Prioritising which services a CCG can afford – and deciding what it can't – is a big and legally risky task. Dr Henrietta Ewart provides some top tips
1. Remember you will be judged on the process, not the decision itself
The biggest potential pitfall for CCGs is the possibility of being challenged on a funding decision via a judicial review. The lesson to draw from PCTs, which have been priority setting for years, is that a judicial review cannot tell a CCG it should have funded a particular treatment for a certain patient – but it can quash the decision if the decision process itself was flawed. In short, you need to be confident you can defend a decision not to fund a treatment if challenged. CCGs are also required to set out their decision-making process in their constitution.
The legal fees involved in a judicial review can run into tens of thousands of pounds and so it is a costly, as well as time-intensive, process for a CCG to find itself in. It is also avoidable if the appropriate time and resource is given to how the CCG decision-making process will operate in the first place. There are four types of decisions you need to have robust, transparent systems in place for:
• which treatments not to routinely fund at all
• restricting access to services or treatments against tight patient selection criteria
• deciding to deliver services differently – for example, in a community rather than a hospital setting
• decisions about individual patients who may be exceptions to general policies.
PCTs have tended to focus on new treatments, but the current context of increasing demand while resources tighten means existing treatments must come increasingly under review. This will make prioritisation harder because it will involve taking services that – while perhaps lacking evidence of effectiveness – are valued by patients and healthcare staff anyway.
2. Start by developing a framework for the ‘three Ps' – principles, policies and processes
• Principles set out the criteria against which options for investment or disinvestment will be considered. They can be described as the ethical framework of the CCG and should reflect its values. Examples include consideration of clinical and cost-effectiveness, and giving greater weight to interventions that have a big impact on health over those with a smaller or uncertain impact. A new challenge for CCGs as a result of tightened resources will be having to consider the comparative effectiveness of a treatment, so principles will need to include how resources will be allocated to achieve maximum benefit – since not everything that is effective will be affordable.
• You will need policies that set out how the principles will be applied to different types of commissioning. For example, you may want to state that decisions will generally be taken as part of an annual commissioning round, to enable true prioritisation between all options, rather than on a single-issue basis throughout the year. You will need a policy that describes the general principles of how you will respond to requests for funding for individual patients – for example, by having a clear statement that the individual funding route should not be used for the in-year introduction of new treatments.
• Processes will describe how decisions will be made – for example, committee structures, membership, technical and administrative support, and how decisions will be implemented, monitored and reviewed.
3. Ensure all GPs know how decisions have been reached
Given that CCGs have to make tough decisions and live with them, it is important they have support from interested parties – including constituent practices – for their principles, policies and processes.
This is so that even when people are not happy with a particular decision they can at least understand how it was reached. In many places, CCGs may plan to adopt existing approaches established by the current PCT. This is good for consistency and building on experience, but may mean that CCGs are not clear on the implications. If this has not been worked through with stakeholders before the policies are adopted, there may be problems.
At worst, a CCG may appear to follow a given policy or process but in practice ignore it, because it was not happy with the decisions that resulted.
If a CCG is confident a decision not to routinely commission a specific intervention is appropriate, it needs to be sure it can implement that decision.
A warning sign is when large numbers of individual requests are received for a ‘not routinely funded' intervention. This suggests the rationale for the decision has not been clearly communicated and some clinicians are finding it difficult to accept. Where this happens, the decision needs either more robust implementation or a rethink.
4. Consider sharing prioritisation processes with other CCGs
Prioritisation processes are resource intensive, so there is sense in having shared arrangements across a group of CCGs. You can decide whether you want to delegate decision making to some sort of consortium or whether you want to delegate only the support elements – for example, evidence reviews, equity impact assessment, local activity and cost modelling – with the final decision remaining with the CCG.
5. Decide whether existing arrangements will meet the future needs of the CCG
CCGs need to find out what arrangements are currently in place for prioritisation in the existing PCT and take a view on whether they will meet their needs in future.
Work with your PCT or cluster to find out whether the current system could be transferred into the new world. CCGs need to understand the methodology that will be used to provide evidence for decision making.
A full-scale academic technology assessment for each clinical issue is likely to be beyond the resources available and would also take too long to be useful for real-world commissioning.
On the other hand, pulling off a few abstracts from PubMed or Google is not a robust process.
There must be an agreed methodology for pragmatic rapid evidence review so that you will be happy with decisions taken on it.
6. Remember, not only patients can challenge decisions
To date, judicial review proceedings against PCT decision making have been made by patients unhappy with funding decisions. With increasing restrictions on funding, other bodies – such as pharmaceutical companies – may raise challenges.
Getting a robust system in place for prioritisation is a daunting task for CCGs, but don't avoid it until difficult decisions or challenges indicate you have a problem.
Work with all your stakeholders to ensure that they can support this in practice and, if not, make sure it is revisited to get their engagement.
Make sure you have the resources to support the methodology and processes you want to follow – if not, decide what is achievable.
Make contact with the person leading the existing arrangements in your PCT – usually a public health consultant.
They will be able to support the organisational development issues in your CCG, advise on what support can be offered through public health – which played a big role in priority setting under PCTs – and guide you through existing arrangements for priority setting at population and individual case levels.
Priority setting is very resource intensive and requires input from the senior players in a CCG. However, the outlay is more than offset by costs avoided – from decisions not to commission certain interventions and, increasingly, through costs saved from decommissioning.
Dr Henrietta Ewart is a consultant in public health medicine at Solutions for Public Health (sph.nhs.uk)
The National Prescribing Centre has guidance on local decision making, including a suite of e-learning resources.
Lessons from the past:
Ann Marie rogers vs Swindon PCT (2006)
Mrs Rogers had HER2+ early breast cancer and been recommended treatment with herceptin.
At the time, herceptin had not been recommended by NICE for this indication and so PCTs could choose whether to fund it or not. There was political sensitivity about this, as the secretary of state for health at the time had expressed her opinion that PCTs should not decline to fund herceptin on ‘financial grounds alone'.
Although this was opinion and had no legal force, it did cause concern to PCTs and SHAs.
Mrs Rogers had HER2+ cancer, so met the indication for the drug and had funded initial treatment privately. When her money ran out she sought funding from the PCT.
The PCT's policy was to consider every patient requesting herceptin in early stage breast cancer as an individual case to see if there was any ‘exceptionality' that would justify funding.
The Swindon Clinical priorities policy stated that in considering requests, it would take into account all relevant evidence but not the cost of the treatment. The PCT declined funding on the basis that it could find nothing exceptional in Mrs Rogers's case, compared with other women with HER2+ early breast cancer – of whom they estimated there were about 20 in the PCT population.
The court found the PCT decision to be ‘irrational and unlawful'. The PCT had stated that financial considerations were irrelevant and had funds to treat the relevant patient group. Once this was established, the court considered that there was no basis for insisting on a demonstration of exceptionality.
Lessons to learn
Be transparent about the basis for the CCG's decision. If you accept that there is evidence for clinical effectiveness but you cannot afford the treatment because there are things you have prioritised more highly, then say so.
AC vs Berkshire West PCT (2011)
AC was a male to female transsexual who had been denied funding for breast augmentation surgery by Berkshire West PCT. The PCT policy made NHS funding available for core services for gender identity disorder, including gender reassignment surgery and hormone treatment.
The PCT had based its decision not to make breast augmentation part of the core services for GID on the basis of an evidence review demonstrating lack of evidence for clinical or cost-effectiveness for this element of treatment.
AC was not satisfied with the breast growth he had achieved from hormones and requested funding for augmentation mammoplasty. As this was outside the core services routinely commissioned, the request was considered for individual funding on the basis of exceptionality.
The PCT concluded that AC did not have any exceptional circumstances compared with other women – whether natal or transsexual – who might seek breast augmentation.
Both the High Court and the Court of Appeal supported the PCT policy on the
basis that its statutory responsibility to manage within budget inevitably required difficult choices, and that the choice to make this intervention low priority was not irrational.
Lessons to learn
The ability to demonstrate how a decision was made in line with clear – and legal – principles, policies and processes will reduce the likelihood of a judicial review challenge being made or being successful.
