Specialty Drug Access Limited by High Out-of-Pocket Costs

Growing out-of-pockets costs associated with reduced utilization of specialty medications.

Recent research has found an association between high out-of-pocket costs for specialty drugs and a significant reduction in drug access.

“High out-of-pocket costs for specialty drugs appear to pose a very real barrier to treatment,” said researcher Jalpa A. Doshi, PhD.

In the first study, evidence was provided of the correlation between cost sharing and decreased use of specialty drugs. The second study found that Medicare Part D co-insurance policies reduced or delayed the use of a lifesaving class of leukemia therapies.

Specialty drugs have shown significant medical advances compared with non-specialty drugs, but they come with an expensive price tag.

In 2014, specialty medications accounted for less than 1% of prescriptions in the United States and nearly one-third of total prescription spending.

Limited research has been available on how insurers who impose higher cost-sharing requirements impact patients.

During the first study, researchers reviewed analyses of specialty drug cost sharing. In particular, researchers wanted to examine cancer, multiple sclerosis, and rheumatoid arthritis, which account for the greatest amount of specialty drug spending.

“Although almost all the prior studies we reviewed were for privately insured patients from a time when cost-sharing levels were much lower than they are today, these studies still commonly found evidence that high out-of-pockets costs were associated with reductions in utilization of these drugs,” Doshi said.

Researchers believe this lower reduction compared with non-specialty drugs may be attributable to specialty drugs typically not having any medically comparable alternatives.

“As a follow-up, it was particularly important to examine the extent to which the aggressive cost-sharing policies for specialty drugs seen under Medicare Part D, which are increasingly making their way into the private insurance market, adversely impact access to these treatments even for a condition like cancer,” Doshi said.

During the second study, published in the American Journal of Managed Care, the impact of high specialty drug cost sharing under Part D in patients with chronic myeloid leukemia (CML) were examined.

Currently, a class of oral specialty drugs called tyrosine kinase inhibitors (TKIs) have transformed CML into a chronic condition, giving patients an almost normal lifespan.

During the study, researchers looked at Medicare data of newly diagnosed CML patients to figure out how soon individuals started TKI treatment.

Patients with low-income subsides and nominal out-of-pocket costs were compared against those with average out-of-pocket costs of $2600 or more for the first 30 day TKI prescription.

The results of the study showed that patients in the high-cost group were significantly less likely to have a Part D claim for a TKI prescription within 6 months of their diagnosis compared with the low cost-sharing group (45.3% and 66.9%, respectively).

Furthermore, the high cost-sharing group took twice as long to initiate TKI treatment.

“Medicare Part D was created to increase access to prescription drug treatment among beneficiaries, but our data suggest that current policies are interfering with that goal when it comes to specialty drugs,” Doshi said. “Policymakers should also consider more clinically nuanced cost-sharing policies that take medication value into account, rather than subjecting all specialty drugs to high cost sharing.”

Additional studies to determine the impact of Part D cost-sharing policies in different disease areas are being pursued. Researchers hope they can gain a better understanding of changes in access to drugs and the long range clinical outcomes and costs associated with delays or treatment interruptions.

“We need to know if the current aggressive cost-sharing arrangements have adverse long-term impacts on health, and perhaps paradoxically increase overall spending due to complications of poorly controlled disease,” Doshi said.