Potentially more impactful, policies are being investigated to ease the cost burden on patients. One option includes a new regulation that would allow Medicare beneficiaries to request a tiering exception for any drug included in the specialty tier within a Part D plan formulary.9  This exception is currently allowed for all drugs not placed on a specialty tier. Bills that use various approaches to reduce or cap out-of-pocket amounts for patients have also been introduced.10 Additionally, pharmaceutical companies are currently prohibited from directly providing copayment assistance for Medicare Part D beneficiaries. There are currently no exceptions to this rule, even for patients in serious need of assistance from drug manufacturers in order to gain access to these medications. However, pharmaceutical  manufacturers can donate to charity organizations through Patient Assistance Programs, which can provide some relief.


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The impact of the out-of-pocket expense of oral oncolytics on patient behavior has recently been documented. In 2011, a study including 1,737 Medicare beneficiaries and 8,771 commercially insured patients showed that 25% of patients prescribed an oral oncolytic with an out-of-pocket expense exceeding $500 had abandoned therapy on the initial claim vs. 6.4% with an out-of-pocket cost of $100 or less. This study also showed higher abandonment rates were directly linked to patients who had more prescriptions to fill, lower incomes, and those with Medicare coverage.11

Since many patients requiring innovative medicines, such as those on the specialty tiers, are being treated for rare, serious, and often life-threatening diseases, more should be done to eliminate the seemingly discriminatory nature of broadly applying high cost-sharing measures that do little to consider the seriousness of the condition. We know that many of the newer targeted therapies in cancer can be very effective. We also know that effective treatments require more expensive medical resources. It is therefore important that policymakers, as well as both public and private insurers, consider the negative impact that high cost-sharing is having on patient access, adherence, and thereby patient outcomes. 


1. Medicines in Development. PhRMA. http://www.phrma.org/research/new-medicines. Accessed January 4, 2013.

2. New Study Finds that 10% of Cancer Patients Abandoned Oral Anti-Cancer Drugs [news release]. Washington, DC: Avalere; May 18, 2011. http://www.avalerehealth.net/wm/show.php?c=&id=881. Accessed January 4, 2013.

3. Navarro RP, Hailey R. Chapter 2: Overview of Prescription Drug Benefits in Managed Care. Jones and Bartlett Publishers, LLC.