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Coverage criteria policies

Eculizumab (SolirisĀ®) - Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Soliris requires prior authorization from Pharmacy Administration.

Coverage

Soliris is generally covered when:

  1. Prescribed by a specialist; and,
  2. Prescribed for
    1. paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and when used according to the FDA-approved regimen of 600 mg infused every 7 days for the first 4 weeks, followed by 900 mg for the fifth dose 7 days later, and then 900 mg every 14 days thereafter; and,
    2. Patients 18 years and older with atypical hemolytic uremic syndrome (aHUS) not caused by Shiga toxin E. coli when used to inhibit complement-mediated thrombotic microangiopathy when used according to the FDA-approved regimen of
    3. mg weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter.
  3. The patient and/or guardian has attested that they will adhere to the treatment plan; and,

Definitions

Soliris is a complement inhibitor indicated for:

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

The effectiveness of Soliris in aHUS is based on the effects on thrombotic microangiopathy (TMA) and renal function.

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hematopoietic stem cell disorder where blood cells lack important complement inhibitors on the cell surface. This makes red blood cells susceptible to breakdown resulting in complications such as clot formation and deposition throughout the body.

Atypical hemolytic uremic syndrome (aHUS) is a genetic disease that results in uncontrolled activation of the complement system, resulting in the formation of blood clots in small blood vessels throughout the body.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPC

Codes

Description

J1300

Injection, eculizumab, 10 mg

NDC

Codes

Description

25682000101

10 mg/mL single-use 30 mL vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

Reference

  1. Soliris prescribing information. Alexion Pharmaceuticals, Inc. 1/2016.

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Policy activity

  • 01/01/2017 - Date of origin
  • 01/01/2018 - Effective date
Review date
  • 04/2017
Revision date
  • 11/06/2017

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