Subject: Promacta-Alvaiz 1928-A SGM P2023a

Drug

PROMACTA  (eltrombopag olamine)

ALVAIZ  (eltrombopag choline)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indications
               Promacta is indicated for:
               1.  Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with
                    persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient
                    response to corticosteroids, immunoglobulins, or splenectomy
               2.  Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation
                    and maintenance of interferon-based therapy
               3.  First-line treatment of severe aplastic anemia in adult and pediatric patients 2 years and
                    older in combination with standard immunosuppressive therapy
               4.  Treatment of patients with severe aplastic anemia who have had an insufficient response
                    to immunosuppressive therapy

               Alvaiz is indicated for:
               1.  Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with
                    persistent or chronic ITP who have had an insufficient response to corticosteroids,
                    immunoglobulins, or splenectomy
               2.  Treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the
                    initiation and maintenance of interferon-based therapy
               3.  Treatment of adult patients with severe aplastic anemia who have had an insufficient
                    response to immunosuppressive therapy

          B.  Compendial Uses
               1.  MYH9-related disease with thrombocytopenia (Promacta only)
               2.  Myelodysplastic syndromes (MDS) (Promacta only)
               3.  Chemotherapy-induced thrombocytopenia (CIT)

          All other indications are considered experimental/investigational and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Persistent or chronic immune thrombocytopenia (ITP):
               1.  For initial requests: pretreatment platelet count
               2.  For continuation requests: current platelet count
         B.  Aplastic anemia continuation of therapy: current platelet count


   III.  EXCLUSIONS

          Coverage will not be provided for members with the following exclusion: Concomitant use of
          the requested drug with other thrombopoietin receptor agonists (e.g., Nplate, Doptelet,
          Mulpleta) or with spleen tyrosine kinase inhibitors (e.g., Tavalisse).


   IV.  PRESCRIBER SPECIALTIES

          A.  For diagnosis of persistent or chronic immune thrombocytopenia (ITP), aplastic anemia,
               MYH9-related disease with thrombocytopenia, myelodysplastic syndromes, and
               chemotherapy-induced thrombocytopenia (CIT), this medication must be prescribed by or in
               consultation with a hematologist or oncologist.
         B.  For diagnosis of thrombocytopenia with hepatitis C, this medication must be prescribed by
               or in consultation with a prescriber specializing in infectious disease, gastroenterology,
               hepatology, or transplant.


    V.  CRITERIA FOR INITIAL APPROVAL

          A.  Persistent or chronic immune thrombocytopenia (ITP)
               Authorization of 6 months may be granted for treatment of persistent or chronic ITP when
               both of the following criteria are met:
               1.  Inadequate response or intolerance to prior therapy with corticosteroids,
                    immunoglobulins, or splenectomy.
               2.  Untransfused platelet count at any point prior to the initiation of the requested medication
                    is less than 30x10⁹/L OR 30x10⁹/L to 50x10⁹/L with symptomatic bleeding (e.g.,
                    significant mucous membrane bleeding, gastrointestinal bleeding or trauma) or risk
                    factors for bleeding (see Appendix).

          B.  Thrombocytopenia associated with chronic hepatitis C
               Authorization of 6 months may be granted to members who are prescribed the requested
               drug for the initiation and maintenance of interferon-based therapy for the treatment of
               thrombocytopenia associated with chronic hepatitis C.

          C.  Aplastic anemia
               1.  Promacta
                    i.     Authorization of 6 months may be granted for first-line treatment of severe aplastic
                           anemia when the requested drug will be used in combination with standard
                           immunosuppressive therapy (e.g., horse antithymocyte globulin [h-ATG] and
                           cyclosporine).
                    ii.    Authorization of 6 months may be granted for treatment of aplastic anemia in
                           members who have had an insufficient response to immunosuppressive therapy.
               2.  Alvaiz
                    Authorization of 6 months may be granted for treatment of aplastic anemia in members
                    who have had an insufficient response to immunosuppressive therapy.

          D.  MYH9-related disease with thrombocytopenia (Promacta only)
               Authorization of 12 months may be granted to members with thrombocytopenia associated
               with MYH9-related disease.

          E.  Myelodysplastic syndromes (Promacta only)
               Authorization of 12 months may be granted for treatment of myelodysplastic syndromes
               (MDS).

          F.  Chemotherapy-induced thrombocytopenia (CIT)
               Authorization of 6 months may be granted for treatment of prolonged thrombocytopenia in
               members who are post-allogeneic transplant and have poor graft function.


   VI.  CONTINUATION OF THERAPY

          A.  Persistent or chronic ITP
               1.  Authorization of 3 months may be granted to members with current platelet count less
                    than 50x10⁹/L for whom the platelet count is not sufficient to prevent clinically important
                    bleeding and who have not received a maximal dose of the requested drug for at least 4
                    weeks.
               2.  Authorization of 12 months may be granted to members with current platelet count less
                    than 50x10⁹/L for whom the current platelet count is sufficient to prevent clinically
                    important bleeding.
               3.  Authorization of 12 months may be granted to members with current platelet count of
                    50x10⁹/L to 200x10⁹/L.
               4.  Authorization of 12 months may be granted to members with current platelet count
                    greater than 200x10⁹/L to less than or equal to 400x10⁹/L for whom dosing for the
                    requested drug will be adjusted to achieve a platelet count sufficient to avoid clinically
                    important bleeding.

          B.  Thrombocytopenia associated with chronic hepatitis C
               Authorization of 6 months may be granted to members who are continuing to receive
               interferon-based therapy.

          C.  Aplastic anemia
               1.  Authorization of up to 16 weeks total may be granted to members with current platelet
                    count less than 50x10⁹/L who have not received appropriately titrated therapy with the
                    requested drug for at least 16 weeks.
               2.  Authorization of up to 16 weeks total may be granted to members with current platelet
                    count less than 50x10⁹/L who are transfusion-independent.
               3.  Authorization of 12 months may be granted to members with current platelet count of
                    50x10⁹/L to 200x10⁹/L.
               4.  Authorization of 12 months may be granted to members with current platelet count
                    greater than 200 x10⁹/L to less than or equal to 400x10⁹/L for whom dosing for the
                    requested drug will be adjusted to achieve and maintain an appropriate target platelet
                    count.

          D.  MYH9-related disease with thrombocytopenia (Promacta only)
               All members (including new members) requesting authorization for continuation of therapy
               must meet all initial authorization criteria.

          E.  Myelodysplastic syndromes (Promacta only) and chemotherapy-induced
               thrombocytopenia (CIT)
               Authorization of 12 months may be granted for continued treatment of myelodysplastic
               syndromes or chemotherapy-induced thrombocytopenia (CIT) in members who experience
               benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced
               need for platelet transfusions).


  VII.  APPENDIX

          Examples of risk factors for bleeding (not all inclusive)
          •   Undergoing a medical or dental procedure where blood loss is anticipated
          •   Comorbidity (e.g., peptic ulcer disease, hypertension)
          •   Mandated anticoagulation therapy
          •   Profession (e.g., construction worker) or lifestyle (e.g., plays contact sports) that
              predisposes member to trauma

Place of Service:

Outpatient

The above policy is based on the following references:

1. Promacta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; March 2023.
2. Alvaiz [package insert]. Parsippany, NJ: Teva Pharmaceuticals; November 2023.
3. Pecci A, Gresele P, Klersy C, et al. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. 2010;116(26):5832-7.
4. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 16, 2024.
5. The NCCN Clinical Practice Guidelines in Oncology® Myelodysplastic Syndrome (Version 1.2024). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed February 16, 2024.
6. Nuenert C, Terrel DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv.2019;3(23):3829–3866. 
7. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv.2019;3(22): 3780–3817. 
8. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. 2010;115(2):168-186.
9. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11):2386-2393.
10. Olnes MJ, Scheinberg P, Calvo KR, et al. Eltrombopag and improved hematopoiesis in refractory aplastic anemia. N Engl J Med. 2012;367(1):11-19.
11. Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag added to standard immunosuppression for aplastic anemia. N Engl J Med.2017;376:1540-1550.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 21, 2024