Prior Auth Protocol

FDA Approved Indications:

Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy

Health Net Approved Indications and Usage Guidelines:

Diagnosis of Stage IA and IB mycosis fungoides-type CTCL

AND

Failure or clinically significant adverse effects to one of the following skin-directed therapy: topical corticosteroids, topical mechlorethamine, topical retinoids (Targretin^R gel, Tazorac^R), Aldara^R, phototherapy

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:

In the Valchlor pivotal trial, qualifying prior skin-directed therapies included topical corticosteroids, phototherapy, Targretin gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies.
Targretin gel is also FDA approved for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
According to National Comprehensive Cancer Network (NCCN) guideline on mycosis fungoides, skin-directed therapies with category 2A recommendation are as follows: 1) For Stage 1A (limited, localized skin involvement): topical corticosteroids, topical mechlorethamine, local radiation, topical retinoids (Targretin gel, Tazorac), phototherapy (UVB, PUVA), topical Aldara, 2) For Stage 1B-2A (generalized skin involvement): topical corticosteroids, topical mechlorethamine, phototherapy (UVB, PUVA), total skin electron beam therapy (TSEBT).

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
*Very High Potency* augmented betamethasone 0.05% (Diprolene^R) ointment, gel, lotion; clobetasol propionate 0.05% (Temovate^R) cream, ointment, gel, solution; diflorasone diacetate 0.05% (Maxiflor^R, Psorcon E^R) cream, ointment; halobetasol propionate 0.05% (Ultravate^R) cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
*High Potency* augmented betamethasone 0.05% (Diprolene^R AF) cream; diflorasone 0.05% (Florone^R, Florone E^R, Maxiflor^R,Psorcon E^R) cream; fluocinonide acetonide 0.05% (Lidex^R, Lidex E^R) cream, ointment, gel, solution; triamcinolone acetonide 0.5% (Aristocort^R, Kenalog^R) cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
*Medium Potency* desoximetasone 0.05% (Topicort^R) cream, ointment, gel; fluocinolone acetonide 0.025% (Synalar^R) cream, ointment; mometasone 0.1% (Elocon^R) cream, ointment, lotion; triamcinolone acetonide 0.025%, 0.1% (Aristocort^R, Kenalog^R) cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
imiquimod (Aldara) cream	Apply 3 times per week for 12 weeks	Up to 12 weeks
Targretin (bexarotene) gel	Apply topically to affected area(s) QOD for the first week. Increase at weekly intervals to QD, then BID, then TID and finally QID according to individual lesion tolerance.	Up to QID application
Tazorac (tazarotene) 0.05%, 0.1% cream, gel	Apply topically to the affected area(s) HS	QD application

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Valchlor	Apply a thin film QD to affected areas of the skin	Length of Benefit

Product Availability:

Clear gel: 60 gm tubes of 0.016% w/w of mechlorethamine (equivalent to 0.02%

mechlorethamine)

References:

Valchlor [Prescribing Information] Malvern, PA: Ceptaris Therapeutics; September 2013.
National Comprehensive Cancer Network. Non-Hodgkin’s Lymphomas Version 2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf. Accessed June 29, 2015.
Lessin SR, Duvic M, Guitart J, et al. Topical chemotherapy in cutaneous T-cell lymphoma: Positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013;149(1):25-32.
Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 29, 2015.
Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 29, 2015.
American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 29, 2015.