NHS Digital Data Release Register - reformatted
Corevitas projects
2 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Epidemiology and treatment of HR+/HER2- breast cancer in England (ROTOR) — DARS-NIC-700547-S2M9L
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012 s261(2)(a)
Purposes: Yes (Consultancy)
Sensitive: Non-Sensitive
When:DSA runs 2024-07-23 — 2025-07-22
Access method: One-Off
Data-controller type: NOVARTIS PHARMACEUTICALS UK LIMITED
Sublicensing allowed: No
Datasets:
- NDRS Cancer Pathway
- NDRS Cancer Registrations
- NDRS Linked Cancer Waiting Times (Treatments only)
- NDRS Linked DIDs
- NDRS Linked HES AE
- NDRS Linked HES APC
- NDRS Linked HES Outpatient
- NDRS National Radiotherapy Dataset (RTDS)
- NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
Objectives:
Novartis Pharmaceuticals UK Limited requires access to NHS England Data for the study Epidemiology and treatment of HR+/HER2- metastatic breast cancer in England
The purpose of this study is to further understanding of the epidemiology, real-world treatment of hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC), and associated healthcare resource use in England. This study is an extension of a previous project which was focused on metastatic HR+/HER2- breast cancer treatment. This comprehensive extension seeks to understand disease progression, from early BC (eBC) to recurrences and metastatic disease, considering the treatment pathway followed in those who do and do not progress, the differences in patient characteristics, and effect of any sociodemographic differences in access to treatment. Furthermore, the implementation of CDK4/6 inhibitors in HR+/HER2- BC will be investigated, including the occurrence of dose reduction. Overall, healthcare resource and the resource associated with the progression HR+/HER2- BC will be described, along with that of adverse treatment events.
The research questions and objectives fall into five themes:
1) Epidemiology,
2) Treatment decisions and pathway,
3) Access to treatment,
4) Wastage and dose reduction,
5) Healthcare resource use.
The research questions for these themes are:
What is the risk of BC progression?
What is the time between eBC (stages I-III breast cancer) diagnosis and progression to metastatic disease?
What is the treatment pathway for BC patients from prior to and following progression to mBC?
Do factors such as age, ethnicity, deprivation, and region affect access to treatment for HR+/HER2- BC?
How often do patients experience a dose reduction and what is the cost of wastage due to dose reduction of CDK4/6is?
What are the health care resource use (HCRU) and costs associated with HR+/HER2- BC disease states in secondary care in England?
What is the occurrence and cost of chemotherapy-related toxicity events amongst patients with HR+/HER2- breast cancer?
The primary objectives of this study are to:
To describe and estimate the risk of progression from eBC (including recurrences) to remission, remission to mBC, mBC to death in patients in England.
To describe the post-diagnosis treatment pathway of patients with HR+/HER2- eBC (stages I-III breast cancer) who receive adjuvant treatment
For the most recent two consecutive calendar years by region and, if possible, hospital trust, calculate the total number and proportion of people with HR+/HER2- BC, broken down into;
1) all eBC,
2) those who progress from eBC and treated with adjuvant therapy to mBC,
3) all mBC,
4) all mBC who receive more than one line of therapy1
To describe and compare age, ethnicity, and deprivation differences in treatment choice for 1st line treatment among patients with HR+/HER2- mBC
To describe the number and proportion of patients with HR+/HER2- mBC treated with Ribociclib, Palbociclib or Abemaciclib who experience a dose reduction
To describe the number and proportion of patients with HR+/HER2- mBC treated with Ribociclib, Palbociclib or Abemaciclib who experience a second dose reduction
To describe and compare the frequency of dose reduction for patients with HR+/HER2- mBC for Ribociclib, Palbociclib, and Abemaciclib
To describe and compare the length of treatment for patients with HR+/HER2- mBC with no dose reduction, one dose reduction and two dose reduction for Ribociclib, Palbociclib, and Abemaciclib
To describe at which treatment cycle and time point within the given cycle that HR+/HER2- mBC patients treated with Ribociclib or Palbociclib experience a dose reduction
To describe the costs associated with wastage (dose reduction) for each of Ribociclib, Palbociclib, and Abemaciclib
To describe the number and proportion of patients with HR+/HER2- mBC who switch CDK4/6 inhibitors, and describe what treatment patients switch from and to
To quantify the total all-cause and breast cancer-related secondary care HCRU events and associated costs for HR+HER2- BC patients whilst in specified disease states, e.g., eBC (including recurrences) to remission, remission to mBC, mBC to death.
To quantify the chemotherapy toxicity-related secondary care HCRU events and associated costs of HR+HER2- BC patients.
Novartis Pharmaceuticals UK Limited have a commercial interest as they produce the CDK4/6 inhibitor Ribociclib, a drug that is used to treat HR+/HER2- breast cancer. The potential commercial benefit to Novartis Pharmaceuticals UK Limited of better understanding this care pathway and health resource utilisation is proportionate to the potential public benefits of increased understanding in this area of care and appropriate use of drugs approved for patients with HR+/HER2- breast cancer. Additionally, the objective to describe access to treatment by age, ethnicity, and deprivation differences will help inform decision-making to improve the standard of care among all demographics. An update via a NICE submission and clinical guidelines for Ribociclib might influence prescribing behaviours of NHS Trusts and clinicians. Indirect commercial benefit may be derived from Novartis Pharmaceuticals UK Limited being on resulting publications, which may increase the awareness of Ribociclib for this indication.
To fulfil the study objectives the following NHS England National Disease Registration Service (NDRS) Data are requested:
NDRS Cancer Registration necessary for classification of breast cancer status and patient characteristics, disease progression, treatment pathway, dose reduction and wastage analysis, and analysis of access to treatment.
NDRS Hospital Episode Statistics Admitted Patient Care (HESAPC) necessary for healthcare resource use analysis and cost calculations among patients with early and metastatic breast cancer.
NDRS Accident & Emergency (HES A&E) - necessary for healthcare resource use analysis and cost calculations among patients with early and metastatic breast cancer.
NDRS Outpatients (HESOP) - necessary for healthcare resource use analysis and cost calculations among patients with early and metastatic breast cancer.
NDRS Diagnostic Imaging Dataset (DIDs) necessary for description and analysis of treatment pathway among patients with early and metastatic breast cancer.
NDRS Linked Cancer Waiting Times (Treatments only) necessary for treatment pathway analysis for description of the pathway and when calculating time to treatment. This dataset will also provide confirmation of classification of breast cancer diagnosis and status.
NDRS Linked National Radiotherapy Dataset (RTDS) necessary for treatment pathway analysis for description of the pathway, dose reduction analysis, as well as providing markers of disease progression.
NDRS System Anti-Cancer Therapy (SACT) necessary for baseline demographics and characterisation of patient population, classification of breast cancer diagnosis, makers for disease progression, treatment pathway analysis, dose reduction and drug wastage analyses. This dataset will also provide covariates which will be considered for adjustment in analyses.
NDRS Cancer Pathway necessary for the treatment pathway analysis and assessing regional differences for access to treatment.
The level of the Data will be Pseudonymised
The available data variables have been carefully considered and only variables necessary for analysis to answer the research questions are being requested. The Data will be further minimised as follows:
Limited to a study cohort identified by NHS England as meeting the following criteria:
Patients diagnosed with breast cancer, aged 18 years and over at diagnosis, between 01/04/2012 and 31/12/2021 (the latest available) for NDRS Cancer Registrations.
Limited to conditions relevant to the study identified by specific ICD or OPCS codes: Male and female breast cancers ICD10 C50x and Estrogen receptor-positive or progesterone receptor-positive AND HER2 negative.
Limited to the following geographic areas: All patients resident in England.
All follow up data for the cohort (NDRS HES, NDRS DID, NDRS Linked Cancer Waiting Times, NDRS RTDS, NDRS SACT and NDRS Cancer Pathway) limited to 60 days prior to diagnosis to the latest available.
A separate dataset, linked to the patients in the cohort, containing details of previous diagnosis of ICD10 C50x and Estrogen receptor-positive or progesterone receptor-positive AND HER2 negative between 01/01/1995 and 31/03/2012. This dataset will contain fields from the Cancer Registry table only (the same fields as selected in supporting data specification data dictionary).
Novartis Pharmaceuticals UK Limited is the sponsor and the sole data controller as the organisation responsible for ensuring that the data will only be processed by Health iQ (the processor) for the purpose described above. CorEvitis is the trading name for Health iQ.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(f) - the processing is necessary for the legitimate interests of the data controller or the legitimate interests of a third party.
Novartis Pharmaceuticals UK Limited (Novartis) has performed a legitimate interests assessment and this has determined that the processing of personal data in this study can be conducted using the legitimate interests basis. Novartis Pharmaceuticals UK Limited's legitimate interest as a pharmaceutical company is to discover new ways to improve and extend peoples lives through the discovery, research and development of innovative treatments and technologies. Novartis Pharmaceuticals UK Limited manufactures Ribociclib which is indicated for breast cancer and anticipates that the data may help with understanding the treatment landscape of HR+ HER2- breast cancer and the outcomes of patients undergoing treatment. There is therefore a legitimate interest for Novartis Pharmaceuticals UK Limited to perform this research, to increase understanding of the treatment pathways for HR+ HER2- breast cancer, patient and HCP needs, and improvement areas in Novartis therapeutic areas of interest'.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
The funding is provided by Novartis Pharmaceuticals UK Limited. The funder will have no ability to suppress or otherwise limit the publication of findings. Funding is in place until 31/12/2024.
Health iQ is the data processor acting under the instructions of Novartis Pharmaceuticals UK Limited. Health iQs role is limited to data storage, data analysis, interpretation. Amazon Web Services (AWS) is a data processor who provides IT hosting services to Health iQ and will store the data as contracted by Health iQ. There are no other organisations involved in this project.
Data will not be accessed by individuals other than substantive employees of the organisations named as processor(s) within this agreement (Health iQ).
Patients and the public have not been involved in the development of this research. The current research is designed to further understanding of the epidemiology, real-world treatment of hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC), and associated healthcare resource use in England. The results generated may lead to future patient involvement in projects which focus on patient centred research, beyond the nature of this work.
In line with the national data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and section 251(11) of the National Health Service Act 2006.
Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out
Expected Benefits:
The findings of this research study are expected to contribute to evidence-based decision-making for policy makers, local decision-makers such as doctors and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.
The use of the data could:
help the health system to better understand the health and care needs of populations.
lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
advance understanding of regional and national trends in health and social care needs.
inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
Patients with HR+/HER2- breast cancer will benefit from better informed treatment decisions. This study will assess access to treatment in terms of age, ethnicity, and deprivation differences which will help to identify areas of good practice and equally areas of poorer practice that need addressed.
It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.
Novartis Pharmaceuticals UK Limited, (as part of supporting an evidence-based health technology assessment) will need to take the necessary action based on the outputs derived from this study in order to generate up-to-date real-world epidemiological and treatment evidence which will be included in a NICE submission and also to realise the potential improvement opportunities. For example, they will need to share the findings with relevant healthcare providers in order to ensure the results influence the best decision making for treatment of patients with HR+/HER2- breast cancer.
Novartis Pharmaceuticals UK Limited plan to disseminate findings through relevant channels, such as peer reviewed journals and conferences, in order to influence improvement of treatment for HR+/HER2- breast cancer patients.
Outputs:
The expected outputs of the processing will be:
A report of findings prepared by Health iQ to Novartis Pharmaceuticals UK Limited throughout the project and at the end.
Submissions to peer reviewed journals with drafting planned to commence in 2024.
Presentations at appropriate conferences, e.g., European Society for Medical Oncology (ESMO) Congress 2025, The Professional Society for Health Economics and Outcomes Research Europe (ISPOR Europe) 2025.
Publication of results on publicly accessible registry.
A database to be utilised as a resource for health research
Results will also be included in Novartis Pharmaceuticals UK Limited future NICE submission for Ribociclib to provide real-world data on HR+/HER2- breast cancer treatment in England
The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
Peer-reviewed journals
Open-source frameworks: This research will be registered on clinicaltrials.gov and will be updated with results when they are available. The clinicalTrials.gov identifier (i.e. NCT number) will be listed in all outputs generated from the study. The research may also be registered on the Novartis Clinical Trials Results database (NovCTR).
Posters displayed at appropriate conferences (listed above).
Drafting is planned to commence in 2024 soon after the completion of the analysis, which Health iQ would aim to have ready by Spring 2025.
Processing:
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). NHS England will provide the relevant records based on the inclusion criteria from the NDRS Cancer Registration, NDRS HESAPC, NDRS HESOP, NDRS HESA&E, NDRS DID, NDRS Linked Cancer Waiting Times, NDRS RTDS, NDRS SACT and NDRS Cancer Pathway datasets to Health iQ. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.
Health iQ stores Data on the Cloud provided by Amazon Web Services UK (AWS).
The Data will not be transferred to any other location.
Health iQ Ltd analysts will access record level data via the AWS Data Warehouse using a secure VPN (with 2FA) connection only. Multifactor authentication (MFA) is required for remote access. The Data will remain on the servers at Health iQ at all times.
All remote access will meet the following obligations required by NHS England:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisations DSPT (or other security arrangements as per this agreement) and complies with the organisations remote access policy.
The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).
The Data will not leave England at any time.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality.
The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data.
Analysts from the Health iQ will process and analyse the Data for the purposes described above.