Q: Dear Donal, I am a renal nurse specialist and wondered if you had heard anything at national level about withdrawal of funding for pre-dialysis EPO? Our local PCT (Cambridgeshire) seems to be thinking this way, and whilst I appreciate the lack of research to support pre-dialysis EPO we have some major concerns about withdrawing it from patients. The following are just a few thoughts
1. The need for blood transfusions for some patients, therefore jeopardising their transplant status because of antibody increase, plus transfusion risk itself.
2. National shortage of blood, so the above will stretch resources further.
3. Some patients will probably start dialysis sooner than really needed as more symptomatic from lower HB's, so not good for the individual or dialysis space provision.
4.Quality of life for individuals from whom it is withdrawn, who know they have improved since they started it- - at least not starting new patients they would never have known anything better.
5. Conservative management patients for whom symptom control and quality of life is paramount, who are then likely to feel worse and perhaps require travel etc for transfusions that could have been avoided.
I would be grateful for your thoughts or any guidance that may help us convince the PCT this is not the way to go. Thank you, Nicky Moncrieff, Renal Nurse Specialist, Addenbrookes Hospital, Cambridge
A: Dear Nicky, thank you for your email concerning ESA prescribing and funding arrangements for those not on dialysis. As you can see I have broadened the issue to the whole of renal anaemia management in those with CKD not on renal replacement therapy. I think a number of people are beginning to look at this issue because of the cost, commissioning arrangements and recent trial data.
Conceptually the anaemia of advanced CKD is similar in the pre-dialysis, dialysis and conservative kidney care patient group although the severity and balance of underlying patho-physiological processes vary, largely with the level of renal function.
It is helpful that we have a NICE guideline on renal anaemia. It was published in September 2006 and would therefore be due for review in September 2010. I believe its underlying principles and advice remain valid but you will no doubt be aware that the TREAT study was published in November 2009. TREAT is by far and away the largest randomised controlled trial of anaemia management in patients not on dialysis ever conducted.
Its conclusions are starting to influence practice and NICE may well consider an earlier review than September 2010 to provide clarity for the NHS.
In TREAT over 4000 patients were randomly assigned to Darbepoetin Alpha treatment to achieve a haemoglobin level of approximately 13 gm per decilitre or placebo. Importantly rescue therapy with Darbepoetin Alpha when the haemoglobin level was less than 9 gm per decilitre was part of the protocol. There was only a modest improvement in patient reported fatigue in the Darbepoetin Alpha group as compared with the placebo group. The use of Darbepoetin Alpha in these patients with diabetes, chronic renal disease and moderate anaemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes, either death or cardiovascular event or death or a renal event. It was associated with an increase risk of stroke. The author’s concluded that for many personnel involved in clinical decision making this risk will out weigh the potential benefits.
It is important to be aware that in the Darbepoetin treated group many of the patients received very high doses of ESA and that might have a bearing on safety. Equally important the placebo group were not allowed to develop severe anaemia i.e. they did receive ESA treatment to prevent haemoglobin falling below 9 gm per decilitre.
How will patients, commissioners and prescribers in the UK respond to this new information? Certainly it would be perverse and costly to increase transfusion needs, which as you say might have a negative impact on future transplant chance, or to have to commence dialysis earlier than would otherwise be needed because of restrictions in access to ESA therapy. My biggest concern however is that those opting for conservative kidney care might have to tolerate the low haemoglobins we saw in the pre-EPO era. This would severely compromise the quality of life of these individuals in the final years and months of their lives. There is good evidence that active anaemia management has a positive beneficial effect on quality of life and feelings of well-being independent of individual’s age or functional status. Anaemia management is a key part of conservative kidney care.
Arrangements for commissioning the care of people with advanced kidney disease not receiving renal replacement therapy vary across the country. In some localities PCTs directly fund all aspects of kidney care except renal replacement therapy, in others pre-dialysis management is considered as part of the specialised commissioning contract for renal services. In some areas the situation is not clear to all concerned. This later situation does not lend itself easily to the mature conversations that are needed between commissioners of care, providers, clinicians and patient groups that should provide the best forum for decision making. Such groups with key representation across the whole pathway are ideally placed to drive quality, equity and productivity. Commissioning across pathways of care is not easy because traditionally the health service has ‘paid’ for particular treatments or episodes of care but for kidney patients considering the whole pathway, what patients benefit from, how to provide optimal therapy at the best value factoring in patient experience and outcomes are essential for high quality care.
Access to treatment should be equitable. Commissioning and delivery of care should both aspire to a seamless continuum across the patient pathway with clinical teams playing to their individual strengths and working collaboratively between the various organisations of the NHS. Easy to say, more difficult to deliver, even more important than previously as we face the challengers resulting from the global financial crisis.
Anaemia management is broader than ESA treatment. We know that intravenous iron is very useful in directly improving renal anaemia as well as in reducing the dose of ESA when they are needed. ANSA, the renal Anaemia Nurse Specialist Association produced a neat guide on IV iron that you may well be aware of. It provides clear protocols for delivery of iron close to patients’ homes and avoiding the unnecessary trips back and forth to hospital, particularly in those not receiving dialysis, both improves their quality and reduces costs for the health service. Kind regards, Donal