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Jynarque Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1092
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 |
7/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Jynarque® (tolvaptan) Tablet |
To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
|
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
ADPKD |
Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited cause of kidney disease that affects approximately 12.5 million people worldwide. Mutations in two genes have been identified to be the major cause of ADPKD. Mutations in the PKD1 gene (located on chromosome 16) account for 85% of cases, while mutations in the PKD2 gene (located on chromosome 4) account for 15% of cases. ADPKD is a systemic disorder characterized by continuous cyst development and growth within the kidneys and other organs, leading to numerous clinical manifestations. End stage renal disease ensues, typically after the fourth decade of life.(2-4)
|
Efficacy(1) |
Tolvaptan was shown to slow the rate of decline in renal function in patients at risk of rapidly progressing ADPKD in two trials; TEMPO 3:4 in patients at earlier stages of disease and REPRISE in patients at later stages. TEMPO 3:4 was a phase 3, double-blind, placebo-controlled, randomized trial which included 1445 adult patients (age greater than 18 years) with early (estimated creatinine clearance [eCrCl] greater than or equal to 60 mL/min), rapidly progressing (TKV greater than or equal to 750 mL and age less than 51 years) ADPKD (diagnosed by modified Ravine criteria). The trial met its prespecified primary endpoint of 3‑year change in TKV (p less than 0.0001). Over the 3-year period, TKV increased by 2.8% per year (95% confidence interval [CI], 2.5 to 3.1) with tolvaptan versus 5.5% per year (95% CI, 5.1 to 6.0) with placebo. The relative rate of ADPKD-related events was decreased by 13.5% in tolvaptan-treated patients, (44 vs. 50 events per 100 person-years; hazard ratio, 0.87; 95% CI, 0.78 to 0.97; p=0.0095). REPRISE was a double-blind, placebo-controlled randomized withdrawal trial in adult patients (age 18-65) with chronic kidney disease (CKD) with an eGFR between 25 and 65 mL/min/1.73 m^2 if younger than age 56; or eGFR between 25 and 44 mL/min/1.73 m^2, plus eGFR decline greater than 2.0 mL/min/1.73 m^2/year if between age 56-65. Subjects were to be treated for 12 months; after completion of treatment, patients entered a 3‑week follow-up period to assess renal function. The change of eGFR from pretreatment baseline to post-treatment follow-up was –2.3 mL/min/1.73 m^2/year with tolvaptan as compared with – 3.6 mL/min/1.73 m^2/year with placebo, corresponding to a treatment effect of 1.3 mL/min/1.73 m^2/year (p less than 0.0001). The key secondary endpoint (eGFR slope in ml/min/1.73 m^2/year assessed using a linear mixed effect model of annualized eGFR (CKD-EPI)) showed a difference between treatment groups of 1.0 ml/min/m^2/year that was also statistically significant (p less than 0.0001). |
Safety(1) |
Jynarque has the following black box warnings:
Jynarque has the following contraindications:
In a 3-year placebo-controlled trial and its open-label extension (in which patients’ liver tests were monitored every 4 months), evidence of serious hepatocellular injury (elevations of hepatic transaminases of at least 3 times the upper limit of normal [ULN] combined with elevated bilirubin at least 2 times the ULN) occurred in 0.2% (3/1487) of tolvaptan treated patients compared to none of the placebo treated patients. To reduce the risk of significant or irreversible liver injury, assess ALT, AST and bilirubin prior to initiation of Jynarque, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter. At the onset of signs or symptoms consistent with hepatic injury or if ALT, AST, or bilirubin increase to greater than 2 times ULN, immediately discontinue Jynarque, obtain repeat tests as soon as possible (within 48-72 hours), and continue testing as appropriate. If laboratory abnormalities stabilize or resolve, Jynarque may be reinitiated with increased frequency of monitoring as long as ALT and AST remain below 3 times ULN. Do not restart Jynarque in patients who experience signs or symptoms consistent with hepatic injury or whose ALT or AST ever exceeds 3 times ULN during treatment with tolvaptan, unless there is another explanation for liver injury and the injury has resolved. In patients with a stable, low baseline AST or ALT, an increase above 2 times baseline, even if less than 2 times upper limit of normal, may indicate early liver injury. Such elevations may warrant treatment suspension and prompt (48-72 hours) re-evaluation of liver test trends prior to reinitiating therapy with more frequent monitoring. |
REFERENCES
Number |
Reference |
1 |
Jynarque prescribing information. Otsuka America Pharmaceuticals, Inc. October 2020. |
2 |
Chapman, A.B., Devuyst, O., Eckardt, K.-U., Gansevoort, R. T., Harris, T., Horie, S., Kasiske, B. L., Odland, D., Pei, Y., Perrone, R. D., Pirson, Y., Schrier, R. W., Torra, R., Torres, V. E., Watnick, T., & Wheeler, D. C. (2015). Autosomal-dominant polycystic kidney disease (ADPKD): Executive summary from a kidney disease: Improving global outcomes (KDIGO) controversies conference. Kidney International, 88(1), 17–27. https://doi.org/10.1038/ki.2015.59 |
3 |
Srivastava, A., Patel, N., Autosomal dominant polycystic kidney disease. American Academy of Family Physician. 2014;90(5):303-307. |
4 |
Soroka, S., Alam, A., Bevilacqua, M., Girard, L.-P., Komenda, P., Loertscher, R., McFarlane, P., Pandeya, S., Tam, P., & Bichet, D. G. (2018). Updated Canadian expert consensus on assessing risk of disease progression and pharmacological management of autosomal dominant polycystic kidney disease. Canadian Journal of Kidney Health and Disease, 5, 205435811880158. https://doi.org/10.1177/2054358118801589 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
Jynarque |
tolvaptan tab |
15 MG ; 30 MG |
M ; N ; O ; Y |
M ; N ; O ; Y |
|
|
Jynarque |
tolvaptan tab therapy pack |
15 MG ; 30 MG ; 45 MG ; 60 MG ; 90 MG |
M ; N ; O ; Y |
N |
|
|
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 |
Effective Date |
|
||||||||||
Jynarque |
tolvaptan tab |
30 MG |
30 |
TABS |
1 |
DAYS |
|
|
59148-0083-13 |
|
Jynarque |
tolvaptan tab |
15 MG |
60 |
TABS |
1 |
DAYS |
|
|
31722-0868-03 ; 31722-0868-31 ; 59148-0082-13 ; 60505-4317-00 ; 67877-0635-02 ; 67877-0635-33 |
|
Jynarque |
tolvaptan tab therapy pack |
15 MG ; 30 MG ; 45 MG ; 60 MG ; 90 MG |
56 |
TABS |
28 |
DAYS |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Jynarque |
tolvaptan tab |
15 MG ; 30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jynarque |
tolvaptan tab therapy pack |
15 MG ; 30 MG ; 45 MG ; 60 MG ; 90 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 |
Jynarque |
tolvaptan tab |
30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jynarque |
tolvaptan tab |
15 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jynarque |
tolvaptan tab therapy pack |
15 MG ; 30 MG ; 45 MG ; 60 MG ; 90 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months 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 |
Evaluation Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 12 months |
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 _ Jynarque Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023