NICE asks for more cost data on Sovaldi
NICE has asked Gilead for more information on hepatitis C treatment Sovaldi before it rules on its cost effectiveness, saying there are 'substantial uncertainties' about its evidence base.
Sovaldi has generated excitement and controversy in equal measure since its launch in the US last year – the drug is the first of a new generation which can cure hard-to-treat patients, but its very high cost has raised questions about how healthcare systems will pay for it.
The drug has still not been officially launched in the UK, with all eyes on NICE and its equivalent in Scotland, the SMC, ruling on its cost effectiveness.
As expected, both bodies are now set to allow the drug's use on the NHS, but restrict the patients it is recommended for.
Last week the SMC ruled that Sovaldi should be used in patients with genotypes 1 to 6, while use in treatment-naive patients with genotype 2 is restricted to those who cannot take peginterferon alfa.
Also use of the 24-week interferon-free regimen of Sovaldi plus ribavirin in patients with genotype 3 is restricted again to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
Now NICE has issued its preliminary judgement, and is indicating similar reservations about recommending it for all patients.
Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, 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. The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources."
The full preliminary appraisal can be found here.
Consultees are now able to comment on the preliminary recommendations which are available for public consultation, which closes on 4 July.
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