The Evolution of Value With Filgrastim in Oncology

Abstract

The recombinant G-CSF filgrastim was first approved in 1991, and its value has been evolving ever since. Initial health technology assessments suggested low value due to high drug cost and no evidence for significant gain in overall survival. However, more recent meta-analyses of placebo-controlled randomized trial data show falling costs due to biosimilar competition and absolute overall survival gains of 3.2% (95% CI: 2.1-4.2%) from filgrastim support of cytotoxic chemotherapy. The launch of biosimilar alternatives merits a re-evaluation of decisions by health technology assessments and explains the first inclusion of filgrastim in the WHO Essential Drug List for cancer >20 years after its original approval in 1991, thus demonstrating the power of biosimilar medicines in transforming healthcare.

Cost-effectiveness of granulocyte colony-stimulating factors (G-CSFs) for the prevention of febrile neutropenia (FN) in patients with cancer

“…The value of G-CSFs changes over time as research identifies patient groups at greater chance of clinical benefit while prices can change due to competition [ 8 ]. To remain relevant, guidelines based around cost-effectiveness estimates, such as the current US and European guidelines for G-CSF use, must also change over time.…”

“…Access to effective prevention of FN by granulocyte colony-stimulating factors (G-CSFs) is often limited by the high cost of these biologic medicines, resulting in restricted reimbursement by multiple health technology assessments (HTA) to only a subset of all the patients who could potentially benefit [ 8 ]. However, the loss of patent protection has enabled biosimilar versions of G-CSFs to be approved, creating competition to check prices.…”

Real World Clinical Experience of Biosimilar G-CSF (Grastofil) for Autologous Peripheral Blood Stem Cell Mobilization: Single Center Experience in Canada Following Early Adoption

“…Approval of biosimilar indications relies upon a tailored regulatory pathway critical to lowering developmental costs to produce lower priced products, which can be coupled with increased competition for availability of less expensive alternatives. Furthermore, the increasing acquisition cost of biologic medicines, particularly evident in the need to reduce the escalating cost of cancer treatment, provides an opportunity for biosimilars to impart greater value to healthcare while most importantly also ensuring similar outcomes [24][25][26]. The regulatory pathway for biosimilars is predicated upon a stepwise process in which biosimilars demonstrate similarity in all critical aspects of the drug, including confirmatory clinical efficacy studies conducted in the most sensitive patient population to reduce uncertainty in concluding biosimilarity [27].…”

How do biosimilars sustain value, affordability, and access to oncology care?

“…When a biosimilar enters the market, there is a need to re-evaluate the value of therapy. Based on a literature review of economic evaluations of filgrastim, Cornes and Krendyukov argued that the value of filgrastim improved over its lifecycle as a result of more recent evidence supporting a significant increase in life expectancy with filgrastim and price reductions arising from biosimilar filgrastim market entry [6]. According to the authors, this improvement in value justified the addition of filgrastim to the World Health Organisation Model List of Essential Medicines.…”