History/Background and/or General Information
Pegfilgrastim is a colony stimulating factor (CSF) that acts on hematopoietic cells by binding to specific cell surface receptors thereby, stimulating proliferation, differentiation, commitment, and end cell functional activation.
Pegfilgrastim is approved by the Food and Drug Administration to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Prophylactic use of pegfilgrastim in patients undergoing chemotherapy reduces the risk of febrile neutropenia and infections. Prophylactic therapy can be considered for patients receiving myelosuppressive chemotherapy if the risk of febrile neutropenia is 20% or greater.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are leukocyte growth factors indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are biosimilar* to pegfilgrastim.
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information).
Covered Indications
Pegfilgrastim will be covered for Food and Drug Administration (FDA) approved label indications. Please see the FDA drug label for the FDA approved indications and dosages. https://labels.fda.gov/.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf will be covered for Food and Drug Administration (FDA) approved label indications. Please see the FDA drug label for the FDA approved indications and dosages. https://labels.fda.gov/.
The recommended dosage of pegfilgrastim is 6 mg administered once per chemotherapy cycle.
The administration should not occur within 14 days before, and 24 hours after, administration of cytotoxic chemotherapy. The following off-label exception to this rule will be allowed as follows:
- If the patient is on a dose dense 14 day chemotherapy cycle, it would be acceptable to administer pegfilgrastim outside of the 14 day before and 24 hour after rule for chemotherapy. Pegfilgrastim would typically be administered on the second day of the 14-day dose dense chemotherapy cycle. An example of this would be a patient receiving dose dense cytoxan/adriamycin and taxol for breast cancer. The chemotherapy drug record/orders should indicate that the patient is on a 14-day dose dense chemotherapy schedule.
Limitations
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
