What price should we put on prolonging a life?

Emma is in her early 40s, she works as a teaching assistant at a school just a few minutes walk from the family home. It’s the same school where her two young children go and until last year she assumed that she would still be helping out in the classroom long after they had moved on.

However, in March, Emma, who had first been diagnosed with breast cancer three years ago, was given the devastating news that the disease had returned and this time there would be no chance of a cure. There was, however, Kadcyla, a revolutionary drug which would not only prolong her life, but would likely ensure that her final months were not overshadowed by the chronic sickness and painful side-effects linked to other cancer treatments.

“The cancer has spread to my liver, lungs and bones, but at the moment I feel well,” she says. “I know the time will come when the drug stops working and when the cancer will take over, but it means that I can enjoy whatever time I have left and spend time with the children. There is nothing easy about cancer, but Kadcyla has thrown me a lifeline. It might be a temporary and fragile one, but right now I will take that.”

There are hundreds of women currently receiving Kadcyla. However, this week the National Institute of Clinical Excellence, which decides what treatment should be available on the NHS, announced that it was not moved to routinely prescribe the drug. The reason it gave was simple. The organisation recognised the impact the treatment can have, but said it costs too much.

“A breast cancer drug like Herceptin costs the NHS £25,000 per patient per year. Kadcyla has a list price of £80,000,” says Robert Coleman, professor of medical oncology at Sheffield University who carried out initial clinical trials of Kadcyla. “However, I have been working in oncology for 30 years and it is one of the most effective and exciting drugs I have been involved with.

“Something like chemotherapy can leave patients feeling very sick, they lose their hair and the entire treatment can be very unpleasant. You simply don’t get that with Kadcyla. When it comes to prolonging life, the quality of that life is key, but this is one drug which can offer that.

“It isn’t something that can be offered to everyone with breast cancer as it’s only effective in those diagnosed with HER2 positive cancer, but those who are eligible for treatment can and have seen incredible results. On average it extends life expectancy by six months to around 18 months, but I have one patient who has been taking it since 2010.”

While the NICE announcement was a blow to both breast cancer sufferers and support charities, it was not entirely unexpected. It had been mooted as long ago as last year that Kadcyla might have priced itself out of the market. Those currently receiving the drug will continue to do so with treatment being paid for by the Cancer Drugs Fund. However, there are fears that the CDF itself is not sustainable.

When the previous Coalition government came to power it announced it wanted to review the pricing and appraisal system used by NICE to decide which drugs are made routinely available.

As an interim measure and to ensure patients didn’t miss out on vital treatment, the CDF was introduced to pay for expensive treatment not currently available on the NHS. The review stalled and while David Cameron has insisted he is committed to the overhaul, with the CDF due to come to an end in March a solution still seems some way off.

“The CDF was only ever supposed to be a temporary measure, but very little has been done and the situation is very worrying,” says Sally Greenbrook, policy manager at Breast Cancer Now. “Under the Coalition government, pharmaceutical companies did sit round the table with various interested parties, including support groups like ourselves, but nothing came to fruition.

“I have no doubt that another consultation will be launched but there is very little time to ensure that those discussions are meaningful. The real worry is that before a new system can be implemented, the CDF may have no option but to reduce the number of drugs it funds.

“It doesn’t have a bottomless pot of money and patients may end up missing out. Kadcyla has allowed mums to look after their children, it has enabled women to go back to work. Those may seem like small things, but when you are given a terminal diagnosis it’s the small things which can make a huge difference.”

Kadcyla contains a combination of emtansine and Herceptin, which is already used to treat breast cancer and key to its success is the fact it directly targets cancer cells unlike chemotherapy which doesn’t distinguish between normal and cancerous cells.

It is one of six drugs deemed to be too expensive to be prescribed on the NHS, but which were available through the CDF. However, earlier this year, three of those drugs were delisted, making them unavailable to new patients. The move has been estimated to have affected around 1,700 women and there are fears that other drugs could go the same way.

Prior to the last General Election, Cameron pledged that no patient eligible for life-prolonging treatments would be denied them. It was a nice soundbite, but one that would have meant the CDF was left more than £80m over budget. While a

“We have 50 or 60 people a day contacting our helpline for advice and support.” says Jane Murphy, clinical nurse specialist for Breast Cancer Care. “Some of those are women who have been told their cancer has returned and who are desperate to know what help is out there. Anyone who is currently being prescribed Kadcyla will continue to do so and it will be still available through the CDF, but we just don’t know what the future will hold an that’s obviously unsettling.”

Roche, the pharmaceutical company which manufactures Kadcyla, recently agreed a significant price discount with NHS England to stop the drug being taken off the CDF. However, the Swiss pharmaceutical company offered a different, smaller discount to NICE for regular NHS use of the drug in England and Wales. NICE says this undisclosed figure is still too high to justify against the drug’s clinical merits.

Sir Andrew Dillon, NICE chief executive, said: “We recognise that Kadcyla has a place in treating some patients with advanced breast cancer, and we have been as flexible as we can in making our recommendation. However, the price that the manufacturer is asking the NHS to pay in the long term is too high.”

While Emma is one of the lucky ones, she is acutely aware that in the future financial constraints may take precedence over the impact drugs can have on patients.

“If I hadn’t been prescribed Kadcyla would I still be here now? Who knows? When I was told that my cancer was terminal I quickly learnt not to try to predict the future,” she says. “What I do know is that it has given me and many, many other women hope and that’s something you can be very short of.

“I have hope that I will see my children open their Christmas presents this year, that I will be around for their next birthdays and who knows I may even be around to buy them their next new school uniforms.

“We have to be realistic, the NHS can’t fund every treatment and pay for every drug which is brought to market, but there doesn’t seem to be a huge amount of point spending millions on research to produce groundbreaking, life-changing drugs when they are then not available to the people who really need them.”