CurrentCignaPolicy IP0471

Tolvaptan (Samsca) for Individual and Family Plans

Defines prior authorization and coverage criteria for Samsca (tolvaptan tablets) for Individual and Family Plans administered by Cigna, including initial and continuation therapy criteria, preferred product rules, and exclusions.

Policy Summary

PayerCigna

PolicyTolvaptan (Samsca) for Individual and Family Plans

Policy CodePolicy IP0471

Change TypeName updatematerial clarification on initial therapy duration

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, baseline serum sodium, symptoms, and prior therapy duration to support approval (30 days initial; 3 months for established therapy).

SourceLink

POLICY UPDATE CHANGES

Policy name updated to 'Tolvaptan Products - Tolvaptan (Samsca) for Individual and Family Plans.'

Clarified language for patients who have already started tolvaptan and received < 30 days of therapy to authorize remaining days to complete 30 total days.

30 daysInitial approval duration

3 monthsRenewal/established therapy

≥18Minimum age

<125Serum sodium threshold

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Coverage Criteria

Coverage criteria — FDA‑Approved Indication (Hyponatremia)

FDA-Approved Indication — Hyponatremia. Approve if patient meets ONE of the following A or B.

Top-level indication: A) Initial Therapy OR B) Patient is Currently Receiving Tolvaptan

The following uses are specifically excluded: Autosomal Dominant Polycystic Kidney Disease (ADPKD) — Samsca is not covered for treatment of ADPKD. The Samsca prescribing information advises that tolvaptan should not be used to treat ADPKD outside of the FDA Risk Evaluation and Mitigation Strategy for ADPKD, and Jynarque (a different tolvaptan product with a distinct dosing regimen) is the product indicated for slowing kidney function decline in adults at risk of rapidly progressing ADPKD. Concomitant use with Jynarque is not recommended and is therefore excluded. Additionally, Samsca is not covered for patients who require urgent intervention to rapidly raise serum sodium to prevent or treat serious neurologic symptoms, as Samsca has not been studied for acute, urgent correction of hyponatremia.

Samsca is considered not medically necessary for any use outside the covered indication(s). This explicitly includes treatment of ADPKD and use in situations where there is an urgent need to rapidly increase serum sodium to prevent or treat serious neurologic symptoms, since Samsca has not been studied in those acute settings. Concomitant or replacement use when the patient is currently receiving Jynarque is also not recommended.

Initial Therapy Criteria

Initial therapy. Approve for 30 days if the patient meets ALL of the following (i, ii, and iii).

Initial approval: Approve for 30 days if patient meets ALL of i, ii, and iii

i: Patient is ≥ 18 years of age

ii: One of: a) serum sodium <125 mEq/L at baseline; OR b) less marked hyponatremia (serum sodium <135 mEq/L at baseline) AND symptomatic hyponatremia; OR c) patient has already been started on tolvaptan and has received <30 days of therapy (approve remaining days to complete 30 total)

Symptoms include nausea, vomiting, headache, lethargy, confusion.

iii:

Continuation Therapy Criteria

Continuation Therapy — Established Tolvaptan Use

Patient is currently receiving tolvaptan (established therapy). Approve for 3 months if BOTH of the following are met.

Continuation approval: Approve for 3 months if patient has been established on therapy for at least 30 days AND prescriber documents response as defined in ii

i: Patient has been established on therapy for at least 30 days

Patients with <30 days or restarting are reviewed under Initial Therapy.

ii: One of: a) prescriber states serum sodium has increased from baseline; OR b) prescriber states patient experienced improvement in at least one symptom (nausea, vomiting, headache, lethargy, or confusion)

Currently receiving tolvaptan (established therapy)

Coding

Covered CPT Codesmixed

No codes listed

Serum sodium thresholds

Automatic eligibility thresholdSerum sodium <125 mEq/L at baseline.

Alternative threshold with symptomsSerum sodium <135 mEq/L at baseline AND symptomatic hyponatremia (symptoms include nausea, vomiting, headache, lethargy, confusion).

Clinical noteSamsca is indicated for clinically significant hypervolemic or euvolemic hyponatremia; not for urgent rapid correction of serious neurologic symptoms.

Less marked hyponatremia (definition)

DefinitionLess marked hyponatremia: serum sodium <135 mEq/L at baseline with symptomatic hyponatremia.

SymptomsExamples include nausea, vomiting, headache, lethargy, confusion.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tolvaptan. Approvals are provided for specified durations: 30 days for initial therapy and 3 months for established therapy (1 month = 30 days). Providers should request prior authorization before submitting claims when possible.

Initial therapy: approve for 30 days.
Established therapy (≥30 days on therapy): approve for 3 months.

Step Therapy

Step Therapy Requirement for Samsca (tolvaptan)

For Individual and Family Plans, step therapy applies to the brand product Samsca (tolvaptan tablets). Coverage of the brand requires trial and failure or contraindication to the bioequivalent generic tolvaptan tablets unless the prescriber documents that a formulation difference in inactive ingredients would cause a significant allergy or serious adverse reaction.

Step requirement: trial of bioequivalent generic tolvaptan tablets is required prior to Samsca.

Step Therapy / Product Preference

Step	Requirement	Exceptions / Prescriber documentation
1
Patient must have tried the bioequivalent generic product (tolvaptan tablets) prior to coverage of brand Samsca
If the patient cannot take the generic, prescriber must document that a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) would cause a significant allergy or serious adverse reaction

Prior Authorization

Must try generic tolvaptan before Samsca unless documented intolerance

Before covering brand Samsca under Individual and Family Plans, the prescriber must document that the patient tried the bioequivalent generic tolvaptan tablets and cannot take it due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.

Examples of formulation differences: dyes, fillers, preservatives
Receipt of sample product does not satisfy criteria requirements

Background

Tolvaptan (Samsca) is a selective vasopressin V2‑receptor antagonist approved for clinically significant hypervolemic and euvolemic hyponatremia. It is indicated for patients with serum sodium <125 mEq/L or for patients with serum sodium <135 mEq/L with symptomatic hyponatremia who have not responded to fluid restriction. Clinical trials (SALT‑1/2 and SALTWATER open‑label follow‑up) demonstrated short‑term increases in serum sodium and maintenance of response in many patients, but Samsca is not indicated for situations requiring urgent rapid correction of sodium.

Definitions

Less marked hyponatremia

DefinitionLess marked hyponatremia: serum sodium <135 mEq/L at baseline with symptomatic hyponatremia.

Symptom examplesNausea, vomiting, headache, lethargy, confusion.

Use in policyQualifies a patient for initial 30-day approval when combined with other initial therapy criteria.

Initial therapy (definition)

DefinitionPatient initiating tolvaptan or who has received <30 days of therapy.

Approval instructionApprove for a sufficient duration to complete 30 total days of therapy when patient has already started and received <30 days.

Age requirement

Revision History

2025-09-01policy_effective_dateLatest

Policy effective date updated to 2025-09-01 (annual revision).

2024-10-15name_and_language_update

Policy name changed to 'Tolvaptan Products - Tolvaptan (Samsca) for Individual and Family Plans' and language clarified to state patients who have received <30 days of therapy should be approved for sufficient duration to complete 30 total days.

Policy Summary

PayerCigna

PolicyTolvaptan (Samsca) for Individual and Family Plans

Policy CodePolicy IP0471

Change TypeName updatematerial clarification on initial therapy duration

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, baseline serum sodium, symptoms, and prior therapy duration to support approval (30 days initial; 3 months for established therapy).

SourceLink

On This Page

Preferred product criteria is met for the product as listed (e.g., trial of bioequivalent generic for Individual and Family Plans or documented intolerance to generic)

See Individual and Family Plans step-therapy rules for brand vs generic requirements.

Initial therapy (definition)

DefinitionPatient initiating tolvaptan or who has received <30 days of therapy.

Approval durationApprove for 30 days total (authorize remaining days if patient has already started and received <30 days to complete 30 total).

Age requirementPatient is ≥ 18 years of age.

Related requirementPreferred product criteria must be met (see product table/plan-specific rules).

DefinitionPatient established on tolvaptan therapy for at least 30 days (currently receiving).

Approval durationContinuation approvals provided for 3 months if response documented.

Response documentationPrescriber must state serum sodium has increased from baseline OR that the patient experienced improvement in at least one symptom (nausea, vomiting, headache, lethargy, confusion).

ContextUsed to determine eligibility under initial therapy when serum sodium is <135 mEq/L but symptomatic and resistant to fluid restriction.

Exception: documented significant allergy or serious adverse reaction to inactive ingredients in the generic.

Receipt of sample product does not satisfy criteria.

Documentation Required

Providers must submit supporting clinical documentation with authorization requests, including but not limited to: diagnosis, baseline serum sodium, symptom status, prior duration of therapy, and prescriber rationale (e.g., serum sodium increase or symptom improvement for continuation). Ensure documentation shows which initial or continuation criteria are met.

Include diagnosis and baseline serum sodium.
Document symptom status and any improvement (nausea, vomiting, headache, lethargy, confusion).
If patient was already started on tolvaptan, document prior duration of therapy (<30 days vs ≥30 days).

Denial Risk

Claims Without Covered Diagnosis Will Be Denied

Claims submitted without a covered diagnosis or appropriate covered codes will be denied as not covered. Prior authorization is recommended to help ensure claims meet coverage criteria and are billed with the appropriate diagnosis and procedure/drug codes.

Claims lacking a covered diagnosis or appropriate codes will be denied as not covered.
Obtain prior authorization for tolvaptan to reduce denial risk and confirm coverage criteria are met.

Patient must be ≥ 18 years of age as part of initial therapy criteria.

Currently receiving tolvaptan (established therapy)

DefinitionPatient established on tolvaptan therapy for at least 30 days (currently receiving).

Continuation approvalApprove for 3 months if prescriber documents serum sodium increase from baseline OR symptomatic improvement in at least one listed symptom.

NotePatients with <30 days of therapy or restarting are reviewed under Initial Therapy criteria.