University of Edinburgh

Dr Mahéva Vallet

Seagen

DL_2022_032

New medicines are in development that may improve survival after treatment for breast cancer. The UK regulators and NHS Scotland need strong evidence on the value of new treatments prior to approving medicines as standard care paid for by the NHS. While clinical trials can provide much of this evidence, there is also a need to provide evidence on the current ‘real-world’ patient population, standard treatments and current outcomes. The project will generate real world evidence on the current metastatic breast cancer patient pathway, on patients from NHS Cancer Centres in Leeds, London and Edinburgh. The anonymised data from Leeds and London will be sent to the NHS Lothian team. The analysis takes place within the NHS by NHS staff, with only a summary report that does not contain individual patient data being released for the purposes of NHS Health Technology Assessment. The project output will enable NHS decision makers to make better informed decisions on future medicines to ensure the NHS is providing high value care to the patients it serves.

New medicines are in development that may improve overall survival after treatment for breast cancer. NHS cancer services need strong evidence on the safety, efficacy, effectiveness and cost-effectiveness of new treatments prior to approving medicines as standard care reimbursed by the NHS. While clinical trials can provide much of this evidence, there is also a need to provide evidence on the current ‘real-world’ patient population, standard treatments and current outcomes within NHS cancer services. This evidence is essential for NHS decision makers to understand how the care that they currently provide might be affected by the future introduction of new medicines. Such evidence can only be generated by the ‘service evaluation’ of routine NHS care. Electronic Health Records are now sufficiently robust to enable such analysis. Since the NHS in Scotland and England relies on drug manufacturers to submit evidence for the appraisal of new medicines a mechanism is required for companies to commission the necessary analysis and generate a suitable real world evidence as an essential component of their submissions to the NHS. Without this evidence the NHS is unable to make a robust assessment of the value of new medicines. We are proposing a service evaluation study in collaboration with Leeds teaching hospital Trust (LTHT), NHS Lothian and Guy’s and St Thomas Hospital (GSTT), to extract, curate and analyse data that are routinely collected during the treatment of metastatic breast cancer patients, thereby enabling a deeper understanding of patient outcomes. The evidence gathered by this retrospective study will also support Seagen in their internal launch strategy of a new agent, support future HTA (Health Technology Assessment) submissions and inform conversations with NHS providers who are assessing adoption strategies with a view to maximising the value of NHS Cancer Services.

Other

12/04/2023

Anonymous

Release