Glycopyrronium (Qbrexza) Form

Glycopyrronium tosylate (Qbrexza®) is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. FDA Approved Indication(s) Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. 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 Qbrexza is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Primary Axillary Hyperhidrosis (must meet all):

1. Diagnosis of primary axillary hyperhidrosis;
2. Prescribed by or in consultation with a dermatologist;
3. Age ≥ 9 years;

4. Failure of a 3-month trial of topical aluminum chloride, unless contraindicated or clinically significant adverse effects are experienced;

   5. Dose does not exceed a single cloth per day. Approval duration:
      Medicaid – 12 months
      Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
   6. 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 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 and CP.PMN.16 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Glycopyrronium

   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 and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Primary Axillary Hyperhidrosis (must meet all):
5. 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);
6. Member is responding positively to therapy;

7. If request is for a dose increase, new dose does not exceed a single cloth per day.
   Approval duration:
   Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less 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 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 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 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 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 Page 2 of 5

   CLINICAL POLICY Glycopyrronium Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Adults: 1 application per day to affected area(s) Xerac™ AC (aluminum chloride hexahydrate) Drysol™ (aluminum chloride hexahydrate) Apply solution sparingly to affected area, as directed. Use QHS for up to 1 week, or as directed; then decrease application frequency to every other night or 1 to 2 times per week, PRN. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza. Examples include: o Glaucoma o Paralytic ileus o Unstable cardiovascular status in acute hemorrhage o Severe ulcerative colitis o Toxic megacolon complicating ulcerative colitis o Myasthenia gravis o Sjogren’s syndrome • Boxed warning(s): none reported V. Dosage and Administration
   Indication Primary axillary hyperhidrosis Dosing Regimen Apply QD to both axillae using a single cloth Maximum Dose A single cloth per day (one cloth used for both axillae) VI. Product Availability
   Pre-moistened cloth: 2.4% (30 pouches in 1 box) VII.