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

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.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 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.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 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.⁵

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, showed that between 2006 and 2007, 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.⁶

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.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 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.

About The Authors

Martha Stutsky, PharmD, BCPS, is a manager of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.

Carolkim Huynh, PharmD, CSP, is a manager of clinical outcomes at Shields Health Solutions in Stoughton, Massachusetts.

References

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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. doi:10.1001/jama.2019.4492
4. Olszewski AJ, Zullo AR, Nering CR, Huynh JP. Use of Charity Financial Assistance for Novel Oral Anticancer Agents. J Oncol Pract. 2018;14(4);221-228. doi:10.1200/JOP.2017.027896
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7. Shankaran V, Leahy T, Steelquist J, et al. Pilot feasibility study of an oncology financial navigation program. J Oncol Pract. 2018;14(2):122-129. doi:10.1200/JOP.2017.024927