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Three Reasons EHRs Need to Treat Biosimilars Differently from Generics
By Tony Schueth
Biosimilars are being introduced in the United States and are expected to quickly become more mainstream in the near future. In response, stakeholders are beginning to work on how to make them safe and useful within the parameters of today’s healthcare system.
The reason is that biosimilars, like biologics, are made from living organisms, which makes them very different from today’s conventional drugs. These differences will create challenges and opportunities in how they are integrated in electronic health records (EHRs) and user workflows as well as how patient safety may be improved.
Normally, there is a lot of lead time before EHR vendors must address such issues. Things are different with biosimilars. Here are some reasons.
There are powerful drivers
Several drivers will stimulate demand for EHRs to address biosimilars sooner rather than later. This is because of central role EHRs play in value-based care coordination and patient safety.
New biologics will be bursting on the healthcare scene. Although biosimilars have recently been approved for use in the US, they have been in use extensively in Europe and Asia for many years. More than 80 biosimilars are in development worldwide, and the global biosimilars market is expected to reach $3.7 billion. This will stimulate rapid adoption by payers and physicians in the US, which, in turn, will create the need for EHRs to capture and share a variety of information about biologics and biosimilars. It is easy to envision the availability of four biosimilars for 10 reference products in 2020, given projected market expansions.
Next, uptake in the US is expected to take off because biosimilars are lower-cost alternatives that will be used to treat the growing number of patients with such chronic diseases as arthritis, diabetes, and cancer. Rand has estimated savings from using biosimilars at $44.2 billion over 10 years. Money talks and payers will create demand for EHRs to fold biosimilars and biologics into EHR functionalities and workflows.
Payers and regulators also will demand enhanced tracking of biologics and biosimilars because they are key pieces of the move toward value-based reimbursement and are a focus of public and private payers. Identifying, tracking, and reporting adverse events that might be associated with biologics and biosimilars are expected to become key metrics for assessing care quality and pay-for-performance incentives.
Biosimilars are not generics
It would be a mistake to think of biosimilars as being synonymous with generics, which have been around for years and use mature substitution methodology. The reason begins with the fact that biologics and biosimilars are medications that are made from living organisms. Unlike generics, which have simple chemical structures, biosimilars are complex, “large molecule” drugs that are not necessarily identical to their reference products, thus the term “biosimilar,” not “bioequivalent.” In addition, biosimilars made by different manufacturers will differ from the reference product and from each other, making each biosimilar a unique therapeutic option for patients.
Furthermore, biologics and biosimilars have varying locations where they are administered, most commonly infused in physician offices, hospitals, or special ambulatory centers, or by patients at home. Given that administration location and type can vary, such information — along with the particulars of the drug that was administered — must get back to the physician and incorporated into the patient’s EHR record.
Getting this information into the patient’s record in the EHR also is important for improving patient safety. That is because it will help in identifying and distinguishing the source of the adverse drug events and patient outcomes from a biosimilar, its reference biologic, and other biosimilars.
Substitution laws are expanding and evolving
Developers of EHR systems will need to keep abreast of evolving state laws concerning substitution. In fact, many states already are considering substitution legislation or have enacted it. According to the National Conference of State Legislatures, as of early January 2016, bills or resolutions related to biologics and/or biosimilars were filed in 31 states. Keeping pace with these new laws is likely to be a challenge to ensure that EHRs are compliant, especially since requirements are apt to vary considerably from state to state. Given the rapid changes in the regulatory landscape, latency of updates to EHR systems is a problem that needs to be addressed.
Not only that, the drug that is dispensed may be very different than what was prescribed. As a result, it is important for physicians to know whether a substitution has been made and capture information about the drug that was administered in the patient’s EHR record. Because of the differences from conventional medications, different, more granular information such as lot number, will also be required. This is important for treatment and follow-up care as well as in cases where an adverse drug event or patient outcome occurs later on.
All in all, EHRs will face a brave new world when it comes to adapting to biologics and biosimilars.
Tony Schueth is CEO and managing partner of Point-of-Care Partners of Coral Springs, FL.