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Drug Category: Blood and Circulation Agents

Medication Class/Individual Agents: Hematopoietic Agents

I. Prior-Authorization Requirements

 Hematologic Agents – Antimetabolites

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

hydroxyurea Droxia test  
hydroxyurea Siklos test  

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.

 

For PA drugs, an FDA-approved indication must be met. For unlabeled uses, approval will be considered based on current medical evidence.

Monitoring:

  • colony-stimulating factors (G-CSF, GM-CSF) – Certain drugs, such as corticosteroids and lithium, may potentiate the myeloproliferative effects of colony-stimulating factors; GM-CSF: fluid retention, occasional transient supraventricular arrhythmias, and dyspnea may occur. Use cautiously in patients with cardiac or pulmonary disease.
  • erythropoietin – Evaluate iron status before and during therapy. Transferrin saturation should be at least 20% and serum ferritin at least 100 ng/mL. Most patients will eventually require supplemental iron.
  • oprelvekin – Fluid retention will occur. Use cautiously in patients with congestive heart failure (CHF) or preexisting fluid collections (e.g., ascites, pericardial, or pleural effusions).
 

 Hematologic Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

l-glutamine Endari PA  

 Hematopoietic Agents – Colony-Stimulating Factors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

filgrastim Neupogen test  
filgrastim-aafi Nivestym PA  
filgrastim-sndz Zarxio PA  
pegfilgrastim Neulasta test  
pegfilgrastim-cbqv Udenyca PA  
pegfilgrastim-jmdb Fulphila PA  
sargramostim Leukine test  
TBO-filgrastim Granix PA  

 Hematopoietic Agents – Erythropoiesis-Stimulating Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

darbepoetin alfa Aranesp PA  
epoetin alfa-epbx Retacrit PA  
epoetin alfa-Epogen Epogen PA  
epoetin alfa-Procrit Procrit PA  
methoxy polyethylene glycol / epoetin beta Mircera ^ test  

 Hematopoietic Agents – Interleukins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

oprelvekin Neumega test  
Table Footnotes
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Anemia in cancer chemotherapy-treated patients (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 in surgery patients (Aranesp, Epogen, Procrit, Retacrit).
  • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (Fulphila, Granix, Nivestym, Udenyca, 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 patients with acute myeloid leukemia (Nivestym, Zarxio).
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (Nivestym, Zarxio).
  • Reduce the incidence and duration of sequelae of severe neutropenia in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (Nivestym, Zarxio).
  • Sickle cell disease (Endari).

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 prior-authorization 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.
  • 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 the member’s condition and requested medication (see below).

  

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • Hemoglobin (Hb) < 10 g/dL (dated within the last 60 days); and
    • member is not receiving hemodialysis; and
    • glomerular filtration rate (GFR) ≤ 30 mL/min; or
    • glomerular filtration rate (GFR) 30-60 mL/min noting that 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); 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 cancer chemotherapy

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • Hb < 10 g/dL (dated within the last 60 days).
  • 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
    • 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).
  • 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:
    • Hb < 10 g/dL (dated within the last 60 days); and
    • one of the following:
      • member is currently being treated with a hepatitis C regimen containing an interferon product, with or without ribavirin; or
      • 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.

   

  • 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.
  • 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.

   

Endari for sickle cell disease

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member ≥ five years of age; and
    • prescriber is a hematologist; and
    • member has experienced two or more sickle cell crises in previous 12 months; and
    • inadequate response, adverse reaction, or contraindication to hydroxyurea.

 

Fulphila and Udenyca

  • Documentation of the following is required:
    • medical records documenting an inadequate response, adverse reaction, or contraindication to Neulasta.

 

Granix, Nivestym, and Zarxio

  • Documentation of the following is required:
    • medical records documenting an inadequate response, adverse reaction, or contraindication to Neupogen.


Original Effective Date: 09/2003

Last Revised Date: 08/2019


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Last updated 10/09/19