The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed documents subsequently submitted by the drug manufacturer in the commenting procedure on the dossier assessment of the fixed-dose drug combination of ledipasvir and sofosbuvir (trade name: Harvoni). According to the findings, a hint of a non-quantifiable added benefit for a further patient group can be derived from this additional information.
This patient group consists of treatment-naive or pretreated patients with hepatitis C virus (HCV) infection of genotype 1 who are also infected with HIV, but have not yet developed cirrhosis of the liver. For genotype 1 patients (without cirrhosis) who have no HIV coinfection, IQWiG had already determined an added benefit in the dossier assessment.
Results are transferable
In the commenting procedure, the pharmaceutical company had submitted further documents on a total of five studies to the G-BA. In comparison with the dossier assessment, this additional information changed the result for one of the seven patient groups differentiated by the G-BA: It shows that the results on the outcome "sustained virologic response" (SVR) for patients without HIV coinfection are transferable to patients with HIV coinfection. However, this only applies if these patients have not yet developed cirrhosis of the liver. For patients with cirrhosis of the liver, sufficient and evaluable data are still not available.
Extent of added benefit non-quantifiable
It still remains unclear, however, in how many patients in whom the virus is no longer detectable, late complications, and liver cancer in particular, can actually be prevented. Therefore the extent of added benefit is "non-quantifiable".
Due to the advantage in SVR, IQWiG had already derived a hint of a non-quantifiable added benefit in two patient groups in the dossier assessment: for patients with HCV infection of genotype 1 when previous therapies have been unsuccessful, and for treatment-naive patients who have not yet developed cirrhosis of the liver.
G-BA decides on the extent of added benefit
The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the manufacturer submitted additional information in the commenting procedure. The G-BA subsequently commissioned IQWiG to assess the data subsequently submitted. IQWiG now presents this assessment in the form of an addendum. The G-BA makes a final decision on the extent of added benefit.