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.    Ranibizumab (Lucentis, Byooviz, Cimerli, Susvimo)

b.    Visudyne

c.    Eylea

5.    Beovu is not currently covered.

6.    Implantable Miniature telescope requires pre-authorization.

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.    Ranibizumab 

a.    Leakage is demonstrated and

b.    Avastin is ineffective or not tolerated.

3.    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

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 —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)    ranibizumab, aflibercept, bevacizumab, and intraocular steroids are 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:

J2778             Ranibizumab injection, 0.1mg

J2779             Injection, ranibizumab, via intravitreal implant (Susvimo), 0.1mg

Q5124            Injection, ranibizumab-nuna, biosimilar, (Byooviz), 0.1mg

Q5128            Injection, ranibizumab-eqrn (Cimerli), biosimilar, 0.1mg

J3395             Verteporfin injection

J3396             Verteporfin injection

C9257            Low-dose Injection, Bevacizumab, 0.25mg

J0178             Injection, Aflibercept, 1mg

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),

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)    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.

4)    Anti-VEGFtherapy is considered experimental and investigational for treatment of central serous retinopathy and cystoid macular edema, because their effectiveness for these indications has not been established.

5)    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.

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.

Addendum

Effective 1/16/2018: Added indication for Choroidal neovascularization due to
progressive/severe myopia (mCNV)

Effective 8/1/2018: Clarification of difference between low-dose bevacizumab for ocular disease and high-dose bevacizumab for patients with cancer or HHT

Effective 02/01/2019: Clarified codes for low-dose and high- dose bevacizumab. Added note regarding limits per treatment for low-dose bevacizumab.

 Effective 04/01/2020: Added note that Beovu is not currently covered due to concerns over safety.

 Effecitve 08/01/2023: Updated to add biosimilar ranibizumab products and remove Macugen references.

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.