Mini NICEs for England?

NHS England has revealed more detail about Regional Medicines Optimization Committees (RMOCs). First suggested back in October 2015 as part of the Accelerated Access Review – an independent review to look at how to speed up adoption of innovation across the NHS in England-they’re intended to help fill the gap when the National Institute for Health and Care Excellence (NICE) doesn’t appraise a medicine. That can and does happen; that might be good news for the company if a NICE ‘no’ is avoided, but equally it can be bad news if that means that the NHS locally takes diverse approaches to looking at whether or not it’s a drug that they want to make available. That translates into a company needing to provide information for many different parts of the NHS on their medicine, as well as potentially diverse views that can hinder access. Plus it’s duplication of effort for the NHS too, as most often there is no reason why the evidence base should be different for a locality, even if the population is.

NHS England has been musing on the idea of RMOCs for a while. They released a discussion paper in May on the back of a workshop in April 2016. It seemed clear that there were many questions raised, but not too much in terms of the answers.

The proposals now out suggest that RMOCs will be there to coordinate and make recommendations on those new medicines and major new indications not scheduled for review by NICE under their Technology Appraisal (TA) programme. RMOCs will however draw on NICE evidence summaries – a shorter look at the available evidence but not a full TA – if they are available from NICE. They will look at unlicensed medicines, a traditionally difficult area for the NHS too. Although there are four RMOCs, the principle is one of mutual recognition so each committee will ensure that they don’t look at the medicines that the others are looking at, and the recommendations from other RMOCs will apply in their patch too.

As well as provide recommendations, RMOCs will also try to tackle unwarranted variation: that old chestnut that just won’t go away for the NHS. They may call on health economic expertise as and when they need it. There are lots of unknowns: how will they decide what medicines/new indications to look at, how they will assess them, how long it will take them and just who, exactly, will make the recommendations and how will they be communicated? It’s also unclear what routes there are for any stakeholders to challenge the advisory recommendations: be they a patient group or a pharmaceutical company.

The really tricky issue is whether the situation will be better – or worse – with RMOCs compared to now. Part of the issue is in exactly how they come up with their recommendations, as well as whether or not the local NHS really does stop their own assessments. The local NHS may not follow RMOC recommendations either. NICE guidance is a mix of both mandatory and advisory guidance: drugs that get a positive Technology Appraisal from NICE have to be funded but clinical guidelines that may also shape how a drug is used do not. In any case, adherence to NICE TAs is still not perfect because just telling the NHS to do something doesn’t necessarily translate into to it being done. In fairness, there are good reasons as well as bad for that: guidance might not cover every eventuality and many will say that clinicians still need to use their expertise to translate guidance to meet the idiosyncratic needs of the patient in front of them. So expecting everyone to follow RMOC recommendations seems a stretch if it can’t yet be achieved for NICE TAs.

The real reason for RMOCs is to try to be a little wiser in the use of expertise in the NHS. There’s so much that needs to be done in medicines optimization that if having the RMOCs assess a drug means that other professionals who would have been doing the same thing are freed up, it’s got to be a good thing. Afterall medicines optimization, according to NHS England is “about ensuring that the right patients get the right choice of medicine, at the right time. And by focusing on patients and their experiences, the goal is to help patients to: improve their outcomes; take their medicines correctly; avoid taking unnecessary medicines; reduce wastage of medicines; and improve medicines safety. Ultimately medicines optimization can help encourage patients to take ownership of their treatment.” Quite the to-do list.

There is no escaping the backdrop of tight finances and there’s more than a hint that medicines optimisation is not just all the warm words about patients but also about making savings - where that does not prejudice patient outcomes.

Just as with every reform in the NHS, time is needed for them to bed in and to give them a chance to deliver. The trouble is, it’s just not clear, especially if there is resource available, why NICE could not have played host and RMOCs could have been set up as additional advisory committees. That would have also meant that the approach of RMOCs could follow well-worn and established processes rather than starting from scratch. Of course, NICE may be too stretched to do this, but they’re likely to be involved in any case.

There’s the bigger question too: why can’t there be a UK wide approach to assessing new medicines? After all the Scottish Medicines Consortium (SMC) looks at pretty much all new medicines, the All Wales Medicines Strategy Group (AWMSG) looks at those new medicines when it looks like NICE guidance may take a year or more to come through. They all differ in their exact approach and people will argue the pros and cons of the different models but it’s at that level that there is considerable duplication. One of the big drivers that may explain why industry does not bring this up is simply that they get, in essence, three attempts at access across the UK. Its really England where it matters most, simply because of the much larger population. And maybe they also – like many others – won’t want to be put in a position to have to pick the ‘best’ approach.

NHS England is asking for views, with all responses due in by 19 September. Expect to hear more about the RMOCs - for good or bad.

Leela Barham is an independent health economist and policy expert. You access her website here and contact her at leels@btinternet.com