Rayaldee ® (calcifediol)



[Date][Payer contact][Title/Pharmacy Director][Payer Company][Payer Address][City, State, Zip]RE: Letter of Medical Necessity for Rayaldee? (calcifediol) extended-release 30 mcg capsulesInsured: [First and last name]Patient: [If different from insured]ID/Policy Number: [insured ID/policy #]Group Number: [insured group #]Patient Date of Birth: [patient date of birth]Dear [Name of Payer contact / Pharmacy Director]:I am writing on behalf of my patient, [patient name], to document the medical necessity for treatment with Rayaldee?. [Patient Name] is an adult who has [Stage 3 or 4] chronic kidney disease and has been further diagnosed with secondary hyperparathyroidism and whose serum total 25-hydroxyvitamin D is <30 ng/mL. This diagnosis, which is consistent with the indication for Rayaldee?, is medically appropriate and necessary, and should be a covered treatment. Below, this letter outlines [insert patient name]’s medical history, prognosis, and treatment rationale.Summary of Patient’s History [You may want to include]:[Note: Exercise your medical judgment and discretion when providing a diagnosis and characterization of the patient’s medical condition.]Patient’s diagnosis, condition, and medical history, including relevant test results (eg, 25(OH)D, eGFR, iPTH, Ca, and P) and ICD-10 codes (eg, stage 3 or 4 chronic kidney disease N18.3 or N18.4, secondary hyperparathyroidism of renal origin N25.81, vitamin D deficiency E55.9)Previous therapies that patient has undergone for SHPT, 25D deficiency, or 25D insufficiency (serum total 25-hydroxyvitamin D <30 ng/mL), including dates and duration of therapyPatient response rate to these therapies, including lab values that indicate disease progression or treatment failureBrief description of the patient’s recent symptoms and conditionSummary of your professional opinion of the patient’s likely prognosis or disease progression without treatmentRationale for TreatmentGiven the patient’s history, condition, and the published data supporting the use of Rayaldee?, I believe the treatment of [insert patient name] with Rayaldee? is warranted, appropriate, and medically necessary.The highlights below from peer-reviewed literature [or attach copies of clinical peer-reviewed published literature and package insert, if desired] document the safety and efficacy of Rayaldee? in adult patients with secondary hyperparathyroidism and stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL:Rayaldee is able to raise 25-D and lower PTH, while its effects on calcium and phosphorus are similar to placebo*1 (*Calcium: Rayaldee 0.2 (0.02) mg/dL versus placebo 0.1 (0.03) mg/dL (P<0.001); Phosphorus: Rayaldee 0.2 (0.03) mg/dL versus placebo 0.1 (0.04) mg/dL 4). Extended-release calcifediol (ERC) therapy produced exposure-dependent reductions in plasma iPTH and bone turnover markers only when mean serum total 25-hydroxyvitamin D reached at least 50.8 ng/ml, indicating that current targets for vitamin D repletion therapy in CKD are too low. 2 In adult patients with Chronic Kidney Disease (CKD) stages 3 – 5 not on dialysis, Kidney Disease: Improving Global Outcomes (KDIGO) suggests that calcitriol and vitamin D analogs not be routinely used. It is reasonable to reserve the use of calcitriol and vitamin D analogs for patients with CKD stages 4 – 5 with severe and progressive hyperparathyroidism. 3Please call my office at [insert telephone number] if I can provide you with any additional information. I look forward to receiving your timely response and approval of this claim.Sincerely,[Insert Doctor name and participating provider number]Enclosures [Attach enclosures as deemed appropriate, such as Rayaldee? Prescribing Information, excerpts from the patient’s medical record, relevant treatment guidelines, or clinical literature] Sprague S, et al. Use of Extended-Release Calcifediol to Treat Secondary Hyperparathyroidism in Stages 3 and 4 Chronic Kidney Disease.? Am J Nephrol 2016;44:316-325, p. 320 Fig. 1 & 2, p. 321, and p. 322 Fig. 4. Strugnell, et al. Rationale for Raising Current Clinical Practice Guideline Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease. Am J Nephrol 2019;49:284-293, p. 1.Kidney Disease: Improving Global Outcomes (KDIGO) CKD–MBD Update Work Group. Kidney International Supplements (2017) 7:16, p. 33. (17)30001-1/pdfRayaldee [Package Insert] ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download