Health watchdog warned of 'bigger challenges ahead'

by Admin 26. February 2014 16:49

A report has commended health watchdog Monitor for delivering ‘value for money’ but warns more changes are needed to cope with ‘bigger challenges ahead’.

In a recent report into Monitor’s work, the National Audit Office (NAO) commended the watchdog for delivering value for money and raising standards but warned of ‘bigger challenges ahead’. 

The NAO concluded that Monitor, with a core budget of £48m for 2012-13, has delivered value for money and proved its effectiveness with improving foundation trusts, especially those dealing with internal issues such as leadership or poor financial management. 

While the NAO admitted it was difficult to assess Monitor’s impact on foundation trusts, the trust staff in case studies took “faster or more effective action, or both, because of Monitor’s intervention than they would otherwise have done.” 

Monitor proved less successful when a “trust’s problems are down to underlying issues in the local health economy, such as where commissioners are also in financial difficulty” said the report, but auditors acknowledged the watchdog has recently tried to redress the balance by adapting its approach.

As the number of foundation trusts in deficit rises, Monitor’s workload is increasing, with the NAO auditor general Amyas Morse warning that “bigger challenges lie ahead for Monitor”.

“It needs to adapt how it works with other bodies to tackle underlying local weaknesses that increase the risk of individual trusts failing, either clinically or financially,” he said. The report urged Monitor to continue using its “informal powers of influence and persuasion to broker solutions”.

Speaking in response to the NAO report, Margaret Hodge, chair of the Commons public accounts committee, said she was “reassured” by the findings but stressed that Monitor needed to “ remain fit for purpose” in increasingly pressured times. She added her hope that the watchdog “quickly recruits the 113 posts that are currently vacant” to help manage the workload.

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Breakthrough Therapy Designation for Hep C drug

by Admin 26. February 2014 10:24

Bristol-Myers Squibb has announced that the US Food and Drug Administration (FDA) has granted its new medicine Breakthrough Therapy Designation.

The investigational daclatasvir and asunaprevir DCV Dual Regimen is designed to treat genotype 1b chronic hepatitis C infection (HCV). Approximately 170 million patients worldwide are infected with hepatitis. The FDA looked at data from the company's phase III clinical trial programme before granting the designation.

The intention of Breakthrough Therapy Designation is to speed up the review of drugs that can have an effect on serious or life-threatening conditions. In order to be granted the status, pharma companies must show preliminary clinical evidence of substantial improvement in regard to one clinically significant endpoint over available drugs.

This is the second time the FDA has granted Breakthrough Therapy Designation to a daclatasvir-based regimen. Brian Daniels, senior vice-president of global development and medical affairs at Bristol-Myers Squibb, said that the granting of the status showed the drug's potential to "address the high unmet needs of the HCV patient population".



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Final approval for Bayer's EYLEA®

by IainBate 26. February 2014 09:40

Bayer HealthCare’s EYLEA®  treatment has been approved in final guidance by The National Institute for Health and Care Excellence (NICE).

NICE has announced that EYLEA (aflibercept solution for intravitreal injection) is recommended as a treatment option for visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO).

CRVO is a common and serious eye condition affecting the main vein in the eye which can cause blindness and other painful eye conditions if left untreated. The final appraisal determination (FAD) means that eligible patients with this condition will now have access to a new medication that improves vision from the start of treatment, allowing them more independence as well as freedom from the need to visit the hospital every month for monitoring or treatment.

Macular oedema, or fluid beneath the macula (a tiny part of the retina at the back of the eye), is one of the complications of CRVO. The impact of the associated vision loss can have a profound effect on vision-related quality of life. 

Helen Jackman, Chief Executive of the Macular Society said: “Losing central vision puts a massive strain on patients, as well as their families, as it takes away their independence…we urge the NHS to implement this guidance within the mandated 90 days so patients can get access to it as soon as possible.’

Commenting on the FAD, Moin Mohamed, Consultant Ophthalmologist, St Thomas’ Hospital, said: “This is good news for ophthalmologists and patients with this unpredictable and difficult to treat condition. Having EYLEA, an established and effective treatment, available for these people is an important step forward in the management of this debilitating condition, where, until recently, very limited treatment options were available.”

EYLEA was licensed in the UK for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) in August 2013. This final recommendation from NICE marks the second indication for EYLEA that has received a final FAD, without the need for additional consultation. 

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Ignore hospital death rates, says expert

by Admin 25. February 2014 11:49

Ahead of his review into hospital mortality data, an expert has advised patients to ‘ignore’ what he brands as ‘spurious’ measures.

Professor Nick Black, an academic currently commissioned by NHS England to review Hospital Standardised Mortality Ratios (HSMR) and their use, has recently spoken out against the use of a measure he deems “spurious”, encouraging patients to simply ignore them.

HSMR have been published by Dr Foster Intelligence since 2001 and compare the expected rate of death to the actual rate of death in any given hospital. While this data has been credited with drawing attention to alarming standards of care, such as at Mid-Staffordshire hospital, Professor Black has now suggested that the data offers no use and could be misleading for patients.

Speaking to the BBC, Professor Black said: “I don’t think there’s any value in the publication of HSMR and I’d go further, I think it’s actually a distraction because it gives... a misleading idea of the quality of care of the hospital.”

He suggested that the accuracy of HSMR is compromised as the measure fails to consider other factors that could affect the figures, such as whether sufficient hospice care is available in the area.

Ahead of his full review due in December, Professor Black said that efforts should be directed towards “measures of the quality of care” and not on “a spurious measure of mortality ratios”.  

His message to patients on HSMR was clear: “Personally, I would suggest the public ignore them.” 

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Biogen’s MS drug needs to woo NICE

by Admin 25. February 2014 10:39

Biogen’s new MS drug Tecfidera is set for a further NICE review as the regulators call for more information from the drug creators.

Biogen Idec, currently seeking approval from the National Institute for Health and Care Excellence (NICE) for Tecfidera as a treatment for relapsing-remitting multiple sclerosis (RRMS) in adults on the NHS, has been asked to offer clarification on certain issues raised by the reviewers.

NICE has announced a draft guideline for consultation until mid March, allowing Biogen time to offer clarification on the number of issues raised by the drug funding regulator on the clinical- and cost-efficiency of Tecfidera.

Chief executive of NICE, Sir Andrew Dillon, said the issues were raised during the independent review into the treatment: “that is why we have requested more details from the manufacturer – we want to ensure that we have as much information as possible to make an informed final recommendation.”

While the initial rebuff is something of a set-back for Biogen, industry insiders are hopeful Tecfidera will soon be granted its full recommendation.

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Janssen’s diabetes drug arrives in the UK

by Admin 25. February 2014 10:15

Janssen’s launches diabetes drug Invokana in the UK amid initial approval from NICE.

The pharma division of Johnson & Johnson, Janssen, has announced it will begin marketing its new diabetes drug Invokana in the UK on the same day the National Institute of Health and Care Excellence (NICE) gives the treatment a preliminary nod.

While NICE has yet to grant the drug full approval, an initial recommendation suggests that Invokana could soon be available on the NHS as a combination treatment with metformin, or in combination with both metformin and a sulfonylurea, offering a new option for patients with type 2 diabetes.

In the meantime, the diabetes treatment will arrive in the UK as a proven means of reducing the blood sugar levels of those with type 2 diabetes and unable to manage their conditions through other means, such as a lifestyle changes or alternative treatments.

A final decision from NICE is expected in the middle of March. If Invokana gets the nod of approval it will become the second sodium glucose co-transporter 2 (SGLT2) inhibitor to be approved by the national body, following AstraZeneca’s Forxiga in 2013. 

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Hospital trusts must pull up their (financial) socks

by Admin 24. February 2014 13:17

Hospital Foundation Trusts need ‘up their game’ financially to deliver savings and safeguard standards.

In a recent study on Foundation Trusts (FT), health watchdog Monitor reported a higher-than-expected number of trusts currently in deficit, demanding the organisations ‘up their game’ to ensure standards are maintained.

Two-thirds of the country’s hospitals are currently Foundation Trusts and operate outside the government’s direction, free to make independent decisions on their budgets and management. Foundation Trusts retain any budget surplus each year and are able to borrow money for investment in new and improved services.  

The report into trusts recenlty undertaken by the health watchdog revealed that 39 of 147 are currently reporting a budget deficit, with the combined figure reaching £180m – 6.6% higher than Monitor had predicted.

Monitor also revealed that 60% of the deficit was concentrated across five organisations already facing regulatory action, with the Midlands area being branded as the most “financially challenged” in the country.

While the majority of trusts remain financially in surplus, their combined annual surplus of £135m is still lower than the planned £173m, and just half of that reported this time last year.

Jason Dorsett, financial reporting director at Monitor, said: “The financial trust sector is doing remarkable well in touch circumstances, but is looking a little frayed around the edges.”

While the trusts have delivered £867m of efficiency savings this year, the figure is still £185m below the sum Monitor expected by this point.

“All trusts need to up their game in delivering efficiency savings this year in order to maintain and improve the quality of care for patients, and ensure the sustainability of services,” said Dorsett.

While the government has confirmed they will offer support to those trusts struggling financially, it was quickly stressed that money should not be seen as the key to better care.

“We are putting recovery plans in the place for any trust in financial difficulty, but as the culture within our NHS changes, we do not accept that delivering safe and compassionate care in the longer term costs more money,” said a spokesman.

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Mending a broken heart with stem cells

by Admin 24. February 2014 10:42

Researchers have embarked on the largest stem cell trial ever run in a bid to reduce deaths and repair damage in heart attack victims.   

The Europe-wide study, known as BAMI (bone acute myocardial infarction), will involve 3,000 heart attack victims across 11 countries, with researchers hoping the stem cell treatment can make key repairs and reduce the number of deaths.

During the study, all participants will receive the standard artery-widening treatment in the day following the heart attack while 50% will have stem cells from their bone marrow injected into their heart. Researchers hope the stem cell treatment will strengthen and repair the heart, reduce the likelihood of another heart attack and thus reduce the incidence of death.

While various, smaller trials have already been undertaken to investigate this treatment, the BAMI study is the largest of its kind and will involve patients at hospitals in London, Paris, Copenhagen, Rome and Frankfurt among others.

 Professor Anthony Mathur, director of cardiology at Barts Health NHS Trust and chief investigator for the study, described it as “the definitive trial” for this type of stem cell treatment.

“After 15 years of research we will now have a clear answer,” he said. “We hope to show that stem-cell injections can cut the number of people dying from heart attacks by 25%. If it works, it would open up a whole new branch of medicine, and give heart attack patients an entirely new treatment.”

The results from the study, which received nearly £5m in funding from the European Commission, are expected in five years time.    

European support for new CPOD therapy

by Admin 24. February 2014 10:06

GlaxoSmithKline has welcomed a recommendation from Europe’s CHMP for its new CPOD therapy.

A positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP) for a new chronic obstructive pulmonary disease (CPOD) therapy has cheered the duo behind it, namely GlaxoSmithKline (GSK) and partner Theravance.

The recommendation from the Committee serves as a first step towards full approval for the CPOD therapy, which uses a combination of umeclidinium and vilanterol to relieve the symptoms of adults with COPD and would be marketed as Anoro.

The support of the CHMP was based on positive data from a phase III pivotal programme that spanned seven clinical studies, with results prompting the Committee to endorse the drug as a once-daily, maintenance bronchodilator treatment.

As the therapy has already been approved in the US and Canada under the name Anoro Ellipta, GSK and Theravance are hoping European approval from the European Commission will be forthcoming, allowing the companies to introduce Anoro as a new treatment option for COPD sufferers in Europe soon.

Patrick Vallance, GSK’s president of pharmaceutical research and development, said the recent recommendation was “a step towards us making this important new medicine available.”

“We are looking forward to the final decision of the European Commission in the near future.”      

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100 GP surgeries could close

by Admin 21. February 2014 11:48

Experts have warned that almost 100 GP surgeries could face closure due to a forthcoming budget cut.

The British Medical Association (BMA) has spoken out in warning ahead of a funding cut that could leave 100 GP surgeries facing closure due to a lack of financial support.

As NHS England unveiled its plans to phase out a support fund for small practices, the BMA has warned that many practices could face closure, leaving large areas of the country without access to a GP service.

The BMA’s warnings come in response to the governing body’s plan to phase out the minimum practice income guarantee (MPIG) fund over the next seven years.

The MPIG is a fund that safeguards the survival of small practices by guaranteeing surgeries a minimum level of funding regardless of the number of patients on their books. As the funding is gradually phased out over the coming years, some GP surgeries will face losing from £3 to £100 per patient per year.

In conjunction with the announcement, the national governing body released a list of 98 practices thought to be at ‘serious risk’ if severe cuts are made to budgets, with experts warning that these surgeries – and more – could be at risk of closure due to the termination of the MPIG.

Chaand Nagpaul, chair of the GP committee at the British Medical Association (BMA), said the government had “severely misjudged the potential impact of its funding changes, especially on rural GP services.”

Nagpaul warned it was “likely” that a few hundred surgeries would face a “noticeable” loss of funding due to the budget changes, with the 98 identified as being at ‘serious risk’ potentially facing closure without support.

“Ministers have got to get a grip on this problem urgently,” said Nagpaul, calling for a national plan to “tackle this problem and safeguard GP services” or risk leaving large areas of the country without access to a GP.

NHS England was quick to deny the claim of rural surgeries being disproportionately affected by the changes, arguing that rural surgeries make up less than 15% of the ‘threatened’ 98.

 The governing body said its decision to phase out the MPIG was a necessary move as the current formula was “not an equitable way of funding practices”.

“NHS England is committed to making sure patients have access to high-quality GP services wherever they live and GPs are properly funded to deliver these services” said a spokesman.  

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