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HealthPartners

Coverage criteria policies

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

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. 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 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; and,
  7. 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.

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; and,
  6. 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.

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:
    1. Two immunosuppressive agents; or,
    2. At least one immunosuppressive agent and at least quarterly plasma exchange or intravenous immune globulin were required; and,
  6. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  7. Soliris is prescribed within the FDA approved dosing regimen; and,
  8. 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.

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; and,
  4. Prescribed within the FDA-approved dosing regimen.

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 antibody positive.
    Limitation of use
    : Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

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.

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

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 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. 121 Seaport Boulevard, Boston, MA, 02210. 7/2018.
  2. Ultomiris prescribing information. Alexion Pharmaceuticals, Inc. 121 Seaport Boulevard, Boston, MA, 02210. 12/2018.

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Policy activity

  • 05/01/2007 - Date of origin
  • 04/01/2019 - Effective date
Review date
  • 05/2019
Revision date
  • 02/04/2019

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