Neulasta Onpro (pegfilgrastim/onpro) / Amgen - LARVOL DELTA

Neulasta Onpro: a coup de grâce? (PubMed, Am J Manag Care) - "With the rapid decline in average sales price of reference pegfilgrastim products due to biosimilar competition, health care institutions and payers may grapple with coverage of Neulasta Onpro."

Journal

Biosimilars May Reduce Disparities in Febrile Neutropenia Treatment (Oncology Nursing News) - "'We [now] have several biosimilars available in the US and around the world, [with the reference agents] filgrastim and pegfilgrastim' said Crawford, in a presentation on new and emerging agents on outcomes of febrile neutropenia during the 2022 Supportive Care in Cancer Annual Meeting.'The potential impact of this is significant; [it represents] greater patient access, greater competition between the companies, and fostered innovation.'"

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A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. (PubMed, Support Care Cancer) - P=N/A | "Pegfilgrastim OBI was associated with a lower FN incidence in patients with breast cancer compared to other options for FN prophylaxis."

Journal • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Palliative care • Solid Tumor

BeyondSpring Pharmaceuticals Announces New Positive Data on Plinabulin from Its Chemotherapy-Induced Neutropenia Prevention Program at the European Society for Medical Oncology 2021 Congress (GlobeNewswire) - P3, N=221; PROTECTIVE-2 (NCT03294577); Sponsor: BeyondSpring Pharmaceuticals; “BeyondSpring Pharmaceuticals…announced new positive data on plinabulin from its chemotherapy-induced neutropenia (CIN) prevention program with three poster presentations at the European Society for Medical Oncology (ESMO) 2021 Congress taking place from September 16-21, 2021…In the PROTECTIVE-2 Phase 3 trial, the combination of plinabulin and pegfilgrastim had superior efficacy in preventing Gr4N versus pegfilgrastim alone; Gr4N of 68% in the combination vs. Gr4N of 86% for pegfilgrastim alone, p = 0.0015. Based on the meta-analysis detailed above in n>7000 patients, the reduction in Gr4N frequency from 86% in pegfilgrastim alone to 68% in the combination is predicted to result in a statistically significant and clinically meaningful reduction (approximately 50% reduction) in key clinically relevant CIN outcomes including mean DSN, FN rate..."

Clinical data • P3 data • Neutropenia • Oncology

FDA Cautions Amgen About Pefilgrastim Advertisement (AJMC) - "After receiving complaints through its Bad Ad Program, the FDA has issued a warning to Amgen to discontinue what it says are misleading claims about its Onpro pegfilgrastim wearable injector kit. The FDA says a banner advertisement used by Amgen falsely claimed that the Onpro is more successful at reducing the incidence of febrile neutropenia (FN) than the prefilled syringe (PFS) form of administering pegfilgrastim. The FDA said the study upon which Amgen based that claim was not geared to provide a reliable comparison of FN incidence between patient populations using Onpro vs PFS. The FDA also contends that the wording of the advertisement could create the false impression that biosimilar forms of pegfilgrastim, all of which are in PFS form, are inferior to Amgen’s wearable injector kit."

Commercial • FDA event • Hematological Malignancies • Neutropenia • Oncology

Conversion from pegfilgrastim with on-body injector to pegfilgrastim-jmdb: Cost-efficiency analysis and budget-neutral expanded access to prophylaxis and treatment. (PubMed, J Med Econ) - "Pegfilgrastim (Neulasta®), biosimilar pegfilgrastim-jmdb (Fulphila), and pegfilgrastim with on-body injector (OBI; Neulasta Onpro) are options for CIN/FN prophylaxis...Simulations of budget-neutral expanded access to prophylaxis with pegfilgrastim-jmdb or to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for diffuse large B-cell lymphoma (DLBCL) were also performed...Conversion from pegfilgrastim to pegfilgrastim-jmdb is associated with significant cost-savings which increase markedly when also accounting for pegfilgrastim-OBI failure and associated FN-related hospitalizations. These general and failure-related cost-savings could be allocated on a budget-neutral basis to provide more patients with additional CIN/FN prophylaxis or antineoplastic treatment."

Journal • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Initial testing of pegfilgrastim (Neulasta Onpro) on-body injector in multiple radiological imaging environments. (PubMed, J Appl Clin Med Phys) - "No device performance issue was identified under the extreme test conditions in x-ray or CT. The device was found to be MR Unsafe. Magnetic field changes around an ultrasound system met the limitation set by manufacture. Patient ultrasound scanning is considered safe as long as the transducers do not inadvertently loosen the device."

Journal • MRI

[VIRTUAL] Retrospective review of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia (ASHP 2020) - " Through the use of the Epic reporting software, all patients receiving treatment with Udenyca® or Neulasta®Onpro® from January 1, 2017 to July 1, 2020 will be identified. The patient’s electronic medical record will be reviewed by the primary investigator for inclusion and exclusion criteria. If the patient meets inclusion criteria, data will be obtained on a collection form and evaluated for appropriateness as documented in current guidelines."

Retrospective data • Review • Hematological Disorders • Oncology • CSF3

[VIRTUAL] Evaluation of pegfilgrastim products for the primary prophylaxis of febrile neutropenia (ASHP 2020) - "Purpose: Neulasta, Neulasta Onpro, and the biosimilar UDENYCA are pegfilgrastim products that have been approved by the FDA for the prevention of febrile neutropenia (FN). not applicable"

Hematological Disorders • Neutropenia

[VIRTUAL] Early versus later pegfilgrastim administration on the prevention of chemotherapy-induced febrile neutropenia in patients with high grade B-cell lymphomas receiving R-CHOP-21 (ASHP 2020) - "Purpose: Guidelines recommend primary prophylaxis against febrile neutropenia with granulocyte colony-stimulating factor (G-CSF) 24 hours to 72 hours after chemotherapy in the high-risk patients, such as those who are elderly treated with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) for high-grade B-cell lymphoma...The G-CSFs products used include pegfilgrastim (Neulasta, Neulasta Onpro on-body injector), pegfilgrastim-cbqv (Udenyca), and filgrastim products... Early administration of pegfilgrastim was associated with a higher incidence of interventional antibiotics use compared to later administration. The incidence of hospital encounters was not different between the early and later pegfilgrastim administration. FN trended toward a lower incidence in the early group."

Clinical • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma. (PubMed, J Med Econ) - "Background: Guidelines recommend febrile neutropenia (FN) prophylaxis following myelotoxic chemotherapy with either daily injections of filgrastim (Neupogen) or biosimilar filgrastim-sndz (Zarzio/Zarxio), single-injection pegfilgrastim (Neulasta), or pegfilgrastim administered through an on-body injector (PEG-OBI; Neulasta Onpro)...Our objective was to estimate, from a US payer perspective, the incremental costs of FN hospitalizations and the total incremental costs associated with PEG-OBI prophylaxis at varying device failure rates over assured FN prophylaxis with daily injections of filgrastim or filgrastim-sndz or a single injection of pegfilgrastim. Cost simulations comparing prophylaxis with PEG-OBI at failure rates of 1-10% versus assured prophylaxis in cycle 1 of chemotherapy were performed for panels of 10,000 patients with lung cancer treated with cyclophosphamide, doxorubicin, and etoposide (1 analysis) or non-Hodgkin lymphoma (NHL) treated with CHOP or CNOP (2..."

Clinical • Journal • Hematological Disorders • Hematological Malignancies • Lung Cancer • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thoracic Cancer

UPMC expert discusses price variation for biosimilars (AJMC) - "Brufsky admits that finding this out was an eye-opener for him. 'It's a very complicated process for the pharmacy, the pharmacy and therapeutics committee, and the financial team to figure out exactly what the benefits of a biosimilar are financially. It really depends on a lot of factors that you ordinarily wouldn't have thought of.'...The goal for many in the health-care system is to figure out what the biosimilar threshold is that represents the perfect balance of cost savings and convenience, he said."

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Given on-body injector failure with pegfilgrastim, biosimilar filgrastim offers greatest cost efficiency (Center for Biosimilars) - "Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency."

HEOR

Racial Differences in Accepting Pegfilgrastim Onpro Kit (On-Body Injector) Use Among Cancer Patients. (PubMed, Clin Oncol (Las Vegas)) - "1.1.Neulasta Onpro kit eliminates need for additional clinic visit after chemotherapy. We believe the current study represents the first look at important racial differences in accepting Onpro kit. Consideration of patients' cultural heritage, race, ethnicity and education may facilitate communication between physicians and patients to achieve optimal cancer care."

Clinical • Journal

Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (Febrile) neutropenia and expanded access based on budget neutral basis. (ASCO 2019) - "...Since pegfil has two forms of availability (Neulasta and Neulasta-Onpro) with the same price, results were to either conversion scenario... Conversion from pegfil to biosim-pegfil can lead to potential cost savings and these savings can be applied to offer increased access to supportive care with biosim-pegfil for patients receiving chemotherapy on a budget-neutral basis. For payers with larger populations, savings can be substantial. More studies are warranted to evaluate such potential cost savings due to use of biosim-pegfil over reference pegfil."

HEOR

UnitedHealthcare will prefer brand-name pegfilgrastim starting in July 2019 (Center for Biosimilars) - "According to the bulletin, use of Neulasta Onpro (a presentation of the pegfilgrastim product in an on-body injector device) or Neulasta in a vial will be required before use of Mylan and Biocon’s biosimilar, Fulphila, or Coherus BioSciences’ biosimilar, Udenyca....Also, as of August 1, brand-name filgrastim, Amgen’s Neupogen, will require prior authorization, as will its biosimilars: Pfizer’s Nivestym, Sandoz’s Zarxio, and Teva’s Granix (a follow-on product approved before the biosimilar pathway was established in the United States)."

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