Category Archives: Commissioning

Call to end NHS rationing of HIV prevention drug PrEP

Once we accept that we have to ration health care, we can start discussing how. Prevention can be expensive, and so can a lifestyle. NHSreality feels that means related co-payments would address this issue well, and even the poorest should pay something for prevention. Commissioners are not allowed to do this, anywhere in the 4 UK health systems, and the official line is that there is no rationing , and indeed we can provide “Everything for everyone for ever for free”.

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The News and Star (Cumberland News) reports 12th October 2018: Call to end NHS rationing of HIV prevention drug PrEP

A charity has called for more gay and bisexual men to be given access to the HIV prevention drug PrEP, a year on from the start of a major trial into the treatment.

The National Aids Trust (NAT) said many men were being turned away from clinics, and some would contract HIV as a result.

Last year, a study funded by NHS England found that a quarter of new HIV cases in England could be prevented by giving high-risk men pre-exposure prophylaxis (PrEP) treatment.

The programme could save the NHS millions as a result of fewer men
getting infected and needing a lifelong supply of drugs to stop them
succumbing to Aids, researchers said.

The first clinic in the PrEP Impact trial opened on October 13 last year.

The three-year trial aims to provide PrEP to 10,000 people, but the NAT said all the allocated places for gay and bisexual men were filled by March.

Since then reallocation of places and a boost of a further 3,000 places on the trial has allowed clinics to reopen, but this provides only temporary relief, and it is expected that most clinic places will be filled up by early next year.

NAT chief executive Deborah Gold said: “PrEP is 100% effective at preventing HIV when taken as prescribed.

“NHS England’s decision-making process concluded that PrEP should be commissioned and just last month the cost of the drug has substantially reduced as a result of court judgments on the patent.

“It is therefore completely unacceptable for people in need of PrEP to be denied it by the NHS.

“NHS England and local authorities must urgently agree a national PrEP programme to start as soon as possible in 2019.

“The Government should play its part by increasing funding to public health so that we maximise the sexual health benefits of the PrEP programme.”

NHS England initially refused to pay for PrEP, arguing that responsibility for HIV prevention lay with local authorities.

It agreed to fund the study at selected clinics after a High Court judge upheld a judicial review application challenging the legality of the original decision.

The treatment involves a pill containing a combination of two anti-HIV drugs, emtricitabine and tenofovir, taken daily or around the time of sexual activity.

A spokeswoman for NHS England said: “While it would be wrong to prejudge the PrEP Impact trial, it is already expanding with the number of places available increasing this year by 3,000 to 13,000.

“The NHS will look at evidence from the trial to expand prevention services in the most effective way.”

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170,000 victims, and nobody takes the blame!! Typical of a nationalised health service…

Just as we need to change the onus of proof on Agricultural products, we need to do the same with non drug medical products. The licensing of the mesh repair products is a case in point, and all 4 health systems should be ashamed of not reporting side effects and complications systemically (all together). The reporting of such problems is just one reason for a large mutual in health. Devolution means smaller numbers and lower standards. The commissioners and the Trust Boards are all to blame, but so is central government. Will any careers be finished? They should be.. Mesh is a foreign body, and as such the default is rejection, and possible infection.

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Hernia mesh complications may have affected up to 170 000 patients, investigation finds ( BMJ 2018;362:k4104 )

Up to 170 000 patients who have had hernia mesh operations in the past six years could be experiencing complications, yet NHS trusts in England have no consistent policy for treatment or follow-up with patients, an investigation by the BBC’s Victoria Derbyshire programme has found.

Around 570 0000 hernia mesh operations have taken place in England over the past six years, figures from NHS Digital show. Leading surgeons think that the complication rate is between 12% and 30%, meaning that between 68 000 and 170 000 patients could have been adversely affected in this period.

Patients who had had hernia mesh operations told the programme about being in constant pain, unable to sleep, and finding it difficult to walk or even pick up a sock. Some patients said that they felt suicidal.

The Department of Health and Social Care and the Medicines and Healthcare Products Regulatory Agency (MHRA) continue to back the use of mesh for hernia repair. The use of surgical mesh for stress urinary incontinence is under ongoing review after it was suspended in July in response to pressure from campaigners and MPs.1 Campaigners are calling for a similar review into the use of hernia mesh.

Owen Smith, a Labour MP who chairs the all party parliamentary group on surgical mesh implants, said that he feared the UK could “potentially have another scandal on our hands.”

He added that the MHRA was not doing enough to listen to the experiences of patients affected. “It reflects the flawed system we have in place,” he said. “Neither the regulators nor the manufacturers have to follow-up on problems.”

Ulrike Muschaweck, a private hernia surgeon, told the programme that she used a suture technique instead of mesh for most hernia operations, but this method was dying out because young surgeons were rarely taught it. She said that she had performed 3000 mesh removals because of chronic pain—after which only two of the patients had not gone on to become “pain-free.”

Suzy Elneil, a consultant urogynaecologist who was a leading voice in the campaign to halt the use of vaginal mesh, said that the mesh used in hernia was the same product. She estimated that treating those who have had complications with hernia mesh would cost a minimum of £25 000 (€28 000; $33 000) a patient—a similar amount to that predicted for vaginal mesh complications. This includes the removal of the mesh, a further operation to treat the hernia, and follow-up care. She said that the manufacturers should be covering the cost rather than the NHS.

The Royal College of Surgeons pointed to a 2018 study, which found that both mesh and non-mesh hernia repairs were effective for patients and were not associated with different rates of chronic pain.2

A spokesperson for the college said that “complications range dramatically from minor and correctable irritations to the more serious complications highlighted [on the] programme. Complications can also occur with non-mesh hernia repairs and by not operating on a hernia at all.”

They said that the college and regulatory authorities would continue to listen to patients’ experiences. “It remains vital that surgeons continue to make patients aware of all the possible side effects associated with performing a hernia repair,” the spokesperson said.

Kath Sansom from campaign group Sling the Mesh told the programme that a lot of the studies into complications were flawed or had short follow-up times. Quality of life questionnaires, for example, asked only about whether the hernia was fixed and not about new onset pain or other complications.

In a statement, the MHRA said: “We have not had any evidence that would lead us to alter our stance on surgical mesh for hernia repairs or other surgical procedures for which they are used. The decision to use mesh should be made between patient and clinician, recognising the benefits and risks in the context of the conditions being treated and in line with NICE guidance.”

An MHRA spokesperson added, “We encourage anyone—patient, carer, or healthcare professional—who is aware of a complication after a medical device is implanted, to report to us via the yellow card scheme, regardless of how long ago the implant was inserted.”

… following hernia repair with an Ethicon Proceed patch have resulted in a product liability lawsuit against the manufacturer
This was caused by what should have been a simple 45-minute operation to fix a hernia … of patient filed lawsuits. “For the ..

New technologies and rationing by post code/region. New treatments and assessments are not available to all UK citizens.

Its good news that we can embrace new technology, and quickly, but the decision raises other issues. Mainly to do with rationing honestly… Other new technologies will follow (Hope of cure for men with aggressive prostate cancer) but whilst there are 4 different health systems, and announcements only apply to one of them, we in Wales will wonder if we can afford what England can. Only this week a friend went to London for a new prostate cancer assessment test (mpMRI) which is not available in Wales. (Sign the petition on line) ( He went Privately) Assessment and staging of Prostate Cancer is essential, and there are far more sufferers than there are with leukaemia.

Paul Kelso for Sky News reports 5th September: NHS England nets ‘game-changing’ childhood leukaemia treatment

The therapy – which has a list price of £282,000 per patient – is currently only available in Europe as part of clinical trials.

The Times also reports: Game-changing NHS treatment to save children with leukaemia

The Telegraph: NHS to fund “game changing” personalised cancer drug.

But can we afford these treatments without rationing the high volume and low cost treatments? How does such technology fit in with “personal health budgets”?

High Tech advances hit NHS funding. A proper debate wont happen however.

Interesting suggestion low cost for high volume treatments to be excluded… GPs will take no notice as their job is to put their patient “at the centre of their concern”.

World class cancer care (and Mental Health care) is possible, if we ration the high volume low cost treatments…

The cost of high tech treatments – that if these become “universal” then the low cost high volume treatments need to be paid for.

Trials of personal budgets will have long term perverse outcomes in an ageing society. Health costs are rising, and geographic variations will become greater….

Wales ‘behind’ in technology to detect prostate cancer – BBC News

Prostate Cancer breakthrough with a more accurate test (Scotland)

PET scans for prostate cancer (Birmingham)

 

NHS rationing under the radar

A reminder of the King’s Fund report from August 2016. The predictions by Ruth Robertson include post coded prioritisation, delays, treatment dilutions, withholding or substituting treatments, overspends, and a lack of data for monitoring exactly where the commissioners are!. She singles out Mental Health and District Nursing for particular dysfunction, and is open about the crisis in Primary and Social care. All of us know that, until “what is not available” is allowed to be discussed, that the “open discussion” is a nonsense. The Trusts under special measures in England are below, but most of those in Wales, and I suspect Scotland and N Ireland are in the same financial distress. Reality is not yet here, and “it’s going to get worse”. The King’s Fund promised a follow up report in 2017 but I am not sure which one it is or if it has been published yet..

NHS rationing under the radar:

After years of increasing deficits, that last year culminated in the NHS posting the largest overspend in its history, local health systems have been told to balance their books.

This intensifies the difficult decisions that commissioners and providers have been facing for some time, about how to prioritise limited funding and balance their budgets in the face of rising demand. While the NHS has always had to set priorities, with these unprecedented financial pressures it is inevitable that some organisations will be forced to restrict access to certain services or dilute quality of care as they seek to curtail spending. In some areas this is happening already.

On an individual level, this is like the bank cutting off the overdraft that you rely on when you have just started a family and your rent has gone up. You are forced to cut spending on non-essentials, but deciding what ‘the essentials’ are is tough.

NHS commissioners are starting to have honest conversations with their local populations about these tough choices…..

….Considering the wider impact of financial pressures on the health care system, it’s important to remember too that it’s not only patients who are affected. NHS staff often act as a buffer, working longer hours or more intensely to ensure the people they treat still receive a high-quality service. This can increase staff stress levels and lead to low morale, something that is particularly worrying given evidence that staff wellbeing can have a direct impact on patients’ experience of care.

The King’s Fund is currently researching how the slowdown in NHS funding since 2010 has affected patients’ access to high-quality care. The findings from this study, which will be published early next year, will provide valuable insight into the impact that financial pressures have had on NHS patients and staff. In the meantime the government should be honest with the public about what the NHS is realistically able to offer with its available funding.

Patients should not be looking forward to a “hard” Brexit. Make sure you have a good stock of medications..

The news is piling up on Brexit, and the majority of people now want another vote, even if they may not change their minds. Sarah Wollaston MP on YouTube/Sky News ‘Patients need to know the full consequences of Brexit’  Hugo Fry, chief executive of Sanofi facetiously suggests air-lifting flu vaccines, but since these are dubious value for money, this is laughable for medics. (Let us airlift flu vaccines after Brexit, says French drugs giant Sanofi – Sabah Meddings August 19th in the Times). Apart from going abroad, patients have little choice other than to obtain a good stock of repeat prescriptions. Going abroad could backfire as Brexit could be postponed or even cancelled if the politicians regain their “guts”. Each individual UK commissioning group may choose to ration differently…. A nightmare?

The Kings Fund did warn us in December 2017: Brexit: the implications for health and social care. 

Most of us want another chance to look at the evidence, rather than the false news, once the deal is on the table.

Henry Zeffman in the Times 20th August reports: No-deal Brexit could leave hospitals with drug shortage, say NHS chiefs

Hospitals are in danger of running out of drugs in a chaotic no-deal Brexit, NHS trusts have privately warned.

Ministers and health service bosses have been accused of failing to prepare adequately for the potential failure to strike a Brexit deal by NHS Providers, the association of NHS trusts.

Chris Hopson, the group’s chief executive, said that “in the event of a no-deal or hard Brexit”, on the first day outside the EU “the entire supply chain of pharmaceuticals could be adversely affected”. He added: “Public health and disease control co-ordination could also suffer and our efforts to reassure, retain and attract the European workforce on which the NHS relies could also be jeopardised.”….

Ben Gartside followed this up in the “Business Insider” 21st August with: A no-deal Brexit could prevent disease control and leave hospitals with drugs shortages

LONDON — Disease prevention would worsen and hospitals would risk running out of drugs under a no-deal Brexit, according to a leaked letter from NHS chiefs to ministers.

The letter was from NHS Providers, the association of NHS trusts, and accuses ministers of failing to prepare adequately for all possible Brexit outcomes.

Significantly, it warned that even a hard Brexit where the UK does strike a deal would risk damaging the UK’s healthcare sector significantly, given the risks to the certification of medicines or isotopes used in cancer treatments across the EU.

The letter warned that “from day one after the UK leaves the EU, the entire supply chain of pharmaceuticals could be adversely affected in the event of no deal or hard Brexit.”….

It continued: “Public health and disease control coordination could also suffer, and our efforts to reassure, retain and attract the European workforce on which the NHS relies could also be jeopardized.”

The letter was sent on Friday to Simon Stevens, chief executive of NHS England, and Ian Dalton, chief executive of NHS Improvement, with several ministers copied in.

An NHS England spokesperson told the BBC: “We will be working with our colleagues and partners across the NHS to ensure plans are well progressed and will provide the NHS with the support it needs.”

‘From what I can see patient care seems acceptable.’

IVF: NHS couples ‘face social rationing’ as providers struggle to fund it

NHSreality if actually “for” rationing, but we could afford all the infertility treatment that could be demanded if we rationed high volume and cheap services: perhaps those costing less that 2 pints of beer and a packet of 20 cigarettes? Figures for the other 4 health services in the UK are of course not available for comparison. They are certainly worse in Wales, but like most important issues after devolution, we cannot compare.

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BBC News reported 20th July: IVF: NHS couples ‘face social rationing’

The parents of the world’s first IVF baby – born 40 years ago next week – would not have got the procedure on the NHS in most of England today because of “social rationing”, a charity has said.

NHS IVF is unavailable to couples in many areas if either of them has children from a previous relationship…… Figures collated by campaign group Fertility Fairness show IVF provision at all 208 clinical commissioning groups (CCGs) across England.

They show eight out of 10 CCGs do not enable access to IVF if one of the couple has children from a previous relationship……Her father already had children from a previous relationship, which would render the treatment unavailable to the couple in many areas today, Fertility Network UK said.

Data chart

Aileen Feeney, chief executive of the charity, said: “If Louise Brown’s parents wanted to try NHS IVF today, they would be turned down by the vast majority of England’s clinical commissioning groups on social rationing grounds: although Mrs Brown was clinically infertile, Mr Brown had a child from a previous relationship.

ITV News reporter Lorna Shaddick reports 23rd July 2018: IVF treatment being rationed as providers struggle to fund it

Couples in the UK seeking fertility treatment are finding that their access varies dramatically, depending on where they live.

This week marks 40 years since the birth of the first test tube baby, Louise Brown, but if rules then had been what they are today, she may not have been born.

Couples in the UK face what campaigners call “social rationing” of fertility treatment on the NHS, meaning its availability to would-be parents varies dramatically depending on where they live.

It is up to each local NHS provider – the Clinical Commissioning Group – to decide which treatments to fund.

The charity Fertility Network UK says if Louise Brown’s parents were seeking IVF on the NHS today, they would be turned down by over 80% of England’s clinical commissioning groups, because her father already had a child from a previous relationship, one of many rules that make it more difficult for couples to get IVF.

The National Institute for Health and Care Excellence (NICE) guidelines say women under 40 who have been trying for more than two years to get pregnant should have access to three full cycles of IVF on the NHS – but crucially those are not binding.

IVF postcode lottery
Image: The availability of IVF depends on where people live

Campaign group Fertility Fairness says the number of CCGs in England meeting those guidelines has gone down, from 24% in 2013 to 12% in 2017, and only four offer what Fertility Network UK calls the “gold standard” of three full IVF cycles, even for couples who have children from previous relationships.

Aileen Feeney, the chief executive of Fertility Network UK, said: “We believe that there should be fair access.

“NICE guidelines are there because financially and medically they are the best way to achieve the outcome that you want.

“So, therefore, we believe that everywhere in the UK should be offering those in line with the NICE guidelines, so three full cycles of IVF.”

Emma Edey and her husband Lee say they are victims of these geographical differences.

Both have health problems that doctors agree would make natural conception difficult, but they live in north east Essex, one of seven areas in England where all NHS IVF treatment has been removed or suspended – and they cannot afford to pay for private treatment.

When Mrs Edey appealed to her local CCG last year, saying that her bowel disease means she is in “exceptional circumstances”, she was refused.

She said: “They’ve just completely taken away everything – all of both of our dreams.

“We just want to be given the opportunity to have what all our friends have got, to be able to celebrate Christmases and stuff like a family, as families do.

“And it doesn’t seem fair that my friends a few miles down the road can have it but I can’t.”

The cost of IVF varies but one cycle at a private clinic can come to more than £5,000.

NHS clinical commissioners told Sky News: “Unfortunately the NHS does not have unlimited resources and ensuring patients get the best possible care against a backdrop of spiralling demands, competing priorities and increasing financial pressures is one of the biggest issues CCGs face.

“As a result there are some tough choices that have to be made, which we appreciate can be difficult for some patients.”

After more than two years of letters and phone calls to her MP, CCG and local hospital, Mrs Edey was told last month that her subsequent appeal has been upheld, and she can receive treatment.

But she says she’ll keep fighting for others in the same situation.

“I won’t stop,” she said.

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A bitter pill: NHS scraps restrictions on life-changing leukaemia drug ibrutinib

Ibrutinab was approved in the US in 2013. 5 years later, under a new owner, it gets approved in the UK. This is rationing, and the state had used up a few years before the product can be reissued in generic form. Did oncologists and haematologists offer this treatment to their patients? Did they suggest it might be purchased privately since the state would not fund? If they have not, then one could argue that they were not putting the patient at the centre of their concern. How long have private insurers been providing the drug?

Sean O’Neill in the Times 10th August reports: NHS scraps restrictions on life-changing leukaemia drug ibrutinib

A life-changing leukaemia drug will be available to thousands of patients after The Times exposed how the health service had secretly imposed restrictions on its use.

NHS England was accused of setting a dangerous precedent when it curtailed access to ibrutinib despite it being declared a highly effective medication that offered value for money by the National Institute for Health and Care Excellence (Nice)…..

Leading Article: Better Pill – Thanks to The Times, thousands will benefit again from a life-changing drug

Injustices do not fix themselves. Ibrutinib, a daily pill, can help thousands of people who suffer from chronic lymphocytic leukaemia and whose cancer has returned after chemotherapy. In March, three months after the drug had been approved for prescription within the health service, its use was quietly curtailed by NHS England for patients who had enjoyed remissions of more than three years. This decision has now been overturned. Those who will benefit are lucky that among their number was the chief reporter for The Times.

This case stands as a fine example of the role that the press can play in highlighting injustices and mistakes that affect the vulnerable. Not all of those who find themselves in such a situation, however, can count upon having allies with suitable platforms, who will so swiftly become aware of their situation.

Ibrutinib is an expensive drug, even if the NHS has always received it at a discount and looks likely to receive it at a greater one thanks to the manufacturer, Janssen. Any public healthcare provider must balance finite resources with public requirements, but such calculations should be rigorous and transparent. As Leukaemia Care notes, in this case they were neither. The wrong decision was taken, apparently arbitrarily, for reasons unknown. If this can happen with one drug, even after its use has been approved, the obvious fear is of a pattern affecting others.

For many cancer sufferers, medical science is on the verge of doing the once unimaginable. This drug is one of the first of a new wave of medicines that minimise the need for gruelling chemotherapy. Survival is an expensive business, and Britain continues to struggle for long-term solutions to ever-increasing healthcare costs. This debate must be public. Quietly depriving patients of vital medicine is not the way.

The Guardian: NHS rationing ‘is denying patients care’ as cash crisis deepens

Survey of doctors reveals concern about adults and children being denied treatment, resulting in emergency care or worsening of long-term conditions