CurrentCareSourcePolicy N/A

Jynarque (tolvaptan) coverage for ADPKD

This pharmacy policy governs prior authorization and coverage criteria for Jynarque (tolvaptan) for members with autosomal dominant polycystic kidney disease (ADPKD) under the CareSource pharmacy benefit in Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyJynarque (tolvaptan) coverage for ADPKD

Policy CodePolicy N/A

Change TypeRemoved prescriber specialty and diuretic-concurrent-use restrictions

Effective DateJan 1, 2022

Next Review Date

Key ActionObtain prior authorization with a valid NDC and provide chart notes documenting diagnosis, imaging or genetic confirmation, and evidence of high risk for rapid progression to receive initial 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

Removed prescriber specialty requirement and requirement that member does not have concurrent use with a diuretic.

New policy for Jynarque created.

12 monthsinitial approval duration if criteria met

Homesite of service allowed

PA Requiredcoverage requirement (Non-Preferred Product)

NDCbilling code requirement

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

ADPKD initial criteria: Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD) confirmed by genetic testing or imaging (eg, ultrasound, CT, or MRI) documented in chart notes.

Age: Member is >= 18 years of age.

High risk for rapid progression (one of)

TKV or imaging change: Total kidney volume (TKV) >= 750 mL by MRI OR TKV increase >5% on repeated imaging.
eGFR decline options:

Policy Summary

PayerCareSource

PolicyJynarque (tolvaptan) coverage for ADPKD

Policy CodePolicy N/A

Change TypeRemoved prescriber specialty and diuretic-concurrent-use restrictions

Effective DateJan 1, 2022

Next Review Date

SourceLink

On This Page

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Confirmed eGFR decline of 25% in 1 year OR confirmed eGFR decline >= 2.5 mL/min/1.73 m2 per year over a 5-year period.

Other risk criteria: Mayo classification 1C, 1D, or 1E; average kidney length >16.5 cm in a patient <45 years; OR PROPKD score >6 (when genetic data available).

Exclusions: Member does NOT have any of the following: eGFR < 25 mL/min/1.73 m2; prior kidney transplant; current dialysis.

These are contraindications to coverage

Continuation Therapy / Reauthorization

Reauthorization covered when ALL of the following are met

Reauthorization: Chart notes demonstrate slower decline in kidney function and improvement of symptoms (for example, slowing of cyst growth and/or rate of eGFR decline, less kidney pain).documented clinical benefit

If met, approve for an additional 12 months

CareSource considers Jynarque (tolvaptan) not medically necessary for indications that are not listed in this policy. This policy covers use only for autosomal dominant polycystic kidney disease (ADPKD); use of Jynarque for other diseases or conditions is not covered under this policy.

Requests for Jynarque for members who have any of the following are excluded from coverage: eGFR <25 mL/min/1.73 m2, a history of prior kidney transplant, or current dialysis. Members meeting any of these conditions do not meet the coverage criteria for Jynarque in ADPKD.

Initial Therapy and Dosing Criteria

Initial therapy and dosing

Initial dosing and approval

Dosing and approval: Initial dose: 45 mg in the morning and 15 mg approximately 8 hours later. Titrate to 60 mg + 30 mg, then to 90 mg + 30 mg based on tolerability with at least weekly intervals between titrations.tolerability-guided titration

If criteria met, medication will be approved for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: Chart notes show slowed kidney function decline and symptom improvement (eg, slowing cyst growth, reduced rate of eGFR decline, less kidney pain).clinical improvement documented

If met, approve for an additional 12 months

Coding and Approval Duration

Billing requirementNDC

NDC	Must use valid NDC code for billing

inv-06: Approval duration

Approval duration12 months

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Jynarque (tolvaptan). Initial approvals will be issued for up to 12 months when all clinical criteria are met. Requests submitted without prior authorization for this non-preferred product may be denied. Billing must use a valid NDC code.

Initial approval duration: 12 months when criteria met
Billing: must use valid NDC
Non-preferred product — prior authorization required; claims without PA may be denied

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Include chart notes confirming diagnosis, evidence of high risk for rapid progression, and baseline and follow-up laboratory or imaging results as applicable.

Required documentation: chart notes confirming ADPKD diagnosis (genetic testing or imaging)
Evidence of high risk for rapidly declining kidney function (see criteria: TKV, eGFR decline, Mayo classification, kidney length, PROPKD score where applicable)
Baseline labs/imaging: total kidney volume (TKV) by MRI or serial imaging, eGFR values demonstrating decline, and other relevant studies
Reauthorization documentation: chart notes showing slowed decline in kidney function or clinical improvement (e.g., less cyst growth, reduced kidney pain)

Note

Provider / Billing Action Required

Actionable provider and billing note: follow the dosing and monitoring guidance when requesting authorization and submit evidence of tolerability and monitoring. Titration schedule and monitoring results should be included in the chart notes.

Initial dosing: 45 mg morning + 15 mg ~8 hours later; titrate to 60 mg + 30 mg then to 90 mg + 30 mg at ~weekly intervals as tolerated
Include documentation of tolerability and monitoring during titration
Site of service allowed: Home

Denial Risk

Denial Risk for Incomplete Requests

Requests for this non-preferred product that lack prior authorization or adequate supporting documentation are at risk for denial.

Denial risk: missing PA or incomplete clinical documentation
CareSource considers Jynarque not medically necessary for indications not listed in this policy

Definitions

inv-12: TKV — total kidney volume definition and threshold

DefinitionTotal kidney volume (TKV) measured by MRI to assess kidney size and disease progression

Threshold — absoluteTKV ≥ 750 mL by MRI

Threshold — relative changeTKV increase >5% on repeated imaging

inv-13: eGFR decline — definition and example thresholds

DefinitionConfirmed decrease in estimated glomerular filtration rate (eGFR) indicating kidney function decline

Threshold — 1-year declineConfirmed eGFR decline of 25% in 1 year

Threshold — multi-year rateConfirmed eGFR decline of ≥2.5 mL/min/1.73 m2 per year over a 5-year period

Background

Autosomal dominant polycystic kidney disease (ADPKD) is a hereditary disorder characterized by progressive growth of renal cysts that leads to declining kidney function. Tolvaptan (Jynarque) is indicated to slow kidney function decline in adults with ADPKD who are at high risk of rapid progression. Treatment initiation requires documentation of a clinical diagnosis by genetic testing or imaging (ultrasound, CT, or MRI) and assessment of risk for rapid progression using measures such as total kidney volume (TKV), serial eGFR decline, Mayo imaging classification, or other validated markers. Therapy is started at a low dose and titrated based on tolerability; when coverage criteria are met, initial approval is for 12 months. Prior authorization is required and billing must use a valid NDC; home administration is allowed.

Step Therapy

Step	Requirement
1	Prior authorization required for this non‑preferred product; coverage considered only when initial authorization criteria for Jynarque (tolvaptan) are met. Billing must use a valid NDC code. Site of service: home allowed.

Site of Care

Note

Home use allowed

Home administration is permitted for Jynarque; the site-of-service restriction does not prohibit home use.

Site of service allowed: Home