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    v1.0.30
    OpenPayerPolicy UpdatesOphthalmology/OptometryAetna anecortave acetate Coverage Update | OpenPay…
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    CurrentAetnaPolicy 0706

    Anecortave Acetate (Retaane)

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    Defines Aetna's coverage stance on anecortave acetate (Retaane) for ocular indications, specifying the drug is considered experimental/investigational for listed conditions and providing related policy links; applies to Aetna's members and provider adjudication.

    Policy Summary
    PayerAetna
    PolicyAnecortave Acetate (Retaane)
    Policy CodePolicy 0706
    Change TypeNo material change
    Effective DateJan 31, 2006
    Last ReviewSep 20, 2023
    Next Review DateAug 8, 2024
    Key ActionDo not request authorization for anecortave acetate (Retaane) for listed ocular indications because it is considered experimental/investigational and not covered.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3indications listed as experimental/investigational
    15 mgmost frequently studied dose

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    530patients in key RCT
    809total participants in RCTs
    20+literature references
    08/08/2024Next review

    Coverage Criteria

    Investigational / Not Medically Necessary Indications

    Anecortave acetate (Retaane) is considered experimental and investigational for the following ocular indications because effectiveness has not been established:

    Investigational / Not Medically Necessary Indications: Age-related macular degeneration

    Listed as experimental and investigational in the policy.

    Investigational / Not Medically Necessary Indications: Glaucoma

    Listed as experimental and investigational in the policy.

    Investigational / Not Medically Necessary Indications: Retinoblastoma

    Listed as experimental and investigational in the policy.

    The following ICD-10 diagnosis codes are referenced in this policy as not covered when used to support the listed investigational indications for anecortave acetate (Retaane): C69.20 - C69.22 (Malignant neoplasm of retina [retinoblastoma]); H35.3110 - H35.3293 (Age-related macular degeneration); and H40.001 - H42 (Glaucoma). These codes correspond to the indications explicitly identified as experimental and investigational in the policy and would not be supported for coverage for those uses.

    Alcon Laboratories withdrew its regulatory application for Retaane according to an European Medicines Agency (EMEA) press release (Doc. Ref. EMEA/76945/2006, March 2, 2006). The policy cites this withdrawal to note that regulatory approval for anecortave acetate was not completed as referenced in the source material.

    Anecortave acetate (Retaane) is considered experimental and investigational for the treatment of age-related macular degeneration, glaucoma, and retinoblastoma because effectiveness has not been established for these ocular indications; use for these conditions is therefore not supported by the policy.

    Coding

    ICD-10 diagnosis codes referenced as not covered for listed indicationsICD-10Not Covered
    C69.20 - C69.22Malignant neoplasm of retina [retinoblastoma]
    H35.3110 - H35.3293Age-related macular degeneration
    H40.001 - H42Glaucoma

    Provider Actions & Authorization

    Denial Risk

    Experimental / Investigational — Denial Risk

    Anecortave acetate (Retaane) is considered experimental/investigational for listed ocular indications; effectiveness not established for these uses.

    • Age-related macular degeneration
    • Glaucoma
    • Retinoblastoma
    Note

    No explicit authorization / denial triggers or prior-authorization details

    The available document chunks do not specify any prior authorization criteria, explicit authorization or denial triggers, or required documentation for claims. Providers should note that no specific prior authorization requirements are stated in this policy content.

    Background

    Anecortave acetate is an angiostatic corticosteroid-related agent developed for peri‑ or posterior juxtascleral depot delivery to release drug to the choroid over an extended interval (approximately every 6 months). The delivery approach—posterior juxtascleral depot (PJD)—uses a blunt‑tipped curved cannula advanced along the scleral surface into the juxtascleral space to place the depot without puncturing the globe. Clinical trial evidence has been mixed: some smaller studies reported stabilization of vision or inhibition of lesion growth with a 15 mg dose, but larger randomized trials and systematic reviews found insufficient evidence of clear benefit compared with placebo or existing therapies; consequently, the agent remains investigational for the ocular indications listed in this policy.

    Definitions

    Posterior juxtascleral depot (PJD)
    DefinitionPosterior juxtascleral depot (PJD) is a delivery method in which a blunt-tipped, curved cannula is advanced along the surface of the sclera into the juxtascleral space and the drug is injected behind the eye without puncturing the globe.
    Procedure noteThe curved cannula follows the scleral surface and once in place the agent is injected into the juxtascleral space overlying the macula; drug is slowly released to the choroid over approximately 6 months.
    PurposeThis delivery approach is intended to avoid intra‑ocular injection risks (such as infection and retinal detachment) and to allow less frequent dosing compared with intraocular injections.
    InstrumentationUses a blunt‑tipped, curved cannula inserted along the sclera without puncturing the globe.
    Anecortave acetate (Retaane)
    Agent
    Policy Summary
    PayerAetna
    PolicyAnecortave Acetate (Retaane)
    Policy CodePolicy 0706
    Change TypeNo material change
    Effective DateJan 31, 2006
    Last ReviewSep 20, 2023
    Next Review DateAug 8, 2024
    Key ActionDo not request authorization for anecortave acetate (Retaane) for listed ocular indications because it is considered experimental/investigational and not covered.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions & AuthorizationBackgroundDefinitions
    Step Therapy

    No Step Therapy Requirements Specified

    This policy does not specify any step therapy requirements or sequencing of therapies for anecortave acetate (Retaane). There is no defined step-therapy path in the provided policy content.

    Documentation Required

    Procedure / Administration Notes

    Posterior juxtascleral depot administration is described: a blunt-tipped curved cannula follows the scleral surface (without penetrating the globe) to deliver anecortave acetate into the juxtascleral space overlying the macula; the drug is slowly released to the choroid over about 6 months.

    Note

    Policy History & Review

    Policy history and review information: Effective date 01/31/2006; Last review 09/20/2023; Next review 08/08/2024. Review history and definitions links are referenced but no additional authorization documentation requirements are provided in the chunks.

    • Effective: 01/31/2006
    • Last Review: 09/20/2023
    • Next Review: 08/08/2024
    Anecortave acetate (Retaane) is an angiostatic steroid formulation under investigation for prevention and treatment of ocular diseases, notably age‑related macular degeneration.
    DeliveryAdministered as a posterior (or anterior in some studies) juxtascleral depot — delivered with a blunt‑tipped curved cannula to the juxtascleral space for slow release to the choroid.
    Clinical contextStudied for subfoveal choroidal neovascularization in ARMD and evaluated in randomized trials (including 15 mg dosing vs photodynamic therapy) and multiple clinical reports and reviews.
    Regulatory / investigational statusAlcon withdrew its application for Retaane (EMEA press release) and the agent is described in the policy as investigational with mixed clinical evidence cited in systematic reviews and trials.
    Typical studied doseMost frequently studied dose in trials cited: 15 mg suspension.