BlueCross BlueShield of Tennessee Medical Policy Manual

Eculizumab

NDC CODE(S)

25682-0001-01 - Soliris 10 MG/ML SOLN (ALEXION)

DESCRIPTION

Eculizumab, a recombinant monoclonal antibody, binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of terminal complement complex C5b-9. The complement system of proteins, which is part of the immune system, destroys abnormal red blood cells. Eculizumab prevents destruction of red blood cells that are deficient in terminal complement inhibitors..

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Paroxysmal nocturnal hemoglobinuria

Loading dose:

600mg every 7 days for the first 4 weeks, followed by 900mg for the fifth dose 7 days later and then 900mg every 14 days thereafter (initial loading dose requires a total of 3,300mg over 5 weeks)

Maintenance dose:

900 mg every 14 days
Atypical hemolytic uremic syndrome

Loading dose:

900mg every 7 days for the first 4 weeks, followed by 1,200mg for the fifth dose 7 days later and then 1,200mg every 14 days thereafter (initial loading dose requires a total of 4,800mg over 5 weeks)

Maintenance dose:

1200 mg every 14 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of eculizumab for the treatment of other conditions or diseases.

SOURCES

Centers for Disease Control and Prevention. (2015, June). Morbidity and Mortality Weekly Report. Use of serogroup B meningococcal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2015. Retrieved February 23, 2016 from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6422a3.htm.

Lexi-Comp Online. (2016). AHFS DI. Soliris®. Retrieved October 27, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Eculizumab. Retrieved October 27, 2016   from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2015, December). Center for Drug Evaluation and Research. Soliris® (eculizumab). Retrieved October 27, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/8/2007

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Eculizumab (Soliris®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the request show ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) diagnosis with ALL of the following?

If yes, go to question #5

If no, go to question #4

  1. Does the individual have a diagnosis of atypical hemolytic uremic syndrome (aHUS) diagnosis if individual is ALL of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following for a period of 12 months or less?

Paroxysmal nocturnal hemoglobinuria

Loading Dose:

60 billable units every 7 days x 4 doses

(days 1,8,15 & 22) and 90 units at day 29

Maintenance Dose:

90 billable units every 14 days

Loading Dose:

600mg every 7 days for the first 4 weeks, followed by 900mg for the fifth dose 7 days later and then 900mg every 14 days thereafter (initial loading dose requires a total of 3,300mg over 5 weeks)

Maintenance Dose:

900 mg every 14 days

Atypical hemolytic uremic syndrome

Loading Dose:

90 billable units every 7 days x 4 doses (days 1, 8, 15 & 22) and 120 units at day 29

Maintenance Dose:

120 billable units every 14 days

Loading dose:

900mg every 7 days for the first 4 weeks, followed by 1,200mg for the fifth dose 7 days later and then 1,200mg every 14 days thereafter (initial loading dose requires a total of 4,800mg over 5 weeks)

Maintenance dose:

1200 mg every 14 days

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response indicated by ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

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