Brooke Loving and her family

Brooke Loving doesn’t take the medication that would keep her von Willebrand disease under control. Because of the cost, she has made the decision to focus on treating her children instead. Brooke and three of her eight children have been diagnosed with von Willebrand disease, which is a bleeding disorder that is characterized by low levels of von Willebrand factor, a protein that helps blood clot.

Two of Brooke’s children take Humate-P, a von Willebrand factor/factor VIII replacement therapy. It’s expensive but CSL Behring, Humate-P’s manufacturer, offers copay assistance of $10,000 a year.

In previous years, Brooke said they would use the copay card when it counted toward their out-of-pocket deductible. “When that ran out, our portion was about $300 a week,” she said.

But Blue Cross Blue Shield of Alabama, Brooke’s insurance company, and the PBM Express Scripts changed its policy and have implemented a program where the copay assistance doesn’t count toward the family’s deductible. (The family’s specialty pharmacy is Accredo).

Brooke and her family decided not to use the copay assistance because it did not count toward their deductible. The family has a high-deductible plan through the employer of Brooke’s husband: $9,100 for an individual and $18,200 for the family, the out-of-pocket maximums set by the Affordable Care Act.

“We needed to meet the deductible to assist with all the other appointments and meds we utilize as a family,” she said. “Originally, we thought it would make more sense, but this may have been an uneducated decision. I didn’t/still don’t feel I understand any of this mess. It should be simple.”

Now her daughter, Katy’s, most recent copay was $5,000 for four weeks of medicine. “I can count numerous times where we’ve had to pick between getting groceries for the week or doing a treatment,” Brooke said. “Unfortunately, in the last six months, I was hit with the fact that I had made a bad mom choice.”

Her choice: she didn’t immediately take her 9-year-old son, Kason, who also has von Willebrand disease, to the doctor when he complained about shoulder pain after he had fallen on the playground. “We were not educated to know and listen to some of the cues, and we did not treat my son, because treating him would be costly.”

Patients Face Access Challenges

Over the past several years, PBMs have implemented restrictions that put more of the costs of specialty medications on patients such as Brooke and her family. One such restriction that has impacted Brooke’s family is called a “copay accumulator,” in which any copay assistance would not count, or accumulate, toward the family’s deductible. Accumulator programs shift costs to patients, and critics say they amount to double-dipping because the plan is getting both the value of the copay and the patient deductible.

Kollet Koulianos

“In November 2016, we noticed some benefit changes to one plan around copay assistance and it not accumulating toward a patient’s out-of-pocket deductible,” Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation, said in an interview. “We knew then that there would severe unintended consequences for both the patient and self-funded plans.”

Since then, copay accumulator programs have become common. According to a 2023 report from The AIDS Institute, at least two-thirds (64%) of health plans in the country include a copay accumulator policy. PBM accumulator programs combined with high-deductible health plans have put many patients with chronic diseases in a difficult position. (See Sidebar below for more information.)

The three largest PBMs — CVS, Express Scripts, and Optum Rx, which control about 80% of the market — use accumulator programs. A spokesperson for Optum Rx said that its program is not new; it was introduced nearly five years ago. CVS and Express Scripts did not respond to requests about their programs. But CVS executives in 2018 said copay cards encourage the use of more expensive therapies by negating the impact of higher cost-sharing tiers on member out-of-pocket cost. And Express Scripts said in 2018 that a copay accumulator helps to level the playing field.

Also growing are the use of “maximizer” programs, which classify a subset of specialty medications as “non-essential.” This removes the Affordable Care Act’s requirements related to maximum out-of-pocket limits. These programs maximize patients’ use of manufacturers’ copay assistance programs by limiting the PBMs’ exposure to specialty drug costs. The proportion of commercial patients exposed to maximizers has tripled since 2019 in the autoimmune brands from 4% to 14%, as well as for multiple sclerosis products from 5% to 15%, according to IQVIA. Among oncology patients, maximizer prevalence more than doubled from 5% to 13%.

But now pharmaceutical companies are fighting back against these PBM efforts to limit patient assistance. Some pharmaceutical companies have begun to lower the total amount of assistance given to patients through copay cards when accumulator or maximizer programs are in effect.

Geoffrey Joyce, Ph.D.

“It’s a basically a mud fight between drug manufacturers and the insurers and pharmacy benefit managers,” Geoffrey Joyce, Ph.D., director, health policy, University of Southern California Schaeffer Center and chair of the department of Pharmaceutical and Health Economics, USC School of Pharmacy, said in an interview. “In the case of accumulators, it doesn’t benefit the patients. All of this is between the manufacturers and the insurers. And each wants a bigger piece.”

One example of a company lowering the value of its assistance is CSL Behring, which produces Humate-P, the therapy that Brooke’s family takes. While the terms for the copay don’t specifically use the term “accumulator,” they do say that patients whose insurance policy impose limitations on copay assistance are not eligible.

CSL Behring isn’t the only pharmaceutical company to change the terms of their copay cards when insurers have accumulator programs. AbbVie, for example, has lowered the annual maximum that patients can receive from copay cards. For its blockbuster arthritis drug Humira (adalimumab), the company has lowered its assistance from $14,000 a year to $4,000 a year if a patient’s plan has an accumulator program. AbbVie has also lowered assistance for another arthritis therapy, Rinvoq and for the psoriasis therapy Skyrizi. For Rinvoq (upadacitinib), the annual is lowered from $14,000 to $6,000 if there is a copay or maximizer program. For Skyrizi (risankizumab-rzaa), the annual limit is also $6,000.

Janssen is another company that is limiting copay cards for patients with accumulator plans for its psoriasis/ulcerative colitis therapy Stelara (ustekinumab). Patients now have a limit of $6,000 annually for its $5-a-dose Stelara WithMe Savings program. For the copay cards for the anticancer therapy Yondelis (trabectedin) and the pulmonary hypertension treatment Tracleer (bosentan), Janssen doesn’t specifically mention accumulator programs, but does say “The cost support is meant solely for patients — not health plans and/or their partners.”

Other companies — such as Teva for Austedo (deutetrabenazine) for tardive dyskinesia and Sanofi/Regeneron for Kevzara (sarilumab) for rheumatoid arthritis — don’t specify whether annual limits will be reduced, but they do say that they reserve the right to change the terms of the copay card.

Matt Gibbs, Pharm.D.

The pharmaceutical companies would not respond to questions about their lowered assistance, but Matt Gibbs, PharmD, president of Capital Rx, said he sees these efforts to lower copay assistance as a veiled threat to PBMs that have accumulator programs. “They’ll never admit this, but it’s probably tied to their global rebate contracting: ‘If you want a rebate on this drug, you can’t be doing this activity.’ Also, this [limiting of assistance] is not on all products. It’s for specific products, which implies they want to continue to drive market share on their drugs.”

All of this leaves patients stuck in the middle between two large healthcare players. Patients often don’t know if their drug coverage includes an accumulator program. If they do, they might understand its implications for copay assistance.

About 70% of people with multiple sclerosis, for example, have relied on patient assistance programs at some point, indicating that patients are struggling with the managing the costs of their disease, Bari Talente, executive vice president, advocacy and healthcare access, for the National MS Society, told Formulary Watch.

“Copay accumulators hurt patients,” she continued. “People with high healthcare costs are stuck in the middle of fights between PBMs/insurers and pharmaceutical manufacturers. While they continue to try and outmaneuver each other, patients are the ones facing the very real consequences.”

But Gibbs doesn’t believe accumulators hurt patients. “At the end of the day, patients are still paying way less than they would have,” he said.

Dea Belazi, president and chief executive officer of AscellaHealth, said the conflict between pharma and PBMs over copay cards create a checks-and-balances system.

“This battle of pharma versus payers has been going on forever,” he said. “But this also creates a balance where both two sides of the table will be a check on each other. Until we figure out a better model, you want both pharma and PBMs on the opposite of the tables duking it out. I'm nervous if one or the other get the upper hand where it’s not going to be okay.”

States, Advocacy Groups Speak Out Against Accumulator Programs

Sarah Emond

Pharma copay programs are a symptom of a problem created by higher and higher list prices, Sarah Emond, MPP, executive vice president and chief operating officer, at the Institute for Clinical and Economic Review (ICER) said in an interview. “The goal of cost-sharing and accumulators was originally to incentivize patients to choose cost-effective, effective, lower cost options,” Emond said. “But the problem comes in when there are they are applied to drugs with no other options. They are not incentivizing any value-based purchasing behavior because patients don't have a choice.”

IQVIA found that from 2019 to 2022, the prevalence of accumulator programs doubled to 14% for autoimmune therapies and 20% for oncology products. The growth is expected to be as high as 25% as vertically aligned specialty pharmacies and PBMs continue to expand their programs and smaller specialty pharmacies develop programs to compete for the specialty pharmacy patients in these markets. 

Some states have implemented legislation to regulate copay accumulators. Laws in 16 states and Puerto Rico require any payment or discount be applied to a consumer’s annual out-of-pocket cost-sharing requirement. At the federal level, a bipartisan bill, H.R. 830, the Help Ensure Lower Patient Copays Act, was introduced earlier this year in the House that would require health plans to count copay assistance toward cost-sharing. The bill is supported by a bipartisan group, including Representatives Earl “Buddy” Carter (R-GA), Nanette Diaz Barragán (D-CA), Brian Fitzpatrick (R-PA), Diana DeGette (D-CO), Mariannette Miller-Meeks (R-IA), Bonnie Watson Coleman (D-NJ), and Yvette Clarke (D-NY).

Patient, provider, and consumer organizations representing a wide range of illnesses support the bill, and in February, 29 organizations signed a brief in support of a Pharmaceutical Research and Manufacturers of America lawsuit against the Department of Health and Human Services for prohibiting copay coupons in Medicare.

Accumulators and High-Deductible Plans Put Patients at Risk for High Costs

PBM accumulator programs combined with high-deductible health plans have put many patients with chronic diseases in a difficult position, Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation, said in an interview. “These are patients with commercial insurance and are contributing members of society, but they live paycheck to paycheck just like many in America,” she said.

More than half (55.7%) of American private-sector workers were enrolled in high-deductible plans in 2021, the highest on record and the eighth straight yearly increase, according to a survey by ValuePenguin, a LendingTree company that provides analysis for consumer financial decision making. This up 83.7% from 2013.

But Koulianos said 59% of patients with hemophilia are part of high-deductible health plans, based on a survey the National Hemophilia Foundation (NHF). And nearly seven in 10 (69%) people with an income less than $40,000 a year who have private coverage say they or a loved one have a high deductible health plan.

“This is a problem because when you have a deductible, regardless of the amount, you must pay the full deductible before insurance kicks in,” she said. “If you have medicines that cost way more than these deductibles, you’re going to be hit every January having to pay for the full cost and patients wouldn’t have yet saved anything in their HSA.”

Health savings accounts, designed to help patients set aside money to pay for medical expenses, have limits on contributions. For 2022, HSA contributions were set at $3,650 for individual coverage and $7,300 for family coverage.

Sixty-five percent of the National Hemophilia Foundation respondents said they have used or are using copay assistance programs for their medications or treatments. Six in 10 patients and caregivers say they would have extreme difficulty affording their treatments and medications without copay assistance programs being applied to their out-of-pocket costs.

High-deductible plans coupled with health savings accounts were part of the Accountable Care Act, which launched in 2014, as a way to provide insurance coverage with lower premiums. But those within the pharmacy benefits industry say the healthcare system, especially after the passage of the Accountable Care Act, has set up the wrong kind of incentives, allowing pharmaceutical companies to set extremely high prices for specialty drugs.

Pramod John, Ph.D.

“It’s the law of unintended consequences,” Pramod John, Ph.D., chief executive officer of Vivio Health. “The ACA’s intent was not that providers now can charge whatever they wanted for a service, whether a drug manufacturer or hospital. It was trying to protect a member who could have million dollar out-of-pocket costs in a year. This is when we started to see expansion of drug pricing because now with out-of-pockets limits, it doesn’t matter whether a drug costs $6,000 or $600,000.”

Pharmaceutical manufacturers, John said, started offering copay cards after high-deductible plans were launched. “Now a drug manufacturer can arbitrarily raise the price of a drug or remove all pricing sensitivity for the cost of the drug by paying patients’ copays and deductibles.”

Ultimately, it’s a steering mechanism, he said. “Copay cards set up economic incentives that favor the wrong behavior,” John said. “We’ve removed pricing sensitivity for patients and incentivized providers to be able to jack up the price of goods and services.”