CurrentBlue Cross Blue Shield - IowaPolicy N/A

Tolvaptan (Jynarque, Samsca) — Coverage Criteria

This policy governs prior authorization, coverage criteria, and quantity limits for tolvaptan products (Jynarque and Samsca) for treatment of autosomal dominant polycystic kidney disease (ADPKD) and for hypervolemic/euvolemic hyponatremia for Wellmark Blue Cross Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTolvaptan (Jynarque, Samsca) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with diagnostic imaging and genetic testing results (if applicable) to support Jynarque initiation and continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moApproval duration

>=15Min eGFR

56/28dJynarque limit

15 mg:30/30dSamsca limits

<125 mEq/LSodium threshold

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Initial Therapy (Jynarque)

Jynarque is considered medically necessary when ALL of the following are met:

Jynarque initial criteria

Renal function threshold: Member's estimated glomerular filtration rate (eGFR) is >= 15 mL/min/1.73m2.

Continuation Therapy (Jynarque)

Jynarque continuation is considered medically necessary when ALL of the following are met:

Jynarque continuation criteria: Member has demonstrated a beneficial response to Jynarque therapy (e.g., slowed kidney function decline, decreased kidney pain); member's eGFR remains >= 15 mL/min/1.73m2; all initial authorization criteria continue to be met for new and existing members.eGFR >= 15 mL/min/1.73m2

Continuation approvals are for 12 months; all members requesting continuation must meet all initial authorization criteria.

Acute Hyponatremia Therapy (Samsca)

Brand and generic Samsca (tolvaptan) are considered medically necessary for hypervolemic or euvolemic hyponatremia when ALL of the following are met:

Samsca initiation criteria: Therapy was initiated or re-initiated in the hospital for hypervolemic or euvolemic hyponatremia; serum sodium was <125 mEq/L or <135 mEq/L with symptoms (e.g., nausea, vomiting, headache, lethargy, confusion) at time of therapy initiation; the member will not receive Samsca continually for >30 days.Serum sodium <125 mEq/L or <135 mEq/L with symptoms; duration <=30 days

Samsca should not be used for patients requiring urgent intervention to raise serum sodium to prevent or treat serious neurologic symptoms.

Samsca (tolvaptan) should not be used when urgent correction of serum sodium is required to prevent or treat serious neurologic symptoms. Patients requiring immediate intervention to raise sodium for neurologic indications are clinical exceptions to Samsca therapy because benefit from rapid sodium correction with Samsca has not been established.

Jynarque (tolvaptan) and brand and generic Samsca (tolvaptan) are not medically necessary for any member who does not meet all of the specific coverage criteria outlined in this policy. Requests that fail to satisfy the stated diagnostic, laboratory, or prior authorization requirements will be denied as not medically necessary.

Procedures, Codes, and Clinical Thresholds

Procedures and billing codesmixed

No codes listed

inv-07: Serum sodium and eGFR thresholds

Samsca serum sodium initiation thresholdSerum sodium <125 mEq/L at time of therapy initiation; alternatively <135 mEq/L if symptomatic (e.g., nausea, vomiting, headache, lethargy, confusion)

Jynarque minimum eGFR for initiation and continuationeGFR >= 15 mL/min/1.73 m2 required for both initiation and continuation of Jynarque

Samsca duration limitMember will not receive Samsca continually for >30 days when used for hypervolemic or euvolemic hyponatremia

Jynarque approval durationApprovals for Jynarque are issued for 12 months

Samsca initiation setting requirementTherapy must be initiated or re-initiated in the hospital for hypervolemic or euvolemic hyponatremia

Prior Authorization, Documentation, and Dosing Rules

Documentation Required

Required documentation for Jynarque prior authorization

Prior authorization is required. Submit diagnostic imaging and genetic testing used to establish diagnosis and to confirm rapidly progressing disease.

Imaging used for diagnosis and confirmation of rapidly progressing disease (e.g., ultrasonography, MRI, CT).
Genetic testing results, if applicable (e.g., positive PKD1 or PKD2 mutation).
Documentation demonstrating height‑adjusted total kidney volume consistent with Mayo class 1C, 1D, or 1E when applicable.
eGFR value showing ≥ 15 mL/min/1.73 m2, when applicable.

Prior Authorization

Dosing limits may apply

Approvals may be subject to dosing limits in accordance with FDA labeling and evidence‑based guidelines.

Denial Risk

Denial risk if criteria or documentation are not met

Jynarque and Samsca are not medically necessary when the specified criteria are not met.

All initial authorization criteria must be met for continuation of therapy.
Failure to provide required diagnostic imaging or genetic testing documentation may result in denial.

Background on Tolvaptan

Tolvaptan is available as Jynarque for slowing kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) who are at risk of rapidly progressing disease, and as Samsca (brand and generic) for clinically significant hypervolemic or euvolemic hyponatremia. Jynarque’s role is disease-modifying in ADPKD and requires confirmation of diagnosis and risk stratification (e.g., Mayo class 1C–1E and eGFR ≥ 15 mL/min/1.73 m2) with approvals typically issued for 12 months. Samsca is indicated for inpatient initiation for hyponatremia when serum sodium is 125 mEq/L (or <135 mEq/L with symptoms), is intended for short-course use (not to exceed 30 days), and should not be used when urgent sodium correction is required. Prior authorization requires submission of diagnostic imaging and genetic testing results for Jynarque when applicable, and approvals may be subject to dosing limits per FDA labeling and guidelines.