ph-9991098
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Samsca (tolvaptan) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-9991098

This program applies to Blue Partner, Commercial, GenPlus, NetResults A Series, SourceRx and Health Insurance Marketplace formularies.

Samsca (tolvaptan) Prior Authorization and Quantity Limit

TARGET AGENT(S)

Samsca® (tolvaptan)a

  1. Generic equivalent available

Brand (generic)

GPI (NDC)

Multisource Code

Quantity Limit

(per day or as listed)

Samsca (tolvaptan)a

15 mg tablet

30454060000320 (59148-0020-**,

60505-4704-**)

M, N, O, or Y

30 tablets/365 days

30 mg tablet

30454060000330 (59148-0021-**, 60505-4705-**, 67877-0636-**)

M, N, O, or Y

60 tablets/365 days

  1. Generic equivalent available

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The requested agent was initiated (or re-initiated) in the hospital

AND

  1. Prior to initiating the requested agent, 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

    1. serum sodium >125 mEq/L and patient has symptomatic hyponatremia that has resisted correction with fluid restriction

AND

  1. The patient does NOT have underlying liver disease, including cirrhosis

AND

  1. Medications known to cause hyponatremia (e.g., amiodarone, amitriptyline, carbamazepine, ciprofloxacin, haloperidol, methotrexate, MAOIs, NSAIDs, opiates, SSRIs, sodium valproate, thioridazine) have been evaluated and discontinued when appropriate

AND

  1. The patient will NOT be using the requested agent in combination with another tolvaptan agent

AND

  1. The patient does not have any FDA labeled contraindications to the requested agent

AND

  1. The patient has not already received 30 days of therapy with the requested agent for the current hospitalization

AND

  1. ONE of the following:
    1. The requested quantity (dose and/or duration of therapy) does NOT exceed the program quantity limit

OR

    1. BOTH of the following:
      1. The requested quantity (dose and/or duration of therapy) is greater than the program quantity limit

  AND

      1. The patient has had an additional hospitalization for hyponatremia and for initiation of the requested agent

Length of Approval:  30 tablets/365 days of the 15 mg tablets

60 tablets/365 days of the 30 mg tablet

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Samsca® (tolvaptan)

Tablet

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

Initial: 15 mg once daily

May increase dose to 30 mg once daily after at least 24 hours

Maximum daily dose: 60 mg, as needed to achieve the desired level of serum sodium

Do not administer Samsca for more than 30 days to minimize the risk of liver injury

CLINICAL RATIONALE

Hyponatremia is a common electrolyte disorder in clinical practice, occurring in up to 15-30% of acute and chronically hospitalized patients. While many cases of hyponatremia are considered mild and relatively asymptomatic, appropriate management of hyponatremia is important for the following reasons: acute severe hyponatremia can cause substantial morbidity and mortality; hyponatremia-related mortality is greater in patients with a wide range of underlying conditions; and too rapid of a correction of serum sodium may cause severe neurologic damage and death.2 

                                     

Hyponatremia can be classified as hypo-, hyper-, and isotonic; with hypotonic hyponatremia being further classified based on a patient’s extracellular fluid volume (as either hypovolemic hyponatremia, euvolemic hyponatremia, and hypervolemic hyponatremia). Hypovolemic hyponatremia is associated with fluid depletion and can arise from a number of conditions. Hypervolemic hyponatremia is caused by fluid overload, as in advanced liver cirrhosis, renal disease, or congestive heart failure. Euvolemic hyponatremia is most commonly associated with Syndrome of Inappropriate Antidiuretic Hormone (SIADH).2

Certain medications are associated with SIADH: 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, thiothixenevinblastine, vincristine, vinorelbine.  Discontinuing these medications can lead to the rapid reversal of SIADH.3

Appropriate treatment should be based on the type of hyponatremia. Treatment strategies can include water replacement/restriction; diuretic therapy; sodium supplementation; hemodialysis in renally impaired patients; demeclocycline, lithium or urea; and arginine vasopressin (AVP) receptor antagonists. The 2013 expert panel recommendations note that, after initiation of fluid restrictions, medications known to cause SIADH should be discontinued or changed.2

Efficacy1

Samsca is a vasopressin V2-receptor antagonist approved for the treatment of patients with hypervolemic or euvolemic hyponatremia. Binding of tolvaptan to the V2-receptor increases serum sodium concentrations by antagonizing the effect of vasopressin, increasing urine water excretion, increasing free water clearance (aquaresis), and decreasing urine osmolality.

Safety1

Boxed Warning

Samsca should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.

Due to the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS program.

Contraindications

  • Use in patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approve REMS
  • Urgent need to raise serum sodium acutely
  • Inability of patient to sense or appropriately respond to thirst
  • Hypovolemic hyponatremia
  • Concomitant use with strong cytochrome P450 3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin).
  • Anuria
  • Hypersensitivity to tolvaptan or any component of the product

Warnings and Precautions

  • Too rapid correction of serum sodium can cause serious neurologic sequelae
  • Liver injury: Limit treatment duration to 30 days. If hepatic injury is suspected, discontinue Samsca. Avoid use in patients with underlying liver disease, including cirrhosis
  • Dehydration and hypovolemia
  • Co-administration with hypertonic saline
  • Drug interactions including use with CYP 3A inducers and CYP3A inhibitors. Consider dose reduction of co-administered with P-gp inhibitors
  • Hyperkalemia or drugs that increase serum potassium

REFERENCES

  1. Samsca Prescribing Information. Otsuka Pharmaceutical Co., Ltd. May 2019.
  2. Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns RH, Thompson CJ. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. https://doi.org/10.1016/j.amjmed.2013.07.006 Am J Med. 2013;126:0.
  3. Spasovski G, Vanholder R, Allolio B, et al. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Neprhol Dial Transplant 2014; 29 Suppl 2:i1.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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