Category Archives: NHS

Skin conditions cost NHS £723m a year

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New research shows that more than three million primary care hours are spent on skin conditions, at a cost to the NHS of £723 million each year.

The research, carried out by the Association of the British Pharmaceutical Industry in collaboration with an independent Dermatology Expert Working Group (EWG), highlights the burden of skin conditions on both patients and the NHS.

According to the findings, around 13.2 million people in England visited their GP with a skin problem in 2016, of which 85 percent said the psychosocial aspects of their condition were a significant part of their illness.

The research also showed that almost 60 percent of patients with severe psoriasis could lose up to 26 days of work a year because of their skin condition.

“Today’s findings bring into sharp focus the staggering amount of time and money the NHS spends on the management of skin conditions in primary care and the significant impact skin conditions can have on people’s lives,” said EQG chair Rt Hon Professor Paul Burstow.

“Ignore dermatology and we miss a huge opportunity to make real and immediate gains for the NHS and for people’s quality of life.”

The group’s report, Making real our shared vision for the NHS: optimising the treatment and care of people with long-term skin conditions in England, makes a stream of recommendations designed to drive efficiencies and improve patient outcomes.

It calls on NHS England to promote and support successful self-management through patient education programmes for specific long-term skin conditions, led by suitably trained healthcare professionals (HCPs), as well as promote promote and incentivise the adoption of technology such as email guidance and smartphone apps.

NHS England should also put in place suitable incentives to encourage commissioners to implement teledermatology pathways to triage patients with skin lesions appropriately and free up face-to-face time for clinicians to see patients with inflammatory skin conditions, it said.

SOURCE: www.pharmatimes.com/news

Five new medical schools to open under ‘biggest ever expansion’ of medical training

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Five new medical schools will launch across in England in September as part of the government’s ‘biggest ever expansion’ of the NHS medical workforce, the DHSC has announced.

The new medical schools will open in Sunderland, Lancashire, Canterbury, Lincoln and Chelmsford. They have been ‘chosen as part of a rigorous bidding process to help place more medical students in areas which traditionally struggle to attract doctors, particularly rural and coastal areas,’ the DHSC said.

As part of the plans to increase the medical workforce the government is also funding 100 additional places at Aston University’s medical school in Birmingham. Twenty further medical schools will also have additional student places funded.

The DHSC said that by 2020 there will be an extra 1,500 doctors in training. Some 630 of these places will be available from September, taking the total number of medical students for 2018/19 to 6,701, which the DHSC said was the highest on record.

The five new medical schools will be based at:

  • University of Sunderland
  • Edge Hill University in Lancashire
  • Anglia Ruskin University in Chelmsford
  • Lincoln – The University of Nottingham in partnership with the University of Lincoln
  • Canterbury – Joint medical school between Canterbury Christ Church University and the University of Kent

Health and social care secretary Jeremy Hunt said: ‘Setting up five new medical schools is part of the biggest ever expansion of our medical and nursing workforce; which will help us deal with the challenges of having around one million more over 75s in ten years’ time.

‘These schools are being set up in parts of the country where it is can be hard to recruit and attract new doctors – but will benefit doctors everywhere as we start to eliminate the rota gaps that add so much pressure to their work.’

SOURCE: www.gponline.com

Row over CF drug funding as NHS rejects Vertex offer

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A deal covering new cystic fibrosis drugs is unlikely to happen unless the manufacturer Vertex agrees to drop its prices, NHS England has indicated.

Vertex is seeking a deal to fund national access in England to its cystic fibrosis (CF) drug, Orkambi (lumacaftor+ivacaftor),  a combination which extends the number of CF whose underlying disease can be treated.

Over the last 12 months NHS England has taken a lead role in negotiating directly with pharma companies, and has created a dedicated Commercial Medicines Unit for the task.  Faced with static NHS budgets and growing budget pressure, it is taking a harder line on prices, but also says it is willing to negotiate deals based on outcomes.

However no such deal has been struck on this occasion. In fact CF campaigners have reacted angrily to this NHS England rejection, and Vertex is critical of how the budget holder has conducted the discussion, saying NHS England has only communicated via email.

MPs are set to debate availability of cystic fibrosis drugs in Parliament later today, after a petition calling for them to be funded by the NHS attracted more than the 100,00 signatures.

But for now NHS England has said it is not interested in a deal covering cystic fibrosis drugs, despite the growing pressure from campaigners.

Vertex is keen to get its CF drugs funded in England and the wider UK because of the high number of patients with the disease here.

With 10,000 patients affected, the UK has the second highest number of CF patients in the world and as such would be an important and valuable market for Vertex.

The manufacturer is seeking a deal that would cover Orkambi and any other future CF drugs that it develops as part of a “portfolio approach”.

This was sparked by NICE’s decision to reject Orkambi in 2016, which was too expensive for NICE despite discounts and greater flexibility in funding for rare disease drugs.

Although the negotiations over pricing are confidential, campaigners united under the hashtag #ukneedsorkambi are speculating that NHS England wants Vertex to expand the number of patients receiving treatment from 400, to almost 4,000 but without receiving any extra funding.

Pharmaphorum quizzed NHS England on the details of the negotiations, and a spokesperson responded with a short statement.

The spokesperson said: “The NHS can only offer treatments which are both effective for patients and offer good value for taxpayers, so it’s crucial that drugs companies work with the NHS to get a positive outcome.”

“Following advice from NICE, the NHS has asked this particular drug company to review its proposed pricing, and unless this happens further progress at this time is frankly unlikely.”

A Vertex spokesperson said the company is “astonished and dismayed” with NHS England’s response.

“It amounts to a refusal to make any additional funding available for Orkambi or future medicines,” a company spokesperson said.

“Cystic fibrosis (CF) is a devastating disease where half of people die by the time they are age 31. The situation with CF in the UK is unique and needs a unique solution – this is what our portfolio approach that we proposed in February offers.”

“Negotiations over email are rarely productive and CF patients do not have time to waste. We call on all parties to come to the table to engage in meaningful dialogue about a way forward – on behalf of CF patients.”

SOURCE: www.pharmaphorum.com/market-access-2

Blood test could predict response to breast cancer drug early

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A new study has found that a blood test for cancer DNA could predict if a woman is responding to the new breast cancer drug palbociclib, months earlier than current tests.

Scientists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, say the test could detect in two to three weeks whether the drug is working, although they caution that the results need replicating before they are used clinically.

The research, published today in the journal Nature Communications, was largely funded by the Medical Research Council (MRC). The researchers tested women with oestrogen receptor positive breast cancer – the most common kind – who were taking part in a clinical trial of palbociclib for advanced breast cancer.

In November 2017, palbociclib was approved for use on the NHS by NICE for women with previously untreated advanced breast cancer.

Currently, women must wait two to three months to find out if palbociclib is working, via a scan.

The new blood test instead looks for circulating tumour DNA – fragments of DNA shed by the cancer that have entered the bloodstream. The DNA mutations associated with the cancer can be detected in these samples.

The researchers found that they could predict if the palbociclib treatment would work by comparing the amount of a gene PIK3CA detected in a blood test before treatment and 15 days after starting treatment. In the study, 73 women had the PIK3CA mutation and were given blood tests before and after starting palbociclib treatment.

In these women, the researchers found that those who had a small decrease in PIK3CA circulating DNA at 15 days had a median progression-free survival (the length of time the patient survived and the cancer did not get worse) of only 4.1 months, compared to women with a large decrease in PIK3CA, who had a median progression-free survival of 11.2 months.

The test could allow the women in the first group for whom the treatment is not as effective to be identified early, so that they could consider altering their treatment.

Professor Nicholas Turner, senior author and Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Palbociclib is one of a new class of drugs that delays cancer progression for patients with advanced breast cancer, but it’s not effective for everybody. The problem is we have to wait for two to three months before doing a scan to see if the therapy is working.

“Our new study found that a blood test for cancer DNA in the first two weeks of treatment indicated whether the drug was likely to be effective. Having an early indication of how likely a treatment is to work might allow us to adapt treatment – switching some patients to an alternative drug that is more likely to benefit them.”

Dr Nathan Richardson, Head of Molecular and Cellular Medicine at the MRC, said: “This study provides early evidence that might help us understand sooner when a drug is successfully treating breast cancer, and if not, it can be discontinued and better approaches pursued.”

The research also received funding from the charity Breast Cancer Now and the pharmaceutical company Pfizer.

SOURCE: www.pharmafield.co.uk/Pf-Fox-News/General/2018/03

Eisai disappointed after NICE rejects earlier use for breast cancer drug

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Eisai has been dealt another disappointment from NICE, which says its breast cancer drug Halaven should not be regularly used on the NHS.

The company noted that the Halaven (eribulin) continues to be available for patients in third line – but more recently NICE had been assessing the drug after one chemotherapy regimen.

In the final guidance NICE said it was unclear whether a 4.6 month overall survival increase compared with capecitabine chemotherapy was down to treatments given after Halaven.

NICE noted that the drug did not increase progression free survival compared with chemotherapy, and that Halaven therapy is usually stopped once the disease progresses.

The uncertainty caused means that the cost per Quality Adjusted Life Year for Halaven in this use is around £69,800, according to NICE’s calculations.

This is too expensive for the NHS, even though NICE has extra leeway above its usual £30,000 threshold.

But Gary Hendler, Chief Commercial Officer Eisai Oncology Business Group, and chairman and CEO Eisai EMEA said he was “disappointed” after another knock-back from NICE.

Although NICE recommended funding for Eisai’s Lenvima (lenvatinib) in thyroid cancer last month, this was after a wait of more than two years primarily because of a change to the way NICE and the Cancer Drugs Fund are organised.

Halaven was also removed from the Cancer Drugs Fund under previous arrangements in 2015 because it was overspent. However this decision was eventually reversed and the drug was eventually rubber-stamped for regular NHS funding in late 2016.

Hendler said in a statement: “Eisai is yet again extremely disappointed with a decision from NICE. Metastatic breast cancer patients can only currently access a limited number of new treatments in England, and as eribulin has been shown to significantly improve overall survival in women with this disease it is an important option that they should have access to as early as possible.”

“Denying earlier access to it for these patients will affect their outcomes and as a company focused on making a positive difference to the lives of patients and their families, NICE’s decision concerns us greatly. Thankfully patients can still access eribulin in the third line.”

Eisai, which has built a multi-million pound manufacturing base in Hertfordshire, has threatened to stop investing in the UK because of difficulties getting drugs reimbursed.

This is despite pharma-friendly initiatives such as tax breaks on drugs that are developed and manufactured in the UK.

SOURCE: www.pharmaphorum.com/news

UK to crack down on 237m annual medication errors

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A new study commissioned by the Department of Health and Social Care has revealed that 237 million medication errors are estimated to be occurring within the UK’s healthcare system each years.

Within these figures, it is predicted that 700 deaths are directly as a result to medication errors and a potential 22,300 further deaths could be as a result of related mistakes.

Errors covered by the study included the wrong medications being given to patients, incorrect doses being delivered or a delay in medication being received.

The study did note that the vast majority, three quarters of cases, would have no impact on the health of patients. However, the cost of these errors is estimated to be worth around £1.6 billion to the NHS each year.

There are a total of 1.15 billion prescriptions made each year, with approximately 91% of these being made by GPs. So, even though the report suggested 71% of errors were made in primary care, it is not GPs that are disproportionately making mistakes but simply due to writing a larger percentage of prescriptions.

Responding to Health and Social Care Secretary Jeremy Hunt’s proposed measures to reduce medication errors in the NHS, Professor Helen Stokes-Lampard, Chair of the Royal College of GPs, said: “Identifying and prescribing the drugs that are most likely to benefit a patient is a core part of a GP’s training and daily practice.

“GPs work hard to avoid making mistakes in the prescribing process, and our patients should be reassured that in the vast majority of cases, prescriptions are made appropriately and correctly. But as well as being highly-qualified medical professionals, doctors are also human, so medication mistakes can and occasionally do happen.”

In response to the study, Jeremy Hunt is expected to announce changes further strengthening linked-up care between primary and secondary care services.

This will involve the wider introduction of electronic-prescribing systems, which will then be checkable by doctors on hospital admission – to ensure no errors has been made with prescription that led to the hospitalisation.

In practice, this will begin with ensuring NSAIDs given patients were delivered alongside a protective to the digestive system, as a test case.

SOURCE: www.pharmafile.com/news/516633

AI predicts heart attack risk factors from retinal scans

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Artificial Intelligence can be used to predict heart attack risk using retinal images, according to new research backed by Google.

The researchers trained deep learning algorithms on data from thousands of patients recorded in a massive UK study, which was used with retinal scans to produce a program that can identify risk factors from the scan information alone.

This predicted cardiovascular risk factors not previously thought to be quantifiable using retinal images: these included age, gender, smoking status, gender, systolic blood pressure and major adverse cardiac events.

Reporting results in the journal Nature Biomedical Engineering, the team used a dataset from the UK’s Biobank, a study where 500,000 were recruited between 2006 and 2010, and agreed to have certain health measurements recorded.

Health outcomes such as hospitalisation, mortality and cause of death were also logged. Smoking status was obtained via survey using a touchscreen interface in the research backed by Google and Verily, Alphabet’s healthcare subsidiary.

Participants were also asked to identify whether they are a current smoker, former smoker, or had never smoked, and blood pressure readings were also taken.

A further 67,725 had paired images of their retina fundus taken, along with a second group that was used to create a training dataset with known risk factors.

The researchers asked a neural network to make an output prediction based on the fundus image.

It was able to analyse images from the group with unknown risk factors, compare it with the training data set and after the process was repeated, was eventually able to predict cardiovascular risk factors from new images.

This is just the latest in a series of studies showing the potential of AI to predict healthcare outcomes, saving lives and reducing costs by ensuring patients receive timely and sometimes life-saving treatments.

Early last month, the government’s life sciences tsar, Sir John Bell, said that similar techniques could save the NHS billions.

A team at Oxford’s John Radcliffe Hospital is using AI to identify abnormalities in ECG read-outs that could be missed by the human eye, for instance.

The hope is that this system could be used in hospitals across the country to prevent unnecessary hospitalisations caused by false positives, and prevent heart attacks where at-risk patients are sent home because doctors have failed to spot problems.

Another AI system outperformed a panel of experts when asked to diagnose breast cancer based on stained tissue samples, in a separate study published in the Journal of the American Medical Association last month.

SOURCE: www.pharmaphorum.com/news

NICE bars NHS access to Lenvima, Nexavar for thyroid cancer

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NHS treatment cost regulators have published draft guidelines rejecting funding for Eisai’s Lenvima and Bayer’s Nexavar for treating certain patients with thyroid cancer.

The decision relates to advanced differentiated thyroid cancer that has spread to other parts of the body and cannot be operated on, in adults whose disease does not respond to radioactive iodine.

The committee heard that thyroid cancer is rare, and that the only option for patients unable to receive treatment with  Lenvima (lenvatinib) or Nexavar (sorafenib) is best supportive care.

In the draft guidelines, NICE notes that both drugs are effective in delaying disease progression compared to best supportive care, but says there is some uncertainty in establishing longer term survival.

The committee concluded that the incremental cost effectiveness ratios (ICERs) were “considerably higher” than what is normally considered to be cost effective to recommend for routine NHS use, but could not provide more specific details as the exact figures are commercially sensitive.

Also, as there are no ongoing clinical trials which might provide more evidence on overall survival benefit, the drugs could not be considered for inclusion in the Cancer Drugs Fund (CDF) either.

Approximately 3,400 people are diagnosed with thyroid cancer each year.

SOURCE: www.pharmatimes.com/news

NICE nod for GSK’s ‘bubble baby syndrome’ gene therapy

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The National Institute for Health and Care Excellence has published draft guidance recommending GlaxoSmithKline’s gene therapy Strimvelis as an option for treating an ultra-rare immune deficiency condition commonly referred to as bubble baby syndrome.

Severe combined immunodeficiency due to adenosine deaminase deficiency, or ADA-SCID, is an inherited genetic condition affecting the body’s white blood cells that renders the body’s immune system unable to function properly, leaving patients at high risk of developing life-threatening, recurrent infections.

Around three babies a year in England are born with ADA-SCID. If left untreated, quality of life is affected by developmental delay, chronic diarrhoea, failure to thrive and recurrent infections, and infants die before school age.

The current treatment for the condition is a stem cell transplant, which can restore the immune system if successful but carry a risk of mortality and graft versus host disease. Also closely matched stem cell donors are hard to find.

Strimvelis is a gene therapy in which a patient’s bone marrow cells are removed and modified outside the body to produce working ADA enzyme, and then reintroduced via an infusion drip into a vein. The draft guidelines recommends Strimvelis when no suitable matched related stem cell donor is available.

Costing 594,000 Euros, the treatment is usually given once only and the effects are thought to be life-long, NICE said. Also, as Strimvelis has to be administered at a hospital in Milan, people will travel to Italy to have the treatment, as part of their care provided by the NHS, it noted.

“Strimvelis represents an important development in the treatment of ADA-SCID, offering the potential to cure the immune aspects of the condition and avoid some of the disadvantages of current treatments,” said professor Carole Longson, director of the centre for health technology assessment at NICE.

“This means that children born with ADA-SCID will now have a better chance of being able to lead as near normal a life as possible, going to school, mixing with friends, free from the constant threat of getting a potentially life-threatening infection.”

SOURCE: www.pharmatimes.com/news

New project to bring world-class medicines ‘smart’ packaging capability to the UK

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The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing, announced it has begun the first phase of its ‘Medicines Smart Packaging’ project.

This phase of the North East Local Enterprise Partnership (LEP) funded project, known as SmartMed, will begin the process of crystallising the needs for innovation in the smart packaging of medicines and medical devices leading to the creation of an innovation capability.

The healthcare sector is in the midst of change, driven by multiple factors including longer life expectancies, a rise in chronic disease and a shift in the pharmaceutical industry towards advanced and personalised therapies.

There is also an increasing number of people taking multiple medicines, putting pressure on the NHS to be able to track exactly where drugs are going and when patients are taking them.

With the Secretary of State for Health, Jeremy Hunt’s target for digital-led NHS treatment by 2018, there is increasing expectation on the sector to use technology, such as smart packaging, to address these issues.

Using smart packaging would also benefit organisations such as distribution companies, who could track and monitor medicines throughout the supply chain, as well as pharmaceutical companies who could use sensors to monitor environmental conditions during storage and delivery including temperature, humidity and damage, to ensure that medicines are effective when they reach the patient.

Smart packaging for medicines could feature printed sensors that can also be used to help with patient compliance. This is a major issue for healthcare, because patients that do not take their medicines as prescribed not only risk their health, but also contribute to significant economic losses for healthcare providers such as the NHS in the UK.

“From manufacture to clinical supply to patients, digital technologies and new types of material have the potential to revolutionise the way in medicines are packaged and therapies of all kinds are delivered. Innovation in this area can help to improve both the effectiveness and experience of treatments for patients,” said Richard Baker, Head of Policy and Strategy at the North East LEP.

“The North East has established strengths in technologies like printable electronics, product formulation and digital application which, if brought together, could make a step change in medicines delivery and also develop approaches of value to other industries such as food and consumer products. We are delighted to be working with CPI and other partners on this project, which will aim to ensure that the North East takes a leading role in this area.”

The Medicines Manufacturing Industry Partnership (MMIP), a partnership between the UK government and industry, has endorsed the creation of a national centre of excellence in packaging for medicines.

This will support the development of the next generation of packaging technology and the associated smart devices required for new and novel medicines, including specialist packaging needed throughout the manufacturing supply chain.

The proposed world-class centre of excellence would allow medicine manufacturing and medical technology companies to build their niche capabilities and differentiate themselves in the global marketplace, securing activity and creating jobs.

CPI will be hosting a series of workshops to speak to the pharmaceutical industry, distribution companies, NHS, pharmacies and patient groups to assess their need for these innovations and the proposed capability creation.

CPI is happy to hear from any companies or groups that may be interested in taking part in these workshops, please contact info@uk-cpi.com for more information.

“The project will focus on defining and crystallising the user requirements leading to a significant and globally recognised innovation capability in the North East, helping UK companies to stay at the forefront,” says Alex Cole, Centre for Process Innovation.

SOURCE: www.manufacturingchemist.com/news