ZEMPLAR, Paricalcitol Form

Paricalcitol (Zemplar®) is a synthetically manufactured active vitamin D2 analog.
FDA Approved Indication(s) Paricalcitol injection (Zemplar) is indicated for the prevention and treatment of secondary hyperparathyroidism (HPT) in patients 5 years of age and older with chronic kidney disease (CKD) 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 Zemplar injection is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Secondary Hyperparathyroidism in Chronic Kidney Disease (must meet all):

1. Diagnosis of secondary HPT due to CKD;
   2. Prescribed by or in consultation with a nephrologist or endocrinologist;
   3. Age ≥ 5 years;
   4. Member is on dialysis;
   5. Lab results over the previous 3-6 months show trending increase in iPTH level or current (within the last 30 days) labs show iPTH above the normal levels;
2. For brand Zemplar requests, member must use generic paricalcitol, unless contraindicated or clinically significant adverse effects are experienced;
3. Failure of generic doxercalciferol injection at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
4. Paricalcitol is not prescribed concurrently with other vitamin D derivatives/analogs (e.g., doxercalciferol);
5. Dose does not exceed 0.24 mcg/kg every other day.
   Approval duration: 6 months 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: Page 1 of 6

   CLINICAL POLICY
   Paricalcitol Injection 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

7. 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 Approval
   A. Secondary Hyperparathyroidism in Chronic Kidney Disease (must meet all):
8. 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);
9. Member is responding positively to therapy as evidenced by a decrease in iPTH;
   3. Paricalcitol is not prescribed concurrently with other vitamin D derivatives/analogs (e.g., doxercalciferol);
10. For brand Zemplar requests, member must use generic paricalcitol, unless contraindicated or clinically significant adverse effects are experienced;
11. If request is for a dose increase, new dose does not exceed 0.24 mcg/kg every other day. Approval duration: 12 months B. Other diagnoses/indications (1 or 2):
12. 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

13. 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.
    Page 2 of 6

    CLINICAL POLICY
    Paricalcitol 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 policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CKD: chronic kidney disease
    FDA: Food and Drug Administration HPT: hyperparathyroidism iPTH: intact 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 and may require prior authorization.
    Drug Name Dosing Regimen doxercalciferol (Hectorol®) injection
    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. 4 mcg/day IV 3 times weekly; may increase at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range
    Dose Limit/ Maximum Dose 18 mcg/week Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypercalcemia, vitamin D toxicity, hypersensitivity to paricalcitol or any of the inactive ingredients in Zemplar • Boxed warning(s): none reported V. Dosage and Administration
    Indication Secondary HPT in CKD
    Maximum Dose Adults: 0.24 mcg/kg
    Pediatric: see dosing regimen Dosing Regimen Adults: Initial: 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered as a bolus dose no more frequently than every other day at any time during dialysis. The dose may be increased by 2 to 4 mcg at 2- to 4- week intervals Pediatric age ≥ 5 years: Initial: 0.04 mcg/kg if baseline intact PTH is < 500 pg/mL, or 0.08 mcg/kg if baseline intact PTH is ≥ 500 pg/mL administered three times per week, no more frequently than every other day, at any time during dialysis. The dose may be increased by 0.04 mcg/kg at 2- to 4- week intervals. Page 3 of 6

    CLINICAL POLICY
    Paricalcitol VI. Product Availability
    • Single-dose vials for injection: 2 mcg/mL, 5 mcg/mL • Multiple-dose vial for injection: 10 mcg/2 mL VII.