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

The National Health Service could face a “diabetes time bomb” according to an audit of patients in England and Wales.
The report says 800,000 Type 1 and Type 2 patients have elevated blood sugar levels which could lead to kidney failure, limb amputation and stroke.

It warned that many of the patients were young or middle aged and could require “substantial hospital care in a matter of years”.

Diabetes UK said the findings highlighted the need for urgent action.

All forms of diabetes result in raised blood sugar levels. If this is not controlled then it can cause serious damage.

The NHS Information Centre report confirmed that the number of cases of diabetes, especially Type 2, is increasing – particularly in deprived communities.

When it came to controlling blood sugar levels, around a third of more than 2 million patients had raised levels that placed them at risk of developing complications.

This was a greater problem for the under 55s.

Nearly 300,000 people were at “high risk” and 144,000 were at “dangerously high risk” in that age category.

The report also found nearly half of patients were not getting the appropriate checks.

The National Institute for Health and Clinical Excellence recommends patients with diabetes receive nine checks annually including: blood sugar levels, whether they are smoking, and an assessment of damage to the eyes or feet due to diabetes.

The study showed that only 53% of patients with Type 2 diabetes and 32% with Type 1 received all nine tests.

Dr Rowan Hillson, National Clinical Director for Diabetes, said: “I am very concerned that the National Diabetes Audit shows that we still have a long way to go in delivering basic standards of diabetes care for everyone.

“In particular, young and middle-aged people with diabetes are not getting the regular checks they need to manage their condition and improve outcomes.

“These checks are vital to reduce serious but avoidable complications. All health care professionals should follow NICE’s clear recommendations. There is no excuse for not doing the basics well.”

Barbara Young, Chief Executive at Diabetes UK, said: “This highlights the need for urgent action to ensure that people with diabetes start to receive all the basic care processes otherwise there will be more amputations, more people going blind, and more cases of kidney failure, heart disease and stroke.”

From: http://www.bbc.co.uk/news/health-13928359

The number of cases of measles in the first five months of this year have surpassed the total for the whole of 2010, according to new data.
The Health Protection Agency (HPA) reported 496 cases of measles in England and Wales up to the end of May this year, compared with 374 for the whole of 2010.

Most cases were in London and the South East, and children and teenagers were most commonly affected.

Small outbreaks have occurred in universities, schools and families, and there have been links with travel abroad after a surge in cases across Europe.

HPA data also show a rise in the proportion of children having the combined measles, mumps and rubella (MMR) vaccine.

The first MMR vaccination is given when youngsters are around 13 months of age, with a booster jab before they start school (usually between the ages of three and five).

Among youngsters aged two, quarterly figures for January to March show 90% had received their first jab – the highest level for 13 years and a 0.6% rise on the previous quarter.

The figures showed that by the age of five, 92.8% of children had received their first dose.

However, not all parents take their child back for the second dose. Among children aged five at the start of the year, only 85.1% had received both doses.

Dr Mary Ramsay, head of the immunisation department at the HPA, said: “We’re very encouraged to see that UK MMR uptake has reached 90% in children aged two, indicating increasing levels of trust by parents in the immunisation programme.

“We’re on the way to reaching our goal of 95% uptake. But anyone who missed out on MMR as a child will continue to be at risk of measles, which explains why we are seeing these new cases in a broad age range.

“It’s that time of year when children are travelling on school trips and family holidays and we are reminding parents and young adults of the importance of immunisation before they travel.

“We cannot stress enough that measles is serious and in some cases it can be fatal.”

From: http://www.independent.co.uk/measles-cases-pass-total-for-2010

Only 56% of the government’s £50 million interim Cancer Drugs Fund – or just under £27.5 million – was spent by Strategic Health Authorities (SHAs) in England during the time the Fund was available from October 2010 to March 31, 2011, new figures show.
This spending rises to just over £32.5 million (65%) if anticipated future costs are included for patients whose treatment was initiated before March 31, says leading charity the Rarer Cancers Foundation (RCF), in a new report evaluating the impact of policies to improve access to cancer treatments.

The study shows that 2,880 applications were made to the interim Cancer Drugs Fund during October 2010-March 31, 2011 (773 applications in March alone) and that, overall, 2,506 cancer patients gained access to treatment as a result of the Fund, although applications for 187 patients were denied.

It also reveals a dramatic postcode lottery with a northsouth divide in approvals, as SHAs in the south of England approved a lower number of applications than those in the north.

For example, NHS South Central approved around 75% of applications during the period whereas NHS North East approved every application it received, and while NHS South West used less than a quarter of its allocated funds, NHS Yorkshire and the Humber spent slightly more than its allocated budget.

Most SHAs have taken steps to expedite the application process for the Fund, with one – NHS East of England – removing the requirement for clinicians to submit exceptional-case applications before they can access the Fund.

Also, six out of 10 SHA operate lists of drugs which will be routinely reimbursed through the Fund. “This approach reduces bureaucracy, enables rapid decision-making and provides greater certainty to clinicians and patients,” says the RCF.

However, NHS North West’s operation of a negative list of drugs which will only be funded in exceptional circumstances breaches the spirit of the Cancer Drugs Fund policy, says the RCF, adding that, despite guidance instructing SHAs to cease using negative lists, NHS North West’s list was still operational on June 3, 2011.

The Fund could potentially benefit more than 30,000 patients, enabling them to access 34 treatments which would not have been routinely available on the NHS, and patients with bowel, kidney and blood cancers have been among the greatest beneficiaries, the report finds.

The most-requested drug – by far – has been Roche’s Avastin (bevacizumab), followed by Merck & Co’s Erbitux (cetuximab), Novartis’ Afinitor (everolimus), GlaxoSmithKline’s Tyverb (lapatinib) and Roche’s MabThera (rituximab).

Commenting on these findings, RCF chief executive Andrew Wilson said that while it was “great news” that thousands of patients have benefited from the Fund, it was concerning that 187 patients had been denied life-extending treatment “despite money going unspent and the emergence of significant regional variations in approval rates.”

The report also looks at progress with Primary Care Trust (PCT) exceptional-case processes. It estimates that 7,743 applications were submitted between April 2007 and December 2010, and suggests that the substantial increase in application rates during October-December last year reflects the fact that many SHAs required clinicians to submit exceptional-case applications to PCTs before a treatment could be considered for reimbursement from the Cancer Drugs Fund.

October-December 2010 (the period in which the interim Fund was introduced) also saw a dramatic drop in the exceptional-case approval rate.

This is likely due to more clinicians being encouraged to apply for treatments which would have stood little chance of being approved before the Fund was introduced, the Foundation suggests, although it adds that this requires further investigation.

Women unable to conceive naturally are being denied IVF on the NHS because they are too young, too old, too fat, smoke or live in Wales – in flagrant breaches of the guidelines.
The postcode lottery nature of the restrictions placed on NHS fertility clinics around the country is revealed in research which shows that more than 70 per cent of primary care trusts are ignoring guidance from the National Institute for Curbing Expenditure (Nice) to offer infertile couples three free cycles of IVF.

Five of the trusts – Warrington, West Sussex, Stockport, North Yorkshire and York, and North Staffordshire – do not provide IVF on the NHS at all.

Most trusts restrict the number of free cycles to one or two, even where they offer them between the ages of 23 and 40. However, women living in Wales have to wait till they are 38 years and six months in many health trusts before qualifying for treatment and must quickly complete their two free allotted cycles – one less than the three recommended by Nice – by the time they are 40. Success rates for IVF decline sharply with age. For every 100 women treated aged 35 and below, 20 will get pregnant; between 36 and 38 around 15 will get pregnant; and at age 39 around 10 will get pregnant.

In 2004, Nice said couples should be given up to three cycles of IVF on the NHS, where the woman is aged 23 to 39.

But despite repeated government reminders, the guidelines have never been fully implemented across the NHS. The latest reminder was sent to trusts (PCTs) by the NHS deputy chief executive, David Florey, in January.

The All Party Parliamentary Group on Infertility sent Freedom of Information requests to all 177 PCTs in England and Wales in March and received 171 replies. Gareth Johnson, Tory MP for Dartford and chairman of the group, said the variation in the criteria showed the Nice guidelines had been “taken out of context and used to place arbitrary restrictions on the provision of IVF”.

He added: “IVF treatment was invented in Britain and so, more than any other country, we should be championing its use.”

Claret Lewis-Jones, chief executive of the patient group Infertility Network UK, said: “It is totally unacceptable that some PCTs are still failing to fund fertility treatment for patients despite the Nice Fertility Guidance issued in 2004. Some PCTs which do fund treatment are only providing one fresh cycle and failing to fund frozen embryo transfers, with many others implementing restrictive access criteria which means eligible patients are denied access to treatment which would be available if they lived elsewhere.”

Tony Rutherford, chairman of the British Fertility Society, said: “Infertility is a devastating condition which affects one in six couples in the UP. The World Health Organisation recognises infertility as a physical illness that requires treatment; however, it can also cause significant emotional and psychological harm to patients. By not being given fair access to fertility treatment on the NHS, patients are being denied the opportunity to start a family of their own.”

The Health minister, Anne Milton, said: “Many PCTs have made good progress towards implementing the Nice recommendations on the provision of IVF treatment. I am aware, however, that a small number of PCTs with historical funding problems have temporarily suspended provision of IVF services. I have already expressed my concerns about this approach and would encourage all PCTs to have regard to the current Nice guidance.”

Couples’ distress can be amplified when they find that a neighbouring town gives access to NHS treatment while theirs doesn’t – as an accident of geography. The unambiguous Nice guidelines were intended to solve that problem and restore the “national” to the National Health Service. But trusts have continued to ignore it.

As the parliamentary group’s report points out, IVF was pioneered in the UP – Professor Robert Edwards received the Nobel Prize for his work with infertile couples – but because of our parsimony and lack of vision we provide less of it than neighbouring countries. Moreover success rates have risen from 14 per cent live births in 1991 to 24 per cent in 2008, so investment in the treatment is delivering more babies for the bucks.

From: http://www.independent.co.uk/more-than-70-per-cent-of-nhs-trusts-break-rules-to-deny-ivf-ndash-and-save-money

Serious concerns have been raised by the NHS care regulator about the way some hospitals in England look after elderly patients.
The Care Quality Commission said three had failed to meet legal standards for giving patients enough food and drink and treating them in a dignified way.

The CQC, which carried out unannounced inspections, also raised concerns about three other NHS hospitals.

The commission has published the first 12 results of 100 such inspections, called for by the health secretary Andrew Lansley after a long campaign by the Patients Association, which highlighted poor care for the elderly.

While its inspectors said there had been many examples of people being treated with respect and given excellent care, in other cases people had not been helped to eat and drink, “with their care needs not assessed and their dignity not respected”.

All six hospitals about which concerns were raised must now say how and when they will improve. The worst three offenders will have to improve or face action from the regulator.

The inspections looked at nutrition and found cases of patients not being helped to eat, poor monitoring of patients’ weight and people not being given enough to drink, with water being out of reach for long periods of time.

In one case, a member of staff at Worcestershire Acute Hospitals NHS Trust said they had to prescribe water on medical charts to ensure patients got enough to drink.

Inspectors also looked at dignity and respect, noting that elderly patients were sometimes not involved in their own care and were given no explanation of the treatment they were to receive or asked for consent.

Staff also treated people in a disrespectful way, spooning food into their mouths without engaging them.

The reports acknowledge examples of excellent care where treatment was explained in a way patients could understand and they were treated with respect and dignity.

Jo Williams, chair of the CQC, said the inspections had built a detailed picture of the care being received by elderly patients in NHS hospitals in England.

“Many of these reports describe people being ‘cared for’ in the truest sense. Sadly, however, some detail omissions which add up to a failure to meet basic needs – people not spoken to with respect, not treated with dignity, and not receiving the help they need to eat or drink.

“These are not difficult things to get right – and the fact that staff are still failing to do so is a real concern. These are the basics that help ensure every patient is treated like an individual – not a nuisance to be ignored or a task that must be completed.

“This is what we expect for ourselves and for our own families, and what every patient should expect from the people who care for them.”
Enforcement powers

Health Secretary Andrew Lansley said that everyone admitted to hospital deserved to be treated as an individual, with compassion and dignity.

More CQC reports will be published over the summer with the findings of the programme of inspections released in the autumn.

From: http://www.bbc.co.uk/news/health-13545780

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

A British man has been sentenced to eight years in prison for his role in what law enforcers describe as the “most serious known breach” of the regulated UK medicines supply chain.
Following a four month trial in Croydon Crown Court, 64-year old Peter Gillespie was found guilty for working with an international network of criminals to introduce fake drugs into the UK’s legitimate supply chain during a five month period in 2007.

The case, known as Operation Singapore, centred on the importation of more than two million doses of counterfeit life saving medicines into the country.

More than half of these were captured by the Medicines and Healthcare products Regulatory Agency, but a huge amount – almost 900,000 doses – initially reached pharmacies and patients.

Despite an immediate recall of Eli Lilly’s antipsychotic Zyprexa (olanzapine), Bristol-Myers Squibb’s bloodthinner Plavix (clopidogrel) and AstraZeneca’s prostate cancer drug Casodex (bicalutamide), 700,000 doses were left unaccounted for, putting the health of many Britons in jeopardy.

Mick Deats, the MHRA’s head of enforcement, also revealed that plans to bring in three other counterfeit drugs – Pfizer/Eisai’s Alzheimer’s drug Aricept (donepezil), UCB’s antiepileptic Keppra (levetiracetam) and Johnson & Johnson’s antipsychotic Risperdal (risperidone) – had been foiled.

“They didn’t get to bring them in but they were definitely well on the way to being prepared to receive them,” he told the media, according to Reuters.

“This is serious criminal activity and puts people’s lives at risk,” Deats said, and stressed that the Agency would not hesitate “to take all appropriate action to eliminate the risks posed by counterfeit medicines and take action against those engaged in their supply”.

However, he also noted current evidence suggests that medicines supplied through the UK legitimate supply chain are genuine and safe to take.

Since 2004 there have been just 15 known instances of counterfeit medicines in the UK regulated supply chain, and given that 850 million prescriptions are dispensed every year in the UK, the likelihood of receiving a counterfeit medicine remains extremely rare, the MHRA said.

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

Health authorities should stop wasting money on “ineffective” operations like tonsil removals and wisdom teeth extractions, according to the quango Audit Commission.
It has calculated that the NHS could save £500 million a year by doing so, that could be put towards more worthwhile treatments.

Its briefing, Reducing expenditure on low clinical value treatments, found that a clearer approach among primary care trusts (PCTs) to what it called “ineffective or inefficient treatments” would ensure more consistency across the country.

It came as another report, by the health think-tank The King’s Fund, criticised “persistent and widespread variations across England in patients’ chances of undergoing surgery for common medical problems”.

Both reports, by coincidence issued on the same day, agreed that some patients were undergoing operations “that do not benefit them”, in the words of The King’s Fund.

However, while the Audit Commission report focused on the potential cost savings of reducing operations, The King’s Fund called for an end to the “unfair” and “inefficient” variations in accessing worthwhile surgery.

The former identified tonsil removals as “relatively ineffective” and hysterectomies in cases of heavy menstrual bleeding as less cost-effective than alternatives.

Wisdom teeth extraction was often not worthwhile, because of a “close benefit and risk balance”, while some procedures, such as orthodontics, were nothing more than “potentially cosmetic”.

Some PCTs, of which there are about 150 in England, could save more than £12 million a year by reducing such operations, the soon-to-be-abolished spending watchdog calculated.

Andy McKeon, its managing director of health, said: “PCTs across the country are currently paying for treatments that cost the taxpayer money, and according to clinical experts have little or no real value to patients. This needs to change.”

The King’s Fund report – Variations in Health Care: the good, the bad and the inexplicable – found that tonsil removal operations in children were 10 times more common in Coventry than in Kingston, even though the procedure “has been queried since the 1930s”.

But it concentrated on lack of access to operations that did work.

For example, it found that rates of admission for hip and knee replacement varied by up to 400 per cent, with people in poorer areas much less likely to receive one.

Rates of coronary artery bypass grafts varied from 34 per 100,000 in Westminster to 197 per 100,000 in Berkshire.

John Appleby, chief economist at The King’s Fund, said: “This report confirms research over decades, both in the UK and internationally, which has shown persistent and unwarranted variations in use of and access to even the most common surgical procedures. This is unfair to patients and inefficient for the NHS.

“Remedying this is urgent given the need to improve quality of care while the NHS grapples with the biggest financial challenge in its history.”

From: http://www.telegraph.co.uk/Tonsil-removals-and-other-ineffective-operations-cost-NHS-500m-a-year

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