Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Abstract

Purpose New treatments are introduced into standard care based on clinical trial results. However, it is not clear if these benefits are reflected in the broader population. This study analysed the clinical outcomes of patients with metastatic castration‐resistant prostate cancer, treated with abiraterone and enzalutamide, within the Scottish National Health Service. Methods Retrospective cohort study using record linkage of routinely collected healthcare data (study period: February 2012 to February 2017). Overall survival (OS) was analysed using Kaplan‐Meier methods and Cox Proportional Hazard models; a subgroup analysis comprised potentially trial‐eligible patients. Results Overall, 271 patients were included and 73.8% died during the study period. Median OS was poorer than in the pivotal trials, regardless of medication and indication: 10.8 months (95% confidence interval [CI] 8.6‐15.1) and 20.9 months (95% CI 14.9‐29.0) for abiraterone, and 12.6 months (95% CI 10.5‐18.2) and 16.0 months (95% CI 9.8—not reached) for enzalutamide, post and pre chemotherapy, respectively. Only 46% of patients were potentially “trial eligible” and in this subgroup OS improved. Factors influencing survival included baseline performance status, and baseline prostate‐specific antigen, alkaline phosphatase, and albumin levels. Conclusions Poorer prognostic features of non‐trial eligible patients impact real‐world outcomes of cancer medicines. Electronic record linkage of routinely collected healthcare data offers an opportunity to report outcomes on cancer medicines at scale and describe population demographics. The availability of such observational data to supplement clinical trial results enables patients and clinicians to make more informed treatment decisions, and policymakers to contextualise trial findings.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

“…• Who pays for the cost of the oncology medicine during the evaluation period -seen as a particular issue with olaratumab [34] • Health authorities may not always be fully compensated in payback schemes when the new oncology medicine is not as effective or costeffective in routine clinical care as expected • Possible difficulties at the time of finishing agreements to lower prices if pertinent to reflect the actual observed effectiveness in clinical practice if there is a reluctance among companies to reduce the prices of their patented medicines (especially in reference priced countries) alongside pressure from clinicians who have already incorporated the new medicine into their clinical protocols collected in busy oncology clinics for any future outcomebased MEA. This builds on approaches such as the Cancer Medicines Outcome Project (CMOP) program in Scotland starting with prostate cancer [80,81], as well as the Data the Systemic Anti-Cancer Therapy (SACT) dataset project in England [82]. This also builds on recent initiatives in the United Kingdom that pharmaceutical companies need to start collecting outcome data for any new oncology medicines targeted for consideration for funding within the UK Cancer Drug Fund, with such situations likely to grow [83].…”

Healthcare Costs for Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone or Enzalutamide

“…Instead, we observed that post-chemotherapy patients in both treatment regimens had higher resource utilisation. Relatedly, the findings from our clinical paper [14] showed that post-chemotherapy patients had lower median overall survival [abiraterone 10.8 months (95% CI 8.6-15.1); enzalutamide 12.6 months (95% CI 10.5-18.…”

Opportunities and challenges when using record linkage of routinely collected electronic health care data to evaluate outcomes of systemic anti-cancer treatment in clinical practice

“…Permission to use all requested datasets for CMOP studies has been approved by the Public Benefit and Privacy Panel for Health and Social Care,[22] and access has been granted through the Glasgow Safe Haven – a secure, closed environment hosted by the University of Glasgow and supported by NHS GGC. [23] Data has been pseudonymised, and no identifying information has been made available to researchers; results to be released from the Safe Haven are subject to statistical disclosure procedures. Therefore, additional ethical approval was not required.…”