mp-254
print Print

Conjunctival Incision with Posterior Juxtascleral Placement of Anecortave Acetate Depot Suspension

Policy Number: MP-254

Latest Review Date: November 2019

Category: Ophthalmology                                                     

Policy Grade: Effective October 1, 2009: Active Policy but no longer scheduled for regular literature reviews and updates.

POLICY:

Conjunctival incision with posterior juxtascleral placement of Anecortave Acetate Depot Suspension is considered not medically necessary and 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 6-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).

KEY POINTS:

Literature review through November 2019.

SUMMARY OF EVIDENCE:

While anecortave acetate is a proposed treatment for ARMD, randomized controlled studies are needed to determine its safety and effectiveness compared to other treatment options for ARMD.

KEY WORDS:

Macular degeneration, Conjunctival incision, posterior juxtascleral placement of Anecortave Acetate Depot Suspension, Anecortave Acetate Depot Suspension, Retaane®, angiostatic cortisone

PRACTICE GUIDELINES AND POSITION STATEMENTS:

Not applicable.

APPROVED BY GOVERNING BODIES:

Not FDA approved

BENEFIT APPLICATION:

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.

CURRENT CODING:

CPT Codes:

There are no specific CPT codes for this procedure

68399              Unlisted procedure, conjunctiva

REFERENCES:

  1. 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=.
  2. Alcon terminates the development of anecortave acetate in age-related macular degeneration.  July 14, 2008, www.medicalnewstoday.com/articles/114883.php.
  3. 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.
  4. Bakri SJ, Kaiser PK.  Anecortave acetate.  Expert Opin Investig Drugs 2006; 15(2):163-9.
  5. 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.
  6. Blue Cross Blue Shield Association.  Conjunctival incision with posterior juxtascleral placement of anecortave acetate depot suspension.  Medical Policy Reference Manual, September 2009.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. www.clinicaltrials.gov/ct2/results?term=anecortave+acetate.
  17. www.medicalnewstoday.com/articles/90480.php. Last accessed March 4, 2009.

POLICY HISTORY:

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.

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.