NHS England making NICE look much nicer?

Is NHS England living up to its promises since its inception in 2012? Leela Barham outlines its remit and examines the evidence to discover whether it is delivering ‘high quality care for all’.

NHS England (NHSE) is the big hitter in today’s NHS. It was created out of the Health and Social Act 2012 with the mission to deliver: ‘high quality care for all, now and for future generations’ underpinned by its purpose to ‘create the culture and conditions for health and care services and staff to deliver the highest standard of care’. The latter statement has a little bit of a reality check though, NHSE adding that it ‘ensures that valuable public resources are used effectively’. Stewardship of those precious NHS pounds is taken very seriously by NHSE.

NHSE’s work is broad; from improving patient experience to emergency preparedness, resilience and response. It has responsibility for supporting the broader commissioning systems in the NHS; basically, this means keeping an eye on the 211 Clinical Commissioning Groups (CCGs) who are responsible for day-to-day services across the NHS and stepping in where necessary.

Its remit excludes the commissioning of General Practice, although that is changing. NHSE is responsible for specialised services; services that are for relatively rare conditions that are better handled with specific expertise rather than across the whole of the NHS. Deciding exactly which services are ‘specialised’ or not, and hence whether it’s for NHSE or the CCGs to cover, is still subject to debate, with recent proposals to transfer responsibilities such as for renal dialysis and morbid obesity surgery. These distinctions are important for industry, with their medicines forming part of those patient pathways and changing whether they need to engage with NHSE and its Area Teams or the numerous CCGs.

NHSE also manages the money, deciding how to allocate it both to itself as a direct commissioner and to the CCGs. NHSE is also a key player in setting the National Tariff – essentially a set of prices for bundles of NHS services – alongside Monitor, the economic regulator. This is also relevant for industry as decisions are made about which medicines are bundled up in tariffs, and which sit outside as pass-through payments.

NHSE and medicines

NHSE has some high-profile responsibilities for medicines; arguably the most public of these is its management of the Cancer Drugs Fund (CDF). In addition, it commissions chemotherapy more generally, covers a whole host of medicines, such as AIDS/HIV antiretrovirals and drugs for rare diseases, such as Fabry’s disease, as well as paying for drugs for individual patients under the Individual Funding Requests (IFRs) and covers areas that support use of some of the newer cancer treatments, including genetics.

The link to NICE

NHSE’s role on commissioning medicines can interlink with NICE if NICE looks at a product under its Highly Specialised Technologies (HST) programme or the Technology Appraisal (TA programme), but not all products go through these. That can leave a gap where NHSE has to make a decision without NICE guidance. The upside to getting NICE guidance is that a ‘yes’ under a TA or the HST programme means NHSE has to find the money to pay for it. Naturally the downside is when NICE says no, leaving a neat reason for NHSE not to pay for it.

The controversies so far

Open, evidence-based, inclusive and transparent…really?

In describing itself NHSE says it is ‘what we want the NHS to be – open, evidence-based and inclusive, to be transparent about the decisions we make, the way we operate and the impact we have’. Unfortunately, many people simply disagree with NHSE about that.

Greg Mulholland MP has been raising his concerns about NHSE and how it approaches decisions for medicines to treat three rare diseases; Morquio disease, Duchenne Muscular Dystrophy and Tuberous Sclerosis. The list of concerns is long; from failing to work with manufacturers to failing to respond to correspondence. Constant delay in making a decision is a continued theme.

BioMarin has also pointed out that decision-making for its treatment for Morquio, Vimizin, has not only taken more than a year – contrary to the EU Transparency Directive – but that NHSE staff haven’t even got the underpinning legislation right, having failed to refer to the 1996 version of the Declaration of Helsinski. The officials at NHSE ought to be able to get their facts right, even if people disagree with their process and decisions (to some degree the latter is inevitable when there isn’t enough money to go around). Apparently the offer of a capped price for Vimizin never received a response from NHSE, leading to BioMarin revoking it.

Not in the spirit of agreements with industry

On the face of it, it doesn’t look like NHSE is keeping to the spirit of key agreements with the industry. For example, the January 2014 compact between specialised services Clinical Reference Groups (groups of clinicians with key responsibilities for commissioning for specific areas) and the Association of the British Pharmaceutical Industry (ABPI) includes a commitment from NHSE to provide ‘facilitation of meetings with individual or multiple companies with stakeholder interest in a particular therapy area’. Apparently NHSE has failed to turn up to meetings with charities and BioMarin; hardly a facilitative approach.

It looks even worse considering what NHSE committed to in a Memorandum of Understanding between NHSE, the ABPI and the British Generic Manufacturers Association (BGMA) signed in September 2014. This said that all parties would ‘work together with integrity and probity for the benefit of patients and the public’. That agreement also included the expectation of typically meeting two-to-three times a year. I wonder if these meetings have happened and, if so, just how tense the atmosphere is!

Interim policies on decision making lasting over two years and only consulted on as a result of legal challenge

Much criticism centres on NHSE’s approach to how it makes decisions and consultation on them. An interim approach was set out in April 2013, in an Ethical Framework for Priority Setting and Resource Allocation and a host of accompanying commissioning policies and standard operating procedures. NHSE said that it has been developing a new Prioritorisation Framework (also known as a scorecard) as part of a special task force on specialised commissioning.

It is worth noting that this task force came in with the new Chief Executive, Simon Stevens, and was widely seen as an effort to sort out what had turned into a financial hole with specialised commissioning in deficit; not a good example to the rest of the NHS. NHSE consulted on its new approach to investing in specialised services between January and April 2015.

Taken in isolation, the NHSE consultation reads like a standard updating of a policy. However, Greg Mulholland wrote to George Freeman, Parliamentary Under Secretary of State for Life Sciences, in March 2015 stating that in a presentation by NHSE to stakeholders earlier that month that ‘no mention was made of the legal challenge and instead a draft scorecard was tested but the Board decided in autumn 2014 was found to need further work’. Mulholland went on to say that ‘Further work was needed because NHS England put together a flawed process in the first place! I do hope that NHS England are not trying to paper over this fact’.

The Specialised Healthcare Alliance, representing 110 patient-related organisations, with support from 15 corporate members, said that ‘a consultation on the principles underpinning these policies was only opened after 18 months and a legal challenge is a poor indictment of NHS England’s ability to keep its promises’. Cancer52, representing 80 small cancer charities, simply said that ‘NHS England faces a credibility problem’. They also noted that a key group within NHSE, the Clinical Priorities Advisory Group (CPAG), had not published any meeting minutes, this despite a commitment made by NHSE to do so.

The legal challenge Mulholland referred to was the threat of Judicial Review from the Society for Mucopolysaccharide Diseases (the MPS Society). The case was instigated because a child with the disease had been on a treatment first as part of a trial, then on a compassionate basis, while awaiting a decision from NHSE. The MPS Society was concerned that the extreme rarity of the disease, coupled with the scorecard likely to give low scores to treatments for such rare diseases, would result in discrimination.

The reality to set against all this posturing is the sobering example of people dying while they wait for decisions to be made about treatment.

The results of the consultation are now in. Not much has changed regarding the proposals with NHSE although it has promised some further work to refine them, and has now taken decisions on services that it will, and won’t, be funding. It has still delayed decisions on both Vimizim for Morquio A syndrome, and Translarna for Duchene muscular dystrophy while it waits for NICE to come to a view on those drugs as part of the HST process.

Delaying paying for cost-effective medicines

NHSE has also been in the spotlight because of a concern that it did not want to pay the high bill for Gilead’s Sofosobuvir for Hepatitis C. Sofosobuvir is expensive; £1 billion for every 20,000 people treated. However, NICE has said it is cost effective. NHSE asked for a delay in implementing the NICE guidance, which is a source of concern to the patient group, the Hepatitis C Trust.

The NICE guidance includes a long discussion of the request for a delay made to NICE. It details why NHSE wanted the delay and NICE’s view. NICE neatly dismisses some of those reasons. NICE also points out that it needs to tread very carefully, as disagreeing with NHSE on the delay would mean that ‘NICE would have to conclude that NHS England was mistaken’.

In the end, the delay was accepted, but with a key proviso that arrangements were put in place quickly to provide access to treatment for the most seriously ill patients.

Comparing NICE and NHSE on their approaches to medicines

Not everyone is a fan of NICE, but most are likely to agree that NICE has evolved over time and has refined its engagement with patients, clinicians and industry.

An Operational Effectiveness Group, with members from companies and NICE, is the jobbing side of that engagement, just as one example.

NICE is also impressive in its efforts to involve stakeholders, proactively contacting those it thinks will have an interest in its guidance, and providing a host of opportunities for engagement. In a TA, that spans the scoping stage all the way through to consulting on draft recommendations, and there’s even the option of appeal if stakeholders don’t feel that NICE has done its job well when appraising a specific technology.

NICE is also very transparent – except when others, like industry, don’t want it to be – such as in handling commercial in confidence data and the scale of discounts under Patient Access Schemes (PAS), where a ‘need to know’ principle appears to be at work.

NHSE, on the other hand, as the current controversies suggest, would do well to take a leaf or two out of NICE’s book.

About the author:

Leela Barham is an independent health economist and policy expert who has worked with all stakeholders across the health care system, both in the UK and internationally. Leela works on a variety of issues: from the health and wellbeing of NHS staff to pricing and reimbursement of medicines and policies such as the Cancer Drugs Fund and Patient Access Schemes. Find out more here and you can contact Leela on leels@btinternet.com

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