Access to specialty drugs is significantly reduced when insurers require patients to share the high costs of these drugs. Specialty drugs are often the only chance for patients with cancer to achieve long-term survival.1,2

“High out-of-pocket costs for specialty drugs appear to pose a very real barrier to treatment,” said Jalpa A. Doshi, PhD, an associate professor of medicine in the Perelman School of Medicine at the University of Pennsylvania, Philadelphia.

The term specialty drugs refers to medications requiring special handling, administration, or monitoring. Many are large-molecule biologics such as monoclonal antibodies, and most are aimed at treating chronic or life-threatening diseases, including cancer. Although specialty drugs tend to offer significant medical advances over nonspecialty drugs, they are correspondingly more expensive. In 2014, such drugs accounted for less than 1% of prescriptions in the United States, but nearly one-third of total prescription spending.

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In their efforts to manage spending on specialty drugs, insurers have been imposing higher cost-sharing requirements.

This research team performed 2 analyses. The first was a review of published analyses of specialty drug cost-sharing, including drugs for cancer.1

“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,” said Doshi.

The study found that cost-sharing had less effect on the patients’ use of cancer specialty drug than on their use of drugs for rheumatoid arthritis.

“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,” said Doshi.

The second study examined the impact of high cost sharing for specialty drugs under the Medicare Part D prescription drug benefit on patients with chronic myeloid leukemia (CML).2 A class of oral specialty drugs, tyrosine kinase inhibitors (TKIs), has revolutionized the treatment of CML, largely transforming it into a chronic condition and enabling many patients to have a near-normal lifespan, particularly compared with a median survival of less than 3 years with prior therapies. This study was published in a supplement sponsored by the Patient Access Network (PAN) Foundation.

The researchers analyzed Medicare data on patients with newly diagnosed CML and compared patients with low-income subsidies and nominal out-of-pocket costs to patients with average out-of-pocket costs of $2600 or more for their first 30-day TKI prescription.

Patients in the high-cost group were significantly less likely (45.3% vs. 66.9%) to have a Part D claim for a TKI prescription within 6 months of their CML diagnosis, compared to the subsidized, low cost-sharing group. Those in the high cost-sharing group also took twice as long, on average, 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,” said Doshi, adding that making Part D out-of-pocket costs more consistent, and limiting them to more reasonable sums would help mitigate this negative impact. “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.”

“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.


1. Doshi JA, Li P, Ladage VP, et al. Impact of cost sharing on specialty drug utilization and outcomes: a review of the evidence and future directions. Am J Manag Care. 2016;22(3):188-197.

2. Doshi JA, Li P, Huo H, et al. High cost sharing and specialty drug initiation under Medicare Part D: a case study in patients with newly diagnosed chronic myeloid leukemia. Am J Manag Care. 2016;22(suppl4):S78-S86.