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Drug - Rayaldee (calcidediol) [Opko Pharmaceuticals LLC]

June 2017

Therapeutic Area - Hyperparathyroidism

Approval criteria

  • Patient is 18 years of age or older AND
  • Patient must be prescribed Rayaldee by or in consultation with a nephrologist or endocrinologist AND
  • Patient must have a diagnosis secondary hyperparathyroidism in stage 3 or 4 chronic kidney disease AND
  • Serum total 25-hydroxyvitamin D level is < 30 ng/mL within the past 3 months AND
  • Serum calcium level is < 9.8 mg/dL within the past 3 months AND
  • Patient must have tried and failed at least two of the following alternative vitamin D analogs:
    • Calcitriol
    • Cholecalciferol
    • Ergocalciferol
  • Initial approval is for 3 months

Renewal criteria

  • Patient must have ALL of the following:
    • Serum calcium (corrected for low albumin) is below 9.8 mg/dL
    • Serum phosphorus is below 5.5 mg/dL
    • Serum 25-hydroxyvitamin D is below 100 ng/mL
  • Renewal approval is for 12 months

Denial criteria

  • Patient has a diagnosis of stage 5 chronic kidney disease OR
  • Patient has end stage renal disease on dialysis

Quantity limits

  • Initial dose is 30 mcg (one tablet) once daily
  • Increase to 60 mcg (two tablets) once daily after 3 months if intact parathyroid hormone is above the treatment goal


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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