Cost regulators for National Health Service treatments in England and Wales have raised an eyebrow or two by asking Gilead for more information on its hepatitis C wonder drug Sovaldi (sofosbuvir).

In draft guidelines the National Institute for Health and Care Excellence (NICE) said it is minded not to recommend Sovaldi, despite the drug being linked with cure rates of over 90% in just 12 weeks.

While the Institute conceded that available evidence shows Sovaldi is an effective treatment for chronic hepatitis C in certain patients, "evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer", it said, explaining its current stance.

"The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources".

Move unexpected

The move came as somewhat of a surprise given that, in April this year, NHS England approved funding for Sovaldi in England and Wales significantly at risk of dying or needing a liver transplant, while the Scottish Medicines Consortium cleared its restricted use on NHS Scotland.

The drug was approved for use in Europe in January this year, but has been in the spotlight globally for some time because of its widely-perceived high price tag as much as its stellar effectiveness. With a 12-week course costing just shy of £35,000 in the UK, there are concerns that the drug could prove to be a devastating drain on healthcare resources.

On the other hand, the price of not using Sovaldi is could run much much higher; one in three patients injected with HCV eventually developing liver cirrhosis and managing these patients is costly.

Charles Gore, chief executive of the Hepatitis C Trust, said the drug's high price "should not put off commissioners because price is not supposed to be the determinant – cost-effectiveness is". 

"If NICE OK Sovaldi, it should be prescribed to anyone who wants it. We have the Pharmaceutical Price Regulation Scheme (PPRS) to cap the drugs budget," he noted.

The closing date for comments on the draft guidance is 4 July 2014.

New combo shows 100% response rates

Meanwhile, Gilead also unveiled Phase III data showing that the fixed-dose combination of the NS5A inhibitor ledipasvir and sofosbuvir achieved 100% sustained virology response in hepatitis C patients in Japan.

The cure rates observed "are impressive because they were achieved without the need for interferon or ribavirin, both of which involve more complex dosing requirements and may be associated with significant side effects,” said Norbert Bischofberger, Gilead’s Chief Scientific Officer. 

The results suggest that the once-daily pill "has the potential to be an efficacious and well-tolerated regimen" for many patients in Japan, he added.