Article - Pegfilgrastim (Fulphila; Neulasta; Neulasta Onpro; Nyvepria; Udenyca; Ziextenzo) J2506 (A59126)

CMS National Coverage PolicyN/AArticle Text1. Same Day AdminstrationPegfilgrastim is a white blood cell growth factorwith labeled use to decrease the incidence of infection (as manifested by febrile neutropenia), in patients with nonmyeloid malignancies receiving myelosuppressive cancer chemotherapy associated with a clinically significant incidence of febrile neutropenia.1The FDA label recommends administration starting 24 hours after the completion of chemotherapy.To improve compliance and convenience for patients by not having to return 24 hours after chemotherapy for administration there is an interest in same day administration. A survey of physicians who administer pegfilgrastim reported that 31.6% were treated on a same day schedule utilizing patient related considerations in the decision such as patient/caregiver travel distance and practice related consideration such as burden on the practice for next day administration as determining factors.2A double blinded phase two non-inferiority study (n=266) concludes non-inferiority of same day administration, but while not statistically significant an increase in neutropenia within the same day administration group as compared to next day administration group was reported. This lead to the authors conclusion to recommendation for administration according to the FDA label.3Multiple retrospective studies support safety and efficacy of same day administration, but also trending to non-statistically significant increase in side effects with same day administration.4-6A systematic review including four randomized or single arm prospective studies and seven retrospective studies support administration at least one day after chemotherapy.7NCCN guidelines state that pegfilgrastim same day administered the day after myelosuppressive chemotherapy is supported by category one evidence, however there is data for and against same day dosing and the FDA approved dosing schedule is still recommended.8Pegfiligrastim is recommended to be given according to FDA approved dosing schedule. CGS will consider same day administration when patient/caregiver circumstances create a significant barrier to compliance, such as lack of transportation to return for dosing within recommended time frame. CGS expects clear documentation for same day administration to be in the medical record and available upon request.2. Billing Instructions for Neulasta and UDENYCANeulasta and UDENYCA are currently available in 2 distinct delivery options. When administered to the patient by means of the prefilled syringe, the appropriate coding procedure is to report the HCPCS code for both the drug (J2506 or Q5111) and the administration of the drug (CPT code 96372).Part B ProvidersWhen Neulasta or UDENYCA are administered to the patient by means of a pegfilgrastim injection device such as the Neulasta Delivery Kit (Onpro) or the UDENYCA ONBODY, the provider does not inject the drug, but instead fills the injector device with the drug and applies the injector device to the patient. Identify the injector device using CPT code 96377 in the medical record to distinguish it from the use of the prefilled syringe which should be identified with CPT code 96372.Use 96377 for the onbody application injector for Neulasta Onpro Kit or UDENYA Onbody.Outpatient Hospital ProvidersCPT code 96377 (Application of on-body injector (includes cannula insertion) for timed subcutaneous injection) is assigned status indicator N (Items and Services Packaged into APC Rates) to indicate that the service is paid under the Outpatient Prospective Payment System (OPPS). However, payment for the administration of Neulasta Onpro/UDENYCA ONBODY is bundled into the payment for other services and not separately payable.References:Lexi-Drugs. Pegfilgrastim.https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7446?cesid=0knhsFEk1hS&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3DPegfilgastrim%26t%3Dname%26va%3DPegfilgastrim. Accessed 5/1//2022.Marion S, Tzivelekis, S., Darden, C. et al. . Same-Day administration of pegfilgrastim following myelosuppressive chemotherapy: clinical practice and provider rationale.Support Care Cancer2016:3886-3896.Burris HA BC, Kaufman PA, et al. . Pegfilgrastim on the same day versus next day of chemotherapy in patients with breast cancer, non-small-cell lung cancer, ovarian cancer, and non-hodgkin's lymphoma: results of four multicenter, double-blind, randomized phase II studies.J Oncol Pract.2010;6(2):133-140.Schuman SI LN, Robson K, et al. . Pegfilgrastim dosing on same day as myelosuppressive chemotherapy for ovarian or primary peritoneal cancer. .J Support Oncol.2009;7(6):225-228.Whitworth JM MK, Shipman KA, Numnum TM, Kendrick JE, Kilgore LC, Straughn JM. . The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies.Gynecol Oncol2009;112:601-604.McBride A, Alrawashdh, N., Bartels, T., Moore, L., Persky, D., & Abraham. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. .Future oncology (London, England).(2021;17(26):34853497.Lyman GH, Allcott, K., Garcia, J. et al. . The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: a systematic review. .Support Care Cancer2017;25:2619-2929.Oncology NCPGi. Hematopoietic Growth Factors Version 1.2022.https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf. Accessed 5/9/2022.