Jynarque - NC Standard

Restricted Product(s)

• Jynarque® (tolvaptan)

FDA Approved Use

• To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has been diagnosed with autosomal dominant polycystic kidney disease (ADPKD) (medical record documentation required); AND 
3. The patient is at risk of rapidly progressive disease (e.g. advanced stage kidney disease according to age, hypertension before age 35, enlarged kidneys) (medical record documentation required); AND 
4. The patient has chronic kidney disease (CKD) stages 2-4 (medical record documentation required); AND 
5. The patients estimated glomerular filtration rate (eGFR) is ≥ 25 ml/min/1.73m2 (medical record documentation required); AND 
6. The patient is being managed by or in consultation with a nephrologist; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 90 days

Continuation Coverage Criteria

1. The patient has been previously approved for Jynarque with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has demonstrated positive clinical response to therapy (i.e. slowed kidney function decline, decreased kidney pain, etc.) (medical record documentation required); AND 
3. The requested medication continues to be prescribed by or in consultation with a nephrologist; AND 

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

July 2022: Criteria change: Added age restriction of 18 years of age or older. Updated criteria to define patient is at risk of rapidly progressive disease. Added chronic kidney disease stage and initial eGFR required. Added complete continuation criteria. Decreased initial duration of approval to 90 days.

January 2021: Criteria update: Clarified the QL on Jynarque 30mg is 1 tablet per day.

May 2020: Criteria update: Added new strengths Jynarque 15mg and 30-15mg therapy packs to the policy.

May 2019: Criteria Update: added new dosage forms to policy

May 2018: Original utilization management criteria issued.