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How can the lottery over access to drugs be improved?

Ministers are talking of speeding up NICE drug approvals and allowing NHS top-ups, but will it be enough to ease variations in access. By Nigel Praities investigates.

By Nigel Praities

Ministers are talking of speeding up NICE drug approvals and allowing NHS top-ups, but will it be enough to ease variations in access. By Nigel Praities investigates.

Alan Johnson is a bit of a departure for the Department of Health – genial, easygoing and not easily ruffled by journalists.

So it is a measure of the controversy surrounding the Government's review of top-up payments last week that the health secretary was left red-faced and indignant, after being accused of undermining the founding principles of the NHS.

The Government's plans - to allow patients to pay for drugs privately without losing their right to NHS care – were branded unworthy of a Labour politician.

But in fact, all political parties have been scrambling to work out how to meet the public's soaring expectations by maximising access to new drugs.

While pharmaceutical companies produce ever more sophisticated and expensive medicines, the NHS is struggling to balance a limited budget with the interests of doctors and patients.

The creation of NICE in 1999 was designed to reduce inequalities in access to drugs across England and Wales and ration treatments fairly on the basis of their cost-effectiveness.

But the institute has been criticised taking too long to approve treatments and of lacking transparency.

Healthcare blight

A report from the Health Select Committee published in January rounded on NICE, saying the delay between the licensing of medicines and NICE guidance ‘blights' healthcare delivery by the NHS.

More recently media reports have exposed the lottery of access to new medicines across England as PCTs wait for NICE appraisals.

Even when the institute does issue guidance, it is often dragged into controversy over its methodology and decisions, with its own clinical advisers in open revolt over appraisals for osteoporosis last week.

Shadow Health Secretary Andrew Lansley says PCTs are using delays in releasing NICE guidance as an ‘excuse' to deny treatment to patients.

‘What we need to do is arrive at a point where doctors are in a position to be able to make these decisions for their patients and are able to provide the care that is right for them,' he says.

The Conservative Party earlier this month proposed making NICE independent from political interference and introducing a new system of ‘value-based pricing' for drugs.

The publication of a five-month review into access to medicines by cancer Tsar Professor Mike Richards could be seen as an attempt by the Government to regain the initiative.

The review's 14 recommendations include speeding up NICE reviews, giving greater transparency over individual PCT funding decisions and the headline-grabbing decision to allow top-up payments for private treatment.

The Government confirmed NICE would issue draft or final guidance within six months of licensing for half of the drugs it appraises next year.

Alan Johnson revealed the Government was ‘hoping to clinch an agreement soon' with the pharmaceutical industry on more flexible drug pricing for new drugs.

While these moves may mollify some of the criticism – and the reaction to the plans was largely positive – critics argue they will not iron out the distortions increasingly evident in the current system.

Dr Bill Beeby, chair of the GPC clinical and prescribing subcommittee, says decisions over new treatments will become harder and that GPs may be placed in a difficult position with patients.

‘We are going to be faced with very difficult situations that we are going to have to support people through,' he claims.

Dr Beeby says as the institute's role expands in primary care – applying its cost-effectiveness criteria to QOF indicators – there is need for greater transparency in the way it reaches decisions.

‘NICE works in mysterious ways and it has to consult widely with a wide variety of people.

‘But when we are talking about extensions to its role, in particular in determining things like the QOF, we have to recognise not everyone who is putting pressure on NICE is giving the sort of evidence we need in general practice,' he says.

The way NICE reaches decisions has come under particular scrutiny of late, with fierce criticism over the body's work on osteoporosis.

Recently published technology appraisals on osteoporosis treatments were openly condemned as ‘unethical and workable' for GPs by members of NICE's own clinical guideline development group.

Flawed model

The guidelines placed restrictions on access to alendronate, even for secondary prevention, and said GPs would have to refuse alternative treatments for patients who were intolerant or had a contraindication for alendronate, unless their fracture risk got worse.

Professor Juliet Compston, professor of bone medicine at the University of Cambridge and a member of the NICE clinical guideline group, points to flaws in the cost-effectiveness model NICE used for the appraisals.

‘NICE changed the model in the absence of new evidence and introduced increasingly conservative assumptions as the price of alendronate fell, thus keeping its recommendations largely unchanged.

‘Alendronate is so cheap, that actually there is quite a lot of wiggle room within the economic model to accommodate alternative treatments at £300 a year,' she explains.

41211433Others defend the way NICE takes decisions. Professor Miranda Mugford, professor of health economics at the University of East Anglia, says the current system is a great improvement on the way decisions used to be made by local health authorities.

‘We used to make decisions on just whether people lived or not, but there is a difference between living with a chronic illness and living with a healthy life,' she says.

Professor Mugford adds that NICE is being considered as a model for drug rationing decisions in other countries, such as Holland, Germany and the US.

But PCTs also have a huge influence on the availability of treatments, often focusing cut-backs on older treatments that have not been considered by NICE, such as fertility treatments or minor surgery.

Conflicting guidance

As Pulse revealed last week, GPs face conflicting guidance over how to deal with a surge in requests for HPV vaccination, with the DH saying GPs should use their ‘clinical judgement' but trusts urging GPs not to use the vaccine Gardasil on the grounds of cost.

Even after NICE guidance has been issued for a treatment, implementation is often patchy.

NICE approved use of the biological therapies etanercept and infliximab for rheumatoid arthritis that had not responded adequately to at least two disease-modifying anti-rheumatic drugs in 2002.

But Dr Chris Deighton, consultant rheumatologist at Derbyshire Royal Infirmary and chair of the clinical affairs committee at the British Society of Rheumatology, says some PCTs are ignoring the guidance.

‘This can be devastating for patients, particularly if they are next door to each other and one is on a biologic and doing incredibly well on it – which most of them do – and another in a neighbouring PCT is still struggling on conventional therapies.'

A BSR survey of UK rheumatologists in 2006 found half had some limitation of access to anti-TNF- drugs, usually a financial cap, even for patients meeting NICE criteria for treatment.

The DH review aims to address such variation, with PCTs to be issued with a set of ‘core principles' for funding decisions about new drugs in advance of NICE guidance.

And the Government's cancer tsar, Professor Mike Richards, who led the review, is urging ministers to ‘urgently consider' how PCTs could work together to make decisions on commissioning and drug approval.

He gives the example of North of England Cancer Drug Approval Group, where PCTs and SHAs have come together to make collaborative decisions on new medicines.

But Dr Deighton warns the UK remains a ‘poor relation' compared with other Western countries and is falling behind on providing new treatments on the NHS. ‘There is an enormous gap,' he says.

With a squeeze on public finances looming, GPs can expect to be faced with further tough rationing decisions in the future.

If Alan Johnson had hoped the top-ups review would ease the hostile media scrutiny on drug access, he may end up disappointed.

Dr Bill Beeby, chair of the GPC clinical and prescribing sub-committees Dr Bill Beeby

We are going to be faced with very difficult situations

Drug rationing in numbers Can variations in access to drugs be eased? The review is unlikely to dramatically increase the range of drugs GPs can prescribe Can variations in access to drugs be eased? The review is unlikely to dramatically increase the range of drugs GPs can prescribe

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