NHS England Specialised Services is committed to routinely assessing that policies for using the drugs, devices and procedures they directly commission are implemented equitably.
Arden & GEM’s specialist public health team, Solutions for Public Health (SPH), was commissioned by NHS England to develop a methodology for delivering the compliance audits and to undertake audits for a selection of commissioning policies that required updating.
SPH was able to select the best data sources for auditing purposes, assess whether implementation met the commissioning criteria set out in the policy and determine whether patients have received the expected benefits from the policy interventions. The audits have also played an essential role in identifying and confirming proposed changes to the commissioning policy in response to new developments.
The challenge
Specialised services are low volume and high cost services that are best commissioned and provided at scale, so that expertise is concentrated in a small number of specialist centres. Specialised services commissioning policies relate to a variety of interventions spanning drug treatments, medical devices and surgical procedures for a wide range of medical conditions.
For the drugs, devices and procedures they directly commission, NHS England Specialised Services is committed to initiating routine compliance testing of the implementation of adopted policies. This includes assessing:
- The number and characteristics of patients who have been treated with the intervention
- The extent to which there is equality of access to treatment throughout the NHS in England
- The extent to which numbers treated and associated costs are in line with those expected when the policy was adopted
- Whether the use of the treatment is compliant with criteria set out in the commissioning policy
- Were the health outcomes experienced by patients similar to the outcomes expected in the policy proposal?
Our approach
In 2023, the SPH team undertook a pilot project to develop an approach to the delivery of clinical audits. The pilot involved taking a specialised commissioning policy for a drug intervention, a medical device and a surgical procedure and identifying the routine data sources that could be used to respond to the compliance audit requirements for each type of intervention.
Identifying the best data
A number of potential data sources are available to inform compliance audits including:
- Secondary Uses Service (SUS)
- Drugs/Devices Patient Level Contract Monitoring (DrPLCM/DePLCM)
- Clinical Utilisation Platform for Integrated Datasets (CUPID)
- Prior approval forms via the Blueteq system
- Clinical registries.
Some of these data sources are held by NHS Arden & GEM, on behalf of NHS England, while others are held by outside agencies. One of the key tasks of the compliance audits is to identify the best data sources to address the questions that need to be answered for each audit.
The pilot assessed the strengths and weaknesses of each data source in relation to the key aims of the compliance audit including the availability of data on the demographic characteristics of the patient population. The pilot exercise resulted in the categorisation of compliance audits into three levels depending on the type of routine data available to support the audit.
Exploring variation
To assess equity of access to interventions provided under the policy, the SPH team analysed the data sources by available demographic characteristics such as age, ethnicity, sex and deprivation. Geographical variation was also assessed by generating population-based activity rates to highlight any differences in activity rates between different regions of England.
Completing compliance audits
Since the completion of the pilot, the specialised services commissioning team has tasked the SPH team with completing compliance audits on:
- Levodopa intestinal gel for Parkinson’s disease
- Rituximab for neuromyelitis optica spectrum disorder (NMOSD)
- Emicizumab for haemophilia A with and without inhibitors to factor VIII.
Outcomes
The key outcomes and findings from the compliance audit work to date have included:
- Identification of additional sources of data to help inform specific compliance audits, for example, we were able to access a clinical database for Ritixumab for the NMOSD audit.
- Added value gained from combining datasets subject to information governance requirements. For example, we have been able to improve the accuracy of ethnic group coding by matching patient records in SUS and DrPLCM/DePLCM and using data from one data source to fill gaps in the other data source.
- There is value in triangulating findings from different data sources, even if the numbers of patients do not entirely match because often the yearly trend is similar.
- The extent to which it is possible to measure compliance against inclusion and exclusion criteria stated in each commissioning policy varies according to the data sources available. Where prior approval forms are completed (for policies developed since 2018) this is easier than for policies where prior approval forms are not available.
- Timeframes for completion need to be flexible to take account of need to follow data request processes and information governance requirements of other agencies.
- Some commissioning policies indicate that registration of patients with a clinical registry is a specific condition of funding the intervention, but this does not appear to always be followed.
Any changes to policy or implementation arising from the audits will be taken forward by the multi-agency clinical reference group responsible for supporting commissioners to develop and implement the policy.
Quotes about the positive impact of the programme:
“Many thanks for the work done. It is a helpful review and we will be using it to inform the discussions once they resume.”
“I’ve only had a quick flick but they look great and exciting to see costs in there too. I’m very grateful to the team for their work”
Other compliance audits are underway on spinal rods for scoliosis and catheter ablation for atrial fibrillation.
Find out more about the work of Solutions for Public Health.