Subject: Lucentis-Byooviz-Cimerli 1976-A SGM P2023

Drug

LUCENTIS  (ranibizumab)

BYOOVIZ  (ranibizumab-nuna)

CIMERLI  (ranibizumab-eqrn)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and
          compendial uses are considered a covered benefit provided that
          all the approval criteria are met and the member has no
          exclusions to the prescribed therapy.

          FDA-Approved Indications
          Lucentis, Byooviz and Cimerli are indicated for:
          1.  Neovascular (wet) age-related macular degeneration
          2.  Macular edema following retinal vein occlusion
          3.  Myopic choroidal neovascularization

          Lucentis and Cimerli are also indicated for:
          1.  Diabetic macular edema
          2.  Diabetic retinopathy

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Diabetic Macular Edema
               Authorization of 6 months may be granted for treatment of
               diabetic macular edema.

          B.  Neovascular (Wet) Age-Related Macular Degeneration
               Authorization of 6 months may be granted for treatment of
               neovascular (wet) age-related macular degeneration.

          C.  Macular Edema Following Retinal Vein Occlusion
               Authorization of 6 months may be granted for treatment of
               macular edema following retinal vein occlusion.

          D.  Diabetic Retinopathy
               Authorization of 6 months may be granted for treatment of
               diabetic retinopathy.

          E.  Myopic Choroidal Neovascularization
               Authorization of 6 months may be granted for treatment of
               myopic choroidal neovascularization.


  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued
          treatment of an indication listed in Section II for members who
          have demonstrated a positive clinical response to therapy (e.g.,
          improvement or maintenance in best corrected visual acuity
          [BCVA] or visual field, or a reduction in the rate of vision decline
          or the risk of more severe vision loss).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lucentis [package insert]. South San Francisco, CA: Genentech, Inc.; March 2018.
2. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern^® Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019.  Available at: https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp.
3. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern^® Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2019.  Available at: https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp.
4. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern^® Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp.  
5. Byooviz [package insert]. Cambridge, MA: Biogen, Inc.; June 2022.
6. Cimerli [package insert]. Redwood City, CA: Coherus BioSciences, Inc.; November 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 18, 2023