New Hepatitis C Drug: Epclusa
Posted: Jul 15 2016
On June 28, 2016 the U.S. Food and Drug Administration (FDA) approved yet another agent for the treatment of Chronic Hepatitis C (CHC) infection.  Epclusa is the newest CHC medication product to enter the prescription drug marketplace.  In addition to its competitive price tag, Epclusa’s clinical characteristics will position the product to have a substantial impact to both MedTrakRx members and  plan sponsors. 

Epclusa is manufactured by Gilead, making it the third product in the company's CHC product portfolio; also including Sovaldi® and Harvoni®. Epclusa is indicated for the treatment for adult patients with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection. The two active ingredients in Epclusa are sofobuvir and velpatasvir; sofosbuvir is an established active ingredient within Gilead's other CHC products, Sovaldi and Harvoni, while velpatasvir is a novel active ingredient. Epclusa was launched earlier this month and is currently available for dispensing from pharmacies. 

Epclusa is the first CHC medication that is effective in treating all six of the known viral genotypes.  Currently available CHC medications are only effective in treating select genotypes.. The efficacy of Epclusa is comparable or superior to currently available Hepatitis C medication therapies, with cure rates demonstrated to be 95% or higher in clinical trials.

Epclusa is a once daily oral tablet given for a duration of 12 weeks for all genotypes, which is an advantage over current CHC products. Overall, Epclusa is considered to be a safe and well-tolerated medication, and its safety profile is very similar to currently available oral CHC therapies.

The price of Epclusa for the standardized 12-week treatment regimen is $89,700 (AWP). This price point demonstrates a definite financial advantage over existing products, even under the most conservative assumptions.

MedTrakRx is currently assessing the impact of this medication to all affected programs and processes in order to better meet the needs of our members.

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