As healthcare costs continue to spiral in the U.S. and more political and regulatory pressure builds on lowering prescription prices, drug manufacturers are having to dig deeper into what will be a rapidly changing landscape in the coming years.
The traditional pharmacy copay model, which was more commoditized by focusing on the value of each transaction and managing patient eligibility, is quickly shifting toward a patient focused format. What was a comfortable and familiar landscape to manufacturers has been challenged by accumulator and maximizer programs, and manufacturers are challenged to pivot to patient value-based plans, risk sharing models and other forward-looking strategies.
“Manufacturers are going to have to re-shift their thinking,” Corey Ford, Senior Director of Reimbursement & Policy Insights at Xcenda, an AmerisourceBergen company, said. “As we move from the traditional model to a more patient-centered model that incorporates financial services, manufacturers are going to have to ensure that copay benefit funds they are providing are going to the patient before it is used at a retail pharmacy or in coordination with a specialty pharmacy or the physician’s office.”
Over the past decade, the financial burden of healthcare shifted to patients through higher copay costs in order to get affordable health insurance. The shift has generally resulted in bigger out-of-pocket expenses for patients.
As a result, patients began to lean more heavily on manufacturer-sponsored assistance programs designed to help offset increased medication costs, especially for specialty drugs that can run into the thousands and sometimes hundreds of thousands of dollars.
The advent of copay accumulator and maximizer programs
In response to escalating costs, payers and pharmacy benefit managers (PBMs) began to adopt copay accumulator programs that limit manufacturer assistance programs from counting toward the cost of a patient’s deductible and their maximum out-of-pocket spending. Under an accumulator program, the payer excludes any copay assistance from the patient’s out of pocket calculation for the purposes of navigating the deductible and reaching the plan out of pocket maximum.
Maximizer programs also exclude any copay assistance from the patient’s out of pocket calculation; however, maximizers raise the patient cost sharing amount to the maximum copay benefit provided by the manufacturer. According to insights from Xcenda’s Managed Care Network, roughly 60% of commercial payers restrict the use of copay assistance through an accumulator or maximizer program.
Higher patient costs result in a decrease in adherence to prescribed therapies. An Xcenda study found that once the patient’s out of pocket cost hits $25 dollars for a medication, adherence begins to decline by up to 10%, and when the cost is higher the impact on adherence climbs as well.
In response to the increase of accumulator and maximizer programs the industry has begun to turn its focus toward patient financial services that encompasses a more holistic approach to patients, their financial wellness and ability to pay for prescriptions. Such services also provide more complete patient data earlier on in order to bypass the risks of accumulator and maximizer programs and be able to nimbly adapt to new initiatives like value-based reimbursement of efficacy warranties.
Implementation of new CMS rule on the horizon
One of the biggest changes facing manufacturers is the implementation of the Centers from Medicare & Medicaid Services’ final rule that goes in place Jan. 1, 2023. At that time, CMS will require drug manufacturers to ensure the full benefit of copay assistance goes to the patient or face Medicaid Best Price calculation implications. The rule places the burden on manufacturers to ensure patients get the direct benefit of manufacturer copay support and is expected to be very challenging due to a lack of transparency around models from commercial payers.
“This is a heavy ask of manufacturers who do not currently have visibility into the ways in which their copay assistance is being applied or not applied to patient out-of-pocket calculations within the Payer and PBM systems,” said Colleen Cummins, product director at Lash Group, an AmerisourceBergen company. “The intent of affordability programs is to provide assistance to patients and not for that money to be redirected into discounts to Payers and PBMs.”
AmerisourceBergen, which has more than 21,000 associates focused on pharmaceutical sourcing, distribution, and commercialization services, has been analyzing the impact the new CMS rule will have on manufacturers and patients.
Both Lash Group and Xcenda stress that manufacturers need to consider three things as they prepare for copay changes:
- Manufacturers need to understand patient coverage demographics. For example, patients insured through employers are most at risk of copay accumulators and maximizers. The ability to identify and segment these patients will provide better data to design new and more flexible copay benefit programs.
- Develop alternate direct-to-patient reimbursement payment methods, such as debit card or by check, that can be distributed either proactively or reactively based on patient data of known treatment or refill cycles.
- Become more adept at forecasting the impact of copay accumulators and maximizers on specific patient populations, specifically the ability to measure the effect of non-adherence on patients in order to respond with innovative patient support programs.
Undoubtedly, operational changes are coming to manufacturers, requiring a tremendous amount of time and effort to analyze and prepare for those changes. The ultimate goal is to improve the patient experience and outcome.
“How manufacturers respond to those changes and how they mitigate the process is going to be very impactful for patients,” Cummins said.
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