Local Coverage Article

Pegfilgrastim (Neulasta) J2505

A55447

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Article ID
A55447
Article Title
Pegfilgrastim (Neulasta) J2505
Article Type
Article
Original Effective Date
01/26/2017
Revision Effective Date
N/A
Revision Ending Date
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Retirement Date
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Article Guidance

Article Text
Medicare covers the use of Pegfilgrastim (Neulasta), J2505, to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The initial 2002 FDA approval and label specified administration starting 24 hours after and no sooner than 14 days before delivery of cytotoxic chemotherapy.

Coverage of Same Day Dosing
Within two years of drug approval, presentations on the utility and non-inferiority of same day dosing of Neulasta with chemotherapeutic agents appeared as abstracts. By 2009, Whitworth and Schuman independently proclaimed the administration of “pegfilgrastim on day 1 appears to be safe, effective and convenient” and “same day…may be determined to be a convenient, safe and effective approach” respectively. A 2010 metaanalysis concluded “the results indicated that same-day administration was statistically non-inferior to next-day administration according to neutropenia duration.” Based on the evidence, the administration of same-day pegfilgrastim has become an accepted standard of care and in particular, in situations where patients are believed to be a higher risk of potential non-compliance with day 2 administration.

Coverage of Less than 14 Day Dosing
In multiple trials of every other week myelosuppressive chemotherapy, pegfilgrastim given within 14 days of the next cycle has been shown to be effective in maintaining dose-density and reducing neutropenic events without any significant concerns for safety. Based on this evidence, the administration of pegfilgrastim before the traditional 14 day window has become an accepted standard of care to maintain dose-density or reduce neutropenic complications in regimens with substantial myelosuppression.

Sources:
Same Day Dosing

    • Whitworth JM, Matthews KS, 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 Oncol 2009; 112:601–604
    • Schuman SI, Lambrou N, Robson K, et al. Pegfilgrastim dosing on same day as myelosuppressive chemotherapy for ovarian or primary peritoneal cancer. J Support Oncol. 2009; 7(6):225-8
    • Burris HA, Belani CP, 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(3):133-40

Less than 14 Day Dosing

    • Brusamolino E, Rusconi C, Montalbetti L, et al. Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphoma: a phase II study of feasibility and toxicity. Haematologica. 2006; 91(4):496-502
    • Burstein HJ, Parker LM, Keshaviah A, et al. Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J Clin Oncol. 2005; 23(33):8340-7
    • Jones RL, Walsh G, Ashley S, et al. A randomized pilot phase II study of doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) given 2 weekly with pegfilgrastim (accelerated) vs 3 weekly (standard) for women with early breast cancer. Br J Cancer. 2009; 100(2):305-10
    • Hecht JR, Pillai M, Gollard R, et al. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer. 2010; 9(2):95-101
    • Pirker R, Ulsperger E, Messner J, et. al. Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer. Lung. 2006; 184(5):279-85.

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Public Versions
Updated On Effective Dates Status
01/20/2017 01/26/2017 - N/A Currently in Effect You are here

Keywords

  • Neulasta,
  • Pegfilgrastim
  • J2505