The announcement that patients may top up their NHS care with unapproved treatments means managers face overseeing segregation of patients and tough commissioning decisions. Helen Crump reports

Last week’s announcement on topping up care shifted the foundations on which the NHS stands.

For the first time, patients’ explicit right to access NHS treatment while paying for additional drugs has been spelled out. This ends the practice of forcing patients who choose to buy drugs that have not been approved by the National Institute for Health and Clinical Excellence to pay for the care they would have normally received on the NHS.

But while the health service has welcomed the clear principles spelled out by national cancer director Mike Richards’ review on co-payments, the practicalities are likely to prove a challenge for managers.

Separation

When Professor Richards began his review, the need to redefine what constituted an “episode of care” was at the heart of his task.

Under the old system, primary care trusts were applying different definitions - some patients were being expected to pay for a small proportion of NHS treatment while others were facing massive bills as a result of stricter interpretations.

To avoid the NHS subsidising private treatment as a result of the rule change, Professor Richards said “private care should be carried out at a different time and place” from NHS care, such as in a part of the hospital designated for private care or with a private provider.

To address the practical difficulties of this recommendation, the Department of Health has produced guidance on treating patients who are paying for extra care, now out to consultation.

Patients will not be allowed to “upgrade” individual elements of care, such as paying for more expensive retinal implants to be used in an NHS operation.

Strategic health authorities will be charged with policing these arrangements, but the jury is out on whether they will hold water.

Daphne Austin, consultant in public health at the West Midlands specialised services team and chair of the UK Commissioning Public Health Network, believes the proposals are “largely implementable”, as long as it is made clear that procedures such as genetic tests allied to cancer drugs are part of the private treatment.

But King’s Fund deputy director of policy Anna Dixon questions whether it is feasible to separate NHS and private care.

“We are talking about very sick patients at the end of their lives… may raise issues around safety.”

NHS Confederation policy director Nigel Edwards warns: “We need greater clarity on what will happen - and who will pay - when things go wrong.”

Managers at South Tees Hospitals trust have been ensuring strict clinical controls for governance and quality in chemotherapy provision by using one closely monitored centralised department - with no distinction between NHS and private patients. Chief executive Simon Pleydell is assembling a team to consider the implications of the review. To create a separate private unit, the trust will need to adapt its approach.

He says: “We’ve worked very hard to centralise and control the quality of what we’re doing… Where we’re using these sophisticated drug regimes, this is immediately something we’re having to think through now.”

Some managers think that services for providing chemotherapy at home could be used as a solution in some cases, but there would be other medications that could not be delivered in this way.

There is also the question of the private income cap on foundation trusts - the Conservatives have warned that foundations allowing patient co-payments, particularly specialist cancer hospitals such as London’s Royal Marsden and the Christie in Manchester, would exceed the cap.

Budgeting

NICE’s contribution to the top-ups review was to announce that it will speed up its processes and amend the way it evaluates drugs for rarer end of life conditions. This will apply to drugs for conditions affecting fewer than 7,000 new patients a year, where the bill for the drug will be greater than NICE’s£30,000 per year threshold of cost-effectiveness.

The DH is also to commission research on international variation in the use of the drugs and on national demand for unfunded drugs.

The end result of this is likely to be that the NHS will be expected to pay for more of these drugs than it does at present.

But no one is able to quantify the likely financial burden, although a survey conducted for the review found that primary care trusts were receiving on average 177 exceptional case requests a year and 43 per cent of trusts had funded drugs NICE had not yet appraised.

The review highlights the finding that 64 per cent of cancer treatment requests and 74 per cent of non-cancer treatment requests are already funded, saying it shows that additional demand may be less than feared. But Dr Austin is concerned the financial implications are unclear.

“There are more and more expensive drugs coming onto the market. We’re likely to say yes to more drugs,” she says.

“In terms of the basic mathematics of income versus outgoings, if you change the threshold, income should increase or you’ll have to spend less on something else.

“What the Richards review hasn’t done is say what we’re going to offset against this by making it a lower priority.”

Ms Dixon predicts that treatments that have a weaker evidence base because they have not been assessed by NICE will be hit hardest.

“They are often the sorts of services that did badly in the past when money was short, such as mental health and community services,” she says, adding that these services may actually be more cost effective than new drugs.

Transparency

Even if NICE speeds up its assessments, PCTs will in some cases still have to make decisions about drugs that have not yet been appraised or where exceptional circumstances requests have been made. To reduce the level of variation within the system, Professor Richards has called on the DH to consider urgently “how PCTs can be encouraged to work together to make proactive commissioning decisions”.

As part of these collaborative arrangements, the review calls for proposals to enable PCTs to make better decisions about funding off-label drugs, “whether as a matter of policy or on an exceptions basis”.

The draft constitution will also be invoked to ensure that this work is “transparent”.

But public health directors believe the causes of the variation run deeper than PCTs simply appraising evidence differently.

North Yorkshire and York PCT director of public health Peter Brambleby says: “PCTs in general want to iron out differences in access which are being driven in principle by differences in funding allocations.

“So going with a majority decision will be a good way to go but it will displace other [treatments] in the poorer PCTs.”

He adds that there may be problems with regional collaborative arrangements, particularly if they are based around cancer networks: “Our PCT population is in three different cancer networks - it [collaboration] really needs to be national.”

Pricing

Dr Austin fears that if decisions are so transparent that drug companies know what price they can set to have their product approved, prices could be pushed up.

“Having a threshold above which we say we’ll not fund drugs is inflationary. If we say that threshold excludes things but won’t say what will be in it, that’s probably less inflationary.”

To soften the financial blow to trusts, health secretary Alan Johnson is negotiating with the pharmaceutical industry over “more flexible approaches to the pricing and availability of new drugs”.

These could involve value based pricing models, but it is acknowledged that such approaches place an administrative burden on the NHS because they require more auditing.

Training and information

The service will have to address training and information needs. The review requires doctors likely to have conversations with patients about treatments not routinely funded on the NHS to have “the necessary knowledge and skills to communicate complex information effectively and in a balanced way”.

It will be up to the royal colleges and the DH to ensure training programmes are put in place and assessment skills are incorporated into recertification processes.

The department is to consider how balanced written information on the benefits, toxicities and, where appropriate, costs of “novel treatments” could be provided to patients.

Dr Brambleby welcomes the aim of providing patients with more information, but thinks there is a role for an independent adviser “a bit like Which?”, separate from both the pharmaceutical industry and from organisations trying to contain costs.

Non-drug treatments

Managers will also have to consider how they commission non-drug interventions in the wake of the review, whose scope was limited to drugs. Professor Richards has asked the government to confirm how situations where patients wish to buy additional devices should be handled.

As the dust settles on the review and the consultations get under way, the questions raised by the service will all need to be answered.

The full impact of the reforms on the NHS will not become clear until all the detail is fleshed out.

But at least patients, their representatives and the health service now know the context in which they will conduct these most sensitive, difficult and challenging negotiations.

MISSION IMPOSSIBLE: MANAGERS’ VIEWS ON THE RICHARDS REVIEW

HSJ carried out a poll of readers’ reactions to the review. Here are some of the things they said:

“It can only lead to ever greater attention to rare and expensive drugs at the expense of people whose basic needs will be ignored.”

“NICE should focus more on putting pressure on drug companies to reduce prices to the NHS.”

“Once the gates are open where do you draw the line?”

“It’s an absolute fudge, and puts the government on the side of health insurers.”

“We have reached the point where this is the only sensible decision.”

“[Richards] has earned his knighthood, but the media will be full of stories of hospitals ‘hounding’ the families of patients who have died despite the use of the latest ‘wonder-drug’ and who cannot afford to pay.”

“This is a disaster for the proper planning and delivery of a comprehensive publicly funded healthcare system.”

“Professor Richards’ remit was truly mission impossible.”

“You can’t forbid someone to take action to make their own condition more comfortable.”

“A shot in the foot for evidence based healthcare.”

HSJ’s conference Reforming Cancer Care is on 29 January 2009.