This article was originally published in the Pharmafocus supplement ‘Breaking into oncology’ in March 2014.
A little more than a year ago, Lisa Hinsley’s prospects were not good. The mother of three had been diagnosed with bowel cancer the previous summer – and the growth had spread to her liver.
After an initial operation to remove the primary tumour, and three months of chemotherapy, she was preparing to go under the knife again. But before the procedure could take place, doctors discovered that the cancer had grown further to a point that surgery was no longer an option.
‘It was awful,’ the 42-year-old recalls, speaking from her home on the Wirral in north-west England. “I was basically put in the box of incurable. It was a shock to think that if I lasted five years I would be lucky.”
Fast forward to the present day and, although she is hesitant to build up expectations, Lisa’s outlook is considerably more positive: “Now I’m sort of beginning to think that maybe I’ll get past this and just live my life as everybody else does.”
For Lisa, the crucial turning point came when her oncologist decided she should be treated with Avastin. Previous chemotherapy had kept her condition stable, but during the subsequent recovery period, her cancer had grown – and three tumours had become 11.
“It was quite a shocking change,” she says, “but after three months of Avastin, [and chemotherapy agents] capecitabine [Roche’s Xeloda] and oxaliplatin combined, I went down to two tumours – which was less than I had originally had. And the growths that were left were nearly 50% smaller.”
However, acquiring Roche’s Avastin (bevacizumab) was not a straightforward matter. Despite being the top-selling cancer drug in the world – with licences for colorectal, ovarian, lung, kidney and breast cancers – it has yet to be approved by UK health watchdog NICE for any indication.
With a price tag of nearly £21,000 per patient per year – and an average added life expectancy of just six weeks for colorectal cancer – the authority does not deem the treatment to be cost-effective, meaning it is unavailable on the NHS.
This meant Lisa’s oncologist had to apply for Avastin through the Cancer Drugs Fund (CDF), a ring-fenced bursary worth £200 million per year established by the coalition government in 2010.
The CDF has both its supporters and detractors. Depending on your political viewpoint, its introduction was either a last-minute quick-fix by Whitehall to counter damning tabloid headlines, or a benevolent, temporary safety net to protect NHS patients while long-standing access issues were addressed.
Regardless of its raison d’être, the simple fact is that over the last three years the CDF has enabled more than 34,000 people to access treatment approved by European regulatory authorities that is unavailable through the UK health service.
For Stuart Barber, campaigns director at the charity Beating Bowel Cancer, the fund’s introduction was a ‘game-changer’ in UK cancer care.
“The CDF changed the conversation between patient and doctor,” he says.
“Before, the conversation was ‘how long have I got left’, now it’s more about ‘what treatment options are available for me’.”
Barber raises the point that cancer treatment is not only about extending life expectancy, but also opening up other treatment options – something the CDF has facilitated.
“Patients have told us that using CDF treatments can act as a gateway to other types of treatment,” he notes.
“For example, a patient could be told their liver tumours are inoperable, but these treatments could allow an operation in the future if they respond well.”
This is exactly what happened in Lisa’s case. The reduction in the number and size of her tumours opened the door to Selective Internal Radiation Therapy (SIRT) – and although she’s not completely in the clear yet, it appears to have had a very positive impact on her condition.
“The radiotherapy seems to have killed the main tumours and there appears to be no growth from the outside,” she says. “So, possibly after the next scan, they might start looking a lot more positively at my prospects.”
Another less obvious benefit of the fund is the fact that it can boost patients’ suitability for clinical trials of new treatments. Paul Catchpole, director of Value and Access at pharma group the ABPI, explains: “It’s allowed patients to get access to some cancer drugs that haven’t been available in the UK for some time because they’ve never been approved by NICE.
“That means that patients who have become established on those treatments may become suitable for clinical trials of newer treatments because their standard of care has been brought up to date, compared to other countries.”
Catchpole’s organisation has been supportive of the fund and welcomed the announcement in September that it would be extended to 2016.
This was a sentiment echoed by many in the charity sector – and the patients with whom they work. Breast Cancer Care’s assistant director of services, Liz Carroll, said at the time that many patients “had been telling us for months of their anxiety around the uncertain future of the Fund”.
She added: “This can be especially relevant for those living with secondary (advanced) breast cancer, for whom time is running out. Many treatments are no longer a choice for them but drugs which have been approved but unlicensed by NICE can offer a lifeline.”
According to Catchpole, the ABPI has always believed that “the CDF should be extended until a time that whatever replaces it is able to demonstrably show levels of patient access equivalent to what we have with the current system.”
He continues: “We’ve made some good progress, so we don’t want to go backwards.”
This eagerness to move forwards raises the question: what was the cancer treatment access landscape like before the CDF? Barber grimly describes it as ‘the bad old days’.
Prior to the Fund’s introduction, patients who wanted access to a drug that was not available on the NHS had to make an individual funding request through their local health authority – or pay out of their own pocket.
The charity executive adds: “Many cancer patients were left wondering why, if their NHS doctor wished to prescribe a treatment that could extend or improve the quality of their lives, they were being forced to sell their homes or spend their life savings to fund the treatment.”
At the time of the fund’s launch, then-health secretary Andrew Lansley heralded it as a ‘crucial step forward’, characterising it as the foundation of “longer-term plans [which] will change the way we pay for drugs so that patients get better access to drugs and the NHS and the taxpayer get better value for money”.
These plans were expected to come to fruition in the form of a new pricing system, value-based pricing (VBP).
However, the government announced in November last year that VBP was to be essentially abandoned in favour of retaining the established Pharmaceutical Price Regulation Scheme (PPRS), albeit with new limits on the NHS’s drugs bill for the next five years. Many in the industry were disappointed by the decision, including Roche, the pharma giant that produces Avastin – the very drug Lisa credits with turning the tide on her bowel and liver cancer.
Stephen Cull, PR lead of the firm’s UK operations tells Pharmafocus: “VBP was a missed opportunity to rectify some of the pricing and reimbursement challenges in areas such as cancer.
“The government needs to ensure that its solution to these challenges put patients first, empowers clinicians and addresses divergence in UK clinical practice compared to the rest of the world.”
Cull like many in the industry, is supportive of the CDF saying that it has “put clinicians in the driving seat” – but as his comments suggest there is general agreement that the fund is not a sustainable solution.
Emlyn Samuel, policy manager at Cancer Research UK says: “The government needs to find long-term ways to fund all effective cancer treatments – be they drugs, radiotherapy or surgery – so that patients are given the best care possible.”
Samuel is concerned that a satisfactory evaluation has yet to be made of the CDF’s clinical benefit – and believes that such an assessment is critical to progress on the issue of access.
“It’s still unclear what impact the CDF has had on patient outcomes. We must collect better data on what drugs cancer patients across the UK need – including the impact of drugs made available through the CDF – to assess whether these drugs are working.”
Such data would put decision-makers in a much stronger position to consider the future of the fund. However, with finite funds in the public coffers and few substantial alternatives outlined, it remains difficult to predict what kind of provisions will be in place by 2016.
For the time being though, patients like Lisa are happy with the CDF as it is – and would have it extended indefinitely if possible.
Back on the Wirral, she is casting a cautious eye to the future. A fiction writer, she has already had two books published in the US: “That’s where I’m hoping to go – and I think it’s getting there. I would love to be a full-time, permanent writer.”
A year ago, the idea of career development was far from her thoughts. “I’m more positive about the future now,” she says. “I don’t think I would even be contemplating a future were it not for the treatment access I had through the CDF.”
With that, she departs to take the family pet out for a walk. She has plenty of errands to run that afternoon before her youngest gets home from school. All routine activities, perhaps, but after the year Lisa’s had, she’s happy to be getting on with normal life.