Potential cost savings with biosimilars
The high prices of biologic pharmaceuticals have placed a burden on the healthcare industry, accounting for a continually increasing share of drug spending in the United States and limiting patient access to appropriate treatment. The Office of the Assistant Secretary for Planning and Evaluation estimates that United States drug spending totaled about $457 billion in 2015, making up 16.7% of overall health care spending. Notably, prescription drug expenditures are rising at a faster rate than overall spending, due to factors such as population growth, inflation, and a higher number of prescriptions per patient.
The estimated total costs of IBD in the United States range from $14.6B to $31.6B. The growing prevalence of the disease worldwide, in conjunction with the high costs, is concerning for the economy and may lead to unsustainable healthcare costs in the future. Compared to patients without the disease, direct medical expenditures have been found to be around $13663 to $17434 higher for patients with CD and $10039 to $12615 higher for patients with UC.
Biosimilars are expected to produce savings across the board in the health care industry as a result of various factors, such as reduced research and development costs, competition driven by patent expiry, and a simpler approval pathway. An Excel-based model of Remsima for the treatment of various inflammatory autoimmune diseases was created to estimate the budget impact of Remsima. The model, which covers five countries (Germany, the United Kingdom, Italy, the Netherlands, and Belgium) projects the biosimilar to induce cost savings over one year of $63 million (pounds converted to dollars) and the treatment of 3900 additional patients. Furthermore, another budget impact model of Remsima in six different countries (Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia) was developed while taking into two scenarios: BSc1 (interchangeability disallowed) and BSc2 (interchangeability allowed, 80% of patients taking IFX are interchanged to biosimilar). In this model, which estimates budget impact of Remsima in the treatment of RA only, savings of $21M (BSc1) and $29M (BSc2) are projected over 3 years, as well as the treatment of an additional 1200 to 1800 patients.
The EU has provided the healthcare industry with a preliminary impression of biosimilar market entry. Biosimilars have been available in the EU since 2006, and the observed average list prices are 30% lower than the RMP, compared to the 70% to 80% savings that generics induce[26,52]. Because biosimilars are more difficult to manufacture, the cost reduction is not expected to be as drastic as seen with generics.
Currently, filgrastim-sndz (Zarxio), an anti-cancer drug, infliximab-dyyb, and adalimumab-atto are the only biosimilars approved in the United States[28,29,53]. The entry of biosimilars into the United States market is important for the overall development and financial success of the pharmaceutical industry, bearing in mind that a majority of world biologics sales come from the United States. From 2014-2024, it is anticipated that the entry of the 11 most likely biosimilars into the market will lead to $250 billion in savings for the American healthcare industry, with the possibility of greater disease control and reduced inpatient stays and outpatient visits.
Wider accessibility for patients
The entry of biosimilars to market is expected to give patients more choices and greater access to treatment. Prior to the development of biosimilars, those who required biologic therapy were either restricted to a limited number of costly treatment options or placed on a waiting list. A cross-sectional study, performed in 49 European countries, revealed that RA patients in lower income countries struggle with affordability and have less access to biologic and synthetic disease-modifying drugs. Fortunately, due to projected cost reductions associated with biosimilars, a large number of patients are expected to have a larger complement of options available to them earlier in the course of the disease.
Furthermore, if switching between a particular RMP and its biosimilar are observed to be clinically noninferior to continued treatment of the RMP, then concerns about biologic shortages and waiting lists would potentially be alleviated. In 2014, there were 1000 additional patients in the Czech Republic who were able to initiate treatment than in the previous year, due to the cost savings of biosimilars.