Category Archives: Drug approval

Scottish decision about prostate cancer drug abiraterone is a ‘let down’

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Man in hospital

Patients will lose out because of today's decision

We’re tremendously disappointed and frustrated at today’s decision by the Scottish Medicines Consortium (SMC) – the body that decides which drugs the NHS should pay for in Scotland – to turn down the prostate cancer drug abiraterone.

Abiraterone isn’t a cure for prostate cancer, but it can give some men with advanced disease precious extra months with their family and friends. Yet the SMC has ruled that the price offered by the manufacturer, Janssen, is too expensive to recommend abiraterone for routine use in Scotland.

This decision follows on from the recent approval of the drug in Wales, and a preliminary ‘no’ from the National Institute for Health and Clinical Excellence (NICE), which does the same job as the SMC for England and Wales. We’ve written about this in detail here.

This situation is a mess. Each of the three appraisals has agreed on one crucial fact – that abiraterone is an effective, life-extending treatment.

But we’re now in the strange position that men have different levels of access to the drug across the UK:

  • Men in England with advanced prostate cancer can ask their doctor to apply for access to abiraterone through the Cancer Drugs Fund. But this is a limited pot of money that’s only available until 2014. Following their initial ‘thumbs down’ to the drug, NICE is consulting with experts, and are making a final decision by May about its routine availability on the NHS.
  • In the meantime, abiraterone is already routinely available through the NHS in Wales, after the All Wales Medicines Strategy Group assessed abiraterone using End of Life criteria, something we’ve urged NICE to consider in their new evaluation. But this decision will be overturned if NICE gives a final ‘no’.
  • In Scotland, the SMC also used End of Life criteria to assess abiraterone, but have still turned down the drug based on cost and a lack of “sufficiently robust economic analysis” from Janssen. This is a final decision that can’t be overturned unless Janssen submits new information – either offering a lower price, or giving more evidence of the drug’s effectiveness.

We need to find a way out of this frustrating bureaucratic maze, so that abiraterone can be routinely available to the men who would benefit from it across the whole of the UK.

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Podcast: New drugs, earlier diagnosis, and an interview with our chief executive

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Click on the logo to download the podcast

In this month’s podcast we find out about a fluorescent dye that could light up the early signs of oesophageal cancer and learn how a faulty gene has been unexpectedly linked to better survival from ovarian cancer.

Plus, our chief clinician responds to the decision by NICE to reject new prostate cancer drug abiraterone on grounds of cost, and we hear about a new drug trial to treat childhood leukaemia.

And finally, we’ve got an exclusive interview with our chief executive Dr Harpal Kumar as Cancer Research UK celebrates its 10th birthday, looking back on the progress we’ve made and the challenges in store for the next decade.

Listen now through the audio player below:

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Or click here to download the podcast as an mp3.

Also, the podcast is available on iTunes to subscribe and download for free.

Alternatively, go to the podcast page on our website, where you can hear the show directly through our own Flash player and explore previous shows in the archive. And there’s also a full transcript of the podcast available here.

We hope you enjoy it – please do let us know what you think of the podcast in the comments below, or email us at podcast@cancer.org.uk.

Why today’s prostate drug decision makes no sense

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A 'no pedestrians' sign

It's a provisional 'no' from NICE

EDIT 16/05/12 – NICE has now approved this drug. More here.

Today the National Institute of Health and Clinical Excellence – NICE, the body that decides which drugs the NHS should pay for – has given a preliminary ‘thumbs down’ to a new prostate cancer drug, abiraterone (Zytiga), after it failed to agree a pricing scheme with its manufacturer.

As regular readers will remember, we played a key role in this drug’s development, from pioneering lab work, through pre-clinical studies, all the way up to early patient trials.

This is a deeply disappointing and frustrating decision. Since it became available last year, abiraterone has become one of the most requested drugs on the NHS Cancer Drugs Fund. Both patients and doctors alike value the extra months it gives men with their families, if their prostate cancer comes back after chemotherapy.

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News digest – oesophageal cancer, HRT, Leveson and more

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If you missed the news this week, read this article

Amid the drama of phone hacking, economic gloom, ‘responsible’ capitalism and sinking cruise ships, the week has also seen several intriguing stories in the world of cancer research.

Here’s our regular digest of the latest developments – just click on the links for the full low-down.

HRT and breast cancer

The link between hormone replacement therapy and breast cancer was back in the news, as researchers published a critique of the landmark Million Women Study (which we help fund). In response, the Study’s authors mounted a robust defence of their work, pointing out that theirs was one among many other studies to find that HRT increases the risk of the disease.

Our news feed covered both sides of the story, while Judith Potts in the Telegraph wondered what to make of it all.

Drugs ’cause cancers to spread’?

Somewhat alarming headlines on Wednesday suggested that certain targeted cancer drugs might inadvertently cause cancers to spread. But we felt this was a bit of a leap, given that the stories were based on lab research not patient data.

In fact, the study focused on a type of blood-vessel cell called a ‘pericyte’, and its role in the spread of cancer. And the findings of increased rates of spread haven’t yet been observed in patients, as our expert Professor Kebs Hodivala-Dilke pointed out in a more balanced take on our news feed.

Detecting oesophageal cancer earlier

A study on detecting oesophageal cancer early, which we co-funded with the Medical Research Council, showed that a fluorescent dye could be used to spot the disease. We put out a press release to accompany it, which was picked up by several news outlets, including the Daily Mail and The Sun.

New gene linked to oesophageal cancer

Sticking with oesophageal cancer, researchers in London pinned down the gene behind tylosis, a rare skin condition linked to the disease. This discovery will lead to new insights into how oesophageal cancer develops, and – possibly – new ways to treat it. Cancer Research UK helped fund the study, and our news feed has the details.

Understanding side effects

An intriguing story appeared on Thursday. An international team of researchers, including some we fund, found out how vemurafenib – a new targeted melanoma drug - also causes some people to develop a second, less serious form of skin cancer. Their results also showed how, in principle, this could be avoided.

We think this is a great example of the difference between the new generation of cancer drugs and the previous one – researchers are already starting to identify and work around problems like side-effects and drug resistance, even before the drugs are in routine use.

New drug for ovarian cancer

On Tuesday, several papers got very excited by the news that the European Medicines Agency had licensed a drug called bevacizumab (a.k.a. Avastin) for ovarian cancer. The drug is now available in the UK via the Cancer Drugs Fund. This is a welcome step forward, as trials suggest the drug can delay the cancer from coming back in women with advanced disease.

However, as our expert Professor Iain McNeish told reporters, there are still questions over its use, particularly whether the drug – which is very expensive – actually prolongs life overall. Still though, we urgently need new treatments for the disease, and this drug looks promising.

Statins and cancer?

The Express ran a front page about how statins – used to treat heart disease – can ‘beat cancer’. This unfortunate headline was the result of a very complex bit of lab work looking at the role of a protein called p53 in a cellular pathway called the mevalonate pathway. Without getting bogged down in the detail, it didn’t show that statins can be used to treat cancer. Our spokesperson, Dr Jo Owens, had the final word in the story:

“To say that statins are a potential new cancer treatment is to oversimplify a very complicated picture. These are laboratory findings and, as the researchers themselves point out, there’s a long way to go to find out if they apply to patients”.

The Leveson Inquiry

Which leads us on to our final story of the week. In the wake of the phone hacking scandal, the government commissioned the Leveson Inquiry to look at standards in the media.

One of the less headline-grabbing aspects of the inquiry is its investigation into standards in science reporting. Our colleagues at the Wellcome Trust invited us, together with the Association of Medical Research, to help draw together some thoughts as to how the situation can be improved. You can read our joint submission here (pdf).

That’s all – see you next week,

Henry

PM announces new measures for cancer patients

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Prime Minister David Cameron is due to make a speech about life sciences this afternoon

This afternoon, David Cameron presented the Government’s strategy for life sciences at a conference in London, announcing a raft of new measures aimed at making the UK a much better place to invest in health and life sciences.

According to the Prime Minister, Government plans to give patients earlier access to promising new drugs, and to improve the way data can be used to stimulate new research. Let’s look at the speech’s key points.

Earlier access to drugs for patients

As previewed in The Sunday Times yesterday (£), the Prime Minister set out plans to reduce the time from a drug being developed to being available to patients. We strongly welcome the plans and think they’re great news for patients, as in some circumstances, it will mean drugs are made available sooner.

It takes around 20 years to get a drug from the early stages of development to patients. We believe that once we know that drugs are safe (after phase 1 trials), under strict supervision and initially for conditions where there are no other treatment options, it makes sense to bring drugs to patients quicker, in  the hope that patients reap the benefits of promising new drugs sooner.

Why is this so important? Because many cancer patients find themselves in the devastating position of having no treatment options available to them – even though there are new drugs in the development pipeline that they might benefit from.  We know that many patients in this situation would be willing to try new drugs that may help to treat their cancer.

This announcement will also be good news for the pharmaceutical industry, as it should create strong incentives for companies to develop drugs for smaller groups of patients, with the potential for an earlier return on their investment. This in turn, has the potential to encourage pharmaceutical companies to invest in the UK.

We want the Government to move quickly to take forward these proposals, and monitor their implementation, so patients gain maximum benefit.

Our chief executive, Dr Harpal Kumar, strongly welcomes the move. Here’s the comment he made to the media yesterday:

The proposed new early access scheme will offer real hope for thousands of people and will also provide a very strong incentive for companies of all sizes to develop new treatments for conditions where there is nothing currently available. We have encouraged the Government to think boldly in this area, and welcome this response.

Enhancing use of patient data in medical research

In his Autumn Statement last week, Chancellor George Osborne announced a number of measures that would improve the use of patient data in research, including the launch of a new secure Clinical Practice Research Datalink. This afternoon the Prime Minister built on these measures – namely a proposal to consult the public on how their data could be more routinely used in research.

At Cancer Research UK we hugely depend on patient data for our lifesaving research. Analysing patient’s records has helped us understand the causes of cancer, including how to prevent the disease and diagnose it at an earlier stage when treatment is more likely to be successful.

We have consistently highlighted the importance of making the NHS a world leader in research like this, as it will benefit patients and the public.

So we welcome government plans to consult on the use of patient data in carefully controlled research studies. Allowing patient data to be shared can be enormously beneficial to research but the process must be subject to strict safeguards. And the government must win public support if it is to simplify the regulatory environment so that it could benefit patients and researchers

As the largest fundraising medical research charity in the UK, Cancer Research UK has played a key role in discussions with the Government to feed into these announcements, ensuring that the priorities of cancer patients are heard.

We’ll be posting with another update looking in the proposals in more detail tomorrow. And we look forward to working further with stakeholders in the weeks and months to come to ensure that these measures become a reality.

Sarah

Sarah Woolnough is Cancer Research UK’s director of policy

News digest – ‘stratified’ medicine, government reforms, and improving survival rates

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Hot off the press... our news digest

There’s been another glut of fascinating stories this week, most of which focused on aspects of the NHS. Here’s our digest – follow the links for the full story:

  • On Monday, we announced that we’d enrolled the first patients into our Stratified Medicine Programme – which aims to help the NHS establish a world-class genetic testing service, while simultaneously generating data for research. As well as our press release, we published full details, including a map, a list of genes to be tested, and a video explaining the programme, on this blog.
  • Tuesday’s news was dominated by a story that showed cancer patients were living much longer than in the 1970s. But the report didn’t find improvements across the board. Some types of cancer have seen dramatic improvements, while others have barely changed – further highlighting how much more work we still have to do
  • As we said above, several stories this week focused on NHS cancer care. The first was an investigation by GP newspaper which found – alarmingly – that several NHS trusts aren’t prescribing cancer drugs that NICE has approved. If this turns out to be the case, it’s extremely concerning, and we’ll be keeping an eye on how this story progresses.
  • We posted a piece about the Government’s NHS reforms and what could mean for people with cancer – a topic that’s generating a lot of media interest at the moment.
  • Researchers at our Beatson Institute in Glasgow, leading an international team of scientists, made an intriguing discovery about how melanoma spreads
  • On Friday, research by the Royal College of GPs looked at how long people had to wait before seeing a cancer specialist. Overall, they found that nearly three quarters of patients only saw a GP once or twice before being referred.
  • Also on Friday, the Department of Health announced it had decided to switch the HPV vaccine it uses to one that protects against virus strains that cause both genital warts and cervical cancer (the previous vaccine only protected against the strains that cause cancer). Here’s their press release.
  • We discussed how we were concerns about media reports of people fundraising for an unproven US cancer clinic.
  • And finally, results of a decade-long French trial showed that some younger patients with an aggressive form of non-Hodgkin’s lymphoma, known as ‘diffuse B-cell’ lymphoma, might benefit from more intensive chemotherapy than normal. The big caveat here is that the side effects are consequently more severe, so doctors will need to carefully select who will benefit.

Cancer research is constantly moving forward – we’ve already spotted several interesting stories for the week ahead, so keep your eyes peeled, and see you next week.

Henry

Radio interview – the challenge of sustaining top-quality cancer care

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Peter Johnson

Our Chief Medical Officer, Professor Peter Johnson, was on the BBC Today programme

Our Chief Clinician Professor Peter Johnson appeared on Radio 4’s Today programme yesterday to talk about the rising costs of cancer care in developed countries.

This conversation was sparked by a newly published report from an international panel of health care professionals, policy makers and cancer survivors, which talks about how cancer is becoming a “major economic expenditure for all developed countries”.

The reasons for the rising cost of cancer care are by no means simple, but one of the underlying reasons is that populations are getting older – and our chances of developing cancer increase with age.

Ironically, our aging population is thanks – in part – to huge improvements in medicine, which mean that we’re less likely to die at a younger age from historical killers like infection.

The result – more people are developing cancer. And more people with cancer means more people to treat.

But, in his interview, Professor Johnson was also keen to point out the more positive side to this story that people aren’t always aware of – thanks to research over the past few decades, cancer survival rates have doubled and are “showing no signs of slowing down”.

In other words, more people are hearing the words “you have cancer”, but more people are surviving their disease.

The big challenge that we face is to continue these improvements into the future.

For those interested in learning more, we highly recommend that you listen to the Today interview in full.

In it, Professor Johnson speaks about the significant challenge of ensuring that our growing understanding of cancer and increasingly sophisticated toolkit of cancer drugs are used effectively for every patient.

If you’re interested in reading more about the Lancet report, there’s an excellent and detailed analysis over on the PLoS blog.

This is a topic we’ll be re-visiting on the blog over the coming months, as the debate about things like the government’s new value-based pricing system for drugs on the NHS heats up.

Olly