Programs that do not count pharmaceutical company coupons and copay assistance toward deductibles have grown over the last five years, but states are stepping in to limit these programs.
The use of copay accumulator and maximizer programs — mechanisms used by PBMs to reduce their spending on specialty drugs — has grown from 14% of commercially-insured patients in 2019 to 33% in 2022, according to a recent paper from IQVIA.
Copay accumulator programs do not allow pharmaceutical company coupons and copay assistance to count toward annual deductibles, while maximizers classify a subset of specialty medications as “non-essential,” which removes Affordable Care Act’s requirements related to maximum out-of-pocket limits. These programs maximize patients’ use of manufacturers’ copay assistance programs to limit the PBMs’ exposure to specialty drug costs.
Specialty medicines represent a growing part of drug spend, they are expected to be about 43% of global spending in 2027 and 56% of total spending in developed markets, according to the recently released report Global Use of Medicines 2023 from IQVIA.
In the report on accumulators and maximizers, IQVIA found that from 2019 to 2022, the prevalence of accumulator programs doubled to 14% for autoimmune therapies and 20% for oncology products. Accumulator prevalence in multiple sclerosis increased more slowly for the one product IQVIA analyzed (17% to 20%). 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%. Among oncology patients, maximizer prevalence more than doubled from 5% to 13%.
The programs, however, are not without controversy. Critics say these accumulator and maximizer programs expose patients to potentially higher costs if they exhaust their manufacturer benefit before reaching their deductibles or out-of-pocket maximums. Patient advocacy groups say they prevent people from accessing the care patients need.
Patient advocacy groups, and even the pharmaceutical industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), have filed lawsuits to stop these programs. In 2021, PhRMA filed a complaint in the U.S. District Court for the District of Columbia, saying that the Medicaid Accumulator Rule — which treats manufacturer assistance to patients as if it were a discount — contradicts the Medicaid rebate statute.
More recently, in November 2022, the Pharmaceutical Coalition for Patient Access (PCPA) filed suit in the United States District Court for the Eastern District of Virginia seeking declaratory judgment relief against the Health and Human Services (HHS) challenging the 2020 Final Rule permitting co-pay accumulator adjustment programs.
Additionally, as of spring 2022, 15 states and Puerto Rico issued new laws addressing the use of copay programs, requiring that these be applied to annual out-of-pocket cost-sharing requirement, according to the National Conference on State Legislatures. Avalere consultants predict that by 2024, state bans on copay accumulators will affect about 13% of U.S. commercial lives — or 18.8 million individuals.
The largest PBMs — CVS Caremark, Optum Specialty/UnitedHealthcare and Express Scripts — all have such programs in place. Express Scripts has said in the past that copay coupons undermine a sponsors cost-control programs, and accumulator programs level the playing field. A spokesperson for Optum Rx said its accumulator program was introduced nearly five years ago, but wouldn’t say why such a program was implemented. CVS Caremark and Express Scripts did not respond to requests from Formulary Watch for comment.