VUITY (pilocarpine)
Self-Administration - ophthalmic solution
Diagnosis considered for coverage:
- Presbyopia of the eye - Indicated for the treatment of presbyopia (gradual loss of ability to focus on nearby objects) in adults.
Coverage Criteria:
For diagnosis of presbyopia:
- Dose does not exceed one drop to affected eye(s) twice daily; AND
- Patient is 18 years of age or older; AND
- Prescribed by or in consultation with an ophthalmologist or optometrist; AND
- Medical record confirms the patient is unable to use or continue to use corrective lenses (e.g., eyeglasses or contact lenses) for presbyopia.
Reauthorization Criteria:
For diagnosis of presbyopia:
- Dose does not exceed one drop to affected eye(s) twice daily; AND
- Documentation of positive clinical response to therapy (e.g., improvement in near vision in low light conditions without loss of distance vision.
Dosing:
- The recommended dosage of VUITY is one drop in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose.
- If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
Coverage Duration:
- Initial: 6 months
- Reauthorization: 1 year
Authorization is not covered for the following:
- The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Contact lens wearers should be advised to remove their lenses prior to the instillation of VUITY and to wait 10 minutes after dosing before reinserting their contact lenses.
- The most common adverse reactions reported in more than 5% of patients were headache and conjunctival hyperemia (eye redness). Ocular adverse reactions reported in 1-5% of patients were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation (tearing).
Policy Updates:
- 05/17/2022 – New policy approved by P&T.
- 12/01/2023 - Update QL to allow twice daily dosing (P&T 11/14/2023).
References:
- American Academy of Ophthalmology (AAO). EyeWiki: Presbyopia. December 7, 2021a. https://eyewiki.org/Presbyopia. Accessed December 17, 2021.
- American Academy of Ophthalmology (AAO). EyeWiki: Presbyopia treatment. December 7, 2021b. https://eyewiki.org/Presbyopia_Treatment. Accessed December 17, 2021.
- American Optometric Association (AOA). Optometric clinical practice guideline. Care of the patient with visual impairment (low vision rehabilitation). 2007. Clinical Practice Guidelines, AOA. Accessed December 17, 2021.
- Baitch, L. American Academy of Optometry (AAOpt): Surgical and pharmacological treatment of presbyopia [abstract 63573-PO]. 2019. Surgical and Pharmacological Treatment of Presbyopia (aaopt.org). Accessed December 17, 2021..
- ClinicalTrials.gov Web site. https://clinicaltrials.gov. Identifiers: NCT03804268, NCT03857542. Accessed December 1, 2021.
- Kaiser PK. Prospective evaluation of visual acuity assessment: a comparison of Snellen versus ETDRS charts in clinical practice (an AOS thesis. Trans Am Ophthalmol Soc. 2009;107:311-324.
- Katz JA, Karpecki PM, Dorca A, et al. Presbyopia - a review of current treatment options and emerging therapies. Clin Ophthalmol. 2021;15:2167-2178. doi: 10.2147/OPTH.S259011.
- Vuity [package insert], North Chicago, IL: AbbVie Inc.; October 2021.
- Waring GO, McCabe C, Wirta D, Safyan E, Guo Q, Robinson MR. GEMINI 1 & 2 pooled phase 3 safety and efficacy: AGN-190584 primary and key secondary endpoints [abstract]. Presented at: AAO; 2021 Nov 12-15; New Orleans, LA.
- Wolffsohn JS, Davies LN. Presbyopia: Effectiveness of correction strategies. Prog Retin Eye Res. 2019;68:124-143. doi: 10.1016/j.preteyeres.2018.09.004.
Last review date: December 1, 2023