Friday, February 20, 2015 10:56:04 AM
((EU DAA pricing looking pretty good so far))
http://www.biocentury.com/dailynews/company/2015-02-19/gilead-agrees-to-sovaldi-price-cuts-in-germany?utm_source=Twitter&utm_campaign=auto_social&utm_medium=web
Published on Thursday, February 19, 2015
Germany's statutory health insurer GKV-Spitzenverband said Gilead Sciences Inc. (NASDAQ:GILD) will offer a 12-week course of Sovaldi sofosbuvir for EUR 43,562 ($49,213), an 11% discount from its German list price of EUR 49,000 ($66,135) and a 44% discount from the regimen's wholesale acquisition price of $84,000 in the U.S. The discount will be retroactive to Jan. 23 and will last for three years (see BioCentury Extra, Feb. 4, 2014).
The discount is in line with what Gilead has said it expects for its HCV drugs in the U.S. this year. During its earnings call earlier this month, Gilead said it expected an adjusted gross to net of 46% in the U.S. for its HCV drugs Sovaldi and Harvoni ledipasvir/sofosbuvir. Last year, the company came to a similar agreement with France's Economic Committee of Health Products, pricing Sovaldi at EUR 41,000 ($51,058) for a 12-week course (see BioCentury Extra, Feb. 4).
At the Bio CEO and Investor conference last week, Gilead President and COO John Milligan said the European market will be a larger part of the Sovaldi business in 2015 compared to 2014, and that the discounts for Sovaldi in France are dependent on the volume of patients treated.
In the U.S., Gilead and AbbVie Inc. (NYSE:ABBV) have been agreeing to rebates with pharmacy benefits managers and payers for their respective HCV regimens in exchange for exclusive or semi-exclusive formulary status. A similar scenario has yet to unfold in Europe where AbbVie's Viekirax plus Exviera was approved last month (see BioCentury, Jan. 19).
AbbVie said the benefit assessment process for Viekirax plus Exviera has already begun in Germany and will take six months, after which pricing negotiations will begin. The U.K.'s NICE has set April 1 as the first committee meeting to discuss a technology appraisal for Viekirax plus Exviera, which is marketed as Viekira Pak in the U.S. Based on its latest 10-K filing, Germany is AbbVie's second largest commercial market. Gilead does not provide a similar breakdown of its commercial markets. Gilead did not respond to BioCentury's request for comments or the status of pricing negotiations for Harvoni in Germany. Harvoni was approved in Europe last November. NICE had its first appraisal meeting for Harvoni on Feb. 3 and has set June 2015 as the "anticipated publication" date for the technology assessment.
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