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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2006 Title: Macular Degeneration Treatments and Diabetic Macular Edema Treatments
Revision Date: 04/01/2020 Document: BI169:00
CPT Code(s): C9257, J0178, J2503, J2778, J3395, J3396, Q2046
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Age related macular degeneration (AMD) is the most common cause of vision loss in persons over 55. There are two basic forms:

1.    Non-neovascular or “dry” is the more common type and leads to gradual loss of vision. There is currently no treatment for dry macular degeneration.

2.    Neovascular or “wet” is the less common form and leads to more sudden loss of vision. There are treatments for “wet” AMD, including several medications:

3.    Diabetic macular edema can also be treated with drug therapy.

4.    Low-dose Avastin does not require preauthorization for treating conditions listed in this policy. These drugs do require preauthorization.   

a.    Lucentis

b.    Visudyne

c.    Macugen

d.    Eylea

5.    Beovu is not currently covered.

6.    Implantable Miniature telescope requires pre-authorization


Medical Statement

1)    Low-dose Avastin 0.25 mg (bevacizumab- C9257) does not require preauthorization for macular degeneration, radiation retinopathy, and diabetic macular edema treatment and is the preferred first-line treatment when appropriate. It is limited to a maximum 10 units per treatment. High-dose Avastin 10 mg (bevacizumab – J9035) requires preauthorization and should be used for patients with cancer (see BI299), not for ocular problems.

2)    Based on questions surrounding the warning by the American Society of Retinal Specialists regarding vision-threatening cases of occlusive retinal vasculitis, Beovu is currently not covered. The drug may be re-evaluated at a later date when additional evidence becomes available.

3)    Choroidal neovascularization (CNV) due to age related macular degeneration (AMD) when meeting the following criteria:

1.    Verteporfin (Visudyne) photodynamic therapy (PDT-V)

a.    When laser photocoagulation is not possible due to the closeness of the vascular lesions to the fovea and;

b.    Fluorescein angiography is done within 1 week of the treatment shows leakage and;

c.    Lesion size <=4 Macular Photocoagulation Study (MPS) disc areas (DA)

d.    Retreatment will be considered medically necessary every 3 months if the fluorescein angiogram shows persistence of the leakage OR;

e.    persistent loss of vision in the same or fellow eye due to a previous episode of CSR and presence of fluid for three months or longer

f.     Avastin is ineffective or not tolerated

2.    Pegaptanib sodium injection (Macugen)

a.    Where leakage is demonstrated and;

b.    Patient is at high risk for thromboembolic event.

c.    Avastin is ineffective or not tolerated

3.    Ranibizumab  (Lucentis)

a.    Leakage is demonstrated and

b.    Avastin is ineffective or not tolerated.

4.    Aflibercept (Eylea)

a.    Leakage is demonstrated and

b.    Avastin is ineffective or not tolerated

4)    Choroidal neovascularization due to progressive/severe myopia (mCNV)

1.    Ranibizumab (Lucentis)

a.    Avastin is ineffective or not tolerated

5)    Diabetic macular edema, macular edema following retinal vein occlusion (RVO), neovascular glaucoma, pseudoxanthoma elasticum, and certain rare causes of choroidal neovascularization (angioid streaks, choroiditis (including choroiditis secondary to ocular histoplasmosis), idiopathic degenerative myopia, trauma, and retinal dystrophies).

1.    Bevacizumab (Avastin)—preferred agent

2.    Ranibizumab (Lucentis)—to be considered if bevacizumab ineffective or not tolerated

3.    Aflibercept (Eylea)—to be considered if bevacizumab ineffective or not tolerated

6)    Macular edema following retinal vein occlusion

a)    Lucentis is considered to be medically necessary

 

7)    Implantable Miniature Telescope (IMT) is considered medically necessary for monocular implantation in members aged 75 years and older with stable, untreatable, severe-to-profound central vision impairment caused by blind spots (bilateral central scotoma) associated with end-stage ARMD as determined by fluorescein angiography when all of the following are met::

a)    Achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart in the eye scheduled for surgery using an external telescope; and

b)    Adequate peripheral vision in the eye not scheduled for surgery, to allow for orientation and mobility; and

c)    Agree to undergo 2 to 4 pre-surgical training sessions with low vision specialist (optometrist or occupational therapist); and

d)    Evidence of a visually significant cataract (grade 2 or higher); and

e)    No active wet ARMD (no sign of active choroidal neovascularization in either eye); and

f)     No sign of eye disease other than well-controlled glaucoma; and

g)    Not been treated for wet ARMD in the previous 6 months; and

h)    Visual acuity poorer than 20/160, but not worse than 20/800 in both eyes; and

i)     Willingness to participate in a post-operative visual rehabilitation program.

Codes Used In This BI:

 

J2503             Pegaptanib sodium injection

J2778             Ranibizumab injection

J3395             Verteporfin injection

J3396             Verteporfin injection

C9257            Low-dose Injection, Bevacizumab, 0.25mg

J0178             Injection, Aflibercept, 1mg


Limits

1)    Visudyne PDT is considered experimental and investigational for the treatment of the following:

a)     CNV secondary to choroiditis and retino-choroiditis,

b)    Angioid streaks

c)    Retinal angiomatous proliferation

d)    Parafoveal CNV (occult CNV lesions with no classic component),

e)    Telangiectasia or CNV associated with macular dystrophy and idiopathic  diseases without CNV, such as;

i)      choroidal hemangioma

ii)    Retinal hamartoma

iii)   Choroidal melanoma

iv)   Angiomatous lesions secondary to systemic diseases

v)    Rubeosis iridis or neovascular glaucoma and all other indications because its effectiveness for these indications has not been established.

2)    The simultaneous use of Visudyne PDT in combination with anti-angiogenic agents for the treatment of CNV due to AMD is considered experimental and investigational because the safety and effectiveness of such combination therapy has not been established.

3)    Pegaptanib (Macugen) 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated. The safety and efficacy of Macugen therapy administered to both eyes concurrently have not been studied.

4)    Macugen is shown to be less effective during the second year of the study than during the first year.

5)    Macugen for the treatment of individuals with diabetic macular edema and all other indications is considered experimental and investigational because its effectiveness for these indications has not been established.

6)    Ranibizumab (Lucentis) injection is considered experimental and investigational for treatment of choroidal neovascularization due to ocular histoplasmosis.  Because its effectiveness for these indications has not been established.

7)    Ranibizumab and bevacizumab injections are considered experimental and investigational for treatment of central serous retinopathy and cystoid macular edema, because their effectiveness for these indications has not been established.

8)    The following are considered experimental/investigative in the treatment of AMD:

a)    Anecortave acetate

b)    Epiretinal radiation therapy

c)    Injection of bevacizumab, Pegaptanib, or Ranibizumab for dry/non-neovascular ARMD

d)    Interferon alpha

e)    Intra-ocular electrically stimulated devices (e.g., optic nerve, cortical, Epiretinal and subretinal)

f)     Intra-vitreal bevasiranib

g)    Intra-vitreal triamcinolone

h)    Laser photocoagulation of macular drusen

i)     Macular/foveal translocation

j)     Proton beam radiotherapy

k)    Simultaneous use of Visudyne PDT in combination with anti-angiogenic agents (for choroidal neovascularization due to ARMD)

l)     Submacular surgery

m)  Surgical implantation of optic nerve

n)    Transpupillary thermotherapy.


Background

The off-label use of bevacizumab (Avastin) to treat a variety of neovascular diseases has been widely accepted clinically.  While there have been reports of both infectious and sterile complications related to these uses of bevacizumab—these appear to be related to contamination in the compounding process, use of certain types of syringes with silicone oil lubricant, not maintaining proper temperature controls or other procedural issues.  The incidence of these potential complications is very low and the clinical consensus is they do not preclude the use of bevacizumab (given the known complications of non-treatment).  While other anti-VEGF products are available for these same indications, there is not clinical consensus that they should be used instead of bevacizumab.  In light of comparable clinical outcomes and dramatic differences in cost, bevacizumab has become the de facto first line treatment for many neovascular conditions.  If bevacizumab is ineffective or not tolerated, other anti-VEGF agents may be considered.

Verteporfin (Visudyne) is a light-activated drug used in photodynamic therapy (PDT). Once Verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived reactive oxygen radicals are generated. Light activation of Verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion.

Because of photodynamic therapy`s potential for selective tissue injury, it offers advantages over conventional laser treatments. PDTs potential to selectively affect choroidal neovascularization is attributable to preferential localization of the photosensitizer dye to the CNV complex and irradiation of the complex with light levels far lower than required for thermal injury.

Macugen (Pegaptanib sodium injection) is an intravitreal injection developed for the treatment of neovascular (wet) AMD. Pegaptanib binds to VEGF and inhibits its binding to cellular receptors. Macugen`s anti-VEGF activity is expected to inhibit abnormal blood vessel proliferation and therefore decrease the vision loss associated with the proliferation of abnormal blood vessels.

On July 6, 2010, the FDA approved the implantable miniature telescope (IMT) (VisionCare Ophthalmic Technologies, Saratoga, CA) for patients aged 75 years and older with stable, untreatable, severe-to-profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage ARMD with evidence of a visually significant cataract.

The IMT device is a compound telescope system that consists of a glass cylinder (4.4 mm in length and 3.6 mm in diameter) housing wide-angle micro-optics.  The height of the glass cylinder approximately equals that of 13 stacked intraocular lenses (IOLs).  The device is heavier (115 mg in air and 60 mg in aqueous) and the carrier haptics are less flexible than those found on 1-piece polymethylmethacrylate IOLs.  The IMT device is surgically implanted in the posterior chamber of the eye after removal of the eye’s lens and is designed to be implanted in one eye only; the implanted eye provides central vision, while the non-implanted eye is used for peripheral vision.  The IMT protrudes 0.1 – 0.5 mm through the pupillary plane, leaving a minimum of 2.0 mm of corneal clearance.  When properly implanted in eyes with anterior chamber depths of 2.5 mm or more, the face of the optic should not touch the corneal endothelium.  The device provides higher resolution images to the central retina and its telephoto effect also allows more to be seen in the central visual field.  The device is used for both near and distance activities, with objects being brought into focus by standard spectacles.  Prior to implantation, patients must agree to undergo training with an external telescope with a low vision specialist to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted.  Patients must also agree to participate in a post-operative visual training program.  The device is available in 2 models: one provides 2.2 x magnification and the other provides 2.7 x magnification.

Because the IMT is large and non-foldable, it requires a much larger incision (12 mm) than phacoemlusification with foldable IOL.  The risk of corneal endothelial cell loss during implantation is higher than conventional anterior segment procedures, but is comparable with that seen after large-incision cataract extraction (Colby, et al., 2007).  Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant.   In the IMT-002 trial, 10 eyes had unresolved corneal edema, with 5 resulting in corneal transplants.  The device was removed from 8 eyes post-operatively (4 subjects requested removal because they were dissatisfied with the device, 2 were removed due to condensation of the telescope portion, and 2 eyes underwent corneal transplantation as a result of corneal decompensation).  The calculated 5-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively (FDA, 2010).  Four device failures were reported during the IMT-002 trial. 

According to the manufacturer`s website, the IMT is intended for monocular implantation in patients aged 75 years and older with stable, untreatable, severe-to-profound vision impairment caused by blind spots (bilateral central scotoma) associated with end-stage ARMD as determined by fluorescein angiography when all of the following are met:

  • Achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart in the eye scheduled for surgery using an external telescope; and
  • Adequate peripheral vision in the eye not scheduled for surgery; and
  • Agree to undergo 2 to 4 pre-surgical training sessions with low vision specialist (optometrist or occupational therapist); and
  • Evidence of a visually significant cataract (grade 2 or higher); and
  • No active wet ARMD (no sign of active choroidal neovascularization in either eye); and
  • No sign of eye disease other than well-controlled glaucoma; and
  • Not been treated for wet ARMD in the previous 6 months; and
  • Stable, untreatable ARMD present in both eyes (end-stage, geographic atrophy or disciform scar) as determined by fluorescein angiography; and
  • Visual acuity poorer than 20/160, but not worse than 20/800 in both eyes; and
  • Willingness to participate in a post-operative visual rehabilitation program.

As a condition of FDA approval, the manufacturer must conduct 2 post-approval studies: (i) VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional 2 years, and (ii) an additional study of 770 newly enrolled subjects will include an evaluation of the ECD and related adverse events for 5 years after implantation.


Reference
  1. Novartis Ophthalmics. Visudyne - wet AMD treatment. Duluth, GA: Visudyne; 2001. Available at visudyne.com
  2. Chakravartyhy U, Soubrane G, Bandello F, et al Evolving European guidance on the medical management of neovascular age related macular degeneration. Br J Ophthalmol. 2006 Sep; 90(9):1188-96.
  3. National Institute for Clinical Excellence (NICE). Guidance on the use of photodynamic therapy for age-related macular degeneration. Technology Appraisal 68. London, UK: NICE; September 2003. Available at  http://www.nice.org.uk/page.aspx?o=86801
  4. Seland JH, Bragadottir R, Hedels C, et al. Photodynamic therapy for age-related macular degeneration. Oslo, Norway: Norwegian Centre for Health Technology Assessment (SMM); 2000.
  5. U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services (CMS). Decision Memo for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R3). Baltimore, MD: CMS; January 28, 2004. Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=101 
  6. Keam SJ, Scott LJ, Curran MP. Spotlight on Verteporfin in subfoveal choroidal neovascularization. Drugs Aging. 2004; 21(3):203-209.
  7. Azab M, Benchaboune M, and Blinder KJ, et al. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: Meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration with Photodynamic Therapy and Verteporfin in Photodynamic Therapy Study Report no. 4. Retina. 2004; 24(1):1-12.
  8. Verteporfin Roundtable Participants. Guidelines for using Verteporfin (Visudyne) in photodynamic therapy for choroidal neovascularization due to age-related macular degeneration and other causes: Update. Retina. 2005; 25(2):119-134.
  9. Gragoudas ES, Adamis AP, Cunningham ET Jr, et al. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004; 351(27):2805-2816.
  10. Ferris FL 3rd. A new treatment for ocular neovascularization. N Engl J Med. 2004; 351(27):2863-2865.
  11. Eyetech Pharmaceuticals, Inc. and Pfizer, Inc. Macugen (Pegaptanib sodium injection). Prescribing Information. LAB-0293-1.0. New York, NY: Pfizer; December 2004. Available at: http://www.macugen.com/
  12. Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003; 22:1-29.
  13. National Horizon Scanning Centre (NHSC). Pegaptanib for age-related macular degeneration - horizon scanning review. Birmingham, UK: NHSC; 2002.
  14. U.S. Department of Health and Human Services, Food and Drug Administration (FDA). FDA approves new drug treatment for age-related macular degeneration. FDA News. P04-110. Rockville, MD: FDA; December 10, 2004. Available at: http://www.fda.gov/bbs/topics/news/2004/new01146.html 
  15. Krzystolik MG, Woodcome HA, Reddy U. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration [Protocol for Cochrane Review]. Cochrane Database Systematic Rev. 2005; 1:CD005139.
  16. Cunningham ET Jr, Adamis AP, Altaweel M, et al. A phase II randomized double-masked trial of Pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005; 112(10):1747-1757.
  17. U.S. Food and Drug Administration, FDA Approves New Biologic Treatment for
    Wet Age-Related Macular Degeneration; June 30, 2006 available at: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html
  18. Genentech, Lucentis (Ranibizumab injection) information for professionals at: http://www.lucentis.com/lucentis/hcp/hcp_index.jsp?fontsize=dec.
  19. Arkansas BlueCross BlueShield, Coverage Policy Manual; Pegaptanib (Macugen) for Age Related Macular Degeneration available at: http://www.arkansasbluecross.com/members/report.aspx?policyNumber=2005006
  20. The CATT Research Group; Ranibizumab and Bevacizumab for Neovascular Age-Related Degeneration; NEJM, May 19, 2011.
  21. Chan, Wai-Man, et al. Intravitreal Bevacizumab (Avastin) for Myopic Choroidal Neovascularization: Six-Month Results of a Prospective Pilot Study. Ophthalmology. 2007; 114(12):2190-2196.
  22. Mandal S, Venkatesh P, Sampangi R, Garg S. Intravitreal bevacizumab (Avastin) as primary treatment for myopic choroidal neovascularization. Eur J Ophthalmol. 2007; 17:620–626
  23. Konstantinidis, L., Mantel, I., Pournaras, JA.C. et al. Intravitreal ranibizumab (Lucentis®) for the treatment of myopic choroidal neovascularization Graefes Arch Clin Exp Ophthalmol. 2009; 247: 311.
  24. Orozco-Hernandez A, et al. Acute sterile endophthalmitis following intravitreal bevacizumab: case series. 2014; 8:1793-1799
  25. Beovu Prescribing Information. East Hanover, NJ;Novartis Pharmaceuticals Corporatoin. October 2019.

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.