Barriers to the Initiation of Oral Oncolytics

Chelsea Gustafson, PharmD BCOP
Oncology Pharmacy Specialist
Community Health Network: Community Regional
Cancer Centers
Kokomo, IN

Caroline Quinn, PharmD BCOP
Clinical Pharmacy Specialist
The University of Texas MD Anderson Cancer Center
Houston, TX

Oral anticancer therapies are an increasingly prevalent part of cancer treatment. Oral cytotoxic agents, small-molecule inhibitors, and other medications may offer several advantages over parenteral anticancer options. These advantages include the convenience of completing therapy at home and a possible decrease in the frequency of office visits. In addition, some patients may appreciate the enhanced sense of responsibility that stems from administering their therapy at home.¹ 

Despite the increasing use of oral anticancer therapy, the process for accessing these medications is often complex and can be time-consuming and confusing for patients and healthcare providers alike. Patients, providers, and other staff members may have to contact an extensive list of organizations, including insurance companies, specialty pharmacies, drug manufacturers, and patient assistance foundations before the patient is ultimately able to access the prescribed medication. Although the particulars of drug procurement, drug cost, and insurance coverage vary from patient to patient, several common barriers to medication access arise, and pharmacists should be aware of these when helping patients who are initiating oral anticancer therapies. In this article, we discuss some of those barriers by using the experience of one patient, PT, as  an example.

PT was a 66-year-old female with metastatic estrogen receptor/progesterone receptor-positive, human epidermal growth factor receptor 2–negative breast cancer diagnosed in late 2019. Her oncologist determined that a CDK4/6 inhibitor and anastrozole were the treatment of choice. A prescription for a CDK4/6 inhibitor was sent to the health network’s specialty pharmacy. PT had Medicare Part D insurance, which required a prior authorization for the new medication. The prior authorization was submitted by a medication assistance coordinator (MAC), a pharmacy technician working specifically to help patients access oncology medications. PT’s health system was very fortunate to have MACs;  many health systems do not have such assistance. Fortunately, PT’s prior authorization was approved on the same day the prescription was sent. However, the copayment for the CDK4/6 inhibitor was more than $2,000 per month, an unaffordable amount by almost any standard. PT’s team also learned that the network specialty pharmacy was not contracted to dispense this specific medication. Therefore, the prescription was sent to another specialty pharmacy. Luckily, the medication’s manufacturer offered a voucher program for the first cycle of the drug. The MAC assigned to PT’s case registered her for the voucher program and provided the patient and voucher information to the new specialty pharmacy. A few days later, the first cycle of the drug was sent to PT with no out-of-pocket cost.

Unfortunately, PT was unable to pay $2,000 monthly for subsequent cycles. PT’s MAC filled out an application for foundational support to help cover future copayments. After extensive income information was obtained from PT (including sensitive information like her tax statements from the previous year and Social Security number), the application was filled out, PT’s oncologist signed the application, and the MAC faxed the packet of information to the foundation. Five days later, PT’s team heard that the foundation was accepting only re-enrollments and that no new patients would be accepted. PT’s team then repeated this application process with the drug manufacturer’s patient assistance program. Approximately 2 weeks later, PT’s team received word that she had been approved to receive the CDK4/6 inhibitor through the patient assistance program until the end of 2020. PT then finally received her second cycle of the drug in the mail, 2 days after she was scheduled to start cycle 2.

PT and her healthcare team ran into some of the most common barriers in oral anticancer therapy access (Figure 1-see PDF). First, as happens with many newly prescribed oral anticancer therapies, PT’s insurance company required a prior authorization for the specialty medication. Although the healthcare team did not have to do this in PT’s case, an appeal letter, peer-to-peer communication, or both are often required in addition to the initial prior authorization request. If that appeal is denied (typically after a minimum of a 72-hour turnaround time), then an external appeal can sometimes be pursued, with another 72-hour turnaround time. The denial of the external appeal, if it occurs, is often the end of the road for prescription insurance coverage. These processes are time-consuming for healthcare teams and may delay a patient’s ability to begin therapy, especially for health systems that lack personnel trained for and designated to the task of coordinating medication assistance.

As seen with PT’s copayment, patients may face significant cost sharing when they are prescribed oral anticancer therapies. The case is different with chemotherapy by infusion: drugs given in the infusion center are covered by medical insurance, not the prescription plan. This difference may cause confusion for patients and members of the healthcare team.  Providers are often unaware of drug coverage at the point of prescribing and are therefore unable to consider affordability in treatment planning. If a patient is ultimately unable to afford the prescribed medication, the process of repeating treatment planning and prescribing an alternative therapy creates even more delays in treatment.1 Changing therapy may cause stress for patients who believe that the initially prescribed medication was the best choice for them. Significant delays in therapy resulting from insurance barriers can also lead to psychological harm for patients who believe that their cancer is progressing between treatments.

Patients with commercial insurance may be eligible for a copay card to cover a portion of the out-of-pocket cost of their medication, if the manufacturer offers a copay card. However, a large proportion of patients at many cancer centers are 65 years of age or older and have Medicare Part D insurance. These patients, as well as patients with Medicaid, are not eligible for copay cards. Patients with either Medicare/Medicaid or commercial insurance may be eligible for patient assistance programs through manufacturers and foundations. These programs often have specific requirements set by the organization offering the funding. Each program requires a separate application, and some of them have income requirements that may eliminate middle-class or higher-earning patients who still find copayments like PT’s challenging to afford. The turnaround time for approval or denial of these programs also varies and may contribute to a delay in starting therapy. Most assistance programs are reserved for products that are still branded, as many oral anticancer therapies are. However, for the few generic options, finding patient assistance can be particularly challenging. For treatments such as capecitabine, healthcare teams may turn to avenues like online coupons to decrease cost, but patients may still be left with a shockingly high copay. Furthermore, at the first of the year many patients must meet a deductible. Usually manufacturer copay cards cover a percentage of the total cost, and the deductible tends to be higher for more expensive therapies.

As PT’s story demonstrates, the path to oral anticancer therapy access is often convoluted and time-consuming. Because patients frequently need new prescriptions when dose adjustments are made to the therapies or when insurance coverage changes, the procurement process may need to be repeated during therapy. Many patients are unaware of potential barriers or ways to overcome them, and they may be frustrated and confused when these barriers lead to delays in therapy. In this process, the pharmacy team is often viewed as holding the magic key to drug acquisition. Although unfortunately we can’t work magic, pharmacists do play a vital role in drug procurement, education of patients and healthcare providers about the process, and coordination of the many people involved in successfully prescribing and dispensing oral anticancer therapies. As oral therapies become more common in the treatment of cancer, awareness of the long and winding road of access to these therapies must be at the forefront of the oncology pharmacist’s practice. 

Reference

1. Weingart SN, Brown E, Bach PB, et al. NCCN Task Force Report: Oral chemotherapy. J Natl Compr Canc Netw. 2008;6 Suppl 3: S1-S14.