tolvaptan — Medica

Initial criteria

• Patient is age ≥ 18 years
• Patient meets ONE of the following: (a) serum sodium < 125 mEq/L at baseline; OR (b) serum sodium < 135 mEq/L at baseline AND symptomatic hyponatremia (e.g., nausea, vomiting, headache, lethargy, confusion); OR (c) patient has already been started on tolvaptan and has received < 30 days of therapy

Reauthorization criteria

• Patient has been established on therapy for at least 30 days
• Patient meets at least ONE of the following: (a) serum sodium has increased from baseline; OR (b) improvement in at least one symptom such as nausea, vomiting, headache, lethargy, or confusion

Approval duration

initial: 30 days; continuation: 3 months