NICE draft guidance does not recommend Afinitor (everolimus), a treatment for advanced breast cancer that can increase progression-free survival by four months.

The Novartis drug, described by charity Breakthrough Breast Cancer as “one of the biggest advances in breast cancer treatment in many years”, does not meet NICE’s criteria for an ‘end of life treatment’.

The decision will heighten concern over NICE’s QALY metric for value, which the European Commission recently declared to be scientifically invalid.

Afinitor, an oral formulation of everolimus (which is already widely used as an immunosuppressant), is licensed for use in post-menopausal women with advanced HER-2 negative breast cancer, which will not respond to Herceptin.

The drug inhibits the division of tumour cells and the growth of blood vessels around a tumour, thereby inhibiting tumour growth and metastasis.

Clinical trial results published in September 2012 found that Afinitor could ‘stall’ advanced breast cancer by four to five months.

Dr Rachel Greig of Breakthrough Breast Cancer said: “Everolimus is one of the biggest advances in breast cancer treatment in many years.”

Though “by no means a cure,” she commented, “it could give patients several extra months of good quality of life with their families.”

Sir Andrew Dillon, NICE’s Chief Executive, explained: “While the independent Appraisal Committee acknowledged that everolimus may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival.”

The failure to extend overall survival was only considered crucial because Afinitor did not meet NICE’s criteria for an ‘end of life drug’, since its target patients had a life expectancy slightly over two years.

Consultation on the draft guidance will remain open until 22 April 2013.

New draft NICE guidance recommends giving tamoxifen or Evista (raloxifene) to women with a family history of breast cancer as a preventative drug.

The provisional guidance update makes new suggestions for genetic testing, screening and preventative treatment in women at high risk of breast cancer.

If confirmed by NICE, the recommendations would mean the first use of a drug by the NHS to prevent breast cancer.

Breast cancer is diagnosed in 50,000 women in the UK each year. Women with a sister and a mother or aunt who have developed breast cancer before the age of 50 are considered at high risk of developing the disease for genetic reasons.

Breast cancer is also likely to occur earlier, and to be harder to treat, in this patient class, who are fewer than 1% of women aged under 30.

Genetic testing can identify either of two mutant genes that are linked to increased risk of breast cancer, as well as ovarian cancer.

NICE emphasises the need to reduce the incidence of breast cancer in high-risk women. It estimates that for every 1000 women treated with tamoxifen or Evista for a five-year period, there would be 20 fewer cases of breast cancer.

However, the drugs have side-effects including increased risk of blood clots, so their preventative use would need to be carefully considered.

Tamoxifen was developed by AstraZeneca but has long been off patent. Lilly’s Evista came off patent more recently. Neither drug has UK marketing authorisation for prevention of breast cancer.

Chris Askew, Chief Executive of the charity Breakthrough Breast Cancer, said the draft guidance was “a historic step for the prevention of breast cancer”.

This month John Pinching is in the big smoke with Crucell’s high-flying city slicker Kate Evans. She has an almost Dickensian ‘rags to riches’ tale to tell – forced to wash pots in order to make ends meet, Kate had a ‘road to Damascus’ moment, and now she’s one of the industry’s shining stars. What better way to kick off the festive season?

A frosty winter’s morn, Oxford Circus (exit 8, to be precise), I meet Kate Evans (right) – resplendent in an aquamarine cardigan – and we alight to a nearby hot beverage purveyor. This ain’t called ‘Coffee Break’ for nothing, dear reader. Realism is essential – we do actually go ‘for coffee’. Having said that, Kate orders a tea, shattering the illusion. I, true to my word, request a latte. The checkout girl seems a bit stroppy, but we proceed with the interview, we are professionals after all...

What do you think of the new mag? It was very eye-catching when it came through the post, which is a good thing, because usually it gets shoved on a pile. It looked different, therefore I read it. It was fun, more relaxed and sharp.

Thanks, the cheque’s in the post. So, Kate, what’s your story?  I was born and brought up in Middlesbrough and went to university in Durham. I got a 2:2 and was mortified; I cried for an entire day. I thought I’d never get a job, but I’ve realised that it’s actually your personality and drive that get you through, not what’s on your degree certificate.

Where are you based now? I arrived in London two years ago when I joined Crucell. My mum still thinks it’s another country, but I had to go and see what it was all about. I go into the office a couple of days a week in High Wycombe and the rest of the time I’m out meeting people. I prefer to be on the road, speaking to the NHS payers at the coal face: finding out about how the reforms are affecting them and how we can work together. I’m nationally based, so I go wherever people want to talk and engage in interesting projects!

How did you get into pharma? After uni I got a position as a peptide chemist, which after doing a Biomedical Science degree seemed the job of choice. It was based in the north east and we were making synthetic proteins for pharmaceutical research and development. After about a year of doing that I was ready to leave the North East and I got a job at Nottingham City hospital as a tumour immunologist researching how to create a blood kit which could detect breast cancer earlier than a mammogram.

What happened to make you change career direction? I used to chat with the reps who came in to sell pipettes and lab equipment to us. Talking to them was the highlight of my day and I used to think, ‘What am I doing every day, just staring down a microscope?’ What they were doing seemed much more ‘me’. You got to chat to people..  At the time I had to work in a pub during the evenings in order to pay my rent. That was when I became obsessed with becoming a pharmaceutical rep.

How did you get your big break? I started trying to find a rep job, but a couple of companies said you’ve got no sales experience, ‘go and work in a call centre.’ There was no way I was going to do that. Eventually I got into the industry through Innovex and worked with them for two and a half years selling MSD products. From there I went on to various positions at Sanofi Pasteur, MSD, and then on to Crucell in 2010.

How is the relationship between NHS and pharma changing? There is still a lot of mistrust stemming back to the era when everything was about a hard sell. Now you have to be able to sell a value proposition, focusing on the new NHS targets. It’s much more about ‘how we can help you with your care pathway, reduce health inequalities and improve patient outcomes’.

What is the best way to ensure relations continue to improve in the future? The key for pharma is deciding who you actually send to the Chief Executive of a CCG, because a Key Account Manager in one company may be very different to another, and some have only ever covered primary care. It is important to understand the whole local health economy and its needs. You need to have at least read the CCG strategy plan, and understood how your product can link to helping them meet their QIPP and QOF targets. I was very passionate about this at the recent Pf Local Insight Forum: many of the people in that room didn’t know what a Joint Strategic Needs Assessment (JSNA) was. In any other business you wouldn’t go and face a client if you knew nothing about what they do. Other feedback I get from customers is that they want someone who can make a quick decision, not someone who has to go back to head office and get agreement.

Have you established some good partnerships with public sector organisations? My own personal experience of working with PCTs has been very rewarding. The uptake of flu vaccines can be low due to various health inequalities, such as transient population, reduced access to clinics, and language barriers. Using local hospital data, you can start to build a business case about how a project may improve vaccination uptake and therefore potentially reduce hospitalisations. It is important to tailor any project to the needs of the local health economy as each has different requirements. I have worked with NHS, pharmacy and other private providers in these ventures. As well as improving patient care, the projects aim to improve uptake and therefore increase the overall market in the process. It shows you can be commercial and still be part of the NHS’s agenda.

You seem passionate about your work. Vaccines, whether they’re paediatric, flu or HPV, have saved millions of lives worldwide and that’s why I’m so passionate about this area. The highlight for me was being chosen by Crucell Global to visit Bangladesh in June this year to see their vaccination campaigns and how money is being put back into developing countries that don’t have a recognised health service. Since merging with Janssen this year it has been very interesting to widen my horizons and apply my skills to other disease areas. I also contribute to the NHS intranet blog for the company, keeping everyone up to date with the reforms.

What other changes excite you? It’ll be really interesting next year to see the emergence of companies like Circle Health, who have already started to fulfil contracts on behalf of the NHS, easing in the whole ‘competition element’ of reform. NHS hospitals are advertising for marketing and business development managers, perhaps because they won’t necessarily get all the referrals from primary care, given that there are some really impressive ‘Any Qualified Providers’ out there.

You’re clearly a bit of a mover and shaker, what does the future hold for Kate Evans? Everyone always wonders where they will be in five years, but I just take opportunities as they come along. As the NHS changes, so will the jobs within pharma. Companies will soon need specific people to handle joint working, for example, and I am sure more even more niched jobs will start to appear as the new NHS goes ‘live’ in April 2013.

Do you have a good work/life balance? In the days when I was winning Rep of the Year in consecutive years, the ratio was more work/work! I don’t stay on the computer until midnight any more; however, sometimes when deadlines are due, work can still start to eat into personal life. I have learnt over the years how to manage my time more effectively; it’s just part of the job. You’ve got to have relaxation time in order to function properly.

Increasing the standard duration of treatment with tamoxifen from five to 10 years could prevent up to 1,000 deaths from breast cancer each year.

Researchers at the University of Oxford have found that doubling the time reduces the risk of tumour recurrence and the mortality rate.

Already the most widely used hormonal drug for treatment of breast cancer in remission, tamoxifen could see its market increased by these findings.

The hormonal drug was originally launched by ICI and is now available in various branded and generic formulations.

Tamoxifen is used to treat women with ER-positive breast cancer, which is accelerated by oestrogen – the drug blocks the hormone’s uptake.

The Oxford research group looked at 6,847 women with ER-positive breast cancer, half of whom were given tamoxifen for five years and half for 10 years.

Tumour recurrence occurred in 21.4% of the 10-year group compared to 25% of the five-year group. Mortality from breast cancer fell from 15% of the five-year group to 12% of the 10-year group.

Since more than 40,000 women are diagnosed with breast cancer in the UK, and most of these are ‘ER-positive’, the longer treatment duration could save up to 1,000 lives each year.

The report stated: “Good evidence now exists that 10 years of tamoxifen in ER-positive breast cancer produces substantial reductions in rates of recurrence and in breast cancer mortality not only during the first decade, while treatment continues, but also during the second decade, long after it has ended”

Dr Caitlin Palframan, Head of Policy at Breakthrough Breast Cancer, said: “This trial is great news for women with this type of breast cancer.”

According to Professor Trevor Powles of Cancer Centre London, these findings “should herald a change in practice".

New research by UK scientists has identified distinct cell types that may be responsible for pre- and post-menopausal breast cancers.

A team at Cancer Research UK’s Cambridge Research Institute (CRI) has determined that the immature ‘progenitor’ cells in mammary glands are of two types, only one of which responds to oestrogen.

The discovery points to the potential for new chemotherapy drugs targeting the oestrogen-positive and oestrogen-negative progenitor cells – which are thought to cause breast cancer in older and younger women respectively.

Progenitor cells, which have the potential for a limited number of cell divisions, are likely ‘roots’ for tumours. The researchers found that some progenitor cells in the human breast have oestrogen receptors while others do not.

The oestrogen-positive progenitor cells survive better in low-oestrogen tissue such as the breast tissue of post-menopausal women, so it may be linked to tumour development in these women.

The oestrogen-negative progenitor cells have a similar genetic makeup to the cells of basal-like tumours – an aggressive form of breast cancer that mostly affects younger women.

Study author Dr John Stingl of the CRI said: “This exciting discovery reveals that mammary glands are much more complicated than scientists initially thought. Uncovering new types of ‘mother’ cells may explain why there are different types of breast cancer, and why young and older women tend to get different types.

“It could also provide new starting points for ways to diagnose and treat the disease in the future.”

Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”

NHS uptake of NICE-approved medicines varies according to location and disease area, according to the Health and Social Care Information Centre (HSCIC).

The HSCIC report shows that for 13 disease areas where comparison was possible, use of NICE-approved drugs was above the expected level in six and below it in six.

Roche’s cancer drug Herceptin (trastuzumab) was among several medicines whose prescription level was lower than expected.

Comparisons between NHS organisations indicate regional variation.

However, HSCIC Chief Executive Tim Straughan said: “Anyone interpreting the figures needs to be clear about the limitations of what the data show and it would certainly be wrong to think they definitively show drugs are being either ‘under’ or ‘over’ prescribed.”

Medicines whose uptake was higher than expected included carmustine implants and temozolomide (for brain cancer), varenicline (for smoking cessation), insulin glargine and detemir (for type 1 diabetes), statins (for high cholesterol) and drugs for osteoporosis.

Medicines whose uptake was lower than expected included riluzole (for MND), naltrexone (for heroin addiction), trastuzumab (for breast and gastric cancer), prucalopride (for chronic constipation), febuxostat (for gout) and drugs for acute coronary syndrome.

Steve Oldfield, Managing Director UK & Ireland of Sanofi, commented: “Many of the medicines appraised by NICE which are absent from the report are not reaching patients as quickly as they should, as local funding pressures in the NHS start to bite.

“More worryingly still, the very latest medicines launched in the last two years are being used significantly less than expected.”

Death rates from cancer in the UK will fall by 17% by 2030, according to a new report from Cancer Research UK.

The biggest improvements will be seen in death rates for ovarian cancer and breast cancer in women, as well as in bowel and prostate cancer.

While a reduction in smoking has impacted on cancer incidence, most of the change is due to improved survival rates due to better diagnosis and treatment.

Overall, it is predicted that the age-adjusted mortality figure for cancer in 2030 will be 142 in every 100,000, compared to 170 in 2010.

Death rates from ovarian cancer are predicted to fall by 43% and female breast cancer by 28%. Strong improvements are also expected for bowel cancer (23%) and prostate cancer in men (16%).

However, the death rate from liver cancer is predicted to rise by 39% and that from oral cancer by 22%, due to a combination of lifestyle factors and increased life expectancy.

Professor Peter Sasieni, epidemiologist at the University of London, said: “For many cancers, adjusting for age, death rates are set to fall dramatically in the coming decades. And what’s really encouraging is that the biggest cancer killers – lung, breast, bowel, and prostate – are part of this falling trend.”

The Department of Health noted that it was aiming “to save 5,000 more lives every year by 2015 - and halve the gap in cancer survival between us and the best-performing countries in Europe”.

Cancer patients in the north of England believe they receive a better experience of care than individuals with the disease in London, a new survey has revealed.

A survey by MacMillan Cancer Support found that nine out of the bottom ten trusts for patient experience were based in the capital; whereas eight out of the top ten performing trusts were located in the north of England.

Harrogate and District NHS Foundation Trust was voted the best performing trust for the second year running with Imperial College Healthcare NHS Trust in London again performing the poorest.

Ciarán Devane (pictured), Chief Executive of Macmillan Cancer Support, said that although hospitals had raised standards “far too many cancer patients are being let down by hospitals failing to provide an adequate level of care.”

The Chief Executive has now called for struggling trusts to “take heed” of the findings and work with the charity to improve the standards of care they offer to patients. “Imperial, while still at the bottom of the table, is committed to addressing the problem and working well with Macmillan and cancer patients,” he said. “But these things take time, and won’t happen if they do not have sustained, top-level commitment.”

In the survey Imperial was criticised on the amount of time outpatients waited to be seen and on the access patients had to a clinical nurse specialist. However, respondents did state that their first appointment with a hospital doctor was sooner than expected.

A spokesperson for the Trust acknowledged that the “experience of some of our cancer patients was below the standard we strive to deliver”.

“We are fully committed to working with Macmillan Cancer Support, as well as other cancer charities and patient groups, and are doing our very best to improve the experience of our cancer patients. We are also continuing to strengthen our relationships with GPs and community services.

“We have listened to patient feedback and have implemented a number of improvement programmes.”

Meanwhile, Harrogate was praised for giving patients easy to understand written information about test results and how ward nurses answered nearly all the questions patients asked.

Research also found that patients with breast cancer felt they were given the best experience of care with those with sarcoma believing they had the poorest experience.

Top 10 performing trusts

*ranked on the number of times they appear in the top 20% of Trusts, further ranked by the number of times they appear in the bottom 20% of Trusts.

Bottom 10 performing trusts

**ranked on the number of times they appear in the bottom 20% of Trusts, further ranked by the number of times they appear in the top 20% of Trusts.

National Cancer Director Mike Richards has outlined plans for a series of public awareness campaigns promoting early diagnosis of cancer.

The DH plans to repeat its national bowel cancer campaign, followed by local campaigns focused on ovarian cancer and ‘constellations’ of cancer symptoms.

Regional pilots are planned for campaigns around breast cancer in elderly women and renal/bladder cancer.

In a letter to NHS trust and PCT chief executives, Richards emphasises the importance of early diagnosis for improving cancer survival rates and notes the Government’s aim of saving 5,000 more lives per year by 2014/15.

The national bowel cancer awareness campaign that ran from January to March 2012 achieved a 50% increase in urgent GP referrals for suspected colorectal cancer in regions not involved in the pilot campaigns.

To build on this effect, the DH plans to repeat this campaign for four weeks from 28 August, using a range of advertising and community engagement strategies. It warns trusts that the campaign may increase pressure on secondary care facilities.

From January to mid-March 2013 the DH will test local campaigns on ovarian cancer and cancer symptom ‘constellations’, and will run regional pilots of campaigns on breast cancer in women over 70 and blood in urine (a potential symptom of renal or bladder cancer).

Hosted by regional Cancer Networks, the campaigns will form part of a national partnership programme to combine primary care and diagnostic services.