Samsca – NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Samsca® (tolvaptan)

FDA Approved Use

• 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).

Criteria for Approval of Restricted Product(s)

1. Samsca (tolvaptan) therapy was initiated (or re-initiated) in the hospital; AND 
2. Prior to initiating therapy, the patient has/had a diagnosis of clinically significant hypervolemic or euvolemic hyponatremia defined by ONE of the following:
   1. Serum sodium <125 mEq/L; OR 
   2. Serum sodium >125 mEq/L and patient has symptomatic hyponatremia that has resisted correction with fluid restriction; AND 
3. The patient has no underlying liver disease, including cirrhosis; AND 
4. Medications known to cause hyponatremia (see table below) have been evaluated and discontinued when appropriate; AND 
5. The patient has not already received 30 days of Samsca (tolvaptan) therapy following the most recent hospitalization; AND 
6. If the requested medication is for brand Samsca: 
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic tolvaptan; AND 
7. The dose requested is according to FDA approved labeling and quantity limits; AND 
8. The patient does not have any FDA labeled contraindications; AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 30 days

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).

Medications Known to Cause Hyponatremia

amiodarone, amitriptyline, bromocriptine, carbamazepine, ciprofloxacin, cisplatin, chlorpropamide, cyclophosphamide (high doses given intravenously), haloperidol, ifosfamide, imatinib (high doses) interferon-alpha, interferon-gamma, lorcainide, melphalan, methotrexate, monoamine oxidase inhibitors, non-steroidal anti-inflammatory agents, opiates, selective serotonin reuptake inhibitors, sodium valproate, thioridazine, thiothixene, vinblastine, vincristine, vinorelbine

References

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

Policy Implementation/Update Information

September 2022: Criteria update: Format changes. Added restriction applies to brand and generic products.
March 2022: Criteria update: Format changes; no updates to criteria
October 2020: Criteria change: Removed ‘30mg’ from criteria point #6 due to generic tolvaptan 15mg tablets becoming available.
June 2020: Criteria change: Reformatted criteria and added generic Samsca (tolvaptan) to the policy.
April 2017: Label reviewed; no changes to criteria.
January 2016: Original utilization management criteria issued.