Prior Auth Protocol

FDA Approved Indications:

For the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (CRPC).

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:

Infusion requires access to a collecting site 3 days in advance of infusion. There are 3 infusions administered 2 weeks apart. Treatment is for autologous use only.
Current American Urological Association (AUA) guidelines recommend Zytiga + prednisone (Level A), Xtandi (Level A), docetaxel (Level B), or sipuleucel-T (Level B) as standard of use for CRPC.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Zytiga^R(abiraterone acetate)*	1,000 mg (four 250 mg tablets) PO QD with prednisone 5 mg PO BID	1,000 mg QD
Xtandi^R(enzalutamide)*	160 mg (four 40 mg capsules) PO QD	160 mg QD

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Provenge	One dose IV over 60 minutes given approximately every 2 weeks for 3 doses Each dose contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, in 250 ml of Lactated Ringer's Injection	6 months or to member's renewal period, whichever is longer

Product Availability:

Minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, in 250 ml of Lactated Ringer's Injection

References:

Provenge [prescribing information].Seattle, WA; Dendreon Corporation; October 2014
Xtandi [prescribing information]. Northbrook, IL; Astellas Pharma US, Inc.; September 2014.
Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. NEJM. 2010;363(5)411-422.
Zytiga [prescribing information].Horsham, PA; Janseen Biotech Inc.; May 2015.
DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 3, 2015.
Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 2, 20154.
National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed May 27, 2015.
American Urological Association Education and Research. Castration-Resistant Prostate Cancer: AUA Guideline. Available at: http://www.auanet.org/common/pdf/education/clinical-guidance/Castration-Resistant-Prostate-Cancer.pdf. Accessed June 2, 2015.