Rayaldee – NC Standard

Restricted Products:

• Rayaldee® (calcifediol)

FDA Approved Use:

• Indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to stage 3 or 4 chronic kidney disease (CKD); AND
3. The patient has a serum total 25-hydroxyvitamin D level less than 30 ng/mL; AND
4. The patient has a serum calcium below 9.8 mg/dL prior to initiating therapy; AND
5. The patient is not on dialysis; AND
6. The patient has tried and failed or had an inadequate response to ONE prerequisite agent [Fosrenol® (lanthanum carbonate), Renvela® (sevelamer carbonate), Renagel® (sevelamer hydrochloride), calcium acetate or calcium carbonate]; OR
7. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL prerequisite agents [Fosrenol® (lanthanum carbonate), Renvela® (sevelamer carbonate), Renagel® (sevelamer hydrochloride), calcium acetate or calcium carbonate]; AND
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

March 2023: Criteria change: Criteria review and formatting changes. Clarified adult patient and listed as 18 years of age or older.

May 2020: Criteria update: Reformatted criteria.

Nov 2016: Original utilization management criteria issued.