Rayaldee

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

Questions?

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