CLL Monthly MinutesLeukemia

Recent Regulation of Copay Adjustment Programs

Copay assistance coupons and copay adjustment programs put patients in the middle of healthcare cost-saving measures.
Web Exclusives – November 17, 2021

As we get older, we are often faced with an increasing number of health conditions that need regular treatment.1 Prescription drugs, therefore, frequently become a crucial part of a person’s daily health regimen.2 However, for approximately 1 in 4 Americans, the out-of-pocket cost of these prescriptions makes it a challenge to afford their medicine.2

Recent advances in medicine have led to more specialized treatments, including biologic drugs that are manufactured in living cells. For example, the chronic lymphocytic leukemia (CLL) treatments rituximab and obinutuzumab are biologic drugs that are produced in cultured animal cells.3,4 These biologic drugs, along with other brand-name, or “specialty” drugs, such as oral targeted therapies for CLL (ie, ibrutinib, acalabrutinib, and venetoclax), can be especially costly for the patients who need them.2

Research has shown that specialty drugs make up a substantial 38% of all retail prescription drug spending, although they only represent a small fraction of prescriptions filled. In a recent analysis, researchers found that the prices of 6 specialty drugs rose an average of 57% between 2014 and 2018.2 Notably, the same analysis showed that prices for generics decreased by 35% during the same period.2

Given that generics for brand-name prescriptions are often available at a much lower price, it begs the question: why are we continuing to choose brand-name drugs over generics? Part of the answer may come from the copay assistance coupons offered by many manufacturers to help offset the cost of prescriptions.2 These coupons not only reduce the amount that patients pay at the pharmacy counter, but they also can be applied to the patient’s annual cost-sharing requirements, such as their deductible.2

Although copay assistance coupons do help limit patients’ out-of-pocket costs, their use may incentivize prescribers to use more expensive brand-name drugs over cheaper generics or other lower-cost medications.2 Furthermore, critics note that the coupons do not actually reduce the price of the drug, but instead shift the cost to health plans, which can increase premiums.2

To control costs, pharmacy benefit managers and insurance companies have developed different tools to encourage patients to choose lower-cost drug options.2 For example, some plans include a “copay adjustment program,” also known as a “copay accumulator” or “maximizer” program, that prevents manufacturer assistance coupons from counting toward a patient’s deductible.2

Although these programs incentivize patients to seek cheaper therapeutic options, they may pose a challenge to patients whose plans allow them to pay a percentage of the cost rather than a flat amount.2 Furthermore, for patients with chronic and complex medical conditions such as cancer, rheumatoid arthritis, and diabetes, expensive prescription drugs may be the only option.2

In May 2020, the Centers for Medicare & Medicaid Services finalized a ruling stating that health plans can include copay adjustment programs, although they deferred the regulation of these programs to individual states.5 As of fall 2021, 12 states and Puerto Rico have enacted laws requiring manufacturer’s assistance coupons to be applied to the consumer’s annual out-of-pocket cost-sharing requirement.2 Several other states have similar legislation pending that may further limit the reach of copay adjustment programs.6


  1. US Food and Drug Administration. As you age: you and your medicines. Accessed November 4, 2021.
  2. National Conference of State Legislatures. Copayment adjustment programs. Accessed November 4, 2021.
  3. RITUXAN (rituximab). [prescribing information]. South San Francisco, CA: Genentech; 2021.
  4. GAZYVA (obinutuzumab). [prescribing information]. South San Francisco, CA: Genentech; 2021.
  5. Covington. CMS finalizes rule expressly permitting copay accumulator programs. Accessed November 4, 2021.
  6. Truveris. Industry update: the impact of recent state legislation on copay accumulator programs. Accessed November 4, 2021.

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Last modified: November 17, 2021

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