Cancer drug could cost NHS £4.7m per year of patient life, says NICE
NICE wants to axe funding for Roche’s daily skin cancer pill, Erivedge (vismodegib), saying in final draft guidance that the NHS could spend almost £4.7 million on the drug to restore a year of good quality life to patients.
Erivedge is among the last in a backlog of 24 drugs that used to be reimbursed by the old Cancer Drugs Fund (CDF) – originally a ring-fenced scheme that paid for oncology medicines rejected by NICE.
NICE was assessing Erivedge, which first became available via the CDF in 2013, as a treatment for adults with symptomatic basal cell carcinoma, or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.
In a worst-case scenario where no survival benefit was assumed, Erivedge’s cost per Quality Adjusted Life Year (QALY) was a massive £4,694,943, NICE calculated.
Assuming that Erivedge gives a survival benefit, according to NICE it would cost the NHS just under £97,000 per QALY gained – well above its usual £30,000 threshold and likely too expensive even if end-of-life criteria had applied.
Cost per QALY gives an indication of the amount of NHS resources that would have to be diverted from other services to give patients an extra year of quality life.
At these costs, NICE was unable to recommend regular NHS funding for Erivedge, even though the manufacturer has offered a confidential discount.
NICE was unconvinced by the dossier of clinical evidence presented by Roche, and as the drug was not considered as meeting end-of-life criteria, the body did not have extra leeway when assessing cost-effectiveness.
There were also uncertainties about Erivedge’s impact on patients’ quality of life in the evidence submitted by Roche.
The CDF was last year reformed following huge overspends and pays for cancer drugs on an interim basis until NICE gathers further evidence to support their cost-effectiveness.
Meanwhile, all the drugs funded by the old scheme were reassessed, and in many cases, NICE has since recommended regular NHS funding after manufacturers agreed to cut prices.
Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “Whilst it is disappointing to recommended that vismodegib be removed from the CDF, NICE must ensure that only medicines that are shown to be good value for money and clinically effective are approved for use on the NHS. As this drug was not cost effective it cannot be considered for use in the CDF.
“We acknowledge this will be disappointing for some patients.”
Roche said it is "extremely disappointed" in the decision but will not appeal because it said the current process will not change NICE's mind, as its assessments are unsuited to rare and complex diseases as in the case.
The drug could be available to patients on a case-by-case basis should their doctors make special applications for funding, and NICE said it will work with health bodies across the UK to ensure all options are considered.
Richard Erwin, general manager at Roche Products Limited said: "Roche is keen to work with NICE to find ways of developing its processes to ensure that they are suitable for medicines used in small patient populations where comparative clinical trials are not always possible and may in some cases be ethically challenging."
Patients currently being treated with Erivedge can continue their treatment.
In a separate decision published today, NICE said it had in final draft guidance recommended regular NHS funding for Bayer’s Stivarga (regorafenib) for gastrointestinal stromal tumours. Stivarga will therefore come off the CDF.
While most drugs from the old CDF have been given regular NHS funding, NICE this summer rejected Ipsen’s Cometriq and Sanofi’s Caprelsa in first draft guidance.
