PROMACTA (eltrombopag)

PROMACTA (eltrombopag) 

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

Treatment of Thrombocytopenia in Patients with Persistent or Chronic Idiopathic Thrombocytopenic Purpura (ITP): Indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta 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 patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Promacta 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. Limitations of use: • Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Treatment of Severe Aplastic Anemia: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. Indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Coverage Criteria:

For diagnosis of Persistent or Chronic Idiopathic Thrombocytopenic Purpura (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 First-Line for Severe Aplastic Anemia: 

• Diagnosis of severe aplastic anemia, AND
• Used for first-line treatment (i.e., patient has not received prior immunosuppressive therapy with any equine antithymocyte globulin plus cyclosporine, alemtuzumab, or high dose cyclophosphamide), AND
• Patient meets at least TWO of the following:
  • Absolute neutrophil count < 500/mcL 
  • Platelet count < 20,000/mcL 
  • Absolute reticulocyte count < 60,000/mcL, AND 
• Used in combination with standard immunosuppressive therapy (e.g., Atgam [antithymocyte globulin equine] and cyclosporine), AND
• Prescribed by or in consultation with a hematologist/oncologist

For diagnosis of Refractory Severe Aplastic Anemia:

• Diagnosis of refractory severe aplastic anemia, 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
  • 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 the diagnosis of Persistent or Chronic Idiopathic Thrombocytopenic Purpura (ITP):

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

For the diagnosis of Refractory Severe Aplastic Anemia:

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

For the diagnosis of Chronic Hepatitis C-Associated Thrombocytopenia:

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

Coverage Duration:

For diagnosis of Persistent or Chronic Idiopathic Thrombocytopenic Purpura (ITP):

• Initial: 12 months
• Reauthorization: 12 months

For diagnosis of First-Line for Severe Aplastic Anemia:

• Initial: 6 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 Persistent or Chronic Immune Thrombocytopenia:

• Adult and Pediatric Patients 6 Years and Older with ITP: Initiate PROMACTA at a dose of 50 mg once daily, except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh class A, B, C).
  • For patients of East-/Southeast-Asian ancestry with ITP: Initiate PROMACTA at a reduced dose of 25 mg once daily.
  • For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, C): Initiate PROMACTA at a reduced dose of 25 mg once daily.
  • For patients of East-/Southeast-Asian ancestry with ITP and hepatic impairment (Child-Pugh class A, B, C): Consider initiating PROMACTA at a reduced dose of 12.5 mg once daily.
• Pediatric Patients with ITP Aged 1 to 5 Years: Initiate PROMACTA at a dose of 25 mg once daily

For diagnosis of  Chronic Hepatitis C-Associated Thrombocytopenia:

• Initiate Promacta at a dose of 25 mg once daily.

For diagnosis of  Severe Aplastic Anemia:

For the diagnosis of Refractory Severe Aplastic Anemia:

• Initiate PROMACTA at a dose of 50 mg once 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.

Policy Updates:

• Policy created July 21, 2016.
• 12/1/2024 (policy effective date)- Updated criteria with additional indications  (P&T 12/01/2024) (P&T Meeting Nov)

References:

1. Promacta Prescribing Information. Novartis Pharmaceuticals Corp. East Hanover, NJ. October 2021. 
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 January 15, 2021. 
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. Promacta product dossier. GlaxoSmithKline. Research Triangle Park, NC. 2013. 
6. 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. 
7. Marsh JC, Ball SE, Cavenagh J, et al. Guidelines for the diagnosis and management of aplastic anemia. Br J Haematol. 2009;147(1):43-70. 
8. Per clinical consult with hematologist/oncologist. June 20, 2018. 
9. 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.
10. Per clinical consult with hematologist/oncologist. January 24, 2019.