Prior Auth Protocol

FDA Approved Indications:

For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

Health Net Approved Indications and Usage Guidelines:

AND

The lesion is positive for the BRAF V600E or V600K mutation as detected by an FDA-approved test.

AND

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.
Treatment of melanoma in patients with wild type BRAF gene.

General Information:

Coadministration of Cotellic with strong (i.e. itrazonazole) or moderate (i.e. erythromycin, ciprofloxacin) inhibitors of CYP3A4 should be avoided. Strong inducers of CYP 3A4 (eg. carbamazepine, pheynytoin, efavirenz, rifampin) may decrease the concentration of Cotellic by as much as 80%.
Dosage modification or discontinuation is recommended for patients who experience cardiomyopathy, rhabdomyolysis, Grade 3 or 4 hemorrhage, severe photosensitivity, retinopathy, retinal vein occlusion or, hepatotoxicity.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
dacarbazine (Dtic-Dome)	250 mg/m² IV days 1-5 every 3 weeks	Dose can vary depending on chemotherapy regimen
*Tafinlar (dabrafenib)	150 mg PO BID	300 mg/day
*Mekinist (trametinib)	2 mg PO QD	2 mg/day
Yervoy (ipilimumab)	3 mg/kg IV every 3 weeks for 4 doses	Limited to 4 lifetime doses within 16 weeks of the initial dose
*Zelboraf (vemurafenib)	960 mg PO BID	1920 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Cotellic	60 mg (three tablets) PO QD for 21 days, then off for 7 days (28 day cycle)	Length of Benefit

Product Availability:

Cotellic tablets: 20 mg

References:

1. Cotellic [Prescribing Information]. South San Francisco, CA: Genentech; May 2016.