Impact of Patient Assistance Programs on Financial Toxicity in Oral Oncology Patients Managed Through Health System Specialty Pharmacies

Impact of Patient Assistance Programs on Financial Toxicity in Oral Oncology Patients Managed Through Health System Specialty Pharmacies

Martha Stutsky, PharmD, BCPS; Carolkim Huynh, PharmD, CSP

Specialty pharmacy medications now represent more than 50% of pharmacy spending in the United States, with oncology medications accounting for 18.3% of the total expenditure.1 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.2

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 out-of-pocket 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.3

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.4 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 co-present 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 toxicity. 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 cancer patients managed by HSSP clinical programs, including:

  • What aspects of the integrated health system specialty pharmacy 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 health system specialty pharmacy?
  • How are patients on oral oncolytics identified as candidates for PAPs?
  • What health system specialty pharmacy staff members are responsible for management of PAPs and what are their roles and responsibilities?
  • What categories of drug and what types of cancer most frequently receive PAP funding?
  • What manufacturer patient assistance programs are considered most effective in improving health outcomes for oral oncology patients?
  • What role do charitable foundation programs play in improving health outcomes for cancer patients?
  • What are the observed impacts of PAPs on clinical outcomes in oral chemotherapy patients (e.g., time to therapy initiation, ER/hospitalization rate related to cancer diagnosis, quality of life)?

The panelists and participants will include pharmacists, nurses, advanced practice pfessionals, and financial coordinators who manage oncology patients through integrated HSSPs.

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.5

A retrospective, cross-sectional analysis of outpatient pharmacy, medical, and cancer registry records at M.D. Anderson Cancer Center in Texas, the largest tertiary cancer center in the U.S., demonstrated that fewer than 5% of the cancer patients who received prescription medications from the outpatient pharmacy were enrolled in a PAP, and the program provided financial support primarily for supportive care medications.6

Elsewhere, in a pilot feasibility study, 34 cancer patients with nonmetastatic solid tumors received a financial education course followed by monthly contact with a financial counselor and case manager for six 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.7

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 copay 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, and 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.

Since 2020, Aptitude Health and Shields, through its wholly owned subsidiary Excelera, have partnered to offer specialty pharmacy-focused education and critical insights to life science companies and healthcare professionals, with the goal of improving cancer care and outcomes. The initiative underscores the importance of extending disease state-specific hematology and oncology insights in support of the integrated health system model and its multi-disciplinary approach to patient care.

1 Tichy EM, Schumock GT, Hoffman JM, et al. National trends in prescription drug expenditures and projections for 2020. Am J Health Syst Pharm. 2020;77(15):1213-30.
2 Coughlin SS, Dead LT, and Cortes JE. Financial Assistance Programs for Cancer Patients.
3 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. JAMA. 2019;321(20):2025-2027.
4 Olszewski AJ, Zullo AR, Nering CR, Huynh JP. Use of Charity Financial Assistance for Novel Oral Anticancer Agents. Journal of Oncology Practice. 2018;14(4);221-228.
5 Zullig LL, Wolf S, Vlastelica L, et al. The Role of Patient Financial Assistance Programs in Reducing Costs for Cancer Patients. J Manag Care Spec Pharm. 2017;23(4): 407-411.
6 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. Community Oncol. 2011 June 1; 8(6): 279- 286.
7 Shankaran V, Leahy T, Steelquist J, et al. Pilot feasibility study of an oncology financial navigation program. Journal of Oncology Practice. 2018;14(2):122-129.