A Look at Copay Assistance Programs and Copay Accumulators
Copay assistance programs are a known tactic deployed by drug manufacturers to help facilitate access to often expensive specialty medications. These financial assistance programs take a comprehensive approach to supporting a patient’s out-of-pocket costs, inclusive of any applicable deductibles and drug cost-share responsibilities – up to a patient’s annual out-of-pocket maximum. The strategic thinking behind these programs is that without them, prescriptions become unaffordable and lead to product abandonment and/or poor adherence. Basically, copay assistance is paramount in achieving the best patient outcomes.
Payers, particularly PBMs, have generally adopted the position that these programs introduce conflict in their ability to manage utilization (and therefore drug spend), which in turn drives up premiums. In an attempt to outmaneuver manufacturers in the last few years, PBMs have deployed copay accumulator programs. While these programs continue to allow the use of manufacturer copay funding, it is how they allow this use that is problematic to both patients and manufacturers. When deployed, accumulator programs prohibit copay assistance funds from being applied to a patient’s deductible and out-of-pocket maximums. When the copay assistance funds reach their annual limit, the patient is then exposed (often unexpectedly so) to their high deductible and have also likely not contributed anything to their annual out-of-pocket maximum. More recently, PBMs have deployed copay maximizer programs, which are a type of accumulator that essentially behaves the same but results in a much greater expense to the manufacturer.
Recent final and proposed rules by the Department of Health and Human Services (HHS) will no doubt accelerate the adoption of copay accumulator programs for group sponsored plans. One rule provides plans with the autonomy to enact accumulator programs with few statutory limitations. Another rule, still proposed, mandates that manufacturers track how their copay assistance programs are implemented at the plan level and how that subsequently impacts government reporting, including best price. What for years has been, “watch and wait” now requires immediate and full attention.
THE DIRECT IMPACT TO PATIENTS
Patients are resilient and navigating their own healthcare is nothing new, however, implementing additional hurdles is most certainly not in a patient’s best interest. Based on experience to-date with accumulator programs, patients can likely expect:
- Further adoption of accumulators by their individual employer plans
- Leads to exposure of higher out-of-pocket costs
- Manufacturer copay assistance is not applicable to deductible and annual out-of-pocket maximum costs
- Continued near meteoric rise in copay maximizer programs
- Many payers require patients to enroll prior to getting their medication
- This is yet another form of utilization controls
- Increased susceptibility of being switched to a different therapy
- An attempt to satisfy payer copay maximizer preferences
THE DIRECT IMPACT TO MANUFACTURERS
The direct impact to patients most certainly has a direct impact to manufacturers, however in the new environment, copay accumulators challenge more than just the market access team. Notable impacts include:
- Decline in patient affordability throughout the course of therapy may negatively affect compliance or encourage discontinuation
- Payer contracting strategy related to rebates and/or other pricing concessions will need to be redefined
- Copay tools and technologies that ensure benefits are received by patients will need to be identified and/or developed
- Awareness of how individual plans utilize copay accumulators and/or maximizers and their impact on government reporting will need to be increased
- Brand forecasts and gross-to-net calculations may need to be adjusted, sometimes substantially (Note: a patient who is subject to a copay accumulator program is likely to pay 4-6 times more than a non-accumulator patient)
WHAT MANUFACTURERS SHOULD BE PREPARED TO DO
- Be aware of and educate internal groups, including executive leadership, on copay accumulators
- Fully understand the new and proposed HHS rules and their wide-reaching impact
- Determine how this impacts a manufacturer’s patient population and brand(s)
- Review payers and identify high-level exposure based on their current payer mix
- Identify necessary changes to existing programs and roadmap implementation
HOW WE CAN HELP
Copay accumulators and maximizers have become an aggressive method certain payers use to manage financial contributions from manufacturers and patients. To date, minimal guidance has existed at the federal level in terms of how plans are able to leverage accumulators and how transparent they must be to the members of the plan. Given the minimal to moderate impact to patient access up until this year, manufacturers have generally not taken action or incorporated this impact into their annual and long-term plans.
The rules that have recently been put into place have been buoyed by continued plan adoption and final federal guidelines that extend discretion to employers and PBMs. A recent proposed federal rule places the burden on manufacturers to understand, at a plan level, how their available copay benefit is being distributed, and then assess any potential impact on their government price reporting obligations.
We have been supporting clients throughout this evolution of copay accumulators and maximizers by helping them be prepared for these changes. Our goal is to support manufacturers and help them better understand how these rules affect their brand. We also partner with manufacturers to develop the strategy and tools that can be put in place that proactively manage patient product access.
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