Keeping an Eye on Hepatitis C Virus Drug Approvals

With the recent approval of new hepatitis C treatments, payers are increasingly concerned with controlling costs in this category through policies that may affect treatment decisions.


Given the recent evolution of hepatitis C virus (HCV) treatment, starting with the 2011 introduction of Incivek and Victrelis and continuing with the late 2013 approval of Olysio and Sovaldi, it’s no surprise that payers now consider the HCV category nearly as important a management priority as cancer, rheumatoid arthritis (RA), or multiple sclerosis (MS) (Online Table 1). These are all high-spend disease states, and have become more so recently. They are all recipients of recent approvals with novel mechanisms of action, oral routes of administration, and improved clinical outcomes. In each category, payers have more to think about with greater financial consequences riding on each treatment decision.

Table 1: Payer Specialty Category Priorities Percentile Ranking: Trend


But just because payers prioritize the management of therapeutic categories for similar reasons doesn’t mean they’ll end up managing them similarly. Access restrictions in cancer look nothing like those in RA. Patients with HIV do not face the same hurdles as patients with MS. Utilization management is not a unilateral pursuit. It’s an ongoing negotiation among payers, doctors, specialty pharmacies, and manufacturers that takes place within limits set by the FDA label and best clinical practices.

As researchers at Zitter, we wanted to find out how these parties would react to the expected steady, almost rhythmic approval of hepatitis C agents expected between 2014 and 2018. In January of this year, we began by surveying 100 payer representatives about their attitudes and management expectations for the category. We also surveyed 150 specialist physicians and 50 primary care doctors to gather their attitudes and reactions to the new entrants and payer decisions. Finally, we conducted interviews with a handful of practice managers at infectious disease and gastroenterology practices to get the story behind how payer policies impact treatment decisions and day-to-day operations.

To start, we were surprised at the speed with which payers developed their formal, final policies for Olysio and Sovaldi, approved within 2 weeks of each other between November and December of 2013. By the end of January 2014, 36% of plans already had written policies. By the end of July 2014, another 32% expected to be finished (Online Table 2). Surprisingly, the rate of policy adoption has been even faster. Our analysis of prior authorization (PA) policies from commercial plans covering 190 million lives shows 75% of plans developed Sovaldi policies within 6 months of launch and 80% created documents for Olysio. In contrast, at 6 months after launch only 48% had policies in place for Xeljanz. Payers were likely in a hurry because they expected patients who deferred treatment to arrive, en masse, at the beginning of the 2014 plan year. Recently, UnitedHealth Group announced it spent “multiple” times what it had expected in Q1 to cover Sovaldi.

Table 2: New Drug Review Timing: Sovaldi


Some portion of that spend is attributable to the combination use of Sovaldi with Olysio. Taken together, the drugs obviate the need for treatment with interferon. However, neither is FDA approved for use with the other (although Janssen, the manufacturer of Olysio, recently applied). Early analysis of PA policies and a survey of payers without extant policies at the time revealed a focus on preventing this particular off-label use. Forty-four percent of payers (representing 35% of covered lives) explicitly forbade combination use of Olysio and Sovaldi (Table 3). Among payers that had not yet written a formal policy, fully three-fourths thought there was no likelihood at all or that it was more unlikely than likely that their organization would cover the 2 together (Table 4). In the end, this is not how coverage played out at all.

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