gerding DN, Johnson S, et al: Clinical practice guidelines for Clostridium difficile infection in adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp. Epidemiol 2010; 31(5): 431-435. http://www.cdc.gov/HAI/pdfs/cdiff/Cohen-IDSA-SHEA-CDI-guidelines-2010.pdf.