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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.
No material clinical or coverage changes in this revision.
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:
Listed as experimental and investigational in the policy.
Listed as experimental and investigational in the policy.
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
| C69.20 - C69.22 | Malignant neoplasm of retina [retinoblastoma] |
| H35.3110 - H35.3293 | Age-related macular degeneration |
| H40.001 - H42 | Glaucoma |
Provider Actions & Authorization
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
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.
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.
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.
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
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
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