Calls for NHS Scotland to approve new cancer drug

Clinical trials which showed benefits to women with advanced breast cancer when treated with the drug Kadcyla, made by Roche. Picture: TSPL

A public meeting of the Scottish Medicines Consortium (SMC), which assesses whether new drugs are cost-effective for use by the NHS, heard evidence from clinical trials which showed benefits to women with advanced breast cancer when treated with the drug Kadcyla, made by Roche.

But the drug has already been rejected by watchdogs in England due to concerns about the high costs, sparking a war of words between assessors and the manufacturer.

The SMC meeting heard studies showed that the drug extended overall life expectancy in women with a type of breast cancer known as HER-2 positive by six months on average compared to other treatments.

Individual doctors and patients have also reported life expectancy extending much longer.

It was also found to improve quality of life with fewer side effects than other treatments.

But it also highlighted weaknesses in the case for approving the drug, including the high cost.

This was estimated to be more than £111,000 per quality adjusted life year (QALY) - a measurement used to assess the cost of giving patients an extended quality of life.

While Roche has offered an undisclosed discount for the NHS in Scotland if the drug is approved, the cost was still considered to be high.

If approved the drug would cost the NHS £1.82 million in its first year, rising to £4.98m after five years.

For the first time the SMC will also consider the opinion of a special group set up as part of efforts to give doctors and patients a stronger voice in the decision-making process - known as a Patient and Clinician Engagement (PACE) group

Reporting back on the findings of the PACE group, Alison Campbell told the meeting that clinicians had described the results from the treatment as “remarkable and unprecedented”.

They said the drug helped give women a normality to their lives which would not normally be expected in patients with advanced breast cancer.

“There was very strong evidence from the PACE group for this development which was considered a major advance in clinical practice,” Mrs Campbell said.

Evidence submitted to the meeting by charity Breakthrough Breast Cancer also revealed powerful testimonies from patients.

One said: “Length of life is only worth having if there is quality of life too. This drug offers both.”

Others said it gave them hope, while one said knowing a drug existed but which they could not access would make them “suicidal”.

But the meeting heard concerns that the drug was “hugely expensive”.

SMC member Ian Crichton said the discount offered on the drug was “not exactly a generous one”.

Questions were also raised about how effective the drug would be compared to treatments currently used on the NHS in Scotland, which were not the same as those studied in the clinical trial discussed.

SMC chair Jonathan Fox said they had heard “powerful statements” from patients and clincians which would be considered when decisions were made.

Speaking after the meeting, James Jopling, director for Scotland, Breakthrough Breast Cancer, said the meeting had heard a “powerful and engaging” case from patients and clinicians about the “remarkable” impact the drug could have on women with breast cancer.

“This is an amazing advance in clinical practice. One of the clinicians was quoted as saying if there is one drug the SMC was to support, it should choose this drug,” he said.

“At this stage in this new process I don’t think I could hope for more than that in terms of compelling evidence being presented for why patients and doctors want to see Kadcyla approved.

“What is very difficult to say is how that is going to be taken account of in the decision making process.

“We’re going to have to wait and see how SMC members weigh up the undoubted strong and passionate case from those who have witnessed this drug and taken this drug versus the fact we know this is a very expensive treatment and one that has already been rejected by the NHS in England.

“It is an incredibly difficult decision but our position is that this is a ground-breaking new treatment for breast cancer for women who don’t have any other options.

“Our only hope is that that message is heard by the people who make the decisions, weighing it up with the undoubted pressures there are on the NHS budget.”

The SMC’s decision on Kadcyla will not be made public until next month.