WHA

Restasis (cyclosporine 0.05%)

Indications for Prior Authorization

Restasis (cyclosporine 0.05%) ophthalmic emulsion
  • For diagnosis of Keratoconjunctivitis sicca
    Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Criteria

Brand Restasis, Generic cyclosporine 0.05% ophthalmic emulsion

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • One of the following:
    • Diagnosis of moderate to severe keratoconjunctivitis sicca (dry eye)
      • OR
    • Diagnosis of Sjogren syndrome with suppressed tear production due to ocular inflammation
    AND
  • One of the following [1, B]:
    • Patient will not be using concurrent topical ophthalmic anti-inflammatory drugs (e.g., corticosteroids, NSAIDs [nonsteroidal anti-inflammatory drugs])
      • OR
    • Topical ophthalmic anti-inflammatory drugs will only be used concurrently for a short period (up to 8 weeks) while transitioning to monotherapy with the requested drug
Brand Restasis, generic cyclosporine 0.05% ophthalmic emulsion

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Documentation of positive clinical response to therapy (e.g., increased tear production or improvement in dry eye symptoms)
    • AND
  • Patient will not be using concurrent topical ophthalmic anti-inflammatory drugs (e.g., corticosteroids, NSAIDs [nonsteroidal anti-inflammatory drugs])

  • Guideline ID
    GL-107977

  • Formulary
    EHB

  • Effective date
    Jun 8, 2022

  • P&T approval date

P & T Revisions

2022-06-08, 2022-02-18, 2021-09-28, 2021-06-02, 2021-05-21, 2020-05-21, 2020-03-25

  1. Restasis Prescribing Information. Allergan Inc. Irvine, CA. July 2017.
  2. American Academy of Ophthalmology Preferred Practice Pattern Cornea/External Disease Committee. Dry Eye Syndrome PPP - 2018. November 2018. https://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2018. Accessed May 28, 2021.
  1. As disease severity increases, aqueous enhancement of the eye using topical agents is appropriate (i.e., emulsions, gels, and ointments can be used). Topical cyclosporine, topical corticosteroids, topical lifitegrast, systemic omega-3 fatty acid supplements, punctual plugs and spectacle side shields/moisture chambers may also be considered in addition to aqueous enhancement therapies in patients who need additional symptom management. [2]
  2. The FDA-approved indication states that during clinical trials, increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. [1]
  • 2022-06-08: New EHB specific guideline.
  • 2022-02-18: Update to include generic restasis and addition of NF section
  • 2021-09-28: 2021 Annual Review, no changes to criteria.
  • 2021-06-02: 2021 Annual Review, no changes to criteria.
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-05-21: 2020 Annual Review, removed drug name from reauth criteria. No changes to clinical criteria.
  • 2020-03-25: Update to remove OTC requirement, updated background references