Pharmacy Prior Authorization Criteria

Promacta (eltrombopag)

Indications for Prior Authorization

Promacta (eltrombopag)

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of 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.

Criteria

Promacta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Persistent or Chronic Idiopathic Thrombocytopenic Purpura (ITP)

• Diagnosis of one of the following:
• Persistent ITP
• Chronic ITP
• Relapsed/refractory ITP [8]
AND
• Baseline platelet count is less than 30,000/mcL [2, 3, 8]
AND
• Trial and failure, contraindication, or intolerance to one of the following: [2, 3, 8]
• 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

Promacta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For 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

Promacta

Prior Authorization

Length of Approval: 6 Months [A]
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) [1]
AND
• Patient meets at least TWO of the following [9, 10]:
• 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) [1]
AND
• Prescribed by or in consultation with a hematologist/oncologist

Promacta

Prior Authorization (Initial Authorization)

Length of Approval: 16 weeks [B]
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 [5-7]
AND
• Patient has thrombocytopenia defined as platelet count less than 30,000/mcL
AND
• Prescribed by or in consultation with a hematologist/oncologist

Promacta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Refractory Severe Aplastic Anemia

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

Promacta

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [C]
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 [1]
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

Promacta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For 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 [1]
AND
• Documentation that the patient reached a threshold platelet count that allows initiation of antiviral interferon therapy with Promacta treatment by week 9 [C]
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

P & T Revisions

2023-10-04, 2022-01-06, 2021-09-27, 2021-05-21, 2021-02-09, 2020-04-14, 2020-01-16

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.

---

End Notes

1. The prescribing information states that the total duration of Promacta treatment for first-line severe aplastic anemia is 6 months. [1]
2. In patients with severe aplastic anemia, hematologic response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting Promacta. 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 Promacta, therapy should be discontinued. [1]
3. Promacta was studied in two phase 3 trials for chronic hepatitis C-associated thrombocytopenia in two periods. Patients received Promacta 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, initiation of antiviral therapy in combination with interferon and ribavirin was administered for up to 48 weeks in the second period. The lowest dose of Promacta should be used to achieve and maintain a platelet count necessary to initiate and maintain interferon-based therapy. Dose adjustments are based upon the platelet count response. [1]

---

Revision History

• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2022-01-06: 2022 Annual Review: Updated indication and diagnosis criteria to include 'Persistent ITP', updated background information
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-02-09: 2021 Annual Review, no changes to criteria.
• 2020-04-14: Updated to add new 25 mg powder pack for suspension.
• 2020-01-16: 2020 Annual Review - No changes to criteria.

---