57665-002-XX Revcovi 2.4 mg / 1.5 mL SOLN (LEADIANT BIOSCIENCES INC)
Elapegademase-lvlr is a recombinant adenosine deaminase (rADA) that is covalently conjugated to monomethoxypolyethylene glycol (mPEG) to produce methoxypolyethylene glycol recombinant adenosine deaminase (SC-PEG rADA), or Revcovi™. It is based on bovine amino acid sequence.
The deficiency of adenosine deaminase (ADA) is associated with SCID,
severe combined immune deficiency, a rare, inherited and often fatal disease. ADA
enzyme is involved in purine metabolism as well as maintaining the proper
number and function of immune cells and decreasing the frequency of opportunistic
infections. Elevated adenosine levels, as occur in ADA deficiency, contribute
to apoptosis and a block in the differentiation of thymocytes, causing
Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number.
See also: Pegademase Bovine
Elapegademase-lvlr for the treatment of adenosine deaminase (ADA) deficiency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Elapegademase-lvlr for the treatment of other conditions/diseases is considered investigational.
Elapegademase-lvlr is considered medically appropriate if ALL of the following criteria are met:
Must not be used in combination with pegademase bovine
Diagnosis of adenosine deaminase deficiency (ADA) in individuals with ALL of the following:
Definitive diagnosis of severe combined immunodeficiency disease (SCID) as determined by ANY ONE of the following:
Deficient ADA catalytic activity (<1% of normal) in hemolysates (in untransfused individuals) or in extracts of other cells (e.g., blood mononuclear cells, fibroblasts)
Detection of pathogenic mutations in the ADA gene by molecular genetic testing
Marked elevation of deoxyadenosine (dAdo) triphosphate (dATP) OR total dAdo nucleotides (dAXP, measured as the sum of dAMP + dADP + dATP) in erythrocytes
Failed or is not a candidate for bone marrow transplantation (BMT)
Absence of severe thrombocytopenia, considered to be platelets<50,000/microliter
Baseline values for plasma ADA activity and red blood cell deoxyadenosine triphosphate (dATP) levels have been obtained
Elapegademase-lvlr is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity e.g., severe injection site reactions (i.e., bleeding), severe thrombocytopenia, etc.
Adequate documentation of disease stability and/or improvement as indicated by one or
more of the following:
Increase in plasma ADA activity (target trough level ≥ 15-35 μmol/hr/mL)
Red blood cell dATP level decreased (target ≤ 0.005 to 0.015 μmol/mL)
Improvement in immune function with diminished frequency/complications of infection
as evidenced in improvement in the ability to produce antibodies
Improvement in red blood cell dAXP levels (target trough level ≤ under 0.02 mmol/L) Individual continues to meet initial approval criteria
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Adenosine Deaminase Severe Combined ImmuneDeficiency (ADA-SCID)
Patients transitioning from Adagen to REVCOVI:
The starting dose of REVCOVI is 0.2 mg/kg weekly, intramuscularly.
If a patient’s weekly Adagen dose is unknown, or a patient’s weekly Adagen dose is at or lower than 30 U/kg, the recommended minimum starting dose of REVCOVI is 0.2 mg/kg, intramuscularly, once a week.
If a patient’s weekly Adagen dose is above 30 U/kg, an equivalent weekly REVCOVI dose (mg/kg) should be calculated using the following conversion formula:
REVCOVI dose in mg/kg = Adagen dose in U/kg divided by 150
Subsequent doses may be increased by increments of 0.033 mg/kg weekly if trough ADA activity is under 30 mmol/hr/L, trough deoxyadenosine nucleotides (dAXP) are above 0.02 mmol/L, and/or the immune reconstitution is inadequate based on the clinical assessment of the patient. The total weekly dose may be divided into multiple intramuscular (IM) administrations during a week.
The starting dose of REVCOVI is 0.4 mg/kg weekly based on ideal body weight, divided into two doses (0.2 mg/kg twice a week), intramuscularly, for a minimum of 12 to 24 weeks until immune reconstitution is achieved.
The dose may be gradually adjusted down to maintain trough ADA activity over 30 mmol/hr/L, trough dAXP level under 0.02 mmol/L, and/or to maintain adequate immune reconstitution based on clinical assessment of the patient.
LENGTH OF AUTHORIZATION
Coverage will be provided for 12 months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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.
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).
Hirschfield, M. (2006, October, Updated 2017, March). Adenosine Deaminase Deficiency. In: Adam, M. P., Ardinger, H. H., Pagon, R. A., et al., eds., GeneReviews®. Seattle (WA): University of Washington, Seattle; 1993-2018. Retrieved October 31, 2018 from https://www.ncbi.nlm.nih.gov/books/NBK1483/.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, October). Elapegademase-lvlr. Retrieved November 6, 2018 from MICROMEDEX Healthcare Series.
National Heart, Lung and Blood Institute Health Topics. (2018) Thrombocytopenia. National Institutes of Health; U.S. Department of Health and Human Services. Retrieved October 31, 2018 from https://www.nhlbi.nih.gov/health-topics/thrombocytopenia.
U.S. Food and Drug Administration. (2018, October). Center for Drug Evaluation and Research. REVCOVI™ (elapegademase-lvlr) injection, for intramuscular use. Retrieved October 31, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 3/2/2019
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit