Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-130-005
Topic: Eculizumab (Soliris)
Section: Injections
Effective Date: May 28, 2018
Issue Date: May 28, 2018
Last Reviewed: February 2018

Eculizumab (Soliris®) is a recombinant humanized monoclonal antibody that binds to complement protein C5 and inhibits its enzymatic cleavage, blocks formation of the terminal complement complex, and thus prevents red cell lysis in paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS).

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Eculizumab (Soliris) may be considered medically necessary for the treatment of an individual 18 years of age or older with documented PNH to reduce hemolysis at initiation of therapy when the following criteria are met:                                                                                                                        

OR

Documented history of a major adverse vascular event (MAVE) from thromboembolism that may include ANY ONE of the following;

Venous thrombosis 

Arterial thrombosis

Eculizumab (Soliris) may be considered medically necessary in an initial six (6) week trial for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy when the following criteria are met:

Continuation of eculizumab (Soliris) following an initial six (6) week trial for the treatment of aHUS is may be considered medically necessary when there is clinical improvement after the initial trial (for example, normalization of platelet count or laboratory evidence of reduced hemolysis).

Eculizumab (Soliris) may be considered medically necessary in an initial 26 week trial for the treatment of individuals 18 years of age or older with a diagnosis of myasthenia gravis when ALL the following criteria are met:

Continuation of eculizumab (Soliris) may be medically necessary for individuals who demonstrate a clinically meaningful response regarding daily activities (greater than or equal to a three (3) point improvement in the MG-ADL from baseline) after 26 weeks of therapy.

Services that do not meet the above criteria will be considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.

Procedure Codes
J1300


*See Table Attachment for additional information.

NOTE: Dosage recommendations per the FDA label.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Eculizumab (Soliris) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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