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Samsca (tolvaptan) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1098
This program applies to Blue Partner, Commercial, GenPlus, NetResults A Series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Samsca® |
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) |
*generic available |
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Hyponatremia |
Hyponatremia is the most common disorder of body fluid and electrolyte balance in clinical practice, occurring in up to 15-30% of acute and chronically hospitalized patients. While many cases are considered mild and relatively asymptomatic, hyponatremia is clinically important for the following reasons: untreated acute severe hyponatremia can cause substantial morbidity and mortality; adverse outcomes, including mortality, are higher in patients with a wide range of underlying conditions; and correction of serum sodium that is too fast may cause severe neurologic damage and death.(2,3) |
Safety |
Samsca is contraindicated in the following conditions:(1)
|
REFERENCES
Number |
Reference |
1 |
Samsca Prescribing Information. Otsuka Pharmaceutical Co., Ltd. April 2021. |
2 |
Verbalis, J. G., Goldsmith, S. R., Greenberg, A., Korzelius, C., Schrier, R. W., Sterns, R. H., & Thompson, C. J. (2013). Diagnosis, evaluation, and treatment of hyponatremia: Expert panel recommendations. The American Journal of Medicine, 126(10). https://doi.org/10.1016/j.amjmed.2013.07.006 |
3 |
Spasovski, G., Vanholder, R., Allolio, B., Annane, D., Ball, S., Bichet, D., Decaux, G., Fenske, W., Hoorn, E. J., Ichai, C., Joannidis, M., Soupart, A., Zietse, R., Haller, M., van der Veer, S., Van Biesen, W., & Nagler, E. (2014). Clinical practice guideline on diagnosis and treatment of hyponatraemia. Nephrology Dialysis Transplantation, 29(suppl_2), i1–i39. https://doi.org/10.1093/ndt/gfu040 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Samsca |
tolvaptan tab |
15 MG ; 30 MG |
M ; N ; O ; Y |
N ; O ; Y |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Samsca |
tolvaptan tab |
15 MG |
30 |
Tablets |
365 |
DAYS |
|
|
31722086803 ; 31722086831 ; 49884076852 ; 49884076854 ; 59148002050 ; 60505431700 ; 67877063502 ; 67877063533 ; 72205013011 |
Samsca |
tolvaptan tab |
30 MG |
60 |
Tablets |
365 |
DAYS |
|
|
31722086903 ; 49884077052 ; 49884077054 ; 59148002150 ; 60505431800 ; 60505470500 ; 60505470501 ; 67877063602 ; 67877063633 ; 72205013111 |
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Samsca |
tolvaptan tab |
15 MG ; 30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Samsca |
tolvaptan tab |
30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Samsca |
tolvaptan tab |
15 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 30 tablets/365 days of the 15 mg tablets NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 30 tablets/365 days of the 15 mg tablets |
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 Blue Cross and Blue Shield of Alabama’s 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.
Commercial _ PS _ Samsca_PAQL _ProgSum_ 07-01-2024
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