Gay couples and women over 40 will be entitled to the same free IVF treatment as heterosexual couples on the NHS for the first time under new guidelines published today.Same sex couples will be given the same rights as heterosexual couples under guidance issued by the killer quango National Institute for Curbing Expenditure (NICE).

The NHS will also extend the upper age limit for IVF by three years to 42, following advice that suggests many women in their late 30s and early 40s could conceive after treatment.

Fertility experts questioned whether health authorities could afford to widen eligibility criteria, when only a quarter currently fund three cycles of IVF for infertile couples, as recommended by Nice.

Gedis Grudzinskas, emeritus professor of obstetrics and gynaecology at Barts and the Royal London Hospital, said that while the new guidance reflects “social changes” there were questions over whether NHS trusts could afford it.

“How do we reconcile the changes in society and equality of access to healthcare, with the economic predicament?” he said.

The new guidelines call on health authorities in England and Wales to fund fertility treatment known as intra-uterine insemination (IUI), using donor sperm, for people in same-sex relationships.

The move follows a relaxation in the law, made under Labour in 2008, to put same sex parenting on an equal legal footing.

The recommendation follows implementation of the Human Fertilisation and Embryology Act 2008. It abolished requirement for fertility clinics to take into account a child’s need for a father or a male role model before agreeing to treatment. Gay couples or single women now need only show they can provide “supportive parenting”.

Demand from gay couples paying privately for fertility services has subsequently boomed, say clinics. Official figures show the number of lesbian couples undergoing IVF rose from 178 in 2007 to 417 in 2010.

One cycle of IVF can cost up to £8,000 privately. Because success rates are low – typically 20 per cent for a 38-year-old – couples can spend tens of thousands on treatment.

Meanwhile Josephine Quintavalle, founder of Comment on Reproductive Ethics, described the same-sex move as “absurd”.

She said: “We are not prepared to accept what constitutes fertility from a biological perspective. Fertility treatment is very important but in this case what we are trying to do is rewrite biology.”

Under the Nice guidelines, women aged 40 to 42 deemed to have no chance of conceiving naturally should be offered one full IVF cycle. In this age group one in eight will give birth after one cycle.

From: http://www.telegraph.co.uk/Gay-couples-and-women-over-40-to-get-free-IVF-treatment-on-NHS

The first pill for MS sufferers is set to be approved for use on the NHS.The National Institute for Curbing Expendtiture (NICE) has overturned previous draft guidance on the drug Fingolimod after the price was discounted and has now ruled that a proportion of people with multiple sclerosis should be treated with it.

MS is a neurological condition that can cause symptoms from dizziness and fatigue to tremors, memory and speech problems. Some patients lose mobility and are wheelchair-bound.

It is often characterised by periods of stability followed be relapses.

Nice has recommended in new draft guidance that people with highly active relapsing remitting MS be treated with fingolimod, also known as Gilenya, made by Novartis.

Studies have shown it can reduce relapses by between 50 and 60 per cent.

It costs around £20,000 per patient per year and thousands of people may benefit.

The qualify patients will have to have unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: “The latest draft guidance from our committee recommends the NHS-use of fingolimod for a specific group of adults who have highly active relapsing-remitting multiple sclerosis.

“Following new information provided during the consultation, the analyses show that for these people, treatment with fingolimod will be a cost effective option for the NHS in this group of people with multiple sclerosis, if Novartis provides the drug at a discounted price, as proposed in its patient access scheme.

“We have published the latest version of our draft guidance on our website so that interested parties can highlight any factual errors or appeal against our final draft recommendations.”

In MS the body’s own immune system attacks the protective coating around nerve fibres which carry signals between the brain and the rest of the body.

The drug prevents the immune cells from attacking the nerve coating.

The Scottish equivalent of Nice, the Scottish Medicines Consortium has not approved the drug.

Nick Rijke, Director of Policy & Research at the MS Society, said: “We are delighted; this decision signifies a major step forward in the treatment of this devastating condition.

“Gilenya has been found to be highly effective in trials and taking a daily tablet will come as welcome relief from frequent, often unpleasant, injections.

“Making this new treatment available will increase patient choice for thousands of people with MS across England and Wales, but we’re deeply disappointed by the SMC’s decision in Scotland – and urge them to reconsider.”

From: http://www.telegraph.co.uk/New-drug-hope-for-thousands-of-MS-sufferers

More than 100,000 people in the UK suffering the “savage” effects of advanced Alzheimer’s disease could benefit from drug treatment to slow its progression. Scientists have shown for the first time that drugs used to slow the disease in its early stages also work when the condition is advanced, greatly extending the population who could be treated.

Advanced Alzheimer’s is marked by the progressive loss of cognitive skills and physical control and leaves individuals stripped of their dignity and personality.

The finding could double the number of patients currently on treatment from 50,000 to over 100,000 in the UK and extend treatment to millions more worldwide.

Only one in five of the 500,000 patients with Alzheimer’s in the UK, a third of whom have advanced disease, are currently receiving drug treatment because of a shortage of clinics to diagnose them.

Professor Robert Howard of the Institute of Psychiatry, Kings College, London, who led the study published in the New England Journal of Medicine, said: “For the first time we have robust and compelling evidence that treatment with these drugs can continue to help patients at the later, more severe stages of disease. Patients were better able to remember, understand, communicate and perform daily tasks for at least a year longer than those who stopped taking the drugs.”

The National Institute for Curbing Expenditure (NICE) came under fire when it initially refused to approve Donepezil, the commonest drug whose brand name is Aricept, and associated drugs on the ground that they were not cost effective. It said the drugs worked in 40 per cent of those treated. Later they were forced to review its decision and recommended the drugs in the early and moderate stages of the disease but not in the late stages.

Although Its current advice says the drugs should only be withdrawn when doctors consider they are no longer of benefit, the latest findings mean its default position – that the drugs do not work in the late stages of the disease – may now have to be reviewed.

Researchers led by Professor Howard  studied 295 patients with  severe Alzheimers over a year and found continued use of donepezil slowed the deterioration characteristic of the disease by one third, equivalent to four months of improved quality of life.

Those who took a second drug, memantine, in combination, did even better.

Professor Clive Ballard, director of research at the Alzheimer’s Society, which funded the study with the Medical Research Council, said the drug was not a cure but significantly relieved the symptoms: “If I had Alzheimers disease or my relative did I would want them to have [the combination].”

Donepezil came off patent in February and its cost has  plummeted. It is now priced at around 80 pence a day compared with £2.50 a day for the patented drug, Professor Ballard said. The next stage of the research would be to examine the cost effectiveness of the drug based on the reduced cost.

Professor Nick Fox of the Institute of Neurology, University College, London, said dementia cost Britain £20 billion a year and one third of the population would be affected at some point in their lives.

“We desperately need therapies that will slow the disease at a stage when we have most to retain. This is a savage disease with a self sustaining momentum of its own.”

http://www.independent.co.uk/life-style/health-and-families/health-news/alzheimers-treatment-in-late-stages-of-disease-does-slow-progression-7544408.html

A new pill costing only £1.40 a day that could save the lives of thousands of heart failure patients every year has been approved by European regulators.New data on Ivabradine suggested it could cut death rates by up to 39 per cent, while experts said it could prevent between 5,000 and 10,000 deaths a year.

The drug was also found to reduce the need for patients to be treated in hospital for heart failure, which affects about 900,000 people in Britain, by 30 per cent.

The drug has been approved by European regulators but has yet to be assessed for widespread use on the NHS as the killer quango NICE has yet to approve it.

It costs £1.40 a day and is already prescribed for patients in this country with angina.

It could reduce the risk of death from all types of cardiovascular disease by 17 per cent and the risk of death from all causes by 17 per cent.

In addition, the drug, which slows down the heart rate, was found to cut the risk of heart failure patients requiring treatment by 30 per cent. The study involved 6,505 people in 37 countries, including Britain.

Heart failure occurs when the organ becomes too weak to pump blood efficiently round the body, leading to fatigue, breathlessness, a higher heart rate and other problems.

Prof Martin Cowie, a consultant cardiologist and specialist in heart failure at the Royal Brompton Hospital in central London, and the British lead investigator for the study, said: “Heart failure is a very common problem, affecting approximately 1 per cent of the population.

“The decision to approve this new indication for ivabradine is great news for both doctors and patients, and is a significant step forward in the management of heart failure.”

Prof Cowie added: “While Ace inhibitors and beta-blockers remain very important in the treatment of this condition, the results of the trial demonstrate the value that a reduction in heart rate with ivabradine can bring both in terms of improving symptoms and preventing disease progression, but also in helping patients return to normal daily activities and increasing their enjoyment of life.”

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.

Critics warn that parts of the Government’s plan to share patient records with private companies give real concern over personal data privacy issues.Mr Burnham said it is “absolutely essential” that patient data is safeguarded, after The Sunday Telegraph revealed David Cameron will use a keynote speech to outline far closer “collaboration” between the health service and life science companies.

The Prime Minister will say that the controversial industry has the potential to be a powerhouse of Britain’s 21st century economy, but that it is stifled by excessive regulation at present.

Speaking to Sky News, Mr Burnham said that while he did not object in principle to close ties between the NHS and private sector life science companies, he was concerned that “one of the patients’ groups that was on the working group looking at this issue has walked away”.

“That gives real cause for concern and rings alarm bells” he said. “The Government simply can’t say: ‘This is all red tape and it all must be brushed away’”.

“Proper regulation, essential safeguards need to be in place when it comes to the use of patient data.”

The move, which will give life science companies more freedom to run clinical trials inside hospitals, is likely to face a backlash from privacy campaigners who have consistently opposed private companies being given access to medical records.

There will be particular opposition from animal rights activists who object vehemently, and sometimes violently, to vivisection, while religious groups, particularly the Roman Catholic Church, could object to firms that use stem cells harvested from embryos being allowed access to NHS data.

One senior executive at a leading drugs company well-known for using animal testing said: “You can look at the NHS as one massive database with 60 million people in it.”

The Prime Minister will stress that greater integration between private companies and the NHS could advance medical science, give patients greater access to cutting-edge treatments and save money, while boosting economic growth.

With Britain teetering on the brink of a double-dip recession, ministers are keen to show that they have a positive vision of the future.

“Britain has the potential to become a powerhouse in the world’s life sciences industry,” said a Downing Street source this weekend.

“We want to see much closer collaboration between the NHS and life science companies — not just greater data-sharing, but more clinical trials in hospitals.

“These changes will not only boost the industry, but also potentially give the NHS early access to new, innovative drugs treatments.”

Welcoming the move, Andrew Witty, the chief executive of GlaxoSmithKline, one of the world’s largest pharmaceutical companies, said: “Any action the Government takes to improve the environment in this country for life science across these activities is welcome.”

Britain is considered uniquely placed to become a world leader in life sciences because of the strength of scientific research at its top universities and the amount of data and expertise amassed by the NHS since its creation in 1948.

The industry already employs about 160,000 people in 4,500 companies, ranging from large multinationals to small businesses.

These firms employ highly skilled researchers with PhDs down to lower-skilled workers in drugs manufacturing plants.

Whether such companies would be charged for access to NHS records was not clear.

Although personal information should be anonymised, the public sector has an appauling history of handling the personal details of citizens.

Numerous health trusts have been criticised for losing patient records in recent years and HM Revenue & Customs has previously lost the financial records of millions of taxpayers.

Privacy campaigners led a vigorous campaign against the previous Labour government’s plans to place every medical record on a central electronic database.

It is understood that the Medicines and Healthcare Products Regulatory Agency would oversee the sharing of NHS data with businesses.

Joyce Robins, from Patient Concern, said many people would be “deeply disturbed” by the notion that their private medical records could be handed to firms seeking new markets.

“Even when they say records will be anonymised, the amount of detail contained in medical records means that companies may be able to find ways to target people with particular conditions,” she said.

“This data is absolutely private; it is not the Government’s to give.”

Health Direct has long warned that patients’ personal data security.

If the Government is genuine in their desire to speed up drug development- they ought to cut red tape.

10 years ago 10% of all new drugs developed in the world were tested in the UK. Since labour created the killer quango National Institute for Curbing Expenditure (NICE) this figure that fallen to only 3%.

Single women are being offered fertility treatment by almost a fifth of NHS trusts casting doubt on the Government’s family friendly credentials.Women not in relationships are receiving publicly funded IVF despite official guidance that suggests support should go to couples who have been trying without success to have a baby for several years.

Meanwhile in other parts of the country married couples are being denied help in starting a family, forcing them to spend thousands of pounds on private treatment.

It comes after a Labour nanny state law removed the requirement for fertility doctors to consider a child’s need to have a male role model before going ahead with IVF.

Critics say the Government, which David Cameron promised would be “the most family friendly we’ve ever had in this country”, should tackle the postcode lottery of IVF provision and ensure that the needs of children are put first.

Frank Field, the Labour MP who carried out a high-profile review into poverty and life chances last year, said: “It’s clearly wrong that while couples in stable relationships can’t get IVF and in other areas, single women can.

“It’s really important that Government ministers speak up for children who are the ones left out of this. It needs someone in a position of authority to reflect what most taxpayers think.”

The Rt Rev Michael Nazir-Ali, the former Bishop of Rochester who once chaired the ethics committee of Britain’s fertility watchdog, said: “The irony is that at the very time research is showing the need for both parents, we are writing fathers out of the legislation.

“It’s one thing for a mother to find herself a single parent because of tragic circumstances. It’s quite another to plan for a situation where the child comes into the world without having a father or any possibility of having a father.”

Most local health authorities stipulate that couples must have been in a relationship for two or three years to qualify for IVF treatment.

That requirement is based on guidance issued in 2004 by the National Institute for Curbing Expenditure (Nice), the NHS rationing body,.

It states: “Couples in which the woman is aged 23–39 years at the time of treatment and who have an identified cause for their fertility problems … or who have infertility of at least three years’ duration, should be offered up to three stimulated cycles of in vitro fertilisation treatment.”

The document does note that the guidelines do not address social criteria “for example, whether it is single women or same-sex couples who are seeking treatment”.

However the Human Fertilisation and Embryology Act 2008 removed the reference to “the need for a father” when considering the welfare of the child when considering fertility treatment, replacing it with “the need for supportive parenting”.

Gareth Johnson MP, who chairs the All Party Parliamentary Group on Infertility, said that trusts offering the service to single women were going against one of the guiding principles of IVF, “that you are treating an infertile couple, not an infertile individual”.

Mr Johnson, the Conservative MP for Dartford, said: “Speaking in a personal capacity, if you are going for IVF, you are trying to create a baby, so there should be some evidence of a stable background, which you would expect to be a couple.”

Earlier this year he led an APPG report that found startling differences between what health authorities offered in terms of IVF.

It found three-quarters of Primary Care Trusts were failing to offer three cycles of IVF, as stipulated by Nice. Each cycle comprises a woman’s ovaries being stimulated to produce eggs, which are then fertilised in vitro and implanted in the womb. Spare eggs should be frozen for use if the first attempt fails.

The report found five trusts offered no IVF at all – Warrington, West Sussex, Stockport, North Staffordshire and North Yorkshire and York. Since then, NHS West Sussex has decided to start funding IVF again.

Many trusts have also started putting in place further barriers to IVF funding – for example demanding obese women lose weight – in part to limit demand as health budgets tighten.

Against a background of increasingly scarce provision, as the NHS tries to save £20billion by 2015, Mr Johnson said the decision to offer IVF to single women was misplaced.

From: http://www.telegraph.co.uk/Single-women-being-offered-IVF-on-the-NHS

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