Martha Stutsky, PharmD, BCPS

Specialty pharmacy medications now represent over 50% of pharmacy spending in the United States, with oncology medications accounting for 18.3% of the total expenditure.

 Oral oncology medications are often associated with high out-of- pocket (OOP) costs, and as novel oral anticancer agents are increasingly utilized for treatment, this can lead to financial stress and have a negative impact on the well-being of patients and caregivers.

Financial toxicity is a relatively new concept that considers the potential health outcomes and other consequences of financial hardship attributed to prescription regimens, such as the impact of skipping doses of medication to delay OOP costs. According to the National Cancer Institute, patients with a cancer diagnosis are more likely than those without cancer to experience financial toxicity, given the combination of OOP drug costs, other medical expenses, and lost work productivity. Even when measures have been taken
to address prescription costs, such as the narrowing of the Medicare Part D coverage gap phase, or “donut hole,” the OOP costs of most orally administered anticancer drugs continue to increase at a rate greater than the rate of inflation.

Patient assistance programs (PAPs) can significantly reduce patient OOP costs for oral oncology therapies. Support through PAPs can be generous, potentially covering the entirety of coinsurance for patients receiving high-cost cancer therapies.

 However, PAPs, which are most often funded by external grants, foundations, and sometimes drug companies, can be confusing and difficult to access.

In June, Shields Health Solutions and Aptitude Health will copresent a program on financial toxicity, specifically in the context of oral oncolytics and how PAPs coordinated by health system specialty pharmacies (HSSPs) can mitigate this type of toxicity. The panelists and participants in this discussion
will include pharmacists, nurses, advanced practice professionals, and financial coordinators who manage oncology patients through integrated HSSPs.

The discussion will explore a variety of questions related to the impact of the cost of oral oncology medications on clinical and economic outcomes
in patients with cancer managed by HSSP clinical programs, including the following:

What aspects of the integrated HSSP care model allow for optimal use and coordination of financial assistance programs for oral oncology patients?

What is the patient journey with respect to a PAP at an integrated HSSP?

How are patients on oral oncolytics identified as candidates for PAPs?

What HSSP staff members are responsible for management of PAPs, and what are their roles and responsibilities?

What categories of drugs and what types of cancers most frequently receive PAP funding?

What manufacturer PAPs are considered most effective in improving health outcomes for oral oncology patients?

What role do charitable foundation programs play in improving health outcomes for patients with cancer?

What are the observed impacts of PAPs on clinical outcomes in oral chemotherapy patients (eg, time to therapy initiation, emergency department/ hospitalization rate related to cancer diagnosis, quality of life)?

Financial toxicity is a stark reminder of disparities in health equity, and there is a great deal to be learned about how best to address the financial challenges of cancer treatment. The results from several studies on the impact of financial assistance programs have been reported in the literature, but these reports tend to be observational, without a full assessment of the impact of the programs on clinical outcomes in this population. For example, a retrospective study of prescription anticancer medication costs and PAP coverage from one academic cancer center’s specialty pharmacy demonstrated that a minority of prescriptions received financial assistance from PAPs, and the proportion of financial assistance was small relative to the price billed to insurance.

A retrospective, cross-sectional analysis of outpatient pharmacy, medical, and cancer registry records at The University of Texas MD Anderson Cancer Center in Houston, the largest tertiary cancer center in the United States, demonstrated that fewer than 5% of the patients with cancer who received prescription medications from the outpatient pharmacy were enrolled in a PAP, and the program provided financial support primarily for supportive care medications.

Elsewhere, in a pilot feasibility study, 34 patients with cancer with nonmetastatic solid tumors received a financial education course followed by monthly contact with a financial counselor and case manager for 6 months. Although self-reported financial burden did not change over time, anxiety about treatment costs decreased in 33% of patients enrolled in the financial education program.

In an integrated HSSP model, a patient’s point of contact with a PAP is likely to be a pharmacy liaison or a financial coordinator or navigator. Often embedded in specialty clinics, the liaisons help speed time to start of therapy, assess needs and provide support with every refill, coordinate drug delivery, address any new insurance and/or co-pay challenges, and monitor for adherence. The benefit of an integrated model in addressing financial toxicity—and other social determinants of health, for that matter— is that the risks will be identified as early as possible, often at the time of first fill. Furthermore, all the relevant resources of the health system, including outreach to a PAP, if available, will be targeted toward solving the problem or mitigating it before the clinical outcome is compromised.

, is a manager of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.

Tichy EM, Schumock GT, Hoffman JM, et al. National trends in prescription drug expenditures and projections for 2020. 

. 2020;77(15):1213-30. doi:10.1093/ajhp/zxaa116

Coughlin SS, Dead LT, and Cortes JE. Financial Assistance Programs for Cancer Patients. 

 2022;14(7):1605. doi:10.3390/cancers14071605

Dusetzina SB, Huskamp HA, Keating NL. Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019. 

. 2019;321(20):2025-2027. doi:10.1001/jama.2019.4492

Olszewski AJ, Zullo AR, Nering CR, Huynh JP. Use of Charity Financial Assistance for Novel Oral Anticancer Agents. 

. 2018;14(4);221-228. doi:10.1200/JOP.2017.027896

Zullig LL, Wolf S, Vlastelica L, et al. The Role of Patient Financial Assistance Programs in Reducing Costs for Cancer Patients. 

. 2017;23(4):407-411. doi:10.18553/jmcp.2017.23.4.407

Felder TM, Lal LS, Bennett CL, et al. Cancer patients' use of pharmaceutical patient assistance programs in the outpatient pharmacy at a large tertiary cancer center. 

. 2011;8(6):279-286. doi:10.1016/S1548-5315(12)70023-2

Shankaran V, Leahy T, Steelquist J, et al. Pilot feasibility study of an oncology financial navigation program. 

. 2018;14(2):122-129. doi:10.1200/JOP.2017.024927

Articles

PAPs can significantly reduce OOP costs for patients.

Assessing the Impact of Patient Assistance Programs on Financial Toxicity in Oral Oncology

Smilow Cancer Hospital at Yale New Haven Health System in Connecticut is 1 of 45 National Cancer Institute—designated comprehensive cancer hospitals and 1 of 27 National Comprehensive Cancer Network (NCCN) hospitals in the United States. In addition to the main cancer center, the health system has 14 cancer hospital care centers throughout Connecticut, serving patients receiving infusion and oral chemotherapy. 

At the Smilow Cancer Hospital, our oncology pharmacists play an important role in the delivery of care for patients with cancer because of the complexity of treatment regimens, the number of available medications, requirements for careful dose review and close lab monitoring, and the need for patient counseling and adverse effect monitoring. This role is even more critical with the rapid development of oral chemotherapy agents and a shift from intravenous (IV) chemotherapy to delivery of oral medications in recent years. With this shift, more of the education and monitoring requirements, self-management responsibilities for complex oral chemotherapy regimens, and adverse effect monitoring requirements are transferring from the care team to the patient.

Prior to the coronavirus disease 2019 (COVID-19) pandemic, Smilow oncology pharmacists managed care for patients receiving both infusion and oral chemotherapies in the acute care and ambulatory settings. The multidisciplinary oral chemotherapy model incorporating treatment plans for every drug, an internal specialty pharmacy hub, patient education and follow-up, monthly refill reminders, and a medication assistance program were all designed to expedite drug access, standardize the consent process, and ensure we had ongoing clinical support for patients with cancer. 

The COVID-19 pandemic has presented challenges to the care of patients with cancer, who may be at higher risk of developing severe disease. Clinicians must carefully consider whether to deliver, modify, or postpone cancer treatment, as delays or therapy changes could lead to disease progression and poor outcomes. Health systems caring for immunocompromised patients, especially those who are currently receiving chemotherapy, must devise strategies to maintain optimal clinical care for this population while decreasing the risk of exposure to the virus. 

The Smilow care teams worked collaboratively to create management strategies, including conversion from IV to oral chemotherapy, when clinically appropriate, for patients with cancer during the COVID-19 crisis. In collaboration with medical and pharmacy leadership, recommendations for changes to regimens and treatment plans, which were based on published data or expertise from the center’s disease teams, have been implemented. Several extended-interval infusion strategies have been implemented, including conversion of weekly paclitaxel to dose-dense chemotherapy for adjuvant breast cancer and every-3-week intervals for metastatic breast cancer. 

Smilow’s treatment plans for checkpoint inhibitors have been changed to allow every-4-weeks or every-6-weeks dosing. Monthly zoledronic acid or denosumab injections have been converted to every 3 months as were extended-interval leuprorelin and goserelin. 

For patients with gastrointestinal malignancies who had received 6 to 8 cycles of the folinic acid, fluorouracil, and oxaliplatin regimen, maintenance capecitabine is recommended at Smilow, resulting in a nearly 60% increase in capecitabine prescription volume at the Smilow specialty pharmacy from February to April 2020. Treatment holidays in patients who had received 6 or more months of therapy for biliary, pancreatic, or gastric cancer are considered. 

Because some surgeries were delayed as a result of the deferral of elective surgeries to reduce hospital census, induction chemotherapy is being used as an alternative. For some patient populations, including those with lymphoma, delayed treatment for those with asymptomatic disease not requiring therapy is considered. 

To decrease the risk of hospitalization and the need for urgent clinic visits because of neutropenia or transfusions, we also evaluated the center’s guidelines on using growth factors based on thand the American Society of Clinical Oncology, and we modified our treatment plans to include these agents when clinically indicated. 

Given the potential risks for disruptions to the pharmaceutical supply chain during the COVID-19 pandemic, ensuring that patients with cancer had an adequate supply of their oral chemotherapy medications at the correct time was essential. Prior to the COVID-19 crisis, the Yale health system’s specialty pharmacy staff worked approximately 5 to 7 days before the medication refill due date to ensure signed oral chemotherapy cycles, release the prescription to the appropriate pharmacy, and set up medication delivery. During the COVID-19 crisis, our pharmacy staff identified patients due for refills of their oral chemotherapy up to 2 weeks in advance and reached out to prescribers to authorize a new cycle of treatment, if clinically appropriate. 

In addition to this strategy, Smilow Cancer Center and clinical pharmacy leadership identified oral chemotherapy and oral hormonal medications that would qualify for a 60- or 90-day supply instead of the typical 1-month supply mandated by the health system and Quality Oncology Practice Initiative oral chemotherapy guidelines. Imatinib, dasatinib, nilotinib, abiraterone, and enzalutamide have been identified as agents that can be prescribed as multiple-month supplies to ensure availability to patients with cancer during the COVID-19 pandemic. 

As a result, the volume of oral chemotherapy prescriptions filled at the health system’s internal specialty pharmacy increased approximately 20% from February to March 2020, potentially because of proactive refill outreach and a change in the approach to days supplied. Smilow’s specialty clinical oncology pharmacists continued to conduct initial and ongoing patient education through telephone communications for patients receiving oral chemotherapy, remotely identifying any adverse effects or toxicities and alerting the oncology care team. 

Pharmacy staff also provided resources for patient support and referrals to a medication assistance program for patients struggling with high co-pays or lapses in insurance.

To reduce the number of high-risk patients with cancer at ambulatory infusion sites, coordination with and transition to home infusion services is facilitated by our health system. Patients with cancer receiving IV immunoglobulin therapy within the health system’s infusion centers successfully transitioned to contracted infusion pharmacies. Those receiving supportive care medications in clinic transitioned to home-administered options or home administration with nursing support. 

Our health system’s specialty pharmacy frequently assisted with benefits investigation and fulfillment of supportive oncology specialty medications as well as the identification of financial assistance options and manufacturer-provided nursing support. The move from clinic-administered supportive care oncology medications to home-administered options potentially shifted revenue from the health system’s infusion centers to the internal specialty pharmacy.

Patients receiving infusion and oral chemotherapy engaged in virtual provider visits when possible to limit exposure in clinic, and as a result, internal policies requiring signed patient consent are modified to allow remote or telephone consent during these telehealth visits. Additionally, telepharmacy staffing models are implemented for both oncology clinical pharmacists and specialty clinical pharmacists, as state regulations provided allowances for remote verification of prescriptions by pharmacists.

The changes implemented by our health system’s cancer center during the COVID-19 crisis demonstrated the ability to maintain access to clinical care, as well as critical medications, while limiting exposure and risk. Changes to infusion chemotherapy regimens and shifts from clinic-administered to home-administered or home infusion therapy presented financial implications to the health system. However, the changes in medication administration also presented new revenue opportunities for the health system’s specialty pharmacy. 

Clinical pharmacists and providers maintained care and close monitoring of our patients with cancer through telephone consultations, telehealth visits, and a remote staffing model that will likely sustain in the post—COVID-19 world for this high-risk population. 

 is employed by Yale New Haven Health System in Connecticut; 

, is manager of oncology pharmacy services at Smilow Cancer Center, Yale New Haven Health System. 

Yale New Haven Health is a member of the Excelera Network, a nationwide network of leading U.S. health systems with owned specialty pharmacies. For more information about Excelera, visit 

At the Smilow Cancer Hospital, oncology pharmacists play an important role in the delivery of care for patients with cancer.