The National Institute for Health and Care Excellence (NICE) will publish quality standards for public health, starting with smoking, alcohol use and obesity.

The Institute will work with experts from Public Health England to develop standards for prevention and treatment at the public health level, now the responsibility of local government.

It is anticipated that the implementation of these standards will help to reduce the burden of diseases related to tobacco, alcohol and obesity on the NHS.

They will be based on existing NICE public health guidance, but will be focused to drive and measure improvements in public health outcomes.

Smoking, excessive alcohol intake and obesity are linked to both acute and chronic ill-health, and medicines feature in the treatment of all three conditions – with Lundbeck’s drug to prevent alcohol abuse, Selincro, being a major new example.

Speaking at NICE’s annual conference, Under-Secretary for Quality Lord Howe said: “Public health quality standards alongside and integrated with those for health and social care will provide a key tool to support Public Health England, local authorities and the wider public health community in achieving excellence.

“Our vision is over the next five years there will be a growing portfolio of NICE quality standards covering all the domains in all three outcomes frameworks.”

Professor Gillian Leng, Deputy Chief Executive and Director of Health and Social Care at NICE, commented that the new public health quality standards “will be a valuable tool for local authorities as they take on their new public health functions, and for Public Health England.

“By bridging the interface across health, social care and public health, NICE public health quality standards will help support integration across the three sectors.”

Steve Turley, Managing Director of Lundbeck, has been re-elected Chair of the European Medicines Group (EMG), the UK voice of pharmaceutical companies based in continental Europe.

Robin Bhattacherjee, General Manager of Actelion, was re-elected vice-Chair of the EMG; and Mike Sumpter, CEO of Servier Laboratories, was elected Treasurer.

Issues highlighted at the EMG’s twelfth AGM included the impact of NHS reform on European-based companies and European perceptions of the UK as a pharmaceutical market and research base.

The EMG’s 15 member companies are Actelion, Almirall, Bayer, Boehringer Ingelheim, Ferring, Lundbeck, Menarini, Merck Serono, Norgine, Novartis, Novo Nordisk, Roche, Sanofi, Servier and UCB.

Steve Turley (pictured) commented: “We have members ranging from the UK’s biggest pharmaceutical companies, through biotechnology specialists to emerging organisations. Yet we all share common challenges and can benefit from being able to view these through a European-focused lens.”

“How the implementation of the NHS reforms affects European-based companies is a key issue this year,” noted Robin Bhattacherjee.

“Upwards of 60% of the medicines our members have introduced in the last decade have not been subject to a NICE health technology appraisal, so... local decision making in the CCGs about the use of these remains a major focus for EMG.”

Mike Sumpter noted: “Globally the UK is viewed as a tough market where innovative new medicines aren’t adopted as readily as similar economies.

“We want to work closely with our NHS stakeholder partners to demonstrate that the UK and the NHS is worth investing in.”

Lundbeck is based in Denmark, Actelion in Switzerland and Servier in France; all three companies have major UK operations.

US biopharma company Intra-Cellular Therapies, Inc. (ITI) has appointed former NICE Chairman Professor Sir Michael Rawlins to its Board of Directors.

Rawlins’ experience in the field of drug assessment, from both clinical and economic perspectives, will be of value to ITI’s ambitious programme of drug development to treat psychiatric and neurological disorders.

As Chairman of NICE from its inception in 1999 to March 2013, Rawlins had a complex relationship with the pharmaceutical industry, which respected his expertise but sometimes challenged his priorities.

With a background in medical practice and clinical pharmacology, Rawlins recently became President of the Royal Society of Medicine, and has received numerous medical awards.

Sharon Mates, CEO of ICT, said: “We are excited to have Sir Michael Rawlins join our board. His expertise in the cost-effectiveness of new pharmaceuticals and other issues in health economics will be invaluable to Intra-Cellular Therapies.

“I look forward to working closely with Michael as we transition our clinical programs through late-stage development and commercial approval.”

Rawlins commented: “ITI has set itself on a course to develop outstanding new pharmaceuticals to treat CNS diseases, surely an ambitious task, but one in which I am pleased to join and help.”

Based in New York, ITI aims to develop drugs for the treatment of dementia and major psychiatric disorders. Its novel antipsychotic ITI-007 is currently undergoing phase II clinical trials as a treatment for schizophrenia.

The plan to introduce value-based pricing (VBP) for NHS drugs was “flawed from the start” and should be scrapped, according to a healthcare think tank.

A report from 2020health argues that VBP could reduce patient access to expensive drugs by replacing the existing patient access schemes.

It also argues that VBP will “politicise” drug pricing by exposing it to lobbyists and media campaigns.

Under the current Pharmaceutical Price Regulation Scheme (PPRS), companies’ total income from the NHS is restricted but individual drug prices are not.

VBP, currently being negotiated between the Government and the ABPI and due to be introduced in 2014, aims to relate drug pricing to value in a broad sense – i.e. to apply NICE’s current decision-making process to drug prices.

The report states: “Value-based pricing sounds like an excellent idea with a well-researched methodology. On further examination the cracks begin to appear... The real concerns of patients, doctors, and carers are only hidden from view.”

One problem, it says, is that the drug access schemes negotiated by the industry and the Department of Health will disappear, potentially reducing patient access to much-needed drugs at a time of NHS austerity.

Another is that “patients could become political pawns” if the availability of a particular drug is focused on by “the press, a political party or an MP”.

Julia Manning, Chief Executive of 2020health, said: “The Government’s new plans for pricing will politicise a formerly non-contentious issue. Despite the intensive negotiations and new promises to include patients further in deliberations, this is an idea it seems was flawed from the start.”

The report urges the Government to improve the existing drug pricing system by further encouragement of patient access schemes, and by tightening controls on any one company’s revenue from the NHS.

NICE has not recommended Novartis’ Jakavi (ruxolitinib) in final draft guidance for the treatment of disease-related splenomegaly or symptoms in adults with myelofibrosis.

An independent appraisal committee concluded the treatment is clinically effective but raised concerns around the manufacturer’s economic model and many of its assumptions.

Sir Andrew Dillon, NICE Chief Executive, said the regulator had to be sure treatments are clinically and cost effective otherwise “money has to be diverted from elsewhere” to fund such drugs in the NHS.

The guidance states that Jakavi is not recommended for the treatment of disease-related cases of an enlarged spleen or its symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

Myelofibrosis is a rare type of blood cancer in which the bone marrow produces too many cells too rapidly. This affects the bone marrow making it less able to create cells. Other organs, such as the liver and spleen, then compensate for this by producing additional cells. The spleen, as it begins to create cells, becomes enlarged.

NICE noted that Jakavi was clinically effective in reducing the size of the spleen in these cases and related symptoms. However, it could not be considered a cost-effective option of NHS resources when compared with existing treatments.

The committee found there were “fundamental issues” with the structure of the economic model supplied by Novartis. It concluded that the associated assumptions made increased the uncertainty of the cost-effectiveness ratio (ICER) for the treatment and that rectifying this would actually increase the ICER.

Final guidance is now expected in June 2013.

Asthma treatment Xolair (omalizumab) has been recommended by NICE in final guidance as an option for treating adults, adolescents and children with severe or persistent allergic forms of the condition.

Xolair has been recommended in people aged 6 years and older as an add-on to optimised standard therapy for patients who require continuous or frequent treatment with oral corticosteroids.

However, the treatment can only be used by the NHS if Novartis Pharmaceuticals UK provides the treatment under the terms of an agreed patient access scheme to lower its price.

The treatment has a UK marketing authorisation as an add-on therapy to standard care to improve asthma with severe persistent allergic asthma. Currently, it is only prescribed to those whose condition remains poorly controlled, despite receiving standard therapy options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, commented: “NICE is pleased to recommend omalizumab, with the agreed patient access scheme submitted by the manufacturer, as an effective add-on therapy for adults, adolescents and children with severe, persistent allergic asthma, which can have a significant effect on a person’s life.”

This month Brigadier Pinching shares a surprisingly palatable civil service coffee with the Department of Health’s NHS/big pharma relationship expert, Naima Khondkar.

I love Elephant and Castle. If you are in any doubt about where you are, just outside the station, there is large sculpture of... an elephant and a castle. Oxford Circus, King’s Cross and Cockfosters have clearly missed out on a neat trick. Anyway, I digress, for I was in central London on important business – to chat with Naima about how the private and public sector could make their marriage work. Having spent six years in curious governmental buildings, this was my territory. Bring on the future!

Hi Naima, what’s your story?

At the Department of Health I work in the Medicines, Pharmacy and Industry Group. The head is Giles Denham and he has a number of teams which sit under him. One looks after the pricing environment – which is very topical right now because of the negotiations – while the pharmacy team takes care of community and pharmacy issues. Another concentrates on prescription policy, and I’m in the industry sponsorship team.

How do you guys roll?

We’re almost account managers for the pharmaceutical industry, within government, and also the first port of call on health policy issues concerning research-based pharma companies, including global outfits that have locations in the UK. There’s a very high-level of strategic engagement, driven by the Ministerial Industry Strategy Group, which combines global heads of pharma, from as far afield as Japan and America, and ministers from health, business, the treasury and UKTI (UK Trade and Investment). The discussions are a great way to highlight how government policy can help partnerships. Our minister, Earl Howe, is a particularly engaging contributor, while ‘No 10’ frequently sends along a representative, indicating how serious the Government is about forming cohesive inter-sector partnerships.

How has the concept of joint working progressed?

Over the last few years we have carefully considered how to fundamentally improve the relationship between industry and the NHS, and a lot of this consideration has been carried out in conjunction with colleagues at the ABPI. There is still a lot of mistrust on both sides, however, and that is one of the greatest challenges reform needs to overcome. The NHS has the perception of pharma as being a big bad wolf, just above the arms and tobacco industries in terms of popularity! For some reason people have a big problem with the pharmaceutical industry making any kind of money. Sometimes I think the level of suspicion is unjustified, but then again, I don’t think pharma do themselves many favours sometimes. It’s important to be open and honest about these things! Equally, the NHS can sometimes be over-sensitive – they don’t like to be told by other people how to do their job.

What needs to change?

There needs to be a shift in how people on both sides view one another and they must learn to wipe the slate clean. Bad relationships can date back to minor incidents that happened 25 years ago, when a young, naive rep went into a meeting with a box of doughnuts to help flog a new product. Something as trivial as this may have resulted in a door being shut. Whereas now NHS representatives need to re-engage, open doors and think about the broader benefits of working together with the pharmaceutical industry towards joint goals. It’s really important that both sides build allegiances and forget past animosities. Ultimately this will benefit everyone.

Do the ‘different’ motivations of the public and private sector make gelling difficult?

There is an incorrect perception that, because pharma makes money, someone else has lost. We must remember that if people have their lives extended due to better treatment then NHS, industry and wider society has won. Recently Helen Bevan, NHS Director for Transformation, said both industries have been very target driven in the last 15 years and, consequently, the humanity factor has eroded. Healthcare professionals on the frontline have been too busy with waiting lists and reductions, while sales reps have been under enormous pressure to shift products and been too focussed on sales. Patient cases have become about performance measurement rather than health outcome, or quality of experience. Clearly there needs to be a radical change in priorities.

What can big pharma do to engender trust?

Their approach can be ill-informed sometimes. Often they think they know the NHS, but actually they need to fully appreciate the complexities of what is an ever-evolving beast. Companies need to consider who they make responsible to forge vital connections and forming sustainable relationships. They regularly send an under-qualified person, who might have the enthusiasm, but not the authority. With joint working one of the big issues has been compliance and, often, the pharma representative at the table can’t actually make a decision about whether a company can work in a certain way. This is one of the areas we are really trying to help with.

How should they alter their approach?

If pharma goes in simply looking for a market share increase, they’ll get figured out straight away. Representatives of the big companies need to prove that they genuinely want to improve a health economy or health outcome, before profits. These are the aspects that make the whole system better, and ultimately everyone wins. The CCGs want more people appropriately treated and that means less hospital admissions and, in turn, more financial resources will be available for commissioning. In this respect pharma needs to look at the bigger picture. Remember, every service that the NHS uses is a business – from nurses to bed sheets – but because of the fractious history, the NHS is suspicious about pharma making money. When they do engage the NHS needs to feel like pharma is an integrated and credible part of the solution, as opposed to a procured service. It’s a fine balancing act.

What are the priorities when it comes to galvanising joint working?

Since joint working was outlined as part of NHS reform we have been keen to establish how it can be improved. A policy working group in 2007 carried out some market research and they came up with some recommendations. The two major areas of focus, on our side, were the issuing of guidance – clear definitions of how the NHS works - and the language that should be used. This is a refreshingly concise 11 page document. We also addressed the practical side by combining with the ABPI to launch the, ‘Joint Working tool kit’. It’s an interactive quick-start guide, which includes exactly what the NHS’s definition of joint working is, essential templates and a versatile project management tool. Above all, it avoids jargon and allows people to understand what is required straight away. This has been endorsed by NICE, the NHS Alliance and Confederation among others. We will be looking again at how we can update these documents and make them more practical in the ‘new world’ and also partnering with industry [through the ABPI] and the NHS to review and revitalise both these tools.

Are you optimistic about fruitful partnerships?

Joint working will continue to be an important focus and a part of my day job. QiPP came and went, so we had to hold fire for a while, but now Innovation Health and Wealth (IHW) has provided a restructure, we are pretty sure of what is happening; six months ago we sat down and established that the shift of power is moving to CCGs. Now individual CCGs. Director of Partnerships, Ivan Ellul is particularly keen on localised, dynamic relationships and Mike Farrar is also a champion. Ian Carruthers is the NHS England lead for IHW and is also keen to encourage this type of engagement.

Do you feel that the tide is turning already?

I’m resolutely positive about changes within the NHS. I’ve had heated discussions with clinicians and pharma about joint working, because a lot of them see it as more rhetoric. Some companies, however, are hugely proactive and want to be pioneers of change. GSK are a good example. They’ve shifted their entire salesforce to encourage new ways of working with NHS counterparts. Their leader, Andrew Witty, is passionate about successfully transforming approaches and he’s someone you can believe in, because GSK have freed up patents, conformed to the ‘alltrials’ ideology and shared data. This has filtered down to the way they engage with the NHS and the company have been very smart, as they realise it’s about increasing the whole market. If a healthcare pathway improves it will produce better diagnosis, and better diagnosis means more appropriate and timely use of medicines.

Well said, thanks Naima!

GSK and Roche have discussed clinical data transparency in a House of Commons Science and Technology Committee session.

Both companies expressed a commitment to greater disclosure of clinical trial results, acknowledging that public opinion on this issue had changed.

Leading medical academic Dr Ben Goldacre (pictured), author of Bad Pharma, questioned the speakers on how effectively these ideals would be realised by industry.

The issue of access to clinical trial data was highlighted by recent controversy over Roche’s trials of the antiviral Tamiflu, data from which were promised but not delivered to the Cochrane research group.

A campaign for the publication of all clinical trial data was fronted by Goldacre and supported by Cochrane, NICE and the BMA.

In recent months, GSK has pledged to publish all clinical trial data relevant to its currently available drugs, while Roche has promised to make redacted versions of the ‘missing’ Tamiflu trials available to Cochrane.

The Parliamentary session debated the industry’s principles and practices in this contentious area.

James Shannon, GSK’s Chief Medical Officer, said the company would only submit clinical study reports to a regulator if it were applying for a product licence – but “all of those studies would be published in a peer-reviewed journal”.

That might be true for GSK, Goldacre commented, but it was not generally true for the industry.

William Burns, a director at Roche, stated: “What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond.”

Goldacre replied that Roche was “making exactly the right kind of noises” about transparency, but had not yet delivered on its “aspirations”.

Both companies reiterated that they were committed to meeting clinical demands for data transparency.

NICE has recommended the use of Esbriet (pirfenidone) in final guidance for certain patients with idiopathic pulmonary fibrosis.

The treatment has been backed as an option for patients who have a forced vital capacity – the amount of air which can be forcibly exhaled after a deep breath – predicted between 50% and 80% of the normal level.

The Institute predicts that its guidance will see around 6,800 patients with the chronic lung condition becoming eligible to use the treatment.

The guidance also advises clinicians that patients should stop taking Esbriet if their disease continues to worsen.

Esbriet is manufactured by InterMune.

Bristol-Myers Squibb’s Orencia (abatacept) has been recommended by NICE as an option to treat rheumatoid arthritis after conventional treatments have failed.

NICE backed the drug following a rapid review of a previous negative appraisal after BMS submitted a patient access scheme to lower the price of the treatment for the NHS.

It is now recommended in combination with methotrexate only if the disease has responded inadequately to two conventional disease-modifying anti-rheumatic drugs (DMARDs) and is used in line with the recommendations for other types of these medicines.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said the guidance will “widen the choice of treatments” available to patients and the health service.

Orencia was not recommended for the same indication in August 2011 as a second line treatment after concerns were raised by NICE over its cost effectiveness when compared to alternatives.

However, the treatment has been backed alongside other treatments as an option for rheumatoid arthritis patients if there has been an inadequate response to one or more TNF inhibitors and if individuals cannot receive MabThera (rituximab) because it is contraindicated or withdrawn because of an adverse event.