## **What is pegfilgrastim-cbqv (Udenyca®)?**
Pegfilgrastim-cbqv (Udenyca®) is a biosimilar to pegfilgrastim, a recombinant granulocyte colony stimulating factor (G-CSF) used to decrease the incidence of infection, manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This indication is specific to patients with non-myeloid malignancies, as the safety and efficacy of pegfilgrastim products have not been established in those with myeloid cancers.
Pegfilgrastim-cbqv is a colony-stimulating factor that acts by stimulating the proliferation and differentiation of hematopoietic cells, increasing the production of white blood cells to help reduce risk of infection. It is administered as a timed single subcutaneous injection once per chemotherapy cycle, including for pediatric patients. This injection is not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
UDENYCA biosimilar is specifically coded under HCPCS Q5111 and is used in clinical practice primarily for patients receiving myelosuppressive chemotherapy drugs, including cytotoxic chemotherapy, that suppress bone marrow function and reduce white blood cell counts. It helps prevent febrile neutropenia, a serious complication manifested by fever and low neutrophil levels, thus reducing infection incidence during chemotherapy cycles. The product is also approved to increase survival for patients exposed to myelosuppressive doses of radiation (acute radiation syndrome). The HCPCS billing unit for Q5111 is defined as 0.5 mg, but the standard recommended dose of pegfilgrastim-cbqv (Udenyca®) is 6 mg given as a single timed subcutaneous injection once per chemotherapy cycle. For billing purposes, this equals 12 billable units of Q5111.
This service includes injection of pegfilgrastim-cbqv biosimilar (Udenyca®), with appropriate procedure coding to ensure accurate billing and documentation. Although some providers assume the service includes cannula insertion, Q5111 in fact covers only the drug itself; administration procedures are billed separately using their own specific code (e.g., CPT 96372).
## **HCPCS code Q5111 documentation requirements**
To bill HCPCS Code Q5111 for injection of pegfilgrastim-cbqv (Udenyca®), documentation should include:
- Medical necessity justification for use to decrease the incidence of infection manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.
- Patient diagnosis documented with appropriate ICD-10-CM codes. The most common prophylaxis billing code is Z51.11 (encounter for antineoplastic chemotherapy), while codes such as D70.1 (agranulocytosis secondary to cancer chemotherapy) may be used when clinically appropriate.).
- Details of the actual dose administered, noting that one billable unit of Q5111 equals 0.5 mg pegfilgrastim-cbqv.
- Injection details including site and timing of the single subcutaneous injection, consistent with chemotherapy cycle schedules.
- Documentation of any prior authorization or preauthorization requirements by the payer, if applicable.
- Records of any adverse reactions or response to treatment as part of clinical decision-making.
## **Q5111 billing requirements**
The following provides the billing guidelines for HCPCS Code Q5111, which represents injection, pegfilgrastim-cbqv (Udenyca®), biosimilar, 0.5 mg.:
- One unit of Q5111 corresponds to 0.5 mg of pegfilgrastim-cbqv (Udenyca®).
- Bill only one service line per administration, as multiple claim lines for the same dose will be denied.
- Include CPT code 96372 or other relevant codes for the subcutaneous injection administration procedure if applicable.
- Follow payer-specific prior authorization or treatment authorization requirements.
- Outpatient claims should be submitted via UB-04 or electronic 837I format as required.
- Verify reimbursement rates with payers, as these vary by region and provider contracts; Medicare's 2025 average rate for Q5111 is around $160.
- Use appropriate modifiers such as -JW for discarded drug wastage if applicable.
## **Other relevant codes**
- **Q5108** – Injection, pegfilgrastim-jmdb (Fulphila®), biosimilar, 0.5 mg
- **Q5122** – Injection, pegfilgrastim-apgf (Nyvepria®), biosimilar, 0.5 mg
- **Q5127** – Injection, pegfilgrastim-fpgk (Stimufend®), biosimilar, 0.5 mg
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