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Home , Fluconazole, Tinea barbae

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Prior Authorization DRUG Guidelines

ANTI-FUNGALS: DIFLUCAN, fluconazole, SPORANOX, LAMISIL Effective Date: 07-28-05 Archive: 10.25.11 – Created Separate Guidelines for Diflucan, Lamisil and Sporanox

Date Developed: 07-28-05 by C. Wilhelmy MD Date Approved by P&T Committee: 07-28-05

Diflucan, Sporanox Lamisil

fluconazole A.

1. One of the following: • Member has diabetes OR, X X X • Member has an iatrogenically-induced or disease- associated immunosuppression, such as that due to AIDS, antirejection treatment for bone marrow or solid organ transplant, or chemotherapy for cancer OR, • Member has a systemic dermatosis with impaired skin integrity (e.g., pemphigus, ichthyosis) OR, • Member has a significant vascular compromise (peripheral) 2. One of the following: • Contraindication to (Lamisil®) OR, • Intolerance to terbinafine (Lamisil) OR, X X • Failure of an adequate trial of 6 weeks of terbinafine (Lamisil) OR, • Presence of hepatic dysfunction or increased risk for OR, • Fungal culture indicating lack of sensitivity to terbinafine (Lamisil) OR, • Non- fungal infection (mixed infection, a or infection) AND 3. One of the following: ® • Contraindication to itraconazole (Sporanox ) OR, X • Intolerance to itraconazole (Sporanox) OR, • Failure of an adequate trial of 6 weeks of itraconazole (Sporanox)

S:VCHCP/Administration/Medical Policy/2005/PA Drug / 1

For onychomycosis, new courses of therapy should not be initiated until 32 weeks following the end of therapy unless infection is noted in a previously unaffected nail (since cure rate continues to increase through the 11th month following initiation of a 12 week course of therapy).

OR Diflucan, Sporanox Lamisil fluconazole itraconazole B. Diagnosis of X X OR C. Diagnosis of X X OR D. Diagnosis of (valley fever) X X OR E. Diagnosis of Coccidiomeningitis X X OR F. Diagnosis of Cryptococcus X OR G. Diagnosis of Febrile X X OR H. Diagnosis of systemic X OR I. Diagnosis of Urinary tract infection or balanitis with X OR J. Diagnosis of Vulvovaginal Candidiasis X OR K. Diagnosis of Recurrent vulvovaginal candidiasis (four or more X episodes of symptomatic VVC within one year) OR L. Diagnosis of Oral (thrush), esophageal, intestinal candidiasis X OR M. Diagnosis of Chronic cutaneous candidal infection X OR N. Diagnosis of HIV/AIDS or cancer X X OR O. Diagnosis of Bone marrow transplant (using for prophylaxis) X OR P. Cutaneous dermatophyte infection 1. Documented diagnosis of cutneous dermatophyte infection X X X AND 2. One of the following: • Contraindication to two (2) formulary alternatives (one of X X X which should be topical, the other generic oral) OR • Intolerance to two (2) formulary alternatives (one of which should be topical, the other generic oral) OR • Failure of an adequate trial of two (2) weeks each of topical and generic oral treatment AND 3. Failure of formulary oral terbinafine (Lamisil) X OR Q. 1. Documented diagnosis of tinea capitis X X X AND 2. One of the following: • Contraindication to the formulary alternative Lamisil®OR X

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 2 • Intolerance to the formulary alternative Lamisil OR • Failure of an adequate trial of two (2) weeks of the formulary alternative Lamisil OR • Member requires a liquid dosage form

Diflucan, Sporanox Lamisil OR fluconazole itraconazole R. Otitis externa 1. Documented diagnosis of otitis externa X AND 2. One of the following: • Contraindication to two (2) formulary topical alternatives X OR • Intolerance to two (2) formulary topical alternatives OR • Failure of an adequate trial of one (1) week each of two (2) formulary topical alternatives OR S. Diagnosis of Chronic Candidal X OR T. Diagnosis of X X 1. Documented diagnosis of tinea versicolor AND 2. One of the following: X X • Contraindication to one (1) formulary alternative (oral or topical ) OR • Intolerance to one (1) formulary alternative (oral or topical ketoconazole) OR • Failure of an adequate trial of one (1) course of one (1) formulary alternative (1 week oral ketoconazole • OR 2 weeks topical ketoconazole)

QUANTITY LIMITS: • According to the manufacturer, a single oral dose of Diflucan or fluconazole 150mg tablets is indicated for vaginal candidiasis

• Diflucan or fluconazole can be dosed at interval(s) as indicated in the table below. A quantity of Diflucan or fluconazole 150mg tablets will be considered medically necessary as indicated in the table below:

Drug Dosing Interval Dosage Strength Quantuty Limits Diflucan, Once Daily 150mgm Up to 2 tablets in 30 flucomazole days

FLUCONAZOLE: FDA-Approved Indications 1. Treatment of vaginal candidiasis. Approve. Only the 150 mg fluconazole dose is FDA- approved for vaginal candidiasis. Several published studies support the efficacy of fluconazole6-8 for vaginal candidiasis and CDC 2006 guidelines for the treatment of STDs recommended fluconazole.

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 3 2. Oropharyngeal and . Approve. Fluconazole is FDA-approved for this condition.1

3. Treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidasis, and pneumonia. Approve. Fluconazole is FDA-approved for this condition.1

4. Cryptococcal meningitis. Approve. Fluconazole is FDA-approved for this condition.1

5. Prophylaxis of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Approve. Fluconazole is FDA-approved for this condition.1

Other Uses with Supportive Evidence

6. Prevention of recurrent vulvovaginal or vaginal candidiasis. Approve. A randomized, prospective, placebo-controlled study demonstrate that weekly fluconazole 150 mg for 6 months reduced the frequency of recurrent VVC compared with placebo.10 The 2006 CDC treatment guidelines for STDs that address VVC recommend various therapies, including fluconazole (100-mg, 150-mg and 200-mg once weekly), as effective maintenance regimens.12

7. . Approve after a trial of a topical agent, except for extensive conditions. Fluconazole has been successfully utilized in the treatment of tinea corporis in several studies.15-19 In one double-blind, parallel-group study, fluconazole 150 mg once weekly and 500 mg once daily for 4-6 weeks displayed similar efficacy in the treatment of tinea corporis.18 However, many topical antifungal agents are similarly effective and are FDA-approved for this condition.13-14 Systemic therapy may be required for effectiveness or more feasible in extensive conditions.

8. , manuum, pedis, and faciei. Approve after a trial of a topical antifungal agent. Fluconazole has demonstrated efficacy in these conditions13,15-22 however, many topical antifungal agents are also effective and FDA-approved for this condition.13-14,22

9. Tinea versicolor (pityriasis versicolor). Approve after a trial of a topical antifungal agent, except for extensive conditions. Topical antifungal agents are highly effective and many are FDA-approved for tinea versicolor.31 Oral therapy may be preferred when the disease is widespread. Several studies demonstrate that fluconazole,23-30 utilized in a variety of dosage regimens, has been effective for the treatment of this condition.

10. Tinea capitis. Approve. Fluconazole has been studied in the treatment of tinea capitis34- 40,64, including a multicenter, single-blinded, randomized comparative study,39 and was been found to be effective.

11. Tinea barbae. Approve. Fluconazole has been cited as effective for tinea barbae in case reports41-42 and in a case series.43

12. Treatment or prevention of other superficial, systemic or suspected fungal infections. Approve. Fluconazole has been well-studied in a variety of other systemic and superficial infections.

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 4 13. Patient has been started and stabilized on IV fluconazole or oral fluconazole for a systemic infection and it is being used as continuation therapy. Approve. Fluconazole is available as IV therapy and once clinical stabilization has occurred, some patients are appropriate candidates for oral therapy.

14. Onychomycosis (refer to the Antifungal Therapy for Onychomycosis Therapeutic Guideline for specific criteria). Fluconazole has been utilized and found effective for the treatment of onychomycosis.67-70

LAMISIL: FDA-Approved Indications 1. Onychomycosis (refer to the Antifungal Therapy for Onychomycosis Therapeutic Guideline for the criteria). Terbinafine is FDA-approved for the treatment of onychomycosis of the toenail or fingernail due to (tinea unguium).1,67

Other Uses with Supportive Evidence

2. Tinea corporis. Approve after a trial of a topical antifungal agent, except for extensive conditions. Terbinafine has been useful for this condition,2-5 however, many topical antifungal agents are equally effective and are indicated for tinea corporis.12-14 However, for extensive conditions, oral antifungal agents may be needed or preferred for practical reasons.

3. Tinea cruris, faciei, manuum, pedis, and imbricate. Approve after a trial of a topical antifungal agent. Terbinafine has been useful for these various tinea conditions;2-3,5-11,15-16 however, many topical antifungal agents are similarly effective and some are indicated for these conditions.12-14,17

4. Plantar- or moccasin-type dry tinea pedis. Approve. Oral antifungal therapy is often required for plantar or moccasin-type tinea pedis as topical antifungal agents have led to poor responses or frequent relapses. Studies with terbinafine have shown good results in the treatment of plantar/moccasin-type tinea pedis. 10,18-22

5. Black . Approve. Case reports document that terbinafine has been useful in black piedra, a condition with limited pharmacologic options.23-25

6. Tinea capitis. Approve. Terbinafine tablets have been effective in the treatment of tinea capitis,29-40

7. Tinea barbae. Approve. Case reports have described terbinafine as useful in tinea barbae.42- 43

8. Cutaneous (skin) candidiasis. Approve after a trial of a topical antifungal agent and an oral antifungal (eg, ketoconazole, fluconazole, or itraconazole). Terbinafine led to a mycological cure rate of 82% of patients with skin candidiasis in a 4-week randomized, double-blind, multicenter study involving 118 patients.44 Topical antifungals agents and other azole antifungals are also effective for this condition.

9. Other superficial fungal skin infections. Approve after a trial of a topical antifungal agent or an oral antifungal agent (eg, itraconazole, fluconazole). Terbinafine has been used in various superficial fungal infections (eg, seborrheic dermatitis,45 cutanenous ,46- 47 cutaneous alternariosis,48 and other subcutaneous infections49 and cutaneous sporotrichosis50-51,65, chromoblastomycosis66). Other antifungal agents and topical antifungal

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 5 agents have been reported to be efficacious in some of these conditions, such as seborrheic dermatitis.52

10. /mycetoma. Approve. In a single-center, open-label study61 27 patients with eumycetoma received terbinafine 500 mg BID for 24-48 weeks. An improvement or cure was noted in approximately 80% of patients. This subcutaneous mycoses is difficult to treat and usually involves surgical intervention.

Coverage of terbinafine tablets is not recommended in the following circumstances:

1. Tinea versicolor (pityriasis versicolor). Oral terbinafine is not recommended for the treatment of tinea versicolor.53-54 Although topical terbinafine is effective for tinea versicolor, oral treatment is not effective.

2. Systemic fungal infections. Data for terbinafine is confined to case serious or case reports such as compassionate cases of bronchopulmonary aspergillosis55, relapsing bronchitis56 and Curvularia lunata endocarditis57 and others58. Very little data exist on the use of terbinafine in the treatment of systemic fungal infections, therefore, its use for these indications should be considered investigational at this time.

3. Oral or esophageal candidiasis. Oral terbinafine is not recommended for the treatment of oral or esophageal candidiasis. Limited data are available regarding the use of terbinafine for these infections.59-60

4. Vaginal candidiasis. Oral terbinafine is not recommended for the treatment of vaginal candidiasis. Limited data have studied its efficacy for this condition and the 2006 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases (STCD) guidelines regarding vaginal candidiasis recommended azole antifungals (e.g., fluconazole) for this condition.62-63

The above policy is based on the following references: 1. Pickering, Larry K. editor, Redbook:American Academy of Pediatrics 26th edition 2003. 2. Product Information Insert. Sporanox® Oral Solution. Janssen Pharmaceutical, Raritan, NJ January 2004. 3. Sporanox internet site accessed Dec 15,2003 http://www.sporanox.com/ 4. Product Information Lamisil® Novartis Pharmaceuticals, East Hanover, NJ, March 2004. 5. Product Information Diflucan® /Roerig, New York, NY, June 2003 6. Bell-Syer SE, et.al. Oral treatments for fungal infections of the skin of the foot.Cochrane Database Syst Rev. 2002; (2): CD003584. 7. CDC. 2002 Guidelines for treatment of sexually transmitted diseases; recurrent vulvovaginal candidiasis. MMWR May 10 2002 ; /Vol. 51/No.RR-6accessed: http://www.cdc.gov/STD/treatment/5-2002TG.htm#VulvovaginalCan 8. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR 2002;51(No. RR-6):45-50. 9. Cohen AD, et.al. An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis. J Dermatolog Treat. 2003 Dec; 14(4): 237-42. 10. Crawford F, Young P, Godfrey C, et al. Oral treatment s for toenail onychomycosis. Arch Dermatol. 2002;138:811-16. 11. Darkes MJ, et. al. Terbinafine: a review of its use in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1): 39-65. Review.

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 6 12. De Punzio C - Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis: a double-blind randomized study Eur J Obstet Gynecol Reprod Biol FEB-2003; 13. Denning DW, Ribaud P, Milpied N, et al. Efficacy and safety of in the treatment of acute invasive . Clinical Infectious Diseases 2002;34:563-71. 14. Denning DW, Tucker RM, Hanson LH, Stevens DA. Treatment of invasive aspergillosis with itraconazole therapy in aspergillosis: study in 49 patients. J Am Acad Dermatol 1990;23:607-14. 15. FDA issues health advisory regarding the safety of Sporanox products and Lamisil tablets to treat fungal nail infections. FDA Talk Paper T01-22, May 9, 2001. 16. Ferris DG, Nyirjesy P, Sobel JD, et al. Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis. Obstet Gynecol 2002;99:419-25. 17. Gilbert DN, Moellering RC, Sande MA, eds. The Sanford Guide to Antimicrobial Therapy 2003. Antimicrobial Therapy Inc. Hyde Park, VT, 2003. 18. Gupta AK - Non-dermatophyte onychomycosis.Dermatol Clin - APR-2003; 21(2): 257-68. 19. Gupta AK, Cooper EA, Lynde CW The efficacy and safety of terbinafine in children. Dermatol Clin. 2003 Jul; 21(3): 511-20. 20. IDSA Guidelines for Treatment of Candidiasis Clinical Infectious Diseases 2004;38:161-189. 21. Lesher JL. Pityriasis versicolor and candidiasis. American Academy of Dermatology. http://www.aad.org/education/pityriasis.htm. (Accessed January 2004). 22. McEvoy GK, editor. American Hospital Formulary Service First Professional Edition , (online) Bethesda, Maryland 2004. 23. Medical Economics, Inc., Physicians' Desk Reference,online. (Montvale, NJ: Medical Economics, 2004). 24. Olin BR, editor. Drug Facts and Comparisons ( 25. Thomson Micromedex USPDI; (online version thru statref). Montvale, NJ. 2003.

26. Lamisil tablets [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2005.

S:VCHCP/Administration/Medical Policy/2005/PA Drug /AntiFungals 7