2024 – Defending Patients and Their Access to Safe, Timely Care

The year 2024 has been tumultuous. Every one of our editorials explored a different way that oncology practices faced new challenges to their patients’ access to the care they need and the resources that can ease the emotional and financial burdens of their treatment. Unfortunately, each of those topics discussed continues to present hurdles to our patients, even at the close of 2024.

Here is an update on 3 related issues that continue to plague safe, effective, and timely access to patient care.

Patients across the country with chronic and acute conditions, including cancer, have complained that alternate funding programs’ vendor involvement increases their emotional stress; delays access to needed treatments by days, weeks, or longer; and adds frustration and confusion to their healthcare journey.

Alternate Funding Programs (AFPs): Growing in Reach Despite National and Federal Concerns

In February, we looked at “AFPs in 2024: A Hotspot for Concern and Action.” We have explored these AFPs since 2021. Vendors generally approach self-insured employers (SIE) with offers to reduce specialty pharmacy costs for employers and their employees. Typically, vendors will contract with the SIE for a list of targeted specialty pharmacy drugs. When the employee is prescribed one of these targeted drugs, their access to that drug is diverted to the vendor—outside of the insurance coverage otherwise enjoyed by the employee. The vendor may attempt to enroll the otherwise fully insured employee in patient assistance programs set up for charitable purposes. Some may seek imported drugs at lower prices as another alternative discounted source. If the AFP vendor is unable to obtain a charitable (free) or imported drug (and thus be paid a service fee by the employer for doing so), the employee is usually then told that the needed drug will now be covered by the original health insurance benefit the employee believed covered them before the AFP vendor was involved. Patients across the country with chronic and acute conditions, including cancer, have complained that AFP vendor involvement increases their emotional stress; delays access to needed treatments by days, weeks, or longer; and adds frustration and confusion to their healthcare journey. The AFP vendors do not mention to their SIE customers that medical practices and patient advocacy organizations have a very streamlined path to enrolling qualified patients (both uninsured and underinsured) in clinically appropriate patient assistance programs. Both drug importation and referral of drug access to specialty pharmacies other than the drug sourcing and delivery recommended by the treating physician are not acceptable to treating providers due to well-established patient safety and medical risk concerns.

Since we addressed the risks and issues that contracted AFP vendors raise for patient access to needed treatment in February, Congress¹ and the FDA² have been asked to investigate the adverse implications of the AFP model for both patients and employers. Several patient advocacy coalitions have testified and provided arguments regarding how patients are being hurt by these models. As discussed in Oncolytics Today, the PAN Foundation recently called for Congress to ban AFP programs.³ The American Medical Association passed Resolution 707 on intended education and advocacy to address the negative impacts of AFPs.¹ Louisiana has formed the Louisiana Alternative Funding Program Task force to study the impact of alternative funding programs on patient access to affordable prescription drugs.⁴

Entering 2025

The AFP model puts employers, patients, and even treating physicians at risk. Access to care is disrupted. Scarce charitable resources are being depleted as a profitable activity for the vendors in the AFP space, and delays in care, even risk-laden drug importation, continue to endanger vulnerable patients. Practices can support federal, state, and employer concerns and challenges to the AFP models for the sake of their patients.

Prescription Drug Affordability Board and Drug Importation

In May, we addressed “Prescription Drug Affordability Boards and Drug Importation—At or Coming to a State Near You?” State legislatures are turning to prescription drug affordability boards (PDABs) as potential tools that they hope will reduce drug costs and increase affordability of healthcare for their residents. Each PDAB is structured differently, but common approaches include reviewing drug prices, implementing price controls, conducting research and reporting on pricing trends and policy strategies, and creation of a board infrastructure to implement these approaches. PDAB policies often do not consider inadvertent adverse consequences on patient access to needed care and treatment that occur when drug access is limited based upon pricing controls.

While a number of states are considering PDAB legislation in 2024 and 2025, states that already have created PDABs are facing increasing challenges to the concept and their strategic models. In October 2024, the Aimed Alliance shared many concerns with the Colorado PDAB, including recommended amendments to the orphan drug designation and patient and caregiver input processes, and urged the PDAB to fully consider how drug prices may affect patient cost-sharing obligations.⁵ Also in October 2024, the Aimed Alliance urged Maryland legislators to make major improvements to the Maryland PDAB Action Plan, including the incorporation of patient perspectives and data related to the impact of initial planned cost-saving measures on direct consumer costs and cost-sharing burdens.⁶

Entering 2025

Despite continued and growing state interest in using PDABs as a control on drug costs, practices can best advocate for their patients by reviewing and commenting on emerging state policies. Most PDABs were not designed to understand the complexities of the drug acquisition and delivery channel process, nor the impact of isolated pricing policies on patient cost-sharing and access to needed medications. Medical practices can play a crucial role by getting involved in PDABs, advocating for patients, and warning about the unintended adverse consequences of such PDABs where they do not yet exist.

Drug Sourcing: Importation

In the May 2024 PDAB editorial, as well as the July 2024 “Drug Sourcing Matters: Protecting Patients Facing Drug Importation, White and Brown Bagging,” we looked at the growing interest in state legislatures and SIEs (based upon advice from brokers and pharmacy vendors) in reducing drug costs by the wholesale acquisition of imported specialty pharmacy drugs from Canada and overseas or by mandated delivery of specialty pharmacy drugs from US-based specialty pharmacies to medical offices for administration and even to patients for self-administration. Most medical practices have put policies in place regarding the reasons they will not accept shipped drugs, whether from domestic or foreign country sources. Yet the interest in and the number of vendors offering just such solutions to states and SIEs have continued to grow throughout 2024.

Medical practices can play a crucial role by getting involved in prescription drug affordability boards, advocating for patients, and warning about the unintended adverse consequences of such boards where they do not yet exist.

The AMA Journal of Ethics published “What Should Prescribers and Policy Makers Know About US Drug Importation,”⁷ which can be a useful resource when physicians feel obligated to challenge the shipment of drugs from unknown domestic or international sources on behalf of their patients. Importation from Canada would exacerbate drug shortages in Canada and potentially open the way for counterfeit drugs to enter the US market.⁷ The Aimed Alliance submitted a Citizen Petition to the FDA regarding international importation practices by some AFP vendors.²

Entering 2025

Medical practices are starting to see patients (who are under the control of external vendors contracted by SIE health plans) receiving drugs from foreign countries. While at the American Society of Clinical Oncology meeting in June 2024, I spoke to one physician who had just had a patient who was not only receiving imported drugs through contracted vendors from his employer health benefits but who had also received the classic warning that these drugs may be different in size, shape, or color than the drugs that you may have been taking before—a significant red flag for risky imported drugs according to an FDA warning.⁸

When medical practices see signs that a patient is being exposed to imported drugs, when we see patients paying good money for premiums that are not delivering sufficient value for their needs or are putting them at risk for unsafe drugs, we need to track, aggregate, and engage. We can use this information to approach state legislators or SIEs with problematic coverage and offer them support and guidance.

Reach Out

There are a number of one-dimensional or siloed patient outreach platforms. There are also a very few that offer patients and practices the next generation of patient support beyond the practice walls. The more we develop these as part of our own patient management, the less patients will be confused by intrusions from other entities. Have you found good platforms yet? Share comments with me at This email address is being protected from spambots. You need JavaScript enabled to view it.. I would be interested in hearing what you have found, or what you are still looking for. It may well be out there.

References

1. American Medical Association. Resolution 707: Alternative funding programs, specialty society resolutions. 2024 Annual Meeting of the House of Delegates. Published June 2024. Accessed November 14, 2024. www.ama-assn.org/system/files/a24-sss-meeting-agenda-resolutions.pdf
2. Aimed Alliance. Aimed Alliance submits citizen petition to the FDA on alternative funding programs. Published April 1, 2024. Accessed November 14, 2024. https://aimedalliance.org/aimed-alliance-submits-citizen-petition-to-the-fda-on-alternative-funding-programs/
3. Niles A. It’s time for Congress to ban alternative funding programs. Oncolytics Today. 2023;5:64-65. www.ncoda.org/wp-content/uploads/2023/10/OncolyticsTodayFall23OnlineFINAL-1.pdf
4. Louisiana State Legislature. HLS 24RS-3545 Engrossed. Accessed November 19, 2024. www.legis.la.gov/Legis/ViewDocument.aspx?d=1375181
5. Aimed Alliance. Comments on draft prescription drug affordability board policy and procedures. Published October 16, 2024. Accessed November 14, 2024. https://aimedalliance.org/wp-content/uploads/2024/11/Aimed-Alliance-Comment-_CO-PDAB-Revised-Rules-Comment.pdf
6. Aimed Alliance. Aimed Alliance calls for changes to Maryland’s PDAB action plan. Published October 18, 2024. Accessed November 14, 2024. https://aimedalliance.org/aimed-alliance-calls-for-changes-to-marylands-prescription-drug-affordability-action-plan/
7. Quasba N, Vice E. What should prescribers and policymakers know about US drug importation? AMA J Ethics. Health Law. Published April 2024. Accessed November 14, 2024. https://journalofethics.ama-assn.org/article/what-should-prescribers-and-policy-makers-know-about-us-drug-importation/2024-04
8. FDA Warning Letter. CanaRx Services Inc, MARCS-CMS 554740. Published February 26, 2019. Accessed November 14, 2024. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/canarx-services-inc-554740-02262019