Prior Auth Protocol

FDA Approved Indications:

For the topical treatment of actinic keratosis lesions of the face, ears, and scalp

Health Net Approved Indications and Usage Guidelines:

Diagnosis of actinic keratosis lesions of the face, ears, and scalp

AND

Failure or clinically significant adverse effects to topical fluorouracil cream 5% (generic Efudex)

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:

Other topical treatment options for actinic keratosis include imiquimod (Aldara, Zyclara, Zyclara Pump) and Picato (ingenol mebutate).

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
fluorouracil 5% topical cream (Efudex)	Actinic Keratosis: Apply to lesions topically BID for 2 to 4 weeks	This field intentionally left blank.
imiquimod 5% cream (Aldara)	Apply two to three times weekly for up to 16 weeks	This field intentionally left blank.
Picato (ingenol mebutate gel)	Actinic Keratosis: Face and scalp: apply 0.015% gel QD to affected area for 3 consecutive days Trunk/extremities: apply 0.05% gel QD to affected area for 2 consecutive days	This field intentionally left blank.
diclofenac 3% gel (Solaraze)	Actinic Keratosis: Apply to lesion area BID for 60-90 days	This field intentionally left blank.

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Tolak	Apply topically QD for 4 weeks in an amount sufficient to cover the lesions with a thin film, massaging uniformly into the skin.	Length of Benefit

Product Availability:

Cream: 40 mg flurouracil per gram of cream (4%) in 40 gram tubes

References:

1. Tolak [Prescribing Information]. Sanford, Florida: Hill Dermaceuticals, Inc.; September 2015.
2. Jorizzo J. Treatment of actinic keratosis. In: UpToDate [Online Database], Post TW (Ed), UpToDate, Waltham, MA. Accessed December 14, 2015).
3. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thompson Healthcare. Updated periodically. Accessed December 2015.