BlueCross BlueShield of Tennessee Medical Policy Manual

Elapegademase-lvir

NDC CODE(S)

57665-0002-XX Revcovi 2.4 MG/1.5ML Solution (LEADIANT BIOSCIENCES)

DESCRIPTION

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 severe T-lymphopenia.  

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

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

 

INDICATION(S) DOSAGE & ADMINISTRATION

Adenosine Deaminase Severe Combined Immune

Deficiency (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.

 

Adagen-naïve patients:

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.

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).

SOURCES

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. (2019, January). Elapegademase-lvlr. Retrieved September 4, 2019 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 September 4, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761092s000lbl.pdf. 

ORIGINAL EFFECTIVE DATE:  3/2/2019

MOST RECENT REVIEW DATE:  10/8/2019

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

MAXIMUM UNITS

Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

23 mg twice weekly