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 new chairs of the National Institute for Health and Clinical Excellence (NICE) and the Care Quality Commission (CQC) have been confirmed.

Following the announcement of David Haslam and David Prior as the Government’s preferred candidates for the two roles, both have been approved by the Health Select Committee.

New NICE chair David Haslam (pictured) is currently National Clinical Adviser to the CQC and chair of NICE’s Evidence Accreditation Advisory Board.

Haslam is a former GP, BMA president and chair of the Royal College of General Practitioners. His appointment can be seen as an attempt to give the GP profession a clearer voice in the NHS.

He will replace Sir Michael Rawlins, chair of NICE since its inception in 2000, in April 2013 – when NICE will extend its remit to social care.

Health Secretary Jeremy Hunt said that Haslam “will bring to this important role a wealth of skills and experience from his distinguished career as both a front line GP and a respected clinical leader.”

David Prior, who will take up the post of CQC chair at the end of January, is currently chair of Norfolk and Norwich University Hospitals NHS Foundation Trust.

He is a former Conservative MP for North Norfolk, and his appointment represents a consolidation of the NHS reform agenda.

Hunt commented: “David brings a wealth of experience to this significant position, as the chair of a foundation trust, a large comprehensive school, and experience in the private sector.”

Prior said: “I do not underestimate the scale of the challenge ahead but look forward to working with the chief executive, David Behan, and the whole of the organisation to ensure CQC is absolutely clear to the general public about the quality of services it inspects: when services are good and when they are not.”

A former GP has been nominated by the Government to replace Sir Michael Rawlins as the Chair of NICE.

Professor David Haslam has been selected as the preferred candidate for the post when Sir Michael departs in April next year.

Health Secretary Jeremy Hunt has now invited the Health Select Committee to hold a public pre-appointment scrutiny hearing and report on Professor Haslam’s suitability for the post.

The potential new chair has a number of years’ experience within healthcare. He is currently the National Clinical Adviser to the Care Quality Commission, Chair of the NICE Evidence Accreditation Advisory Board and an expert member of the NHS National Quality Board.

He also serves as the immediate Past President of the British Medical Association and was President of the Royal College of General Practitioners from 2006-09. Prior to that he served as a GP in Huntingdon.

The chair of NICE will be accountable to the Health Secretary and will be expected to provide leadership and challenge to the Institute.

The National Institute for Health and Clinical Excellence (NICE) has been drawn into the ongoing row over Roche’s failure to disclose clinical trial data.

The British Medical Journal’s Editor in Chief, Fiona Godlee, has asked NICE to withdraw its recommendation for antiviral drug Tamiflu (oseltamivir) until the missing data are available.

NICE’s Chairman, Sir Michael Rawlins, has said that Roche could be reported to the General Medical Council (GMC) if the company is found to have withheld data relevant to the NICE appraisal.

The BMJ is campaigning for the release of data from at least 123 clinical trials which, according to the Cochrane Collaboration, were promised by Roche in 2009, when Tamiflu received marketing authorisation in Europe.

The Cochrane researchers recently rejected a proposal from Roche to form a joint panel that would discuss what clinical trial data were needed, in order to balance commercial confidentiality with public interest.

Godlee’s letter to NICE proposed that the regulator withdraw its guidance on Tamiflu until it “has received and reviewed the full clinical trial data”.

She also accused NICE of “colluding with the status quo” by failing to insist on seeing the missing clinical trial data at the time of its approval – and pointed out that the FDA has not given the same approval to the drug because it has “performed a more thorough assessment of the trial data”.

Rawlins replied that if the missing data supported the use of Tamiflu then “patients would be damaged by precipitate withdrawal of our guidance” – thus implying a Catch-22 situation.

However, he noted, if Roche’s medical director had “knowingly” withheld relevant data then NICE would report the matter to the GMC.

NICE has backed moves by the Department of Health to make NHS organisations publish which of their technology appraisals are included in local formularies from April next year.

Research has found that certain PCTs are blacklisting expensive treatments recommended by NICE creating a postcode lottery for patients across England.

That led to NICE chair Sir Michael Rawlins calling for patients to sue trusts which do not provide access to treatments recommended by the regulator.

Sir David Nicholson, NHS Chief Executive, has since written to SHAs and PCTs saying that he “wants to see” which NICE technology appraisals are included on local formularies.

“Formularies have an important role in underpinning safe and effective use of medicines,” he said in his letter. “However, they should not duplicate NICE assessments or challenge an appraisal recommendation. Once in formularies, there should be no further barriers to the use or prescription of technologies or medicines.”

Professor Gillian Leng, Deputy Chief Executive of NICE, welcomed the instructions by Sir David and said NICE is now working on creating a best practice guide to developing local formularies.

“This will help ensure consistency in the way in which local formularies are produced, and ensure there is no local evaluation of drugs that have been positively appraised by NICE.

“NICE-approved drugs should not be excluded from local formularies on the grounds of cost. We want all patients to have access to medicines that we consider to be effective.”

NHS Chief Executive Sir David Nicholson will require CCGs to state which NICE-approved treatments are available on their formularies.

In a letter to all NHS organisations, Nicholson linked this requirement to the NICE ‘compliance regime’ outlined in the Government’s innovation strategy.

His response follows a public argument between NICE and the NHS Confederation over delays in the availability of NICE-approved drugs.

In an online article, NICE Chairman Sir Michael Rawlins criticised NHS trusts for “trying to pretend” that they were capable of rethinking NICE decisions.

David Stout, Chief Executive of the NHS Confederation, responded that “every NHS organisation has a finite amount of money available” and that the NHS needed to be “open” about the “trade-offs” forced on it by economic pressures.

Nicholson’s letter attempts to bring together both sides of the argument by stating that PCTs and CCGs must make a public, online statement of which drugs on their formularies are NICE-approved.

The letter noted that local formularies should not “duplicate NICE assessments or challenge an appraisal recommendation”, and that addressing variations in compliance with NICE recommendations was important for the NHS.

However, it stopped short of explicitly banning local commissioners from failing to make any NICE-approved drug available. This is already a legal requirement – but NHS rationing is a sensitive issue, given the current strict cost controls.

Local formularies will be required to include “clear, simple and transparent” online lists of their NICE-approved drugs by 1 April 2013.

Sir Michael Rawlins wants campaigners to take legal action against trusts that deny patients access to NICE-recommended drugs. Maxine Vaccine asks whether this is a powerful strike against bureaucracy or a pointless fit of sulking.

It’s not easy being NICE. When you decide a drug is not cost-effective, the manufacturer contacts a bunch of patient groups on Facebook and passes on soundbites to the press that make you out to be the most heartless despot since King Herod. When you decide a drug is cost-effective, the NHS quietly ignores you.

The Government says it will force trusts to make NICE-approved treatments available to patients – but at the same time, the recession comes back for whatever it forgot to wreck the first time, and the NHS is told it has to make deep spending cuts for the foreseeable future. Andrew Lansley first praises the NHS for hacking nearly £6 billion from its budget, then says rationing of NHS treatments is “unacceptable”. Simon Burns tells Radio Five Live that Monitor will sack CCG leaders who ration services, then the DH shamefacedly explains that he meant to say the Commissioning Board would do that.

And just to make matters worse, if you’re Sir Michael Rawlins, people confuse you with Sir Andrew Dillon and vice versa. Is it your fault that you both look exactly like 1970s newsreaders? Having good taste in neckwear wasn’t part of your job description. And you both have something of the knight about you. It’s time you stood up for yourself.

At least, that’s my rationalisation of why Rawlins went on the HSJ website and revealed that he encouraged the RNIB to take legal action against the NHS. I could be wrong, however. He may have had a touch of the sun, or a bout of lansley that his GP wasn’t allowed to prescribe for.

Whatever the reasons, his blog was in the awesome NICE tradition of standing on the moral high ground and waxing ironic over those below. He recommended that patient groups should use legal measures to “blow the whistle” on trusts that use “delaying tactics” to save money – thereby forcing them to put in place “appropriate financial arrangements” for the drugs in question to be provided. Then came his parting shot: “That would be a much better use of the time of formulary committees than trying to pretend they have the knowledge and skills of a NICE appraisal committee.”

Strangely enough, that didn’t go down too well with the NHS. David Stout, Chief Executive of the NHS Confederation, responded with an air of wounded dignity: “We must remember the reality is that every NHS organisation has a finite amount of money available. Every new treatment covered and funded under a NICE technology appraisal means fewer resources for other treatments.

“The issue raised by Sir Michael Rawlins leads us on to the wider debate that we need to have about the fact that the NHS is facing an unprecedented financial challenge,” he continued. “We need to be open and honest with the public about what the consequences of this financial challenge are, and the fact that trade-offs will be required if we are to improve standards of care while keeping the NHS affordable.”

That is rather good – and it cuts through the DH’s excuses like a scalpel through the contents of an inflamed colorectal tract. We need a public debate about NHS rationing – its economics, its democratic basis, its medical and social impact – not confused denials that such activity was ever dreamt of. If it was Rawlins’ intention to force that debate into the public space, he did well.

Bring it on.

Maxine’s views are not necessarily those of Pharmaceutical Field.

The NHS Confederation has called for greater levels of transparency in order to stop patients taking cash-strapped trusts to court over prescribing decisions.

David Stout, NHS Confed Chief Executive, said trusts need to be honest about the financial challenges they are facing to help patients understand why certain treatments approved by NICE are not prescribed.

He was responding to comments made by NICE chair Sir Michael Rawlins who claimed that patients should take trusts to court if they were being denied recommended medicines.

Mr Stout agreed that trusts should be providing treatments to patients they are “legally entitled to”. But he added that “every NHS organisation has a finite amount of money available” and that funding for new treatments means “fewer resources for other treatments”.

“NHS organisations are faced with the difficult challenge of achieving the best outcomes and highest quality care for patients while balancing their budgets,” he said.

“The issue raised by Sir Michael Rawlins leads us on to the wider debate that we need to have about the fact that the NHS is facing an unprecedented financial challenge. All NHS organisations are facing budgetary pressures while striving to maintain high quality care.

“We need to be open and honest with the public about what the consequences of this financial challenge are, and the fact that trade-offs will be required if we are to improve standards of care while keeping the NHS affordable.”

New innovations from ten of the world’s leading drug companies will compete for the most prestigious distinction in pharmaceutical research later this year – a globally revered Prix Galien medal.

Twelve medicines have made the shortlist for the final of UK Prix Galien, which will return to the House of Commons this coming September.

The shortlist reflects the strength and diversity of pharmaceutical innovation, with treatments for a broad range of disease areas set to be assessed by Prix Galien’s esteemed judging panel – led by NICE Chairman Professor Sir Michael Rawlins. Medicines developed to treat schizophrenia, hepatitis C, MS, DVT, constipation, coronary disease and a variety of cancers will battle it out for the Innovative Drug Award. A treatment for the rare bone cancer in adolescents, osteosarcoma, will be considered for the Orphan Drug Award. All shortlisted products were launched or granted a new indication in the UK between 1 January 2010 and March 31 2012.

The 2012 ceremony comes at a time when the value of medical innovation finds itself under great scrutiny in the UK. The Innovation Health and Wealth Review, published at the end of 2011, outlined the growing need to accelerate the adoption and diffusion of innovation in the NHS – setting out a blueprint designed to ensure innovations that can improve health outcomes actually reach their target patients.

“The challenge for the UK pharmaceutical industry is to demonstrate that its medicines truly add value, and can help the NHS meet its quality and productivity goals. The ethos of Prix Galien is very much aligned with the aspirations of both QIPP and Innovation Health and Wealth. It provides the perfect platform for the UK industry to promote its position as world leaders in pharmaceutical research and development,” says Karen Westaway, Joint Chief Executive at WG Consulting, which has owned the UK Prix Galien franchise for eight years and managed the process since 1996.

UK Prix Galien takes place every two years and is judged by a highly respected panel of influential, eminent and experienced NHS professionals. Alongside Professor Sir Michael Rawlins, the judging team includes experts such as Professor Dame Carol Black, Professor Parveen Kumar, Professor Gordon Duff and the current National Cancer Director, Professor Sir Michael Richards.

“The judges are all high-achieving, influential stakeholders who have shaped, and are still shaping, healthcare,” says Karen Westaway. “Their continued commitment to Prix Galien is itself an endorsement of the process.”

UK Prix Galien 2012

The 2012 ceremony will take place on Wednesday 26 September at the House of Commons, London. The Rt. Hon. Kevin Barron, MP, a former shadow health minister and chair of several all-party parliamentary groups including those relating to the pharmaceutical industry and health, takes over from Lord Walton of Detchant as the Parliamentary Sponsor. Current Secretary of State for Health, Andrew Lansley, is a long-standing supporter of UK Prix Galien and was the Parliamentary Sponsor for many years. The Health Secretary presented the most recent UK Prix Galien awards in 2010, describing them as a ‘fascinating occasion’ that allows people to acknowledge ‘the volume of innovation and new medicines that have been coming through.’

The 2010 Prix Galien medal for innovation was won by Xarelto (rivaroxaban), Bayer Healthcare’s revolutionary treatment for the prevention of venous thromboemolism (VTE). Shire Pharmaceuticals’ Firazyr (icatibant), a treatment for hereditary angioedema, won the Orphan Drug Award.

Prix Galien around the world

Prix Galien is internationally renowned, with a further ten national franchises conducting ceremonies around the globe, as well as an International Prix Galien every two years. The award has been described as ‘the highest distinction which may honour a pharmaceutical product’, and ‘a prestigious testimony and acknowledgement of the vitality of our pharmaceutical research.’ In 2008, US President Barack Obama said: “The Prix Galien is a welcome initiative to stimulate creative research and promote excellence.”

For more information about UK Prix Galien, please visit www.prixgalien.co.uk

NICE chairman Professor Sir Michael Rawlins has said patients should sue their local health trust if they are not receiving the most effective recommended drugs.

The head of the Government’s Medicines Advisory Board believes that trusts are making illegal decisions when failing to prescribe expensive treatments as a result of current economic pressures.

Speaking to the Financial Times he said he wished a patient organisation would take a Trust to court for “failing to comply” with prescribing instructions.

Professor Rawlins also defended NICE’s record for recommending expensive new treatments on the grounds of cost-effectiveness. He insisted that the majority of the Institute’s recommendations were actually in favour of prescription and pointed towards other bodies which prevent the use of expensive treatments.

Sir Michael pointed the finger at local lists of approved treatments across the NHS which “second-guess” the advice given by NICE and in some cases ignore its recommendations.

The NICE chairman, who was recently reappointed for a further year until March 2013, deflected criticism from patient groups – which are often backed by pharma companies – that attack the Institute for not recommending the use of expensive new treatments. Sir Michael insisted that any criticism should be directed at pharma companies for the high prices they charge for new treatments.