‘Ere Guv…boxes of edoxaban going cheap…’

Brenda comes to see you in your morning surgery. One look at her expression tells you that she is not happy. No, this is not an incoming complaint about access and lack of face-to-face appointments (phew, small win), Brenda is cross because she has been keeping up with patient forums on the TwitteringSnap’osphere and has been told that she is going to have to switch her apixaban to edoxaban. Brenda is generally a very understanding patient and accepts the financial pressures of the NHS, but this is the final straw. She was originally put on edoxaban when she developed AF 3 years ago, but developed some abdominal side effects at the start so was switched to apixaban, although you were never really sure whether it was the edoxaban causing the GI symptoms or just ‘one of those things’. Anyway, Brenda does NOT want to go back on edoxaban, and is generally fed up with a steady flow of her medications being changed for ‘cheaper alternatives’.

It’s first worth confirming that the recommendations discussed below for edoxaban are specific for AF, NOT VTE treatment -  both edoxaban and dabigatran are very much second line for VTE as they require 5 days of low molecular weight heparin before they can be initiated for VTE. And although these recommendations are focussed on England, it may lead to changes elsewhere in the UK depending local health board decisions.

When the recent NICE guideline on AF (NG196) came out in 2021 all DOACs were recommended as options for AF - interestingly this was changed from the draft version which originally recommended apixaban and dabigatran as 1st line options with edoxaban and rivaroxaban 2nd line.

So why is edoxaban being pushed as a first line DOAC for AF now? Well, I’m afraid there is no way of sugar coating this - it is all about the money. As discussed in the Impact and Investment Fund (IIF) 2022/23, in 2021 NHSE undertook a procurement to given all DOAC suppliers an opportunity ‘to update their value proposition to the NHS’ and ‘Daiichi Sankyo offered the most significant discount for their product, edoxaban’. Then in January 2022 national commissioning recommendations were published (somewhat under the radar given the massive surge of COVID and general workload at the time), that edoxaban should be recommended 1st line for AF, and that ‘commissioners may wish to consider developing local policy to review patients currently prescribed apixaban, rivaroxaban or dabigatran, where clinically appropriate’. Then in March 2022 the IIF component of the Network Contract DES 2022/23 followed suit by incentivising PCNs to increase the number of patients on edoxaban as a percentage of total DOAC use for AF. The guidance does stress that ‘It is important that switching patients who are currently prescribed a different brand of DOAC to Edoxaban is done in a clinically appropriate way and as the result of a shared decision-making conversation.’

But it does have a bit of a whiff of the ‘Only Fools and Horses’ about it…Del Boy doing a deal in the pub for some knock-down boxes of edoxaban with a limited amount of scrutiny or transparency. Is using edoxaban first line for AF (or switching from an alternative DOAC) clinically appropriate? Well, we don’t really know. We have indirect evidence suggesting apixaban may be the safest DOAC (observational evidence from BMJ 2018;362:k2505, although edoxaban wasn’t included in this and the DOAC indications were mixed) and that apixaban gives the best balance of safety and efficacy for AF (meta-analysis BMJ 2017;359:j5058), but without head-to-head DOAC trials we can't be really sure. And how much money are we saving? Again we don’t know as the details of these agreements remain locked behind commercially sensitive firewalls. And this deal runs to March 2024, but the edoxaban patent doesn’t run out until 2028, so what happens in those intervening 4 years is anybodies guess - Extension of deal? Massive upsurge in costs to the NHS? Or yet more medicine switching? 

I have a huge amount of sympathy for commissioners and medicines management teams. The financial budgets they have to work to are ridiculously tight, and often unmanageable. And I remember the discussions in my CCG when DOACs first came on the market with the dawning realisation that these drugs could literally ‘blow the budget’. And indeed this is happening - DOACs are now the highest spend drug in primary care at over £500 million/yr and if no action happens the projection is for a doubling of these costs. We all have a duty to use NHS resources as cost effectively as possible, so if this deal really does save loads of money for other services, and if the bold claims of NHSE that this deal ‘will make DOACs more affordable, allowing the local NHS to provide them to 610,000 more patients’ and that it ‘will help to prevent an estimated 21,700 stokes and save the lives of 5,400 patients from a fatal outcome over the next three year’ then I’m sure we are all on board. But when we don’t really know what the cost savings are, or indeed if switching DOACs is safe, I think we are all a little more hesitant. 

So as is often the case, we are left with that tricky juggling act of balancing financial pressures, individual patient circumstances and wider public health needs. Not new territory for Primary Care Teams, and this will be, I’m sure, a Team effort to make sure those judgements are balanced as best as possible. But as one of my colleagues nicely summed it up ‘I’m not sold on it’.