Centene Tolvaptan Coverage Update

Coverage Criteria

Initial Therapy - ADPKD

Covered when ALL of the following are met:

ADPKD Initial Approval: 1. Diagnosis of autosomal dominant polycystic kidney disease (ADPKD); 2. Request is for Jynarque or generic tolvaptan; 3. Prescribed by or in consultation with a nephrologist; 4. Age ≥ 18 years; 5. Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2; 6. Member is at risk of rapidly progressive disease as evidenced by one of the following (a or b): (a) Mayo Image Classification (MIC) class 1C–1E; OR (b) historical rate of eGFR decline ≥ 3 mL/min/1.73 m2 per year; 7. If request is for Jynarque, member must use generic tolvaptan unless contraindicated or clinically significant adverse effects occur; 8. Dose does not exceed 120 mg per day.see text

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Initial Therapy - Hyponatremia

Covered when ALL of the following are met:

Hyponatremia Initial Approval: 1. Diagnosis of hypervolemic or euvolemic hyponatremia; 2. Request is for Samsca or generic tolvaptan; 3. Prescribed by or in consultation with a nephrologist, cardiologist, or endocrinologist; 4. Age ≥ 18 years; 5. One of the following (a or b): (a) recent serum sodium < 125 mEq/L within 7 days; OR (b) symptomatic hyponatremia resistant to correction with fluid restriction; 6. If request is for Samsca, member must use generic tolvaptan unless contraindicated or clinically significant adverse effects occur; 7. Dose does not exceed 60 mg per day.see text

Approval duration: 30 days.

Continuation Therapy - ADPKD

Covered when ALL of the following are met:

ADPKD Continuation: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is receiving medication and enrolled in continuity of care regulations; 2. Request is for Jynarque or generic tolvaptan; 3. Member is responding positively to therapy; 4. If request is for Jynarque, member must use generic tolvaptan unless contraindicated or clinically significant adverse effects occur; 5. If request is for a dose increase, new dose does not exceed 120 mg per day.see text

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy - Hyponatremia

Covered when ALL of the following are met:

Hyponatremia Continuation: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is receiving medication and enrolled in continuity of care regulations; 2. Request is for Samsca or generic tolvaptan; 3. Member is responding positively as evidenced by increased serum sodium since baseline; 4. Member has not received more than 30 days of Samsca treatment; 5. If request is for Samsca, member must use generic tolvaptan unless contraindicated or clinically significant adverse effects occur; 6. If request is for a dose increase, new dose does not exceed 60 mg per day.see text

Approval duration: 30 days.

Other/Off-label Uses

If requested use is not listed:

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow applicable formulary/no-coverage or non‑formulary policies for the relevant line of business; OR 2. If the requested use is not specifically listed and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business.see text

Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

ADPKD — Initial coverage (3Q 2025 updates)

Covered when ALL of the following are met (summary from 3Q 2025 updates):

ADPKD initiation: Member meets the minimum eGFR requirement and is at high risk for rapidly progressive ADPKD as defined by the 2025 KDIGO guideline and alignment with pivotal trial eligibility; criteria are applied per policy.minimum eGFR per policy and high-risk per KDIGO

Exact numeric eGFR threshold and detailed risk criteria appear elsewhere in the full policy document.

Hyponatremia (Samsca) — Initiation and duration

Coverage for Samsca when initiation requirements met:

Samsca initiation: Initiation and re-initiation of Samsca should occur in a hospital setting per policy update; contraindication language has been aligned with the prescribing information.hospital initiation

See policy for monitoring and inpatient initiation details.

Duration for hyponatremia: Duration for continued hyponatremia treatment with Samsca is clarified by the policy; typical approval duration is 30 days for initial/continuation use as specified elsewhere in the criteria sections.per policy details

Exact duration values and re-initiation rules are in other sections of the policy.

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety per applicable off‑label use policies (for example, CP.CPA.09 for commercial lines of business, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid).

The policy language for Samsca contraindications has been revised to align with the product prescribing information. Providers should follow the contraindication guidance in the Samsca label when evaluating suitability for therapy; explicit excluded conditions and the updated contraindication wording are documented in the policy’s contraindications section consistent with the 3Q 2022 update.

Patients who require urgent intervention to raise serum sodium to prevent or treat serious neurologic symptoms should not be treated with Samsca. In such scenarios, alternative emergent interventions are indicated because Samsca is not appropriate for acute, life‑threatening hyponatremia management.

The 3Q annual reviews repeatedly note no significant changes in multiple years. Where applicable, the reviews also document operational clarifications—for example, the 3Q 2022 update clarified that Samsca initiation and re‑initiation should occur in a hospital setting and revised contraindication wording to align with prescribing information; other NMN (not medically necessary) conditions are detailed elsewhere in the policy.

Coding and Product Formulations

No CPT/HCPCS/ICD codes listed in this partmixed

No codes listed

Product formulations (not billing codes)mixed

N/A	Product strengths and pack sizes listed (Jynarque 45 mg with 15 mg, 60 mg with 30 mg, 90 mg with 30 mg blister packs; Jynarque tablets 15 mg and 30 mg [30-pack]; Samsca tablets 15 mg, 30 mg)

inv-14: eGFR threshold — ADPKD initial approval

Numeric thresholdeGFR ≥ 25 mL/min/1.73 m2

ContextRequired for initial ADPKD approval (adult patients) per policy initial approval criteria

Associated age requirementAge ≥ 18 years required for ADPKD initial approval

Related dosing limitDose must not exceed 120 mg per day for ADPKD

inv-15: Serum sodium threshold for Samsca — criteria for hyponatremia treatment

Serum sodium thresholdRecent (within 7 days) serum sodium < 125 mEq/L

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for tolvaptan (generic), Jynarque, and Samsca. Requests must include documentation supporting the requested indication and that the member meets all clinical criteria. Failure to provide adequate clinical documentation may result in denial.

PA required with documentation for requested indication
A request for branded Jynarque will be redirected to generic tolvaptan unless contraindicated (generic-first policy)

Documentation Required

Required Documentation and Product Formulation

Provider must submit supporting clinical documentation (office chart notes, laboratory results including serum sodium and eGFR, imaging reports such as Mayo Image Classification, and treatment history). Include documentation of product strength and pack information when applicable.

Office notes and relevant consultation notes

Background

Tolvaptan is a selective vasopressin V2‑receptor antagonist used in two distinct clinical settings: to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) and to treat clinically significant hypervolemic or euvolemic hyponatremia. Jynarque (the branded ADPKD product) carries a boxed warning for serious liver injury and is available only through a REMS program; Samsca (the hyponatremia product) requires inpatient initiation and careful monitoring of serum sodium. The policy directs use of branded products toward generic tolvaptan when appropriate and specifies monitoring, specialist involvement, and eGFR/serum sodium thresholds for the respective indications.

Definitions and Clinical Classifications

inv-26: MIC (Mayo Image Classification) — classes 1A–1E and prognostic implication

MIC classesClasses 1A, 1B, 1C, 1D, 1E

Prognostic implicationClasses reflect htTKV/age and disease severity; higher classes indicate faster growth and worse prognosis

Growth rates by class1A: <1.5%/yr; 1B: 1.5–3%/yr; 1C: 3–4.5%/yr; 1D: 4.5–6%/yr; 1E: >6%/yr

Use in policyMIC class 1C–1E is accepted evidence of risk for rapidly progressive ADPKD for treatment eligibility

inv-27: eGFR — definition and policy requirement of eGFR ≥ 25 mL/min/1.73 m2 for ADPKD initial approval

DefinitionEstimated glomerular filtration rate (eGFR) — measure of kidney function

Revision History

2025-06-17material_updateLatest

ADPKD criteria updated to add minimum eGFR and requirement for high risk of rapidly progressive disease per 2025 KDIGO; Jynarque requests redirected to generic tolvaptan.

2024-05-14revision

Policy/criteria revised to also include generic tolvaptan; references reviewed and updated.

2022-03-25revision

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Tolvaptan (Jynarque, Samsca) — Coverage Criteria

Coverage Criteria

Coding and Product Formulations

Provider Actions and Requirements

Background

Definitions and Clinical Classifications

Revision History