NHS patients could face wait to access life-saving drugs

Patients could face delays accessing drugs on the NHS after health bosses agreed that the most expensive treatments can be stalled.

Even when a drug has been approved by the National Institute for Health and Care Excellence (Nice) – which already has strict rules on affordability – bosses at NHS England can now slow down its delivery to patients.

The move applies to any drugs that are expected to cost £20m or more in any of the first three years of their rollout across the NHS.

This could apply to cheaper drugs that will be used by hundreds of thousands of people or very expensive drugs used by a small number of people. Drugs used to treat a range of conditions, including diabetes or cancer, could be affected.

Under the move, NHS England can ask Nice to extend the amount of time the NHS has to bring the drug in for all patients – in some cases for three years. At present, the NHS has 90 days to make Nice-approved drugs available.

The new system also means NHS England and drug firms will have more time to discuss potentially lowering the cost of the drugs.

Charities have objected to the move and also worry that NHS England will try to restrict access to certain groups of patients.

Sarah Woolnough, Cancer Research UK’s executive director of policy and information, said: “If Nice thinks a cancer treatment is clinically effective and represents value for money, then patients should receive it without delay.

“A system that could add up to a three-year delay before patients can access treatments deemed clinically and cost effective is unacceptable.

“Cancer patients may lose their lives while they wait. We need to decide whether we want a world-class health system in the UK, and if so we need to pay for it.

“Manufacturers should be encouraged to price drugs responsibly, but we hope the government will reconsider the introduction of this new test, otherwise it will be patients, their families and carers who could pay the heaviest price.”

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said: “Today’s proposals from Nice/NHS England break the Conservative party’s 2015 manifesto promise to speed up the introduction of cost-effective medicines into the NHS.

“Thousands of patients will wait longer for treatment for conditions like heart disease, cancers and diabetes while medicines which stand to benefit the most people are caught up in the system.

“Use of new medicines in the UK is already poor, with patients seven times more likely to get a newly launched medicine in places like Germany or France.”

Sir Andrew Dillon, the Nice chief executive, said: “We hope, and we think it is perfectly possible, that for some treatments which exceed the £20m budget impact in their first three years, there will be commercial agreements between companies and NHS England which will at least minimise and in some cases avoid completely the need for any delay for access for patients.

“Even where there is a delay beyond the standard 90 days, NHS England has committed to ensuring that there is some funding available to provide access throughout the phased implementation period.”

He said the move would be reviewed in three years to see what impact it is having on allowing access to new drugs.

NHS England’s acting director for specialised commissioning, John Stewart, said it was “committed to working closely with companies that are willing to price their products responsibly”.

He said the “new flexibility will help us develop innovative win/win/win agreements – good for patients, good for taxpayers and good for those companies that are willing to price responsibly”.

Other changes agreed by the Nice board include the introduction of a new fast-track option for treatments which cost less than £10,000 per year of good quality of life to patients.

The upper end of Nice’s standard threshold range is £20-30,000 per year. The new fast-tracking will mean cheaper treatments go through the appraisal process in six months rather than nine.

NHS patients could face wait to access life-saving drugs

Life-saving alcohol services face devastating cuts

When a man in his early 20s, who was an alcohol-dependent heroin user, turned up at hospital with a gastrointestinal bleed, Helene Leslie didn’t think he had long left to live.

Yet three weeks later, Leslie, an alcohol liaison nurse at the Royal Infirmary of Edinburgh, saw him in intensive care and was tasked with trying to get him to give up drinking: “I was surprised that he was alive given how sick he’d been,” she remembers. “I thought I wouldn’t get anywhere, but amazingly, with support, the guy’s really turned his life around and hasn’t drunk for 10 years. People like that keep me going.”

Leslie, 53, who has been an alcohol liaison nurse for 24 years, was one of the very first. But in 2001, the Royal College of Physicians called for there to be an alcohol specialist nurse in every hospital in the UK. What has happened since then, and have they had an impact?

“On the whole, it’s been a success,” says Prof Sir Ian Gilmore, ex- president of the Royal College of Physicians and chair of the Alcohol Health Alliance. “They keep patients out of hospital. There’s good evidence that the nurses are able to send patients home. They can deliver interventions that have been shown to be highly cost-effective.”

Dr Kieran Moriarty, consultant gastroenterologist at Bolton NHS foundation trust and alcohol lead for the British Society of Gastroenterology, did an evidence-based review looking at the impact of specialist alcohol workers. It cited a study at St Mary’s hospital in Paddington, London, which showed that for every two referrals to an alcohol health worker, there was one fewer reattendance to A&E the following year.

Gilmore says that in 2000 there were fewer than 10 alcohol care teams, whereas now the majority of acute hospitals have some sort of service.

Alcohol-related admissions are still rising – more than 1 million were related to alcohol consumption in 2013-14 – despite a fall in per capita consumption in the UK in the past few years. And it’s not just people getting drunk and fighting, says Gilmore. The NHS estimates that about 9% of adult men and 4% of adult women in the UK show signs of alcohol dependence. Alcohol is also a contributing factor in many diseases, including cancers – and the number of people with alcohol-related brain damage is rising.

Amid this pressure, however, cuts are being made to public health budgets responsible for alcohol services. In 2015-16, 46% of local authorities implemented cuts in alcohol services, and this has risen to 72% for 2016-17.

Moriarty is concerned: “A lot of the good is going to be lost. Alcohol nurses can play a major role in prevention and identification of alcohol problems at an early stage.”

Gilmore is keen to emphasise their impact: “A brief intervention – a semi-structured interview of up to 20 minutes by a health worker – is highly effective in changing behaviour even six months down the line.”

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Life-saving alcohol services face devastating cuts

Watchdog accuses Actavis of hiking price of lifesaving drug by 12,000%

Pharmaceutical company Actavis is facing accusations from the competition watchdog that it hiked the price of life-saving hydrocortisone tablets by over 12,000%, sending the annual cost to the NHS spiralling from £522,000 before 2008 to £70m by 2015.

The Competition and Markets Authority said the price rises took place after the patent lapsed on the drug. About 943,000 packets of the tablets – prescribed to people whose adrenal glands do not produce enough steroid hormones, such as those suffering from Addison’s disease – were distributed over the last year.

As the CMA set out its reasons why the company had broken competition law, the regulator’s senior responsible officer, Andrew Groves, said: “This is a lifesaving drug relied on by thousands of patients, which the NHS has no choice but to continue purchasing.

“We allege that the company has taken advantage of this situation and the removal of the drug from price regulation, leaving the NHS – and ultimately the taxpayer – footing the bill for the substantial price rises,” said Groves.

The watchdog is continuing other investigations into the pharmaceutical sector. The latest allegations come after last week’s £84.2m fine on Pfizer for increasing the cost of an anti-epilepsy drug. The drugs distributor Flynn Pharma was fined £5.2m for charging excessive and unfair prices in the UK for an epilepsy treatment.

Groves said the current findings against Actavis were provisional and that it was too early to conclude there had been a breach of competition law. “The CMA will carefully consider any representations of the parties under investigation before determining whether the law has been infringed,” said Groves.

Actavis – formerly Auden Mckenzie – is facing accusations about the prices of two forms of the hydrocortisone tablets. The CMA said the increase in price to the NHS for 10mg packs rose from 70p in April 2008 to £88 by March 2016 – a 12,000% rise. For 20mg sizes the price rise was 9,500% – increasing to £102.74 per pack by March 2016, compared with £1.07 when the treatment was still branded.

Once medicine and treatments are no longer branded – known as generic medicine – they are no longer subject to price regulation, a move that is usually expected to reduce the cost rather than inflate it.

Actavis did not immediately comment.

Watchdog accuses Actavis of hiking price of lifesaving drug by 12,000%

Hepatitis C sufferers in England denied lifesaving liver drug

Thousands of folks in England with a persistent form of liver condition are being denied accessibility to daily life-conserving medicines that are offered to individuals in Wales, Scotland and Northern Ireland.

Regardless of becoming suggested by European regulators and accessible in nations such as France and Germany, draft advice not too long ago issued by the National Institute for Wellness and Care Excellence (Nice), the body that advises NHS England on whether to fund certain medication, recommends restricting the use of Daklinza in England. The stance will impact the therapy of adult sufferers with a specific strain of hepatitis C.

The move has dismayed wellness specialists and liver disease charities who say it will indicate a large subset of the sickest and most at risk sufferers in England will not receive the treatment they need to avoid them from possibly fatal liver failure or cancer.

They have urged Great to rethink and take into account the benefits of trials as properly as clinical practice that, they say, have proved the drug’s efficacy towards a ailment that is estimated to affect more than 200,000 individuals in the United kingdom but remains undiagnosed in tens of 1000′s.

Hospital admissions and deaths due to hepatitis C, a virus spread by get in touch with with infected blood that infects the liver, are predicted to continue increasing in England until about 2030, according to wellness officials.

About a third of individuals contaminated with the virus ultimately create cirrhosis, exactly where normal liver tissue is replaced by scar tissue. A few individuals with chronic hepatitis C and cirrhosis also go on to build liver cancer.

Final 12 months the European regulator approved Daklinza for use, in conjunction with other medication, as a remedy for 4 principal strains of hepatitis C genotypes. But Wonderful has not recommended it for the treatment method of sufferers with the genotype 3 of the illness, which accounts for all around 45% of all circumstances in England. Individuals from south Asia are especially affected by the genotype three, which leads to an aggressive kind of the ailment.

Present different treatments for genotype 3 can not be offered to people with the most sophisticated kinds of the disease because of their toxicity. They can also outcome in hair reduction and flu-like signs and symptoms that discourage people from finishing the total program, or even searching for therapy in the first location.

Great, which is consulting on the use of Daklinza, says that prescribing the drug for genotype 3 patients is not cost-powerful. A total program of Daklinza can cost up to £48,700.

But Dr Anna Maria Geretti, professor of virology and infectious conditions at the University of Liverpool, stated studies had shown that, when employed in blend with other drugs, practically 100% of sufferers taking Daklinza have been cured. She mentioned research in 2014 of virtually 500 patients in the United kingdom at 17 centres had also proven that it worked greater than option treatment options.

She stated: “Nice has left us with a situation in which we are not ready to comply with the European suggestions, despite them creating a sturdy recommendation. We are not in a position to offer you remedy to a considerable proportion of our individuals with genotype three who require it and are not able to get the much more toxic therapy.”

She recommended that up to 1,000 men and women in England could benefit from the drug, despite the fact that Great is understood to put the figure at nearly 3,000.

“My message to Nice is that I would like the evidence coming from our experience of treating nearly 500 folks with really superior hepatitis C infections – which includes over one hundred with genotype three – to be taken into account, so some new treatment options might be permitted for folks that have genotype three and are not able to obtain the substitute, a lot more toxic medication,” Geretti stated.

Bristol-Myers Squibb, which tends to make the drug, mentioned: “Nearly one hundred,000 individuals in the Uk are considered to have hepatitis C genotype 3. This group could endure extreme remedy inequality from this choice. BMS will be functioning closely with Wonderful to see if a solution can be identified, and hope that this selection can be urgently reassessed so that patients do not suffer.”

Hepatitis C sufferers in England denied lifesaving liver drug

NHS individuals are missing out on life-saving robot surgical treatment

A gynaecologist uses a robot. Photograph: Jean-Paul Chasse/Alamy

New life-saving surgical techniques are not being adopted quickly enough in British hospitals. That is the stark conclusion of a report by the Royal College of Surgeons (RCS) which warns this week that patients are missing out on new procedures because the NHS is failing to set up programmes to promote their use in the UK.

The report, Innovation to Adoption: Successfully Spreading Surgical Innovation, stresses the need to find ways to introduce new surgical techniques as quickly as possible, thus saving lives and helping the NHS to save money.

New surgical techniques – involving robotics, 3D-imaging and lasers – have been developed in recent years, but in many cases have only been introduced in a haphazard manner in British hospitals. This failure to act coherently is now causing concern among surgeons.

“Many patients are not benefiting from ground-breaking procedures, even when surgeons firmly believe that they can save or extend lives. This cannot continue,” said Professor Norman Williams, the RCS president. “We cannot afford to neglect the kind of surgical innovation that has made such a difference to survival and recovery, such as keyhole surgery and advancements in transplant surgery.” He added that the NHS, the government and doctors had to understand how to accelerate innovative surgical practices in the UK.

The point was backed by David Neal, professor of surgical oncology at Cambridge University. “The NHS is the perfect place to test new technologies,” he said. “It covers the whole country and gives us an ideal platform for showing the worth of a new surgical technique. Unfortunately, this is not being done. The NHS does not seem to be able to tackle this sort of thing. Instead, we are relying, in many cases, on tests being done in the US, where there are commercial pressures involved.”

Neal has been involved in using a semi-automated technique known as robot-assisted radical prostatectomy (Rarp) to treat prostate cancer in the UK. “The technique greatly improves a human surgeon’s performance,” said Neal. “Using current methods, a patient is typically in hospital for around five days, while around 20% of them need blood transfusions. With Rarp, they can leave the next day and only about 1% of patients need a transfusion.”

About 200 prostate cancer patients are now being treated every year using the new technique. “That is far to low a figure,” Neal added. “We need to introduce the technique to enough hospitals to treat around 10,000 patients a year, but that is not happening.” He added that the UK needed a network of about 10-15 hospitals where new medical techniques would be taught to surgeons.

The need to promote robots in medicine is seen as being particularly important in future. The first robot procedure was offered to NHS patients in 2004, but the NHS has yet to fund the purchase of a single surgical robot and has relied instead on charities and endowments to provide cash to buy them.

A programme to help surgeons learn keyhole colorectal surgery for patients with bowel cancer and other conditions was set up in 2007. Mark Coleman, a consultant at Plymouth Hospital involved in creating the programme, said: “In 2008, 10% of operations on the colon involved keyhole surgery. Now that figure has reached 50% and the saving for the NHS over that period has been calculated as being around £11m.”

NHS individuals are missing out on life-saving robot surgical treatment

New mothers lack lifesaving guidance, says Netmums survey

The Royal College of Midwives says its members are annoyed by not having sufficient time to spend with new mothers and infants. Photograph: Compassionate Eye Basis/Getty Pictures

Almost half of new mothers – 47% – are not produced conscious within 24 hours of providing birth of how to spot unsafe conditions that could destroy them or their little one, a poll suggests.

Only 24% of respondents to the Netmums survey mentioned that they could remember acquiring data about warning signs, regardless of guidelines from the Nationwide Institute for Health and Care Excellence (Good) which say they must have the info inside 24 hours of offering birth.

Netmums co-founder Sally Russell described the benefits, primarily based on 486 responses on the parenting website, as “deeply worrying”. “A lot of circumstances are less complicated to deal with if ladies realise sooner they are at risk of turning out to be unwell, so it is crucial this info will get to them early,” she said. “Strain on budgets might imply not each family is acquiring the details they want but this is a false economic system. If a girl becomes sick it will price far a lot more to treat her than the value of passing on this essential data.”

Indicators the Royal University of Midwives (RCM) says women should be told to appear out for consist of hefty or persistent vaginal bleeding, fever, a rash, headaches, shortness of breath, discomfort or swelling in the legs, vulval or perineal areas, and difficulty or ache in passing urine.

In babies, symptoms consist of a temperature over 38C, a rash, feeding less than normal, floppiness, grunting even though breathing and nappies becoming significantly drier than typical.

The RCM mentioned its members have been annoyed by not having enough time to commit with new mothers and babies and that addressing considerations about postnatal care was vital as the majority of maternal deaths take place post-birth. It carried out its personal poll of 2,123 midwives, 950 student midwives and 98 maternity help workers, which found that 36% would like to do a lot more for mothers and infants.

Two-thirds of midwives mentioned the amount of postnatal visits ladies had was dictated by their hospital’s “organisational pressures”, with 24% citing the women’s demands. The RCM stated the two polls gave weight to its campaign for four,800 more midwives to be recruited so that there is time to give females crucial details about their safety and their baby’s.

Chief executive Cathy Warwick said: “It is clear that our members are taking the strain of an underfunded and beneath-resourced postnatal support – a services that with out ample implies can lead to dangerous consequences on the health of mothers and children that the maternity team struggle to care for.”

New mothers lack lifesaving guidance, says Netmums survey