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HealthPartners

Coverage criteria policies

Eculizumab (Soliris®) and Ravulizumab-cwvz (Ultomiris™) - 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

Eculizumab (Soliris) and ravulizumab-cwvz (Ultomiris) require prior authorization from HealthPartners Pharmacy Administration.

Coverage

Soliris and Ultomiris are generally covered subject to the indications listed below when all of the following criteria are met, and per your plan documents:

Initial Authorizations:

Paroxysmal Nocturnal Hemoglobinuria:

  1. Prescribed by or in consultation with a hematologist or nephrologist; and,
  2. Patient is diagnosed with paroxysmal nocturnal hemoglobinuria (PNH); and,
  3. Patient has been vaccinated against meningococcal infection prior to therapy; and,
  4. The patient and or guardian has attested that they will adhere to the treatment regimen; and,
  5. Patients ≥ 18 years of age who are naïve to complement inhibitor therapy prescribed Soliris must try and fail treatment with Ultomiris first; and,
  6. Prescribed within the FDA approved dosing regimen

Atypical Hemolytic Uremic Syndrome:

  1. Prescribed by a specialist; and,
  2. Patient is ≥18 years of age; and,
  3. Patient is diagnosed with atypical hemolytic uremic syndrome (aHUS) not caused by shiga toxin E coli, when used to inhibit complement-mediated thrombotic microangiopathy; and,
  4. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  5. Soliris is prescribed within the FDA approved dosing regimen

Myasthenia Gravis:

  1. Prescribed by a specialist; and,
  2. Patient is ≥18 years of age; and,
  3. Patient is diagnosed with anti-acetylcholine receptor antibody positive generalized myasthenia gravis (e.g. Myasthenia Gravis Foundation of American (MFGA) clinical classification of Class II, III or IV); and,
  4. Patient has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 6 or higher upon initiation of therapy; and,
  5. Patient has had disease or symptom progression after one year of therapy on one of the following:
  6. Two immunosuppressive agents; or,
  7. At least one immunosuppressive agent and at least quarterly plasma exchange or intravenous immune globulin were required; and,
  8. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  9. Soliris is prescribed within the FDA approved dosing regimen

Initial Authorizations:

Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) authorizations will be provided for twelve months.

Generalized myasthenia gravis (gMG) authorizations will be provided for six months.

Reauthorizations:

  1. Patient has been seen by provider in the past 12 months; and,
  2. Patient has been adherent to therapy; and,
  3. Patient has a clinically meaningful response to therapy as defined by:
    1. For paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, a reduction in transfusions, or improvement in markers of hemolysis; or,
    2. For generalized myasthenia gravis, a 3 point reduction in MG-ADL score from baseline.

Reauthorizations will provided for twelve months

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 treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

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

ULTOMIRIS is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

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.

Generalized myasthenia gravis (gMG) is a chronic neuromuscular disease resulting from autoimmune dysfunction.

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

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J1300

Injection, eculizumab, 10 mg

J3590

Unclassified biologics

NDC

Codes

Description

25682000101

Soliris 300 MG/30ML SOLN

25682002201

Ultomiris 300 MG/30ML SOLN

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

Products

This information is for some, 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. 10/2017.
  2. Ultomiris prescribing information. Alexion Pharmaceuticals, Inc. 121 Seaport Boulevard, Boston, MA, 02210. 12/2018.

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Policy activity

  • 01/01/2017 - Date of origin
  • 04/01/2019 - Effective date
Review date
  • 05/2018
Revision date
  • 02/04/2019

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