Pharmacy Prior Authorization Criteria

Tolvaptan Products - PA, NF

Indications for Prior Authorization

Samsca (tolvaptan)

• For diagnosis of 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).

  Important limitations: Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with Samsca. It has not been established that raising serum sodium with Samsca provides a symptomatic benefit to patients.

Jynarque (tolvaptan)

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

Criteria

Brand Samsca or Generic tolvaptan

Prior Authorization

Length of Approval: 30 Days [1]

• One of the following:
• Diagnosis of significant euvolemic hyponatremia [1-3, A-B]
• Diagnosis of significant hypervolemic hyponatremia [1-3, A, C]
AND
• Treatment has been initiated or re-initiated in a hospital setting prior to discharge within the past 30 days [1, D]
AND
• Trial and failure or intolerance to generic tolvaptan (applies to Brand Samsca only)

Jynarque

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
AND
• One of the following:
• Both of the following:
• Patient is new to therapy or has received Jynarque for less than or equal to 18 months
AND
• 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 [E]
OR
• Both of the following:
• Patient has received Jynarque for longer than 18 months
AND
• ALT, AST, and bilirubin will be measured at least every 3 months [E]
AND
• Patient does not have a history of significant liver impairment or injury, not including uncomplicated polycystic liver disease [E]

Jynarque

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• One of the following:
• Patient does not have signs or symptoms consistent with hepatic injury [E]
OR
• 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
• 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 [E]
OR
• Both of the following:
• Patient has received Jynarque for longer than 18 months
AND
• ALT, AST, and bilirubin will be measured at least every 3 months [E]

Jynarque

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient is new to therapy or has received Jynarque for less than or equal to 18 months
AND
• 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 [E]
OR
• Both of the following:
• Patient has received Jynarque for longer than 18 months
AND
• ALT, AST, and bilirubin will be measured at least every 3 months [E]
AND
• Patient does not have a history of significant liver impairment or injury, not including uncomplicated polycystic liver disease [E]

Jynarque

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• One of the following:
• Patient does not have signs or symptoms consistent with hepatic injury [E]
OR
• Patient has uncomplicated polycystic liver disease
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient has received Jynarque for less than or equal to 18 months
AND
• 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 [E]
OR
• Both of the following:
• Patient has received Jynarque for longer than 18 months
AND
• ALT, AST, and bilirubin will be measured at least every 3 months [E]

P & T Revisions

2024-02-29, 2024-02-23, 2023-10-04, 2023-03-14, 2022-04-06, 2022-02-08, 2021-10-17, 2021-04-08, 2020-08-19, 2020-06-30, 2020-04-28, 2019-08-22

References

1. Samsca Prescribing Information. Otsuka America Pharmaceuticals, Inc. Rockville, MD. April 2021.
2. Ghali JK. Mechanisms, risks, and new treatment options for hyponatremia. Cardiology. 2008;11:147-157.
3. 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.
4. Jynarque Prescribing Information. Otsuka America Pharmaceuticals, Inc. Rockville, MD. October 2020.

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End Notes

1. Normal extracellular fluid volume and osmolality are maintained when the serum sodium concentration is regulated within a narrow range (136 to 148 mEq/L). [2] Hypotonic hyponatremia, a disorder of impaired water excretion rather than salt depletion, results from the kidneys' inability to excrete enough free water to offset water intake. [2] Hypotonic hyponatremia is classified based on the patient's extracellular fluid (ECF) volume status as hypovolemic hyponatremia, euvolemic hyponatremia, or hypervolemic hyponatremia. [3] Samsca is indicated for the treatment of clinically significant euvolemic and hypervolemic hyponatremia, defined as a serum sodium of less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction. [1]
2. Many different hypo-osmolar disorders can potentially present clinically with a normal ECF volume, or euvolemia, in part because it is difficult to detect modest changes in volume status using standard methods of clinical assessment. [3] Most patients with hyponatremia have clinical euvolemia (most commonly associated with the syndrome of inappropriate secretion of antidiuretic hormone [SIADH] or due to other causes [e.g., hypothyroidism, adrenal insufficiency, other disorders of excess water intake]) and are generally diagnosed clinically from the history, physical examination, and laboratory results. [2-3] Patients without clinical signs of volume depletion (e.g., orthostatic decreases in blood pressure and increases in pulse rate, dry mucus membranes, decreased skin turgor) or volume expansion (e.g., subcutaneous edema, ascites) should be considered to have euvolemia unless there is alternative evidence suggesting an abnormal ECF volume status. [3] Supportive laboratory results include a normal or low blood urea nitrogen (BUN) and a low serum uric acid level. [3] A spot urine sodium concentration should be greater than or equal to 30 mmol/L in most patients with euvolemic hyponatremia unless they have become secondarily sodium depleted. [3]
3. The presence of clinically detectable increased ECF volume generally reflects hypervolemia from some degree of body sodium excess. [3] Hyponatremia with ECF volume excess can arise in a variety of diseases (e.g., congestive heart failure, cirrhosis, renal failure). [3] Because intravascular volume cannot be easily measured directly, volume excess is generally diagnosed clinically from the history, physical examination, and laboratory results. [3] Patients with clinical signs of volume overload (e.g., subcutaneous edema, ascites, pulmonary edema) should be considered to have hypervolemia unless there are alternative explanations for these findings. [3] Elevation of plasma levels of brain natriuretic peptide (BNP) provides useful laboratory support for the presence of volume overload. [3] The urine sodium, or fractional sodium excretion, is usually low (spot urine sodium of less than 30 mmol/L) in patients with hypervolemic hyponatremia due to activation of the renin-angiotensin-aldosterone system (RAAS) with secondary renal sodium conservation despite the whole-body volume overload. [3]
4. Because of the risk of osmotic demyelination associated with overly-rapid correction of serum sodium, tolvaptan should be initiated in a hospital so that the serum sodium concentration can be monitored easily. If therapy is discontinued for any reason and the patient becomes hyponatremic, tolvaptan should be re-initiated in a hospital if further treatment with tolvaptan is indicated. "In a hospital" means anywhere in a hospital where the patient can be observed and serum sodium levels can be obtained (e.g., an emergency department, an observation unit, or an inpatient bed). [1]
5. Jynarque can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. ALT, AST and bilirubin should be monitored prior to initiation, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter. [4]

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Revision History

• 2024-02-29: 2024 UM Annual Review. No criteria changes. Updated guideline name to include "PA, NF"
• 2024-02-23: Updates to initial auth criteria for Jynarque to clarify that criteria requiring patients have received Jynarque for less than or equal to 18 months also includes patients new to therapy. No changes to clinical intent
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-03-14: 2023 UM Annual Review. No criteria changes. Separated out PA and NF criteria for Jynarque
• 2022-04-06: Addition of generic tolvaptan 15 mg as a target drug and a prerequisite for brand Samsca. Annual review - no criteria changes; reference updates.
• 2022-02-08: Updated Jynarque criteria to clarify lab monitoring requirements
• 2021-10-17: Addition of OptumRx SP EHB formulary
• 2021-04-08: New program
• 2020-08-19: 2021 Guideline Loading created from HPMS Submission file
• 2020-06-30: Added generic product GPI to guideline.
• 2020-04-28: Annual review: Background updates.
• 2019-08-22: 2020 Migration Upload No Change (Formulary Copy)

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