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Table 4: Hematologic Agents - Hematopoietic and Miscellaneous Hematologic Agents


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Blood and Circulation Agents

Medication Class/Individual Agents: Hematopoietic Agents

I. Prior-Authorization Requirements

 Hematopoietic Agents – Colony-Stimulating Factors

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

eflapegrastim-xnst Rolvedon test   MB
filgrastim Neupogen test  
filgrastim-aafi Nivestym test  
filgrastim-ayow Releuko test  
filgrastim-sndz Zarxio test  
pegfilgrastim Neulasta test  
pegfilgrastim-apgf Nyvepria test  
pegfilgrastim-bmez Ziextenzo test  
pegfilgrastim-cbqv Udenyca test  
pegfilgrastim-fpgk Stimufend test  
pegfilgrastim-jmdb Fulphila test  
pegfilgrastim-pbbk Fylnetra test  
sargramostim Leukine test  
TBO-filgrastim Granix 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 members 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 members will eventually require supplemental iron.
  • oprelvekin – Fluid retention will occur. Use cautiously in members with congestive heart failure (CHF) or preexisting fluid collections (e.g., ascites, pericardial, or pleural effusions).

 

Please note for evaluation criteria of inadequate response to erythropoiesis-stimulating agent (ESA) treatment, hyporesponsiveness is defined as the need for > 300 units per week of epoetin alfa or > 1.5 mcg/kg per week of darbepoetin alfa, no increase in hemoglobin (Hb) concentration from baseline after the first month of ESA treament with appropriate weight-based dosing, or two ESA dose increases up to 50% beyond the dose previously stabilized on to maintain a stable Hb concentration.

 

 Hematopoietic Agents – Erythropoiesis-Stimulating Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

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   MB

 Hematopoietic Agents – Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

daprodustat Jesduvroq PA  

 Hematopoietic Agents – Interleukins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

oprelvekin Neumega test  
Table Footnotes
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 

II. Therapeutic Uses

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)
  • Dialysis dependent anemia of chronic kidney disease (Jesduvroq)
  • Reduce the need for blood transfusions during surgery (Aranesp, Epogen, Procrit, Retacrit)

 

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.

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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.
  • 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

  • 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
    • for Procrit or Retacrit, clinical rationale for use of the requested agent instead of Epogen; 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); 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.

 

Jesduvroq

Documentation of the following is required:

  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
  • member has been receiving hemodialysis or peritoneal dialysis for ≥ four months; and
  • appropriate dosing; and 
  • inadequate response (defined as indicated by hyporesponsiveness) or adverse reaction to one or contraindication to all of the following: Aranesp, Epogen or Procrit, Mircera, Retacrit.


Original Effective Date: 09/2003

Last Revised Date: 05/2024


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Last updated 06/24/24

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