Over the last decade, commercial health insurance plans have placed more of the cost-sharing burden on patients via higher out-of-pocket (OOP) obligations. As a result, patients are increasingly relying on manufacturer-sponsored copay assistance to help cover the cost of their medications, particularly for specialty drugs. Traditionally, this financial assistance counted toward a patient's OOP cost accrual for the purposes of exhausting the deductible and hitting the plan OOP maximum, with the insurance plan covering subsequent prescription costs once the patient reaches the annual limit. In recent years, however, many payers have adopted copay accumulator programs that block a manufacturer's copay support from applying to the patient's deductible or out-of-pocket accrual.

How could the impact of these tactics impact patient adherence? What operational solutions should manufacturers consider for mitigating the potential negative effects on patients?

Payers' cost control efforts

Insights from an Xcenda Managed Care Network survey conducted over the last three years reveal that commercial health plans identify specialty drugs as a key cost driver. To manage this cost, both commercial and health insurance exchange plans have adapted their benefit designs to require greater cost-sharing for specialty pharmaceuticals. This trend underscores the need for copay assistance to help alleviate the financial burden of high OOP costs.

As the utilization of copay assistance has skyrocketed over the last decade, a growing number of commercial health plans are deploying copay accumulators or copay maximizers, which exclude the use of copay assistance from the patient's OOP cost accrual or calculation. While copay maximizers are a bit more patient-friendly since the total value of a manufacturer's financial assistance is applied evenly over the benefit year, the assistance still does not count against the patient's cost-sharing obligations.

As of 2020, 60 percent of payers are targeting copay assistance with accumulators and/or maximizers. While commercial payers initially used copay accumulator programs given the ease of operationalizing them, over the past three years, commercial payers have moved to offering both accumulators and maximizers.

Large employers are driving most accumulator uptake. Both self-funded and fully-insured employers are leading the charge with over 60 percent of the surveyed plans' employer customers applying a copay accumulator from 2018-2020.

The product acquisition channel matters in terms of the copay accumulator impact specifically. Specialty pharmacy continues to be the channel where the most plans — 70 percent in 2020 — can identify the use of manufacturer copay assistance, and therefore, apply copay accumulators. With greater control over the process, payers can identify and flag when a traditional copay card is being deployed to help pay for medication. The scenario of greatest control is the vertical integration happening across the industry, where the payer owns the PBM and also manages the specialty pharmacy.

Recent regulatory guidance from the federal government in 2020 may further hamper manufacturer copay assistance by fostering the growth of copay accumulators. In May of 2020, the Centers for Medicare and Medicaid Services (CMS) finalized the Notice of Benefit and Payment Parameters for 2021 (NBPP 2021), which allows health plans to implement copay accumulators even for brands without a generic equivalent. Then in December, CMS released a final rule requiring drug manufacturers to ensure the full benefit of copay assistance goes to the patient or face Medicaid Best Price calculation implications. This policy, initially effective January 1, 2023, places the burden on manufacturers to determine whether health plans are applying copay accumulators against a patient's drug. This process can be incredibly challenging given the lack of transparency around these models from commercial payers. At the time of this article, the Biden Administration has paused this regulation and its future remains unclear.

What it all means for manufacturers

The new CMS rules, along with the rapid adoption of copay accumulators, create an environment that is compelling drug manufacturers to reevaluate the design of their copay assistance programs.

According to the Xcenda survey, 40 percent of plans believe manufacturers may have to explore new models or redesigns under the new CMS regulations. Whether that's the case or not, manufacturers may have to grapple with the widespread impact of copay accumulators on their patients and programs. These include:

• The impact to patient satisfaction and increased frustration from patients maneuvering the copay process and blaming the brand instead of the PBM when there is a perceived misalignment of the patient experience to the brand promise.
• The impact to outcomes when it takes more time for patients to start therapy or they face increased barriers to stay on therapy and achieve sustained outcomes.
• The impact on copay program finances when costs increase to offer additional copay assistance and prescription volume potentially decreases with therapy abandonment.

Operational solutions to address copay accumulators

As copay accumulators and maximizers continue to gain popularity with commercial payers, manufacturers can — and should — adapt. Consider three operational steps to brace for the impact on copay programs:

1. Understand patient coverage demographics 
   Patients insured through their employers are most likely to fall risk to copay accumulators and maximizers. Identifying and segmenting these patient populations will better inform benefit design, benefit maximums, and copay program assistance flexibility.
2. Provide alternate payment methods 
   Evaluating how patients pay at the pharmacy can uncover opportunities to reduce financial distress. Manufacturers could reimburse patients proactively or retroactively based on known treatment or refill cycles. These funds could be provided directly to a patient via a debit card solution or by check.
3. Forecast the impact of copay accumulators 
   Organizations should take the time to closely examine the accumulator programs that affect their brands. Utilizing an exposure modeling method to understand the impact of accumulators to the brand and measure the impact of non-adherence on patient populations will enable the proactive implementation of innovative patient support programs.

Looking ahead

We expect copay accumulators and maximizers to be quite prevalent within the commercial market into the foreseeable future. However, there remains uncertainty whether the Biden Administration will change course on copay accumulators and adopt a more patient-friendly posture on patient access issues.

Engaging with aligned advocacy group partners will be crucial to helping them educate and influence policymakers. Additionally, we recommend manufacturers take steps to gauge payer perceptions, assess the financial impact of copay accumulators, segment their patient populations to understand affected populations, and work with a copay partner that offers customized solutions.