Boceprevir (1) – Victrelis®

• Clinical trials
  • The G-BA reached its decision on whether an additional benefit of boceprevir compared with the appropriate comparator therapy could be established on the basis of the benefit assessment prepared by the IQWiG and the opinions presented during the written and oral consultation procedures.

a) In combination with peginterferon + ribavirin versus peginterferon + ribavirin in treatment-naïve patients with chronic hepatitis C virus (cHCV) infection (genotype 1)

• The extent of the additional benefit is non-quantifiable; the additional benefit falls within the range between ‘minor’ and ‘major’.
• In the present case, however, it should be noted that the patient groups of treatment-naïve and treatment-experienced patients, for which an additional benefit was established in each case, also include groups of patients with cirrhosis and patients with co-infections.
• Consequently, no definitive conclusions can be drawn regarding the primary endpoint (SVR) for these patient groups.
• Furthermore, the potential benefits of boceprevir must be weighed against its potential for harm.
• Both in treatment-experienced and treatment-naïve patients, there is a significantly higher incidence of anaemia during treatment with boceprevir.
• In the registration trials with boceprevir, erythropoiesis-stimulating active ingredients (ESAs) were used significantly more frequently.
• The extent to which anaemia occurs more frequently or is more serious during treatment with boceprevir without the administration of ESAs, or whether it can be managed by reducing the ribavirin dose, cannot be deduced from the available study data.
• Taking all these factors into account, the G-BA concludes that boceprevir offers additional benefit for both treatment-naïve and treatment-experienced patients with chronic hepatitis C infection, though the extent of this is non-quantifiable because the scientific evidence does not permit it.
• Morbidity – Sustained Virological Response (SVR)
  • The additional benefit would therefore, in principle, be quantifiable.
• Side effects – anaemia
  • Both treatment-experienced and treatment-naïve patients experience a significantly higher incidence of anaemia whilst on treatment with boceprevir.
  • In the registration trials with boceprevir, erythropoiesis-stimulating active ingredients (ESAs) were used significantly more frequently.
  • ESAs do not have marketing authorisation for this indication in Germany.
  • It cannot be deduced from the available study data to what extent anaemia occurs more frequently or is more serious during treatment with boceprevir without the administration of ESAs, or whether it can be managed by reducing the ribavirin dose.

b) In combination with pegylated interferon + ribavirin versus pegylated interferon + ribavirin in treatment-experienced patients with chronic HCV infection (genotype 1)

• The extent of the additional benefit is non-quantifiable; the additional benefit falls within the range from minor to major.
• In this case, however, it should be noted that the groups of treatment-naïve and treatment-experienced patients, for which an additional benefit was identified in each case, also include patients with cirrhosis and those with co-infections.
• Furthermore, the group of treatment-experienced patients also includes the group of non-responders.
• There are insufficient data available to assess the additional benefit for these patient groups with cirrhosis and non-responders.
• No data are available for the group of patients with co-infections.
• Consequently, no definitive conclusions can be drawn regarding the primary endpoint (SVR) for these patient groups.
• Furthermore, the potential benefits of boceprevir must be weighed against its potential risks.
• Both in treatment-experienced and treatment-naïve patients, there is a significantly higher incidence of anaemia during treatment with boceprevir.
• In the registration trials with boceprevir, erythropoiesis-stimulating active ingredients (ESAs) were used significantly more frequently.
• The extent to which anaemia occurs more frequently or is more serious during treatment with boceprevir without the administration of ESAs, or whether it can be managed by reducing the ribavirin dose, cannot be deduced from the available study data.
• Taking all these factors into account, the G-BA concludes that boceprevir offers additional benefit for both treatment-naïve and treatment-experienced patients with chronic hepatitis C infection, though the extent of this is non-quantifiable because the scientific evidence does not permit it.
• Morbidity – Sustained Virological Response (SVR)
  • The additional benefit would therefore, in principle, be quantifiable.
• Side effects – anaemia
  • Both treatment-experienced and treatment-naive patients experience a significantly higher incidence of anaemia whilst on treatment with boceprevir.
  • In the registration trials with boceprevir, erythropoiesis-stimulating active ingredients (ESAs) were used significantly more frequently.
  • ESAs do not have marketing authorisation for this indication in Germany.
  • It cannot be deduced from the available study data to what extent anaemia occurs more frequently or is more serious during treatment with boceprevir without the administration of ESAs, or whether it can be managed by reducing the ribavirin dose.

Courtesy translation only, please refer to the German original.