High Cost Not the Only Barrier to Patient Access to HCV Drugs

New drug treatments for the hepatitis C virus (HCV), such as those containing sofosbuvir (SOF) or simeprevir (SIM), are more effective, but they are more expensive than traditional HCV therapies. Nearly all state Medicaid programs require prior authorization (PA) in order to manage access to these newer, expensive drugs and ensure that patients who can benefit most from them have priority for these drugs. However, Massachusetts Medicaid (MassHealth) is unusual in that it has relatively few restrictions on HCV medications and does not limit access based on disease severity or the presence of a substance use disorder (SUD).

A new retrospective study in Journal of Managed Care & Specialty Pharmacy by Karen Clements, ScD, MPH, from the University of Massachusetts Medical School at Shrewsbury, and colleagues evaluated PA requests for treatment with SOF- and SIM-based treatments among MassHealth members with HCV from December 2012 to July 2014. They identified demographic, clinical, and provider-level characteristics associated with treatment requests in order to see what kind of drug-use patterns existed among Medicaid members, and to identify which patients might face barriers to treatment at the provider or patient level. The study is the first population-based analysis of the percentage and characteristics of Medicaid members requesting treatment with SOF- and SIM-based regimens during the first 8 months of the drugs’ availability.

The study found that even though there were few restrictions placed on MassHealth members’ access to SOF- or SIM-containing medications via the PA process, the percentage of patients making a treatment request for these medications was low. After adjusting for clinical and demographic variables, researchers found that HCV patients who did make PA requests for SOF and SIM drugs were more likely to be male, older, white, have standard MassHealth insurance, and were less likely to be homeless. Members with a PA request were also more likely to have been treated for HCV in the past year and have advanced disease, but were less likely to have SUD.

“This low number likely reflects patient-level barriers to care and provider decision,” the authors noted. Members with SUD had only about two-thirds the odds of having a PA request for SOF- and SIM-containing regimens submitted, compared with members without SUD.

The researchers hypothesize that MassHealth members with SUD have low levels of preventive care and are thus less likely to have had a discussion with their primary care providers during the study period that resulted in a PA request or a referral to a specialist for assessment. Healthcare providers may also be reluctant to prescribe treatment to patients with SUD because of concerns about adherence or reinfection.

It remains to be seen whether these patterns will continue as patients and providers gain more experience with the new medications for HCV, the authors say.

“To reduce future health care costs and premature mortality associated with HCV, the number of patients receiving these potentially curative antiviral treatments must be increased,” they wrote.

The barriers to treatment access shown in this study will have to be addressed in order to achieve this goal.