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
Hematologic Agents – Chemokine receptor type 4 (CXCR4) inhibitor |
Clinical Notes |
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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:
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. |
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Hematopoietic Agents – Colony-Stimulating Factors |
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Hematopoietic Agents – Erythropoiesis-Stimulating Agents |
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Hematopoietic Agents – Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor |
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Hematopoietic Agents – Interleukins |
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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 due to chemotherapy treatment for cancer (Aranesp, Epogen, Procrit, Retacrit)
- Anemia due to chronic renal failure (Aranesp, Epogen, Procrit, Retacrit)
- Anemia due to a myelosuppressive medication regimen for HIV (Aranesp, Epogen, Procrit, Retacrit)
- Decrease the need for blood transfusions during surgery (Aranesp, Epogen, Procrit, Retacrit)
- Dialysis dependent anemia of chronic kidney disease (Jesduvroq)
- Multiple myeloma requiring autologous hematopoietic cell transplantation (Aphexda)
- Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome with CXCR4 mutation (Xolremdi)
non-FDA-approved, for example:
- Anemia due to a myelosuppressive medication regimen for Hepatitis C (Aranesp, Epogen, Procrit, Retacrit).
- Anemia due to myelodysplastic syndrome (MDS)
- Anemia post-renal transplant
- Idiopathic sideroblastic anemia
Note: The above lists may not include all FDA-approved and non-FDA-approved indications.
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.
Aphexda
- Documentation of the following is required:
- appropriate diagnosis; and
- prescriber is an oncologist or hematologist or consult notes from an oncologist or hematologist are provided; and
- requested agent will be used in combination with a granulocyte colony stimulating factor (G-CSF); and
- clinical rationale for use of the requested agent instead of plerixafor; and
- appropriate dosing.
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
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit; and
- glomerular filtration rate (GFR) ≤ 60 mL/min.
- 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 chemotherapy treatment for cancer
- Documentation of the following is required:
- appropriate diagnosis; and
- Hb < 10 g/dL (dated within the last 60 days); and
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit.
- 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 a 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
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit; and
- member is on myelosuppressive medication for the treatment of HIV that includes zidovudine or zidovudine-containing products.
- 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
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit.
- 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 a myelosuppressive medication regimen for Hepatitis C
- Documentation of the following is required:
- appropriate diagnosis; and
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit; 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 due to 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
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit.
- 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
- requested strength is the minimum strength necessary to administer the requested dose; and
- for Procrit, adverse reaction or contraindication to both of the following: Epogen, Retacrit.
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.
Xolremdi
- Documentation of the following is required:
- appropriate diagnosis; and
- results from genetic testing confirming diagnosis of WHIM syndrome; and
- member is ≥ 12 years of age; and
- prescriber is an immunologist or hematologist or consult notes from a nephrologist are provided; and
- baseline absolute neutrophil count (ANC) ≤ 0.4 x 103/μL; and
- appropriate dosing; and
- requested quantity is ≤ four units/day.
Original Effective Date: 09/2003
Last Revised Date: 01/2025
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Last updated 01/06/25