CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tolvaptan (Jynarque) — Prior Authorization and Coverage Criteria for ADPKD

Covers prior authorization, documentation, and medical necessity criteria for Jynarque (tolvaptan) to slow kidney function decline in adults with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Affects providers prescribing to Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTolvaptan (Jynarque) — Prior Authorization and Coverage Criteria for ADPKD

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with imaging and/or genetic test results and confirm member meets age, eGFR (>=25 mL/min/1.73m2), and Mayo htTKV class criteria before prescribing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

6 monthscontinuation authorization duration

>=25minimum eGFR required

Mayo 1C/1D/1Erequired htTKV disease class

1-2 tabs/day

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daily dispensing limits

Coverage Criteria for Tolvaptan (Jynarque)

Initial approval

Covered when ALL of the following are met

Age and diagnosis

Imaging/genetic diagnostic options: (1) Age 18 to <40 with first-degree relative: >=3 cysts (unilateral or bilateral) OR (2) Age 40 to <60 with first-degree relative: >=2 cysts per kidney OR (3) Age >=60 with first-degree relative: >=4 cysts per kidney OR (4) No family history: positive PKD1/PKD2 genetic test

Prescriber: Prescribed by, or in consultation with, a nephrologist or physician specializing in ADPKD management

Rapidly progressing disease: Member has or is at risk for rapidly progressing disease as confirmed by height-adjusted total kidney volume compatible with Mayo class 1C, 1D, or 1EMayo class 1C-1E

Renal function: Member's estimated glomerular filtration rate (eGFR) is >= 25 mL/min/1.73m2>= 25 mL/min/1.73m2

Contraindications absent: Member does not have any of the following contraindications: liver impairment or injury, concurrent strong CYP3A4 inhibitor use, inability to sense or respond to thirst, abnormal serum sodium (particularly hypernatremia), hypovolemia, concomitant diuretic use, or uncorrected urinary outflow obstruction

Continuation/reauthorization

Covered when ALL of the following are met

Benefit demonstrated: Member has demonstrated a beneficial response to Jynarque therapy (e.g., slowed kidney function decline, decreased kidney pain)

Examples provided in policy

Renal function maintained: Member's estimated glomerular filtration rate (eGFR) is >= 25 mL/min/1.73m2>= 25 mL/min/1.73m2

Same eGFR threshold for continuation

Use of Jynarque (tolvaptan) for any indication other than to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) is considered experimental/investigational and is not covered.

All other indications beyond the FDA‑approved ADPKD indication are not medically necessary and will not be authorized.

Coding and Quantity Limits

Quantity-limited formulationsNDC

Jynarque pak 15-15mg, 30-15mg, 45-15mg, 60-30mg, 90-30mg	specified package formulations with quantity limit of 2 tablets per day
Jynarque 15mg & 30mg	formulations with quantity limit of 1 tablet per day

Quantity limits by formulation (summary)mixed

Jynarque pak 15-15mg, 30-15mg, 45-15mg, 60-30mg, 90-30mg	quantity limit: 2 tablets per day
Jynarque 15mg	quantity limit: 1 tablet per day
Jynarque 30mg	quantity limit: 1 tablet per day

inv-06: eGFR threshold — clinical threshold value

eGFR threshold for initial and continuation approval>= 25 mL/min/1.73m2

Source policy sectionMember's estimated glomerular filtration rate (eGFR) is greater than or equal to 25 mL/min/1.73m2 for initial approval (Section III, D)

Continuation requirementSame eGFR threshold (>= 25 mL/min/1.73m2) required for reauthorization/continuation (Section IV)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization may be granted for up to 6 months for adults (age ≥18) meeting diagnostic and disease-progression criteria for ADPKD; prescriber must be a nephrologist or physician experienced in ADPKD management or in consultation with one.

Authorization duration: up to 6 months
Prescriber requirement: nephrologist or in consultation with nephrology

Documentation Required

Required Documentation for Prior Authorization

Providers must submit diagnostic imaging (ultrasound, MRI, or CT) demonstrating cyst burden and Mayo classification, and genetic testing results when applicable, to confirm rapidly progressing ADPKD.

Acceptable imaging: ultrasonography, MRI, or CT
Genetic testing: results required if no family history or when used to confirm diagnosis (PKD1 or PKD2 mutation)

Background

Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disorder marked by progressive development of renal cysts and enlargement of the kidneys, leading to declining kidney function. Tolvaptan (Jynarque) is FDA‑approved specifically to slow kidney function decline in adults at risk of rapidly progressing ADPKD, and use should be limited to that indication per the approval.

Definitions and Diagnostic Criteria

inv-13: Ultrasound diagnostic cyst criteria — diagnostic imaging criteria by age and family history for ADPKD

Age 18 to <40 with first‑degree relative>= 3 cysts (unilateral or bilateral) by any radiologic method

Age 40 to <60 with first‑degree relative>= 2 cysts per kidney by any radiologic method

Age >=60 with first‑degree relative>= 4 cysts per kidney by any radiologic method

No family historyRequires positive genetic test for ADPKD (PKD1 or PKD2 mutation) instead of imaging criteria

inv-14: Mayo classification (htTKV) — Height-adjusted total kidney volume Mayo classes indicating rapidly progressive disease (1C/1D/1E)

Mayo htTKV classes indicating rapidly progressing diseaseMayo class 1C, 1D, or 1E

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTolvaptan (Jynarque) — Prior Authorization and Coverage Criteria for ADPKD

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with imaging and/or genetic test results and confirm member meets age, eGFR (>=25 mL/min/1.73m2), and Mayo htTKV class criteria before prescribing.

SourceLink

On This Page

Note

Indication Limits

Indication limited to slowing kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). All other uses are considered experimental/investigational and not medically necessary.

Denial Risk

Clinical Contraindications — Deny/Exclude

Do not approve if any contraindications are present: eGFR < 25 mL/min/1.73 m2, liver impairment or injury, concurrent strong CYP3A4 inhibitor use, inability to sense or respond to thirst, abnormal serum sodium (especially hypernatremia), hypovolemia, concomitant diuretic use, or uncorrected urinary outflow obstruction.

eGFR threshold: < 25 mL/min/1.73 m2 — contraindication
Listed contraindications: liver impairment/injury; strong CYP3A4 inhibitors; inability to sense/respond to thirst; abnormal serum sodium; hypovolemia; concomitant diuretics; uncorrected urinary outflow obstruction

Prior Authorization

Provider Action — Required Steps to Support PA

Provider action: confirm member is 18 years or older with ADPKD per radiologic or genetic criteria, confirm Mayo class 1C/1D/1E by height-adjusted total kidney volume, ensure eGFR ≥ 25 mL/min/1.73 m2, collect required imaging/genetic documentation, and verify prescriber specialty or consultation.

Age: ≥ 18 years
Diagnostic confirmation: radiologic cyst criteria by age group OR positive PKD1/PKD2 genetic test if no family history
Progression criteria: height-adjusted total kidney volume compatible with Mayo class 1C, 1D, or 1E
Renal function: eGFR ≥ 25 mL/min/1.73 m2
Documentation: submit ultrasound/MRI/CT images and genetic test results (if applicable)
Prescriber: nephrologist or consultation with nephrology

Use for initial approvalMember has or is at risk for rapidly progressing disease as confirmed by height‑adjusted total kidney volume compatible with Mayo class 1C–1E (Section III, C)