Evaluation of the effect of patient assistance programs on financial toxicity in oral tumors

Project-affected people can significantly reduce OOP costs for patients.

Specialty pharmacy drugs now account for more than 50% of pharmacy spending in the United States, with oncology drugs accounting for 18.3% of total spending.1 Oral oncology drugs are often associated with high costs (OOP), and as the use of new oral anticancer agents for treatment increases, 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 takes into account potential health outcomes and other consequences of financial hardship attributable to prescription systems, such as the effect of skipping drug doses to delay OOP costs. According to the National Cancer Institute, patients diagnosed with cancer are more likely than non-cancer patients 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 narrowing the Medicare Part D coverage gap period, or “the donut hole,” OOP costs for most oral anticancer drugs continue to increase at a rate greater than the rate of inflation.3

Patient assistance programs (PAPs) can significantly reduce OOP costs for oral oncology treatments. Support through PAPs can be generous, potentially covering the entirety of co-insurance for patients receiving high-cost cancer treatments.4 However, the people affected by the project, who are mostly funded by external grants, foundations, and sometimes pharmaceutical companies, can be confusing and difficult to reach.

In June, Shields Health Solutions and Aptitude Health will co-present a program on financial toxicity, specifically in the context of oral oncology and how PAPs coordinated by Health System Specialty Pharmacies (HSSPs) can mitigate this type of toxicity. Speakers and participants in this discussion
It will include pharmacists, nurses, advanced practice specialists, and financial coordinators who manage oncology patients through integrated HSSPs.

The discussion will explore a variety of questions regarding the impact of the cost of oral oncology drugs on clinical and economic outcomes
In cancer patients managed by HSSP clinical programmes, including the following:

  • What aspects of the HSSP allow for optimal use and coordination of financial assistance programs for patients with oral tumors?
  • What is the patient’s journey regarding PAP in an integrated HSSP?
  • How are patients undergoing oral oncology analysis identified as project-affected candidates?
  • Who are the Health, Safety and Security Program staff responsible for managing the Project Affected Persons, and what are their roles and responsibilities?
  • What classes of drugs and types of cancer are most often funded by the humanitarian assistance programme?
  • Which manufacturers are most effective in improving the health outcomes of oral tumor patients?
  • What is the role of charitable programs in improving health outcomes for cancer patients?
  • What are the observed effects of PAPs on clinical outcomes in oral chemotherapy patients (eg, time to start treatment, emergency department/hospitalization rate related to cancer diagnosis, quality of life)?

Financial toxicity is a stark reminder of the disparities in health equity, and there is much to learn about how best to address the financial challenges of cancer treatment. The results of several studies on the impact of financial assistance programs have been reported in the literature, but these reports tend to be observational, without fully evaluating the impact of programs on clinical outcomes in this population. For example, a retrospective study of prescription anti-cancer drug costs and PAP coverage from a specialty pharmacy at an academic cancer center showed that a minority of prescriptions received financial assistance from PAPs, and that the proportion of financial assistance was small compared to the rate charged for insurance.5

A retrospective cross-sectional analysis of the outpatient, medical pharmacy, and cancer registries at the University of Texas MD Anderson Cancer Center at Houston, the largest Class III cancer center in the United States, showed that less than 5% of patients with cancer who received prescription drugs from a pharmacy Outpatients were enrolled in the Personal Assistance Program, and the program provided financial support primarily for supportive care medications.6

Elsewhere, in a pilot feasibility study, 34 cancer patients with non-myeloid solid tumors received a financial education course followed by monthly contact with a financial advisor and case manager for 6 months. Although the self-reported financial burden did not change over time, concern about treatment costs decreased in 33% of patients enrolled in the financial education program.7

In an integrated HSSP model, the patient’s point of contact with the PAP is likely to be a pharmacy contact, financial coordinator, or navigator. Liaisons are often an integral part of specialty clinics, helping to expedite treatment start time, assess needs and provide support with each refill, coordinate drug delivery, address any new insurance and/or co-pay challenges, and monitor compliance. The benefit of the integrated model in addressing financial toxicity—and other social determinants of health—is that risks will be identified as early as possible, often at the time of first mobilization. Furthermore, all resources relevant to the health system, including access to project affected people, if any, will be directed towards resolving or mitigating the problem before clinical outcome is compromised.

About the authors

Martha Stotsky, Ph.D., Baltimore County Public Schoolsdirector of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.

Karolkim Huynh, PharmD, CSPdirector of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.


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