Nocdurna (desmopressin acetate sublingual tablets) — Medica

Initial criteria

• Patient is age ≥ 18 years; AND
• Diagnosis of nocturnal polyuria has been confirmed with a 24-hour urine collection before treatment initiation; AND
• Patient meets ONE of the following: (i) Patient is < 65 years of age and nocturnal urine volume exceeds 20% of total 24-hour urine volume; OR (ii) Patient is ≥ 65 years of age and nocturnal urine volume exceeds 33% of total 24-hour urine volume; AND
• Prior to desmopressin therapy, patient awakens at least two times per night to void; AND
• Patient has serum sodium concentrations within the normal range (135 to 145 mmol/L); AND
• Prescriber has verified that the patient does NOT have any of the following conditions or circumstances: (i) currently receiving loop diuretics; OR (ii) currently receiving systemic or inhaled glucocorticoids; OR (iii) renal impairment with an estimated glomerular filtration rate < 50 mL/min/1.73 m2; OR (iv) heart failure; OR (v) polydipsia; OR (vi) known or suspected syndrome of inappropriate antidiuretic hormone secretion; AND
• Patient has tried non-pharmacologic techniques or lifestyle interventions to manage nocturia (e.g., nighttime fluid restriction, avoidance of caffeine and alcohol, earlier timing of medications, leg elevation, or use of compression stockings); AND
• Medication is prescribed by or in consultation with a nephrologist, urologist, geriatrician, or endocrinologist.

Approval duration

1 year