The National Institute for Health and Care Excellence (NICE) has limited the use of Bristol-Myers Squibb’s (BMS) Daklinza (daclatasvir) to treat adult patients with chronic hepatitis C infection in the UK.
According to the published data, daclatasvir-based regimen has the capability to cure hepatitis C infection in patients with a difficult-to-treat and often aggressive form of hepatitis C (genotype 3).
In April, the European Association for The Study of the Liver (EASL) recommended daclatasvir-based regimen for genotype 3 patients based on most recent data.
Bristol-Myers Squibb UK and Ireland general manager Johanna Mercier said: "This is a disappointing decision by NICE, which contrasts with the assessments from other clinical and regulatory bodies across the UK, and does not provide equality of access across the UK.
"Daclatasvir provides an important option for some of the most in-need patients who, without effective treatment, face an uncertain future."
In the UK, around 100,000 patients are expected to have hepatitis C genotype 3, while about 215,000 people are expected to have hepatitis C.
The draft NICE guidance will restrict the use of the drug to patients with hepatitis C genotype 3, which accounts for around 45% of all cases in England.
Hepatitis C genotype 3 is said to be associated with faster disease progression and is difficult to treat with oral regimens compared with other genotypes.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of Maria Teresa Catanese, Martina Kopp, Kunihiro Uryu, and Charles Rice.