CurrentCignaPolicy N/A

Desmopressin Products -Nocdurna Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Nocdurna (desmopressin acetate sublingual tablets 27.7 mcg and 55.3 mcg) for treatment of nocturia due to nocturnal polyuria in adults.

Policy Summary

PayerCigna

PolicyDesmopressin Products -Nocdurna Prior Authorization Policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is recommended/required for Nocdurna; approvals are provided for 1 year and require prescribing by or in consultation with a nephrologist, urologist, geriatrician, or endocrinologist.

SourceLink

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

1Covered Indication (FDA-approved)

7Required criteria items

1Approval duration (years)

Coverage Summary

Scope: Defines prior authorization requirements and medical necessity criteria for coverage of Nocdurna (desmopressin sublingual) for treatment of nocturia due to nocturnal polyuria in adults. Coverage stance: covered_with_criteria. Drug/subject: Nocdurna (desmopressin sublingual). Indication: FDA‑approved for nocturia due to nocturnal polyuria in adults who awaken at least two times per night. Approval duration: 1 year when criteria are met. Boxed warning: Nocdurna carries a Boxed Warning for hyponatremia and has multiple contraindications (including use with loop diuretics or systemic/inhaled glucocorticoids, renal impairment with eGFR < 50 mL/min/1.73 m2, heart failure, polydipsia, SIADH, and prior hyponatremia).

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Initial Therapy Criteria (FDA‑Approved Indication)

FDA-Approved Indication: Nocturia due to Nocturnal Polyuria (Approve for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, E, F, and G):

ALL of the following

Patient is ≥ 18 years of ageAge ≥ 18 years
ALL of the following
- Patient meets ONE of the following
  - Patient is < 65 years of age: The nocturnal urine volume exceeds 20% of the total 24-hour urine volumenocturnal urine volume > 20% of 24-hour urine volume (if age < 65)
  - Patient is ≥ 65 years of age: The nocturnal urine volume exceeds 33% of the total 24-hour urine volumenocturnal urine volume > 33% of 24-hour urine volume (if age ≥ 65)
Prior to desmopressin therapy, patient awakens at least two times per night to void≥ 2 nightly voids
Patient has serum sodium concentrations within the normal range (135 to 145 mmol/L)serum sodium 135-145 mmol/L
Document baseline serum sodium prior to initiation and monitor throughout treatment
ALL of the following
- NONE of the following (i-vi) are present
  - Currently receiving loop diuretics (examples: furosemide, torsemide, bumetanide)
  - Currently receiving systemic or inhaled glucocorticoids
  - Renal impairment with an estimated glomerular filtration rate < 50 mL/min/1.73 m2eGFR ≥ 50 mL/min/1.73 m2 required
  - Heart failure
  - Polydipsia
Patient has tried non-pharmacologic techniques or lifestyle interventions to manage the nocturia
Examples include nighttime fluid restriction, avoidance of caffeine and alcohol, earlier timing of medications, leg elevation, or use of compression stockings
The medication is prescribed by or in consultation with a nephrologist, urologist, geriatrician, or endocrinologist

Contraindications / Exclusions

Contraindicated conditions

Presence of any of the following

Hyponatremia or history of hyponatremiaserum sodium below 135 mmol/L
Boxed warning for hyponatremia
Polydipsia
Heart failure
Renal impairment with an estimated glomerular filtration rate < 50 mL/min/1.73 m2eGFR < 50 mL/min/1.73 m2
Currently receiving loop diuretics (e.g., furosemide, torsemide, bumetanide)
Do not administer concomitantly
Currently receiving systemic or inhaled glucocorticoids
Do not administer concomitantly
Known or suspected syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Nocdurna. Approvals are provided for 1 year and the medication must be prescribed by or in consultation with a nephrologist, urologist, geriatrician, or endocrinologist.

Documentation Required

Confirm diagnosis with 24-hour urine collection

Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection before initiating therapy. Report the nocturnal urine volume as a percentage of the 24-hour urine volume and compare to age-based thresholds.

Report nocturnal urine volume as % of 24-hour urine volume
Age-based thresholds: >20% if age <65; >33% if age ≥65

Documentation Required

Serum sodium monitoring

Document baseline serum sodium within the normal range (135–145 mmol/L) prior to initiation of Nocdurna and monitor serum sodium concentrations throughout treatment.

Documentation Required

Prior non-pharmacologic therapy

Document a trial of non-pharmacologic or lifestyle interventions for nocturia prior to approval. Examples include nocturnal fluid restriction (avoidance of caffeine and alcohol), restriction of total fluid intake, emptying the bladder before bed, earlier timing of diuretic or other medications, leg elevation above heart level before bedtime, and use of compression stockings.

Nighttime fluid restriction (avoid caffeine/alcohol)
Restriction of total fluid intake and emptying bladder before bed
Earlier timing of medications (e.g., diuretics)
Leg elevation before bed; use of compression stockings

Denial Risk

Contraindicated conditions

Authorization is inappropriate for patients with conditions or circumstances that increase risk with Nocdurna. Do not approve if any of the following are present: hyponatremia (or history of hyponatremia), polydipsia, heart failure, estimated glomerular filtration rate <50 mL/min/1.73 m2, current use of loop diuretics, current use of systemic or inhaled glucocorticoids, or known or suspected syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Clinical Evidence & References

Key references: International Continence Society consensus on diagnosis and treatment of nocturia (2019) supports evaluation and conservative measures and advises fluid restriction for desmopressin‑treated patients. Prescribing information: Nocdurna prescribing information, Antares; November 2020 (includes Boxed Warning for hyponatremia and safety/monitoring guidance). Primary guideline support is the International Continence Society consensus (2019).

Background & Definitions

Background: Nocdurna (desmopressin sublingual) is indicated for nocturia due to nocturnal polyuria in adults who awaken at least two times per night. Nocturnal polyuria is defined as nocturnal urine volume > 33% of 24‑hour urine volume for patients ≥ 65 years or > 20% of 24‑hour urine volume for patients < 65 years. Nocdurna has a Boxed Warning for hyponatremia and is contraindicated or not recommended in patients with conditions that increase hyponatremia risk or fluid/electrolyte imbalance (examples include hyponatremia, excessive fluid intake/polydipsia, current loop diuretic or systemic/inhaled glucocorticoid use, eGFR < 50 mL/min/1.73 m2, heart failure, known or suspected SIADH).

Key clinical thresholds

Age≥ 18 years

Nocturnal urine volume (age <65)> 20% of 24-hour urine volume

Nocturnal urine volume (age ≥65)> 33% of 24-hour urine volume

Nightly voids≥ 2 times per night

Serum sodium135-145 mmol/L

Renal function (eGFR)≥ 50 mL/min/1.73 m2

Policy Summary

PayerCigna

PolicyDesmopressin Products -Nocdurna Prior Authorization Policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Desmopressin Products -Nocdurna Prior Authorization Policy

Coverage Summary

Initial Therapy Criteria (FDA‑Approved Indication)

Continuation Therapy Criteria

Contraindications / Exclusions

Provider Actions / Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History