3 Key Considerations for Implementing Biosimilars in Health Systems

Rick Lozano is the Vice President of Biosimilars and Integrated Business Development for AmerisourceBergen. His responsibilities span across AmerisourceBergen, working with internal teams and manufacturer partners to create and manage innovative biosimilar and follow-on biologic manufacturer relationships. In addition to his leadership in biosimilars, Lozano leads the team connecting AmerisourceBergen’s manufacturer sourcing and commercialization capabilities across all types of products to expand existing manufacturer partnerships and forge new business development opportunities.
September 24, 2018
It’s no secret that hospitals and health systems continue to face pressure to improve patient outcomes while managing the total cost of care. Now, biosimilars present an opportunity to address both needs. They are clinically equivalent to reference biologic products and offer potentially significant savings. Yet many hospitals struggle to change their formularies and physician preferences for these medications. 

Still, health systems are a critical channel not only to ensure biosimilars’ success, but also to ensure that patients, providers, and the collective healthcare system are receiving the full benefit of this new class of therapies. Manufacturers will need to work with hospital teams to develop a process to evaluate and support biosimilars as an addition to or replacement for reference products. That starts by understanding 3 key considerations for assisting health systems implementing biosimilars: safety and efficacy, operational support and economic impact, and workflow and access.

Safety, Efficacy, and Economics
Given that a biosimilar mimics an existing FDA-approved reference product, the FDA’s approval pathway for a biosimilar is abbreviated. Since there is already a reference product on the market, the biosimilar approval process relies heavily on analytical characterization and leverages relevant previous studies. While this has long been the industry standard for the FDA’s biosimilar approval process, not all providers are comfortable with the product class yet. If providers are not confident enough to prescribe biosimilars, the products’ potential cost savings and the work manufacturers do to support their introduction to hospital workflow will be irrelevant. 

To encourage provider confidence, hospital executives and pharmacy and therapeutics committees should look at safety and efficacy, FDA label indications, and comparative clinical data to reinforce to their physicians that a biosimilar is as safe and effective as its reference product. Absent a centralized database of this information, manufacturers should educate physicians about a product’s rigorous approval process to ensure that they feel comfortable prescribing a biosimilar in lieu of an innovator biologic. 

Patients also must feel comfortable if a provider prescribes a biosimilar. More biosimilars are expected to be approved to treat cancer, and a patient with cancer may not be immediately receptive to a switch to a similar version of their biologic treatment. Manufacturers will also need to equip hospital staff to have these conversations with patients. 

Pharmacy teams who understand the requirements for biosimilar approval, as well as the key components of biosimilars, will be prepared to guide their health system on how to evaluate these drugs for formulary inclusion and encourage provider confidence. Manufacturers would be remiss to not consider these internal stakeholders at health systems who can advocate for their products. 

If providers and patients can accept that biosimilars are as safe and effective as their reference products, the choice to prescribe them becomes clear. By their nature, biosimilars can only claim to be as effective as biologics; the more significant benefit for biosimilars is economic. Therefore, sharing safety and efficacy data is inextricably linked to demonstrating the financial benefits associated with biosimilars. This is critical in an environment where health systems are being impacted by consolidation and the need to reduce the overall healthcare spending with increased efficiencies. With biosimilars, a physician can achieve the same outcome as with a reference product, but with a more cost-effective option, to the benefit of both the patient and the health system. 

Operational Support
Biosimilars’ savings are particularly important when considering that, in a 2017 survey, hospital executives agreed that reviewing and optimizing existing operational and clinical processes was their hospital’s top strategy for containing costs in the next 3 years. This is an environmental challenge that biosimilar manufacturers need to keep in mind in order to successfully launch their products in to the health system setting.

When implementing a new product, hospital executives have to consider utilization management, care management, and drug dispensing, but they also have to plan for contracts with insurers, clinical training of staff on specialty disease states, nursing support, and software for case management. With the regulatory and policy environment in flux, many are also waiting to see how regulations impact payer protocols and reimbursement before adding biosimilars to formularies. 

Operational challenges specific to biosimilars that hospitals will need to consider include storage and handling, differences in dosage sizes or strengths between a reference product and a biosimilar, and how to differentiate electronic health records when stocking the reference product and biosimilar. It is crucial that, when a biosimilar is launched, it has as much support and surrounding services as its reference product does. The health system will be looking to the manufacturer to not only prove the product belongs in its formulary clinically but also demonstrate that support services, like patient assistance programs, and payer requirements for prior authorization will be met. Health systems need manufacturer partners who will provide an implementation team that is accountable across every function of the hospital, from providers to the pharmacy to patients. 

Providing Optimal Access
The third consideration is access. If biosimilars are to be successful, hospitals are a critical channel, meaning manufacturers need to be thoughtful about which distribution model works best not only for their product but also their customers. Biosimilar manufacturers need to prioritize models that allow their products to seamlessly fit into a hospital or health system’s workflow and ensure availability, no matter where a patient presents. 

For example, we are starting to see the first biosimilar, Zarxio, gain US market share as it appears to have found the appropriate channel strategy. Manufacturers should work with distribution partners in advance of their product’s launch to ensure that it is available to customers via the most efficient and optimal channel for serving patients. 

Maintaining flexibility with regard to channel strategy may also be a differentiator for a biosimilar, particularly if its reference product is only available through specialty distribution. By launching a biosimilar via a non-traditional specialty channel, it may be answering an existing market-access need that the innovator product is not addressing—a critical component of success for biosimilars. 

Conclusion
As biosimilars launch, they are shaping the treatment landscape. These new options are also creating opportunities for health system leaders to expand their influence on patient outcomes and the total cost of care. The supportive care agents approved today are giving way to products that will treat diseases like cancer, requiring greater education, support, and coordination between manufacturers and health systems. With authentic partnership and a systematic approach to implementation, manufacturers can successfully help health systems navigate the biosimilar landscape and offer more cost-effective options for their patients. 
 

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