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Added Benefit of HCV Drug Unproven Due to Insufficient Data
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In a manufacturer dossier assessment, the Institute for Quality and Efficiency in Health Care in Germany was unable to deem daclatasvir more beneficial for the treatment of hepatitis C virus infection than other therapies because of insufficient data provided by the manufacturer, according to a press release.
The dossier assessment is a procedural part of the Reform of the Market for Medicinal Products Act, overseen by the Federal Joint Committee (G-BA). The G-BA conducts a commenting procedure once the dossier assessment is complete and then determines the extent of the added benefit determined by the Institute for Quality and Efficacy in Health Care (IQWiG).
According to the IQWiG, the manufacturer for daclatasvir (Daklinza, Bristol-Myers Squibb) provided data only on treatment-naive patients with HCV genotype 1 infection without cirrhosis and patients with HCV genotype 4 infection, not data for patients with HCV genotype 1 infection that were pretreated, untreated patients with cirrhosis and with HIV coinfection, and for patients with HCV genotype 3 who were treatment experienced or had compensated cirrhosis. The IQWiG called the data provided by the manufacturer “unsuitable” to prove an added benefit of daclatasvir over other therapies, according to the release.
In its dossier, the manufacturer provided an indirect comparison for HCV genotype 1 patients without cirrhosis, but a search in trial registries had not been conducted in relation to this, which was a requirement for the dossier, according to the release. Additionally, the manufacturer did not meet requirements of the Bayesian benchmarking analysis due to the lack of search in trial registries and did not address side effects of therapy.
Data provided by the manufacturer for patients with HCV genotype 4 showed “missing values in the outcome of SVR” due to treatment discontinuations, according to the release, and were unreasonable since they did not comply with the Summary of Product Characteristics.
The European Commission approved the use of daclastivar, an NS5A complex inhibitor, in combination with other drugs for the treatment of adults with HCV in August.
The FDA issued a response letter to Bristol-Myers Squibb in November, requesting more data for its new drug application for daclatasvir.