Simplifying biosimilar interchangeability for prescribers
In recent years, biosimilar drugs have emerged as a promising solution to the rising costs of specialty medications, offering equivalent efficacy and safety to their reference biologics at potentially lower costs. Most of the FDA-approved biosimilars to date are currently not interchangeable, but later this year some biosimilars for inflammatory conditions are expected to gain interchangeability status.
The concept of interchangeability – the ability to substitute between a biosimilar and its reference product – can present challenges for prescribers trying to optimize patient care while navigating regulatory requirements and ensuring therapeutic equivalence. In this article, we explore the role of specialty pharmacies like Accredo in assisting prescribers as they navigate the complexities of biosimilar interchangeability.
Understanding interchangeability in biosimilars
Interchangeability is a critical concept because it determines whether a biosimilar can be substituted for its reference product without the intervention of the prescriber, unless required by state pharmacy laws.
Achieving interchangeable status requires robust scientific evidence. It must demonstrate that the biosimilar produces the same clinical result as the reference product, with no greater safety risk or risk of reduced efficacy from alternating or switching between it and its reference product.
Challenges and opportunities for prescribers
For prescribers in specialty practice, navigating interchangeability in biosimilars can be complex and time consuming without appropriate support.
- Keeping up to date with evolving regulatory guidelines and requirements for demonstrating interchangeability can be a struggle for prescribers, particularly in rapidly evolving therapeutic areas such as inflammatory conditions.
- Determining when and how to incorporate interchangeable biosimilars into treatment plans is daunting because it requires careful consideration of many nuanced factors such as clinical efficacy, patient preferences, high concentration options and cost considerations.
- Educating patients about biosimilar interchangeability and addressing concerns or misconceptions requires time and resources that are often limited in a busy clinical practice.
Alternatively, interchangeability offers opportunities for prescribers to customize treatment plans that ultimately help improve patient outcomes through access and affordability.
- Expanded treatment options allow prescribers to tailor treatment plans to their individual patient’s needs, potentially improving adherence and outcomes.
- Biosimilars typically offer cost savings compared to their reference products. Prescribers can leverage these cost-effective alternatives without compromising therapeutic efficacy or safety.
The role of a specialty pharmacy
Specialty pharmacies like Accredo play a critical role in simplifying the process for prescribers navigating the challenges and opportunities of biosimilar interchangeability. Here is how:
- Expertise in regulatory compliance – Specialty pharmacies have dedicated teams of pharmacists and clinicians who stay updated on regulatory guidelines and requirements related to biosimilar interchangeability. They can provide prescribers with up-to-date information and guidance on specific therapies.
- Clinical support in decision making – Accredo’s specialized pharmacists collaborate closely with prescribers to evaluate the suitability of biosimilar alternatives for individual patients. They provide support to prescribers through evidence-based recommendations and insights into clinical efficacy, safety profiles and cost savings.
- Personalized patient education and counseling – Specialty pharmacies offer comprehensive patient education and counseling services to support prescribers in addressing patient concerns and misconceptions about biosimilar interchangeability. Pharmacists engage with patients to provide clear information, address questions and promote adherence to treatment plans.
Interchangeability can be a seamless process
Interchangeability in biosimilars presents both opportunities and challenges for specialty prescribers. Specialty pharmacies like Accredo support prescribers in navigating these complexities, providing expertise in regulatory compliance and pricing, and support clinical decision making and patient education. By leveraging the resources and support services offered by a specialty pharmacy, prescribers can optimize patient care, enhance treatment outcomes and improve affordability in the era of biosimilar drugs.
To best support our prescribers and patients as more interchangeable biosimilars enter the market, Accredo has mobilized a multichannel model of proactive communications to support seamless therapy conversions.
Download the infographic to learn how we do it.
