Prior Auth Protocol

FDA Approved Indications:

In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of multiple myeloma (MM)

AND

Used in combination with Revlimid and dexamethasone

AND

Prescribed by an Oncologist

AND

Patient has received at least one prior therapy

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:

According to the National Comprehensive Cancer Network guidelines, preferred primary treatment of multiple myeloma includes the following agents used either alone or in combination: Velcade, Cytoxan, Adriamycin, Revlimid, Thalomid, Alkeran.
According to the National Comprehensive Cancer Network guidelines, preferred therapy for previously treated patients includes the following agents used either alone or in combination: Velcade, Cytoxan, Revlimid, Adriamycin, Thalomid, Kyprolis, Darzalex, Toposar, Platinol, Empliciti, Pomalyst, Doxil and Farydak.
In clinical trials, stem cell transplantation was considered a prior therapy.
Ninlaro is currently being studied for treatment of newly diagnosed multiple myeloma.
Patients are currently being recruited for trials using Ninlaro in relapsed and/or refractory follicular lymphoma, surgically unresectable urothelial cancer, relapsed or refractory systemic light chain amyloidosis, and relapsed or refractory acute myeloid leukemia.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Velcade^R (bortezomib)*	Various	Varies
Doxil^R (liposomal doxorubicin)*	Various	Varies
Kyprolis^TM (carfilzomib)*	Various	Varies
Empliciti^TM (elotuzumab)	Various	Varies
Revlimid^R (lenalidomide)*	Various	Varies
Farydak^R (panobinostat)*	Various	Varies
Pomalyst^R (pomalidomide)*	Various	Varies
cyclophosphamide (Cytoxan)*	Various	Varies
Thalomid^R (thalidomide)*	Various	Varies
Darzalex^TM (daratumumab)*	Various	Varies
cisplatin (Platinol)*	Various	Varies
etoposide (Toposar^R ,Vepesid^R, Etopophos^R)*	Various	Varies
Alkeran^R (melphalan)*	Various	Varies

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Ninlaro	4 mg PO QD once a week on days 1, 8, and 15 of a 28-day treatment cycle. Reduce the starting dose of Ninlaro to 3 mg in patients with moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease.	Length of Benefit or until disease progression

Product Availability:

Ninlaro capsules: 2.3, 3, and 4 mg

References:

1. Ninlaro [Prescribing Information]. Cambridge,MA: Takeda Pharmaceutical Company Limited; November 2015.
2. National Comprehensive Cancer Network. Multiple Myeloma Version 3.2016. Available at: http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf . Accessed January 19, 2016.

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