Cost regulators are backing the use of Janssen’s Olysio (simeprevir) for the treatment of hepatitis C on the National Health Service, but only in a restricted group of patients.
The drug was approved in Europe in May to treat HCV genotypes 1 and 4, as well as in combination with Gilead Sciences’ Sovaldi (sofosbuvir) as part of the very first 12-week, all-oral, once-daily, interferon-free combination.
But in draft guidelines published today, NICE has only endorsed Olysio, in combination with peginterferon alfa and ribavirin, as a treatment option for genotype 1.
It has, however, requested more information on the drug’s use for this group of HCV patients, specifically “a detailed rationale” about whether the clinical effectiveness in people with genotype 1 can be generalised to those with genotype 4 HCV.
The Institute also said evidence was not robust enough for it to approve Olysio alongside Sovalidi, which will no doubt be disappointing news for patients.
Nod for GSK’s Tafinlar
Elsewhere, NICE has backed the use of GlaxoSmthKline’s Tafinlar (dabrafenib) for the treatment of melanoma which has spread or can’t be completely removed by surgery and tests positive for the BRAF V600 mutation, which is linked to 50% of aggressive forms of the disease.
According to the data provided, the drug works just as well as Roche’s Zelboraf (vemurafenib), which also targets melanoma with the BRAF V600 mutation. “Having two treatments available with different side-effect profiles could increase the number of patients who gain access to targeted treatment for melanoma,” said Professor Paul Workman, Interim Chief Executive of The Institute of Cancer Research, welcoming the move.
As the committee was able to fully recommend Tafinlar in line with its marketing authorisation, a consultation document was not needed for this appraisal, and so the recommendations have gone straight to a final draft in order to speed up access to this treatment, NICE said.
NICE has already recommended Zelboraf and Bristol-Myers Squibb Yervoy (ipilimumab) for advanced melanoma.
“Drugs like dabrafenib are also thought to have very rapid positive effect for patients, even in those who are very unwell or bed-ridden,” said Professor Carole Longson, centre for health technology evaluation director at NICE, noting that, in some cases, it has even “enabled people to resume everyday activities”.