During a pandemic, regular and ongoing collaboration with healthcare agencies is vital to managing the risks to the delivery of patient facing services. Systemic responses to COVID-19, gave rise to significant risks for managed access evidence generation. NICE has sought to minimise the impacts of these challenges in collaboration with all stakeholders.

A risk assessment was performed to evaluate the impact of COVID-19 on Managed Access Agreements (MAAs) in England. Risks were grouped into three broad categories: (i) safe, continued treatment access, (ii) data delivery, and (iii) outcomes. Each risk was prioritized as immediate, short- or long-term and actioned accordingly with agreement from stakeholders.

Disrupted access to treatment was identified as an immediate risk; some patients were self-isolating and therefore unable to attend hospital. This risk was addressed urgently via a statement outlining flexibilities for patients (e.g. relaxed compliance rules, permitting treatment holidays) and clinicians (e.g. remote monitoring and reduced assessment load). Missing data is a short-term risk; assessments during lockdown may not be conducted under standardised, validated conditions, and data entry is delayed due to reduced capacity at treatment centres. In the longer-term statistical analysis plans will need to be reviewed to account for treatment gaps and changes in behaviour which may contribute to drug efficacy outcomes. Reduced uptake during the pandemic may result in decreased power and shorter follow-up duration.

The disruption to healthcare systems caused by the response to COVID-19 will impact on MAAs however the severity of this impact in the long-term is yet to be determined. In the immediate and short-term, activity has focused on minimizing undue harm to patients and preserving the outputs of the MAA data collection. NICE will regularly monitor data collection via our Oversight Committees and further actions to minimise risks will be advised in future presentations of this work.