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New diagnostic tests help physicians predict HCV drug resistance


Hep C virus testing supports value of diagnostics in precision medicine.

Quest Diagnostics recently expanded its chronic hepatitis C virus (HCV) test services to include new capabilities to help physicians identify or predict resistance to several HCV therapies.

Related: Predictions for the future of high-cost specialty drugs

These therapies include the recently FDA-approved Zepatier (Merck) and Daklinza (Bristol-Myers Squibb).

This will help enhance the ability of physicians to determine the type, dose or duration of treatment with direct acting antiviral agents (DAAs) therapies that inhibit the NS5A protein, which influences hepatitis C viral replication.

The use of diagnostic testing to guide clinicians to the most appropriate medication is an advance toward more personalized care, according to Mark Ginestro, a principal at KPMG Strategy who works with life sciences companies.


“We are starting to see that more drugs are being paired with companion diagnostics because they help focus the therapy on the right patients and also provide the manufacturer with a greater likelihood of approval and a more focused, less-costly trial,” Ginestro tells Managed Healthcare Executive. “The use of diagnostics in hepatitis C will allow the clinician to determine if the patient has more options on which drugs can be used.” 

By using these diagnostics, payers will likely seek to create more price competition in populations where more options are applicable.

“Regardless of the use of these diagnostics, all the recently launched hepatitis C drugs are still expensive on a one-time basis,” Ginestro says. “However, given the 90+% curative rates, the high costs are still justified.”

Ginestro points out that it is important to note that the public references of significant price differences between the marketed HCV products are almost always comparing list prices. “List prices are rarely the ultimate price,” he explains. “Therefore, much of the public discussion of price comparison between the HCV products is not soundly based. While the drugs in the hepatitis C category are expensive and the prices generate a lot of headlines, it’s important not to overlook the value being delivered in terms of lower long-term overall treatment costs for millions of people carrying the virus.” 

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