Pharmacy Prior Authorization Criteria

Restasis (cyclosporine 0.05%) - PA, NF

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 (Tier 1*)

NOTE: *This criteria is to be used for generic cyclosporine 0.05% ophthalmic emulsion that is on Tier 1 ONLY. This criteria does NOT apply to generic cyclosporine 0.05% ophthalmic emulsion on Tier 2 or Tier 3.

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

Generic cyclosporine 0.05% ophthalmic emulsion (Tier 2 or Tier 3*)

Note: *This criteria is to be used for generic cyclosporine 0.05% ophthalmic emulsion that is on Tier 2 or Tier 3 ONLY. This criteria does NOT apply to generic cyclosporine 0.05% ophthalmic emulsion on Tier 1.

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
AND
• All of the following:
• At least 6 months use of brand Restasis within the previous 365 days (document drug, duration, and date of use)
AND
• Documentation provided stating that brand Restasis has not been effective
AND
• Justification provided for why the generic is expected to provide benefit when brand Restasis has not been shown to be effective

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])

Generic cyclosporine 0.05% ophthalmic emulsion

Non Formulary

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
AND
• All of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming at least 6 months use of brand Restasis within the previous 365 days (document drug, duration, and date of use)
AND
• Submission of documentation provided stating that brand Restasis has not been effective
AND
• Submission of justification provided for why the generic is expected to provide benefit when brand Restasis has not been shown to be effective

P & T Revisions

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

References

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.

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End Notes

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]

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Revision History

• 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

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