CurrentUnitedHealthcarePolicy 2025 P 2145-10

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Nocdurna (desmopressin acetate)

UnitedHealthcare prior authorization program defining clinical criteria for initial authorization and reauthorization of Nocdurna (desmopressin acetate) sublingual tablets for adults with nocturia due to nocturnal polyuria; includes safety monitoring requirements and program operational notes.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs - Nocdurna (desmopressin acetate)

Policy CodePolicy 2025 P 2145-10

Change TypeAnnual review (no changes)

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization demonstrating all initial authorization criteria including diagnosis, >=2 nightly voids, nocturnal polyuria, serum sodium normal now and for prior 6 months, evaluation of other causes and prescriber attestation.

POLICY UPDATE CHANGES

Annual review 2/2025 - No changes.

2/2024 Increased initial authorization to 12 months.

2/2023 Updated initial authorization to 6 months (prior history).

12 moAuthorization duration

>=2Required nightly voids

6 moSerum sodium look-back

Coverage Summary

Coverage stance: covered_with_criteria for Nocdurna (desmopressin acetate) sublingual tablets. Scope: UnitedHealthcare prior authorization program defining clinical criteria for initial authorization and reauthorization of Nocdurna for adults with nocturia due to nocturnal polyuria; includes safety monitoring requirements and program operational notes. Policy number: 2025 P 2145-10. Effective date: 2025-05-01. Status: CURRENT. The drug carries a boxed warning for hyponatremia and has high-level contraindications including hyponatremia or history of hyponatremia, SIADH, significant renal impairment, uncontrolled hypertension, and certain heart failure classes; detailed approval criteria (e.g., serum sodium monitoring, nocturnal polyuria definition, wake frequency) are specified in the criteria groups.

Initial Therapy Criteria

Initial Authorization

Nocdurna will be approved based on all of the following:

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Prior Authorization

Obtain prior authorization

Submit a prior authorization request that demonstrates all initial authorization criteria are met. Include: diagnosis of nocturia due to nocturnal polyuria; documentation that the patient awakens >=2 times per night to void; documentation that serum sodium is currently within the laboratory reference range and has been within normal limits for the prior 6 months; documentation that other medical causes have been evaluated and that treatments for identifiable causes were not effective, not tolerated, or are contraindicated; and a prescriber attestation that the risks (including hyponatremia) have been assessed and that benefits outweigh risks.

Diagnosis: nocturia due to nocturnal polyuria (nighttime urine > one-third of 24‑hour production)
Nightly voiding frequency: >= 2 times per night
Serum sodium: current normal and within normal limits over prior 6 months
Evaluation of other causes and documentation of failure/intolerance/contraindication
Prescriber attestation that risks outweigh benefits

Reauthorization / Continuation Criteria

Reauthorization

Nocdurna will be approved for reauthorization based on all of the following:

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Billing Rule

Authorization duration

Authorizations for Nocdurna — both initial approvals and reauthorizations — will be issued for a 12‑month period.

Contraindications / Denial Risk

Contraindications and high-risk populations include: hyponatremia and history of hyponatremia, SIADH, estimated GFR < 50 mL/min/1.73 m2, uncontrolled hypertension, and New York Heart Association Class II–IV congestive heart failure. Older adults (age ≥65) are noted to be at increased risk for hyponatremia and desmopressin is listed in the AGS Beers Criteria as potentially inappropriate in this population. The FDA package insert includes a boxed warning for hyponatremia; these contraindications may lead to denial or require careful consideration prior to initiation.

Denial Risk

Contraindications/age risk

Contraindications and age‑related risks may result in denial of therapy. Do not initiate Nocdurna in patients with hyponatremia or a history of hyponatremia, SIADH, eGFR <50 mL/min/1.73 m2, uncontrolled hypertension, or NYHA Class II–IV congestive heart failure. Exercise caution in patients aged >=65 due to increased risk of hyponatremia; desmopressin is included in the AGS Beers Criteria.

Contraindications may lead to denial
Special caution and avoidance advised for age >=65

Provider Actions / Documentation Requirements

Documentation Required

Baseline and ongoing serum sodium monitoring

For initiation, document a baseline serum sodium level that is within the laboratory reference range and include records showing serum sodium has been within normal limits over the previous six months. For reauthorization, document routine/ongoing monitoring of serum sodium levels during therapy.

Baseline serum sodium within normal limits
Look‑back demonstrating sodium within normal limits over prior 6 months for initiation
Ongoing serum sodium monitoring required for reauthorization

Documentation Required

Document alternative treatment evaluation

Document that the patient was evaluated for other medical causes of nocturia and that treatments for identifiable causes were either ineffective, not tolerated, or contraindicated. Examples to document include evaluation/treatment for overactive bladder (OAB), benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS), elevated post‑void residual (PVR) urine, and heart failure.

Document evaluation for other causes
Document failure, intolerance, or contraindication to treatments (examples: OAB, BPH/LUTS, elevated PVR, heart failure)

Prior Authorization

Automated approval possible

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claims or medication history, diagnosis codes, and/or automated claim logic. Automated approval and re‑approval processes vary by program and therapeutic class.

Clinical Evidence & Safety Notes

Evidence includes the FDA prescribing information: Nocdurna package insert, November 2020 (includes a boxed warning for hyponatremia). Guideline reference: American Geriatrics Society 2023 Beers Criteria (lists desmopressin as potentially inappropriate in older adults). Safety summary: baseline and ongoing serum sodium monitoring is required—document a baseline serum sodium within normal laboratory reference range and review results over the prior 6 months; routine sodium monitoring is required during therapy. The program is intended to ensure appropriate prescribing and monitoring of Nocdurna prior to and during therapy.

Boxed warning: HyponatremiaSafety risk (boxed warning)

Contraindicated: eGFR <50Renal function threshold / contraindication

>=2Required nightly voids for eligibility