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Prior Authorization Protocol
LUCENTISR (ranibizumab injection), EYLEAR (aflibercept injection),
MACUGEN
R (pegaptanib injection), VISUDYNER (verteporfin)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Lucentis:
      • For the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD)
      • For the treatment of patients with Macular Edema Following Retinal Vein Occlusion
      • For the treatment of patients with Diabetic Macular Edema
      • Diabetic Retinopathy in patients with DME
    • Eylea
      • For the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration
      • For the treatment of patients with Macular Edema Following Retinal Vein Occlusion (RVO)
      • For the treament of patients with Diabetic Macular Edema
      • Diabetic Retinopathy in patients with DME
    • Macugen
      • For the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration
    • Visudyne
      • For the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of Neovascular (Wet) Age-Related Macular Degeneration (AMD) confirmed by an ophthalmologist
    AND
      • For Lucentis or Eylea only, must have failed or had clinically significant adverse effects to Avastin
    AND
      • For Macugen or Visudyne only, must have failed or had clinically significant adverse effects to two of the following drugs: Avastin, Lucentis, or Eylea
    OR
    • For Lucentis, Eylea, and Macugen only, Diagnosis of Diabetic Macular Edema confirmed by an ophthalmologist
    AND
      • For Eylea only, the patient's baseline visual acuity is 20/50 or worse
    OR
      • For Lucentis and Eylea, must have failed or had clinically significant adverse effects to Avastin
    OR
      • For Macugen only, must have failed or had clinically significant adverse effects to Avastin, Lucentis, and Eylea.
    OR
    • For Eylea and Lucentis only, Diagnosis of Neovascular Macular Edema Following Retinal Vein Occlusion confirmed by an ophthalmologist
    OR
    • For Eylea and Lucentis , must have diagnosis of macular edema following Retinal Vein Occlusion (Branch or Central) confirmed by an ophthalmologist
    OR
    • For Eylea and Lucentis only, must have diagnosis of diabetic retinopathy in patients with DME confirmed by an ophthalmologist

    OR

    • For Visudyne only, Diagnosis of predominantly classic subfoveal choroidal neovascularization due to pathologic myopia or presumed ocular histoplasmosis
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • In the Comparison of AMD Treatments Trials study, the difference in mean visual acuity improvement for patients treated with Avastin compared to Lucentis was -1.4 letters (95% [CI], - 3.7 to 0.8) at two years. The proportion of patients with arteriothrombotic events was similar in the Lucentis-treated patients (4.7%) compared to the Avastin-treated patients (5.0%; p=0.89). The proportion of patients with one or more systemic serious adverse events was higher with Avastin (39.9%) than Lucentis (31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; p=0.009). Serious systemic adverse events included all cause mortality, non-fatal stroke, non-fatal myocardial infarction, vascular death, venous thrombotic events and hypertension.
    • In the ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularisation in AMD (ANCHOR) trial, the number of patients that lost fewer than 15 letters at 12 months was achieved by 96.4% of patients treated with Lucentis 0.5 mg compared to 64.3% of patients treated with Visudyne (p<0.001). Rate of intraocular inflammation was higher for patients treated with Lucentis 0.5 mg at 15% compared to Visudyne at 2.8%.
    • In the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW)-1 trial, the difference in the number of patients who lost fewer than 15 letters at 52 weeks between Eylea every 8 weeks compared to Lucentis was 0.6% (95.1% CI -0.32, 4.4). In terms of the number of patients who gained at least 15 letters, the mean difference between Eylea every 8 weeks was 6.6% (95.1% CI -1.0, 14.1). There were no adverse events that were found to be significant from the Lucentis arm.
    • In the VEGF Inhibition Study in Ocular Neovascularization (VISION) trial, the proportion of patients who lost fewer than 15 letters at week 54 for patients treated with Macugen 0.3 mg was 70%, compared to 55% for placebo (p<0.001). There was a significant difference in adverse events between patients treated with Macugen compared to placebo for vitreous floaters (33% vs. 8%, p<0.001), vitreous opacities (18% vs. 10%, p<0.001), and anterior chamber inflammation (14% vs. 6%, p=0.001).
    • In a trial comparing Eylea, Avastin and Lucentis, the Diabetic Retinopathy Clinical Research Network found in patients with diabetic macular edema that when the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with Eylea, 7.5 with Avastin, and 8.3 with Lucentis (P>0.50 for each pair wise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with Eylea, 11.8 with Avastin, and 14.2 with Lucentis (P<0.001 for Eylea vs. Avastin, P=0.003 for Eylea vs. Lucentis, and P=0.21 for Lucentis vs. Avastin).
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Avastin

    Neovascular (Wet) Macular Degeneration
    1.25 to 2.5 mg administered by intravitreal injection every 4 weeks
    Neovascular Glaucoma
    1.25 mg administered by intravitreal injection every 4 weeks
    Macular edema secondary to retinal vein occlusion
    1 mg to 2.5 mg administered by intravitreal injection every 4 weeks
    Proliferative diabetic retinopathy
    1.25 mg administer by intravitreal injection 5 to 20 days before vitrectomy
    Diabetic Macular Edema
    1.25 mg administered by intravitreal injection

    Neovascular (Wet) Macular Degeneration
    2.5 mg
    Neovascular Glaucoma
    1.25 mg
    Macular edema secondary to retinal vein occlusion
    2.5 mg
    Proliferative diabetic retinopathy
    1.25 mg
    Diabetic Macular Edema
    1.25 mg

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Lucentis

    Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    0.5 mg (0.05 mL) administered by intravitreal injection once a month.
    Alternative dosing:
    Once monthly injections for three months followed by
    4-5 doses dispersed among the following 9 months
    Or
    Treatment may be reduced to one injection every 3 months after
    the first 4 injections if monthly injections are not feasible.
    Macular Edema Following Retinal Vein Occlusion
    0.5 mg (0.05 mL) administered by intravitreal injection once a month.
    Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in
    patients with Diabetic Macular Edema
    0.3 mg (0.05 mL) administered by intravitreal injection once a month.
    6 months
    Reauthorization for 6 months will be made upon receipt of documentation the patient has not lost > 15 letters from baseline visual acuity or final Best Corrected Visual Acuity (BCVA) of <20/400

    Eylea

    Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    2 mg (0.05 mL) administered by
    intravitreal injection once a month for 3 months then once every 2 months.

    Macular Edema Following Retinal Vein Occlusion
    2 mg (0.05 mL) administered by
    intravitreal injection once a month

    Diabetic Macular Edema and Diabetic Retinopathy (DR) inpatients with Diabetic Macular Edema
    2mg administered by intravitreal injection once a month for the first 5 injections
    followed by 2 mg via intravitreal injection once every 2 months.
    6 months
    Reauthorization for 6 months will be made upon receipt of documentation the patient has not lost > 15 letters from baseline visual acuity or final BCVA of <20/400

    Macugen

    Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    0.3 mg (0.09 mL) administered by
    intravitreal injection every 6 weeks
    Diabetic Macular Edema
    0.3 mg (0.09 mL) administered by
    intravitreal injection once every 6 weeks
    6 months
    Reauthorization for 6 months will be made upon receipt of documentation the patient has not lost >15 letters from baseline visual acuity or final BCVA of <20/400
    Visudyne
    Predominantly classic subfoveal choroidal neovascularization
    due to age-related macular degeneration,
    pathologic myopia or presumed ocular histoplasmosis
    6 mg/m2 Body Surface Area IV diluted with 5% dextrose
    to a final volume of 30 mL infused over 10 minutes
    6 months
    Reauthorization for 6 months if choroidal neovascular leakage is detected on fluorescein angiography
  7. Product Availability:
    Lucentis: 10 mg/mL in 2 mL vials or 6 mg/mL in 2 mL vials
    Eylea: 2 mg/0.05 mL in 3 mL vials
    Macugen: 0.3 mg/0.09 mL prefilled syringe
    Visudyne: 15 mg vials
  8. References:
    1. Lucentis [Prescribing Information] South San Francisco, CA: Genentech, Inc.; February 2015.
    2. Ranibizumab versus Bevacizumab to Treat Neovascular Age-related Macular Degeneration: One-Year Findings from the IVAN Randomized Trial. The IVAN Study Investigators, Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC. Ophthalmology. 2012;7:1399-1411. Epub 2012 May 11.
    3. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, et al. Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration: Two-Year Results. Ophthalmology; 2012;7:1388-98.
    4. Weigert G, Michels S, Sacu S, et al. Intravitreal bevacizumab (Avastin) therapy versus photodynamic therapy plus intravitreal triamcinolone for neovascular age-related macular degeneration: 6-month results of a prospective, randomised, controlled clinical study. Br J Ophthalmol. 2008 Mar;92(3):356-360.
    5. Bashshur Zf , Haddad Za, Schakal A, et al. Intravitreal Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration: A One-year Prospective Study. Am J Ophthalmol. 2008;145:249256.
    6. Yazdani S, Hendi K, Pakravan M, et al. Intravitreal bevacizumab for neovascular glaucoma: a randomized controlled trial. J Glaucoma. October-November 2009;18(8):632-637.
    7. Brouzas D, Charakidas A, Moschos M, et al. Bevacizumab (Avastin.) for the management of anterior chamber neovascularization and neovascular glaucoma. Clinical Ophthalmology. 2009;3:685-688.
    8. Moraczewski AL, Lee RK, Palmberg PF, et al. Outcomes of treatment of neovascular glaucoma with intravitreal vevacizumab. Br J Ophthalmol, 2009;93:589-593.
    9. Costagliola C, Cipollone U, Rinaldi M, et al. Inravitreal bevacizumab (Avastin.) injection for neovascular glaucoma: a survey of 23 cases throughout 12-month follow-up. Br J Clin Pharmacol, 2008;66(5):667-673.
    10. di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010;248:785-791.
    11. Rizzo S, Genovesi-Ebert F, Di Bartolo E, Vento A, Miniaci S, Williams G. Injection of intravitreal bevacizumab (Avastin) as a preoperative adjunct before vitrectomy surgery in the treatment of severe proliferative diabetic retinopathy (PDR). Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):837-842.
    12. Arevalo JF, Sanchez JG, Wu L, et al. Primary intravitreal bevacizumab for diffuse diabetic macular edema. Ophthalmology. August 2009;116(8):1488-1497.
    13. Roh MI, Byeon SH, Kwon OW. Repeated intravitreal injection of bevacizumab for clinically significant diabetic macular edema. Retina, the Journal of Retinal and Vitreous Diseases. 2008; 28(9): 1314-1318.
    14. Kook D, Wolf A, Kreutzer T, et al. Long-term effect of intravitreal bevacizumab (Avastin) in patients with chronic diffuse diabetic macular edema. Retina, the Journal of Retinal and Vitreous Diseases. 2008; 28(8): 1053-1060.
    15. Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;334:14321444.
    16. Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR; VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16.
    17. Product Dossier: EyleaTM (aflibercept). Tarrytown; November 2011. Regeneron Pharmaceuticals, Inc. Data reviewed February 14, 2012.
    18. Visudyne [Prescribing information]. Rochester, MI: Parkedale Pharmaceuticals, Inc.; May 2014.
    19. Macugen [Prescribing information]. New York, NY: Eyetech Pharmaceuticals, Inc.: October 2011.
    20. Eylea [Prescribing Information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.: March 2015.
    21. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 18, 2015
    22. Lucentis In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed June 18, 2015
    23. Eylea In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/
    24. Macugen In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/
    25. Visudyne In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/
    26. Glassman AR et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. NEJM February, 2015 published online ahead of print (DOI: 10.1056/NEJMoa1414264)
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.