RETIRED LCD Reference Article Article

Pegfilgrastim (Neulasta) J2505 and Q5122 - (Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria))

A55447

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NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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General Information

Source Article ID
N/A
Article ID
A55447
Original ICD-9 Article ID
Not Applicable
Article Title
Pegfilgrastim (Neulasta) J2505 and Q5122 - (Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria))
Article Type
Article
Original Effective Date
01/26/2017
Revision Effective Date
04/01/2021
Revision Ending Date
11/01/2023
Retirement Date
11/01/2023

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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. Medicare also coveres Pegfilgrastim-apgf, biosimilar (Nyvepria) Q5122 for use in ASC. 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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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/22/2023 R2

Coverage articles may be retired due to lack of evidence of current problems or CMS may have issued guidance regarding national coverage. The Noridian guidance in the retired article may still be helpful in assessing medical necessity. Where providers have adjusted their billing and coding practices to correspond to the guidance in a coverage article, they will want to be very careful in departing from these practices just because the article is retired. Provider offices remain responsible for correct performance, coding, billing, and medical necessity under Medicare. This responsibility for correct claims submission is unchanged whether or not there is a coverage article in place.

04/01/2021 R1

Per CR 12175, effective 4/1/2021 HCPCS code Q5122 is payable in an ASC.

Updated to indicate this article is not an LCD Reference Article.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Public Versions
Updated On Effective Dates Status
11/22/2023 04/01/2021 - 11/01/2023 Retired You are here
11/16/2023 04/01/2021 - N/A Superseded View
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Keywords

  • Neulasta,
  • Pegfilgrastim
  • J2505
  • Q5122