Specialty drugs are typically high-cost prescription drugs used to treat complex chronic and/or life threatening conditions. Many do not have substitutes available at lower costs. Over the last decade, the Medicare Part D benefit has imposed high out-of-pocket costs as a way to control costs of specialty drugs. This is causing many patients not to fill prescriptions. Some patients may be adding costs to the system by getting drugs more expensively by injection in doctors’ offices, where they are covered by Medicare supplemental insurance.
Prescription drug plans maintain lists of drugs, called formularies, which define their benefits in terms of which drugs are covered by the plan. Over the years, formularies have become tiered, making patients liable for higher out-of-pocket costs for medicines placed on higher tiers.
Most prescription drugs plans offered under Medicare Part D have five tiers, according to research by Jack Hoadley and colleagues at the Kaiser Family Foundation. The fifth tier consists of specialty drugs, which Medicare defines as drugs that cost at least $600 per month.
These drugs are subject to very high coinsurance of up to 33 percent under Part D’s initial coverage period. This year, after having spent $2,960 on drugs, a Medicare patient who does not qualify for low-income subsidies hits the coverage gap (or “doughnut hole”). In the doughnut hole, the patient pays 45 percent of the drug cost. Eventually, the patient’s out-of-pocket liability declines to five percent after the patient. This benefit design is reducing access to medicines used by very sick patients, according to research conducted by Professor Jalpa A. Doshi, of the Perelman School of Medicine at the University of Pennsylvania, and colleagues (and presented at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research in May).
Doshi and colleagues examined the relationship between out-of-pocket costs and initiation of treatment among Medicare Part D beneficiaries newly diagnosed with leukemia in 2011 through 2013. These cancer patients were prescribed tyrosine kinase inhibitors (such as Gleevec®). Although in clinical use for just a decade and a half, these drugs have transformed leukemia from a death sentence to a chronic condition for many patients.
The average out-of-pocket cost for a 30-day supply was $2,600 or higher for Medicare Part D beneficiaries who did not receive low-income subsidies. This caused many of these patients not to fill their prescriptions. Low-income patients got extra help with their costs, resulting in out-of-pocket payments of just $5 or less. Only 21 percent of the patients with potentially high out-of-pocket costs had initiated treatment within one month of their diagnosis, versus 53 percent of patients with nominal out-of-pocket costs. And this remained a problem in subsequent months. Within three months, the proportions were 36 percent versus 65 percent. At six months, they were 45 percent versus 67 percent. The patients with potentially high out-of-pocket costs may have struggled to pay the high coinsurance for their medicine and hence may have delayed or abandoned filling their prescriptions.
Doshi and colleagues found similar results for Medicare beneficiaries with rheumatoid arthritis, from 2007 through 2009. Although the study design was different, the difference in outcomes between non-poor and low-income patients was similar. During the initial coverage period at the start of a new plan year, the non-poor paid (on average) $484 for a 30-day supply of biologic medicines, while low-income patients paid only $5. Only 61 percent of the non-poor filled their prescriptions, versus 73 percent of the low-income patients. Even among those who filled their prescriptions, non-poor patients were more likely to have interruptions in their biologic treatments than the low-income patients.
This problem has arisen fairly recently. Doshi and colleagues have reviewed evidence from 2009 and earlier, finding most studies had examined privately insured patients many of whom faced monthly copayments of $30 or less for specialty drugs. However, there is evidence the private market is moving in the same direction as Medicare has.
The current Medicare policy on specialty drugs does not appear to have countervailing benefits.
First, Medicare part D prescription drug plans do not bear financial risk if patients have more frequent visits to doctors or hospitalizations because they do not take their medicines. In their study of patients with rheumatoid arthritis, Doshi and colleagues found the non-poor were twice as likely as low-income patients to have a biologic medicine administered in a doctor’s office.
Second, this approach is not contain costs of specialty drugs. According to Express Scripts, prices of specialty drugs increased 11 percent in 2015, while utilization increased 6.8 percent. According to IMS Health spending on specialty drugs increased 22 percent last year. Premiums for Medicare Part D prescription drug plans increased 13 percent this year. There has got to be a better way.
(A version of this column was published by Forbes.)