Originally published in Pharmaceutical Executive as a guest post from Chris Dowd, ConnectiveRx SVP of Market Development.
As new litigation looms in the debate over use of copay accumulator programs, a look at potential next moves for payers—and steps drug manufacturers should take to ward off cost-driven non-adherence.
The legitimacy of copay adjustment programs, also known as copay accumulator or maximizer programs, remains an open-ended question with many states implementing copay accumulator program bans. As payers and manufacturers wait for the next round of litigation, these programs continue to make headlines in the healthcare industry.
As I outlined in a recent piece,1 there are practical steps manufacturers can take to support their patients and their own bottom line. Meanwhile, payers are no doubt hard at work planning for the near and long-term future of copay adjustment programs.
So, what can we expect next from payers that manufacturers should be anticipating, and what can be done to protect patients from cost-induced non-adherence to critical specialty medications?
Why do accumulators and maximizers exist in the first place?
The primary reason that payers created copay adjustment programs lies within the very nature of their business, namely that insuring patients means taking on the risk of patients’ lives for the pharmaceutical benefit. Additionally, the payers’ clients— employers—demand that payers and pharmacy benefit managers (PBMs) keep drug costs under control since the cost of providing healthcare to their employees remains high.
Over the years, formularies, exclusions, and prior authorizations have been created to support this cost control, but using the accumulator technique, in which the patient’s annual out-of-pocket (OOP) maximum is affected by taking off the manufacturer’s contribution, is a newer approach. It all stems from the same reasoning—payers are seeking ways to control costs to benefit their bottom line, while employers are seeking ways to control the costs of providing healthcare to their employees.
Maximizers continue to expand where accumulators cannot
A government ruling last year struck down a 2021 federal rule that allowed payers to exclude copay assistance from annual OOP maximums, mandating that payers and PBMs must instead follow a 2020 rule in which accumulator programs can only be applied to brand-name drugs that have generic equivalents available. Importantly, this ruling did not specifically address maximizer programs, which payers use to exhaust the maximum available patient assistance that a manufacturer offers to patients for their medication while not counting that assistance toward patients’ annual OOP maximums.
However, there is some positive news on maximizers as it relates to individual and small group plans. The 2025 Notice of Benefit and Payment Parameters blunts the process whereby insurers and employers classify certain drugs as “non-essential health benefits” (as often used in maximizer plans), thus allowing health plans to set patient copays above Affordable Care Act maximums and leverage the full amount of copay assistance from drug manufacturers while preventing such copay assistance from counting toward a patient’s deductibles and OOP maximums. It directs that all drugs covered by a health plan (both those included in the state benchmark plan as well as any other drugs covered) are essential health benefits. This new directive applies only to the individual and small group markets for now, but the departments of Labor, Treasury, and the Health and Human Services (HHS) plan to issue a new rule to end this practice for large group and self-funded plans as well.
So, it appears maximizer programs will continue to proliferate for now in large group and self-funded plans, forcing patients to pay hundreds or even thousands of additional dollars in increased deductible, copayment, and coinsurance costs that should be satisfied by patient assistance programs in order to obtain their medication.
Additionally, accumulators are continuing to fall out of favor from a legal perspective, but manufacturers should not assume that payers are going to simply give them up without a fight. Despite the DC District Court decision that struck down the rule allowing insurers to not count copay assistance for prescription drugs as part of patient cost-sharing (except when a generic alternative is available), the willingness of HHS to enforce that ruling is still in question. Payers are also going to continue to fight against additional state-level bans, so manufacturers should continue to work with partners that can identify such programs and work with them to get affordable medications into the hands of patients.
Will payers eventually abandon accumulators completely?
Given the number of bans on accumulators on the state level, plus the hope given to patients and manufacturers with last year’s federal ruling, there may be temptation to begin looking beyond accumulators. However, accumulators are likely here to stay, but possibly not in their current broad form.
Manufacturers, especially those in some of the more expensive specialty spaces, should be on the lookout for more evolved accumulators that target specific therapeutic areas. Accumulators, by and large, have gathered negative press over the years in addition to being banned by many states across the country, so it may be in payers’ best interests to focus their efforts on specific therapeutic areas in order to fly under the radar of negative attention.
Honing in on specific therapeutic categories gives payers the flexibility to establish stronger partnerships, which can help in sharing risk with employers and becoming more aggressive with patients in the process.
Payers will be able to experiment with new ways of executing these programs, leveraging ever more detailed data and tracking methods to continually tweak programs that benefit payers, PBMs, and employers.
While all of this is going on, remember that payers will also continue to find ways to collect premiums, skirt covering care, and prevent patients from receiving assistance to access their medication. It is up to manufacturers and their patient assistance program partners to keep up with this morbid game of whack-a-mole to ensure that patients can access their medication.
To help ensure patient access and adherence, manufacturer and patient assistance teams must understand which patients are affected by copay adjustment programs and the financial impact these programs have. Then, leveraging hub program data and educating both patients and healthcare professionals will help reduce the impact of these programs as they continue to evolve.
Reference
1. Dowd, C. Copay Adjustment Programs: What’s Next for Manufacturers? Pharmaceutical Executive. 2024. 44 (3), 22-24. https://www.pharmexec.com/view/copay-adjustment-programs-what-s-next-for-manufacturers