Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

Natpara will be approved when the ALL of the following are met:

1. The patient has a diagnosis of hypocalcemia associated with hypoparathyroidism
   AND
2. The patient does NOT have a baseline vitamin D level below the testing laboratory’s lower limit of normal
   AND
3. The patient’s baseline serum calcium level (albumin-corrected) is above 7.5 mg/dL
   AND
4. The patient is NOT at increased baseline risk for osteosarcoma (e.g., Paget’s disease of bone, unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, history of external beam or implant radiation therapy involving the skeleton, pediatric and young adult patients with open epiphyses)
   AND
5. The patient will NOT be using the requested medication in combination with alendronate for the requested indication
   AND
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, nephrologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
7. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Natpara will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. The patient has a diagnosis of hypocalcemia associated with hypoparathyroidism
   AND
3. The patient has had clinical benefit with the requested medication
   AND
4. The patient is NOT at increased baseline risk for osteosarcoma (e.g., Paget’s disease of bone, unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, history of external beam or implant radiation therapy involving the skeleton, pediatric and young adult patients with open epiphyses)
   AND
5. The patient will NOT be using the requested medication in combination with alendronate for the requested indication
   AND
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, nephrologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
7. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months