The authors of the overview article look at administration choices and financial concerns for pegfilgrastim biosimilars in supportive oncology in the USA with the aim of maximizing profit to sufferers.
Due to the “growing acceptance of same-day administration of pegfilgrastim and the monetary burden of ever-present medicines for sufferers,” the authors say, this can be a related matter. Their overview discusses administration choices with a give attention to minimizing clinic visits and suggests a patient-centered pegfilgrastim administration mannequin for febrile neutropenia prophylaxis.
The biologic granulocyte colony-stimulating issue (G-CSF) filgrastim and pegfilgrastim are used to scale back the danger of febrile neutropenia in sufferers present process myelosuppressive chemotherapy, by stimulating neutrophil manufacturing, maturation, and survival. Based on the authors, febrile neutropenia can delay therapy and require dose discount, restrict the effectiveness of therapy and negatively have an effect on the affected person’s well being or scale back the survival fee. Of the two, pegfilgrastim, which is the pegylated, long-acting type of filgrastim, is essentially the most generally used G-CSF in the USA.
Though the excessive price of biologics can restrict entry to therapy, the authors notice that low-cost pegfilgrastim biosimilars have been obtainable for a number of years. There are at the moment 6 pegfilgrastim biosimilars accredited within the US for the prophylaxis of febrile neutropenia.
Commentators wrote that price financial savings might have a “important affect on the monetary stress skilled by most cancers sufferers,” citing analysis that discovered as much as 48% of most cancers survivors expertise monetary toxicity. They added that monetary stress might trigger survivors to skip future medical care.
Administrative Choices to Decrease Clinic Visits
Basically, pegfilgrastim is run as soon as per cycle of chemotherapy and is normally injected 24 hours or extra after chemotherapy. Though the FDA-approved indication for febrile neutropenia prophylaxis is next-day administration within the clinic, the authors say a number of choices can be found.
For instance, the Nationwide Complete Most cancers Community additionally helps same-day administration, which they are saying has helped to attenuate clinic visits throughout the COVID-19 pandemic. The authors added that same-day administration could also be higher for sufferers who dwell removed from the clinic or favor to attenuate visits on account of “emotional and bodily exhaustion after chemotherapy.”
Reviewers talk about the positives and negatives related to 3 approaches to pegfilgrastim administration that decrease clinic visits:
- Similar day administration after chemotherapy
- Use of an on-body injector (OBI) that delivers pegfilgrastim roughly 27 hours after chemotherapy
- Self-administration by the affected person or caregiver not less than 24 hours after chemotherapy. Their view is that “consideration of every choice needs to be primarily based on the affected person’s particular wants and luxury degree.”
Though self-administration reduces clinic visits and may enhance sufferers’ high quality of life, correct self-injection approach is vital. Obstacles to self-injection embody worry, anticipated ache, affected person age and comorbidities. The OBI gadget is used on the identical day as chemotherapy and delivers a regular dose of pegfilgrastim 27 hours after software. Failure charges for OBI vary from 1.7% to six.9%. Not all sufferers obtained the gadget, and “affected person schooling could also be wanted to make sure the effectiveness of pegfilgrastim OBI and to handle gadget failure.”
OBI gives a substitute for self-injection, however an OBI gadget that delivers biosimilar pegfilgrastim at a decrease price just isn’t at the moment obtainable. Based on the authors, 1 biosimilar pegfilgrastim (pegfilgrastim-cbqv) OBI is in growth.
A 3rd choice to attenuate clinic visits is the off-label use of pegfilgrastim injection on the identical day after chemotherapy. This selection nonetheless eliminates a second clinic go to, and it might be a greater choice for sufferers who’re unable or unwilling to self-inject pegfilgrastim and are uncomfortable having an OBI gadget hooked up to their pores and skin.
Based on the commenter, the priority about same-day administration stems from the remark that the shorter-acting filgrastim might worsen neutropenia in some circumstances. tumor sort didn’t detect a distinction in consequence in contrast with next-day administration,” they wrote.
Similar-Day Administration of Pegfilgrastim within the Context of COVID-19
Commenters stated that minimizing clinic visits is a vital goal, as most cancers sufferers have a higher threat of an infection than wholesome people, and “frequent hospital visits might additional enhance the danger of contracting COVID-19 throughout the present pandemic, significantly in immunocompromised sufferers.” aged with poor practical standing.” Whereas the epidemic continues, they stated, outpatient visits for most cancers sufferers needs to be minimized “with out compromising satisfactory affected person care.”
Though same-day administration has not been studied within the context of the COVID-19 pandemic, the authors write, “this technique was used efficiently earlier than the COVID-19 pandemic and will present a threat discount alternative.” Additionally, same-day administration might have further advantages: “Decreasing affected person visits can also scale back the workload for healthcare staff, who’re at the moment overburdened and overworked on account of COVID-19.”
Commenters advocate that the strategy of administration of pegfilgrastim “needs to be primarily based on the particular wants of the affected person, whereas contemplating mitigating elements, such because the financial burden related to biologic medicine and the danger of COVID-19.”
Humphreys SZ, Geller RB, Walden P. Pegfilgrastim biosimilars in US supportive oncology: a story overview of administrative choices and financial concerns to maximise affected person profit. Oncol Ther. 2022:1-11. doi: 10.1007/s40487-022-00207-2