Professor Sir Michael Rawlins- head of the government’s medicines’ quango has said patients should sue their health trust if they are not getting the best recommended drugs.The killer quango- National Institute for Curbing Expenditure (NICE) was set up by labour to stop the NHS spending money on it’s drugs bill- so it’s unusual for him to speak out about NHS rationing.

Professor Rawlins, the chairman of NICE said the economic pressure on trusts meant that “completely illegal” decisions were being made to limit the use of expensive drugs.

He told the Financial Times: “I just wish a patient organisation would take a Trust to court for failing to comply.”

Nice has been criticised for ruling against the prescription of expensive new drugs on the grounds that they are not cost-effective.

But Sir Michael told the paper that most of Nice’s recommendations were in favour of prescription and that it was other bodies that blocked the drugs’ use.

Sir Michael criticised the local lists of approved medicines drawn up across the NHS which “second-guess” and sometimes ignore Nice recommendations.

While patient groups for particular diseases – often helped by pharmaceutical companies – have attacked Nice for advising against the use of some expensive new medicines, Sir Michael said they should be directing more criticism instead to the drug companies for charging high prices.

The government’s own innovation review recognised the problem by pledging a Nice “compliance regime” to reduce regional variation – the so-called “postcode lottery” – and to improve adherence to the agency’s guidelines.

It cautioned that local decisions should not act as a barrier to the medicines that Nice had approved.

The first new skin cancer treatment since the 1970s has been rejected by the NHS’s rationing body, in a decision branded a “death sentence” for patients.Clinical trials had shown that half of those who were given the drug were still alive a year later, twice as many as those given an alternative treatment.

The drug, called ipilimumab, works by teaching the immune system how to tackle melanomas and was widely seen as an important advance on “old-fashioned” chemotherapy.

But in draft guidance NICE- the National Institute for Curbing Expenditure has recommended that NHS trusts do not prescribe the treatment, because it costs about £80,000 per patient and because it had doubts over the research data.

It means that unless the manufacturer cuts the price, the only way that the growing number of advanced melanoma sufferers can access the drug is by applying to the Government’s Cancer Drugs Fund.

The decision comes after a provocative academic report claimed that some expensive cancer drugs are “futile” as they cost a lot and cause toxic side-effects yet only give dying patients a few more weeks to live.

In a joint statement, the support group Factor 50 and charity SKCIN said: “The breakthrough that patients and clinicians throughout the UK have been waiting for has arrived in the form of this drug.”

“Standard treatments that have been available since the 1970s are ineffective and to deny this drug to patients, many of whom are young and with very young families, has undoubtedly handed them down a death sentence.”

“To have come so close to a breakthrough and to be told no at this stage is truly devastating.”

Dr Pippa Corrie, Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust, added: “Licensing of this drug for use in the UK marked a step change in melanoma patient care, and whilst the Nice decision is predictable, it is disappointing.

“It is essential that we all work to avoid any negative impact on facilitating patient access to this drug. Our patients have waited too long already.”

Rates of skin cancer are rising faster than any other type of the disease in Britain and it affects teenagers and young adults more than any other group.

Almost 12,000 people now develop the most serious kind, malignant melanoma, every year and about 2,000 will die after it spreads across the body.

For the past 30 years the only treatment has been a type of chemotherapy called dacarbazine which is not seen as particularly effective and leaves patients tired and at greater risk of infection.

The new treatment, marketed by Bristol-Myers Squibb as Yervoy, is taken in just four injections, one every three weeks and is said to have fewer side-effects.

In a trial on patients who had undergone prior therapy for skin cancer, 46 per cent who took the new drug were still alive after a year compared with 25 per cent who had not taken it.

In addition, 24 per cent were still alive at two years compared with 14 per cent of those who did not take the drug, and the median survival was 10.1 months compared with 6.4 months among those who did not take it.

But Nice, which assesses whether or not new treatments should be widely available on the NHS in England and Wales, has recommended against its use.

Sir Andrew Dillon, its chief executive, said: “We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.”

He said the evidence showed that ipilimumab was only effective for a “small percentage” of patients, it was not clear how long its effects last, and that it was linked to “a number of adverse reactions”.

“The Committee considered all these factors and concluded that, on the basis of the evidence provided so far, ipilimumab could not be considered a cost-effective use of NHS resources.”

But he added that the decision is open to public consultation while the manufacturer can offer to cut the cost.

Amadou Diarra, European Vice President and General Manager at Bristol-Myers Squibb UK, said: “We are fully committed to demonstrating that Yervoy represents real value for money to the NHS, and we will be submitting further evidence the hope that Nice will reconsider this decision so that all patients with metastatic melanoma can access this potentially life-extending treatment.”

From: http://www.telegraph.co.uk/Death-sentence-as-NHS-watchdog-rejects-skin-cancer-drug

A drug that can give advanced prostate cancer sufferers an extra two months to live has been rejected by the NHS’s rationing body.The National Institute for Curbing Expenditure (Nice) said that the medicine, called cabazitaxel, was not a cost-effective treatment for men who have already undergone hormone therapy.

It said that although the drug did extend survival for patients with advanced prostate cancer, it was “concerned” about the side-effects experienced in clinical trials and that at an average cost of £22,000 per patient it was too expensive.

The move comes after an important study commissioned by The Lancet Oncology warned that the cost of cancer care is becoming unsustainable in developed countries, and that it makes no sense to keep giving “toxic” and costly drugs to patients with just a few weeks to live.

Sir Andrew Dillon, the chief executive of Nice, said: “The committee concluded that cabazitaxel would not be a cost effective use of limited NHS resources.”

But Owen Sharp, chief executive of the Prostate Cancer Charity, said: “Cabazitaxel is an important treatment, only recently licensed for use here in the UK, which can help to extend the lives of men in the final stages of prostate cancer for whom existing treatments have stopped working.

“These men currently have very few treatment options open to them when their cancer reaches this advanced stage. Increasing the number of treatments that may extend the lives of these men and allow them to spend precious time with their families is essential.”

Prostate cancer is the most common form of the disease among British men, with 37,000 cases diagnosed every year.

Some men live for years with slow-growing tumours, but in other cases it develops aggressively and kills after spreading to other organs.

Treatments often attempt to reduce the production of testosterone, a hormone that fuels the growth of the tumours, but patients can develop resistance to this type of therapy.

In clinical trials, men with advanced prostate cancer who were given cabazitaxel in combination with prednisone, a drug that suppresses the immune system, lived for an extra 10 weeks.

But Nice said there was “uncertainty” about the new drug’s effect on patients’ hearts and livers, and it did not meet its criteria for being considered as an end-of-life drug worthy of additional funding.

It means that anyone who hopes to obtain the new type of chemotherapy on the NHS must make an individual application through the Cancer Drugs Fund.

Nice is still assessing the value of a daily pill that can treat advanced prostate cancer, called abiraterone acetate, which is believed to have kept the Lockerbie bomber alive longer than expected.

From: http://www.telegraph.co.uk/NHS-rationing-body-rejects-prostate-cancer-drug

The Government’s drugs spending watchdog has decided that the first pill to treat multiple sclerosis (MS) is too costly to be prescribed on the NHS.The draft decision dashes the hopes of thousands of sufferers with the auto-immune disease who receive little benefit from current drugs.

There was enormous excitement among Britain’s 100,000 MS sufferers in January when EU drugs regulators gave fingolimod preliminary marketing approval.

Novartis, which markets fingolimod under the brand name Gilenya, subsequently applied for it to be prescribed on the NHS in situations where existing drugs do not work.

To receive these drugs, called interferon therapy, patients either have to self-inject every few days or go to hospital for supervised infusions.

A trial, published last year in the New England Journal of Medicine, showed that fingolimod halved the number of disabling relapses compared with interferon beta.

However, the National Institute of Curbing Expenditure (Nice) has decided that – at £20,000 a year – fingolimod “would not be a cost effective use of NHS resources”.

Prof Carole Longson from Nice said: “Unfortunately our independent committee wasn’t given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used.”

MS charities last night said the decision was “disappointing”.

Simon Gillespie, chief executive of the MS Society, warned: “It will leave some people with no effective treatment option.”

He added: “Access to MS treatments in the UK is very poor – in fact people with MS would be better off living almost anywhere else in Europe, and this decision will only deepen that inequality.”

The German health service is already paying for 2,000 people to receive fingolimod for highly active relapsing-remitting MS (RRMS).

Fingolimod is an immumosuppressant and, while it is well tolerated by most patients, it does have side effects in some.

From: http://www.telegraph.co.uk/MS-pill-rejected-as-too-costly-by-Nice.html

Women over 50 who persistently feel bloated or have lower abdominal pain should be offered a £20 blood test to check for ovarian cancer, a panel of experts has recommended.
Campaigners say hundreds of lives could be saved a year if GPs were quicker to spot symptoms of the disease – dubbed a “silent killer” because it is hard to diagnose early enough.

Ovarian cancer kills almost 4,400 women in Britain every year – one every two hours – making it the fourth most common cancer in females.

While almost three times as many die from breast cancer, those diagnosed with ovarian cancer are far more likely to die earlier.

Figures published in The Lancet show that about 82 per cent of British women with breast cancer survive to at least five years after diagnosis. For ovarian cancer the figure is just 36 per cent. The key reason for the difference is late diagnosis.

Consequently, the National Institute for Curbing Expenditure (Nice) is publishing its first guidelines to help doctors identify and manage the disease.

These include checking the level of a blood protein called CA125, if a women tells her GP she has been persistently experiencing symptoms which could be ovarian cancer.

The test, which costs around £20, is already available on the NHS but offering it sooner could give women a greater chance of survival by speeding up diagnosis and treatment.

Dr Fergus Macbeth, director of Nice’s Centre for Clinical Practice, said older women were often misdiagnosed with irritable bowel syndrome (IBS) when they actually had early stage ovarian cancer. Other possible symptoms include feeling full quickly and the need to urinate urgently or quickly.

He said: “While the symptoms are nonspecific, their persistence can be an important indicator of the disease.”

Women who experienced them 12 or more times a month should see a doctor, the guidelines say.

Although the CA125 test is a useful indicator, they cautioned that it only picked up around 50 per cent of early stage ovarian cancers. Sometimes women with tumours had no raised level of the protein, while others with raised levels sometimes did not have ovarian cancer.

Frances Reid, of the charity Target Ovarian Cancer, said: “This guidance tackles for the first time critical issues facing women who develop ovarian cancer, and could save hundreds of lives. British women must no longer die from delayed diagnosis”, she said.

From: http://www.telegraph.co.uk/GPs-should-offer-20-ovarian-cancer-blood-test

Killer quango NICE- The National Institute for Curbing Expenditure has launched a new online money saving tool – NICE Pathways – that pulls together connected National Health Service guidance into one easy-to-use resource.
For the first time, doctors and commissioners will be able to view and navigate all of NICE’s separate sets of recommendations that relate to a single care pathway in a user-friendly electronic flow chart, as part of a bid to improve the use of its evidence across the nation.

The postnatal care pathway, for example, covers everything from the baby’s first 24 hours up until the first two – eight weeks after birth, providing an immediately accessible overview of all recommended care, as well as links to other products such as the Institute’s Quality Standards and implementation tools.

Launching the new tool at NICE’s 11th annual conference in Birmingham, Gillian Leng, the Institute’s deputy chief executive, said that 18 care pathways have already been completed and that the target is to have 60 on the site by the end of the year.

“NICE Pathways will provide a useful starting point for users new to a topic, while giving specialists confidence that they are up to date with everything NICE has recommended,” she said.

The move comes under a wider plan to improve the digital format of its guidance, which, in future, is likely to remain a crucial element of the new system of value-based pricing for new medicines planned by the government for 2014.

While NICE’s exact role going forward is yet to be defined, in his address to the conference health minister Earl Howe stressed that the Institute – which is to be re-established under primary legislation – will continue to provide independent advice to clinicians, and be a source of advice on cost effectiveness.

From: http://www.pharmatimes.com/NICE_unveils_new_digital_guidance_tool_at_annual_conference

Health Direct notes the use of the phrase “a source of advice on cost effectiveness” as it evokes the memory of labour’s spin- the type of phraseology that labour used to use for cost cutting.

A doubling of new HIV infections in the UK in the past decade is leading experts to tell GPs to offer testing to all adult male patients in some areas.
The Health Protection Agency data shows new UK-acquired cases rose from just under 2,000 in 2001 to nearly 3,800 in 2010.

Many of these new cases are among men who have sex with men and it is this group that campaigners hope to target.

The National Institute for Curbing Expenditure (NICE) has launched new guidelines for doctors in England.

NICE says GPs should now offer and recommend HIV testing to all men who register with a practice in an area with a large community of men who have sex with men or an area that has a high prevalence of HIV – meaning more than two diagnosed cases per 1,000 people.

Increased testing should help stop the spread of HIV by identifying men at risk, NICE believes.

Men who have sex with men remain the group most at risk of becoming infected with HIV.

New diagnoses in this group alone have increased by 70% in the past 10 years.

There are more than 30,000 men who have sex with men living with HIV in the UK and experts estimate nearly a third of these are currently undiagnosed and unaware that they are infected.

Another high-risk group that would benefit from increased HIV testing, according to NICE, is the black African community living in England.

In 2009, more than 2,000 black Africans were diagnosed with an HIV infection, one-third of all new diagnoses in the UK.

Some of the Primary Care Trusts in England where HIV prevalence greatly exceeds two per 1,000

* Brighton And Hove City PCT
* Camden PCT
* City And Hackney Teaching PCT
* Hammersmith And Fulham PCT
* Islington PCT
* Lambeth PCT
* Newham PCT
* Manchester Teaching PCT
* Southwark PCT

Professor Mike Kelly from NICE said: “HIV is still a serious problem in this country, with a large proportion of people unaware they are infected.

“This new guidance from NICE makes a number of practical recommendations which aim to increase HIV testing by encouraging healthcare professionals to offer it routinely to people in areas where there are a high number of people living with HIV.”

This would include parts of large cities like London and Manchester, as well as areas like Brighton and Hove.

Dr Valerie Delpech, head of HIV surveillance at the HPA, said: “These expanded HIV testing policies should be prioritised for implementation as soon as possible.

“The impact of late diagnosis is clearly demonstrated when you look at deaths among people with HIV – three out of five of HIV-positive individuals that die are diagnosed too late to gain the most health benefits from their treatment, like increased life expectancy.”

HIV charities said the guidelines were a “vital step forward”.

From: http://www.bbc.co.uk/news/health-12817564

It is looking increasingly likely that PharmaMar’s Yondelis will not be available on the National Health Service for patients with ovarian cancer, after cost regulators again rejected the drug on questions over efficacy.
The National Institute for Curbing Expenditure (NICE) has republished draft guidance turning down the use of Yondelis (trabectedin), in combination with pegylated liposomal doxorubicin (PLDH), as a treatment for ovarian cancer that has returned six months or more after initial treatment with chemotherapy, including platinum for platinum-sensitive disease.

Ovarian cancer is the fifth most common cancer in women in the UK, with more than 6,500 patients diagnosed every year.

In around 80% of cases the cancer will return following first-line treatment, and it is estimated that just over two fifths of these could be eligible for treatment with Yondelis, a marine-based anticancer drug derived from the sea-squirt that attacks cancer cell DNA to prevent cell growth and spread.

But the Institute’s Appraisal Committee said it has serious concerns over how Yondelis’ effectiveness compares to that of other treatments available on the NHS. Crucially, PharmaMar did not submit any evidence comparing its drug to platinum-based chemotherapy regimens in treating relapsed disease, despite the latter being the gold standard therapy in such cases.

“This means that we cannot be sure that [Yondelis] extends patients’ lives for longer than the most routinely used treatments,” explained NICE chief executive Andrew Dillon.

Evidence ‘not robust’

New evidence considered did suggest that Yondelis might be most effective in women with ‘partially platinum-sensitive’ ovarian cancer, i.e. when the disease comes back between six and 12 months after initial platinum chemotherapy.

However, the Committee said it was not sure that the effectiveness of the drug in this subset of patients was “genuinely different from that seen in the wider group of patients for which the drug is licensed”, and so concluded that the data were not robust enough.

Taking all the uncertainties into account, the Committee calculated that the incremental cost-effectiveness ratio (ICER) for Yondelis could be higher than £95,000 per QALY gained for the entire eligible population, and £68,000 for the partially platinum-sensitive subgroup, despite a proposed patient access scheme under which PharmaMar offered to pick up the tag for treatment with its drug following the fifth cycle of treatment.

“Even when taking into consideration the Patient Access Scheme, through which the manufacturer limited the total cost of the drug, the committee concluded that the cost of trabectedin was too high relative to the uncertain benefits it may provide patients,” Dillon said.

Meanwhile, the Institute has announced that Sir Professor Sir Michael Rawlins has been reappointed as its chair for another year’s term, until March 31, 2012.

Professor Rawlins has held the position since NICE was created by the then Labour government in 1999 to curb the NHS’s expenditure on drugs.

From: http://www.pharmatimes.com/Another_NICE_no_for_PharmaMar_s_Yondelis

Dying cancer patients have been refused costly life extending drugs on cost grounds despite a Government promise to end the “scandal” forever.
Their requests have been rejected by regional health authorities who were accused of operating covert “blacklists” to restrict dozens of treatments to save money.

An investigation by The Sunday Telegraph has uncovered more than 80 cases in which desperately sick NHS patients have been refused the cancer drugs their doctor sought, in the four months since a £200 million fund was introduced to stop health authorities rationing treatments.

The fund was a key move by the Coalition so that those suffering from cancer would never again be refused drugs on grounds of cost.

Ministers were responding to years of anger over a system which meant patients were unable to secure life-extending drugs because central NHS rationers had decided the treatments were not “cost effective”.

Announcing the fund last summer, Andrew Lansley, the Health Secretary, promised to end “the scandal” of cancer patients being refused the drugs that their doctors sought, because of restrictions by the National Institute for Health and Clinical Excellence (NICE).

A £50 million stopgap version of the fund was launched in October, before the annual £200 million investment starts in April.

But this newspaper’s investigation has raised serious concerns over its operation, including:
* At least 86 cases involving terminally-ill patients being turned down;
* Extreme variations in access to drugs, with one NHS region promising free access to more than three times as many cancer treatments as another;
* Local policies so restrictive that in many parts of the country, consultants are expected not to even bother asking for drugs which are not on the “priority lists”.

In its first four months, the fund has paid for approximately 1,300 patients’ drugs – even though research last March suggested up to 20,000 cancer patients’ lives were being shortened each year by drugs rationing.

The Government has allowed each NHS regional health authority to set its own rules about which drugs are put on priority lists, creating a postcode lottery across the country.

If treatments are not on the list, patients and their doctors have to fight harder to justify why they should get them.

Bureaucrats have created complex structures, leaving terminally-ill patients to spend their last months fighting for drugs which could increase their survival.

The policies say every possible funding route for drugs must be exhausted before the NHS will even consider dipping into the fund.

Cancer charities warned that some NHS authorities were attempting to “drive a coach and horses” through the Government pledge.

They fear the £50 million fund may actually end the financial year underspent because of the restrictions.

Andrew Wilson, chief executive of charity The Rarer Cancers Foundation, said: “We are deeply concerned that health authorities are creating really restrictive policies which go entirely against the spirit of the fund – which was that clinicians would be able to decide what treatment their patients need.

“Some organisations are effectively operating blacklists of drugs, while others are making every patient go through lengthy bureaucracy to apply as an exceptional case, when in fact they are a cancer patient requiring treatment should be sufficient. The way some of these organisations are operating drives a coach and horses through the principle of the scheme.”

In most parts of the country, if a patient requires a treatment such as Avastin for bowel cancer – which NICE says is too expensive – their doctors must first apply to see if their primary care trust will fund it as an “exceptional case”.

If that is refused, as would normally be the case, a separate application is then made to request authorisation from the cancer drugs fund – and if that too is refused, patients and doctors are left to attempt an appeal.

Patients refused include those seeking Avastin for advanced bowel, breast and brain cancer, Tyverb for breast cancer and drugs to treat tumours of the bladder and kidney.

NHS authorities said they had turned down requests because they did not think there was enough evidence patients would benefit from drugs their doctors sought. In other cases, they were refused help because their medical history did not match the precise criteria drawn up by trusts.

There is also concern over the “postcode lottery” in availability of drugs.

NHS North West has cited 22 drugs which should normally be funded – while NHS South Central, spanning five counties from Oxfordshire to the Isle of Wight, lists just six treatments which would automatically be allowed.

The policies are so restrictive that in Yorkshire and the Humber, just 82 patients have been given funding. Yet across the East of England, with a similar population, 201 cases were funded.

Even those areas which seemed to have the most generous policies have tightened their belts as end of financial year approaches.

In the North West, which had backed the use for Avastin for some advanced breast cancers, and Glivec for cancer of the stomach, says patients who have not been given funding will now have to wait until April before their cases are even considered.

Several have changed their rules even in during the four months since the fund was set up, so that several patients in London were denied drugs under one set of criteria, only to have their cases reconsidered all over again as their health declined.

Mike Hobday, head of policy at charity Macmillan Cancer Support, said he was “very worried” by the findings of the investigation.

He said: “Every cancer patient should get the drugs their doctor recommends, regardless of what type of cancer they have, or where they live.

“A few extra months towards the end of a patient’s life can mean the difference between seeing a child get married or graduate.”

Health Minister Anne Milton said: “Since October, more and more patients are being treated with life-extending drugs that they wouldn’t have got under the previous system. Demand for the fund will vary across the country; we set up the fund in order to balance out existing variation in access.”

From: http://www.telegraph.co.uk/Cancer-sufferers-refused-life-extending-drugs-despite-Government-pledge

Men with prostate cancer are five times more likely to die in some parts of the country than others, highlighting a “postcode lottery” in NHS care, campaigners claim.Experts warned that inequalities in care across the country were “getting worse”.

The disease is one of the most common forms of cancer in men. About 35,000 men are diagnosed with prostate cancer in Britain every year and about 10,000 die from the disease.

Figures show that men diagnosed with the condition in south east Cambridgeshire are almost five times less likely to die from the disease than those in Tottenham, north London.

The statistics, collated by the Prostate Cancer Charter for Action, also show that 96 of England’s 529 parliamentary constituencies have a death rate 25 per cent higher than the England average.

The figures show that in Tottenham, 57 men per 100,000 died from the disease, 131 per cent higher than the national average.

In south east Cambridgeshire the figure was 12 per 100,000.

An earlier report found that areas of the country which had failed to implement NHS guidelines on improving care had a mortality rate 4 per cent higher than those areas were the guidance had been taken up.

Dr Frank Chinegwundoh, a consultant urologist, said: “It is not enough that prostate cancer services are improving as a whole, if patients face such a lottery in the care they receive.”

“We need better services for all patients across the country, not just a lucky few.”

David Smith, of the Prostate Cancer Support Federation, said: “All men with prostate cancer should benefit from better services, yet these figures suggest that the inequalities in prostate cancer are getting worse.

“There can be no excuse for services in some areas of the country to be performing so much worse than in others.

“This situation cannot be allowed to continue.”

Mark Simmonds, the Tory shadow health minister, said: “We have been warning for some time about the inequalities in access to treatment for cancer.

“We want an NHS focused around the needs or patients and the outcomes they want to see.

“And the way funding is allocated to local NHS organisations needs to reflect the burden of disease across the country better.”

Professor Mike Richards, the NHS’s national clinical director for cancer, said: “The Department of Health recognises the importance of implementing the Improving Outcomes Guidance published by NICE and we have asked Strategic Health Authorities to submit action plans to demonstrate how they will implement this.

“Raising the public awareness of prostate cancer is one of the key challenges for the future. We want men to know what their prostate is, what it does, and what can go wrong with it and we are tackling this through the National Awareness and Early Detection Initiative.

“Also for the first time, as a result of the work of the Prostate Cancer Advisory Group, we now have a definitive set of consistent key messages for the general public about the prostate, including prostate cancer. These clear messages provide men and their families with information about the prostate that they need to be aware of and are designed in such a way as not to cause unnecessary anxiety.”

From: http://www.telegraph.co.uk/health/healthnews/5531954/Postcode-lottery-in-protate-cancer-treatment.html