VELPHORO, Sucroferric Oxyhydroxide Form

The following are non-calcium containing phosphate binders requiring prior authorization: ferric citrate (Auryxia®), lanthanum carbonate (Fosrenol®), sevelamer carbonate (Renvela®), sevelamer hydrochloride (Renagel®), and sucroferric oxyhydroxide (Velphoro®). ____ *For Health Insurance Marketplace (HIM), if request is through pharmacy benefit, Auryxia and Renagel are non- formulary and should not be approved using these criteria; refer to the formulary exception policy, HIM.PA.103.
FDA Approved Indication(s) Non-calcium containing phosphate binders (Auryxia, Fosrenol, Renvela, Renagel, and Velphoro) are indicated for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis or with end stage renal disease (ESRD).
Auryxia is also indicated for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. 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 Auryxia, Fosrenol, Renvela, Renagel, and Velphoro are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hyperphosphatemia (must meet all):

1. Diagnosis of hyperphosphatemia associated with CKD or ESRD;
   2. Prescribed by or in consultation with a nephrologist, or member is on dialysis;
   3. Member meets one of the following (a or b): a. Auryxia, Fosrenol, Renagel, Velphoro: Age ≥ 18 years; b. Renvela: Age ≥ 6 years;

2. Member meets one of the following (a, b, c, or d):
   a. Failure (e.g., serum phosphorus > 5.5 mg/dL) of a 4-week trial of calcium acetate at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; b. Hypercalcemia as evidenced by recent (within the previous 30 days) corrected total serum calcium level > 10.2 mg/dL; c. Plasma parathyroid hormone (PTH) levels < 150 pg/mL on 2 consecutive measurements in the past 180 days; Page 1 of 9

   CLINICAL POLICY Non-Calcium Phosphate Binders d. History of severe vascular and/or soft-tissue calcifications;

3. For Auryxia, Renagel, or Velphoro: Failure (e.g., serum phosphorus > 5.5 mg/dL) of a 4-week trial of Fosrenol (generic is preferred) or Renvela (generic is preferred) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated; *Prior authorization may be required for Fosrenol and Renvela
4. For Fosrenol, member must use generic lanthanum carbonate, unless contraindicated or clinically significant adverse effects are experienced;
5. For Renvela, member must use generic sevelamer carbonate, unless contraindicated or clinically significant adverse effects are experienced;
6. For Renagel, member must use generic sevelamer hydrochloride, unless contraindicated or clinically significant adverse effects are experienced;
7. Dose does not exceed any of the following (a, b, c, d, or e): a. Auryxia: 2,520 mg ferric iron (12 tablets) per day; b. Fosrenol: 4,500 mg per day; c. Renagel: 13 g per day;
   d. Renvela: 14 g per day; e. Velphoro: 3,000 mg (6 tablets) per day. Approval duration:
   Medicaid – 12 months HIM – 12 months for Fosrenol, Renvela, and Velphoro (refer to HIM.PA.103 for Auryxia and Renagel) Commercial – 12 months or duration of request, whichever is less B. Iron Deficiency Anemia (must meet all):
8. Request is for Auryxia;
   2. Diagnosis of iron deficiency anemia with CKD;
   3. Member is not on dialysis;
   4. Failure of a 4-week, adherent trial of alternative oral iron therapy (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate), unless contraindicated or clinically significant adverse effects are experienced;
9. Dose does not exceed 2,520 mg ferric iron (12 tablets) per day. Approval duration:
   Medicaid – 12 months HIM – refer to HIM.PA.103 for Auryxia
   Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):

10. 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 2 of 9

    CLINICAL POLICY Non-Calcium Phosphate Binders 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

11. 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. All Indications in Section I (must meet all):
12. 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);
13. Member is responding positively to therapy (e.g., reduction in serum phosphorus from pretreatment level; maintenance of serum phosphorus level ≤ 5.5 mg/dL; increased hemoglobin);
14. For Fosrenol, member must use generic lanthanum carbonate, unless contraindicated or clinically significant adverse effects are experienced;
15. For Renvela, member must use generic sevelamer carbonate, unless contraindicated or clinically significant adverse effects are experienced;
16. For Renagel, member must use generic sevelamer hydrochloride, unless contraindicated or clinically significant adverse effects are experienced;
17. If request is for a dose increase, new does not exceed any of the following (a, b, c, d, or e): a. Auryxia: 2,520 mg ferric iron (12 tablets) per day; b. Fosrenol: 4,500 mg per day; c. Renagel: 13 g per day;
    d. Renvela: 14 g per day; e. Velphoro: 3,000 mg (6 tablets) per day. Approval duration:
    Medicaid – 12 months HIM – 12 months for Fosrenol, Renvela, and Velphoro (refer to HIM.PA.103 for Auryxia and Renagel) Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

18. 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: Page 3 of 9

    CLINICAL POLICY Non-Calcium Phosphate Binders 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

19. 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 – 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 CKD: chronic kidney disease ESRD: end-stage renal disease FDA: Food and Drug Administration PTH: parathyroid hormone 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 1,500 mg/day total elemental calcium 4,500 mg/day 14 g/day calcium acetate Hyperphosphatemia 2 capsules PO TID with meals; titrate to phosphorus < 6 mg/dL and calcium < 9.5 mg/dL lanthanum (Fosrenol®) sevelamer carbonate (Renvela®) Hyperphosphatemia 1,500 mg PO daily in divided doses; titrate by 750 mg/day every 2 to 3 weeks based on serum phosphorus level Hyperphosphatemia Starting dose for adult dialysis patients based on serum phosphorus level If serum phosphorus is:

    5.5 to < 7.5 mg/dL: 0.8 g PO TID w/ meals ≥ 7.5 mg/dL: 1.6 g PO TID w/ meals Starting dose for pediatric patients (6 years and older) based on body surface area (BSA) Page 4 of 9

    CLINICAL POLICY Non-Calcium Phosphate Binders Drug Name Dosing Regimen Dose Limit/ Maximum Dose

    0.75 to < 1.2: 0.8 g PO TID w/ meals 1.2: 1.6 g PO TID w/ meals Starting dose for patients switching from calcium acetate to Renvela based on calcium acetate 667 mg/capsule dosing schedule • Calcium acetate 1 cap PO TID: Renvela 0.8 g PO TID w/ meals • Calcium acetate 2 caps PO TID: Renvela 1.6 g PO TID w/ meals • Calcium acetate 3 caps PO TID: Renvela 2.4 g PO TID w/ meals Iron Deficiency Anemia 100 to 200 mg elemental iron PO daily in 2 to 3 divided doses (or daily with extended release tablets) ferrous sulfate, ferrous fumarate, ferrous gluconate 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. Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Auryxia: iron overload syndromes (e.g., hemochromatosis) o Fosrenol: bowel obstruction, ileus, and fecal impaction o Renagel: bowel obstruction; known hypersensitivity to sevelamer hydrochloride or to any of the excipients o Renvela: bowel obstruction; known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients o Velphoro: none reported • Boxed warning(s): none reported V. Dosage and Administration
    Indication Drug Name Dosing Regimen ferric citrate (Auryxia) Iron deficiency anemia 1 tablet PO TID with meals. Adjust dose as needed to achieve and maintain hemoglobin goal. Maximum Dose 12 tablets/day Hyper- phosphatemia 2 tablets PO TID with meals; titrate by 1 to 2 tabs/day at 1-week or longer intervals based on serum phosphorus level 12 tablets/day Page 5 of 9

    Maximum Dose 4,500 mg/day 14 g/day 13 g/day CLINICAL POLICY Non-Calcium Phosphate Binders Drug Name Indication Dosing Regimen lanthanum (Fosrenol) Hyper- phosphatemia sevelamer carbonate (Renvela) Hyper- phosphatemia sevelamer hydrochloride (Renagel) Hyper- phosphatemia 1,500 mg PO daily in divided doses; titrate by 750 mg/day every 2 to 3 weeks based on serum phosphorus level Starting dose for adult dialysis patients based on serum phosphorus level If serum phosphorus is:

    5.5 to < 7.5 mg/dL: 0.8 g PO TID w/ meals ≥ 7.5 mg/dL: 1.6 g PO TID w/ meals Starting dose for pediatric patients (6 years and older) based on body surface area (BSA) 0.75 to < 1.2: 0.8 g PO TID w/ meals 1.2: 1.6 g PO TID w/ meals Starting dose for patients switching from calcium acetate to Renvela based on calcium acetate 667 mg/tablet dosing schedule • Calcium acetate 1 tablet PO TID: Renvela 0.8 g PO TID w/ meals • Calcium acetate 2 tablets PO TID: Renvela 1.6 g PO TID w/ meals • Calcium acetate 3 tablets PO TID: Renvela 2.4 g PO TID w/ meals Starting dose based on serum phosphorus level • > 5.5 to < 7.5 mg/dL: Renagel 800 mg

    • 1 tab PO TID; 400 mg - 2 tabs PO TID w/meals • ≥ 7.5 to < 9 mg/dL: Renagel 800 mg - 2 tabs PO TID; 400 mg - 3 tabs PO TID w/meals • ≥ 9 mg/dL: Renagel 800 mg - 2 tabs PO TID; 400 mg - 4 tabs PO TID w/meals Starting dose for patients switching from calcium acetate to Renagel based on calcium acetate 667 mg/tablet dosing schedule Page 6 of 9

    CLINICAL POLICY Non-Calcium Phosphate Binders Drug Name Indication Dosing Regimen Maximum Dose • Calcium acetate 1 tablet PO TID: Renagel 800 mg - 1 tab PO TID; 400 mg - 2 tabs PO TID • Calcium acetate 2 tablets PO TID: Renagel 800 mg - 2 tabs PO TID; 400 mg - 3 tabs PO TID • Calcium acetate 3 tablets PO TID: Renagel 800 mg - 3 tabs PO TID; 400 mg - 5 tabs PO TID 500 mg PO TID with meals 3,000 mg/day Availability Tablet: 210 mg ferric iron (equivalent to 1 g ferric citrate) Chewable tablets: 500 mg, 750 mg, 1,000 mg Oral powder: 750 mg, 1,000 mg Tablet: 800 mg Oral powder, packet: 0.8 g, 2.4 g Tablets: 400 mg, 800 mg Chewable tablet: 500 mg
    sucroferric oxyhydroxide (Velphoro) Hyper- phosphatemia VI. Product Availability
    Drug Name ferric citrate (Auryxia) lanthanum (Fosrenol) sevelamer carbonate (Renvela) sevelamer hydrochloride (Renagel) sucroferric oxyhydroxide (Velphoro) VII.