Summary

Real-world data collected beyond the clinical trial setting are important for understanding how cancer treatments perform in routine clinical practice. Systemic anti-cancer therapies (SACTs), including chemotherapy, are provided across the English National Health Service (NHS) – and real-world data on the resulting patient outcomes can help improve the effectiveness and efficiency of cancer care. The National Cancer Registration and Analysis Service at Public Health England collects these real-world data using the SACT dataset. Introduced in 2012, the data set collects monthly standardised reports on SACT provision from all NHS providers in England. Information from the data set is reported back to healthcare providers, commissioners and regulatory bodies to improve cancer care, monitor chemotherapy drug wastage and increase patient access to innovative treatments.

 

Problem

The systemic anti-cancer therapies (SACTs) that are available to people with cancer are continually expanding and improving through clinical trials research and subsequent regulatory approval.1 Despite efforts to promote clinical trials, less than 10% of people with cancer are treated in trials.2 As such, research findings from clinical trials may not be representative of most people with cancer in the real world; trial participants are typically younger and fitter, with fewer comorbidities and concomitant medications.3 4 Furthermore, clinical trials generally focus on treatment efficacy, often lacking additional information on long-term treatment safety and patients’ quality of life following treatment.5

Real-world data – patient outcomes data beyond clinical trial settings – offer additional information on the benefits and risks associated with new cancer treatments, often with longer follow-up periods than clinical trials.5 Examples of the unique insight offered by real-world data include information about rates of treatment use, treatment outcomes for different patient and tumour groups, incidence of rare adverse events and patients’ quality of life.5 6 While SACT has been offered by the English National Health Service (NHS) for decades, real-world data on patterns of provision and treatment effectiveness have been limited. Although individual NHS trusts may have collected local data on SACT, comparison across trusts has been hindered by the lack of standardised/consistent data collection and a centralised data repository.1 7

Solution

The SACT data set was launched in 2012 in response to this need. It is a nationally comprehensive data set on real-world SACT use in England, covering all cancer patients treated in the NHS – adult and paediatric patients; acute inpatient, outpatient and community settings; solid and haematological cancers; and patients in clinical trials. The data set is submitted monthly by NHS trusts and is collated by Public Health England (PHE).1 8

Trusts report 43 items, covering patient and tumour characteristics, trust and consultant details, treatment characteristics (e.g. drug names and combinations) and resulting patient outcomes. National, regional and trust-level information is reported back to healthcare providers, commissioners and regulatory bodies, informing the use of different cancer treatments and identifying potential areas for improvement in clinical practice.7 8

 

What has it achieved?

Improving clinical practice

PHE has published data on patient mortality within 30 days of SACT treatment as a potential indicator of avoidable treatment-related harm.6 9 Based on these data, the Blackpool Teaching Hospitals NHS Foundation Trust discovered that a small minority of its cancer patients died from neutropenic sepsis (a life-threatening complication of SACT). The trust subsequently implemented additional measures to prevent neutropenic sepsis in patients undergoing SACT treatment.10

Improving patient access to treatment

Analysis of the SACT data set is carried out to support the evaluation of treatments in the revised Cancer Drugs Fund (CDF) – a source of funding for cancer drugs in England.11

In 2016, NHS England introduced a new appraisal approach for drugs funded by the CDF. In this managed-access scheme, patients are given earlier access to new and promising treatments while uncertainties about the clinical efficacy and cost-effectiveness of the treatments are investigated. During the CDF managed-access period, additional data are collected to answer any outstanding questions about the new treatment and this information is used to determine whether the drug should be routinely funded.11

The final decision as to whether a new drug should enter routine funding in the NHS is made by a committee from the National Institute for Health and Care Excellence (NICE), which considers both real-world data from clinical practice and the evidence from any ongoing clinical trials run by the pharmaceutical company. The real-world data generally come from PHE, which analyses the SACT data at the end of the CDF data-collection period.11

Since its introduction in 2016, the revised CDF has given more than 5,000 patients early access to innovative cancer treatments.12

Monitoring chemotherapy drug wastage

Chemotherapy doses were previously calculated and prepared for each individual patient – a costly and time-consuming process. The NHS Dose Banding initiative standardises chemotherapy doses to streamline drug preparation, reduce drug wastage and save healthcare costs. Patients are treated within a chemotherapy ‘band’ with a ready-made dose that falls within 5% to 10% of their required dose, shortening treatment waiting times and reducing the risk of dispensing errors.13-15 In one hospital trust, dose banding reduced drug wastage from 35% to 15%, with estimated cost savings of £325,000 per year.13

Using reports provided by PHE from the SACT data set, trusts can identify treatments that fall outside of the recommended dose bands (i.e. potential sources of chemotherapy drug wastage). Data can be filtered by tumour and drug type, and can be compared with data from similar trusts.7

 

Next steps

Future efforts will focus on improving the quality of the SACT data set by increasing the completeness and accuracy of data and ensuring timely data reporting by all NHS providers within designated deadlines.7

PHE will continue publishing 30-day mortality data from the SACT data set. Mortality estimates adjusted for patient factors (i.e. case-mix adjusted mortality rates) will be published as indicators of cancer care quality. The team aims to start sending the NHS numbers of all patients who died within 30 days of SACT to the treating trust once every three months, to facilitate internal patient reviews and the identification of inappropriate care.16

 

Further information

    • The SACT data set website with background information, publications/reports by the SACT team and details about ongoing partnerships (e.g. Cancer Drugs Fund and NHS Dose Banding Initiative)
    • The National Cancer Registration and Analysis Service website
  • References:

    1. National Cancer Registration and Analysis Service. Systemic anti-cancer therapy dataset Available here: http://www.ncin.org.uk/collecting_and_using_data/data_collection/chemotherapy [accessed: May 2019]
    2. Booth CM, Tannock IF. 2014. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. British Journal Of Cancer 110: 551
    3. Lewis JH, Kilgore ML, Goldman DP, et al. 2003. Participation of patients 65 years of age or older in cancer clinical trials. Journal of Clinical Oncology 21(7): 1383-9
    4. Hutchins LF, Unger JM, Crowley JJ, et al. 1999. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. The New England Journal of Medicine 341(27): 2061-7
    5. Skovlund E, Leufkens HGM, Smyth JF. 2018. The use of real-world data in cancer drug development. European Journal of Cancer 101: 69-76
    6. Wallington M, Saxon EB, Bomb M, et al. 2016. 30-day mortality after systemic anticancer treatment for breast and lung cancer in England: a population-based, observational study. The Lancet Oncology 17(9): 1203-16
    7. Turnbull A. 2019. Interview with Marissa Mes at The Health Policy Partnership [telephone]. 17/05/19
    8. National Cancer Registration and Analysis Service. About SACT. Available here: http://www.chemodataset.nhs.uk/about_sact/ [accessed: April 2019]
    9. National Cancer Registration and Analysis Service. 2018. 30 day mortality after receiving SACT in England, 2015-2016. London: Public Health England
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    11. NHS England Cancer Drugs Fund team. 2016. Appraisal and funding of cancer drugs from July 2016 (including the new Cancer Drugs Fund): a new deal for patients, taxpayers and industry. London: NHS England
    12. NHS England. New Cancer Drugs Fund benefitting thousands of patients and releasing £140 million for the NHS. [Updated 29/01/18]. Available here: https://www.england.nhs.uk/2018/01/new-cancer-drugs-fund-benefiting-thousands-of-patients-and-releasing-140million-for-the-nhs/ [accessed: May 2019]
    13. Oswald K. 2016. Chemotherapy dose banding to be rolled out across England [online]. The Pharmaceutical Journal. Available here: https://www.pharmaceutical-journal.com/news-and-analysis/news/chemotherapy-dose-banding-to-be-rolled-out-across-england/20201231.article [accessed: May 2019]
    14. NHS England. B02. Chemotherapy. Available here: https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b02/ [accessed: May 2019]
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    16. National Cancer Registration and Analysis Service. 2018. 30 day mortality rates post SACT: evaluation survey and next steps. London: Public Health England