Patients with newly diagnosed advanced skin cancer will currently not be able to access a pioneering cancer drug on the NHS.
Today the National Institute for Health and Care Excellence (NICE) has issued draft guidance which denies access to ipilimumab – also known as Yervoy – for NHS patients with untreated advanced melanoma, not involved in clinical trials.
Ipilimumab is currently recommended by NICE for the treatment of adults with previously-treated advanced skin cancer and, in November, European regulators extended its licence to include use in previously untreated patients.
Scores of people with the disease had taken part in clinical trials of the ground-breaking drug at Newcastle’s Northern Centre for Cancer Care.
The pivotal Phase III clinical trial involved more than 20 people who had already received chemotherapy, however, today’s rejection by NICE is different as it refers to those who would use ipilimumab as a first-line treatment.
Karen Verrill, head of Maggie’s North East cancer centre (pictured), said: “When drugs such as this are delayed it can be very stressful and upsetting for people who may benefit, and also their family and friends. If somebody thinks that they will benefit from this type of drug, and there is some evidence that it works, then they are going to want it to be available for them as soon as possible.”
NICE insisted there needed to be further research into the effectiveness of the skin cancer drug.
In preliminary draft guidance, it recommends that the treatment is used only in the context of research as a first-line option. It also states that people currently receiving ipilimumab as part of their NHS care should continue with the treatment until they and their doctor consider it appropriate to stop.
Sir Andrew Dillon, NICE chief executive, said: “There are limited first-line treatment options available for patients with this type of advanced skin cancer.
“Which is why it is disappointing that the evidence put forward did not conclusively demonstrate the degree to which the regulator approved dose of ipilimumab can extend life when compared with current standard care in the NHS.
“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.”
The National Cancer Drug Fund panel has reviewed ipilimumab in untreated patients and decided to refer it for baseline commissioning by NHS England. This is a six-month process, during which time patients will not be able to access the treatment through the National Cancer Drugs Fund.
In the last decade the North East has seen a 49% increase in the number of people diagnosed with malignant melanoma. Data from a clinical trial of ipilimumab in previously-treated patients showed 46% of patients given the drug were alive at one year compared to 25% receiving another treatment. In addition, 24% of patients were alive at two years compared to 14%.
A spokesperson for the Cumbria, Northumberland, Tyne and Wear area team of NHS England, said: “Clinicians in the North East will still have a range of effective treatments available.
“We have full confidence in the services which our local hospitals provide for the management of this condition. Ipilimumab is available via the NHS and is fully funded by NHS England for patients whose condition has not responded adequately to first-line treatment in accordance with guidance from NICE.”