May 3, 2016
The role of oncology pharmacists is evolving as the indications for immuno-oncology agents continue to expand. In order to gain insight about this role, we spoke with newly elected ACCC Secretary Ali McBride, MS, PharmD, BCPS, BCOP—Clinical Coordinator, Department of Pharmacy, the Arizona Cancer Center, Tucson, Arizona. Here, Dr. McBride shares his perspective on the expanding role for oncology pharmacists in immuno-oncology in terms of reimbursement processes, medication management, and supportive care.
Dr. McBride: Our first goal as oncology pharmacists is to make sure we have provisions available to provide therapies to the patient based on the indication for continued treatment. Immuno-oncology is growing in three different areas right now for currently approved products—melanoma, lung cancer, renal cell cancer—and we expect probably another five and six indications coming out in the next year or two for different therapies, as well as for combination therapies. Pharmacists have to be aware of current and future indications, so one of the main roles that we’re seeing clinical pharmacists contribute in is in terms of off-label use requirements and patient assistance programs.
Reimbursement is a key issue for immuno-oncology. We have to make sure that we’re going to get reimbursed for these high-cost drugs while also maximizing efficacy and safety for patients. The pharmacist can play a large role in the community setting alongside the physician and advanced practice clinicians to ensure that these high-cost therapies are being used on label, or that there’s an off-label process in place. If a drug is being used off-label, we’re making sure that this therapy is being worked evaluated with payors for approval or evaluating and providing evidence for free drug replacement in cases where it may not be payable alongside our financial counselors and finance department.
Patients themselves are the most important piece of the puzzle and if they can’t get treatment or if they have issues with treatment, that will actually change outcomes. I see a lot of patients experience financial toxicity with cancer treatments. The oncology clinical pharmacist has an integral role in optimizing patient outcomes with immuno-oncology-based therapies by making sure patients are adhering to their current treatment plan, and directing patients to other resources that provide copay assistance, free drug replacement, or out-of-pocket support.
Patients are seeing copays vary depending on their insurance. It may actually fall to the oncologist pharmacist to work with the Finance Department to ultimately achieve a better outcome by providing a better perspective on what the patient is going through, and looking and reviewing different medication or patient assistance programs that can be used for the patient based on the indication of treatment. The oncology pharmacist address upfront cost issues with the Financial Department by looking at the actual indications of a drug, and making sure the patients are actually [completing] the correct financial assistance applications for indications and supporting measures. In some cases, we’re looking for drug replacement, and where that is occurring, we can make sure that the free drug has been shipped to our pharmacy.
A second role that the clinical oncology pharmacist plays concerns medication-based therapy management. One of the [key] things with immuno-oncology is really understanding the function—and sometimes dysfunction—of our immune system. For instance, we are seeing issues occurring with our patient populations, such as hyper or hypothyroidism, that really require supportive care measures. In such cases, our patients are coming in for continued treatment and their thyroid function may be changed. Therefore, our clinical pharmacists are working on some of the thyroid regulation medications, for example levothyroxine, to provide supplemental support for those patients.
In addition, we can also proactively evaluate adrenal dysfunction so that we can see how patients are doing and whether supportive care measures are necessary to ensure that patients can continue treatment without any change in current dosing regimens. We also work to ensure that the checklists for the patient before each treatment are correct and order any labs that need to be tested while on treatments.
At The University of Arizona Cancer Center, our clinical pharmacists are in the clinic with the physicians and working together with the patient to mitigate any issues that may occur. Our physicians, our clinical pharmacist, our nurse coordinators, nurse navigators, and advanced practitioners work together, for instance, to mitigate many of the side effect profiles or other issues that occur with immuno-oncology treatment. So working together we’re able to proactively address these issues up front and make sure we order any extra lab testing that is required, or [that] need[s] to be evaluated for patients who are being treated long-term with immuno-based therapy.
Dr. McBride: We’re seeing a larger role for supportive care-based therapies and for providing different types of care than we’re used to. For instance, we saw thyroid effects in melanoma and we’re seeing thyroid effects with some of the checkpoint inhibitors. With classical cytotoxic chemotherapy, supportive care consists of growth factor support, evaluation of chemotherapy-induced nausea and vomiting, and in some cases, we might also look at erythropoiesis stimulating agents (ESAs) as well.
However, there’s a different side effect profile with immunotherapy-based treatments, and we’re seeing some immune dysfunction. We’re seeing adrenal dysfunction. We’re seeing thyroid dysfunction. With these side effect profiles, we are providing a new area of supportive care that wasn’t really part of the last 20 to 30 years of cytotoxic chemotherapy. So the change in treatment approach has allowed the oncology pharmacist to play a composite role in this treatment modality, and, alongside other team members, evaluate and manage the side effects of immuno-oncology agents.
For instance, there may be cases where an endocrinologist is working with the pharmacist to maintain certain thyroid levels for our patients during treatment. So we’re really seeing an overall change in the workforce and also workflow in a supportive care realm with immuno-oncology.
What do you see as the value of having oncology pharmacists and formulary management strategies in place in relation to immuno-oncology agents?
Dr. McBride: The key issue is to optimize outcomes for patients. Formulary management is very important, because we’re often dealing with pathway-based management based on some insurance companies that will actually delineate or dictate to us the type of treatment that we can use for patients. These are usually labeled indications in which we are actually going through on that pathway management.
Some institutions may also have their own institutional pathways based on their Pharmacy and Therapeutics (P&T) Committee and that may also affect the type of treatment and when the type of treatment occurs in that pathway cycle. The oncology pharmacist usually works on developing those pathways with the team or physician and provides that content to the Finance Department.
There is a role for the oncology pharmacist, especially in academic settings, to assist physicians and financial teams to develop pathways and processes in a multifactorial way that involves a multitude of people working to create those pathways. In the community setting, this role is perhaps dictated by some of the insurance companies, but each setting is different. Some larger community practices may already have their own therapeutic or pathway committee of which oncology pharmacists are a part.
Resource: Oncology Pharmacy Education Network (OPEN)
OPEN provides education and supports the interests of oncology pharmacists and their staff. Resources on the following topics are available at OPEN:
Dr. McBride: One of the great things is that we have seen ACCC really embrace the concept of the multidisciplinary cancer care team. ACCC has done and continues to develop this focus great job really looking at the oncology pharmacist’s role in terms of a number of different responsibilities, including management, the pharmacy director’s role, and the oncology pharmacy setting of care. We have seen a number of other organizations also address this as well, such as the American Society of Health-System Pharmacists (ASHP) and the Hematology/Oncology Pharmacy Association (HOPA).
The take-home point is that there is a larger role for oncology pharmacists as we see more immuno-oncology agents and combination therapies emerge. Oncology pharmacists can have a much larger role not only starting the patient on therapy and looking at the financial aspects of treatment, but also addressing the supportive measures necessary to support for continued treatment.
There’s a huge advantage in having an oncology pharmacist on the immuno-oncology team to ensure that patients adhere to current treatments, are being treated with the correct supportive care measures, and have support for financial issues related to their treatment.