Were NHS chiefs right to deny ‘miracle’ life-giving pancreatic cancer drug?
IT WAS hailed by campaigners as a ‘miracle’ drug and the first true breakthrough in treatment of deadly pancreatic cancer since the 1970s. Abraxane doubled the life expectancy of terminally-ill patients, giving them precious extra months. Some patients even survived for years.
So the news in late 2015 that the National Institute for Health and Care Excellence (NICE), which operates in England and Wales, had rejected Abraxane on cost grounds – despite having given approval a year earlier – was understandably met with anger from patient groups.
Such was the outcry that manufacturer Celgene agreed last year it would lower the price of the £28,000 a year treatment, and NICE last week confirmed that it is reviewing its decision. A new ruling is due in November – a move welcomed by leading charity Pancreatic Cancer UK, which is pushing for Abraxane’s reintroduction.
Abraxane was accepted for use within NHS Scotland in February 2015 by the Scottish Medicines Consortium after it deemed the drug ‘an effective treatment’.
There has been one major study into Abraxane, carried out in 2013. It found that when given alongside chemotherapy, it increased survival by an average of 55 days.
However, in 2014, leading cancer specialists warned that headline promises of increased survival thanks to the drug were ‘inappropriately rosy’.
In a letter to the prestigious New England Journal of Medicine, oncologists from the Memorial Sloan Kettering Cancer Center in New York claimed that the additional weeks of life came with severe and debilitating side effects for many patients.
Head of gastrointestinal oncology Dr Leonard Saltz, and Dr Peter Bach, director of the hospital’s Centre for Health Policy, warned that reports may have led to an ‘unbalanced perception of the study findings.’
‘The 2013 study showed very modest benefit and considerable side effects,’ Dr Saltz confirmed on Friday. ‘People just see “improved survival” and they’re not going to stop and read that it is, in fact, 55 days with the increased risk of side effects. I don’t think when measuring survival in weeks that we can talk about a breakthrough.’
So were NHS England health chiefs right to deny patients this life-giving ‘wonder drug’?
Pancreatic cancer affects about 9,600 Britons a year. Four in five patients are diagnosed at an advanced stage as there are few early symptoms. If there are any signs, they are often put down to stress or other illnesses.
Once the cancer has invaded surrounding organs, surgery to remove it – the only true hope for a cure – is no longer an option. In these patients, treatment can only ever promise to extend life for as long as possible. Those with advanced, inoperable pancreatic cancer are expected to survive between two to six months from diagnosis. Given this bleak outlook, even a few extra weeks could be seen as significant.
The current gold standard lifeextending treatment is Folfirinox, a combination of several powerful drugs. But while effective in extending life for an average of 11 months, there are downsides.
HALF of patients suffer serious side effects requiring hospital treatment, and almost one in 20 will die from the toxicity of the drug, rather than the cancer itself. But a similar number of Abraxane patients also suffer severe side effects, such as nerve damage in their hands and feet, sepsis, and severe fatigue.
After initially making the drug available to NHS patients in March 2014, NICE reversed its decision a year later, claiming the cost of Abraxane – £2,241 per cycle, plus up to £3,550 for chemotherapy, compared to £2,228-a-cycle for Folfirinox – was ‘not justified by its limited benefit’.
Officials added that other trials showed a combination of chemotherapy and another drug, £30-a-cycle capecitabine, extended life by an average of 27 days, which made it ‘similarly effective’ to Abraxane.
But campaigners argue that for people with little time left, the risk of side effects is one worth taking – and for some patients the drug extends their life way beyond the 55 days found in the 2013 trial.
Alex Ford, chief executive at Pancreatic Cancer UK, said: ‘Treatment of pancreatic cancer has seen very little progress since the early 1970s and patients must have access to Abraxane on the NHS.’
Ramesh Ramanathan, professor of medicine at the Mayo Clinic College of Medicine in Minnesota and the lead author of the 2013 Abraxane study, was more circumspect, saying: ‘NICE looks at the findings and evaluates for best practice, but it is constrained by economics. I believe the hesitancy regarding Abraxane has been cost and not efficiency. It is an expensive drug. But we don’t have many options in pancreatic cancer treatment. This is the best we have.’