Pharmafocus: A Year in Review
pharmafile | January 17, 2008 | Feature | Research and Development, Sales and Marketing |Â Â 2007, biotech, pharma, year in reviewÂ
A look back at some of the biggest stories to affect the UK pharmaceutical industry in 2007, including a string of exclusives only to be found in the pages of Pharmafocus
NICE and the Alzheimer’s battle
The very public row over access to Alzheimer’s drugs in 2007 was a landmark for NICE, the industry and patients, and a complex and difficult moral debate.
In January Eisai and Pfizer launched the first ever legal challenge to a NICE decision in the shape of a Judicial Review, with patient group the Alzheimer’s Society also mounting a challenge which was backed by money raised by readers of the Daily Mail newspaper.
NICE’s decision to deny full access to the drugs was backed by the Judicial Review in August, a crucial decision for the Institute which continues to be the centre of controversy.
But as everybody in the NHS and the pharma industry knows, NICE has no powers to enforce its guidance – whether favourable to the industry or not – and so it was with Alzheimer’s drugs prescribing.
Pharmafocus was the only news publication to carry one incongruous but very real fact: prescribing of cholinesterase inhibitor drugs continued to rise since NICE issued its final ‘No’ to them in May 2006.
Data from IMS Health showed prescribing of the drugs rose 55% over two years, suggesting doctors have been actively defying NICE.
Added to that was the possibility that doctors could manipulate MMS scores to ensure patients receive the drugs, and the story highlighted just how complicated the reality of access to medicines on the NHS can be.
A new kind of NHS partnership
In October news of a groundbreaking new alliance between a PCT and a group of pharmaceutical companies grabbed the front page of Pharmafocus.
Launched in December, the Happy Hearts project is jointly funded by Nottingham City PCT and a group of six pharmaceutical companies comprising Novartis, Merck Serono, Sanofi-Aventis, Solvay, Schering-Plough and Merck Sharp & Dohme.
The project is significant in that it could represent a quantum leap forward in pharma-NHS partnerships, and Pharmafocus was the first to break the news ahead of its official launch.
The project is the first to be co-ordinated by the ABPI as part of its NHS Outreach Programme, and was developed in response to member companies reporting that NHS organisations in some areas of the country were particularly impenetrable to industry contact and collaboration.
Jan Balmer is an independent consultant and acts as one of three regional co-ordinators for the ABPI Outreach programme.
She said: “This is a completely new approach – it’s not like the traditional sponsorship model where the NHS body decides what it wants to do and asks pharma to bankroll it, and it’s not like traditional industry offerings which often don’t match up with NHS priorities. The pharma stakeholders have been involved from the start and have had direct input into the scope and development of the project.”
The project centres around the use of specially recruited and trained clinical healthcare assistants in the Nottingham PCT area, which contains some of the most deprived areas in England.
Thirteen of these new frontline practitioners are now being recruited for the project to identify people in the area who are at high risk of developing coronary heart disease, diabetes or stroke. These patients will be helped to make healthier lifestyle choices, and where necessary, will be referred to their GP for appropriate pharmaceutical and medical interventions.
Unlike previous projects, Happpy Hearts focuses on preventing future ill-health rather than managing existing disease and also runs across practice boundaries, targeting a specific population cohort and provides advice on heart health, with strongly focused lifestyle advice and support.
The ABPI Outreach programme is currently being piloted in three regions in the UK, East Midlands, North West and South West SHAs. Additional work is also under way in Scotland and Wales. In all, around nine collaborative projects are expected to go live by the end of 2007.
The end of the junket?
In May, Pharmafocus gave its front page over to a story charting the changing relationships between the UK pharmaceutical industry and doctors – namely the rapid drying up of ‘sponsored’ travel to conferences – which at their worst were rightly labelled ‘junkets’ and or ‘jollies’ for doctors.
Extensive research by Pharmafocus journalists helped build up a clear picture of a rapidly-changing industry-doctor relationship, with an estimate emerging of a 50% drop in the number of doctors sponsored to attend conferences since early 2006.
The change was brought about by the new ABPI Code of Practice, introduced in January 2006, which has rapidly altered the nature of industry/medical relationships, with educational events now more truly focused on education than ever before.
Dr Martin Goldman, senior medical advisor at Forest Laboratories, told Pharmafocus in May: “When one goes to these meetings they tend to be lower key, with not as much money being spent – certainly the alcohol has ceased to flow. We’ve been to one or two meetings where there’s no alcohol at all, which is unusual.”
The report followed research carried out early in the year by the Pharmafocus team into the changing nature of the ABPI Code of Practice and salesforces.
In March, the new phenomenon of sales reps blowing the whistle when their own companies broke the ABPI rules was examined.
Regulatory consultant and former compliance officer for AstraZeneca UK marketing company Steven Gray told Pharmafocus that reps now had to be constantly vigilant.
“They are the ones that have got to take the decision on the spot about what they can and can’t do,” he said.
A month earlier in February, Pharmafocus was the only publication to publish new data which highlighted the rapid fall in sales representatives in the field.
Figures obtained from the ABPI showed the number of reps taking its exam in 2006 had dropped 50% compared to the year before. The ABPI said numbers had been in decline for four consecutive years, but that 2006 had seen the greatest fall.
The report coincided with news that Pfizer was to reduce its European salesforce by 20%, with the UK sales headcount dropping by 250. Another of UK pharma’s biggest employers, AstraZeneca also announced major cuts in 2007.
Practice Based Commissioning in trouble
The signs were clear from early 2007 that Practice-based Commissioning was not enjoying the popularity among GPs the government had hoped for.
The flagship reform was intended to put general practitioners in the driving seat, but although some early adopters have achieved tremendous results with PBC they remain the exception to the rule. Instead, PBC has hit resistance from PCTs unable or unwilling to hand over commissioning to GPs, and has been held back by widespread apathy among doctors.
A survey commissioned by the government and conducted by MORI found just 16% of England’s GP’s were actively engaged in PBC – such a source of embarrassement to the government that they buried the results. But in October, Pharmafocus reporter Nicola O’Brien uncovered the results and produced an in-depth report on why PBC wasn’t catching on, plus insight into how the industry should respond to the reforms.
Key to pharma’s response to the reform should be understanding local priorities for PBC groups and getting to grips with the complex controls that govern it, industry experts said.
Cozaar and pressure on GP prescribing
In September, Pharmafocus reported the story behind Merck Sharp & Dohme’s decision to cut the price of its market-leading hypertension treatment Cozaar.
The company slashed the price of the drug by a third, a drastic action virtually unheard of in UK pharma but indicative of growing price pressure on the industry’s biggest sellers.
The UK’s sixth biggest selling drug and the market leader in the angiotensin receptor blocker (ARB) class, Cozaar earned £118 million in the 12 months to March 2007 – but these revenues were expected to slide in 2007 under intense pressure.
Merck Sharp & Dohme was reluctant to explain the reasons behind the price cut, citing only ‘changing market conditions’, but Pharmafocus learnt that the drug has been one of the prime targets for PCTs looking to reduce spending.
Increasing numbers of England’s PCTs have targeted the drug, using prescribing incentive schemes to deter GPs from prescribing it wherever possible, and persuade them to either use cheaper rival drugs or avoid the ARB class altogether.
The Cozaar story was important beyond the hypertension market because it reflected an unprecedented focus on cost containment across all NHS budgets.
Independent consultant pharmacist Noel Staunton commented: “Prescribing advisors are under intense pressure and what seems to be happening is that if there is a financial overspend in the PCT, turnaround teams go in and make a whole range of suggestions that they’ve simply ‘cut and pasted’ from other PCTs.”
But PCT prescribing incentive schemes are not the only reason for the Cozaar price cut. Parallel traders have been flooding the UK with cheap supplies of losartan from other European countries, and claim to have seized a massive 75% of all NHS prescriptions for the drug.
The PPRS and UK prices
Without doubt one of the most momentous stories of the year was the Office of Fair Trading’s report on the UK’s pharmaceutical pricing system the PPRS.
In August, Gordon Brown’s newly re-shuffled government announced that it agreed with the OFT conclusion that the system needed to be updated.
Competitiveness minister Stephen Timms said the dreaded – but expected – words in August.”We agree with the OFT that it is time to develop a pricing system which is fit for purpose in the 21st Century.”
Throughout the year, Pharmafocus tracked the story as it developed, explaining the much talked-about but little understood proposals, including ‘ex-ante’ pricing reviews, the core of a proposed ‘Value-Based Pricing’ system, based on the way it’s done in Sweden.
The OFT claimed Sweden’s industry liked the system. But Chris Round, managing director of Merck, Sharp & Dohme in the UK, formerly his company’s country manager in Sweden, gave a slightly different take on it to Pharmafocus. “As a system, it is theoretically interesting, but in practice it is causing real difficulty,” he said.
Negotiations are underway between the UK government and the ABPI, and the outcome – whatever it is – will undoubtedly be one of the major issues of 2008.
UK pharma research
This year’s most important stories weren’t just covered in our news section – our specially commissioned features also provided exclusive insight into the UK, European and global environment for the industry.
Highlights from our coverage of research and development were numerous, including exclusive interviews with Sally Davis, head of R&D at the Department of Health, and John Patterson, AstraZeneca’s R&D supremo.
One of the biggest developments in 2007 across the global industry was the movement of pharma investment into conducting all levels of research in Asia, where lower costs and fast-growing markets stand in particular contrast with Europe.
Prof Graham McClelland, global head of Roche’s centre for applied clinical development, and Dr Catriona McMahon, head of clinical research at AstraZeneca UK, both contributed to our September feature on the state of UK clinical trials within this rapidly changing global picture.
While both were generally upbeat about the UK clinical trials environment, Prof McClelland made it very clear the country had lost ground to competitors.
While both were generally upbeat about the UK clinical trials environment, Prof McClelland made it very clear the country had lost ground to competitors.
“Clinical research is a very competitive area. We saw that very clearly when the European Clinical Trials Directive came in and the UK lost out heavily as its commercial advantage in this area disappeared,” he explained.
“We still have the advantages of our history and healthcare provision – and the cultural advantage of the natural British curiosity, which is always trying to challenge existing beliefs – but we now have some extra bureaucracy, and a cost disadvantage compared with some of the emerging markets in the new European Union members, and also China and India, whose technical skills are now improving.
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