This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.
Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.
Clinical records should document either immunization with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab or that the risks of delaying eculizumab outweighed the risk of meningococcal infection.
When used for the treatment of an individual with PNH, the following should be documented at initiation of therapy:
- Flow cytometry confirming the diagnosis of PNH and either of the following (a or b)
- Evidence of clinically significant hemolysis; or
- Documented history of a major adverse vascular event (MAVE) from thromboembolism.
Note: for individuals with confirmed PNH who do not meet the documentation requirements above and who were started on a course of eculizumab prior to the effective date of this document, continuation of therapy may be allowed based on the potential risk of adverse events which may occur upon discontinuation or interruption of therapy.
When given as an initial trial (generally 6-12 weeks) for the treatment of aHUS, the individual was assessed and both:
- Had no signs of Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); and
- Thrombotic thrombocytopenic purpura (TTP) was ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP could not be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvement
When eculizumab is continued following an initial trial for aHUS, the records should reflect that there had been clinical improvement (for example, increased platelet count or laboratory evidence of reduced hemolysis).
When eculizumab is given for biopsy proven dense deposit disease, elevated serum levels of sC5b-9 (serum Membrane Attack Complex (sMAC) must be documented.
FDA and Compendia Review:
Clinical Pharmacology website http://www.clinicalpharmacology.com/. Accessed 09/08/2022.
FDA label for Soliris (eculizumab). FDA website http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/08/2022.
Micromedex DrugDex®. http://www.thomsonhc.com/home/dispatch. Accessed 09/08/2022.
National Comprehensive Cancer Network website http://www.nccn.org/index.asp. Accessed 09/08/2022.