Alternative Funding Programs Present Ethical, Legal Considerations

Alternative funding programs (AFPs) are a relatively new phenomenon in health care that has emerged over the past few years; however, the detrimental effects of AFPs are quickly coming to the fore. Within a health plan, an AFP allows the insurer to exclude some or all specialty medications from its formularies. These exclusions are often focused on high-cost specialty medications, resulting in fewer options for patients who need these medications. Further, an increasing number of employer-sponsored health plans are using AFPs to lower costs, with a reported 6% of employers using AFPs in 2021 and 14% in 2022.¹

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On page 47, authors Sarder Sadid, PharmD, and Amy Niles, MBA, discuss the different ways that AFPs can impact patients and their treatment. According to the authors, when medications are excluded from a health plan’s formulary because of an AFP, patients are directed to third-party vendors that are not insurance companies. These third-party vendors then inform patients that they will reach out to patient assistance programs (PAPs) for assistance on their behalf; however, these vendors have been known to mislead PAPs by saying the patient they represent is uninsured. This carves up resources for the most vulnerable patients on behalf of those who should have been covered by their health plans in the first place. Sadid and Niles note that on top of the clear ethical concerns for AFPs, there are also legal concerns. Specifically, AFPs have been found to discriminate against provisions of the Health Insurance Portability and Accountability Act and the Affordable Care Act, as well as FDA regulations surrounding the importation of medications.

Also in the issue, author Glenn Roma, PharmD, PhD, BCOP, discusses new bispecific T-cell engagers for the treatment of relapsed/refractory multiple myeloma in the cover story on page 22. With 7 new agents receiving FDA approval since October 2022, Roma addresses dosing and administration, as well as the adverse effect and clinical efficacy profile for each agent.

The issue also contains coverage of the European Society for Medical Oncology Congress 2023 in Madrid, Spain starting on page 56. The coverage focuses on data from the phase 3 CheckMate 77T study (NCT04025879), the phase 3 KIMMTRAK study (NCT03070392), a preplanned interim analysis of the phase 3 monarchE trial (NCT03155997), and the prospective phase 2/3 ADAPT trial (NCT01779206). Additionally, author Jessica Samuel, PharmD candidate, attended the 2023 NCODA International Fall Summit in Orlando, Florida, and discusses the federal legislation updates provided at the conference on page 66.

We will continue our conference coverage in the New Year with our special January 2024 conference issue, which will contain highlights from the upcoming American Society of Hematology and San Antonio Breast Cancer Symposium conferences being held in December 2023.

Reference

Fein AJ. Employers expand use of alternative funding programs—but sustainability in doubt as loopholes close. Drugs Channels Institute. May 17, 2023. Accessed October 8, 2023. https://www.drugchannels.net/2023/05/employers-expand-use-of-alternative.html