FDA-approved, for example:

• aTTP (Cablivi)
• Chronic, relapsed, or refractory ITP (Alvaiz, Doptelet, Nplate, Promacta, Tavalisse)
• Hematopoietic syndrome of acute radiation ayndrome (HS-ARS)/acute exposure to myelosuppressive doses of radiation (Nplate)
• Severe aplastic anemia (Alvaiz, Promacta)
• Thrombocytopenia due to CLD in a member scheduled to undergo a procedure (Doptelet, Mulpleta)
• Thrombocytopenia in the setting of hepatitis C with interferon therapy (Alvaiz, Promacta)

Non-FDA-approved, for example:

• Chemotherapy-induced thrombocytopenia (Nplate)
• Thrombocytopenia in the setting of hepatitis C independent of interferon therapy (Promacta)

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• 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.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

Alvaiz

• Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
  • appropriate diagnosis; and
  • member is ≥ six years of age; 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 ≤ 54 mg/day; and 
  • medical necessity for the requested agent instead of Promacta; and
  • for the 9 mg tablet, requested quantity is ≤ one unit/day; and
  • one of the following:
    • inadequate response or adverse reaction to one or contraindication to both of the following: corticosteroid, immunoglobulin; or
    • member has had a splenectomy.

• Documentation of the following is required for a diagnosis of severe aplastic anemia:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • platelet count < 50,000 cells/mcL; and
  • requested dose is ≤ 108 mg/day; and
  • medical necessity for the requested agent instead of Promacta; and
  • for the 9 mg tablet, requested quantity is ≤ one unit/day; and
  • inadequate response, adverse reaction, or contraindication to immunosuppressive therapy with anti-thymocyte globulin (ATG); and
  • inadequate response, adverse reaction, or contraindication to immunosuppressive therapy with cyclosporine.

• Documentation of the following is required for a diagnosis of thrombocytopenia in the setting of hepatitis C with interferon therapy:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested dose is ≤ 72 mg/day; and
  • medical necessity for the requested agent instead of Promacta; and
  • for the 9 mg tablet, requested quantity is ≤ one unit/day; 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.

Cablivi

• Documentation of the following is required for a diagnosis of aTTP:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested agent will be used initially in conjunction with immunosuppressive therapy; and
  • requested quantity is ≤ one unit/day after initial bolus injection.

Doptelet

• Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; 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 eltrombopag; and
  • requested quantity is ≤ two units/day; and
  • one of the following:
    • inadequate response or adverse reaction to one or contraindication to both of the following: corticosteroid, immunoglobulin; or
    • member has had a splenectomy.

• Documentation of the following is required for a diagnosis of thrombocytopenia due to CLD in a member scheduled to undergo a procedure:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • platelet count < 50,000 cells/mcL; and
  • one of the following:
    • if platelet count is 40,000 to < 50,000 cells/mcL, requested dose is 40 mg (two tablets) once daily for five days; or
    • if platelet count is less than 40,000 cells/mcL, requested dose is 60 mg (three tablets) once daily for five days.

Mulpleta

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

Nplate

• Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
  • appropriate diagnosis; and
  • member is ≥ one year of age; 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 or adverse reaction to one or contraindication to both of the following: corticosteroid, immunoglobulin; or 
    • member has had a splenectomy; and
  • inadequate response, adverse reaction, or contraindication to eltrombopag.

• Documentation of the following is required for a diagnosis of HS-ARS/acute exposure to myelosuppressive doses of radiation:
  • appropriate diagnosis; and
  • requested dose is 10 mcg/kg for a one-time administration.

• Documentation of the following is required for a diagnosis of chemotherapy-induced thrombocytopenia :
  • appropriate diagnosis; and
  • platelet count < 100,000 cells/µL; and
  • treatment plan, including target platelet count goal; and
  • requested dose is ≤ 10 mcg/kg weekly.
• For recertification, prescriber provides documentation of both of the following:
  • positive response to therapy as indicated by an increase in platelets from baseline; and
  • one of the following:
    • platelet count < 100,000 cells/ µL; or
    • both of the following:
      • platelet count ≥ 100,000 cells/µL; and
      • medical necessity for continued use of requested agent.

Promacta

• Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
  • appropriate diagnosis; and
  • member is ≥ one year of age; 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 
  • for the 12.5 mg tablet or packet, requested quantity is ≤ one unit/day; and
  • one of the following:
    • inadequate response or adverse reaction to one or contraindication to both of the following: corticosteroid, immunoglobulin; or
    • member has had a splenectomy.

• Documentation of the following is required for a diagnosis of severe aplastic anemia:
  • appropriate diagnosis; and
  • member is ≥ two years of age; and
  • platelet count < 50,000 cells/mcL; and
  • requested dose is ≤ 150 mg/day; and 
  • for the 12.5 mg tablet or packet, requested quantity is ≤ one unit/day; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to immunosuppressive therapy with anti-thymocyte globulin (ATG) and cyclosporine; or
    • member is treatment naïve and the requested agent will be used in combination with ATG and cyclosporine.

• Documentation of the following is required for a diagnosis of thrombocytopenia in the setting of hepatitis C with interferon therapy:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested dose is ≤100 mg/day; and
  • for the 12.5 mg tablet or packet, requested quantity is ≤ one unit/day; 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.

• Documentation of the following is required for a diagnosis of thrombocytopenia in the setting of hepatitis C independent of interferon therapy:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested dose is ≤100 mg/day; and
  • for the 12.5 mg tablet or packet, requested quantity is ≤ one unit/day; and
  • current platelet count is ≤ 75,000 cells/mcL; and
  • member is not currently using interferon therapy and does not intend to begin therapy; and
  • inadequate response, adverse reaction, or contraindication to immunoglobulin.

Tavalisse

• Documentation of the following is required for a diagnosis of chronic, relapsed, or refractory ITP:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; 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 eltrombopag; and
  • requested quantity is ≤ two units/day; and
  • one of the following:
    • inadequate response or adverse reaction to one or contraindication to both of the following: corticosteroid, immunoglobulin; or
    • member has had a splenectomy.