BlueCross BlueShield of Tennessee Medical Policy Manual

Voretigene Neparvovec-rzyl

NDC CODE(S)

71394-0415-XX Luxturna 5 x 1012 vg (Spark Therapeutics, Inc.)

DESCRIPTION

Voretigene neparvovec-rzyl is a live, non-replicating adeno-associated virus serotype 2 which has been genetically modified to express the human RPE65 gene using recombinant DNA techniques.  Prepared in a suspension, it is a vector-based gene therapy for subretinal injection containing 5 x 1012 vector genomes (vg) per mL.

This normal copy of the RPE65 gene encodes the human retinal pigment epithelial 65 kDa protein (RPE65) and delivers it directly to the cells of the retina in those individuals with mutations in the RPE65 gene. REP65 protein is normally produced in the retinal pigment epithelial (RPE) cells and is necessary to the visual or retinoid cycle, which in turn is critical to phototransduction, the biological conversion of a photon of light into an electrical signal in the retina.  Mutations in the RPE65 gene lead to reduced or absent levels of RPE65 which blocks the visual cycle resulting in visual impairment. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Biallelic RPE65 mutation-associated retinal dystrophy

For subretinal injection only.

Preparing for Administration:

  • Luxturna should be administered in the surgical suite under controlled aseptic conditions by a surgeon experienced in performing intraocular surgery.

  • Dilate the eye, give adequate anesthesia to the patient, and administer a topical broad spectrum microbiocide

  • Complete a vitrectomy

  • Do not administer Luxturna in the immediate vicinity of the fovea.

Luxturna Injection:

  •  Under direct visualization, administer Luxturna into the affected eye [1.5 x 1012 vector genomes (vg) in a total volume of 0.3 mL]

  • Perform subretinal administration of Luxturna to each eye on separate days within a close interval, but no fewer than 6 days apart.

  • Recommend systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of Luxturna to the first eye), and followed by tapering the dose during the following 10 days. The same corticosteroid dosing regimen applies for the administration of Luxturna to the second eye. If the corticosteroid taper following Luxturna administration to the first eye is not complete three days prior to the planned Luxturna administration to the second eye, then the corticosteroid regimen for the second eye replaces the taper for the first eye

Notes:  Store LUXTURNA and Diluent frozen at ≤ -65 °C. Thaw prior to infusion.  LUXTURNA is an adeno-associated virus vector-based gene therapy. Follow universal biohazard precautions for handling.

LENGTH OF AUTHORIZATION

Coverage will be provided for each eye 1.5 x 1012 vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL and may not be renewed

Click here to view DOSAGE LIMITS

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

Russell, S., Bennett, J., Wellman, J.A., et al. Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial. Lancet. 2017 Aug 26;390 (10097):849-860.

U. S. National Library of Medicine. (2017, October). National Center for Biotechnology Information. Genetic Testing Registry. RPE65: RPE65, retinoid isomerohydrolase. Retrieved December 21, 2017 from https://www.ncbi.nlm.nih.gov/gtr/genes/6121/.

U. S. Food and Drug Administration. (2017, December). Center for Drug Evaluation and Research. Luxturna™ (voretigene neparvovec-rzyl) intraocular suspension for subretinal injection.  Retrieved December 21, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589541.pdf.

ORIGINAL EFFECTIVE DATE:  1/26/2018

MOST RECENT REVIEW DATE:  1/26/2018

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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

Biallelic RPE65 mutation-associated retinal dystrophy

For each eye 1.5 x 1012 vector genomes (vg) in a total volume of 0.3 mL