ALVAIZ (eltrombopag)

ALVAIZ (eltrombopag)

Self-Administration – tablets

Diagnosis considered for coverage:

• Treatment of Thrombocytopenia in Patients with Persistent or Chronic Immune Thrombocytopenia: Indicated for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
• Treatment of Thrombocytopenia in Patients with Hepatitis C Infection: Indicated for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
• Treatment of Severe Aplastic Anemia: Indicated for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
• Limitations of Use: ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndromes (MDS). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Coverage Criteria:

For diagnosis of Immune thrombocytopenia (ITP):

• Diagnosis of one of the following: 
  • Persistent ITP 
  • Chronic ITP 
  • Relapsed/refractory ITP, AND
• Baseline platelet count is less than 30,000/mcL, AND
• Trial and failure, contraindication, or intolerance to one of the following: 
  • Corticosteroids 
  • Immunoglobulins
  • Splenectomy, AND
• Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding, AND
• Prescribed by or in consultation with a hematologist/oncologist 

For diagnosis of Refractory Severe Aplastic Anemia:

• Diagnosis of refractory severe aplastic anemia (SAA), AND
• Trial and failure, contraindication, or intolerance to immunosuppressive therapy with antithymocyte globulin (ATG) and cyclosporine, AND
• Patient has thrombocytopenia defined as platelet count less than 30,000/mcL, AND
• Prescribed by or in consultation with a hematologist/oncologist 

For diagnosis of Chronic Hepatitis C-Associated Thrombocytopenia:

• Diagnosis of chronic hepatitis C-associated thrombocytopenia, AND
• One of the following: 
  • Planning to initiate and maintain interferon-based treatment, OR
  • Currently receiving interferon-based treatment, AND 
• Prescribed by or in consultation with one of the following: 
  • Hematologist/oncologist 
  • Hepatologist 
  • Gastroenterologist 
  • Infectious disease specialist 
  • HIV specialist certified through the American Academy of HIV Medicine 

Reauthorization Criteria:

For diagnosis of Immune thrombocytopenia (ITP):

• Patient demonstrates positive clinical response to therapy as evidenced by an increase in platelet count to a level sufficient to avoid clinically important bleeding 

For diagnosis of Refractory Severe Aplastic Anemia:

• Patient demonstrates positive clinical response to therapy as evidenced by an increase in platelet count 

For diagnosis of Chronic Hepatitis C-Associated Thrombocytopenia:

• One of the following: 
  • For patients that started treatment with Alvaiz prior to initiation of treatment with interferon, Alvaiz will be approved when both of the following criteria are met: 
    • Currently on antiviral interferon therapy for treatment of chronic hepatitis C, AND
    • Documentation that the patient reached a threshold platelet count that allows initiation of antiviral interferon therapy with Alvaiz treatment by week 9, OR
  • For patients that started treatment with Alvaiz while on concomitant treatment with interferon, Alvaiz will be approved based on the following criterion: 
    • Currently on antiviral interferon therapy for treatment of chronic hepatitis C 

Coverage Duration: 

For diagnosis of Immune thrombocytopenia (ITP):

• Initial: 12 months
• Reauthorization: 12 months

For diagnosis of Refractory Severe Aplastic Anemia:

• Initial: 16 weeks
• Reauthorization: 12 months

For diagnosis of Chronic Hepatitis C-Associated Thrombocytopenia:

• Initial: 3 months
• Reauthorization: 12 months

Dosing: 

For diagnosis of Immune thrombocytopenia (ITP):

• Starting adult dose: 36 mg orally once daily
• Maintenance dose: After initiating ALVAIZ, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 54 mg daily.

For diagnosis of Refractory Severe Aplastic Anemia:

• Starting adult dose: 36 mg orally once daily
• Maintenance dose: Adjust the dose of ALVAIZ in 36-mg increments every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 109/L as necessary. Do not exceed a dose of 108 mg daily.

For diagnosis of Chronic Hepatitis C-Associated Thrombocytopenia:

• Starting adult dose: 18 mg orally once daily
• Maintenance dose: Adjust the dose of ALVAIZ in 18-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Do not exceed a dose of 72 mg daily. 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Eltrombopag was studied in two phase 3 trials for chronic hepatitis C-associated thrombocytopenia in two periods. Patients received eltrombopag in the first period for a maximum of 9 weeks in order to achieve a pre-specified threshold platelet count (greater than or equal to 90 x 10^9/L for Trial 1 and greater than or equal to 100 x 10^9/L for Trial 2); if the pre-specified threshold platelet count was reached, eltrombopag was administered in combination with pegylated interferon and ribavirin for up to 48 weeks in the second period. The lowest dose of Alvaiz should be used to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Dose adjustments are based upon the platelet count response.[1] 
• In patients with refractory severe aplastic anemia, hematologic response requires dose titration, generally up to 108 mg, and may take up to 16 weeks after starting Alvaiz. The dose should be adjusted every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 10^9/L. If no hematologic response has occurred after 16 weeks of therapy with Alvaiz, therapy should be discontinued.

Policy Updates:

• 12/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 11/20/2024) (P&T meeting date) 

References:

1. Alvaiz Prescribing Information. Teva Pharmaceuticals Inc. Parsippany, NJ 07054. November 2023. 
2. Neunert C, Terrell D, Arnold D, et al. The American Society of Hematology 2019 Evidence-based practice guideline for immune thrombocytopenia. Available at: https://ashpublications.org/bloodadvances/article/3/23/3829/429213/American-Society-of-Hematology-2019-guidelines-for. Accessed March 8, 2024. 
3. Bussel JB, Cheng G, Saleh MN, et al. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. New Engl J Med. 2007;357(22):2237-47. 
4. Saleh MN, Bussel JB, Cheng G, et al. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. 2013;121:537-45. 
5. Desmond R, Townsley DM, Dumitriu B, et al. Eltrombopag restores trilineage hematopoiesis in refractory severe aplastic anemia that can be sustained on discontinuation of drug. Blood. 2014;123(12):1818-25. 
6. Per clinical consult with hematologist/oncologist. June 20, 2018. 
7. Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag added to standard immunosuppression for aplastic anemia: Supplementary appendix. N Engl J Med 2017;376:1540-50.