Steve How, Paul Midgley and Oli Hudson of the Wilmington Consulting Team find some answers in recently updated NHS England guidance

Transforming services is key to making the NHS sustainable and recently introduced integrated models of care and budgetary management aim to rapidly drive this type of fundamental change.

The assurance process that commissioners should follow in order to obtain approval for major service change is outlined in recently updated NHS England guidance on Planning, assuring and delivering service change for patients.

One particularly interesting aspect of the guidance is the centrality of clinician involvement in transformation and the assertion that front line clinicians should be involved in developing proposals.

Key requirements for major NHS service change

NHS England’s Planning, assuring and delivering service change for patients, which was updated in March, provides a good practice guide for commissioners on the NHS England assurance process for major service changes and reconfiguration.
Many elements of it, particularly the need for clinical engagement and approval, and strong clinical evidence, can also be applied to lower levels of change, such as the introduction of new drugs to improve care pathways.

According to the document, the government’s four tests of service change are: strong public and patient engagement; consistency with current and prospective need for patient choice; clear clinical evidence base; and support for proposals from clinical commissioners.

With regards to developing plans for service change, the guidance makes it clear that front line clinicians affected by proposed changes should be involved. It says clinicians should ‘determine and drive the case for change, based on the best available evidence’.

It also states: “Clinicians are powerful advocates and play an important role in communicating the benefits of change to a wider community.”  For complex change, it suggests that commissioners should consider seeking Clinical  Senate advice.

Although clinical engagement currently happens at a micro level, with some commissioners taking leads from particular clinicians, it often gets overlooked in transformational change involving multiple pathways and transformations.

This can, of course, lead to major problems further down the line if clinicians do not get the chance to voice concerns about change until it has been introduced, or simply do not understand the need for it.

However, although it makes perfect sense for the staff involved in implementing service change to be the people who ‘drive’ the original concept, the reality is that front-line clinicians and clinical commissioners tend to have very  different priorities. Consequently, clinicians often find it hard to make the case for a transformative product or service because they do not understand the wider commissioning priorities and are not able to couch their case for change in the right terms.

Equally, commissioners can find it hard to win clinicians’ hearts and minds on change, specifically when it entails variations to their normal routines.

Why is assurance important for pharma?

If transformation is happening within a service and it is affecting a relevant product or disease and therapy area, pharma needs to understand the levels of assurance required and ensure that local transformation agencies are aware of them too.

To engage with key stakeholders, pharma should highlight the relevance of its product in the context of transformational change and show how it will enhance care pathways in terms that will resonate with different audiences involved  in assurance.

Strong evidence-based material will be essential for these conversations. To help gather the required evidence, pharma could, for example, encourage customers to upload case studies on to the NICE website, where NHS evidence gets an impartial star rating. Pharma should also consider posting evidence on other life sciences repositories of peer  reviewed papers.

Getting it wrong with regards to service change can be very costly and the guidance cites a high-profile programme that has been subject to both Judicial Review and referral to the Secretary of State. It is estimated to have cost more than £6 million and the proposed changes have not been implemented.

To support the assurance process it is, therefore, important for pharma to try to ‘risk-proof’ its proposals by ensuring that they align with current NHS best practice, such as NHS RightCare, which has defined optimal patient journeys for various conditions. Another good example is Getting It Right First Time (GIRFT) – a national programme, led by frontline clinicians to help improve the quality of medical and clinical care within the NHS by identifying and reducing unwarranted variations in service  and practice.
If pharma feels that assurance processes have not been followed, for example, with regards to clinician involvement, it could challenge commissioners about their clinical evidence base and the people they have consulted.

It could also help clinicians who are concerned about service change, and feel they have not been fully consulted, to gain a wider consensus of opinion among other groups of clinicians and establish an evidence base. Pharma could also help those clinicians identify the right person to approach to make a complaint; the best channel of communication to use and the most effective way in which to couch the concerns to ensure they will be heard.

Block contracts and clinical assurance

In earlier articles, we identified that, as part of integrating services, many contracts are moving from Payment by Results (PbR) to block contracts with outcomes metrics, as a step towards capitated fees. However, it has come to our attention that some of these ‘new’ block contracts are less than robust in the context of  the Five Year Forward View (FYFV).

For example, due to statutory requirements and short-term financial and workforce pressures within organisations, some services are moving patients wholesale on to subcutaneously administered biologics to save on infusion costs, as within a block contract there is an incentive to reduce service cost. However, if there is a clinical outcomes and whole pathway cost case for utilising an infused biologic – in the context of optimal care – clinicians could challenge this ‘wholesale transformation’ as part of the system-wide assurance process. The wholesale switch to subcutaneous biosimilars, as part of an incentive within block contracts, could also be challenged by clinicians on  similar grounds.

Interestingly, the issue of winding the clock back to block contracts as a mechanism to manage population-based payments is being challenged within the accountable care contract legal cases.

Engaging with clinicians and other key stakeholders

The fact that clinicians – the key stakeholders with whom pharma holds relationships – are so central to service change provides a golden opportunity for industry to make its case for potentially transformative products and services.

Pharma can educate clinicians about transformational change that is happening in their area, the implications of it and why a  potentially transformative new product or service is needed from the clinician’s perspective.

It can also enable clinicians to ‘drive’ service change by helping them to understand transformation from the perspective of a commissioner who is likely to take a much wider view on the improvements and cost-savings that change can bring to other parts of the NHS, such as A&E.

Once clinicians are on board, pharma should identify and engage with those involved in commissioning and service transformation. For example, pharma needs to identify the person leading the programme office to develop the change. It also needs to identify the senior responsible officers leading the change; the programme managers leading some of that transformation; and the clinical and commissioning staff involved and which services they sit in.

Pharma should then define the needs of those different groups and develop messaging for them. It could also support and help transformation leads, particularly at the micro level, in getting wider consultation and ensuring that new products and services are signed off at the right level and that clinicians fully understand the need for change and are supportive of it.

Service transformation is essential for the future of the NHS; however, it can be a risky business and getting it wrong can be extremely costly. The assurance processes laid out by NHS England for commissioners are, therefore, key to helping minimise those risks and deliver better and more sustainable care.

They also provide useful insights for pharma on why it should tailor its own approach to transformation in line with NHS best practice, and the level and type of engagement required to gain the necessary assurance.

This engagement should range from educating a clinician about a product or service and helping them to drive change by understanding the wider transformation picture, to liaising with commissioners and transformation leads to prove how a proposal will be truly transformational.

Steve How, Paul Midgley and Oli Hudson are all part of Wilmington Healthcare’s Consulting Team. For information on Wilmington Healthcare, log on to