By Casey Speer, Principal, and Miranda Brekke, Senior Consultant
As the oncology and hematology landscapes continue to evolve with the development of more complex therapies and competitive treatment options, bispecific antibody therapies (BsAbs) have emerged as a key player, particularly in the multiple myeloma and lymphoma markets. Importantly, there are key differences in the adoption of bispecific treatments between community practices and larger health systems. Here’s how manufacturers can manage expectations in terms of the adoption of these therapies, as well as three future trends to watch in the marketplace.
Early BsAb approvals began with Blincyto to treat acute lymphoblastic leukemia in 2014 and have ramped up in recent years. While most products have initially been approved in later line settings (for example, 5L+ for multiple myeloma and 3L+ for lymphoma), many are in clinical trials for earlier line use as well as in additional indications and in combination regimens.
BsAbs are now a rival option to chimeric antigen receptor T-cell (CAR-T) therapies, with impressive efficacy data and the ability to deliver a unique value proposition for community oncology accounts. BsAbs have lower risk for severe adverse events, including high grade cytotoxic-release syndrome (CRS), and generally less stringent monitoring requirements compared to CAR-T products with regards to hospitalization or facility-proximity requirements.
BsAbs also give community practices an opportunity to offer patients best-in-class treatment with access to novel, complex therapy administration close to home, catering to patient convenience and increasing patient retention. Many community practices previously engaging in and taking first strides in developing CAR-T capabilities have since shifted priorities to BsAb capability development, recognizing the significant opportunity and need to keep up with the evolving landscape with a new potential standard of care. However, despite greater feasibility for adoption in the community and early precedent across select organizations, many practices face significant hurdles with program development, such as infrastructure and investments, training and expertise, and hospital relationships for adverse event support. Therefore, manufacturers need to understand operationalization expectations, monitor shifts in standard of care, and refine engagement strategies to mitigate community adoption barriers.
How Manufacturers Can Manage Expectations
For BsAb adoption, manufacturers should set realistic goals for community practices, as many may misjudge overall timelines for operationalization milestones such as risk evaluation and mitigation strategies (REMS) certification, standard operating procedure/protocol development, and staff training. To fuel BsAb infrastructure development at community practices with high patient opportunity potential, manufacturers should aim to reduce barriers to adoption, such as through protocol development support, as well as enhanced product education and awareness. In the community setting, the key to BsAb adoption is an ardent internal champion, likely an operational or clinical stakeholder, to catalyze infrastructure development and mitigate potential barriers.
Three Key Bispecific Antibody Therapy Trends to Watch
With increased bispecific approvals across indications and label expansions for on-market BsAbs, it’s important to understand areas to monitor across channels to further anticipate impact within the community space. Here are three trends to watch:
- Maintenance vs. step-up dosing capabilities: As community practices continue to enhance or develop internal BsAb capabilities, it’s important for manufacturers to determine whether the practices intend to develop maintenance and/or step-up dosing capabilities, as this dynamic influences the location of treatment decision-making and product selection. With maintenance treatment, community practices can retain the patient by establishing relationships with local hospitals or academic centers to manage the requirements associated with step-up dosing, such as hospitalization and overnight/on-call staff. These relationships can be monitored, as they may be an indicator of full-scale infrastructure development in the future.
- Standard of care evolution: As select BsAbs are currently in the pipeline pushing for expansion to earlier lines of therapy, the impact on standard of care should continue to be monitored across therapeutic areas. For disease areas in which CAR-T is non-curative or not prioritized based on disease-specific nuances, bispecifics may be viable as an earlier-line option (instead of using solely for post-CAR-T failure, for example). Additionally, oral options across therapeutic areas with BsAb approvals, such as multiple myeloma and follicular lymphoma, may also be monitored as increased convenience for both the practice and patient may impact selection and uptake in the community setting.
- Payer and provider preferencing: Across provider and payer stakeholders, preferencing is likely as more BsAb options enter various therapeutic areas and are compared based on efficacy and tolerability profiles, route of administration, cost, convenience (dosing schedule), and requirements such as hospitalization.
While step edits are unlikely to be a long-term phenomenon for bispecifics, the increasing competition, high cost, and growing pool of eligible patients will certainly attract the attention of payers. Should payers begin to leverage even soft preferencing mechanisms such as restrictive criteria or oncology benefit managers, community utilization may be impacted given fewer resources to navigate payer restrictions than sophisticated health systems.
For providers, preferencing could manifest as the preference for a single bispecific per therapeutic area within the organizational formulary (for instance, one BsAb for multiple myeloma, diffuse large b-cell lymphoma, and follicular lymphoma). These preferences could be reflected within internal decision support tools such as clinical pathways and EMR systems which typically have very high adherence in the community setting. Although provider organizations are likely to adopt multiple BsAbs once capabilities are established, the importance of early adoption cannot be understated, as physician familiarity and training drive demand internally.
BsAbs are a promising advancement in oncology and hematology, offering community practices a new standard of care that balances improved efficacy with greater convenience versus other complex therapies. While BsAb adoption is growing across the community landscape, accounts still face significant challenges in developing the infrastructure needed for BsAb programs, such as staff training, protocol development, and hospital coordination. Manufacturers must understand realistic BsAb adoption timelines and goals across the community setting, provide operationalization support, and monitor account readiness and progress to ensure early adoption and successful integration of these therapies.
Want to learn more about how The Dedham Group can assist with your bispecific antibody adoption strategies? Contact us.
