CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Encelto (revakinagene taroretcel-lwey) Criteria

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This policy governs prior authorization for Encelto for adults with idiopathic macular telangiectasia type 2 (MacTel). Coverage requires detailed ocular-disease, treatment-safety, monitoring, and prior-treatment criteria.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyEncelto (revakinagene taroretcel-lwey) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document satisfaction of all 13 approval criteria before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum patient age

≥1Additional MacTel feature required

1 yearInitial approval period

3 monthsInterval since intravitreal therapy

4 weeks

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Encelto (revakinagene taroretcel-lwey) Criteria

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Sign up for all New Hampshire Department of Health and Human Services policy alerts

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyEncelto (revakinagene taroretcel-lwey) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document satisfaction of all 13 approval criteria before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum patient age

≥1Additional MacTel feature required

1 yearInitial approval period

3 monthsInterval since intravitreal therapy

4 weeks

Interval since YAG treatment

Encelto Coverage Criteria

Encelto approval criteria

Covered when ALL of the following are met:

ALL approval criteria

Patient eligibility and diagnosis
- Age: Patient is 18 years of age or older.≥18 years
- MacTel diagnosis
  - ONE of
    Hyperpigmentation outside a 500 micron radius from the center of the fovea.
    Retinal opacification.
    Crystalline deposits.
    Right-angle vessels.
    Lamellar cavities: Inner/outer lamellar cavities.
- No neovascular or advanced disease: Patient does not have neovascular MacTel.
- Treatable disease: Patient does not have evidence of advanced disease that would preclude treatment of MacTel, such as significant retinal scarring and atrophy with retinal tissue that cannot be preserved.
- SD-OCT findings: Patient has an inner segment-outer segment junction line (IS/OS) photoreceptor break and an area of ellipsoid zone (EZ) loss, as measured by spectral-domain optical coherence tomography (SD-OCT).
Absence of specified ocular conditions and exclusions
- No intraretinal neovascularization or SRNV: No intraretinal neovascularization or subretinal revascularization (SRNV) in either eye, as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid.
- No central serous chorioretinopathy in either eye.
- No pathologic myopia in either eye.
- No significant opacity: No significant media or corneal opacities in either eye.
- No specified prior ocular surgery: No history of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
Infection and hypersensitivity
- No infection: Patient does not have ocular or periocular infections.
- No Endo-SFM hypersensitivity: Patient does not have known hypersensitivity to Endothelial Serum Free Media (Endo-SFM).
Monitoring and treatment safety
- Vision and endophthalmitis monitoring: Patient will be monitored for signs and symptoms of vision loss, such as best corrected visual acuity (BCVA) changes, and infectious endophthalmitis at baseline and periodically during treatment.
- Retinal tear or detachment monitoring: Patient will be monitored for signs and symptoms of retinal tears and/or retinal detachment, including acute onset of flashing lights, floaters, or loss of visual acuity.
- No other ocular disease: Patient does not have evidence of other ocular disease that would preclude treatment of MacTel.
- Antithrombotic interruption: Patient will temporarily discontinue antithrombotic medications, such as oral anticoagulants, aspirin, or nonsteroidal anti-inflammatory drugs, prior to the insertion surgery.

Treatment is excluded for neovascular MacTel or advanced disease that would preclude treatment, including significant retinal scarring and atrophy when retinal tissue cannot be preserved. Coverage is also excluded for specified ocular diseases or findings, including intraretinal or subretinal neovascularization, central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, ocular herpes, intraretinal hyperreflectivity, active ocular or periocular infection, or other ocular disease that would preclude treatment. Specified surgical histories, including vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty, also exclude treatment. Lens opacity beyond the policy limits, lens removal within the previous 3 months, YAG laser treatment within the previous 4 weeks, and recent intravitreal steroid or anti-VEGF therapy for non-neovascular MacTel are likewise excluded.

Encelto is not approved when the patient fails to meet any of the policy’s approval criteria.

Diagnostic and Treatment Parameters

MacTel diagnostic disease features

Required findingTypical fluorescein leakage

Additional disease featuresAt least 1 additional feature is required

Examples of additional featuresHyperpigmentation outside a 500 micron radius from the center of the fovea; retinal opacification; crystalline deposits; right-angle vessels; or inner/outer lamellar cavities

Hyperpigmentation location

Required locationOutside a 500 micron radius from the center of the fovea

FindingHyperpigmentation

Policy application

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Requires All 13 Criteria

Prior authorization is required. Approval requires satisfaction of all 13 approval criteria for Encelto; partial fulfillment is insufficient.

Patient is ≥18 years old.
MacTel type 2 is documented in at least one eye with typical fluorescein leakage and at least one additional disease feature.
No neovascular MacTel or advanced disease that would preclude treatment.
SD-OCT documents an IS/OS photoreceptor break and area of ellipsoid zone loss.
No specified contraindicating ocular findings, infections, hypersensitivity, or other ocular disease that would preclude treatment.
The patient will receive required monitoring for vision loss, infectious endophthalmitis, retinal tears, and retinal detachment.
Antithrombotic medications will be temporarily discontinued before insertion surgery.
No intravitreal steroid or anti-VEGF therapy for non-neovascular MacTel was received within the preceding 3 months.

Policy Background

Encelto (revakinagene taroretcel-lwey) is addressed under this policy for treatment of adults with idiopathic macular telangiectasia type 2 (MacTel), a retinal disease characterized by the clinical and structural findings specified in the coverage criteria.

Clinical Definitions

Idiopathic macular telangiectasia type 2 (MacTel)

DiseaseIdiopathic macular telangiectasia type 2 (MacTel)

Clinical descriptionA retinal disease

Policy indicationEncelto is indicated for treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)

IS/OS photoreceptor break

StructureInner segment-outer segment junction line

TermIS/OS photoreceptor break

Assessment methodMeasured by spectral-domain optical coherence tomography (SD-OCT)

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyEncelto (revakinagene taroretcel-lwey) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document satisfaction of all 13 approval criteria before treatment.

SourceLink

On This Page

Lens opacity limits: No cortical opacity greater than standard 3, posterior subcapsular opacity greater than standard 2, or nuclear opacity greater than standard 3.Cortical ≤ standard 3; posterior subcapsular ≤ standard 2; nuclear ≤ standard 3

Recent ocular procedures: No lens removal within the previous 3 months and no yttrium-aluminum-garnet (YAG) laser treatment within the previous 4 weeks.Lens removal: none within 3 months; YAG: none within 4 weeks

No ocular herpes: No history of ocular herpes virus in either eye.

No intraretinal hyperreflectivity: No evidence of intraretinal hyperreflectivity by optical coherence tomography (OCT).

No recent intravitreal therapy: Patient has not received intravitreal steroid therapy or intravitreal anti-vascular endothelial growth factor (VEGF) therapy for non-neovascular MacTel within the last 3 months.No such therapy within 3 months

Counts as an additional feature supporting a diagnosis of MacTel

Cortical lens opacity

Opacity typeCortical lens opacity

Maximum permitted severityMust not be greater than standard 3

Exclusion thresholdCortical opacity greater than standard 3 is not permitted

Posterior subcapsular lens opacity

Opacity typePosterior subcapsular lens opacity

Maximum permitted severityMust not be greater than standard 2

Exclusion thresholdPosterior subcapsular opacity greater than standard 2 is not permitted

Nuclear lens opacity

Opacity typeNuclear lens opacity

Maximum permitted severityMust not be greater than standard 3

Exclusion thresholdNuclear opacity greater than standard 3 is not permitted

Recent lens removal

ProcedureLens removal

Required intervalMust not have occurred within the previous 3 months

Coverage exclusionLens removal in the previous 3 months is not permitted

Recent YAG laser treatment

ProcedureYttrium-aluminum-garnet (YAG) laser treatment

Required intervalMust not have occurred within the previous 4 weeks

Coverage exclusionYAG laser treatment within 4 weeks is not permitted

Recent intravitreal therapy

Therapies excluded from the recent-treatment windowIntravitreal steroid therapy or intravitreal anti-vascular endothelial growth factor (VEGF) therapy

Disease contextNon-neovascular MacTel

Required intervalNo such therapy within the last 3 months

Documentation Required

Document MacTel Diagnostic Findings

Submit clinical documentation establishing the patient's age and MacTel type 2 diagnosis in at least one eye. The diagnosis must include typical fluorescein leakage plus at least one additional characteristic feature.

Patient is 18 years of age or older.
Typical fluorescein leakage on diagnostic evaluation.
At least one of the following: hyperpigmentation outside a 500-micron radius from the foveal center; retinal opacification; crystalline deposits; right-angle vessels; or inner/outer lamellar cavities.
SD-OCT demonstrates an inner segment-outer segment junction (IS/OS) photoreceptor break and an area of ellipsoid zone (EZ) loss.

Documentation Required

Complete Ocular Safety and Exclusion Assessment

Document a complete ocular safety and exclusion assessment for both eyes. Treatment is not approvable when neovascularization, advanced irreversible disease, or any listed contraindicating ocular condition is present.

No neovascular MacTel and no advanced disease that would preclude treatment, such as significant retinal scarring and atrophy with retinal tissue that cannot be preserved.
No intraretinal neovascularization or subretinal revascularization (SRNV), including hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid.
No central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, or intraretinal hyperreflectivity on OCT.
No history of vitrectomy, penetrating keratoplasty, trabeculectomy, trabeculoplasty, or ocular herpes virus.
No lens opacity exceeding cortical standard 3, posterior subcapsular standard 2, or nuclear standard 3; no lens removal within 3 months or YAG laser treatment within 4 weeks.
No ocular or periocular infection, known hypersensitivity to Endo-SFM, or other ocular disease that would preclude MacTel treatment.

Documentation Required

Document Baseline and Ongoing Monitoring

Document the planned monitoring protocol before treatment and periodically during treatment. Monitor for vision loss and infectious endophthalmitis, as well as retinal tears or detachment.

Assess vision loss, including best corrected visual acuity (BCVA), at baseline and periodically during treatment.
Monitor for signs and symptoms of infectious endophthalmitis at baseline and periodically during treatment.
Monitor for retinal tears or retinal detachment, including acute flashing lights, floaters, or loss of visual acuity.

Documentation Required

Manage Perioperative and Recent Intravitreal Medications

Document perioperative medication management before insertion surgery. The patient must temporarily discontinue antithrombotic medications and must not have received prohibited recent intravitreal therapy.

Temporarily discontinue antithrombotic medications before insertion surgery, including oral anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs, as clinically appropriate.
Confirm that the patient has not received intravitreal steroid therapy or intravitreal anti-VEGF therapy for non-neovascular MacTel within the previous 3 months.

Denial Risk

Failure to Meet Any Criterion Results in Denial

Coverage is denied when the patient fails to meet any one of the approval criteria. The initial approval period is 1 year.

Failure to satisfy any of the 13 criteria results in denial.
Incomplete or insufficient documentation of a required criterion may result in denial.

Denial Risk

Clinical or Safety Criteria Not Met

Review both clinical and safety requirements before submitting authorization. Denial risk is increased when diagnostic findings are missing, disease is neovascular or too advanced for treatment, or a contraindicating ocular condition has not been excluded.

Missing age documentation, fluorescein leakage, qualifying MacTel features, or required SD-OCT findings.
Neovascular MacTel, SRNV, hemorrhage, hard exudate, retinal or intraretinal fluid, or advanced retinal scarring and atrophy.
Central serous chorioretinopathy, pathologic myopia, significant media or corneal opacity, prohibited surgical history, significant lens opacity, recent lens removal or YAG treatment, ocular herpes, or intraretinal hyperreflectivity.
Ocular or periocular infection, Endo-SFM hypersensitivity, another ocular disease precluding treatment, failure to arrange required monitoring, inability to discontinue antithrombotic medication, or prohibited recent intravitreal therapy.

EZ loss

StructureEllipsoid zone

TermEZ loss

Assessment methodAn area of ellipsoid zone loss measured by spectral-domain optical coherence tomography (SD-OCT)