Prior Auth Protocol

FDA Approved Indications:

For the treatment of advanced renal cell carcinoma after failure of one systemic chemotherapy.

Health Net Approved Indications and Usage Guidelines:

OR

Patient has unresectable, recurrent/persistent or metastatic thyroid cancer (Follicular carcinoma, Hurthle cell carcinoma, Papillary carcinoma).

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:

Advanced disease refers to relapse or stage IV and medically or surgically unresectable.
The 2015 revised National Comprehensive Cancer Network (NCCN) Practice Guidelines for advanced renal cell carcinoma have the following recommendations for first line therapy: clinical trial or Sutent^R or Torisel^R or Avastin^R + interferon or Votrient^R or high dose interleukin 2 (for patients with good performance status) or Inlyta or Nexavar^R.
Inlyta is primarily metabolized by CYP3A4/5; avoid concomitant use of Inlyta and strong CYP3A4/5 inhibitors (e.g. ketoconazole) and inducers (e.g. rifiampin).
Per NCCN compendia, consider Inlyta if clinical trials or other systemic therapies are not available or appropriate for treatment of progressive and/or symptomatic iodine-refractory thyroid cancer. This is a class 2A recommendation for unresectable, recurrent/persistent local tumors or metastatic disease for Follicular Carcinoma, Hurthle Cell Carcinoma or Papillary Carcinoma.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Proleukin^R(interleukin 2)*	0.037 mg/kg administered by a 15 minute IV infusion Q 8 hours for a maximum of 14 doses followed by 9 days of rest and then repeated for another 14 doses	Patient is re-evaluated after 4 weeks and again prior to start of next cycle. Separate each treatment cycle by a rest period of at least 7 weeks.
Votrient^R(pazopanib)*	800 mg PO QD without food	800 mg/day
Nexavar^R (sorafenib)*	400 mg PO BID	800 mg /day
Sutent^R(sunitinib)*	50 mg PO QD	87.5 mg/day
Avastin^R(bevacizumab)* in combination with Intron A^R(interferon alfa-2b)*	10 mg/kg IV infused over 60-90 minutes Q 2 weeks in combination with interferon alfa 3 million IU SC/IM 5 times per week or up to 36 million IU SC/IM 3 times per week	10 mg/kg IV infused over 60-90 minutes every 2 weeks in combination with interferon alfa 3 million IU SC/IM 5 times per week or up to 36 million IU SQ/IM 3 times per week
Torisel^R(temsirolimus)*	25 mg IV infused over 30-60 minutes once a week.	50 mg/week
Afinitor^R(everolimus)*	10 mg PO QD	20 mg PO QD

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Inlyta	5 mg PO BID	Length of benefit or until disease progression

Product Availability:

Tablets: 1 mg and 5 mg

References:

1. Inlyta [Prescribing Information]. New York, NY: Pfizer; August 2014.

2. National Comprehensive Cancer Network. Kidney Cancer Version 3.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed June 9, 2015.

3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 9, 2015.

4. Inlyta. American Hospital Formulary Service Drug Information. Available at: http://medicinescomplete.com/mc/ahfs/current/. Accessed June 9 2015.

5. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/. Accessed June 9, 2015.

6. DRUGDEX^RSystem [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 9, 2015.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending