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The use of tracking systems -- such as copay accumulators and copay maximizers -- to scrutinize patients' use of drug manufacturer copay assistance programs is causing controversy inside and outside of the federal government, as well as concerns among physicians and patients.

"These programs harm patients by discouraging the appropriate utilization of specialty therapies and reducing adherence to recommended treatment," the American Society of Clinical Oncology said in an email to 麻豆传媒. Several studies have found that "patients under such programs -- particularly for autoimmune and cancer drugs -- had significantly lower monthly prescription fill rates, further exacerbating non-persistence for, non-adherence to, and discontinuation of prescribed treatment."

Insurers and pharmacy benefit managers (PBMs) are notified when their patients use copay coupons, and many of them use the data to compile "copay accumulator" records for enrollees. Often, insurers won't allow the money paid by drugmakers to count toward a patient's deductible or out-of-pocket costs. A "copay maximizer" spreads the copay assistance out over the year, allowing patients to receive the drug at little or no cost to them for a longer period of time. However, the assistance is still not applied to the patient's deductible.

Copay assistance programs are vitally important to patients with chronic illnesses, Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in a phone interview. For example, "HIV drugs and hepatitis drugs are costly and usually on specialty [formulary] tiers ... and more and more people are in high-deductible plans," he said. "Anyone who relies on prescription drugs, particularly for chronic conditions, relies on copay assistance. It was $12 billion last year."

Is a copay maximizer better for patients than a copay accumulator? "You know, it's sort of like asking, 'Would you rather jump in a zero-degree pool or a boiling pot of water?'" said Madelaine Feldman, MD, president of the Coalition of State Rheumatology Organizations. "Both of them are bad ... because it should count towards their deductible. Yes, it's better for the patient to have a maximizer because then they don't lose access to the drugs, and it's definitely better public relations for the PBM or insurance company or whatever sort of company that they contracted with to handle the copay card, but still, none of this still goes towards the deductible."

Feldman said she could understand the use of accumulators in which a lower-cost alternative is available -- for example, a case in which a drugmaker takes two non-prescription drugs that both cost very little at the pharmacy and combines them into a prescription pill that costs several thousand dollars. "That's a situation where the copay card is to entice someone to take an expensive drug that you can go and buy at Walgreens without a prescription, and that's bad," she said.

Asked to comment on the issue, the Pharmaceutical Care Management Association, which represents PBMs, focused on that latter issue.

"Drug manufacturers offer coupons to insured patients, regardless of their incomes, to induce patients to take a more expensive brand drug instead of a less costly generic or equally effective, less expensive, alternative with lower cost-sharing," the association said in a statement. "Manufacturers use coupon programs, which are banned in Medicare, to retain or increase market share for their brand-name drugs once more affordable generics come to market. Copay coupons undercut prescription drug formularies and lead to unnecessary spending on more expensive brand-name drugs."

Recently, copay maximizers have become more popular, according to Kate Sikora, associate principal at Avalere, a healthcare consulting firm in Washington. Although accumulators have been popular with insurers and PBMs since 2016, "maximizers are taking over the system because there's little impact to patients."

States have taken an interest in the issue, with 15 of them passing laws banning the use of copay accumulators, Sikora said; some contain exceptions for cases in which the patient is choosing a brand-name drug even when a much cheaper generic version is available. Mark Gooding, principal at Avalere, said he'll be following the growth in state regulation in this area. "If we see continued growth in states implementing these bans, will that drive interest at the federal level to increase federal regulations?" he wondered.

Some federal action is already taking place. A rule scheduled to go into effect in January 2023 would require that manufacturers who sell prescription drugs to Medicaid patients ensure that health plans and PBMs include coupons and other copay assistance as part of patients' deductibles and out-of-pocket costs; drugmakers who don't will face stiff financial penalties. Pharmaceutical companies who participate in the Medicaid program are required to provide their products at the "best price" they give to other customers, including commercial health insurers; manufacturers who don't comply with the copay assistance rule would have to subtract the copay assistance from their "best price" calculation.

In May 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA), a lobbying group for drugmakers, over this rule. "By treating assistance given to patients as part of the "price" manufacturers provide to health insurers, the Accumulator Rule contradicts the Medicaid rebate statute," PhRMA said in a . "It violates the letter of the law by stretching the meaning of the word 'price' beyond all commonsense recognition. And it violates the spirit of the law by essentially taxing manufacturers for providing assistance to patients."

On Tuesday, the U.S. District Court for the District of Columbia and set aside the regulation. "A manufacturer's financial assistance to a patient does not qualify as a price made available from a manufacturer to a best-price-eligible purchaser," Judge Carl Nichols wrote. "Rather, a manufacturer's financial assistance is available from the manufacturer to the patient. And a patient is not a best-price-eligible purchaser."

The copay programs are also causing issues on the commercial insurance side. In May, drugmaker Johnson & Johnson sued SaveOnSP, a company that says it helps "plan sponsors and their participants manage the skyrocketing costs of specialty pharmaceutical drugs." Johnson & Johnson alleged that SaveOnSP has caused the company "to pay at least $100 million more in copay assistance than it otherwise would have." The suit is ongoing.

Gooding urged providers to keep an eye on the issue. "There is likely to be some disruption in how these copay programs are implemented, partly because of the risks that these programs represent to the manufacturers," he said. "So be mindful of any potential changes that may be implemented in the coming months, and be aware of any potential policy or regulatory changes that may limit the extent to which these accumulators and maximizers are implemented or allowed to be implemented at all."

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