Many Medicare beneficiaries without low-income subsidies do not fill high-price specialty drug prescriptions, new research shows.
For the four conditions studied — cancer, hepatitis C, immune system disorders, and hypercholesterolemia — researchers found that noninitiation “was nearly twice as frequent among those without subsidies.” For beneficiaries with cancer who did not have subsidies, almost 30% of initial prescriptions for specialty oncology drugs went unfilled.
The reason: These drugs can cost 100 times more for patients who don’t receive a subsidy.
“The out-of-pocket expenses for an initial fill of a high-price drug is typically hundreds or thousands of dollars for an enrollee without a low-income subsidy versus less than $10 for a beneficiary with a full low-income subsidy,” Stacie Dusetzina, PhD, Vanderbilt University Medical Center, Nashville, Tennessee, and colleagues say.
The study was published online in the April issue of Health Affairs.
Failing to initiate treatment occurs often; it is estimated that more than 20% of all prescribed medications go unfilled. However, studies that evaluate noninitiation of newly prescribed, high-priced drugs are rare and are limited in scope.
Dusetzina and colleagues sought to understand barriers to noninitiation of high-price specialty drugs covered under Medicare Part D in four disease areas, known for particularly costly medications — cancer, hepatitis C, immune system disorders, and hypercholesterolemia.
In each disease category, investigators identified expensive specialty drugs prescribed to patients aged 65 years and older. The main variable was noninitiation, or failure to fill a new prescription, within 90 days of the order date.
Across 11 healthcare systems that contributed data, 17,076 new prescriptions were issued between 2012 and 2018. Of these, nearly 8800 were for 6990 patients with cancer, 1368 for 1210 patients with hepatitis C, almost 5300 for 4275 people with immune system conditions, and 1628 hypercholesterolemia prescriptions for 1364 patients. Among those with cancer, 11% had either full or partial Part D subsidies, and 89% had no low-income subsidy.
The researchers found that, on average, almost 40% of prescriptions went unfilled, though noninitiation varied by condition. Noninitiation rates were close to 28% for cancer drugs, 21% for hepatitis C drugs, 54% for immune system agents, and almost 67% for hypercholesterolemia medications.
Compared to Medicare beneficiaries who had full or partial subsidies, those with no subsidy were 37% less likely to fill their prescription overall (adjusted relative risk [aRR], 0.63). For cancer drugs, patients with no subsidy were 35% less likely to fill their prescription than those with a subsidy (aRR, 0.65).
The reason for noninitiation is clear. Under the 2021 standard benefit Part D Plan Finder, a single fill for the cancer drug lenalidomide (Revlimid) would cost a patient over $3000 without a low-income subsidy, compared to $10 out of pocket with a full subsidy.
“Our findings indicate that noninitiation of high-price specialty drugs covered under Medicare Part D is frequent and concerning,” Dusetzina and colleagues write.
To reduce the cost burden associated with specialty drugs, the US Senate passed legislation in November 2021 that proposed a redesign of the Part D benefit, in which an annual cap of $2000 would be placed on out-of-pocket spending. Combining this annual cap with a monthly cap on out-of-pocket payments could help ensure that beneficiaries do not forgo or delay prescribed care because of out-of-pocket liability.
“Our findings support current legislative efforts to increase the accessibility of high-price medications by reducing out-of-pocket expenses under Medicare Part D, particularly for beneficiaries without low-income subsidies,” the authors write. “Such legislation would substantially improve affordability and could reduce noninitiation of specialty drugs among beneficiaries without low-income subsidies.”
The authors acknowledge that the clinical implications of noninitiation of high-price specialty drugs remain unclear, but given the high rates of noninitiation revealed in the study and the severity of illnesses examined, “it is likely that some patients were harmed by medication noninitiation,” they conclude.
Health Aff. Published online April 2022. Abstract