Prior Auth Protocol

FDA Approved Indications:

For the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

Health Net Approved Indications and Usage Guidelines:

Patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease.

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:

Based on results from two phase II studies, National Comprehensive Cancer Network (NCCN) has recommended use of vorinostat in combination with bortezomib (Velcade^R) as a treatment option for relapsed or refractory multiple myeloma.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Topical high potency corticosteroids: i.e., betamethasone, clobetasol	Dosage varies depending on area affected	Dosage varies depending on area affected
Methotrexate (Rheumatrex^R, Trexall^R)	5-50 mg PO, IM, IV once weekly; 15-37.5 mg PO, IM, IV twice weekly for poor responders to weekly therapy	50 mg once weekly or 37.5 mg twice weekly
Targretin^R (bexarotene)	Capsules: Initial dose is 300 mg/m²/day. Dosage may be adjusted depending on patients response and tolerability. Gel: Apply once every other day for the 1^st week. The application should be increased at weekly intervals to once daily and titrated up to four times daily depending on lesion tolerance	Oral dose can be titrated up to 400 mg/m²/day based on clinical response
Electron beam / phototherapy	Weekly-monthly	Dosage varies upon protocol and patient tolerance
Romidepsin (Istodax^R)*	14 mg/m²IV days 1,8,15 repeated in 28-day cycles	Dosage varies upon protocol and patient tolerance
Isotretinoin (Amnesteem^R,Claravis^TM, Sotret^TM)*	1 to 3 mg/kg/day PO	Dosage varies upon protocol and patient tolerance
Doxil^R (liposomal doxorubicin)*	20-40 mg/m² IV q4 weeks for up to 8 cycles	Dosage varies upon protocol and patient tolerance

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Zolinza	400 mg PO QD with food.	Length of Benefit

Product Availability:

Capsule: 100 mg

References:

Zolinza. [Prescribing information] Whitehouse Station, NJ:Merck & CO; April 2013.
NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkins Lymphomas, V.2.2013. http://www.nccn.org/. Accessed June 30, 2015.
Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed July 7, 2015
American Hospital Formulary Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 7, 2015.
Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo:.Thomson Healthcare. Updated periodically. Accessed July 7, 2015.