mp-254 - mp-254 - Medical Policies
Conjunctival Incision with Posterior Juxtascleral Placement of Anecortave Acetate Depot Suspension
Policy Number: MP-254
Latest Review Date: March 2021
Policy Grade: Active Policy but no longer scheduled for regular literature reviews and updates.
Conjunctival incision with posterior juxtascleral placement of Anecortave Acetate Depot Suspension is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Anecortave acetate (Retaane) (Alcon, Inc.) is an angiostatic steroid under investigation for the prevention and treatment of ocular diseases, in particular age-related macular degeneration (ARMD). It is administered with a blunt-tipped, curved cannula as a posterior juxtascleral depot. The curved cannula follows the surface of the sclera, without puncturing the globe. Once the cannula is in place, anecortave acetate is injected in the juxtascleral space (behind the eye) overlying the macula and the drug is slowly released to the choroid over a six-month period. This novel method of drug delivery is intended to avoid the risk of intra-ocular infection and retinal detachment, the most common side effects associated with injecting therapeutic agents directly into the eye, and it requires less frequent dosing compared to other drugs.
Advantages to the posterior juxtascleral placement of a pharmacologic agent may include reduced risk for retinal detachment, endophthalmitis and other safety issues associated with repeated intravitreal injections (a common route of administration for pharmaceutical agents in the treatment of ocular disorders).
This policy is reviewed regularly with the most recent literature review performed through March 23, 2021.
Summary of Evidence
The ocular delivery of anecortave acetate was tested in preclinical and clinical pharmacokinetic and metabolism studies. Results of initial studies led to the design of a new cannula that could effectively deliver anecortave acetate as a posterior juxtascleral depot, providing adequate retinal and choroidal drug concentrations for up to six months after a single administration. A counter-pressure device was designed to prevent drug reflux during and immediately after posterior juxtascleral depot administration. Pharmacokinetic studies support the effectiveness of these devices. Anecortave acetate is rapidly hydrolyzed by esterases to pharmacologically active anecortave desacetate, and is further reductively metabolized to one major and several minor products that circulate as glucuronide conjugates. Low levels of these anecortave acetate metabolites were detectable for only approximately two weeks in the plasma after a 15-mg posterior juxtascleral depot administration to age-related macular degeneration patients. Studies show that posterior juxtascleral depot administration of anecortave acetate is an effective, minimally invasive method of delivering this drug to the choroid and retina. However, randomized controlled studies are needed to determine its clinical utility compared to the standard of care. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
Macular degeneration, Conjunctival incision, posterior juxtascleral placement of Anecortave Acetate Depot Suspension, Anecortave Acetate Depot Suspension, Retaane®, angiostatic cortisone, age-related macular degeneration, anecortave acetate, posterior juxtascleral depot, retina
APPROVED BY GOVERNING BODIES:
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Unlisted procedure, conjunctiva
- Alcon Laboratories, Inc. Alcon discontinues development of anecortave acetate for intraocular pressure reduction. Press Release, July 2, 2009. Available at invest.alconinc.com/phoenix.zhtml?c=130946&p=irol-newsArticle&ID=1304229&highlight=.
- Alcon terminates the development of anecortave acetate in age-related macular degeneration. July 14, 2008, www.medicalnewstoday.com/articles/114883.php.
- Augustin AJ, D’Amico DJ, Mieler WF, et al. Safety of posterior juxtascleral depot administration of the angiostatic cortisene anecortave acetate for treatment of subfoveal choroidal neovascularization in patients with age-related macular degeneration. Graefes Arch Clin Exp Ophhthalmol 2005; 243(1): 9-12.
- Bakri SJ, Kaiser PK. Anecortave acetate. Expert Opin Investig Drugs 2006; 15(2):163-9.
- Blue Cross Blue Shield Association. Special report: Current and evolving strategies in the treatment of age-related macular degeneration. Technology Evaluation Center (TEC), October 2005.
- Blue Cross Blue Shield Association. Conjunctival incision with posterior juxtascleral placement of anecortave acetate depot suspension. Medical Policy Reference Manual, September 2009.
- Dahlin, Rahimy. Pharmacokinetics and Metabolism of Anecortave Acetate in Animals and Humans, Survey of Ophthalmology. Volume 52, Issue 1, Supplement, 2007, Pages S49-S61, ISSN 0039-6257. https://doi.org/10.1016/j.survophthal.2006.11.002. Accessed March 23, 2021.
- D’Amico DJ, Goldberg MF, Hudson H, et al. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology 2003; 110(12): 2372-85.
- D’Amico DJ, Golbert MF, Hudson H, et al. Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD): interm (month 6) analysis of clinical safety and efficacy. Retina 2003; 23(1): 14-23.
- Geltzer A, Turalba A and Vedula SS. Surgical implantation of steroids with antiangiogenic characteristics for treating neovascular age-related macular degeneration. Cochrane Database Syst Rev 2007; (4):CD005022.
- Geltzer A, Turalba A, Vedula SS. Surgical implantation of steroids with antiangiogenic characteristics for treating neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2013; 1:CD005022.
- Hodge W, Brown A, Kymes S, et al. Pharmacologic management of neovascular age-related macular degeneration: Systematic review of economic evidence and primary economic evaluation. Can J Ophthalmol. 2010; 45(3):223-230.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Regillo CD, D'Amico DJ, Mieler WF, et al. Clinical safety profile of posterior juxtascleral depot administration of anecortave acetate 15 mg suspension as primary therapy or adjunctive therapy with photodynamic therapy for treatment of wet age-related macular degeneration. Surv Ophthalmol 2007; 52(suppl 1):S70-8.
- Prata TS, Tavares IM, Mello PA, et al. Hypotensive effect of juxtascleral administration of anecortave acetate in different types of glaucoma. J Glaucoma. 2010; 19(7):488-492.
- Schmidt-Erfurth U, Michels S, Michels R, Aue A. Anecortave acetate for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration. Eur J Ophthalmol 2004; 15(4): 482-5.
- Slakter JS, Bochow TW, D'Amico DJ, et al. Anecortave Acetate Clinical Study Group. Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology 2006; 113(1):3-13.
Medical Policy Group, October 2005 (2)
Medical Policy Administration Committee, October 2005
Available for comment October 24-December 7, 2005
Medical Policy Group, September 2006 (1)
Medical Policy Group, September 2007 (1)
Medical Policy Group, March 2009 (4)
Medical Policy Group, October 2009 (1): Active Policy but no longer scheduled for regular literature reviews and updates effective October 1, 2009
Medical Policy Group, December 2013 (1): 2014 Coding Update: added unlisted code 68399, effective for use 01/01/2014; moved deleted code 0124T to Previous Coding section, effective 01/01/2014
Medical Policy Group, November 2019 (6): Updates to Description, Key Points and References.
Medical Policy Group, March 23, 2021 (9): Updates to Description, Key Points, References. Key words added: age-related macular degeneration, anecortave acetate, posterior juxtascleral depot, retina. Policy statement updated to remove “not medically necessary,” no change to policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.