Prior Auth Protocol

FDA Approved Indications:

Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

Health Net Approved Indications and Usage Guidelines:

AND

OR

AND

Failure or clinically significant adverse effects to at least one standard therapy (i.e. corticosteroids, immunosuppressive/cytotoxic agents, antimalarials) (Not applicable to Medicare Part B requests)

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.
Patients who are autoantibody negative

General Information:

In a study that enrolled both autoantibody negative as well as autoantibody positive patients with SLE, no significant differences between any of the Benlysta groups and the placebo group were observed. Further analysis revealed that Benlysta offered benefit to autoantibody positive patients. Because of this lack of efficacy of Benlysta in autoantibody negative patients and since the FDA has approved Benlysta in autoantibody positive patients, coverage will not be authorized for patients who are autoantibody negative.
Autoantibodies may include: ANA (antinuclear antibodies), ds-DNA (double stranded DNA), Sm (Smith antigen), RNP (ribonucleoprotein), Ro/SSA, La/SSB
Standard of therapy may include any of the following classes of medication: Corticosteroids (e.g prednisone, methylprednisolone), Immunosuppresive/cytotoxic agents (e.g. azathioprine, methotrexate, mycophenolate), antimalarials (e.g. hydroxychloroquine)
Per package insert, the efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Hydroxychloroquine (Plaquenil^R) FDA approved for SLE	200 - 400 mg PO QD or BID	800 mg/day
Prednisone (various) FDA approved for SLE	5 - 60 mg PO per day	100 mg/day
Methylprednisolone (Solu-Medrol^R) FDA approved for SLE	1 gm IV QD for 3 days	1 gm/day
Azathioprine (Imuran^R)	1-2.5 mg/kg PO QD	2.5 mg/kg/day
Ibuprofen (Motrin^R)	400-800 mg PO up to four times daily	3200 mg/day
Mycophenolate (Cellcept^R)	Up to 1 gm PO BID	2 gm/day
Methotrexate (Rheumatrex^R)	7.5-25 mg PO/IM every week	30 mg/week
Leflunomide (Arava^R)	100 mg/day PO for 3 days followed by 20 mg/day	20 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Benlysta	10 mg/kg administered as an IV infusion over 1 hour every 2 weeks for the first 3 doses and at every 4 weeks thereafter. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis.	6 months or to member's renewal period, whichever is sooner.

Product Availability:

120 mg and 400 mg single-use vials containing lyophilized powder

References:

Benlysta [package insert]. Rockville, MD: Human Genome Sciences/GlaxoSmithKline; March 2012.
Navarro SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet. 2011;377:721-31.
Thomson MICROMEDEX, Thomson Healthcare, Inc. http://www.micromedex.com/ . Accessed June 16, 2014.
Schur PH, Wallace DJ. Overview of the therapy and prognosis of systemic lupus erythematosus in adults. Available at: http://www.uptodate.com. Accessed June 16, 2013.
Bartels C, Muller D. Systemic Lupus Erythematosus. Available at http://emedicine.com. Accessed June 17, 2013.
Lupus Foundation of America. Understanding lupus. Available at: http://www.lupus.org/webmodules/webarticlesnet/templates/new _learnunderstanding.aspx?articleid=22318zoneid-523 Accessed June 17, 2013.
Gladman DD, Urowitz MB, Esdaile JM, et al. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. 1999;42:1785-1796.
Dubois EL. Antimalarials in the management of discoid and systemic lupus erythematosus. Semin Arthritis Rheum. 1978;8:33-51.