Keeping an Eye on Hepatitis C Virus Drug Approvals

On January 29, 2014, the American Association for the Study of Liver Diseases (AASLD) released treatment guidance for use of the new agents. Somewhat surprisingly, it endorsed the concomitant use of Sovaldi and Olysio for patients intolerant to interferon. Practically overnight, payers reversed their existing prohibitions and those writing new policies were not so eager to implement utilization management counter to the AASLD’s recommendation (Table 3).

As new drugs enter the market in the next 6 to 12 months, the AASLD will continue to update its treatment recommendations. A recent, quick pulse check of payers (n = 21) that participated in our original research indicates that plans intend to follow along (Online Table 5). Analogies to the role the National Comprehensive Cancer Network’s guidelines play in influencing payer management of oncology come to mind. But unlike oncology’s situation, the new direct-acting antiviral agents to treat HCV promise a cure. And unlike the majority of oncology subtypes, the market will soon see multiple, directly competitive therapeutic options.

{Click image to enlarge}

Table 5: Policy Alignment with Future AASLD Guideline Updates

By the time 3 of these new options receive approval, payers expect contracting for preferential treatment to evolve in the market. More specifically, payers believe it’s more likely than not that contracting will evolve at the genotype level, allowing them the option to circumscribe utilization tightly while limiting their contractual exposure with manufacturers (Online Figure 6). Of course, stakeholders’ ability to contract will rest on the breadth of treatment options endorsed by the AASLD, or, conversely, payers’ willingness to define best practices more narrowly. Finally, manufacturers will have to want to participate as well.

{Click image to enlarge}

Perhaps surprisingly, specialists are on board with (or maybe resigned to) preferential contracting as a determinant of access. Of specialists surveyed in January, 73% were okay with payer/manufacturer contracting as long as 3 options were on the market, and a majority (53%) were satisfied with 2 choices (Table 7).

Doctors are more critical, however, of some common criteria within payers’ prior authorization policies. Specialists indicated that reauthorization timelines within the recommended treatment duration or liver biopsy requirements would be most burdensome to them (Table 8). Recent analysis of PA documents shows both have already found their way into Olysio and Sovaldi policies.

Related Articles

Top news of the day from across the health care landscape.
Top news of the day from across the health care landscape.
An analysis of a quality improvement project at an oncology specialty pharmacy showed that pharmacist interventions can reduce financial toxicity for patients.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.