Pharmacy Prior Authorization Criteria

Presbyopia Agents - PA, NF

Indications for Prior Authorization

Vuity (pilocarpine)

• For diagnosis of Presbyopia of the eye
  Indicated for the treatment of presbyopia in adults.

Qlosi (pilocarpine hydrochloride ophthalmic solution)

• For diagnosis of Presbyopia of the eye
  Indicated for the treatment of presbyopia in adults.

Criteria

Qlosi, Vuity

Prior Authorization (Initial Authorization)

Length of Approval: 1 Month(s)

• Diagnosis of presbyopia
AND
• Prescribed by or in consultation with ONE of the following:
• Ophthalmologist
• Optometrist
AND
• Provider confirms valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)

Qlosi, Vuity

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Patient demonstrates positive clinical response to therapy ( e.g., improvement in near vision in low light conditions without lost of distance vision)
AND
• Prescribed by or in consultation with ONE of the following:
• Ophthalmologist
• Optometrist

Qlosi, Vuity

Non Formulary

Length of Approval: 1 Month(s)

• Diagnosis of presbyopia
AND
• Prescribed by or in consultation with ONE of the following:
• Ophthalmologist
• Optometrist
AND
• Submission of medical records (e.g., chart notes) confirming valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)

P & T Revisions

2025-01-13, 2024-05-29, 2023-11-29, 2023-11-16, 2023-01-02, 2022-03-30, 2022-02-15, 2022-01-21

References

1. Vuity Prescribing Information. Abbvie Inc. North Chicago, IL. March 2023.
2. Qlosi Prescribing Information. Orasis Pharmaceuticals, Inc. Ponte Vedra, FL. October 2023.
3. ClinicalTrials.gov. Available at: Study Details | An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) | ClinicalTrials.gov. Accessed January 12, 2025.
4. ClinicalTrials.gov. Available at: Study Details | An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) | ClinicalTrials.gov. Accessed January 12, 2025.
5. Mckenzie, K.. A Look at a New Presbyopia Treatment - American Academy of Ophthalmology. Accessed January 12, 2025.
6. Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia. October 18, 2023. Accessed January 12, 2025
7. Another Attempt at Presbyopia. December 15, 2023. Available at: Another Attempt at Presbyopia | PatientPoint. Accessed January 12, 2025.

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Revision History

• 2025-01-13: update guideline
• 2024-05-29: update guideline
• 2023-11-29: 2024 Annual Review.
• 2023-11-16: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-01-02: 2023 Annual Review
• 2022-03-30: Guideline Update
• 2022-02-15: Update Guideline
• 2022-01-21: 2022 New Um PA Criteria

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