NICE and the 2015 General Election

What could the forthcoming UK General Election in May 2015 mean for the always evolving National Institute for Health and Care Excellence (NICE)? Leela Barham takes a look at how the health watchdog has changed since its inception and speculates on its direction from 2015.

NICE describes itself as providing 'national guidance and advice to improve health and social care'. Perhaps most famously, NICE conducts Technology Appraisals (TAs), to look at the clinical effectiveness and cost effectiveness of technologies. NICE says yes most of the time (62 per cent of its 557 recommendations from 1 March 2000 to 31 August 2014 were positive).

However, if you are the company and it is your new medicine, or you are the patient who will either have to pay yourself or go without if the NHS does not pick up the tab, knowing that you're part of the minority of cases where NICE says no is probably of little comfort. The 'silent' society that NICE represents because of the opportunity costs of these decisions, may not even notice. Agencies and payers across the world will check out the NICE website to find out what they think of a new medicine too.

NICE covers a much broader remit than it had at its introduction in 1999. New responsibilities have been added and big changes have been made to its approach to TAs, including:

• 2005: NICE took on responsibility for guidance on public health interventions and Single Technology Appraisals (STAs) were introduced, to speed up provision of guidance

• 2008: NICE International was set up, offering advice around the globe

• 2009: Flexibilities were introduced, allowing NICE to recommend products for patients at the end of their life, equating to a higher cost per Quality Adjusted Life Year (QALY) threshold for these medicines

• 2013: Social care and Quality Standards were added to NICE's responsibilities. NICE was also established as a Non-Departmental Public Body, giving it greater independence from Government, introduced by the Health and Social Care Act 2012

The controversies

Independent?

NICE has been controversial from the outset. Its first Technology Appraisal was for Glaxo Wellcome's (now GlaxoSmithKline) Relenza, a treatment to reduce the severity of 'flu. NICE initially said 'no', but later changed its mind, recommending use in high-risk groups. Glaxo Wellcome didn't take the initial knock-back lying down, asking for an urgent meeting with the Prime Minister, and warning about companies pulling out of the UK. (It is worth noting that much debate continues about Relenza and another treatment, Tamiflu, not least regarding access to trial data and conflicts of interest).

Political interference has also been at play. For example, in 2005 Patricia Hewitt, then Secretary of State for Health, stepped in and said that Herceptin should be made available, before NICE had had a chance to come to its view on its use in early breast cancer. NICE subsequently recommend use in 2006.

"Concerns were raised about the independence of experts NICE used because of their links to the companies producing the drugs"

NICE's approach to statins has caused upset too; in a 2014 update to NICE guidance concerns were raised about the independence of experts NICE used because of their links to the companies producing the drugs.

But, at the same time as people have wondered about outside influences on NICE, the agency itself has been credited with becoming more outspoken, commenting on everything from efficiency of R&D to how companies set prices.

Growing influence on UK prices?

NICE's 'no' decision for disease modifying therapies for multiple sclerosis (MS) in 2002 resulted in the very first risk-sharing scheme in the UK, with prices dropped at the start and future prices subject to change in light of real-world results. This opened the door for Patient Access Schemes (PAS), which were then included in the broader framework for pricing and reimbursement of branded medicines, in the 2009 Pharmaceutical Price Regulation Scheme (PPRS). PAS allow companies to offer a special 'deal' to the NHS, mostly in the form of confidential discounted prices. NICE had to set up a special unit, the Patient Access Scheme Liaison Unit (PASLU) to handle companies' offers of schemes and its Appraisal Committees had to take into account the impact on cost effectiveness.

"There has been the recent furore about the price of Roche's breast cancer medicine, Kadcyla"

The debate about NICE and prices of new medicines doesn't stop there though, as there has been the recent furore about the price of Roche's breast cancer medicine, Kadcyla. Roche has set a price of £90,000 per patient and NICE has come out fighting by pointing out that "The company is well aware that we could not have recommended Kadcyla at the price it proposed". Not only that, but NICE chief executive Sir Andrew Dillon also said that the discount Roche offered made "little difference". And, in an interesting turn in public opinion, there is currently an online petition calling for Roche to lower its price (instead of the usual call for NICE to change its approach).

Opaque?

NICE has also been the subject of Judicial Reviews (JR), wherein a judge reviews the lawfulness of a decision or action by a public body. In 2009 NICE was scrutinised in a JR for its guidance on Servier's Protelos to treat osteoporosis. The key issue was release of the cost effectiveness model. This time the Judge singled out Andrew Dillon, as chief executive, as "going through the motions so that they could claim they had done their duty". The Judge ruled that NICE had wrongly failed to disclose the economic reasoning that lay behind the decision not to recommend Protelos.

And these are just some of the controversies that have surrounded the agency over its almost 15-year history. Others include concerns about letting people go blind or even the expenses that the agency has incurred.

The patients

Cancer52, an umbrella organisation representing 80 patient groups for patients with rare and less common cancers, has highlighted issues that are key for NICE in its Manifesto for 2015. Although NICE isn't named, we can all guess who they are talking about when they say 'we want all parties to commit to decision-making where patient experience and their perspectives on what is 'worth it' involve patients rather than it being some cursory tick box exercise'.

Patients Involved in NICE (PIN), another umbrella group with over 80 members, also has issues that it wants NICE to address. These range from wanting a code of conduct for NICE Appraisal Committee members, to ensuring NICE actually has enough resource to deliver against its expanded remit.

The industry

It's no surprise that NICE has been a focus for the pharmaceutical industry. The ABPI has released its 2015 Manifesto, calling for 'a review of how NICE can better align to meet the UK's priorities, including reviewing the suitability of the Quality Adjusted Life Year (QALY)'. The current president of the ABPI, Jonathan Emms, has made it clear he wants 'political reform'. He describes NICE's methods as being dominated by a small number of health economists with a certain view of the world.

The future?

The political rhetoric is already ramping up in the run-up to the General Election, with the NHS being a key battleground. I doubt any party would credibly call for the abolition of NICE as part of its electioneering, so it will be here to stay. But the focus will be on what it needs to do, as well as on how it goes about it.

The last election gave us the Cancer Drugs Fund (CDF), now worth £280 million a year, to spend on medicines that NICE hasn't appraised or rejected. It was a promise in the Conservative Manifesto last time round and, although it was originally seen in some quarters as undermining NICE, given that it has blown the (supposedly fixed) budget, NICE is widely anticipated to play a much bigger role in deciding what gets added, stays and goes from that list. The CDF may even be dropped, although it is tempting to keep it - it is political gold to point to the 'thousands' of individual patients that the Tory policy has helped in England.

The last election also saw the Conservatives promise to reform how companies are paid for NHS medicines through the introduction of Value Based Pricing (VBP), now known as Value Based Assessment (VBA). But that has practically disappeared, amid accusations that NICE's approach to its introduction is ageist. Instead, NICE has decided to call for a wider debate on everything from development of medicines to their adoption in the NHS. So I'd be surprised if we were to see a promise of pricing reform this time, especially with the 2014 PPRS only just settling in (and bringing in millions in real money to the NHS).

One easy option for the parties to promise is the addition of an Office of Innovation as part of NICE, as it wouldn't require any legislative changes and innovation is a bit like motherhood; everyone likes it. Plus NICE came up with the idea itself, so there would be no need to convince the organisation's strong-minded leaders of its merits. This may even come in soon, before the Election, as it's so easy to implement.

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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