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HealthPartners

Coverage criteria policies

Eculizumab (Soliris®)

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 HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

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

Initial Approvals

  1. Prescribed by a specialist; and,
  2. Prescribed for
    1. Patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis ; or,
    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 ; or
    3. Myasthenia gravis as follows:
      1. Patients 18 years and older 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,
      2. with a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 6 or higher upon initiation of therapy; and,
      3. with disease or symptom progression after one year of therapy on two immunosuppressive agents OR at least one immunosuppressive agent and at least quarterly plasma exchange or intravenous immune globulin were required; and,
  3. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  4. Soliris is prescribed within the FDA-approved dosing regimen; and,
  5. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Approvals will be authorized as follows:

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.

Reauthorization

Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) reauthorizations will be provided for twelve months. Annual reauthorizations will require medical chart documentation that the patient has been seen within the past 12 months and that markers of disease (e.g., hemolysis) are improved by therapy.

Generalized myasthenia gravis (gMG) will reauthorizations will be provided for 12 months. Annual reauthorizations will require medical chart documentation that the patient has been seen within the past 12 months and that the MG-ADL score is reduced by 3 from baseline.

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 antibody positive.

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.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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

Soliris 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 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. 10/2017.

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Policy activity

  • 05/01/2007 - Date of origin
  • 04/01/2018 - Effective date
Review date
  • 05/2018
Revision date
  • 02/05/2018

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