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Drug Category: Blood and Circulation

Medication Class/Individual Agents: ITP Agents

I. Prior-Authorization Requirements

 Immune Thrombocytopenia (ITP) Agents – Thrombopoietin Agonists

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

avatrombopag Doptelet PA  
eltrombopag Promacta PA  
lusutrombopag Mulpleta PA  
romiplostim Nplate PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

  • Thrombopoietin agonists are approved for the treatment of refractory thrombocytopenia in those patients who have had an insufficient response to corticosteroids, immunoglobulin, or splenectomy.
  • Eltrombopag is also approved for the treatment of severe aplastic anemia and thrombocytopenia in the setting of hepatitis C.
  • These agents are not approved for the normalization of platelet counts and should only be used in those whose clinical condition is associated with a high risk of bleeding.
  • Fostamatinib is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). It is approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
  • Avatrombopag and lusutrombopag are indicated for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.
    • For avatrombopag, dosing should begin 10-to-13 days before scheduled procedure. Patients should undergo their procedure five-to-eight days after the last dose.
    • For lusutrombopag, dosing should begin eight-to-14 days before scheduled procedure. Patients should undergo their procedure two-to-eight days after the last dose.
 

 Immune Thrombocytopenia (ITP) Agents – Tyrosine Kinase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

fostamatinib Tavalisse PA  
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • Chronic, relapsed, or refractory immune thrombocytopenia (Nplate, Promacta, Tavalisse)
  • Severe aplastic anemia (Promacta)
  • Thrombocytopenia due to chronic liver disease (Doptelet, Mulpleta)
  • Thrombocytopenia in the setting of hepatitis C (Promacta)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

Doptelet

  • Documentation of the following is required for a diagnosis of thrombocytopenia due to chronic liver disease (CLD):
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • member is scheduled to undergo a procedure and date is provided; and
    • platelet count < 50,000 cells/mcL; and
    • inadequate response, adverse reaction, or contraindication to Mulpleta; and
    • one of the following:
      • if platelet count is 40,000 to < 50,000 cells/mcL, requested dose is 40 mg (2 tablets) daily for five days; or
      • if platelet count is less than 40,000 cells/mcL, requested dose is 60 mg (3 tablets) daily for five days.

   

Mulpleta

  • Documentation of the following is required for a diagnosis of thrombocytopenia due to CLD:
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • member is scheduled to undergo a procedure and date is provided; and
    • platelet count < 50,000 cells/mcL; and
    • requested dose is 3 mg daily for a maximum of seven days.

   

Nplate

  • Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory immune thrombocytopenia (ITP):
    • appropriate diagnosis; and
    • age ≥ one year; and
    • one of the following:
      • platelet count < 30,000 cells/mcL; or
      • medical necessity for platelet elevation (upcoming surgery, peptic ulcer disease or condition that may predispose member to bleeding); and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one corticosteroid and immunoglobulin; or
      • member has had a splenectomy; and
    • inadequate response, adverse reaction, or contraindication to Promacta.

  

Promacta

  • Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
    • appropriate diagnosis; and
    • age ≥ one year; and
    • one of the following:
      • platelet count < 30,000 cells/mcL; or
      • medical necessity for platelet elevation (upcoming surgery, peptic ulcer disease or condition that may predispose member to bleeding); and
    • requested dose is ≤ 75 mg/day; and 
    • if request is for Promacta 12.5 mg, quantity is ≤ 30 tablets/month; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one corticosteroid and immunoglobulin; or
      • member has had a splenectomy.

 

  • Documentation of the following is required for a diagnosis of severe aplastic anemia:
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • platelet count < 50,000 cells/mcL; and
    • requested dose is ≤ 150 mg/day; and 
    • if request is for Promacta 12.5 mg, quantity is ≤ 30 tablets/month; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to immunosuppressive therapy with anti-thymocyte globulin (ATG) and cyclosporine; or
      • clinical rationale for use in combination with ATG and cyclosporine.

 

  • Documentation of the following is required for a diagnosis of thrombocytopenia in the setting of hepatitis C:
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • requested dose is ≤100 mg/day; and
    • if request is for Promacta 12.5 mg, quantity is ≤ 30 tablets/month; and
    • one of the following:
      • member intends to initiate therapy with interferon and current platelet count is ≤75,000 cells/mcL; or
      • both of the following:
        • member has already begun interferon therapy and platelet count supports continued use; and
        • member has met criteria for continued interferon therapy based on treatment futility protocols per most recent PA for hepatitis antiviral agents.

 

Tavalisse

  • Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • one of the following:
      • platelet count < 30,000 cells/mcL; or
      • medical necessity for platelet elevation (upcoming surgery, peptic ulcer disease or condition that may predispose member to bleeding); and
    • inadequate response, adverse reaction, or contraindication to Promacta; and
    • quantity requested is ≤ 60 units/30 days; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one corticosteroid and immunoglobulin; or
      • member has had a splenectomy.


Original Effective Date: 03/2013

Last Revised Date: 03/2019


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Last updated 07/15/19