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The ongoing battle over controversial copay adjustment programs that shift more of the costs of specialty medications onto patients—otherwise known as accumulators and maximizers—continues to draw significant interest from the healthcare community. Indeed, a recent online panel discussion hosted by ConnectiveRx drew more than 1,000 registrants and generated far more audience questions than could be answered during the session.¹ As payers and manufacturers clash over cost-shifting strategies while state and federal courts increasingly become involved, patients keep getting caught in the middle.

Since these programs are designed to ensure that manufacturer copay assistance payments no longer count toward a patient's deductible or out-of-pocket costs, the stakes are particularly high for manufacturers. With their assistance coupons restricted from counting toward their annual out-of-pocket maximums, patients are far more likely to stop taking their medications because they can no longer afford them.

To understand how manufacturers can best support their patients moving forward, we should take the lessons learned from the past and apply them to both short- and long-term planning.

The government’s impact on copay adjustment programs

In somewhat of a victory for patients and manufacturers, a government ruling last October struck down a 2021 federal rule that allowed payers to exclude copay assistance from annual deductibles. The ruling mandated that payers and pharmacy benefit managers (PBMs) must instead follow a 2020 rule in which accumulator programs can only be applied to brand-name drugs that have generic equivalents available—ensuring patients have a strong cost-saving option. Without that option, patients are often left with no affordable way to access help or medication, negatively impacting adherence.

The dismissal in January of the government’s appeal seeking more clarity around copay adjustment programs through its filing of a motion to clarify is recognition that the Court has officially reinstated the 2020 rule. Despite this dismissal, it is important to note that the government has not issued any statements indicating it is going to comply with the rule and we should not assume it will until it issues a statement accordingly.

If it gives any indication that it is not abiding by the rule, another round of litigation will ensue. And since this is an election year, conventional wisdom dictates that we should not expect much to get done by the Department of Health and Human Services or Congress on the issue. 

With copay program enforcement highly unlikely in the near future, the back and forth between pharmaceutical manufacturers and payers is all but guaranteed to continue through 2024. For now, though, the 2020 rule lives—and that is good for patients and manufacturers.

Three keys to overcoming accumulators

For the foreseeable future, accumulators will remain active outside of those states that have banned them. Fortunately, manufacturers do not have to just sit back and wait for the legal issues to work themselves out.

The ongoing patient services work should continue and manufacturers can take three key steps to mitigate non-adherence due to this situation:

1. While payers’ use of cost-shifting strategies may ebb and flow, they are likely to exist in some form for years to come as payers continue to tweak them and leverage increasingly complex data. To mitigate their impact, manufacturers should increase their knowledge around who their patients are and the various ways to reach them. This requires a holistic approach that would include representatives from finance, procurement, access, and brand strategy. Keep in mind that copay adjustment programs are not widely understood among patients, so it is imperative that all internal parties understand the interconnected relationships of how the program will operate in order to better serve patients.
2. Patient knowledge of adjustment programs is generally limited to the fact that they eventually end up paying more out of pocket for already expensive medications. Building off of step one, focusing on sharing simple, targeted messages with patients and their providers at the point of care allows manufacturers to provide insight about what these programs mean and what the brand is doing on their behalf. This can make frustrated, confused patients feel more comfortable, and a helpful, educational approach translates over time to a better patient experience.
3. Manufacturers should continue to evaluate the gross to net of their programs, reassessing profitability, the overall cost to them, and whether it makes sense to adjust income and other requirements of their patient assistance programs (PAPs). For example, they may become more comfortable eliminating patients who are clearly part of a maximizer program or specialty carveout.

Bringing together the right people to develop a thorough understanding of which patients are impacted by accumulator and maximizer programs and the financial impact they will have, undertaking proactive patient and healthcare professional (HCP) education, and leveraging hub program data can together help reduce copay adjustment programs’ impact and ultimately improve patient access and adherence.

State battles continue while payers shift their strategies

Through their government relations teams, manufacturers have so far been heavily engaged in state-by-state lawsuits against copay adjustment programs. This is a tactic that manufacturers should continue through 2024, and possibly beyond.

Barring a ruling at the federal level, these state-level advocacy programs should ride the momentum and continue the push to eliminate adjustment programs. While there is no guarantee this tactic will yield the desired outcome, the state scorecard is evolving and has the potential to influence federal regulators as they evaluate the impact and constitutionality of these programs.

In the meantime, manufacturers should expect that payers and PBMs will continue to make moves to increase patient out-of-pocket costs, turning this situation into a very different multi-player game where the key players watch each other’s moves and adjust their strategies. Along those lines, keep in mind that the government ruling did not apply to maximizer programs, so payers are likely to pivot to maximizers in the near term.

Simply because these programs aren’t called accumulators and operate slightly differently from them, they are not subject to the ruling, so PBMs have more leeway with them and are likely to take more risks in shifting to them. Knowing this, and using the tactics laid out here, can help keep patients on therapy without subjecting them to unreasonably high costs.

Specialty patients may be seeing their deductibles rise and fall depending on the push and pull of the payer and manufacturer, leaving them caught in the middle and simply trying to make it through the year on their copays without going broke. But we have seen clear evidence that manufacturers can and do have the power to help patients overcome these barriers and stay adherent to medication. By not letting up while the legal process plays out and making actionable changes, manufacturers can reduce the harm to patients due to cost-shifting strategies.

About the Author

Chris Dowd is senior vice president, market development, at ConnectiveRx.

Reference

1. The Battle of Accumulators and Maximizers: What You Need To Know for 2024. ConnectiveRx webcast. Accessed February 19, 2024. https://www.connectiverx.com/accumulators