Feature / Exceptional support

The costs of individual funding requests vary widely across PCTs. But the National Prescribing Centre can help PCTs balance financial accountability, ‘exceptional’ clinical need and the demands of the NHS Constitution, says Philip Grant.

Expectations have risen to unprecedented levels as patients and their carers have been promised high-quality and prevention-focused services available when they need them. Nowhere is this expectation more intensely and emotively felt than through the increasing number of professionally submitted requests for low-volume, high-cost medicines or procedures.

These are typically for procedures or drugs that a primary care trust has a policy not to fund, perhaps awaiting review and guidance by the National Institute for Health and Clinical Excellence (NICE), but where a doctor considers the patient to be exceptional to the general policy. Alternatively, the treatment may be for a very rare condition not covered by the contractual arrangements between PCTs and their providers. Doctors wishing to use these interventions as part of patient treatment are required to make funding requests to the relevant PCT.

Individual funding request (IFR) panels, which consider such pleas, must make tough decisions that may have significant financial consequences for their primary care trust.

These requests are submitted in the full knowledge that the NHS Constitution gives a legal right not to be discriminated against in the provision of NHS services, and the right to expect local decisions about the funding of medicines and treatments to be made following proper consideration of the evidence. 

The NHS Constitution says: 'If the local NHS decides not to fund a drug or treatment you or your doctor feel would be right for you, they will explain that decision to you.'

So how does this sit with very clear QIPP (quality, innovation, productivity and prevention) expectations that the NHS will deliver £15bn -£20bn of efficiency savings by the end of 2013/2014? How does it fit with promises made by the previous and current governments to give patients more choice, convenience and control over their care? And how does it sit with limited financial growth for the foreseeable future after 2010/11?

These are significant challenges. But the combination of primary care prescribing alongside the cost of secondary care procedures and the significant secondary care drugs bill is a big target against which QIPP savings can be secured. This is particularly true when the extent of IFRs potentially approved outside of the budgeted contracting process are considered.

Tricky decisions

So how do you distinguish between highly emotive, but poorly evidenced arguments and the rights of often under-represented patients entitled to rare procedures or medicines? How do you make sure your decision-making processes stand up to the most tenacious of potential challenges inevitably conducted in the very public gaze of local, and sometimes national media audiences? 

In a survey of 130 PCTs commissioned by the National Prescribing Centre in 2008/09, the number of exceptional funding cases considered by individual PCTs during the financial year varied from just one to approximately 1,000, with 12% of PCTs saying they had considered more than 200 cases. Even before the cost of the procedures or drugs are considered, this must result in significant variations in the cost of administering the specific funding panels, as well as the associated appeals process.

The same survey revealed that on average across England 47% of all appeals were upheld resulting in enforced costs of the treatment or medication referenced within the claim. It also raises questions about the robustness of the governance process underpinning the original funding panels and the decisions reached.

One of the fundamental underpinning principles of patient choice and control agenda, and of the QIPP framework, is driving up quality. Providing high-quality services results in longer-term productivity and efficiency savings. This principle is equally applicable to the processes for decision-making about medicines, and PCTs should strive to improve their arrangements. An interim QIPP challenge to make £10bn of efficiency savings by 2012/13 must include quality improvements. 

Putting the frontline first: smarter government, published in 2009, made clear the previous administration's intention to drive down the costs of management, back office support functions and procurement across public services, releasing £1.8bn of annual savings.

Aligning the significant and high-cost variations between IFR processes and decisions across PCTs has the potential to make substantial contributions to these expectations. In support of this agenda the National Prescribing Centre (NPC) was commissioned in 2009 by the Department of Health to work with leading experts to provide support to local NHS organisations and equip them with the tools to review and develop their local decision-making. The NPC also supports consistency in the generic training of local decision-making groups, as well as providing a mechanism for sharing best practice and interaction.

Northern light

One PCT to begin to draw on the available expertise and support is NHS Bradford and Airedale. It has initiated a review of its local panel decision-making after identifying that in a typical month its panel made recommendations with cost implications in the region of £200,000. These were made without formally connecting such decisions to the PCT’s mainstream commissioning processes.

Greg Fell, the PCT's consultant in public health, hopes the review will lead to robust discussions on the part of commissioning managers. They have no additional budgets for such cases and may therefore be expected to deliver further efficiency savings from their commissioning budgets to fund these costs. 'We anticipate an initial barrage of shock-horror reactions as people come to terms with the amount we spend on IFRs, [and] then a whole lot of interest in how and why we come to these decisions,' he says.

The PCT is supported by Paul McManus, one of seven regional NPC local decision-making (LDM) facilitators (see box), and pharmacist adviser to the Yorkshire and Humber Specialist Commissioning Group. He says the PCT is drawing on the support tools and resources on the NPC’s website.

Mr Fell confirms the website has been a useful free resource and highlights the lawyers' briefings. 'They help us in being crystal clear about our decision-making. We are then able to ensure we make robust recommendations based on clinical exceptionality,' he says.

The ability of local decision-making processes to respond quickly, underpinned by robust governance structures is also vital in supporting health communities' collaborative approach to considering new acute treatments, drugs or technologies. Section 38.8 of the standard acute contract sets out a process for considering potential extra costs to the commissioner. But the robust decision-making processes endorsed by the NPC resources aim to limit subsequent IFRs and the potential risk of successful legal challenge.

The variation between PCTs is potentially greater across London where, says Harry Turner, finance director at Haringey Primary Care Trust, the reconfiguration of 31 PCTs into six agencies or sector teams is offering the opportunity to move towards best practice.

'We have a suspicion some providers see our individual funding panels as a way of getting approval for a procedure we have not decided to commission,' he says. 'PCTs operate a variety of approaches to their management of exceptionality criteria. Everyone likes their own system best, so the LDM suite of resources is one of the vehicles we’ve been using to standardise arrangements and ensure quality as well as price is used as an underpinning rationale for decisions and behaviours.'

An online suite of free resources to help organisations, LDM facilitators and local decision-making groups is accessible at www.npc.co.uk/policy. Harriet Lewis, the NPC's head of implementation and project support, says the site is useful for members of local decision-making and priority setting panels as well as area prescribing committees and those involved in the IFR process. As well as accessing e-learning materials on the legal and ethical framework for local decision-making, visitors can listen to podcasts of people sharing their experiences on key issues.

She advises: 'The latest additions to the site are a suite of e-learning resources on priority setting and health economics – the process all PCTs should be using to allocate resources fairly and effectively.'