Josh Howell, PharmD, BCOP

Oncology had a pivotal moment with the first FDA approval of a supportive care biosimilar in 2015, bringing to the forefront an alternative therapy to a costly innovator drug. This was followed by the approval of primary therapy biosimilars in 2019. Since then, a multitude of biosimilar oncology treatments have emerged, challenging providers to keep up with the growing body of science that comes with each new development.

Consequently, providers have turned to oncology-trained pharmacists more and more to gain a critical understanding of the emerging new agents on the market. As this increased reliance on pharmacists has come to the fore, the pharmacist has become even more vital as the trusted advisor to medical oncologists and the care team. Because of this shift, pharmacists have supported increased utilization of biosimilars due to their enabling providers to become comfortable using these new agents.

As the cost of cancer drugs continues to escalate, many practices are utilizing biosimilar therapeutic interchange (TI) processes as a way to reduce cost of care, enabling success in value-based delivery models. Given the deep expertise of oncology pharmacists, they are well positioned to play a leading role in developing and managing these rapidly growing TI programs.

Traditional distribution activities are still the core function of the work of pharmacists who are specifically trained in oncology, as they oversee the safe acquisition and preparation of specialized oncology drugs prior to patient administration. Additionally, these pharmacists assist the care team in complex drug selection, adverse event monitoring, and treatment of adverse effects. In many organizations, pharmacists are also assuming an even larger role by developing and managing TI programs, making them a vital member of the practice.

TI processes are best driven by pharmacists, as they are highly skilled at navigating the complicated decision-making process of selecting drugs in the same category with similar therapeutic indications. Further, handling biosimilars that have similar nomenclature has introduced the risk of medication-related safety events because of misreading, and pharmacists participating in this workflow can help mitigate these types of errors. Having these clinically trained specialists review and ensure the safe use of biosimilar agents has become a necessary investment every care team should make to improve patient care.

A critical first step in building a TI program is to establish a pharmacy and therapeutics (P&T) committee. Functioning as a governing body of the provider, the P&T committee provides a framework that gives more autonomy to pharmacists to make changes and ensures that physicians agree with the TI processes. Pharmacists tend to support most P&T committees and play a critical role in gathering the clinical and cost data about the drugs to inform decision makers when picking a preferred agent.

TI programs enable practices to efficiently move toward more utilization of biosimilars, providing many benefits to stakeholders, including the following:

• Patients have access to cheaper treatment options without sacrificing clinical efficacy. Specifically, this is facilitated through the growing number of biosimilars increasing competition, decreasing the price to patients who are facing rising deductibles and coinsurance costs.

• Biosimilar utilization that is enabled by TI programs provides a foundation for practices to succeed in value-based care, because biosimilars can provide significant cost savings over innovator products.

• Through TI programs, payer relationships can be enhanced, as biosimilars enable practices to utilize drugs that are still effective but lower priced. This provides tremendous value to payers by helping to control cost of care.

Obstacles exist that can block or slow TI. In smaller clinics, pharmacies often concentrate on the distribution channel more than other initiatives. However, the emergence of new drugs, such as biosimilars, makes it essential for practices to invest in bringing pharmacists onto care teams. These knowledgeable specialists keep up with changes and new therapies, facilitating adherence to agreed-upon P&T initiatives for preferred drugs.

Additionally, because providers want to remain independent, implementing a TI program can be met with resistance because it adds a layer of supervision. To effectively address this resistance, building trust between providers and the pharmacy is critical. Further, pharmacies can implement processes and procedures that can help them overcome any pushback.

The US Oncology Network Offers Remote Clinical Reviewer Services

Evidence continues to demonstrate the value oncology pharmacists bring to a practice. In a recent review of chemotherapy regimen orders within a community oncology practice, investigators found substantial benefits could be gained by using a clinical pharmacist trained in oncology.

The investigators observed that of the documented reviews over a 10-week period, 49.2% lead to modifications by the pharmacist, resulting in improvements of $106,000 and a $462,000 reduction in total cost of care for medications.

 Based on these results, the investigators concluded that an oncology pharmacist was a cost-effective and valuable member of the care team, improving safety and regimen optimization and demonstrating a significant financial impact for practice, payers, and patients.

Unfortunately, despite the clear benefits of having pharmacists on the care team, many small community practices either do not have pharmacists or they have a small pharmacy staff with limited time to review regimens, which can make TI less likely to occur. Because of this current deficit in pharmacists at smaller centers, The US Oncology Network developed a clinical pharmacist review program called ClinReview, which provides remote pharmacist services to practices.

Oncology-trained pharmacists electronically review all chemotherapy regimens, identifying opportunities to modify therapies based on clinical components, waste reduction, and responsible stewardship of financial resources. Practice policies determine which modifications may be made by their pharmacy staff, and other recommendations are discussed with the patient’s oncologist. The program provides a strong return on investment by optimizing medication regimens, improving medication utilization and safety, and reducing medication expenses.

Many biosimilars that have been around for several years are now highly utilized, with some payers making their own policy decisions for these agents. However, these decisions can often create challenges for practices by requiring step edits. When this occurs, layers of paperwork and scrutiny inhibit care while providers dispute arbitrary drug selection.

Pharmacists can help with these challenges by educating physicians on the payer’s changing landscape of drug selection and showing payers why step edits should not be followed for a particular drug. This ultimately allows the provider to make the best decision in cost- effective drug selection. By demonstrating the continued success of this process, payers may remove the practice from step edit processes.

Oncology is getting more complex by the day, not only because of biosimilars and TI programs but also because of the continued evolution of new drugs and oral therapies. These agents are very specific and are targeted to the disease and to specific disease states within a cancer diagnosis.

Because of this growing complexity, a highly knowledgeable specialist should be monitoring all aspects of these treatments—a role ideally suited to oncology pharmacists. These clinically trained professionals should be part of the care team and have clearly defined responsibilities, empowering them to play a vital role in ensuring patients receive safe, high-quality care.

, is vice president of pharmacy and clinical programs for the US Oncology Network.

1. Kula J, Hough S, Howell J. Impact of a central review oncology clinical pharmacist in a community oncology practice. 

. 2020;39(suppl 28):68. doi:10.1200/JCO.2020.39.28_suppl.68

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