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

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

In January, adalimumab-act was 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 more were launched on the US market. These launches represent the first wave of self-administered biosimilars expected in the coming years. The net result should be positive: biosimilars are estimated to reduce direct spending on biological 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.

Although the familiarity and acceptance of biosimilars have improved in recent years, knowledge gaps remain. Understanding prescriber and pharmacist perceptions of these therapies and addressing any gaps is critical to ensure a streamlined patient experience.

Prior to the expected surge in self-administered biosimilars, CPS Solutions (CPS) implemented 2 online surveys to better understand the barriers to adoption among gastroenterologists, dermatologists, rheumatologists and specialty pharmacists in the healthcare system in early 2023 to assess awareness of these new products. Prescribers were included if they were caring for patients with an autoimmune disease and were prescribing self-administered biologics for conditions such as Crohn’s disease, ulcerative colitis, and rheumatoid arthritis. Pharmacists were included if they were clinically managing patients who had been prescribed a self-administered biologic product to treat their autoimmune condition.

Our findings confirmed the need for more 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, consistent with findings from other surveys, participants expressed low levels of comfort when prescribing biosimilars, discussing biosimilars with patients, or advising patients to switch to a biosimilar from a reference product.^[2] There was also a lack of familiarity with state laws and regulations on interchangeability and substitution of biosimilars.

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

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

As drug experts, pharmacists are well positioned to serve as a resource for providers, not only letting them know which biosimilars are covered under a patient health plan, but in cases where there may be 2 or more choices on par with a payroll form, reviewing the characteristics of each product and helping them select the most clinically and financially appropriate one.

Pharmacists working for specialty pharmacies in the healthcare system have a unique advantage in filling knowledge gaps and encouraging acceptance of biosimilars. They provide integrated, localized care and are often integrated into patient care clinics, where they are viewed as trusted pharmacotherapy resources by providers and patients. They provide training in 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 need additional support when switching from the reference product. Pharmacists and intermediaries will need to conduct new benefit inquiries and prior authorizations. They will also need to help patients navigate new co-pay card and financial assistance programs.

If there are supply chain or availability issues, administrative work will be required to switch patients to a product from a different manufacturer. Also, there may be logistical issues to make operational. With the rapid rollout of more biosimilars for products like adalimumab, pharmacies will need to think about how to manage inventory, refrigeration and storage space.

Finally, as we move forward, it will also be vital to keep track of data. Our partner hospitals and healthcare systems are equipped with technology solutions integrated into electronic health records that can monitor when patients switch from the reference product to biosimilar or from one biosimilar to another, the reason for the switch and any disruptions or interventions resulting from such steps. This data will enable our pharmacists to easily monitor new starts and proactive changes and take the appropriate interventions to improve patient outcomes. Over time, trends in this data can be analyzed, enabling providers to proactively change patient management processes to optimize care and provide valuable insights to paying and manufacturing partners.

Fortunately, we can apply the lessons learned from the rollout of biosimilars in hospital settings to help prepare. By 2020, hospitals and healthcare systems were faced with similar knowledge gaps, hesitations and biases between providers and pharmacists as the first wave of provider-administered biosimilars became available.^[3]

In that time, CPS worked with our partner hospitals and healthcare systems to implement evidence-based clinical initiatives, updated processes and procedures, educational resources for providers, and technology-enabled financial modeling and benchmarking tools to address the barriers. Ultimately, our approach helped our partners increase the adoption rate of 7 innovative biologics to approximately 80%, significantly exceeding the national average, saving approximately $130 million over 3 years.

Now is the time for healthcare systems to review processes and inventory the knowledge of providers and pharmacists on self-administered biosimilars and equip your teams with additional education, technology or other resources as needed. Familiarize yourself with the products. Monitor your state laws. Together, we can design processes and best practices to move us forward.

References

1. Mulchy A, Case S. Cost savings of biosimilars in the United States: initial experience and future potential. RAND Corporation. Published in 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 gaps in knowledge. 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 perceptions of biosimilars. NORM. Published April 2021. Accessed August 5, 2022.