Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?

Biosimilars have been talked about for the better part of the last 2 decades. Since filgrastim-sndz was approved by the FDA in 2015, prescribers and pharmacists have learned to incorporate biosimilars into inpatient care processes. Now, we are at a defining moment for biosimilars, this time for self-administered medications—a therapy class with one of the highest drug spend in specialty. Specialty pharmacies have an opportunity to proactively support patients who will have access to these therapies.

In January, adalimumab-atto launched commercially, the first of 9 FDA-approved adalimumab biosimilars for autoimmune diseases expected to be released this year. In the first 3 days of July 2023, 7 others launched on the US market. These launches represent the first wave of self-administered biosimilars expected over the next few years. The net result should be positive—biosimilars are estimated to reduce direct spending on biologic therapies by $54 billion without compromising safety or efficacy.^[1] However, we are likely to face some hurdles before these products are seamlessly integrated into our patient care regimens.

While familiarity and acceptance of biosimilars has improved over the last several years, knowledge gaps remain. There is a critical need to understand prescribers’ and pharmacists’ perceptions regarding these therapies and address any gaps to ensure a streamlined patient experience.

In advance of the anticipated wave of self-administered biosimilars, CPS Solutions (CPS) implemented 2 online surveys to better understand barriers to adoption among gastroenterologists, dermatologists, and rheumatologists and health system specialty pharmacists in early 2023 to assess knowledge about these new products. Prescribers were included if they serviced patients with an autoimmune disease and prescribed self-administered biologics for conditions such as Crohn disease, ulcerative colitis, and rheumatoid arthritis. Pharmacists were included if they clinically managed patients prescribed a self-administered biologic product for treatment of their autoimmune condition.

Our findings confirmed there is a need for greater education and support for these professionals to be ready to adopt self-administered biosimilars. On the plus side, participants expressed high familiarity with biosimilars and their importance in contributing to cost savings. However, in line with findings from other surveys, participants expressed low levels of comfort prescribing biosimilars, discussing biosimilars with patients, or counseling patients on switching to a biosimilar from a reference product.^[2] There also was low familiarity with state laws and regulations about interchangeability and biosimilar substitution.

The full results have been submitted for publication. But they highlight immediate steps we can all take to be better prepared.

There are several potential challenges we can work to address. First, there is a need to increase understanding of biosimilar interchangeability and substitution from the reference product. There also is a need for more learning regarding the FDA’s review and approval process for biologics, biosimilars, and interchangeable products, as well as resource materials that can provide guidance on this topic.

As medication experts, pharmacists are well-positioned to serve as a resource for providers, not only letting them know which biosimilars are covered by a patient’s health plan but in cases where there may be 2 or more choices at parity on a payer’s formulary, reviewing the characteristics of each product and helping them select the one that is the most clinically and financially appropriate.

Pharmacists working for health system specialty pharmacies have a unique advantage to close knowledge gaps and encourage acceptance of biosimilars. They provide integrated, localized care and are frequently embedded in patient care clinics, where they are viewed as trusted pharmacotherapy resources by providers and patients. They provide education on proper administration techniques to promote medication adherence and persistence. Educating these pharmacists on aspects of biosimilar therapy such as cost, reimbursement, previously published data, federal and state laws, and FDA regulations will further empower them to better support patients and providers.

Second, we must be prepared to address key operational areas. Patients will require additional support when switching from the reference product. Pharmacists and liaisons will need to conduct new benefits investigations and prior authorizations. They will also need to help patients navigate new co-pay card and financial assistance programs.

If there are any supply chain or availability issues, some administrative legwork will be required to switch patients to a product from a different manufacturer. Additionally, there may be logistical issues to operationalize. With the rapid launch of multiple biosimilars to products like adalimumab, pharmacies will have to think through how to manage inventory, refrigeration, and storage space.

Finally, as we go forward, it also will be critical to track data. Our partner hospital and health systems are equipped with electronic health records-integrated technology solutions that can track when patients switch from reference product to biosimilar or between biosimilars, the reason for the switch, and any discontinuations or interventions that result from those switches. This data will enable our pharmacists to easily monitor new starts and switches proactively and make interventions as appropriate to enhance patient outcomes. Over time, trends in these data can be analyzed, enabling providers to proactively change patient management processes to optimize care and provide valuable insights to payer and manufacturer partners.

Fortunately, we can apply learnings from the launch of biosimilars in the in-patient clinic settings to help prepare. By 2020, hospitals and health systems faced similar knowledge gaps, hesitancies, and biases among providers and pharmacists as the first wave of provider-administered biosimilars became available.^[3]

At that time, CPS worked with our partner hospitals and health systems to implement evidence-based clinical initiatives, updated processes and procedures, provider education resources, and technology-enabled benchmarking and financial modeling tools to address obstacles. Ultimately, our approach helped our partners increase the adoption rate for 7 innovator biologics to around 80%—significantly outpacing national average—yielding around $130 million in savings over 3 years.

Now is the time for health systems to review processes and take inventory of providers’ and pharmacists’ knowledge of self-administered biosimilars and equip your teams with additional education, technology or other resources as needed. Become familiar with the products. Monitor your state laws. Together, we can design optimal processes and procedures to carry us forward.

References

1. Mulchy A, Case S. Biosimilar cost savings in the United States: Initial experience and future potential. RAND Corporation. Published 2017. Accessed June 26, 2023.

https://www.rand.org/pubs/perspectives/PE264.html.

2. Stevenson J, McCabe D, McGrath M, McBride A. Pharmacist biosimilar survey reveals knowledge gaps. J Am Pharm Assoc. 2023;63(2):P529-537. doi: 10.1016/j.japh.2022.11.001

3. Wilde S, Schapiro L, Fletcher M, Pearson C. Understanding stakeholder perception of biosimilars. NORC. Published April 2021. Accessed August 5, 2022.