Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Revakinagene taroretcel-lwey (Encelto) may be considered medically necessary when
ALL
of the following criteria are met:
-
Individual is 18 years of age or older;
and
-
Individual has a diagnosis of macular telangiectasia type 2 as confirmed by optical coherence tomography (OCT);
and
-
Imaging confirms that individual has an inner segment - outer segment junction line (IS/OS) photo receptor (PR) break in the ellipsoid zone between 0.16 and 2.00 mm
2
;
and
-
Individual's best corrected visual acuity (BVCA) is a 54-letter score or better (20/80 or better);
and
-
The medication is prescribed by an ophthalmologist with experience in vitreoretinal surgery;
and
-
Individual has not received an intravitreal anti-vascular endothelial growth factor (VEGF) injection in the affected eye within the past three (3) months;
and
-
Individual does
NOT
have any of the following:
-
Intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye;
or
-
Central serous chorio-retinopathy in either eye;
or
-
Pathologic myopia in either eye;
or
-
Significant corneal or media opacities in either eye;
or
-
Individual has undergone lens removal in the previous 3 months or YAG laser within 4 weeks;
or
-
History of ocular herpes virus in either eye;
or
- Individual has any of the following lens opacities as measured on the Age Related Eye Disease Study (AREDS) clinical lens grading system:
-
Cortical opacity greater than standard 3;
or
-
Posterior subcapsular opacity greater than standard 2;
or
- Nuclear opacity greater than standard 3
Note:
The safety and effectiveness of repeat administration of revakinagene taroretcel-lwey (Encelto) has not been evaluated. Therefore, coverage will be limited to once per lifetime per eye.
The use of revakinagene taroretcel-lwey (Encelto) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
