JYNARQUE, SAMSCA (tolvaptan)

JYNARQUE, SAMSCA (tolvaptan)

SELF-ADMINISTRATION - oral

Indications for Prior Authorization:

• Jynarque

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD): Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.

Limitations for use:

JYNARQUE is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the JYNARQUE REMS Program because of the risks of serious liver injury.

• Samsca, tolvaptan:

  • Hyponatremia (hypervolemic and euvolemic): Indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Limitations for use:

SAMSCA and generic tolvaptan should not be used to treat patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms.

SAMSCA and generic tolvaptan tablets have not been established to provide a symptomatic benefit to patients.

Coverage Criteria:

1.    For diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD):

• Dose does not exceed 120 mg total daily dose; AND

• Patient is 18 years of age or older; AND

• Prescribed by or in consultation with a nephrologist; AND

• Diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD); AND

• Will not be used with Samsca; AND

• One of the following:

  • Both of the following:

    • Patient has received JYNARQUE for less than or equal to 18 months; AND 

    • Provider attestation that alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin will be measured prior to initiation, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months of therapy; OR

  • Both of the following:

    • Patient has received JYNARQUE for longer than 18 months; AND 

    • Provider attestation that ALT, AST, and bilirubin will be measured at least every 3 months; AND

• Patient does not have a history of significant liver impairment or injury, not including uncomplicated polycystic liver disease

2.    For diagnosis of Hyponatremia (hypervolemic and euvolemic):

• Dose does not exceed 60 mg once daily; AND

• Patient is 18 years of age or older; AND

• Diagnosis of significant euvolemic OR hypervolemic hyponatremia; AND

• Documentation supporting treatment has been initiated or re-initiated in a hospital setting prior to discharge within the past 30 days; AND

• For Brand SAMSCA only: Medical records confirm trial and failure or intolerance to generic tolvaptan 

Reauthorization Criteria:

1.    For diagnosis of Autosomal Dominant Polycystic Kidney Disease (JYNARQUE only):

• Dose does not exceed 120 mg total daily dose; AND

• Documentation of a positive clinical response to therapy; AND

• One of the following:

  • Patient does not have signs or symptoms consistent with hepatic injury

  • Patient has uncomplicated polycystic liver disease; AND

• One of the following:

  • Both of the following:

    • Patient has received JYNARQUE for less than or equal to 18 months; AND 

    • Provider attestation that alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin will be measured prior to initiation, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months of therapy; OR

  • Both of the following:

    • Patient has received JYNARQUE for longer than 18 months; AND

    • Provider attestation that ALT, AST, and bilirubin will be measured at least every 3 months

Coverage Duration:

1.    For diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD):

• Initial: 1 year

• Reauthorization: 1 year

2.    For diagnosis of Hyponatremia (hypervolemic and euvolemic):

• 30 days

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dose and administration:

  • Jynarque recommended dosing:

    • Initial dose: 60 mg (total daily dose)

      • 45 mg (1st dose taken upon waking)

      • 15 mg taken 8 hours later

    • Titration step: 90 mg (total daily dose)

      • 60 mg (1st dose)

      • 30 mg taken 8 hours later

    • Target dose: 120 mg (total daily dose)

      • 90 mg (1st dose)

      • 30 mg taken 8 hours later

    • Concomitant use with moderate CYP3A inhibitors: reduce dose of Jynarque

  • Samsca recommended dosing:

    • Usual starting dose is 15 mg once daily

    • Increase dose to 30 mg once daily (after at least 24 hours) (maximum of 60 mg once daily)

• Contraindications

  • Taking strong CYP 3A inhibitors 

  • Unable to sense or respond to thirst 

  • Hypersensitivity (e.g., anaphylaxis, rash) to tolvaptan or any component of the product  

  • Anuria 

  • Hypovolemia

  • Uncorrected urinary outflow obstruction 

• JYNARQUE specific contraindications:

  • History, signs, or symptoms of significant liver impairment or injury. This contraindication does not apply to uncomplicated polycystic liver disease 

  • Uncorrected abnormal blood sodium concentrations 

• SAMSCA, tolvaptan specific contraindication:

  • Autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS

• Drug Interactions:

  • Avoid moderate to strong CYP3A inhibitors

  • Avoid V2-receptor antagonists 

  • Avoid hypertonic saline (SAMSCA)

Policy Updates:

• 05/28/2019 – Initial Review of Jynarque

• 06/01/2023 – Updating Jynarque policy to include Samsca and updating formatting

References:

• Ghali JK. Mechanisms, risks, and new treatment options for hyponatremia. Cardiology. 2008;11:147-157. 

• Jynarque Prescribing Information. Otsuka America Pharmaceuticals, Inc. Rockville, MD. October 2020.

• Muller RU, Messchendorp AL, Birn H, et al. An update on the use of tolvaptan for autosomal dominant polycystic kidney disease: Consensus statement on behalf of the ERA Working Group on Inherited Kidney Disorders, the European Rare Kidney Disease Reference Network, and Polycystic Kidney Disease International. Nephrol Dial Transplant. 2022;37:825-839

• National Kidney Foundation. Polycystic kidney disease. Available at: https://www.kidney.org/atoz/content/polycystic. Accessed on March 11, 2023.

• Samsca Prescribing Information. Otsuka America Pharmaceuticals, Inc. Rockville, MD. April 2021. 

• Verbalis JG, Goldsmith SR, Greenberg A, et al. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. The American Journal of Medicine. 2013;126(10 Suppl 1):S1-42.