England’s ‘world-first’ cancer database – can it deliver on its promise?

The first ever national database of cancer treatment outcomes has been launched in England – but pharma and charities say it needs more time to fulfil its potential.

A world first has been achieved this week in England with the first publication of national ‘real-world evidence’ (RWE) and outcomes in cancer patients.

England’s National Health Service (NHS) has struggled to improve its cancer survival times in line with similar countries, but the Systemic Anti-Cancer Therapy (SACT) could be part of the solution to that.

Data collection and analysis is increasingly the key to improving healthcare in the 21st Century, and SACT will allow England’s health service to track how a range of different cancer patients respond to cancer drugs in the real world – including whether or not the drugs significantly extend lives.

This week’s publication of a study in the Lancet Oncology is a big step forward for SACT, which has been held back by problems with data collection and data quality. Though first launched in 2012, for many years not enough NHS hospitals have been supplying data. Data collection has now been made mandatory, and confidence in the database is growing, but doctors, charities and pharma all agree that there is still lots to be done before SACT can fulfil its promise.

This is vital for the future of England’s plan for cancer treatment: England’s updated Cancer Drugs Fund (CDF) will call on its data to make decisions about whether some treatments should be funded on the NHS or not.

The new CDF includes a ‘managed access fund’ system whereby drugs which are promising but have less than robust data are given two years to prove themselves on the market. Companies will be able to use maturing data from clinical trials or data from other sources. NHS England has gone one step further than ever before, stipulating that collection of RWE is mandatory in these circumstances, and says SACT is the favoured real world database.

This evidence will then be used to persuade England’s cost effectiveness watchdog NICE to approve permanent funding for a drug.

But the reality is that there is great scepticism and doubt among pharma companies and cancer charities about whether the new CDF will work, and this includes the move to greater use of RWE.

The new CDF was launched just over a month ago, and there is no official word if any company will rely on SACT data to help build an evidence base to bring to NICE.

‘Real promise’ of improved cancer care

Nevertheless, the Lancet Oncology publication (read it in full here) is a welcome sign that the vision of a world-leading cancer database is a step closer.

Public Health England is the body which runs SACT, and it funded the study which looks at 30-day mortality for patients with breast and lung cancer treated with chemotherapy.

This first analysis didn’t focus on how patients responded to different drugs, but rather looked at the ‘big picture’ of how variable factors such as age, general well-being and regional variations in care can affect mortality.

Not surprisingly, the study confirmed that the sickest patients (those with a low ‘performance status’) were more likely to die within 30 days that healthier patients, and also found evidence of significant variation between different cancer centres.

This first study is a landmark for SACT, but also highlights the complexity and pitfalls of trying to interpret RWE.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“These new data provide an interesting first glance at the effectiveness of cancer treatments in the real world. But we mustn’t jump to conclusions at this early stage, and any slight variances in 30-day mortality from chemotherapy across England, which could be due to a number of factors, will now need to be investigated further.”

Baroness Morgan says SACT offers ‘real promise’ in improving the ability to monitor and improve the quality of healthcare in England, and particularly in assessing the effectiveness of new drugs.

But she added: “If it is to be put to the greatest use, the database now needs to be even more complete and accurate.

“Non-compliance by hospitals remains the biggest stumbling block for a variety of reasons, and if we are to make the most of this real-world data, this must be remedied to provide a full picture of our healthcare delivery.

“This important database could, for example, now become critical to the Cancer Drugs Fund as it gathers patient data for new medicines, and we very much look forward to its continued use.”

Writing in a linked comment in the Lancet journal, Professor David Cameron, Edinburgh Cancer Centre, Western General Hospital, Edinburgh, Scotland, says: “This is a very welcome report, and gives for the first time a national picture of factors that affect the likelihood of death, and complements the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) report’s focus on the process of care.”

However he too adds that there remain “significant gaps and deficiencies in the national dataset”.

“To someone who has worked in the UK National Health Service their whole clinical life, it remains a tragedy that we still cannot get complete national (anonymised) datasets to inform clinicians and patients and to drive real improvements in patient care.

“This study, despite its limitations, sets a standard for what healthcare systems should achieve: to routinely record, collate, and report at a national level the negative consequences of medical interventions to improve the quality of health care.”

Pharma’s view

Paul Catchpole, Value & Access Director at industry association the ABPI spoke to pharmaphorum a few months ago, shortly before the launch of the new CDF.

He said that, despite the promise of SACT, most companies would be relying on maturing data from global clinical trials in phase 2, phase 3 or post-marketing studies, to support NICE submissions.

Catchpole said that the development of SACT and RWE was ‘absolutely the right thing to do’, but added: “There is a huge way to go to make that work and there are many outstanding questions.”

Among these were questions about the quality and completeness of SACT data, as well as governance arrangements including who would have access to the data.

These sentiments are in line with the wider feeling among pharma companies and charities that the new CDF remains ‘experimental’ with a system and policy environment sketched out, but with an infrastructure still not in place to implement it.

And stepping back from the inevitable technical difficulties of setting up a groundbreaking clinical database, the big question for England’s NHS is whether the government will adequately fund cancer treatment.

Recent years have seen NHS funding falling further below the European average (as a percentage of GDP), a trend which could undermine any advances towards health data management and personalised healthcare.