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Michael Rawlins: playing fair on treatments

A few weeks ago, Steve Winyard, head of policy and campaigns at the Royal National Institute of Blind People (RNIB), asked to see me.

Although the National Institute for Health and Clinical Excellence and the RNIB have at times held differing opinions, I respect the organisation’s integrity and so of course agreed to meet. It transpired that he wanted my advice about the availability of dexamethasone intravitreal implants (Ozurdex) for the treatment of retinal vein occlusion.

There are many rotten conditions awaiting us as we grow old and one of them is retinal vein occlusion. Occlusion of a retinal vein causes retinal oedema, which is followed by scarring and loss of vision. It gives rise to difficulties with reading, recognising faces, getting out and about safely, and using computers. It also has a significant impact on a person’s independence such as the ability to do housework or cook meals.

In July 2011 NICE had published (TA229) a technology appraisal on the use of dexamethasone intravitreal implant which concluded that “dexamethasone intravitreal implant represents a cost-effective use of NHS resources”.

NICE’s appraisal committee determined that, compared to best supportive care, the treatment offered real advantages to patients. Furthermore, with an incremental cost-effectiveness ratio of £26,300 per quality adjusted life year, it provided good value for money.

As I explained in my previous article (15 March 2012), I consider an innovative product to be one that makes a substantial difference to patients at an affordable cost. Dexamethasone intravitreal implants tick both these boxes.

Section 2a of the NHS Constitution states: “You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.”

Moreover, a direction to the NHS dated 11 December 2001 made it clear that NHS bodies are required to make such treatments available not more than three months after a positive NICE guidance technology appraisal has been published. Dexamethasone intravitreal implants should therefore have been available to all NHS patients by - at the very latest - November 2011.

In February this year RNIB contacted the 125 hospital trusts in England with eye health services, asking whether they were providing dexamethasone intravitreal implants for patients with retinal vein occlusion. Of the trusts that responded, 45 were providing a full service and 37 were providing either a restricted or no service.

Quite clearly numerous trusts are acting unlawfully. They are denying patients an innovative and cost-effective treatment, recommended by NICE, that significantly improves their quality of life.

The reason, of course, is that trusts do not wish to use their resources in this manner. Although they know they are required to make NICE-approved products available, they introduce delaying tactics. Hospital trusts may claim that the additional treatment costs of the new product are not covered by the contracts with their local primary care trusts.

With PCTs claiming they are covered, many months pass with the arguments going back and forth.

The notion that any trust formulary committee is competent to “second guess” NICE’s appraisal committee is highly questionable. And for trusts to expect my clinical colleagues to spend time making a case for each of their patients to receive treatments, guaranteed by the NHS Constitution, is unacceptable.

So what was my advice to Steve Winyard? In a nutshell I said he should make application to the High Court and seek Judicial Review. The court would unquestionably uphold the claim, not that any case would ever reach the courts.

Any other ideas? Yes, I want my clinical colleagues to start exercising leadership and “whistle-blow” when their trusts fail to meet their legal obligations. The Francis inquiry may well propose new avenues by which “whistle-blowers” can be better heard. In the meantime I suggest my colleagues should inform the chair of the trust board. If NHS managers wish to avoid this they should arrange for NICE’s forward agenda to be examined, with care, by their formulary committees.

These committees could then advise their trust boards on what innovative products are likely to become available in the coming 12 to 18 months and which of them might be particularly relevant for their own patient population.

Trust boards could then make plans, with their PCTs (or clinical commissioning groups), for appropriate financial arrangements to be put in place. That would be a much better use of the time of formulary committees than trying to pretend they have the knowledge and skills of a NICE appraisal committee.

Sir Michael Rawlins is chair of NICE.

Readers' comments (3)

  • eric watts

    I expect it is the familiar problem that NICE judges cost effectiveness without regard to cash flows in the NHS - ie the provider Trust pays up, may receive reimbursement from the purchaser.
    The purhaser paye from it's annual budget but is unlikely to recoup its outlay that year.
    NICE do need to appreciate how finance operates within the NHS - the High Court may also be unaware of the many pressures on budgets. If we are to implement NICE recommendations we will need a system that operates the way NICE thinks it should.
    We need a funding system that operat

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  • There are plenty of financial mechanisms in the acute trust contract schedules, like pass through payments, prior approvals etc - the trouble is not all commissioners include medicines because the focus is on e.g. activity in emergency admissions or OP referrals etc - and not all acute CEOs sign their contracts either. Levers are there as is the insight into provider business planning, it's mostly a combination of capacity and chaotic reforms that don't help.

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  • NICE has the resources and expertise to consider the clinical and cost effectiveness evidence about a treatment or care pathway. PCTs do not have these resources. Although there may be some issues about NICE it's ultimate aim is raise clinical standards and patient outcomes in the NHS to be on a par with other leading economies. PCTs that ignore NICE guidelines are certainly not delivering patient-centred care and compromise standards of health care delivery and patient outcomes. PCTs have little local accountability to patients and the public.

    One must question how the PCTs rationing decisions and lack of compliance with NICE clinical guidelines are reached. It is unlilkely to be by even more careful consideration of the evidence than NICE. It is also unlikley to be by careful financial management comparing cost effectiveness. It certainly does not consider patients.

    In our recent FOI survey of all English PCTs some were unable to tell us how many hysterectomies they purchased, even though this is one of the commonest operations, few had any mechanism for ensuring NICE guidleines were adhered to or that patients were properly informed about all the treatment options and some didn't commission a treatment for fibroids which was safer, less expensive for the NHS and patients and recommended by NICE - uterine artery/fibroid embolisation. This together with proper consideration of full treatment costs and outcomes of other newer medical technologies could have resulted in a considerable saving to NHS and patients, improved outcomes and greater patient choice.

    From this evidence it would appear that there is considerable opportunity for improving NHS commissioning based on proper analysis of managment and clinical data and cost information, involving patients and clinicians and complying with NICE appraisals and clinical guidelines. It is very important that commissioning is improved and the greater local accountability and more clinical and patient involvment with CCGs will help.

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