CurrentMass General Brigham Health PlanPolicy N/A

Restasis (cyclosporine ophthalmic emulsion) — Prior Authorization

Defines prior authorization, continuation, and quantity/authorization limits for Restasis (cyclosporine ophthalmic emulsion) under Mass General Brigham Health Plan pharmacy benefit for Commercial/Exchange and other plans.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRestasis (cyclosporine ophthalmic emulsion) — Prior Authorization

Policy CodePolicy N/A

Change TypeRevised

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Restasis; ensure member trial/failure of artificial tears and eligibility as new-to-plan within 90 days when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated criteria to clarify the NSAID requirements and removed documentation requirement from policy.

12Approval duration (months)

90New-to-plan window (days)

2-4Allowed overlap (weeks)

Coverage Criteria for Restasis (cyclosporine ophthalmic emulsion)

Initial and Continuation Therapy

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Authorization will be granted when ALL of the following are met:

Overall: Requested drug is prescribed for dry eye disease; member has tried and failed or been intolerant to artificial tears

Reflects initial therapy requirements

Anti-inflammatory / Punctal Plug Conditions

ONE of
- Condition: No concurrent ophthalmic anti-inflammatory use: Member will not be using ophthalmic anti-inflammatory drugs concurrently with the requested drug
  Avoid concurrent use
- Condition: Short concurrent use allowed: Member will be using ophthalmic anti-inflammatory drugs concurrently with the requested drug for a short period (2 to 4 weeks) while transitioning to monotherapy with the requested drug2 to 4 weeks
  Temporary overlap permitted for transition

Continuation: Member demonstrates a positive response to therapy; requests for reauthorization will be approved when the following criteria are met

Continuation requires documented clinical improvement

Increased tear production was not demonstrated in patients who were concurrently using topical ophthalmic anti-inflammatory drugs or who had punctal plugs in place; these situations may affect expected benefit and should be considered when evaluating requests for Restasis.

Pharmacy Coding and Authorization Duration

Pharmacy CodesNDC

NDC	Not specified in document

inv-04: Authorization duration

Authorization durationInitial approvals and reauthorizations: 12 months

Renewal requirementReauthorization may be granted when continuation criteria (documented positive response) are met

Applies toInitial and continuation therapy under the pharmacy benefit for Restasis

Provider Actions, Prior Authorization and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for Restasis (cyclosporine ophthalmic emulsion). Note that prior authorization rules include special handling for members new to the plan.

Applies to pharmacy benefit (Restasis)
Contact: All Plans Phone: 877-519-1908, Fax: 855-540-3693

Step Therapy

Step Therapy: Trial of Artificial Tears

Approval requires a trial of and inadequate response or intolerance to artificial tears prior to approval of Restasis.

Member must have tried and failed or been intolerant to artificial tears prior to starting Restasis

Documentation Required

Operational Note: Documentation Requirement Removed

Documentation requirement was removed from the policy per the review history. Clinical information supporting medical necessity (for example, history of prior treatments and intolerance) should still be included as applicable when submitting an authorization request.

Removed documentation requirement (01/08/2025) — retain relevant clinical information as applicable

Denial Risk

Denial Risk Conditions

Authorization may be denied for members who do not meet new-to-plan rules or are not currently receiving treatment/resupply as specified.

Not new-to-plan within past 90 days and not currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance programs) may result in denial
Denial possible if member is not currently receiving treatment or resupply of the requested medication

Definitions and Indication

inv-10: Indication

Indication (FDA/Policy)Increase tear production in patients whose tear production is presumed suppressed due to ocular inflammation associated with keratoconjunctivitis sicca

Clinical noteIncreased tear production was not seen in patients concurrently using topical anti-inflammatory drugs or punctal plugs

DrugRestasis (cyclosporine ophthalmic emulsion)

Background

Restasis (cyclosporine ophthalmic emulsion) is a topical calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.