Calcifediol (Rayaldee) Form

Calcifediol (Rayaldee™) is a prohormone of the active form of vitamin D3 (calcitriol). FDA Approved Indication(s) Rayaldee is indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitation(s) of use: Rayaldee is not indicated in patients with stage 5 CKD or end-stage renal disease 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 Rayaldee is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Secondary Hyperparathyroidism (must meet all):

1. Diagnosis of secondary hyperparathyroidism;
2. Age ≥ 18 years;
3. Member has stage 3 or 4 CKD defined by eGFR of 15-59 mL/min;
4. Current (within the last 30 days) serum total 25-hydroxyvitamin D level is less than 30 ng/mL;
   5. Failure of ergocalciferol or cholecalciferol, at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated;

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;

   7. Dose does not exceed 60 mcg (2 capsules) per day. Approval duration: Medicaid/HIM – 12 months
      Commercial – 12 months or duration of request, whichever is less Page 1 of 6

   CLINICAL POLICY
   Calcifediol 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.
      II. Continued Therapy A. Secondary Hyperparathyroidism (must meet all):

6. 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);

   2. Member is responding positively to therapy (suspend dosing if intact PTH is persistently abnormally low, serum calcium is consistently above the normal range or serum 25-hydroxyvitamin D is consistently above 100 ng/mL);
   3. If request is for a dose increase, new dose does not 60 mcg (2 capsules) 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):
   4. 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: Page 2 of 6

   CLINICAL POLICY
   Calcifediol 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 – 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 eGFR: estimated glomerular filtration rate
      FDA: Food and Drug Administration 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 for all relevant lines of business and may require prior authorization.
      Dosing Regimen Drug Name Dose Limit/ Maximum Dose 1,000 IU/day 50,000 IU/week cholecalciferol (Vitamin D3) ergocalciferol (Calcidol®, Drisdol®)
      1,000 international units (IU) PO daily
      50,000 IU PO once weekly for 8 weeks; repeat for another 8 weeks if 25-hydroxy vitamin D than 30 nanograms/mL levels are less 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 None reported Appendix D: General Information
      The stages of CKD are as follows: • Stage 1: eGFR at least 90 mL/min/1.73 m2
      • Stage 2: eGFR between 60-89 mL/min/1.73 m2 • Stage 3: eGFR between 30-59 mL/min/1.73 m2
      • Stage 4: eGFR between 15-29 mL/min/1.73 m2
      • Stage 5: eGFR less than 15 mL/min/1.73 m2 (or dialysis) Page 3 of 6

   CLINICAL POLICY
   Calcifediol V. Dosage and Administration
   Indication Secondary hyperparathyroidism Dosing Regimen 30 mcg PO once daily at bedtime. Increase the dose to 60 mcg once daily after 3 months if intact PTH is above the treatment goal. Additionally, ensure serum calcium is below 9.8 mg/dL, phosphorus is below 5.5 mg/dL and 25-hydroxyvitamin D is below 100 ng/mL before increasing the dose. Maximum Dose 60 mcg per day VI. Product Availability
   Extended-release capsules: 30 mcg VII.