Prior Auth Protocol

FDA Approved Indications:

In combination with bortezomib (Velcade^R) and dexamethasone, treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib (Velcade^R) and an immunomodulatory agent

Health Net Approved Indications and Usage Guidelines:

Diagnosis of multiple myeloma (MM)

AND

Failure or clinically significant adverse effects to at least 2 prior regimens including Velcade^R and an immunomodulatory agent (e.g., dexamethasone)

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:

Accelerated FDA approval for this indication is based on progression free survival. Its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
According to National Comprehensive Cancer Network guideline, category 1 recommendation for the treatment of multiple myeloma is listed as follows: a) maintenance therapy when in remission: Revlimid^R, Thalomid^R, and b) therapy for previously treated MM: Velcade^R, Velcade^R/liposomal doxorubicin, Kyprolis^TM/Revlimid^Rdexamethasone, Revlimid^R/dexamethasone. Therapy for previously treated relapsed/refractory MM is considered in the following conditions: patients with relapsed disease after allogeneic or autologous stem cell transplant (SCT), patients with primary progressive disease after initial allogeneic or autologous SCT, and patients with ineligible for SCT with progressive or relapsing disease after initial primary therapy.
Because of severe diarrhea and cardiac toxicities, Farydak has a Risk Evaluation and Mitigation Strategy (REMS) program that consists of a Medication Guide and a Dear Healthcare Professional Letter. Patient and physician enrollment in the manufacturers REMS program is required.
Farydak is currently being studied for the treatment of myelodsyplastic syndrome, acute myeloid leukemia, myelofibrosis, refractory Hodgkins lymphoma, advanced solid tumors (breast, brain, prostate), non-small cell lung cancer, chronic myelogenous leukemia, and renal cell carcinoma.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
dexamethasone (pulse dose as single agent)	Multiple Myeloma (Conventional primary therapy) Dexamethasone: 40 mg PO days 1-4, 9-12, 17-20	As recommended in dosing regimen
Pomalyst^R (pomalidomide)*	Multiple Myeloma 4 mg PO QD on days 1-21 of repeated 28-day cycles until disease progression. Pomalyst may be given in combination with dexamethasone Avoid Pomalyst in patients with a serum creatinine greater than 3.0 mg/dL	As recommended in dosing regimen
Revlimid^R (lenalidomide)*	Multiple Myeloma Revlimid: 25 mg PO QD on days 1-21 of repeated 28 day cycles Dexamethasone: 40 mg PO QD on days 1-4,9-12,17-20 of each 28 day cycle for the first 4 cycles then 40 mg PO QD for days 1-4 every 28 days	As recommended in dosing regimen
Thalomid^R (thalidomide)/ dexamethasone	Multiple Myeloma Thalomid: 200 mg PO QD Dexamethasone: 40 mg PO QD on days 1-4,9-12,17-20 for odd cycles and days 1-4 for even cycles Repeat cycle every 28 days	As recommended in dosing regimen
melphalan/prednisone (MP)	Multiple Myeloma (Conventional primary therapy) Melphalan: 8 mg/m²/day PO on days 1-4 Prednisone: 60 mg/m²/day PO on days 1-4 Repeat cycle every 28 days	As recommended in dosing regimen
vincristine/doxorubicin/dexamethasone (VAD)*	Multiple Myeloma (Conventional primary therapy) Vincristine: 0.4 mg/day IV continuous infusion on days 1-4 Doxorubicin: 9 mg/m²/day IV continuous infusion on days 1-4 Dexamethasone: 40 mg PO QD on days 1-4, 9-12, 17-20 Repeat cycle every 28-35 days	As recommended in dosing regimen
Velcade (bortezomib)*	Multiple Myeloma 1.3 mg/m² SC or IV Retreatment may be considered for patients with MM who had previously responded to treatment with Velcade and who have relapsed at least 6 months after completing prior Velcade treatment.	As recommended in dosing regimen
Kyprolis (carfilzomib)*	Multiple Myeloma 20 mg/m² IV on two consecutive days each week for 3 weeks (Days 1, 2, 8, 9, 15 and 16) followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. If tolerated in cycle 1, the dose should be escalated to 27 mg/m² and in the subsequent cycles.	As recommended in dosing regimen

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Farydak	20 mg PO QOD for 3 doses per week (on Days 1, 3, 5, 8, 10, and 12) of Weeks 1 and 2 of each 21-day cycle for 8 cycles Reduce the starting dose of Farydak to 15 mg in patients with mild hepatic impairment and 10 mg in patients with moderate hepatic impairment or when coadministered with strong CYP3A inhibitors	Length of Benefit or until disease progression

Product Availability:

Capsule: 10 mg, 15 mg, 20 mg

References:

1. Farydak [package insert]. East Hanover, MJ: Novartis Pharmaceuticals; February 2015.

2. National Comprehensive Cancer Network. Multiple Myeloma Version 3.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed June 30, 2015.