CurrentWashington State Health Care AuthorityPolicy 30.45.40-1

Vasopressin Receptor Antagonists - Oral

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This policy governs Washington Apple Health prior authorization and medical-necessity coverage for oral tolvaptan products used for autosomal dominant polycystic kidney disease and hypervolemic or euvolemic hyponatremia. It applies to providers requesting coverage for generic tolvaptan, Jynarque, or Samsca.

Policy Summary

PayerWashington State Health Care Authority

PolicyVasopressin Receptor Antagonists - Oral

Policy CodePolicy 30.45.40-1

Change TypeNo material clinical or coverage change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit documentation of nephrologist prescribing or consultation, ADPKD diagnosis, eGFR greater than 25 mL/min/1.73 m² before initiation, and provider attestation that the patient is at risk for rapid disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered clinical indications

6 monthsInitial ADPKD authorization duration

12 monthsADPKD reauthorization duration

1 monthHyponatremia authorization duration

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CurrentWashington State Health Care AuthorityPolicy 30.45.40-1

Vasopressin Receptor Antagonists - Oral

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 30.45.40-1 alerts

Get alerted when Policy 30.45.40-1 changes without checking for updates manually.

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Policy Summary

PayerWashington State Health Care Authority

PolicyVasopressin Receptor Antagonists - Oral

Policy CodePolicy 30.45.40-1

Change TypeNo material clinical or coverage change

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered clinical indications

6 monthsInitial ADPKD authorization duration

12 monthsADPKD reauthorization duration

1 monthHyponatremia authorization duration

2 agentsRequired preferred-agent failures or intolerance

30 daysMaximum hyponatremia treatment duration

Coverage Criteria

Initial Therapy — ADPKD

Tolvaptan may be approved when all of the following documented criteria are met.

Initial ADPKD therapy

Prescriber: Prescribed by, or in consultation with, a nephrologist
ADPKD diagnosis and risk: Diagnosis of autosomal dominant polycystic kidney disease with eGFR greater than 25 mL/min/1.73 m² before starting and provider attestation that the patient is at risk for rapid disease progressioneGFR > 25 mL/min/1.73 m²; rapid progression risk such as Mayo class 1C, 1D, or 1E

Continuation Therapy — ADPKD

Tolvaptan may be reauthorized when all of the following documented criteria are met.

ADPKD reauthorization: Documentation is submitted demonstrating decline in disease progression or a positive clinical response

Examples include a decreased rate of GFR decline or slowed increase in total kidney volume. If the criterion is met, authorization is for 12 months.

Initial Therapy — Hypervolemic or Euvolemic Hyponatremia

Tolvaptan may be approved when all of the following documented criteria are met.

Initial hypervolemic or euvolemic hyponatremia therapy

Age: Patient is 18 years of age or older≥ 18 years
Treatment initiation: The medication was initiated in a hospital setting
Diagnosis and laboratory threshold: Diagnosis of hypervolemic or euvolemic hyponatremiaSerum sodium < 125 mEq/L
Liver status:

Continuation Therapy — Hypervolemic or Euvolemic Hyponatremia

Tolvaptan may be reauthorized when all of the following documented criteria are met.

Hyponatremia reauthorization

Initial criteria: Criteria 1 through 5 from the initial hyponatremia authorization are met
Distinct episode: The episode of hyponatremia is a separate occurrence, distinct from any previous episode of hyponatremia

Tolvaptan is not indicated to correct sodium levels in hypovolemic hyponatremia, which is commonly caused by dehydration, and is contraindicated in liver failure.

For coverage of tolvaptan for hypervolemic or euvolemic hyponatremia, the provider must attest that the patient does not have cirrhosis of the liver.

Coding

Codingmixed

N/A

Pre-treatment eGFR for ADPKD

Required pre-treatment eGFR> 25 mL/min/1.73 m² before starting tolvaptan

Applies toAutosomal dominant polycystic kidney disease (ADPKD)

Related coverage requirementProvider attestation that the member is at risk of rapid disease progression

Serum sodium for covered hyponatremia

Required serum sodium< 125 mEq/L

Applies toHypervolemic or euvolemic hyponatremia

Associated coverage requirement

Provider Actions

Prior Authorization

Prior Authorization for Non-Preferred Drugs

New-to-market drugs added to this class through the Apple Health Preferred Drug List (AHPDL), as well as other non-preferred agents, require prior authorization before coverage.

Check the current AHPDL for preferred and non-preferred status.
If a drug receives a new FDA-approved indication, medical necessity for that indication is determined case by case based on FDA labeling.

Prior Authorization

ADPKD Initial Authorization

For autosomal dominant polycystic kidney disease (ADPKD), tolvaptan may be authorized for six months when all initial clinical and documentation requirements are met.

The request must document the required nephrology involvement, ADPKD diagnosis, eGFR, and risk of rapid disease progression.

Prior Authorization

Background

Autosomal dominant polycystic kidney disease (ADPKD) is an irreversible inherited disease that causes progressive loss of kidney function. Mayo classes 1C, 1D, and 1E identify patients at high risk for progression to end-stage kidney disease. In high-risk ADPKD, tolvaptan may slow the decline in eGFR and the increase in total kidney volume.

Definitions

Mayo classification

DefinitionA Mayo classification system that stratifies patients into classes 1A through 1E based on patient characteristics.

Patient characteristicsAge, height, and total kidney volume

High-risk categoriesClasses 1C, 1D, and 1E are considered high risk for progression to end-stage kidney disease.

ADPKD

DefinitionAutosomal dominant polycystic kidney disease, an inherited disease for which tolvaptan coverage requires documented diagnostic criteria.

Pre-treatment kidney functioneGFR greater than 25 mL/min/1.73 m² before starting treatment

Progression-risk requirement

Initial Therapy Criteria

ADPKD Initial Therapy

Tolvaptan may be approved for ADPKD when all of the following documented criteria are met.

ADPKD initial therapy

Prescriber: Prescribed by, or in consultation with, a nephrologist
ADPKD diagnosis: Patient has a diagnosis of autosomal dominant polycystic kidney disease
Pre-treatment kidney function: eGFR is greater than 25 mL/min/1.73 m² before starting treatmenteGFR > 25 mL/min/1.73 m²

Continuation Criteria

ADPKD Continuation

Tolvaptan may be approved for ADPKD reauthorization when all of the following documented criteria are met.

ADPKD continuation: Documentation demonstrates decline in disease progression or a positive clinical response

Examples include a decreased rate of GFR decline or slowed increase in total kidney volume. Authorization duration is 12 months.

Hyponatremia Continuation

Tolvaptan may be approved for hyponatremia reauthorization when all of the following documented criteria are met.

Hyponatremia continuation

Initial criteria remain met: The initial authorization criteria, criteria 1 through 5, remain met

Step Therapy

Preferred agents available	Requirement for non-preferred agent	Required documentation
Two or more preferred agents	Failure or intolerance of at least two preferred agents	Inadequate response or documented intolerance due to a severe adverse reaction or contraindication
Only one preferred agent	Failure or intolerance of the one preferred agent	Inadequate response or documented intolerance due to a severe adverse reaction or contraindication

Quantity Limits

Tolvaptan (Jynarque)

15 mg tablet1 tablet per day

30 mg tablet1 tablet per day

Dose pack56 tablets (1 carton) per 28 days

Tolvaptan (Samsca, generic)

Approved dose15 to 60 mg once daily

15 mg tablet1 tablet per day

30 mg tablet2 tablets per day

Site of Care

Billing Rule

Initiate hyponatremia treatment in a hospital

For the hyponatremia indication, the medication must be initiated in a hospital setting.

Document hospital initiation in the request.
Treatment initiated outside a hospital setting does not meet this criterion.

Policy Summary

PayerWashington State Health Care Authority

PolicyVasopressin Receptor Antagonists - Oral

Policy CodePolicy 30.45.40-1

Change TypeNo material clinical or coverage change

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

Provider attests that the patient does not have cirrhosis of the liver

Treatment duration: Total length of treatment will not exceed 30 days≤ 30 days

Total length of treatment will not exceed 30 days

ADPKD Reauthorization

ADPKD reauthorization may be approved for 12 months when documentation demonstrates decreased disease progression or a positive clinical response.

Examples include a decreased rate of GFR decline or a slowed increase in total kidney volume.

Prior Authorization

Hyponatremia Initial Authorization

For hypervolemic or euvolemic hyponatremia, tolvaptan may be authorized for one month when all five initial clinical documentation requirements are met.

Document age 18 years or older.
Document initiation in a hospital setting.
Document hypervolemic or euvolemic hyponatremia with serum sodium below 125 mEq/L.
Document that the patient does not have cirrhosis of the liver.
Confirm that total treatment will not exceed 30 days.

Prior Authorization

Hyponatremia Reauthorization

Hyponatremia reauthorization may be approved for one month only when the initial authorization criteria continue to be met and the current episode is distinct from any previous episode.

The separate occurrence must be documented as a new episode of hyponatremia.

Step Therapy

Preferred-Agent Step Therapy

A non-preferred agent requires documentation of an inadequate response or intolerance to preferred therapy before authorization.

Document inadequate response or intolerance due to a severe adverse reaction or contraindication to at least two preferred agents.
If only one preferred agent exists in the class, document inadequate response to that one agent.

Unsupported block type: documentation

Documentation Required

ADPKD Clinical Documentation

ADPKD initial requests must include documentation supporting the prescriber’s qualifications, diagnosis, kidney function, and risk of rapid progression.

The drug must be prescribed by or in consultation with a nephrologist.
Document autosomal dominant polycystic kidney disease.
Document eGFR greater than 25 mL/min/1.73 m² before starting therapy.
The provider must attest that the member is at risk for rapid disease progression, such as Mayo class 1C, 1D, or 1E.

Documentation Required

ADPKD Response Documentation

ADPKD reauthorization requests must include evidence that treatment is slowing disease progression or producing a positive clinical response.

Document a decreased rate of GFR decline, a slowed increase in total kidney volume, or another clinically relevant positive response.

Documentation Required

Hyponatremia Clinical Documentation

Hyponatremia requests must document all initial clinical criteria before tolvaptan can be authorized.

Patient is at least 18 years old.
Tolvaptan was initiated in a hospital setting.
Diagnosis is hypervolemic or euvolemic hyponatremia with serum sodium below 125 mEq/L.
Provider attests that the patient does not have liver cirrhosis.
Total treatment duration will not exceed 30 days.

Documentation Required

Hyponatremia Reauthorization Documentation

Hyponatremia reauthorization requires documentation that all initial criteria remain satisfied and that the current hyponatremia episode is separate from any prior episode.

Re-submit or reference documentation for age, hospital initiation, qualifying diagnosis and sodium level, absence of cirrhosis, and the 30-day treatment limit.
Document that the episode is a distinct occurrence from previous hyponatremia.

Denial Risk

Step-Therapy Requirement Not Met

If the required preferred-agent step therapy is not documented, the non-preferred drug request may be denied or remain subject to prior authorization.

Document inadequate response to the required number of preferred agents or documented intolerance due to severe adverse reaction or contraindication.
If only one preferred agent is available, documentation for that one agent is required.

Denial Risk

ADPKD Criteria Not Met

An ADPKD request may be denied when required clinical criteria are absent or not documented.

Prescriber is neither a nephrologist nor consulting with a nephrologist.
ADPKD diagnosis is not documented.
Pretreatment eGFR is not greater than 25 mL/min/1.73 m².
Provider does not attest to risk of rapid disease progression.
Any other required initial or reauthorization documentation is missing.

Denial Risk

Hyponatremia Criteria Not Met

A hyponatremia request may be denied when required patient, treatment-setting, laboratory, safety, or duration criteria are not met.

Patient is younger than 18 years.
Medication was not initiated in a hospital setting.
Serum sodium is not below 125 mEq/L or the diagnosis is not hypervolemic or euvolemic hyponatremia.
Cirrhosis is present or the required attestation of no cirrhosis is missing.
Treatment exceeds the 30-day limit or other initial criteria are not documented.

Denial Risk

Distinct Hyponatremia Episode Required

Hyponatremia reauthorization may be denied when the request does not establish a new, distinct episode separate from any previous episode.

Document the continued initial eligibility criteria and evidence that the current episode is a separate occurrence.
A repeat request for the same unresolved episode does not satisfy the distinct-episode requirement.

Provider attestation that the patient is at risk for rapid disease progression, such as Mayo class 1C, 1D, or 1E

Hypervolemic or euvolemic hyponatremia

DefinitionHyponatremia caused by an imbalance of water relative to sodium in which the patient is hypervolemic or euvolemic.

Policy sodium requirementSerum sodium < 125 mEq/L

ExclusionsTolvaptan is not indicated for hypovolemic hyponatremia and is contraindicated in liver failure; coverage also requires that cirrhosis be absent.

REMS

DefinitionA Risk Evaluation and Mitigation Strategy for Jynarque because of the risk of severe liver damage.

Laboratory monitoringRequires comprehensive laboratory monitoring

Enrollment requirementsPrescribers and pharmacies must be enrolled in the REMS program

Risk of rapid progression:

Provider attests that the patient is at risk of rapid disease progression

Examples include Mayo class 1C, 1D, or 1E

Hyponatremia Initial Therapy

Tolvaptan may be approved for hypervolemic or euvolemic hyponatremia when all of the following documented criteria are met.

Hyponatremia initial therapy

Age: Patient is 18 years of age or older≥ 18 years
Hospital initiation: The medication was initiated in a hospital setting
Covered hyponatremia diagnosis: Patient has hypervolemic or euvolemic hyponatremiaSerum sodium < 125 mEq/L
Absence of cirrhosis: Provider attests that the patient does not have cirrhosis of the liver
Treatment duration: Total length of treatment will not exceed 30 days≤ 30 days

Separate episode: The episode of hyponatremia is a separate occurrence, distinct from any previous episode of hyponatremia