Patients with advanced skin cancer will be disappointed with news that cost regulators are planning to bar 'routine' first-line access to Bristol-Myers Squibb's Yervoy (ipilimumab) on the National Health Service in England and Wales.
The National Institute for Health and Care Excellence (NICE) has published draft guidelines recommending that the skin cancer treatment only be used by the NHS for patients in clinical trials, because current evidence is lacking.
The Institute has already endorsed Yervoy as a second-line treatment for advanced malignant melanoma, but says the evidence provided by B-MS fails to conclusively show the degree to which the drug can extend life in previously untreated patients when compared with current standard care.
“We understand that clinical trials are ongoing that could provide an answer to this important question, and are keen to see the recruitment and continued follow up of patients in these trials encouraged," noted NICE's chief executive Sir Andrew Dillon.
Unsurprisingly, B-MS has slammed the decision, arguing that, if upheld, it will restrict newly-diagnosed patients from accessing "one of the most significant treatment advances for this disease in many years" which has "the potential to significantly increase overall survival".
According to Professor John Wagstaff, Consultant Oncologist at the South West Wales Cancer Institute & Swansea School of Medicine, the drug "has demonstrated its ability to increase overall survival in this cancer, in some cases having a long-term effect on the survival of previously-treated patients," and so "making it available as a first treatment option should therefore be seen as an important step in helping to maximise survival in this disease".
"Advanced melanoma is a devastating diagnosis, yet treatment options remain severely limited for many patients facing this disease. Unless reversed, this decision by NICE will sadly continue this trend and will leave some patients without a medicine that could potentially help extend their lives," added Gill Nuttall of Melanoma UK.
Newly-diagnosed patients are also currently unable to access Yervoy via the national Cancer Drug Fund.