FDA-approved, for example:

• Anemia in cancer chemotherapy-treated members (Aranesp, Epogen, Procrit, Retacrit).
• Anemia of chronic renal failure (Aranesp, Epogen, Procrit, Retacrit).
• Anemia due to myelosuppressive medication regimen for HIV (Aranesp, Epogen, Procrit, Retacrit).
• Decrease need for blood transfusions during surgery (Aranesp, Epogen, Procrit, Retacrit).
• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in members with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (Granix, Nivestym, Releuko, Zarxio).
• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (Nivestym, Zarxio).
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of members with acute myeloid leukemia (Nivestym, Releuko, Zarxio).
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae, in members with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (Nivestym, Releuko, Zarxio).
• Reduce the incidence and duration of sequelae of severe neutropenia in symptomatic members with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (Nivestym, Releuko, Zarxio).

non-FDA approved, for example:

• Anemia due to myelosuppressive medication regimen for Hepatitis C (Aranesp, Epogen, Procrit, Retacrit).

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 prior-authorization 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 result in additional restrictions.

Aranesp, Epogen, Procrit, and Retacrit for anemia due to chronic renal failure

Aranesp, Epogen, Procrit, and Retacrit for anemia due to cancer chemotherapy

• Documentation of the following is required:
  • appropriate diagnosis; and
  • Hb < 10 g/dL (dated within the last 60 days); and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen.
• For recertification, documentation of the following is required:
  • Hb level ≤ 12 g/dL (dated within the last 60 days); and
  • member continues to receive the causative agent.

Aranesp, Epogen, Procrit, and Retacrit for anemia due to myelosuppressive medication regimen for HIV

• Documentation of the following is required:
  • appropriate diagnosis; and
  • Hb < 10 g/dL (dated within the last 60 days); and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen; and 
  • member is on myelosuppressive medication for the treatment of HIV that includes zidovudine or zidovudine-containing products; or
  • all other causes of anemia have been ruled out (iron, vitamin B12, folate deficiency, and hemolysis).
• For recertification, documentation of the following is required:
  • Hb level ≤ 12 g/dL (dated within the last 60 days); and
  • member continues to receive the causative agent.

Aranesp, Epogen, Procrit, and Retacrit for anemia due to idiopathic sideroblastic anemia/myelodysplastic syndrome

• Documentation of the following is required:
  • appropriate diagnosis; and
  • Hb < 10 g/dL (dated within the last 60 days); and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen.
• For recertification, documentation of the following is required:
  • Hb level ≤ 12 g/dL (dated within the last 60 days); or
  • Hb level > 12 g/dL (dated within the last 60 days) and the request addresses if the erythropoietin dose is to be held or reduced to remain with the appropriate target.   

Aranesp, Epogen, Procrit, and Retacrit for anemia due to myelosuppressive medication regimen for Hepatitis C

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen; and
  • one of the following:
    • Hb < 10 g/dL (dated within the last 60 days) and member is currently being treated with a hepatitis C regimen containing an interferon product, with or without ribavirin; or
    • Hb < 10 g/dL (dated within the last 60 days) and member is currently being treated with a hepatitis C regimen containing ribavirin without interferon, and ribavirin dose reduction to 600 mg per day has been attempted; or
    • member is currently being treated with a hepatitis C regimen containing ribavirin without interferon and ribavirin dose reduction to 600 mg per day is not indicated by one of the following:
      • Hb < 8.5 g/dL (dated within the last 60 days); or
      • Hb < 12 g/dL (dated within the last 60 days) and member has a history of cardiac disease.

• For recertification, documentation that the member continues to receive the causative agent is required.   

Aranesp, Epogen, Procrit, and Retacrit for anemia post-renal transplant

• Documentation of the following is required:
  • appropriate diagnosis; and
  • Hb < 10 g/dL (dated within the last 60 days); and
  • member is not receiving hemodialysis; and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen.
• For recertification, documentation of the following is required:
  • Hb level ≤ 12 g/dL (dated within the last 60 days); or
  • Hb level > 12 g/dL (dated within the last 60 days) and the request addresses if the erythropoietin dose is to be held or reduced to remain with the appropriate target. 

Aranesp, Epogen, Procrit, and Retacrit to decrease the need for blood transfusions due to surgery

• Documentation of the following is required:
  • appropriate diagnosis; and
  • Hb ≤ 13 g/dL (dated within the last 30 days); and
  • surgery is planned within the next 3 months and date is provided; and
  • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen.

Granix

• Documentation of the following is required:
  • diagnosis of reduction in the incidence of infection‚ as manifested by febrile neutropenia‚ in members with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to Neupogen.

Nivestym and Zarxio

• Documentation of the following is required:
  • diagnosis of one of the following: 
    • reduction in the incidence of infection‚ as manifested by febrile neutropenia‚ in members with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; or
    • reduction in the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of members with acute myeloid leukemia; or 
    • reduction in the duration of neutropenia and neutropenia-related clinical sequelae, in members with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; or 
    • mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; or
    • reduction in the incidence and duration of sequelae of severe neutropenia in symptomatic members with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to Neupogen.

Releuko

• Documentation of the following is required:
  • diagnosis of one of the following: 
    • reduction in the incidence of infection‚ as manifested by febrile neutropenia‚ in members with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; or 
    • reduction in the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of members with acute myeloid leukemia; or 
    • reduction in the duration of neutropenia and neutropenia-related clinical sequelae, in members with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; or 
    • reduction in the incidence and duration of sequelae of severe neutropenia in symptomatic members with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to Neupogen.