BlueCross BlueShield of Tennessee Medical Policy Manual

Ravulizumab-cwvz

NDC CODE(S)

25682-0022-XX Ultomiris 300 MG/30ML SOLN (ALEXION PHARMACEUTICALS)

DESCRIPTION

Ravulizumab-cwvz is a vascular endothelial growth factor (VEGF) inhibitor.  It is a fragment of a monoclonal antibody which binds to and inhibits the biologic activity of VEGF-A.  VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion.  It is thought to contribute to the pathophysiology of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema.  The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION

DOSAGE & ADMINISTRATION - requires dilution to a final concentration of 5 mg/mL

 

Paroxysmal

Nocturnal

Hemoglobinuria

Body Weight Range (kg)

Loading Dose (mg)

Maintenance Dose (mg)

greater than or equal to 40 to less than 60

2,400

3,000

greater than or equal to 60 to less than 100

2,700

3,300

greater than or equal to 100

3,000

3,600

Starting 2 weeks after the loading dose administration, begin maintenance doses at a once every 8-week interval. The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS™) but the subsequent dose should be administered according to the original schedule. 

For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer maintenance doses once every 8 weeks, starting 2 weeks after loading dose administration, as shown in the Table

 

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

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, January). Ravulizumab-cwvz. Retrieved January 10, 2019 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Ultomiris™ (ravulizumab-cwvz) injection, for intravenous use. Retrieved January 10, 2019 from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf.

ORIGINAL EFFECTIVE DATE: 5/31/2019

MOST RECENT REVIEW DATE:  5/31/2019

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; 300 mg/30 mL (10 mg/mL) single-dose vial

DIAGNOSIS

MAXIMUM UNITS

PNH

3000 mg loading dose – 10 vials

3600 mg maintenance dose every 8 weeks (Begin 2 weeks after loading dose) – 12 vials