Patiromer (Veltassa) Form

Patiromer (Veltassa®) is a non-absorbed potassium-binding polymer. FDA Approved Indication(s) Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients 12 years of age and older. Limitation(s) of use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. 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 Veltassa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hyperkalemia (must meet all):

1. Diagnosis of hyperkalemia;
2. Age ≥ 12 years;

3. If age ≥ 18 years, failure of Lokelma®, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Lokelma

   4. Dose does not exceed 25.2 g per day. Approval duration:
      Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
   5. 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 Page 1 of 6

   CLINICAL POLICY Patiromer 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. Hyperkalemia (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);
4. Member is responding positively to therapy;

5. If request is for a dose increase, new dose does not exceed 25.2 g per day. Approval duration:
   Medicaid/HIM – 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, 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.
      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 – Page 2 of 6

   CLINICAL POLICY Patiromer CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Dosing Regimen Drug Name Lokelma (sodium zirconium cyclosilicate) 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. Initial: 10 g PO TID for up to 48 hrs Maintenance: 10 g PO QD (adjust dose by 5 g as needed at weekly intervals) Dose Limit/ Maximum Dose 15 g/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to Veltassa or any of its components • Boxed warning(s): none reported
   Appendix D: General Information
   • Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer Veltassa at least 3 hours before or 3 hours after other oral medications except those shown to not have a clinically important interaction.
   V. Dosage and Administration
   Indication Hyperkalemia Adult dosing: Dosing Regimen Maximum Dose 25.2 g/day Initial dose is 8.4 g PO daily Adjust dose by 8.4 g as needed at weekly intervals Pediatric dosing 12 years of age and older:
   Initial dose is 4 g PO daily
   Adjust dose by 4 g as needed at weekly intervals
   VI. Product Availability
   Packets, powder for oral suspension: 1 g, 8.4 g, 16.8 g, and 25.2 g VII.