CurrentAvMedPolicy N/A

Encelto (revakinagene taroretcel-lwey) medical prior authorization for macular telangiectasia type 2

Defines prior authorization clinical criteria, dosing limits, and documentation requirements for coverage of Encelto (J3403) for treatment of macular telangiectasia, type 2. Applies to providers requesting medical benefit coverage through AvMed.

Policy Summary

PayerAvMed

PolicyEncelto (revakinagene taroretcel-lwey) medical prior authorization for macular telangiectasia type 2

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a complete prior authorization with prescriber signature and all supporting documentation (SD-OCT measurements, fluorescein angiography, chart notes, dosing and diagnosis) via fax to AvMed at 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 per eyeMaximum authorized doses

>=18Minimum member age for approval

0.16–2.00 mm^2Required EZ loss (SD-OCT)

Authorization Criteria — All required for approval

Coverage will be provided when ALL of the following are met. Documentation (labs, diagnostics, chart notes) must be provided for each checked item.

Policy Summary

PayerAvMed

PolicyEncelto (revakinagene taroretcel-lwey) medical prior authorization for macular telangiectasia type 2

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Member is at least 18 years of age

ALL of the following

At least one additional feature of disease (in addition to fluorescein leakage)
- Hyperpigmentation outside a 500-micron radius from the center of the fovea
- Retinal opacification
- Crystalline deposits
- Right angle vessels
- Inner/outer lamellar cavities

Member has an inner segment-outer segment (IS/OS) photoreceptor break and area of ellipsoid zone (EZ) loss measured by spectral domain OCT between 0.16 mm^2 and 2.00 mm^2>= 0.16 mm^2 and <= 2.00 mm^2

Measurement must be by SD-OCT

Member does NOT have neovascular macular telangiectasia

Member does NOT have evidence of advanced disease that would preclude treatment (e.g., significant retinal scarring and atrophy with retinal tissue that cannot be preserved)

Member must NOT have any of the following conditions (exclusion list)

Intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye
Central serous chorioretinopathy in either eye
Pathologic myopia in either eye
Significant media or corneal opacities in either eye
History of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty
Any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or nuclear opacity > standard 3

Member does NOT have a known hypersensitivity to Endothelial Serum Free Media (Endo SFM)

Member does NOT have evidence of other ocular disease that would preclude treatment of MacTel

Member has NOT received intravitreal steroid therapy or intravitreal anti-VEGF therapy for non-neovascular MacTel within the last 3 monthsno intravitreal steroid or anti-VEGF within past 3 months

Member is free of ocular and/or peri-ocular infections

Member will be monitored for signs and symptoms of vision loss (e.g., BCVA) and infectious endophthalmitis at baseline and periodically during treatment

Monitoring plan must be documented

Member will be monitored for signs and symptoms of retinal tears and/or retinal detachment (e.g., acute onset of flashing lights, floaters, and/or loss of visual acuity)

Member will temporarily discontinue antithrombotic medications (e.g., oral anticoagulants, aspirin, NSAIDs) prior to the insertion surgery

Documentation of plan to discontinue antithrombotic meds required

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization submission required

Prescribing physician must sign and clearly print their name on the PA request form (preprinted stamps not valid). Provide complete member, prescriber, drug, dosing, diagnosis, weight (if applicable), and supporting documentation (e.g., SD-OCT measurements, fluorescein angiography, chart notes, prior therapies). Fax the completed form to AvMed at 1-877-535-1391.

Physician signature and printed name required; preprinted stamps not valid
Include phone and fax numbers on form to avoid delays
Attach SD-OCT, fluorescein angiography, chart notes, and prior therapy documentation
Fax to 1-877-535-1391

Documentation Required

Required clinical documentation

Submit evidence of typical fluorescein leakage plus at least one additional listed feature of MacTel type 2; provide SD-OCT measurement documenting an IS/OS photoreceptor break and EZ loss area within 0.16–2.00 mm2; confirm absence of any exclusion conditions; include a documented monitoring plan for vision and infectious endophthalmitis and for retinal tear/detachment monitoring; and indicate whether the medication will be provided by the physician’s office or a specialty pharmacy.

Fluorescein angiography showing typical leakage plus ≥1 additional disease feature (e.g., hyperpigmentation, retinal opacification, crystalline deposits, right-angle vessels, inner/outer lamellar cavities)
SD-OCT report with IS/OS break and EZ loss area between 0.16 mm2 and 2.00 mm2
Documentation confirming none of the exclusion criteria apply (e.g., neovascularization, prior vitrectomy, significant media opacities, hypersensitivity to Endo SFM)
Monitoring plan for BCVA and infectious endophthalmitis at baseline and periodically, and monitoring for retinal tears/detachment
Specify medication source: physician’s office or specialty pharmacy

Documentation Required

Dosing and reuse restriction

Only one dose is authorized per affected eye and therapy may not be renewed; a maximum of 2 doses accounts for bilateral treatment (one single‑dose implant per eye).

Maximum authorized units: 2 doses total (per administration to both eyes)
Coverage provided for one dose per affected eye and may NOT be renewed

Denial Risk

Incomplete or illegible PA can delay or cause denial

Authorization may be delayed or denied if the PA form is incomplete, incorrect, or illegible, or if required supporting documentation (labs, diagnostics, chart notes) is not provided.

Incomplete, incorrect, or illegible information on the PA request can delay authorization
Missing required documentation may result in denial

Prior Authorization

Urgent review process

For urgent reviews (where a standard review could seriously jeopardize life, health, or ability to regain maximum function), call the AvMed Pre-Authorization Department in addition to submitting the PA form.

Call AvMed Pre-Authorization Department for urgent review in addition to faxing the PA form

Documentation Required

Verification of prior therapies

Previous therapies will be verified via pharmacy paid claims or submitted chart notes; use of medication samples to initiate therapy does not satisfy preauthorization/step-edit criteria.

Verification sources: pharmacy paid claims or chart notes
Sample use does not meet PA/step-edit criteria

Clinical & Administrative Background

Encelto is an investigational/specialized implant therapy intended for treatment of non‑neovascular macular telangiectasia, type 2, comprising a single‑dose intraretinal implant (one implant contains approximately 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF). Indications require a documented diagnosis of MacTel type 2 with typical fluorescein leakage plus at least one additional characteristic disease feature (for example, hyperpigmentation outside a 500‑micron radius from the foveal center, retinal opacification, crystalline deposits, right‑angle vessels, or inner/outer lamellar cavities), and a quantifiable IS/OS (ellipsoid zone) break area between 0.16 mm2 and 2.00 mm2 measured by spectral domain OCT. Treatment is restricted by disease‑specific eligibility criteria and a list of ocular exclusions and precautions because of potential ocular risks; authorization is limited to one dose per affected eye (maximum 2 doses for bilateral treatment) and the therapy may not be renewed.

OpenPayer

Encelto (revakinagene taroretcel-lwey) medical prior authorization for macular telangiectasia type 2

Authorization Criteria — All required for approval

Dosing Limits and Renewal Policy

Relevant Billing Codes

Prior Authorization & Documentation Requirements

Clinical & Administrative Background

Defined Terms

Policy Update Changes