Two drugs that represent a major advance in hepatitis C are set to be routinely available on the NHS in England and Wales, after NICE issued final draft guidance recommending both Gilead Sciences’ Sovaldi (sofosbuvir) and Janssen’s Olysio (simeprevir) to treat people with the infection.
Both drugs were approved in Europe in 2014 based on impressive clinical data and have gone on to record substantial sales, helped by the fact that both Olysio and Sovaldi were approved as part of shorter oral regimens that do not require the use of interferon, an injection that needs to be taken over several months.
However, both Gilead and Janssen expressed disappointment with some aspects of the NICE guidance.
For Gilead the issue is a delay in access, with NHS patients unlikely to be offered treatment with Sovaldi until August due to an extension to the deadline that requires NHS England to have services and funding in place to meet the treatment recommendations for patients.
Stelios Karagiannoglou, Gilead’s UK and Ireland general manager, said: “We are disappointed that the majority of patients will not gain access to this important medicine until later this year.”
The high price of Sovaldi has led to it being the most successful pharma launch of all time in terms of revenues, but it has meant that Gilead has struggled with access in some areas.
In France the drug is provided at a steep discount, while US insurance firm Express Scripts recently dropped the drug from its formulary in favour of a cheaper rival from AbbVie.
In recognition of this delay in access NHS England has committed to fast-track an interim policy to provide the drug as part of an all-oral regimen to all patients with cirrhosis and this is set for April.
Decision on interferon-free Olysio postponed
The NICE guidance for Olysio was also far from straightforward, recommending the drug only when combination with peginterferon alfa and ribavirin, meaning no oral option is available.
However, there was a positive in that the drug was recommended for treating both genotype 1 and genotype 4 forms of the condition, when in previous guidance it was just recommended in genotype 1 patients.
Olysio could still be on course for use as part of an oral regimen at some stage though, with Janssen confirming that a decision on the use of the drug in combination with Sovaldi as part of a 12-week interferon-free course has been postponed while real-world observational data is collected.