Real world data included in NICE

Real-world data (RWD) sources for oncology products included within the NICE cancer drugs fund (CDF)


The UK’s “cradle-to-grave” system has allowed the collection of a vast amount of electronic health data and administrative records. Arguably, the most extensive data collection has been in the field of oncology through the national cancer registration and analysis service (NCRAS). In this article, we explore the data available within NCRAS and how this has been and can be utilized within the cancer drugs fund (CDF) overseen by National Institute for Health and Care Excellence (NICE), in partnership with NHS England.

What is NCRAS?

NCRAS is one of the largest, most advanced, and complex cancer data curation services in the world, providing near real-time data services covering the entire cancer pathway on all patients in England.

The service collects data on and follows-up ~500,000 patients diagnosed with cancer in England each year (of which ~300,000 are new diagnoses of invasive cancer). A longitudinal, health-care event-based linked dataset is created for each patient.

The NCRAS dataset merges data from multiple datasets and contains three types of tables for patient information, tumour information and treatment information, which are linked by NHS number. In addition, NCRAS curate’s data from several additional datasets enabling linkage between various systems. These datasets include: the cancer outcomes services dataset (COSD), the systemic anti-cancer therapy dataset (SACT), the radiotherapy dataset (RTDS) and the national cancer diagnosis audit (NCDA).

What RWD are routinely collected for drugs in the CDF?

As discussed in previous Remap Consulting news articles, oncology drugs assessed by NICE may be recommended for use within the CDF, enabling a managed access agreement (MAA) period where further data can be collected and analysed before a reappraisal. The MAA period enables companies to conduct further clinical trials or real-world evidence (RWE) generation. In addition, a fundamental element of the CDF is the cancer data partnership between NHS England and Public Health England (PHE). The partnership provides insights into patient outcomes, including duration of treatment and survival based on routinely reported data from the SACT dataset.

The SACT dataset is a mandatory, comprehensive collection of data on systemic anti-cancer therapy use in England. Data is collected for all healthcare trusts in England and covers adult and paediatric patients in the acute inpatient, outpatient and community settings and in clinical trials. There are over 43 dataset items covered by SACT, including but not limited to: patient information, primary diagnosis, morphology, drug name, state date of regimen and final date of treatment.

The SACT dataset is a strongly preferred RWD source by NICE due to its comprehensive and established nature, inclusion within the wider cancer collection landscape at PHE and established data governance processes. However, it should be noted that SACT data collection is not without limitations. Firstly, although SACT data collection is mandatory, data completeness can vary significantly by field. Indeed, a study conducted in 2019, found SACT data completeness in the 2017 to 2018 period varied between 12 to 77%. In addition, whilst many fields in the SACT dataset are beneficial, there are number of key endpoints where it has limited use. For instance:

  • Overall survival is not captured (although this can be collected separately from the Office of National Statistics)
  • Remission is difficult to assess as the outcomes summary does not specify date of remission or capture post-treatment test results
  • Morphological changes cannot be tracked as although this is captured at the start of treatment, it is not recorded at the end of treatment.

A further limitation to be aware of it that the value of data obtained from the SACT during a products time in the CDF will depend heavily on the duration of the managed access period. For products included in the CDF for only short periods, there may be insufficient time to gain valuable information from the dataset.

Nevertheless, despite these weaknesses, SACT is still an important tool for drugs within the CDF. Indeed, a result report published on the NCRAS, states that RWD reported by PHE was the primary information used to answer NICE uncertainty for 25% of CDF treatments (PHE, 2020).

What additional RWE sources can manufacturers utilise?

In addition to routine SACT data collection during the CDF data collection period, manufacturers are able to use the CDF period to conduct further clinical trials or RWE studies. For manufacturers choosing to conduct further RWE generation, there are number of opportunities. For instance, PHE and NICE are open to discussing additional data collection strategies with manufacturers including facilitation of retrospective questionnaires to specialists sent out by PHE on behalf of companies.

Moreover, if additional data sources are required (for oncology and non-oncology drugs alike), the UK offers a number of potential options, including the Clinical Practice Research Datalink (CPRD), which acts as a source of longitudinal and representative, real-time UK primary care data and which can be linked to other UK data sources (including NCRAS). The CPRD covers 42 million patients and includes data on demographics, diagnoses, symptoms, drug exposures, vaccination history, laboratory tests and referrals to hospitals and specialist care.


In summary, the UK has a wealth of RWD sources. For products in the CDF, data is routinely collected from NCRAS (via SACT) as a preferred data source by NICE. However, there is also opportunity to agree additional data collection with PHE on a case by case basis. Furthermore, if primary care data can be beneficial for a specific case, utilising the CPRD and linking this to datasets from NCRAS can provide an overview of a complete patient journey and potentially provide valuable information to support NICE evaluation. It should also be noted that whilst this article has focused specifically on the CDF, this is not the limit for use of NCRAS or the CPRD. Both sources, along with the many other UK data sources, can be highly beneficial for conducting RWE studies for drugs across various indications.

Paul Craddy & Graham Foxon, Managing Directors – Remap Consulting

We always welcome your thoughts and opinions on the topics raised here. Do contact us (, Tel: +44 7957 028493;, Tel: +44 7415 946778) or share your thoughts with us on Twitter (@remapconsulting), where you can also find the latest news.

Stay in the know, subscribe to our newsletter

Be the first to receive exclusive content on the latest from the pharmaceutical and market access sector.