Pharmacy Prior Authorization Criteria

Nocdurna (desmopressin)

Indications for Prior Authorization

Nocdurna (desmopressin acetate sublingual tablet)

• For diagnosis of Nocturia
  Indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. In the Nocdurna clinical trials nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production. Before starting Nocdurna: (1) Evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and address other treatable causes of nocturia. (2) Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously.

Criteria

Nocdurna

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)

• Diagnosis of nocturia due to nocturnal polyuria
AND
• Nighttime urine production exceeds one-third of the 24-hour urine production [A]
AND
• Patient wakes at least twice per night on a reoccurring basis to void
AND
• Initial serum sodium level prior to initiating therapy is within normal limits of the normal laboratory reference range
AND
• One of the following: [B]
• Underlying causes of nocturia have been ruled out (e.g., overactive bladder, benign prostatic hyperplasia (BPH), Parkinson’s disease, excessive bedtime fluid intake)
OR
• Underlying medical causes of nocturia are treated prior to initiating therapy (e.g., use of alpha-adrenergic blockers or 5-alpha reductase inhibitors for BPH, vaginal estrogens for vaginal atrophy)

Nocdurna

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Documentation of positive clinical response to therapy
AND
• Patient has routine monitoring for serum sodium levels

P & T Revisions

2024-05-19, 2023-05-25

References

1. Nocdurna Prescribing Information. Antares Pharma, Inc. Ewing, NJ. August 2021.

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Revision History

• 2024-05-19: 2024 Annual Review.
• 2023-05-25: New program for Nocdurna

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