Prior Auth Protocol

FDA Approved Indications:

Topical treatment of cutaneous lesions in patients with acquired immune deficiency syndrome (AIDS)-related Kaposi`s sarcoma (KS). Panretin gel is not indicated when systemic anti-KS therapy is required (e.g., more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement).

Health Net Approved Indications and Usage Guidelines:

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:

There is insufficient evidence to support the use of Panretin in the treatment of T-cell lymphoma and classic KS.
Panretin is topical, not systemic therefore it cannot treat visceral KS nor prevent the development of new lesions where it has not been applied.
Evidence of systemic disease includes: more than 10 new lesions in the prior month or greater than 25 total lesions, symptomatic lymphedema, symptomatic pulmonary Kaposi's sarcoma, symptomatic visceral disease.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
*These agents are used for systemic disease. Panretin has not been studied in combination with these drugs.* DaunoXome^R(liposomal daunorubicin)	40 mg/m² IV q 2 weeks	Varies
Doxil^R (liposomal doxorubicin)*	20 mg/m² IV q 3 weeks	Varies
Taxol^R(paclitaxel)*	100 mg/m² IV q 2 weeks or 135 mg/m² IV q 3 weeks	Varies
Intron^R A(interferon-alfa-2b recombinant)*	30 mIU/m² SQ or IM TIW (Note: Do not use Intron A Solution for Injection in vials or multidose pens)	110 mIU/week

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Panretin (alitretinoin)	Apply to lesions twice daily. May increase to 3-4 times daily.	Length of Benefit

Product Availability:

0.1% Gel: 60 gm tube

References:

Panretin. Prescribing information Woodcliff Lake,NJ. Eisai Inc. July 2009.
Bodsworth NJ, Bloch M, Bower M, Donnell D, Yocum R. International Panretin Gel KS Study Group. Phase III vehicle-controlled, multi-centered study of topical alitretinoin gel 0.1% in cutaneous AIDS-related Kaposi`s sarcoma. Am J Dermatology. 2001;2(2):77-87.
Duvic M, Friedman-Kien AE, Looney DJ, et al. Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi`s sarcoma using alitretinoin gel: results of phase 1 and phase 2 trials. Arch Dermatology. 2000;136(12):1461-9.
Dezube BJ. Management of AIDS-related Kaposi`s sarcoma: advances in target discovery and treatment. Expert Rev of Anticancer. Ther. 2002;2(2):193-200.
Pantanowitz L, Dezube BJ AIDS related cancer:new entities, emerging targets, and novel tactics. Abstr Hemocology Oncology. 2005:8(1):20-30.
Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/. Accessed July 1, 2015
Panretin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 1, 2015
DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Truven Health Analytics. Updated periodically. Accessed July 1, 2015