Michael Rawlins: playing fair on treatments

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.