Prior Auth Protocol

FDA Approved Indications:

For the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Health Net Approved Indications and Usage Guidelines:

Relapsing remitting multiple sclerosis (RRMS) confirmed by a neurologist

AND

Failure or clinically significant adverse effects to two of the following: Aubagio, Extavia, Tecfidera, Gilenya, Avonex, Betaseron, Plegridy, Copaxone, Glatopa or Rebif

Coverage is Not Authorized For:

Primary progressive multiple sclerosis
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:

Zinbryta has black box warnings for hepatic Injury including autoimmune hepatitis
Zinbryta can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. Obtain transaminase and bilirubin levels before initiation of Zinbryta. Monitor and evaluate transaminase and bilirubin levels monthly and up to 6 months after the last dose
Zinbryta is contraindicated in patients with pre-existing hepatic disease or hepatic impairment

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Avonex	30 mcg IM Q Wk Avonex may be titrated to reduce the incidence of flu-like symptoms, starting with 7.5 mcg for the first week and increasing the dose by 7.5 mcg each week for the next 3 weeks until the recommended dose of 30 mcg weekly is obtained.	30 mcg IM Q Wk
Betaseron	250 mcg SC QOD Generally, start at 0.0625 mg (0.25 mL) SC QOD, and increase over a six week period to 0.25 mg (1 mL) QOD.	250 mcg SC QOD
Copaxone	20 mg SC QD or 40 mg SC TIW Doses are not interchangeable	20 mg SC QD or 40 mg SC TIW
Glatopa	20 mg SC QD, dose is not interchangeable with glatiramer acetate 40 mg/ml	20 mg SC QD
Plegridy	125 mcg SC every 14 days Dose should be titrated, starting with 63 mcg on day 1, 94 mcg on day 15, and 125 mcg (full dose) on day 29	125 mcg SC every 14 days
Rebif	22 mcg or 44 mcg SC TIW	22 mcg or 44 mcg SC TIW
Aubagio	7 mg or 14 mg PO QD	7 mg or 14 mg PO QD
Tecfidera	120 mg PO BID for 7 days followed by 240mg PO BID	120 mg PO BID for 7 days followed by 240mg PO BID
Extavia	250 mcg SC QOD	250 mcg SC QOD
Gilenya	0.5 mg PO QD	0.5 mg PO QD

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Zinbryta (daclizumab)	150 mg SC once monthly	Length of Benefit

Product Availability:

Injection: 150 mg/mL solution in a single-dose prefilled syringe

References:

1. Zinbryta [Prescribing information] North Chicago, IL: AbbVie Inc., May 2016
2. Avonex [Prescribing information] Cambridge, MA: Biogen, Inc. August 2014.
3. Rebif [Prescribing information] Rockland, MA: Serono, Inc. March 2015.
4. Betaseron [Prescribing information] Montville, NJ: Berlex Laboratories. January 2014.
5. Extavia [Prescribing Information] Montville, NJ: Novartis. December 2014.
6. Copaxone [Prescribing information] North Wales, PA: Teva-Neuroscience, Inc. January 2014.
7. Plegridy [Prescribing information] Cambridge, MA: Biogen Idec Inc. August 2014.
8. Mitoxantrone [Prescribing information] North Wales, PA: Teva, March 2012.
9. Aubagio [Prescribing Information] Cambridge, MA: Sanofi Company. October 2014.
10. Gilenya [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; April 2014.

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