NICE has recommended three new treatment options for hepatitis C in draft guidance – but has been criticised for excluding major patient groups from treatment with some drugs.
The draft guidance issued by the UK healthcare watchdog recommended Bristol-Myers Squibb’s Daklinza (daclatasvir) as treatment for hepatitis C infection in the UK.
Around 215,000 people in the UK are thought to have hepatitis C. The draft NICE guidance of Dazklinza excludes patients with hepatitis C genotype 3, which accounts for around 45% of all cases in England. Hepatitis C genotype 3 is associated with faster disease progression and liver damage and is more difficult to treat with oral regimens than other genotypes.
The news is a significant blow to Bristol-Myers Squibb, who are backing on Daklinza to help the firm hit its 2015 financial predictions. Johanna Mercier, general manager of Bristol-Myers Squibb UK & Ireland, comments: “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. We will be working closely with NICE to see if a solution can be found, and hope that this decision can be urgently reassessed so that patients do not suffer as a result.”
Liz Carroll, chief executive of The Haemophilia Society says: “This decision by NICE does not appear to be in the best interest of patients, particularly for those with genotype three. This is a difficult-to-treat subtype, with little other treatment options available, especially for those who have already undergone extensive treatment previously.
“Those who are living with serious liver damage need rapid, tolerable and effective treatment to prevent further progression of their disease. It is imperative that NICE reviews its stance on this regimen to avoid endangering very unwell people who are in real need of support.”
NICE has also published a second provisional guidance document, confirming its decision to recommend Harvoni (ledipasvir-sofosbuvir) for the treatment of chronic hepatitis C in England and Wales.
Charles Gore, chief executive of The Hepatitis C Trust, says: “This preliminary decision to give access to interferon-free drugs to people with little or no liver damage is therefore very welcome and a great relief to many who had feared access would be restricted only to those with advanced disease.”
NICE also recommended AbbVie’s Viekirax (ombitasvir-paritaprevir-ritonavir) with or without Exviera (dasabuvir) as an option for treating chronic hepatitis C in adults.