Prior Auth Protocol

FDA Approved Indications:

Treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)
Lamisil granules only: Treatment of tinea capitis in patients 4 years of age and older

Health Net Approved Indications and Usage Guidelines:

TINEA CAPITIS - LAMISIL TABLETS OR LAMISIL GRANULES

Diagnosis of Tinea capitis

OTHER TINEA INFECTIONS - LAMISIL TABLETS ONLY

Diagnosis of other Tinea infections (e.g., Tinea pedis, Tinea corporis, Tinea cruris)

Coverage is Not Authorized For:

Treatment of Tinea (pityriasis) versicolor
Onychomycosis for HNOR Commercial members (onychomycosis treatment is a benefit exclusion)
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:

Controlled clinical trials have not shown oral Lamisil tablets to be effective for the treatment of tinea (pityriasis) versicolor
Only the Lamisil granules, not the tablet formulation, are FDA approved for tinea capitis. The European Society for Pediatric Dermatology issued a Grade A recommendation (strength of evidence Ia) for terbinafine, itraconazole, or fluconazole tablets for tinea capitis in children caused by Trichophyton species since efficacy rates and potential adverse effects are similar to those of griseofulvin while requiring a shorter duration of treatment.
There is some evidence that a longer duration of treatment (e.g., 6-8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Topical antifungals for tinea corporis, cruris, pedis econazole (Spectazole^R) 1% cream**	Tinea corporis or cruris: Apply QD x 2 weeks Tinea pedis: Apply QD x 4 weeks	This field intentionally left blank
Exelderm^R (sulconazole) 1% cream, solution**	Tinea corporis or cruris: Apply QD-BID x 3 weeks Tinea pedis: Apply BID x 4 weeks	This field intentionally left blank
ketoconazole (Nizoral^R) 2% cream**	Tinea corporis or cruris: Apply QD x 2 weeks Tinea pedis: Apply QD x 6 weeks	This field intentionally left blank
ciclopirox (Loprox^R) 0.77% cream**	Tinea corporis or cruris: Apply BID x 4 weeks Tinea pedis: Apply BID X 4 weeks	This field intentionally left blank
Naftin^R (naftifine) 1% cream, gel**	Tinea corporis or cruris: Apply to affected area QD, (BID) x 2-4 weeks Tinea pedis: Apply to affected area QD, (BID) x 4-6 weeks	This field intentionally left blank
Oxistat^R (oxiconazole nitrate) 1% cream, lotion**	Tinea corporis or cruris: Apply QD-BID x 2 weeks Tinea pedis: Apply QD-BID x 4 weeks	This field intentionally left blank
Topical antifungal and corticosteroid combination for tinea corporis, cruris, pedis clotrimazole/ betamethasone (Lotrisone^R)1%/ 0.05% cream, lotion	Tinea corporis or cruris: Apply BID x 2 weeks Tinea pedis: Apply BID x 4 weeks	This field intentionally left blank
Topical OTC antifungals for tinea corporis, cruris, pedis** clotrimazole (Lotrimin^R, Lotrimin AF^R,Desenex^R, Cruex^R) 1% cream, lotion, soln, spray powder	Tinea cruris: Apply BID x 2 weeks Tinea corporis and pedis: Apply BID x 4 weeks	This field intentionally left blank
miconazole (various brands) 2% ointment, cream, powder, spray powder/liquid	Tinea corporis or cruris: Apply BID x 2 weeks Tinea pedis: Apply BID x 4 weeks	This field intentionally left blank
terbinafine (Lamisil AT^R) cream, spray, gel	Tinea corporis or cruris: Apply QD-BID x 1-4 weeks Tinea pedis: Apply BID x 1-4 weeks	This field intentionally left blank
tolnaftate (various brands) 1% cream, soln, powder, spray liquid/powder	Tinea corporis pedis or cruris: Apply BID x 2-6 weeks	This field intentionally left blank
Oral Antifungal Agents for tinea infections griseofulvin microsize tablets (Grifulvin V^R)	Tinea pedis Adults 1 g PO QD Children 10 mg/kg PO QD for 4-8 weeks Tinea corporis Adults 500 mg PO QD Children 10 mg/kg PO QD for 2-4 weeks Tinea cruris Adults 500 mg PO QD Children 10 mg/kg PO QD until infection cleared Tinea capitis Adults 500 mg PO QD or in divided doses for 6-12 weeks Children 10-20 mg/kg	1000 mg/day
griseofulvin ultramicrosize tablets (Gris-PEG^R)	Tinea pedis Adult 750 mg PO in divided doses Children 25-187.5 mg PO QD (16-27 kg) or 187.5-375 mg QD (>27 kg) for 4-8 weeks Tinea corporis Adult 375 mg PO QD Children 25-187.5 mg PO QD (16-27 kg) or 187.5-375 mg QD (>27kg) for 2-4 weeks Tinea cruris 375 mg PO QD Children 25-187.5 mg PO QD (16-27 kg) or 187.5-375 mg QD (>27kg) until the infection clears Tinea capitis Adults 375 mg PO QD Children 10-15 mg/kg PO QD for 4-6 weeks Gris-PEG is only FDA indicated for Children > 2 yrs.	750 mg/day
itraconazole (Sporanox^R)*	Tinea capitis 3-5 mg/kg PO QD for 4-6 weeks (non FDA approved)	5 mg/kg/day
* Requires prior authorization ** OTC products are a benefit exclusion	This field intentionally left blank.	This field intentionally left blank.

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Lamisil^R (terbinafine granules)	<25 kg patient 125 mg PO QD 25-35 kg patient 187.5 mg PO QD >35 kg patient 250 mg PO QD	6 weeks
Lamisil (terbinafine tablets)	Tinea corporis, cruris, or pedis <20 kg patient: 62.5 mg PO QD 20-40 kg patient: 125 mg PO QD >40 kg patient: 250 mg PO QD Tinea capitis <20 kg patient: 62.5 mg PO QD 20-40 kg patient: 125 mg PO QD >40 kg patient: 250 mg PO QD	Tinea corporis, cruris, or pedis 2 weeks Tinea capitis 6 weeks

Product Availability:

Tablet: 250 mg
Granules (Packet): 125 mg, 187.5 mg

References:

Lamisil [Prescribing information]: East Hanover, NJ: Novartis Pharmaceuticals; February 2015.
Lamisil granules [Prescribing Information]. East Hanover, NJ: Novartis; February 2015.
Brautigam M, Nolting S, Schopf, RE, et al. Randomized double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection. BMJ 1995;311:919-922.
Tosti A, Piraccini BM, Stinchi C, et al. Treatment of dermatophytes nail infections: an open randomized study comparing intermittent terbinafine therapy with continuous terbinafine treatment and intermittent itraconazole therapy. J Am Acad Dermatol 1996;34:595-600.
Haria M, Bryson HM, Goa KL. Itraconazole. A reappraisal of its pharmacological properties and therapeutic use in the management of superficial fungal infections. Drugs 1996;51:585-620.
Physician letter. Novartis Pharmaceuticals May 2001
Kakourou T, Uksal U, European Society for Pediatric Dermatology. Guidelines for the management of tinea capitis in children. Pediatr Dermatol 2010;27:226.
Sanford JP. The Sanford Guide to Antimicrobial Therapy. 40th edition. Sperryville, VA: Antimicrobial Therapy, Inc; 2010.
Dermatophyte (Tinea) Infections. UpToDate, UpToDate, Inc. www.uptodate.com/. Accessed July 2015.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 02, 2015.