Prior Auth Protocol

FDA Approved Indications:

For use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Health Net Approved Indications and Usage Guidelines:

Use with emetogenic chemotherapy agent

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:

Highly emetogenic chemotherapy agents: doxorubicin or epirubicin with cyclophosphamide, cyclophosphamide >1,500 mg/m², carmustine >250 mg/m², cisplatin, dacarbazine, doxorubicin ≥60 mg/m², epirubicin >90 mg/m², ifosfamide ≥2g/m², mechlorethamine, streptozocin
Moderately emetogenic chemotherapy agents: aldesleukin >12-15 million IU/m², amifostine >300 mg/m²,arsenic trioxide, azacitidine, bendamustine, busulfan, carboplatin, carmustine ≤250 mg/m², clofarabine, cyclophosphamide ≤1500 mg/m², cytarabine >200 mg/m², dactinomycin, daunorubicin, doxorubicin <60 mg/m², epirubicin ≤90 mg/m², idarubicin, ifosfamide <2 g/m², interferon alfa ≥10 million IU/ m², irinotecan, melphalan, methotrexate ≥250 mg/m², oxaliplatin, temozolomide
Concurrent use with thioridazine, a CYP2D6 substrate is contraindicated.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Emend^TM(aprepitant)	125 mg PO 1 hour prior to emetogenic chemotherapy, followed by 80 mg PO QD on days 2 and 3 (in combination with a 5-HT3 antagonist as well as dexamethasone 12 mg on day 1. Dexamethasone 8 mg PO QD on days 2 to 4 is additionally required for highly emetogenic chemotherapy).	125 mg/day
Akynzeo^R (netupitant and palonosetron)	Highly-emetogenic chemotherapy (including cisplatin-based) One capsule PO 1 hour prior to initiation of chemotherapy on day 1 (with dexamethasone 12 mg 30 min prior to initiation of chemotherapy) Chemotherapy not considered highly emetogenic One capsule PO 1 hour prior to initiation of chemotherapy on day 1 (with dexamethasone 12 mg 30 min prior to initiation of chemotherapy)	Highly-emetogenic chemotherapy (including cisplatin-based) One capsule of Akynzeo (netupitant 300mg and palonosetron 0.5mg)/day Chemotherapy not considered highly emetogenic One capsule of Akynzeo (netupitant 300mg and palonosetron 0.5mg)/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Varubi	180 mg PO 1 hour prior to chemotherapy (antiemetic regimen also requires 5HT3 antagonist as well as dexamethasone 20 mg PO 30 min prior to chemotherapy on day 1. Dexamethasone 8mg PO BID on days 2 to 4 is additionally required for highly emetogenic chemotherapy).	Length of Benefit

Product Availability:

Tablet: 90 mg

References:

1. Varubi [Prescribing Information]. Waltham, MA: Tesaro, Inc.; September 2015.

2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice guidelines in Oncology: Antiemesis Version I.2015. http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf. Accessed September 11, 2015.

3. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. Journal of Clinical Oncology. 2011; 29:4189-4198.

4. Roila F, Gerrstedt J, Aapro M, et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Annals of Oncology. 2010; supplement 5:v232-243.