Telaprevir (1) – Incivo®
Chronic hepatitis C
Characteristics
| Start date | 15.10.2011 – Marketing authorisation: 19.09.2011 |
|---|---|
| Resolution | 29.03.2012 |
| INN | Telaprevir |
| Brand name | Incivo® |
| Pharm. company | Janssen Cilag GmbH |
| G-BA Procedure ID | D-022 |
| ATC code | J05AP02 Antivirals for treatment of HCV infections (J05AP) |
| DDD | 2.25 g O |
| Therapeutic area | Infectious diseases Hepatitis C (HCV) |
| Reason for procedure | Initial assessment |
| Regulatory status | authorisation withdrawn by manufacturer |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): - who are treatment-naïve; - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | In combination with peginterferon + ribavirin versus peginterferon + ribavirin in therapy-naive patients with chronic hepatitis C virus (cHCV) infection (genotype 1). | Peginterferon plus ribavirin |
| b) | In combination with peginterferon + ribavirin versus peginterferon + ribavirin in treatment-experienced patients with chronic HCV infection (genotype 1). | Peginterferon plus ribavirin |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (Realize) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- The G-BA reached its decision on whether an additional benefit of telaprevir 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.
- Taking all these factors into account, the G-BA concludes that telaprevir offers additional benefit for both treatment-naïve and treatment-experienced patients with chronic hepatitis C infection, but that the extent of this added benefit is non-quantifiable because the available scientific evidence does not permit this.
- Morbidity – Sustained Virological Response (SVR)
- The additional benefit would therefore, in principle, be quantifiable.
- 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 patients with co-infection and cirrhosis.
- There is insufficient data available for these patient groups to assess the additional benefit; consequently, no definitive conclusions can be drawn regarding the primary endpoint, SVR.
- Overall assessment
- Taking all these factors into account, the G-BA concludes that telaprevir offers an additional benefit for both treatment-naïve and treatment-experienced patients with chronic hepatitis C infection, although the extent of this added benefit is non-quantifiable because the scientific evidence does not permit this.
b) In combination with peginterferon + ribavirin versus peginterferon + ribavirin in treatment-experienced patients with chronic HCV infection (genotype 1)
- The extent of the additional benefit is non-quantifiable; the additional benefit lies between the orders of magnitude ‘minor’ and ‘major’.
- Taking all these factors into account, the G-BA concludes that telaprevir offers an additional benefit for both treatment-naive and treatment-experienced patients with chronic hepatitis C infection, but that the extent of this added benefit is non-quantifiable because the scientific evidence does not permit this.
- Morbidity – Sustained Virological Response (SVR)
- The additional benefit would therefore, in principle, be quantifiable.
- In the present case, however, it should be noted that the patient groups of treatment-naïve and treatment-experienced patients, for whom an additional benefit has been established in each case, also include patients with co-infection and cirrhosis.
- There is insufficient data available for these patient groups to assess the additional benefit; consequently, no definitive conclusions can be drawn regarding the primary endpoint, SVR.
- Overall assessment
- Taking all these factors into account, the G-BA concludes that telaprevir offers an additional benefit for both treatment-naïve and treatment-experienced patients with chronic hepatitis C infection, however, the extent of this added benefit is non-quantifiable because the scientific evidence does not permit this.
Courtesy translation only, please refer to the German original.
Associated procedures
| Telaprevir (1) | Incivo® | Janssen Cilag GmbH | Chronic hepatitis C | 46,000 | 100% Indication of non-quantifiable additional benefit |
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