BERLIN, Nov 21 (APM) - Janssen's hepatitis C drug Olysio (simeprevir) was found to show 'considerable', 'minor', or 'no added benefit' under German health technology assessment (HTA), depending on the patient group the drug was being used in.
Germany highest HTA authority G-BA stratified the ratings depending on the disease's genotype, as well as whether the patients had been previously treated, had relapsed or were unresponsive to previous treatment, had cirrhosis, or HIV co-infection, according to the decision published on the G-BA's website on Thursday.
The ratings are to feed into pricing negotiations for the drug between Janssen and German payers, with each rating to be considered in establishing a single price for the drug. It pronounced in seven broad groups.
Adding Olysio to a dual therapy pegylated interferon alpha (peg-IFN)+ribavirin showed considerable added benefit over the dual therapy alone in previously untreated genotype 1 patients with or without cirrhosis, according to the G-BA.
Olysio in combination with peg-IFN+ribavirin against the dual therapy alone also showed considerable added benefit in previously treated HCV genotype 1 patients who have relapsed.
The Janssen - Johnson & Johnson - drug combined with peg-IFN+ribavirin showed considerable added benefit over the dual therapy combined with protease inhibitors such as Merck Sharp & Dohme's Victrelis (boceprevir) or Janssen's Incivo (telaprevir) in genotype 1 patients unresponsive to previous treatment.
Olysio+peg-IFN+ribavirin showed minor added benefit over peg-IFN+ribavirin alone in genotype 4 who have previously been untreated, or relapsed after treatment.
However, the Olysio combination showed no added benefit over peg-IFN+ribavirin in genotype 4 patients unresponsive to previous treatment.
The combination with Olysio showed minor added benefit over the dual therapy in previously untreated patients without cirrhosis and previously treated, relapsed patients without cirrhosis with an HIV co-infection of genotypes 1 and 4.
The Olysio combination showed no added benefit over peg-IFN+ribavirin in previously untreated patients with cirrhosis, and patients unresponsive to previous treatment with or without cirrhosis, or relapsed with cirrhosis with an HIV co-infection of genotypes 1 and 4.
Two months earlier, first assessing institute IQWIG said Olysio (simeprevir) showed added benefit in genotype 1 disease, but no added benefit in HIV co-infection or genotype 4. (APMMA 39557)
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