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The Pharmafocus Interview: Martin Dawkins

Published on 04/09/08 at 11:57am

 

Martin Dawkins is an Englishman born and bred, but has spent most of his career working abroad, including the US, Japan, Germany and Denmark. He finally came back for good when he was appointed head of Bayer in the UK and Ireland two years ago, and was taken aback at the changes the country had undergone in the 15 years he had been away.

"Before I came back in 2006, I would only ever visit the UK once a year, so never really formed an impression of how things were changing. But when I took my current job on, I was amazed at how the country had changed," he says.

Like many long-term expats, Martin says that for a while he felt like a foreigner in his own country, and was astounded how the social and economic life of the country had been transformed.

Citing a humorous example, he says the standard of cars driven by pharma company sales reps was very different to the early 1990s.

"When I left everyone had a Ford Mondeo or Vauxhall Cavalier, and the choice was somewhat limited for the sales rep. Now we get complaints if the new Audi comes out and the sales reps can't afford it! So we now have more Audis and BMWs than anything else, and these were only for senior executives only 15 years ago."

He says the every day affordability of 'premium' cars and other consumer goods is one of the most remarkable ways the UK has become more affluent in the last decade and a half, as well as the way families live their lives.

But he says these huge improvements in the standards of living are in clear contrast to how the NHS has - or has not - changed over the same period. Having had to get to grips with the healthcare systems in Scandinavia, Japan and the US, Dawkins was also able to look at the NHS with outsider's eyes.

"There have been incredible improvements in the UK's standard of living and the economic strength of the country, but the NHS has gone backwards in comparison to other healthcare systems I've seen abroad," he says.

He says he sees a stark contrast in how many continental European healthcare systems have been allowed to evolve, and the way that problems in the NHS system have been ignored because of political sensitivities. Of course Dawkins has not only seen that in personal experience of his family using the NHS, but also in Bayer's struggle to give patients access to its cancer drug Nexavar.

Nexavar

Bayer Schering Pharma (Bayer's pharma division) launched Nexavar in the UK in 2006, closely followed by Pfizer's Sutent. The drugs are both in the multikinase inhibitor class and represent the first new treatments for renal cell carcinoma (RCC) for a decade.

Since then, Wyeth has launched Torisel and Roche's Avastin has also gained a licence to treat RCC.

But as with other high cost cancer drugs, UK uptake of the drug has remained extremely low compared to other European countries, and access to the drugs remains patchy across the country.

After two years of waiting for NICE's decision on the drugs, the Institute ruled on 7 August that none of the drugs were cost effective enough for use on the NHS.

Dawkins was speaking to Pharmafocus a few weeks before NICE announced its decision, but the ruling comes as no surprise to Bayer and its competitors, as many other cancer drugs have been rejected in similar circumstances.

For patients seeking access to the new drugs, the difference is clear, says Dawkins: an extended survival period and a better quality of life with fewer severe side effects compared to existing treatments.

He says many stories in the media have now raised awareness of individual suffering, but adds that lack of patient access will have long term negative effects for the UK. In particular, he says the fact that leading UK specialists are not free to use these new drugs is damaging the country's status as a centre for research.

"This will become one of the least attractive markets in Europe - it is getting very close to it already, Dawkins insists. "Nexavar is used in every market in the world apart from here. So when we look to invest our research money, while there's a lot of encouragement to put our research money in, particularly clinical development money - it's extremely difficult to actually invest here."

Bayer invest heavily in phase III trials in the UK, but Dawkins says the rationale for this spending is diminishing. "I am questioning whether we want to continue investing at the current level," he admits.

"In the past, the UK has been a very good reference country for clinical excellence, but the question is whether or not it remains a valuable market in the future, and worth making those investments in.

"The knock on effect of making those investments is in creating clinical expertise in the people [academic and clinical research leaders] you are working with; they become expert in the products and potentially users of the product.

"Through the process we have [NICE and NICE blight] one of the reasons we have for doing development in the country is taken away."

Patient rights

In July, health minister Lord Darzi unveiled his long-awaited Next Stage Review of the health service, a key component of which was a new NHS Constitution.

At the core of the new Constitution is a set of patient 'rights', including the 'right' to access any drugs and treatments approved by NICE if it is deemed clinically appropriate.

This new initiative also coincided with a speeding up of NICE's process, and a promise that most drugs could be reviewed within a few months of their launch.

Finally, national cancer czar Mike Richards launched a review of the current ban which stops patients from paying 'top up' fees to pay for cancer drugs and other treatments not funded by the NHS.

Dawkins says he has followed Darzi's initiatives closely, and says he doesn't want to be either too cynical or too hopeful about the plans.

He says the most obvious catch to the new patient rights is that they will have no legal status, and thus remain merely implied rights. Dawkins suggests it is the current attitude of the NHS towards new drugs that needs to change - but that where it needs to change first is not clear.

"You don't have to put these things into law to make sure they get adopted widely, but the fact is that the NHS has been allowed to resist these things. And whether it is the medical profession or the mandarins or the PCTs [responsible for this] there is still an option not to comply with the 'rights'.

"The NHS hasn't got the recent history to suggest that that change will happen."

NICE submissions and risk-sharing schemes

The decision to speed up NICE decision-making so that it is more in line with the Scottish SMC's rapid appraisals is certainly welcome, however.

But Dawkins suggest one further change - to shorten the review period where NICE looks again at treatments. Currently this stands at two years for all technology appraisals, but he says this should be reduced when 'significant' new data emerges for innovative drugs.

"This is particularly important in innovative medicines, because you often get new data really quite rapidly and early on in a drug's life. But if NICE doesn't speed up the second review period, it is still going to be more of a hurdle than a help to new medicines.

"You can't have everyone calling for a second review every six months, so a guideline would have to be established to decide exactly what 'significant new data' would mean, but that is quite possible.

"If that area could be made more transparent and speeded up, that would drive a lot of improvements in the NICE process," he says.

In a clear demonstration of pharma industry frustration at the NICE process, Roche recently decided not to submit any data to the Institute for the appraisal of Avastin in two new indications, breast cancer and lung cancer. Roche concluded that NICE was certain to reject the drug in these patients, and decided the appraisal would therefore be futile and a waste of time and energy.

Martin Dawkins says he sympathises with Roche's decision, and says Bayer is considering doing the same for its forthcoming appraisal of Nexavar in hepatocellular carcinoma (HCC), its second approved indication.

Dawkins says that the current health economic calculations used (including QALYs), combined with the fact that Nexavar can only be used when the liver cancer is advanced means NICE is unlikely to approve it.

"We are waiting to see the reaction to Roche's move, but it makes sense. To be honest, why would we waste our time if there is no hope of success?" He adds that company is likely to have more success by going through the 'exceptional cases' route in individual PCTs.

A number of UK pharma companies with cancer products have shown willingness to consider new and flexible pricing agreements, including a number of different 'risk sharing' approaches.

Bayer is now introducing its own variation on this theme, by offering the first cycle of treatment for free, with the PCT only paying for continuing treatment in patients who respond to the drug.

"The risk sharing approach addresses the PCTs' concerns that not every patient responds to the drugs, for whatever reason. This gives them a little bit more security that they aren't exposed financially for patients who don't respond.

We are rolling it out now to PCTs, and trying to encourage and help them when they are looking at exceptional cases to get the patients on sooner. That's why we have done it - because the longer you leave it, the worse the prognosis is for the patient.

Co-payment

For many in the industry, 'co-payment' is the way forward for overstretched healthcare systems struggling to pay for cutting-edge treatments. In insurance-based health systems in Europe and the US, co-payment - where patients 'top up' the basic care system with their own money - is a commonplace practice. Co-payment for drugs has always been banned on the NHS, but now the government is reviewing its policy in the light of growing pressure for access to drug treatments rejected by NICE.

But the government is treading extremely carefully, as ending the ban could open them up to allegations of wrecking the central tenet of the NHS that care should be equitable and 'free at the point of care' for all.

"I think it's very encouraging that they are reviewing the private 'top up' issue, which is going to need a lot of discussion and debate.

"I'd like to see patients or private insurance to be allowed to pay top-up fees within the system. I understand concerns around allowing a two-tier system within the NHS, but it doesn't have to mean only people with money get the treatment - there are lots of other means of getting funding.

"At the moment, there is inequality because the better informed people can make the system work for them, while others can't. So those changes would open up access more fairly."

Dawkins says he and other UK pharma company heads are due to meet cancer czar Mike Richards before he presents his conclusion to ministers in October, and predicts it will be a delicate matter for government.

"The political case is going to be the most difficult one," says Martin. "Intellectually you can see how it could work, but you need to convince the public that it's a positive thing, rather than the media focusing on where the potential downsides are."

Xarelto - a genuine breakthrough product

Amid all the talk about access to Nexavar, the company has another major product due for launch later this year. Xarelto (rivaroxaban) is a new pill which, along with a number of rival products, is set to revolutionise the prevention of potentially fatal blood clots.

After many years of development, Xarelto has now been approved in Europe as a treatment for venous thromboembolism (VTE) in patients who have undergone elective hip or knee surgery.

It is estimated that VTE kills around 60,000 people every year in the UK - five times more deaths than caused by breast cancer, AIDS and road traffic accidents combined.

Meanwhile around 10% of all deaths in UK hospitals are due to VTE, accounting for 25,000 preventable deaths a year. These astonishing facts emerged from studies published last year, and at the same time the widespread public and political ignorance about VTE also became apparent. Dawkins says one of the biggest jobs facing Bayer is in educating the public, politicians and clinicians about the extent of the problem, and of course the new opportunity to treat it.

"These treatments are revolutionary in terms of the benefits and convenience for patients. At the moment, if your grandmother has a hip replacement operation, she may receive good supportive care to prevent VTE, or she may not. And that could be the difference between life or death. But these new treatments means she can take one tablets for the next 20 days and dramatically reduce the risk of VTE.

As is so often the case in pharma today, Bayer is not alone in bringing its groundbreaking treatment to market. Fellow German company Boehringer Ingelheim has its rival treatment Pradaxa, and others are not far behind.

Pradaxa is already available in Europe, and indeed has just gained NICE approval, while Xarelto is currently scheduled for its UK launch in October.

Dawkins says clinical trials of Xarelto make him confident it will prove to be the most successful in the field. Market analysts estimate that the global market for the new generation of oral anticoagulants is 4-6 billion euros, and Bayer's chiefs recently estimated Xarelto's peak sales at around 2 million euros.

"There are a number of compounds coming to market, and you have got greater or lesser benefits," says Dawkins. "Significantly, we have shown an improvement [on existing treatments] while some of our competitors have just shown equivalence, so we have got quite a significant advantage on them in terms of effectiveness of treatment."

Asked if Bayer takes encouragement from NICE's recommendation of Pradaxa, he replies: "We do, having seen that, we do our own analysis of NICE and we feel there is a very strong argument using NICE's criteria to support these treatments.

"That is one where I am not expecting too many nasty surprises - for a change!"

Xarelto and its rivals are targeting injectable post-operative anticoagulants like Sanofi-Aventis's Clexane in the short-term, but have set their sights on replacing drugs used over longer periods. Patients with atrial fibrillation or venous thromboembolism are at chronic risk of blood clots which could potentially kill or disable them, and warfarin is the current standard treatment for UK patients.

But warfarin requires careful monitoring of blood clotting, creating considerable expense and frequently means patients are often at risk of either dangerous bleeding or a clot.

If Xarelto can prove its safety and efficacy in treating these patients, it will simultaneously transform (even save) the lives of patients, advance medical care in the field, and also transform Bayer's fortunes and profile.

Bayer's UK operations are now gearing up for Xarelto's launch and its post-marketing development in the next few years.

A culture of diversity

Returning to his theme on how the UK has changed, Dawkins says Bayer has benefitted from the prosperity that has brought people from other nations and backgrounds into the country.

Comparing Bayer to how it was 15 years ago, he says: " We are much more culturally integrated and diverse, with people with experience from outside the company and outside the country, and from different ethnic, social and economic areas.

"That brings a wonderful social strength to the company, because you have that diversity of experience that means they challenge the status quo all the time.

"We have people here from France, Spain, the US, Germany - and those are just the people who work directly for me!

"That is what has helped the UK economic model stay competitive, not just taking advantage of local innovation but taking advantage of talent from all round the world."

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