Gilead's Sovaldi shows 'indication of added benefit for specific patients,' says IQWiG

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether US biotech firm Gilead Sciences’ (Nasdaq: GILD) new controversially high-prices hepatitis C drug Sovaldi (sofosbuvir) offers added benefit in comparison with the appropriate comparator therapy.

The dossier submitted by the drug’s manufacturer provides indications of added benefit for non-pretreated patients infected with the virus of genotype 2. However, the extent cannot be quantified. There were no suitable data in the dossier for patients who are infected with other virus types (genotype 1 and 3 to 6) or who are co-infected with HIV, says the IQWiG.

Sofosbuvir has been available since January 2014 as a treatment for chronic hepatitis C infection. The German government will rely on the recommendation to decide whether to approve the 49,000 euros ($68,000) for a 12-week course that Gilead has put on Sovaldi (sofosbuvir) there. The drug is prices at $84,000 for a 12-week course, in the USA, and has already generated sales of $2.3 billion for Gilead in the first quarter of 2014 (The Pharma Letter April 23).