Blood cancer is an extremely costly cancer to both patients and payers. According to The Leukemia and Lymphoma Society, the average annual spending for treating blood cancer is $156,000 in the first year after diagnosis1. Blood cancers include leukemia, lymphoma, myeloma, and bone marrow disorders. These cancers are also known to have higher out-of-pocket costs (OOP) for patients and can cost in the range of thousands per year 1. The impact of these exorbitantly high healthcare bills is not only detrimental to patients but also hinders the physician’s ability to provide high-quality treatment.
But are there ways to provide effective treatments to patients without burning a hole through their savings? Treatments using biosimilars could be the answer. Biosimilar is a biologic product that is derived from a living system, such as a microorganism, plant or animals2. Biosimilars can be confused with biologics. But in fact, they are imitations of biologics and closely resemble their reference products (biologics) and have been approved by the FDA after they have proved in human clinical trials to have shown that there are no differences between the reference product and the biosimilar in terms of safety and effectiveness 3.
The main point of difference is that biologics are protected by patents and can be considered as “branded.” Due to this brand name, treatments could cost patients $10,000-$20,000 per month. It is only when this original branded biologic patent expires, other competing pharmaceutical companies can imitate these original biologics which are called biosimilars4. These shouldn’t be confused with ‘generic’ drugs because it’s close to impossible for biosimilars to follow a standard manufacturing scheme unlike in the case of generic drugs, where the manufacturers can replicate the branded agent’s chemical structure 2.
Biosimilars had an initial slow start but recently the US Food and Drug Administration has approved 18 biosimilars out of which 10 have direct relevance to hematologists and oncologists. Erythropoietin (EPOs) and filgrastim (G-CSF) were the first biosimilars to be produced for use in
“The cost burden of blood cancer care – Leukemia & Lymphoma Society.” 25 Oct. 2018, http://www.lls.org/sites/default/files/Milliman%20study%20cost%20burden%20of%20blood%20cancer%20care.pdf. Accessed 29 May. 2019.
2″Biosimilars and Their Role in Cancer Treatment | Lungcancer.org.” https://www.lungcancer.org/find_information/publications/353-biosimilars_and_their_role_in_cancer_treatment. Accessed 28 May. 2019.
3 “Biosimilars | Leukemia and Lymphoma Society.” https://www.lls.org/treatment/types-of-treatment/chemotherapy-and-other-drug-therapies/types-of-drug-therapies/biosimilars. Accessed 29 May. 2019.
4 “Biosimilars in Hematology: A Work in Progress – ASH Clinical News.” 1 Dec. 2018, https://www.ashclinicalnews.org/perspectives/biosimilars-hematology-work-progress/. Accessed 28 May. 2019
hematology-oncology 1. Pegfilgrastim, another recombinant form of G-CSF analog filgrastim biosimilar was approved by the FDA in June of 2018 2.
That said, researchers in the field of hematology-oncology are now working towards a new generation of biosimilars known as monoclonal antibodies (MoAbs). MoAbs are anticancer drugs rather than merely being supportive treatments like their predecessors 3. These biosimilars will indeed revolutionize how blood-related cancers are treated.
Adopting biosimilars for treatment by oncologists can result in an estimated cost saving of $54 billion from 2017-2026 4. The switch to biosimilars can be an opportunity for oncologists to incorporate a value-based approach in oncology treatments. In June of 2016, the Center of Medicare and Medicaid launched a voluntary Oncology Care Model initiative as part of its initiative to reduce healthcare cost and increase the quality of oncology care. OCM is a two-part payment program for physicians to manage cancer care. The second is a semi-annual performance-based incentive system based on metrics such as quality achievements and savings in Medicare expenditure5.
In summary, biosimilars can be a win-win for all the stakeholders in the healthcare system i.e patients, payers and physicians. It is also of utmost importance that providers adequately acquaint themselves with the available evidence on safety and efficacy of biosimilars along with terminologies such as immunogenicity, drift, extrapolation, and interchangeability and also how to differentiate from the originator and other biosimilars 5.
5 “Ask the Hematologist: Safety and Efficacy of Biosimilars for ….” 27 Apr. 2019, https://hematology.org/Thehema tologist/Ask/9516.aspx. Accessed 29 May. 2019.
6 “FDA Approves Coherus’ Pegfilgrastim Biosimilar, Udenyca.” 2 Nov. 2018, https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca. Accessed 29 May. 2019. 6 “FDA Approves Coherus’ Pegfilgrastim Biosimilar, Udenyca.” 2 Nov. 2018, https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca. Accessed 29 May. 2019.
7 “The evolving role of biosimilars in hematology-oncology: a … – NCBI.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649606/. Accessed 29 May. 2019.
8 “Unlocking the Potential of Biosimilars in Community Oncology ….” 18 Apr. 2019, https://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/biosimilar-potential-oncology-oncology-treatment-risk/. Accessed 30 May. 2019.
9 “The Role of Biosimilars in Value-Based Oncology Care | Cancer ….” 19 Dec. 2018, https://www.cancernetwork.com/biosimilars/role-biosimilars-value-based-oncology-care. Accessed 31 May. 2019.