Tolvaptan (generic Samsca) Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Tolvaptan (generic Samsca) will be approved when ALL of the following are met:

1. The requested medication was initiated (or re-initiated) in the hospital
   AND
2. Prior to initiating the requested medication, the patient has or had a diagnosis of clinically significant hypervolemic or euvolemic hyponatremia defined by ONE of the following:
   1. Serum sodium is less than 125 mEq/L
      OR
   2. Serum sodium is 125 mEq/L or greater AND patient has symptomatic hyponatremia that has resisted correction with fluid restriction
      AND
3. The patient does NOT have any FDA labeled contraindications to the request medication
   AND
4. The patient does NOT have any underlying liver disease, including cirrhosis
   AND
5. Medications known to cause hyponatremia have been evaluated and discontinued when appropriate
   AND
6. The patient has NOT already received 30 days of therapy with the requested medication following the most recent hospitalization for initiation of therapy
   AND
7. The requested dose is within the FDA labeled dosing for the requested indication
   (Recommended starting dose is 15 mg once daily. Dosage may be increased at intervals greater than or equal to 24 hours to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. Do not administer for more than 30 days to minimize the risk of liver injury.)

Length of approval: 30 days

Medications Known to Cause Hyponatremia

Antidepressants (SSRIs, tricyclics, MAOIs, venlafaxine), anticonvulsants (carbamazepine, oxcarbazepine, sodium valproate, lamotrigine), antipsychotics (phenothiazines, butyrophenones), anticancer (vinca alkaloids, platinum compounds, ifosfamide, melphalan, cyclophosphamide, methotrexate, pentostatin), antidiabetic (chlorpropamide, tolbutamide), vasopressin analogues (desmopressin, oxytocin, terlipressin, vasopressin), miscellaneous (amiodarone, clofibrate, interferon, NSAIDs, levamisole, linezolid, monoclonal antibodies, nicotine, opiates, PPIs)