CurrentCignaPolicy IP0287

Tolvaptan (Jynarque)

Defines Cigna prior authorization and medical necessity criteria for tolvaptan (Jynarque and generic) for treatment of autosomal dominant polycystic kidney disease (ADPKD) in adults, and specifies product-preference rules for employer plans.

Policy Summary

PayerCigna

PolicyTolvaptan (Jynarque)

Policy CodePolicy IP0287

Change TypeCriteria revisedpreferred product rule added

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis of rapidly-progressing ADPKD, baseline eGFR (prior to tolvaptan), age ≥18, and that patient is not on renal replacement therapy.

SourceLink

POLICY UPDATE CHANGES

Policy name updated and manufacturer/generic availability noted; criteria updated to require baseline eGFR ≥ 25 mL/min/1.73 m2 and added explicit prohibition of patients on renal replacement therapy.

Preferred product requirement criteria added for employer plans requiring trial of bioequivalent generic before brand Jynarque unless allergy to inactive ingredients.

≥25Required baseline eGFR for coverage

≥3.0Rapid eGFR decline threshold

1C–1EMayo class indicating rapid progression

1 yr

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Coverage Criteria for Tolvaptan (Jynarque)

FDA-Approved Indication: Autosomal Dominant Polycystic Kidney Disease

Covered when ALL of the following are met (approve for 1 year):

FDA-Approved Indication: Autosomal Dominant Polycystic Kidney Disease: A) Patient is ≥ 18 years of age; AND B) Prescriber documents the patient has rapidly-progressing autosomal dominant polycystic kidney disease; AND C) At baseline, the patient has an estimated glomerular filtration rate ≥ 25 mL/min/1.73 m2; AND D) Patient is not on renal replacement therapy; AND E) Medication is prescribed by or in consultation with a nephrologist; AND F) Preferred product criteria is met for the product(s).

Initial approval duration = 1 year; baseline eGFR is prior to any tolvaptan treatment.

Tolvaptan is not medically necessary for uses other than autosomal dominant polycystic kidney disease (ADPKD). Requests for tolvaptan for any non-ADPKD indication will be considered not medically necessary under this policy.

Concomitant use of tolvaptan products is not recommended. Specifically, patients currently receiving Samsca (tolvaptan tablets indicated for clinically significant hypervolemic and euvolemic hyponatremia) should not be treated concurrently with other tolvaptan products; Samsca should be used when the indication is hyponatremia.

Reiterating coverage stance: tolvaptan use for indications other than ADPKD, including treatment of hyponatremia, is not medically necessary under this policy. Samsca is the tolvaptan product indicated for hyponatremia and should be used for that condition rather than prescribing tolvaptan for non-ADPKD indications.

Drug/Product and Clinical Threshold Codes

Drug product referencesmixed

Jynarque / tolvaptan

Brand and generic product names referenced; no specific billing codes listed in document

inv-06: eGFR baseline threshold

Required baseline eGFREstimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2 at baseline (prior to any tolvaptan treatment)

Approval durationInitial approval granted for 1 year when baseline eGFR criterion is met

Related prior definitionBaseline refers to measurement prior to treatment with any tolvaptan product

inv-07: eGFR decline indicating rapid progression

Historical eGFR decline thresholdHistorical rate of eGFR decline ≥ 3.0 mL/min/1.73 m2 per year indicates rapid progression

Supporting guideline durationConsensus definitions reference decline measured over a period (e.g., ≥4 years) to define rapid progression

Prior Authorization, Documentation, and Product Preference Rules

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for coverage of tolvaptan. Approvals are provided for durations noted in the policy (initial approval = 1 year for FDA‑approved ADPKD indication when criteria are met). Tolvaptan must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., nephrologist).

Prior authorization is required for tolvaptan; initial approvals for ADPKD are for 1 year when criteria are met.
Prescriber requirement: prescribed by or in consultation with a specialist (nephrologist).

Step Therapy

Preferred Product Prior Authorization Rule (Employer Plans)

Preferred product requirement for Employer Plans: a trial of the bioequivalent generic tolvaptan tablets (including tablet therapy pack when applicable) is required prior to approving the brand product Jynarque (tolvaptan) unless the prescriber documents that the patient cannot take the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that would, in the prescriber’s judgment, cause a significant allergy or serious adverse reaction.

Background on Tolvaptan and ADPKD

Tolvaptan is a vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly-progressing autosomal dominant polycystic kidney disease (ADPKD).

Key Definitions

inv-14: Definition example for rapidly-progressing ADPKD

Example definitionRapidly-progressing ADPKD is exemplified by a historical eGFR decline ≥ 3.0 mL/min/1.73 m2 per year

Mayo classificationMayo Classification 1C–1E indicates rapid progression (1C requires further evaluation)

Clinical guidanceTotal kidney volume changes should not be used as a marker of progression in individual patients

inv-15: Baseline definition

Baseline definitionBaseline refers to kidney function measurement prior to treatment with any tolvaptan product

Context in criteriaBaseline eGFR requirement (≥ 25 mL/min/1.73 m2) applies at this baseline measurement

Policy Revision History

2025-09-01material_changeLatest

Criteria updated to require baseline estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2 and baseline defined as prior to any tolvaptan treatment; patients receiving renal replacement therapy (dialysis or transplantation) were excluded from coverage.

2024-10-15clarification

Added examples of rapidly declining renal function (eGFR decline ≥ 3.0 mL/min/1.73 m2 and Mayo Classification 1D–1E) and added note defining Stage 5 CKD as eGFR < 15 mL/min/1.73 m2 (note later replaced by the baseline eGFR requirement).

2025-09-01administrative_addition

Documentation Required

Required Clinical Documentation and Prior Authorization/Coding Rules

Required Clinical Documentation and Coding: Requests must include documentation of the covered diagnosis and relevant clinical information. Requests lacking a covered diagnosis or appropriate codes will be denied. Prescribers must document: diagnosis of rapidly‑progressing autosomal dominant polycystic kidney disease (ADPKD), baseline estimated glomerular filtration rate (eGFR) prior to tolvaptan (≥ 25 mL/min/1.73 m2), patient age ≥ 18 years, that the patient is not on renal replacement therapy (dialysis or transplant), that treatment is prescribed by or in consultation with a nephrologist, and that preferred product criteria (or documented exception) are met.

Document diagnosis of rapidly‑progressing ADPKD (examples: eGFR decline ≥ 3.0 mL/min/1.73 m2; Mayo classification 1C/1D/1E).
Document baseline eGFR prior to tolvaptan (must be ≥ 25 mL/min/1.73 m2).
Document patient age ≥ 18 and not on renal replacement therapy (dialysis or transplant).
Document prescriber specialty (nephrologist) or consultation with specialist.
Include evidence of trial of bioequivalent generic tolvaptan or documented exception for inactive ingredient–related allergy/serious adverse reaction.
Requests without covered diagnosis or appropriate codes will be denied. Use most appropriate codes as of date of submission.