Pilocarpine (Vuity) Form

Pilocarpine (Qlosi™, Vuity®) is a cholinergic muscarinic receptor agonist. FDA Approved Indication(s) Qlosi and Vuity are indicated for the treatment of presbyopia in adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Qlosi and Vuity are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Presbyopia (must meet all):

1. Diagnosis of presbyopia;
2. Prescribed by or in consultation with an optometrist or ophthalmologist;
3. Member meets one of the following at the time of therapy initiation (a or b): a. Vuity: Age between 40 and 55 years; b. Qlosi: Age between 45 and 64 years;
   4. Failure of corrective eyeglasses or contact lenses to resolve the presbyopia symptoms, unless contraindicated or clinically significant adverse effects are experienced;
   5. Member does not have glaucoma or ocular hypertension;

4. Requested agent is not prescribed concurrently with any other ophthalmic pilocarpine formulation;

   7. Dose does not exceed one of the following (a or b): a. Vuity: 1 drop per eye per day, followed by an additional dose in each eye administered 3 to 6 hours after first dose; b. Qlosi: 1 drop per eye per day, followed by an additional dose administered 2 to 3 hours after first dose. Approval duration: 6 months
      B. Other diagnoses/indications (must meet 1 or 2):
   8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 1 of 5

   CLINICAL POLICY Pilocarpine a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Presbyopia (must meet all):
   3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
5. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. Vuity: 1 drop per eye per day, followed by an additional dose in each eye administered 3 to 6 hours after first dose; b. Qlosi: 1 drop per eye per day, followed by an additional dose administered 2 to 3 hours after first dose. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 2 of 5

   CLINICAL POLICY Pilocarpine of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to the active ingredient or to any of the excipients • Boxed warning(s): none reported V. Dosage and Administration Drug Name Pilocarpine hydrochloride (Vuity) Pilocarpine hydrochloride (Qlosi) Dosing Regimen 1 drop per eye per day; a second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose 1 drop per eye per day; a second dose (one additional drop in each eye) may be administered 2-3 hours after the first dose for an effect up to 8 hours Maximum Dose 2 drops per eye/day 2 drops per eye/day VI. Product Availability Drug Name Pilocarpine (Vuity) Pilocarpine (Qlosi) Availability Ophthalmic solution bottle: 1.25%
   Ophthalmic solution single-patient-use vials: 0.4% VII.