Prior Auth Protocol

FDA Approved Indications:

For use in the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
For use in the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Health Net Approved Indications and Usage Guidelines:

Prior to therapy initiation, menigococcal vaccination at least 2 weeks is required.

AND
Atypical hemolytic uremic syndrome (aHUS)

Diagnosis of aHUS

OR

Paroxysmal nocturnal hemoglobinuria (PNH)

Diagnosis of PNH
AND
Has had at least one transfusion in the prior 24 months due to documented hemoglobin of less than 7 g/dL in patients without anemia symptoms or less than 9 g/dL with anemia symptoms
OR
Has had history of major adverse vascular events from thromboembolism
AND

Has flow cytometric confirmation of at least 10% PNH cells where available

AND

Has a platelet count of at least 30,000/microliter

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:

The use of Soliris increases the risk of meningococcal infection.
Soliris is only available through the REMS (Risk Evaluation and Mitigation Strategy) program.
Soliris is contraindicated in:
- Patients with unresolved serious N. meningitides infection
- Patients who are not currently vaccinated against N. meningitides, unless the risk of delaying Soliris outweighs the risk of developing a meningococcal infection.
The safety and efficacy of Soliris in the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS) has not been established.
Vascular events due to thromboembolism include but are not limited to: thrombophlebitis, deep vein thrombosis, pulmonary embolus, renal vein thrombosis, mesenteric/splenic vein thrombosis, hepatic/portal vein thrombosis, acute peripheral vascular occlusion, clinically apparent distal embolization (e.g., lower extremity ulceration, tissue necrosis, gangrene, limb amputation or other end-organ damage), cerebrovascular accident, transient ischemic attack, unstable angina and myocardial infarction.
The safety and efficacy of Soliris for PNH have not been evaluated in pediatric patients under 18 years old; however, the safety and effectiveness of Soliris for aHUS in pediatric patients older than 2 months and weigh at least 5 kg in three clinical studies appear similar to adult patients.
Soliris is a pregnancy category C drug. There are no adequate and well-controlled studies in pregnant women or nursing mothers.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Soliris

(Adults 18 years of age or older)

Paroxysmal Nocturnal Hemoglobinuria (PNH)
600 mg IV weekly for the first 4 weeks, followed by 900 mg IV for the fifth dose 1 week later, then 900 mg IV every 2 weeks thereafter

Atypical Hemolytic Uremic Syndrome (aHUS)
Adults 18 year of age or older
900 mg IV weekly for the first 4 weeks, followed by 1200 mg IV for the fifth dose 1 week later, then 1200 mg IV every 2 weeks thereafter

6 months or to member's renewal period, whichever is longer

Soliris

(Pediatrics under 18 years of age for aHUS)

Pediatrics under 18 years of age for
Atypical Hemolytic Uremic Syndrome (aHUS)

Body Weight	Induction	Maintenance
40 kg and over	900 mg IV weekly x 4 doses	1200 mg IV at week 5; then 1200 mg IV every 2 weeks
30-40 kg	600 mg IV weekly x 2 doses	900 mg IV at week 3; then 900 mg IV every 2 weeks
20-30 kg	600 mg IV weekly x 2 doses	600 mg IV at week 3; then 600 mg IV every 2 weeks
10-20 kg	600 mg IV weekly x 1 dose	300 mg IV at week 2; then 300 mg IV every 2 weeks
5-10 kg	300 mg IV weekly x 1 dose	300 mg IV at week 2; then 300 mg IV every 3 weeks

6 months or to member's renewal period, whichever is longer

Product Availability:

Vial: 300 mg single-use vials containing 30 mL of 10 mg/mL solution

References:

Soliris [Prescribing Information] Cheshire, CT: Alexion Pharmaceuticals, Inc; April 2014.
Borowitz MJ, Craig FE, DiGiuseppe JA, et al. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Cytometry Part B Clin Cytom. 2010;78:211-30.
Hillmen P, Young NS, Schubert J, et al. The Complement Inhibitor Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2006;355:1233-43.
Brodsky RA, Young NS, Antonioli E, et al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Blood. 2008;111:1840-47.
Legendre CM, Licht C, Muus P, et al. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013;368:2169-81.
Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/. Accessed July 2, 2015
Soliris. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015
DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Truven Health Analytics. Updated periodically. Accessed July 2, 2015