Earlier Access to New Therapies in the NHS

Earlier Access to New Therapies in the NHS


Does this mean earlier access? – A new, fast-track route into the NHS for “breakthrough” medicines and technologies has been announced by the Government in a bid to dramatically speed up the time it takes for patients to benefit from ground-breaking products for conditions such as cancer, dementia and diabetes.

From April 2018, the new Accelerated Access Pathway will mean selected products with the greatest potential to change lives could be available up to four years earlier by reducing the time taken to negotiate the evaluation and financial approvals necessary before the NHS can purchase them.

Under the scheme, each year a number of products would receive “breakthrough” designation, unlocking a comprehensive package of support that will allow firms to accelerate clinical development and benefit from a fast-track route through the NHS’s approval processes.

Health Minister, Lord O’Shaughnessy, said:

“I want the UK to be the best place in the world to develop new drugs and medical technology – but despite the innovation happening here, our uptake in the NHS can be too slow.

“Today’s new measures will not only benefit patients by improving how quickly and easily we can get innovative products from the lab to the bedside, but will guarantee future collaboration between the life sciences sector and the NHS post-Brexit – benefiting the British economy and creating jobs.”

Sir Andrew Witty, former chief executive of GlaxoSmithKline will lead the Accelerated Access Collaborative, which will make decisions on which products should be granted access to the pathway, drawing on advice from patients, clinicians and industry.

In return, life sciences firms will be expected to deliver additional value for the taxpayer, with a new Strategic Commercial Unit being created within NHS England to help negotiate cost effective deals with innovators.

Sir Andrew Witty, Chair of the Accelerated Access Collaborative, said:

“Patients, scientists and the UK economy will all benefit from the positive steps outlined by the government today.

“The opportunity to ensure the NHS gets rapid access to cost effective breakthrough technologies is vitally important, and I’m delighted to help lead the effort to deliver this.”

UK Bio Industry Association CEO, Steve Bates, said:

“This new fast track pathway should both speed up access for NHS patients to the latest therapies and help to ensure the UK remains a globally attractive cluster in which to start, scale and grow leading life sciences businesses.

“Sir Andrew Witty’s leadership of the Accelerated Access Collaborative means significant industrial insight into the selection process for products able to access this new accelerated route to market.”

The Government is also providing an £86 million funding package to help innovators of all sizes to access the NHS market, and help ensure that these products get to the patients that need them.

This includes:

  • More support for small and medium-sized enterprises to help them build a stronger evidence base for their products, with £35 million over four years to help SMEs with digital products, and a £6 million scheme to support medtech, diagnostics and pharmaceutical products.
  • £6 million to support clinicians to use new treatments and technologies in everyday practice.
  • £39m to encourage grassroots adoption and uptake of new medical technologies, driven by 15 Academic Health Science Networks which are responsible for identifying high potential products, supporting their adoption regionally and sharing lessons across the wider NHS.

A Full Press release by the UK Government in response to the Accelerated Access Review can be found here

The Pumping Marvellous Foundation response

So does this mean earlier access to the latest therapies?

Earlier access through the new Accelerated Access Scheme to innovative therapies seems to demonstrate  a firm commitment to better patient access with the extension of the medical score card system now including medical technologies which is an important area of progressive treatments for people with heart failure.

The area of concern and where this may just be a big sound bite is that it seems –

  • Light on detail
  • Reimbursement models and incentives are not clear
  • How will the Accelerated Access Scheme interact with everyday life in the health system especially with the remodelling throughout the system

These are fundamental questions that need to be answered before the scheme becomes real.

heart failure's decade?

Heart Failure’s Decade?

Is this Heart Failure’s Decade?

Heart Failure has been the classic “Cinderella Syndrome”, under invested, under resourced. The vast majority of the public don’t know what it is. Until the Pumping Marvellous Foundation, formed in 2013 as a registered charity, there has never been a successful orchestrated attempt to advocate for the patient. Naturally you would stand back and say, “Aren’t we doing this for the patient?” Is this Heart Failure’s Decade?

The phrase used by so many in the health system is “the patient voice”. I hear it so many times it keeps me up at night. To be honest I don’t really know what it means.

Is this Heart Failure’s Decade? The patient voice

For too long the “patient voice” has been a tick box for many stakeholders to demonstrate they are in “working in alignment” with the patient needs. Heart Failure has the potential to be the straw that broke the camel’s back.

Is this Heart Failure’s Decade? Scale of the challenge

Around 900,000 people in the UK will be living with heart failure. The condition is debilitating and has a significant physical, psychological, social impact on people lives, and that of their families. However, the impact is further widespread than the micro health economy. It impacts macro economies. Outcomes are poor. The survival rate is worse than prostate or breast cancer. It is suggested that 30-40% of people being diagnosed with it die in the first year; the statistics go on and on. How much evidence do you need: “we must do better.” Heart failure is one of the NHS’s big red flags.

Good news

There has been some good news. Only recently the National Heart Failure Audit, which looks at hospital admissions in the NHS, saw a drop in the mortality rate, not enough, but it’s in the right direction. It also seems that the new treatment pipeline is swollen with opportunity. The challenge is to get it through the regulatory bodies into the hands of the NHS quicker.


Amid all the roller coaster statistics I believe we have turned a corner. Stakeholders are collaborating, producing forward momentum. Personally, I don’t think we have reached our peak yet. Ensuring that the patient is not only at the centre of all we do, but is out there in a leadership role, collaborating and shaping what the future holds. So is this heart failure’s decade?

Population insights

Instead of getting individual patient insights, healthcare professionals get this every day, I believe we should be talking to vast populations of patients, delivering insights back into researchers, academics, healthcare professionals, NICE, the Department of Health and companies. Why? Because your customers can help you make better decisions that affect them.

Talented energetic people

Coming from such a poor position things can only get better for those living with Heart Failure. There are bright, committed and talented people out there in heart failure land who are making a difference, I know many of them and the patients need to support them, as they need to support the patients, which they do daily. Heart failure has an opportunity to be shaped naturally by the many hundreds of thousands of patients insights informing people in the know what patients need. I also believe there is a movement, a ground swell of optimism from patients that needs “bottling” and distributing to those who make decisions. Those in the know need not think it’s a “genie” in the bottle, they need to believe in the value of those insights. The challenge of heart failure is bigger than those in the know. We not only need to deliver this bottle but we need to validate their understanding. This is the role of the patient group, this is what we do.

The Pumping Marvellous Foundation

The Pumping Marvellous Foundation not only works to support the many heart failure patients in the UK with patient information delivered to over 160 NHS heart failure teams in the UK, but also provides the socio-psychological support people need; it works with thousands of patients and family members to build marvellous insights through its social media channels, which are being driven to those in the know. Every time I get invited to speak at a conference where do I go to get my presentation content? The patient community of course, therefore my presentations reflect the needs of the many, not just one person’s opinion.

Nick Hartshorne-Evans
Founder and CEO of the Pumping Marvellous Foundation

Some useful links for you

Our “Marvellous Guides” – download them for useful information on how to live better with heart failure

Learn about about medicines for heart failure

See our YouTube channel PMTVLive

Join our patient community on Facebook

Clinical Management of Heart Failure

Clinical Management of Heart Failure

Clinical Management of Heart Failure in Europe

A new report out focussing on the state of play in Europe around the clinical management of heart failure has just been published by the Heart Failure Policy Network. The group is an independent, multidisciplinary group working to raise awareness of heart failure across Europe.

It identifies many policy priorities across the continent of Europe. The good, the bad and the ugly. The state of play examining the clinical management of heart failure is important. People diagnosed with heart failure deserve the very best treatments. This is vital to ensure that people pursue the very best quality of life. This can be coupled with determined self-management.

The crux of the report clearly identifies a simple theme. We know what to do but we just aren’t doing it. This document will provide stakeholders in heart failure with a clear set of tools. Tools that can be taken to the few who can change policy. This will make life better for people and their families managing their heart failure.

These policy documents are very useful to help stakeholders create conversations with policy makers and politicians at a national level. The question for the Pumping Marvellous Foundation is “when do we see the action”. The challenge is everybody is producing great content but when do we put that content into gear and drive the agenda.

Heart failure seems to have a very fractionated infrastructure across Europe where connecting the stakeholders to documents like this and working as one voice enables change. We could learn a lot from the cancer movement around pooling action and getting results for the benefit of the patient and their families.

Read the report click here

You can view the Heart Failure Policy Network here to see other work they do link to website

To find out more about what we do please click here for further information

2017 “Marvellous Awards” Announced

Patients identify heart failure specialists for the Marvellous Awards 2017″

Preston, Lancashire, December 2016 – Health Care Professionals throughout the UK have been recognised and honoured by patients for their exceptional quality of care and treatment. Sponsored by The Pumping Marvellous Foundation, this award acknowledges the value that these Health Care Professionals bring to the treatment of Heart Failure, improving patient outcomes throughout the UK. Measured by the individual patients’ experience, this award reflects the direct impact these eight outstanding Health Care Professionals have in the local community, producing the highest standards of care for their patients.

As the representative of the UK heart failure patients’ voice, The Pumping Marvellous Foundation emphasises the importance of the patient perspective in recognising and rewarding health care professionals.
“We are delighted that our patient community has chosen such worthy winners to receive these yearly awards from the charity. It’s so important that patients and their families can work with and operate as a team. A superb achievement and all eight of the Health Care Professionals should be proud of themselves”, explains Nick Hartshorne Evans, Founder and CEO of The Pumping Marvellous Foundation.
Awards have been received by Health Care Professionals this week alongside a personalised commendation letter explaining the reasons behind their selection.
“Congratulations to all the winners. We recognise that there are so many fantastic Health Care Professionals out there and to all those who haven’t won, I’d like to take this opportunity to thank you for all your amazing work,” says Angela Graves, Clinical Lead of The Pumping Marvellous Foundation.

The Winners

Vicky Baines, Senior Cardiac Rehab Sister who works at County Hospital, Stafford, Staffordshire

Carys Barton, a Heart Failure Nurse for Guys and St Thomas NHS Foundation Trust, London

Dr Stephen Page, Consultant Cardiologist who works at Leeds General Infirmary, West Yorkshire

Jan Rayner-Barton, Heart Failure Specialist Nurse who works at the Heartlands Hospital in Solihull, Birmingham, West Midlands

Dineo Raeleng, Heart Failure Specialist Nurse who works at the Heartlands Hospital in Bordesley Green, Birmingham, West Midlands

Tim Dent, Senior Genetics Nurse who works at the John Radcliffe Hospital, Oxford, Oxfordshire

Toni Weldon, Heart Failure Specialist Nurse who works at Rochdale Infirmary, Rochdale, Lancashire

Professor Andrew Clark, Consultant Cardiologist at Castle Hill Hospital, Hull, East Riding



HO HO HOPE for Heart Failure Twibbon
Add a HO HO HOPE for Heart Failure Twibbon to your social media profile to support HF patients

Entresto (sacubitril valsartan) recommended by CHMP for EU approval

Entresto (sacubitril valsartan) recommended by CHMP for EU approval

A positive review puts Entresto in a position to be approved for heart failure with reduced ejection fraction by the end of 2015 in the EU.

Entresto (sacubitril valsartan) recommended by CHMP for EU approval

Press Release Novartis – Frimley

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto™ (sacubitril valsartan). Pending final approval by the European Commission (EC), Entresto (sacubitril valsartan), previously known as LCZ696, will be licensed for use in the UK for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

“Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. The CHMP’s endorsement of Entresto brings hope to heart failure patients in the UK,” said Hugh O’Dowd, General Manager at Novartis UK & Ireland.

The CHMP’s decision, which follows previous US and Swiss approvals, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto (sacubitril valsartan) significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril1. At the end of the study patients who were given Entresto (sacubitril valsartan) were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed that Entresto (sacubitril valsartan) had a similar tolerability profile to enalapril.

“The striking results in the PARADIGM-HF trial led me to believe that, once approved, LCZ696 could quickly replace what has been the bedrock treatment for more than 20 years, ACE-inhibitors,” said Professor John McMurray of the University of Glasgow and one of two Principal Investigators. “Thousands of lives could be extended and hospital admissions prevented with LCZ696’s unique ability to boost natriuretic peptides, heart-helpful hormones, while simultaneously inhibiting the RAAS system.”

Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly2. As a consequence, patients face a high risk of death, repeated hospitalisations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life. Heart failure affects around 550,000 people in the UK3 and costs the NHS about £2.3bn a year4. Even though so many people live with heart failure, most fail to recognise the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.

Early this month, Entresto (sacubitril valsartan) was given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need. This allows Entresto (sacubitril valsartan) to be made available to eligible patients before the EC makes a final European licensing decision based on the recommendations of the CHMP.


For further information – Link to Novartis press release 

LCZ696 (sacubitril valsartan) available to NHS through EAMS

LCZ696 (sacubitril valsartan) available to NHS through EAMS

New heart failure medicine LCZ696 (sacubitril valsartan) is to be made available to the NHS under the Early Access to Medicines Scheme (EAMS).

This is a good day for heart failure patients after Bayers announcement earlier in the day

Novartis LCZ696 (sacubitril valsartan) press release

Novartis’s LCZ696 (sacubitril valsartan) is the first non-oncology drug to gain EAMS status under the Medicines and Healthcare products Regulatory Agency’s (MHRA) programme for innovative medicines. Novartis will provide LCZ696 (sacubitril valsartan) to the NHS for eligible patients enrolled in EAMS.

Frimley, September 1, 2015 – Novartis today announced that its investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need. This allows LCZ696 (sacubitril valsartan) to be made available to eligible patients before a final European licensing decision is made.

It is the first time a drug not intended to treat cancer has been recognised under EAMS.

Heart failure affects around 550,000 people in the UK and costs the NHS about £2.3bn a year1,2 . Heart failure has a poor prognosis: around 60% of patients diagnosed with heart failure die within five years3 and survival rates are worse than certain cancers, such as breast and prostate4 .

“This is great news for patients with heart failure. The EAMS positive scientific opinion ensures patients with this debilitating condition can access sacubitril valsartan earlier than expected,” said Prof Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust. “Based on what we’ve seen in clinical trials, access to this new medicine will help patients live longer and keep them out of hospital, compared to currently available treatment.”

The MHRA has given LCZ696 (sacubitril valsartan) a positive scientific opinion based on the high level of unmet need in heart failure and data from the PARADIGM-HF study that showed LCZ696 (sacubitril valsartan) significantly improved patient outcomes compared to the current gold standard treatment, including a reduction both in cardiovascular deaths and hospitalisations due to heart failure5 .

Hugh O’Dowd, General Manager at Novartis UK & Ireland, said: “Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. So it’s very encouraging that LCZ696 (sacubitril valsartan) will be available via the EAMS, allowing patients in the UK with this debilitating condition to gain benefit. We are working closely with the NHS to ensure eligible patients have rapid access under the scheme while we await the final European licensing decision.” 2/4

Life Sciences Minister George Freeman said: “Heart failure is a devastating condition that affects hundreds of thousands of people in the UK, so I am delighted that patients will now be able to access this life-enhancing treatment. The UK’s Early Access to Medicines Scheme is making a real difference in speeding up access to drugs and almost 300 patients with complex conditions have already received innovative treatments earlier than they otherwise would have thanks to the scheme.

Media contacts Novartis Media Relations Michael Amos Novartis Communications UK Ltd. Tel: +44 7920 467679 (Press Office) Email: press.office@novartis.com

Aurora Healthcare Communications Claire Eldridge Managing Director +44 20 7148 4179 (direct) +44 7736 277 106 (mobile) claire.eldridge@auroracomms.com Maya Anaokar Account Director +44 207 148 4170 +44 7976 835 658 (mobile) maya.anaokar@auroracomms.com

About – LCZ696 (sacubitril valsartan) in heart failure LCZ696 (sacubitril valsartan) is an ARNI (angiotensin receptor neprilysin inhibitor) and has a unique mode of action, which is thought to reduce the strain on the failing heart6 . It harnesses the body’s natural defences against heart failure, simultaneously acting to enhance the levels of natriuretic and other endogenous vasoactive peptides, while also inhibiting the renin-angiotensin-aldosterone system (RAAS)6 .

In the Phase III trial, PARADIGM-HF, in patients with heart failure with a reduced ejection fraction, patients on LCZ696 (sacubitril valsartan) were significantly less likely to die from cardiovascular causes than those on the comparator, ACE-inhibitor enalapril5 . In PARADIGM-HF, LCZ696 (sacubitril valsartan) 5 :

 Reduced the risk of dying from a cardiovascular cause by 20% (p=0.00004) vs enalapril

 Reduced heart failure hospitalisations by 21% (p=0.00004) vs enalapril

 Reduced the risk of dying from any cause by 16% (p=0.0005) vs enalapril

 Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalisation (p=0.0000002). Patients’ reports of how they felt and doctors’ assessments of disease severity were also significantly better with LCZ696 (sacubitril valsartan) than enalapril7 .

About the Early Access to Medicines Scheme The Early Access to Medicines Scheme (EAMS), which is run by the Medicines and Healthcare products Regulatory Agency (MHRA), aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Under the scheme, the MHRA gives a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission is made. The opinion lasts for a year and can be renewed. The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines. 3/4

The scientific opinion is provided after a two-step evaluation process: the promising innovative medicine (PIM) designation and then the early access to medicines scientific opinion. LCZ696 (sacubitril valsartan) was awarded the PIM designation in April 2015, based on the results of the PARADIGM-HF trial. More information is available on the MHRA website at https://www.gov.uk/apply-for-the-early-access-to-medicines-scheme eams.

About heart failure

Around 550,000 people in the UK have heart failure1 ; both the incidence and prevalence of heart failure increase with age4 . The risk of heart failure is higher in men than in women but there are more women than men with heart failure due to population demographics4 .The most common cause of heart failure in the UK is coronary artery disease4 . Heart failure has a poor prognosis: 60% of patients diagnosed with heart failure die within five years 3 . Survival rates are similar to those for cancer of the colon, and worse than those from cancer of the breast or prostate4 . Heart failure has a major impact on quality of life and is associated with mood disorders4 .

On average, a general practitioner looks after 30 patients with heart failure and will diagnose ten new heart failure patients annually4 . Heart failure accounts for a total of 1 million inpatient bed days – 2% of all NHS inpatient bed-days – and 5% of all emergency medical admissions to hospital4 . It is estimated that the total annual cost of heart failure to the NHS is around 2% of the total NHS budget: approximately 70% of this total is due to the costs of hospitalisation4 . As well as NHS costs, heart failure also places a burden on other agencies such as social services and the benefits system, and of course on the patients with heart failure and their families and caregivers4 .

Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as “being investigated,” “thought,” “plans,” “growing,” or similar terms, or by express or implied discussions regarding potential marketing approvals for LCZ696 (sacubitril valsartan), or regarding potential future revenues from LCZ696 (sacubitril valsartan). You should not place undue reliance on these statements. Such forwardlooking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that LCZ696 (sacubitril valsartan) will be approved for sale in any market, or submitted for approval in any additional markers, or at any particular time. Neither can there be any guarantee that LCZ696 (sacubitril valsartan) will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that LCZ696 (sacubitril valsartan) will be commercially successful in the future. In particular, management’s expectations regarding LCZ696 (sacubitril valsartan) could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forwardlooking statements contained in this press release as a result of new information, future events or otherwise. 4/4

About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 fulltime-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

1 British Heart Foundation. At-home treatment for heart failure patients eases burden for families and for NHS. 9 June 2015. Available at: https://www.bhf.org.uk/news-from-the-bhf/newsarchive/2015/june/at-home-treatment-for-heart-failure-patients-eases-burden-for-families-and-fornhs Last accessed August 2015

2 NHS Choices. The NHS in England. About the National Health Service (NHS). January 2015. Available at http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx Last accessed August 2015.

3 Sutherland K. Bridging the quality gap: heart failure. 2010. London. Health Foundation. Available from: http://www.health.org.uk/sites/default/files/BridgingTheQualityGapHeartFailure_0.pdf Last accessed August 2015 4 National Clinical Guideline Centre. Chronic heart failure: the management of chronic heart failure in adults in primary and secondary care. 2010. London: National Clinical Guideline Centre. Available from: http://guidance.nice.org.uk/CG108/Guidance/pdf/English Last accessed August 2015

5 McMurray JJV, et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure. N Engl J Med.2014;371:993-1004

6 Langenickel TH and Dole WP. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discov Today Ther Strateg. 2012;9:e131-e139

7 Packer M, et al. Angiotensin-Neprilysin Inhibition and Clinical Progression in Surviving Patients with Heart Failure Circulation.2015;131:54-61

Bayer moves into heart failure

Bayer moves into heart failure

Reuters has reported that Bayer, a large German pharmaceutical has published preliminary results from its phase II trial of Finerenone

Finerenone is still several years from reaching the market, is an improved version of a class of heart drugs called mineralocorticoid receptor antagonists (MRAs).

Existing MRAs spironolactone and eplerenone, branded as Inspra by Pfizer, are unsuitable for many patients since they can cause abnormally high levels of potassium in the

blood, leading to irregular heart beat or even cardiac arrest.

Existing MRAs spironolactone and eplerenone, branded as Inspra by Pfizer, can cause high levels of potassium in the blood leading to arrhythmias. The two older medicines, whose patents have expired, are also linked to kidney problems.

Bayer’s pill, however, works in a different way and appears to avoid these issues.

Reuters goes on to report

“If you can eliminate hyperkalaemia (high potassium) that would be a huge benefit to patients,” said Mary Norine Walsh, vice president of the American College of Cardiology, who was not involved in the research.

Phase II trial data presented in London on Monday showed finerenone led to fewer deaths and hospital admissions among participants during 90 days of initial treatment, when compared to a control group on eplerenone.

“We were somewhat surprised by this striking reduction in CV (cardiovascular) events,” Gerasimos Filippatos, the study’s principal investigator, told the European Society of Cardiology’s annual meeting.

Larger trials needed

The greatest relative risk reduction of 44% was seen in patients who started at 10 mg daily of finerenone, which Filippatos said appears to be the optimal dose.

“We didn’t expect to see these clearly better results already in Phase II,” said Frank Misselwitz, head of the therapeutic area cardiovascular and coagulation at Bayer.

Larger tests are now needed to confirm the benefit.

A blood reading to measure stress on the heart, which was the trial’s primary efficacy measure, was at levels comparable to the control group, as was the level of overall side effects.

Bayer will enroll more than 3,600 patients with heart failure and diabetes and/or kidney disease in its final-stage Phase III study. It has said previously it would also start even bigger Phase III tests of the drug in diabetic kidney disease.

There has been little progress for more than a decade in treating heart failure where the heart fails to pump enough blood around the body, but competition is starting to heat up which is good for HF patients.

Heart failure patient quote

Heart failure patient quote

The UK’s heart failure charity the Pumping Marvellous Foundation receives lot’s of very pertinent quotes from it’s members on what’s it like to live with heart failure. Once in a while one turns up and as somebody who lives with heart failure knows it really resonates. This quote so understandable from the sufferer’s point of view and should be understandable to those who don’t have it. It is worth contemplating this quote so as to understand the psychological impact of what this really means…

Patient quote -HF is like growing old

Heart Failure Community Management

Heart Failure Community Management

Heart failure community management care treatment provided by nurses at home is a viable alternative to hospital care for heart failure patients, according to Australian researchers.

A study has suggested that post-discharge condition management provided at home could be a cost-effective alternative for recently hospitalised elderly patients with chronic heart failure.

“The net benefit of home-based intervention appeared to be pronounced among the patients with a low level of self-care confidence or with fewer co-existing diseases” said Shoko Maru, Lead Study Author.

It showed that specialist home care could both reduce mortality and readmissions to hospital among heart failure patients.

The study, a collaboration between Griffith University in Queensland and the Australian Catholic University in Melbourne, involved data on 280 patients at public sector hospitals.

It compared a home-based intervention delivered by specialist nurses and community-based health professionals – GPs and community pharmacists – versus the traditional clinic-based intervention delivered by a specialist clinic based in the hospital.

Intervention was provided for up to 1.5 years with median follow-up of 3.2 years.

The groups were compared in terms of total healthcare costs and quality-adjusted life-years – years of life adjusted for their quality.

<h2>Heart Failure Community Management Study Outcomes</h2>

“Compared with clinic-based intervention, home-based intervention is likely to be cost-effective in elderly CHF patients with significant comorbidity,” said the researchers in the International Journal of Cardiology.

Dr Maru said those in the home-based group lived longer and when they did require readmission their hospital stay was shorter.

She added: “Our findings inform the long-term cost-effectiveness of intervention intended for a lifelong disease such as chronic heart failure.”

Hopefully this study will further demonstrate the benefits of heart failure community management. Patients value the intervention of having a heart failure community management program delivered by specialist nurses either at home or in a community setting.

Heart failure aware

Heart failure aware

Here are some of the latest images from our intrepid adventurers who are raising heart failure awareness by climbing Africa’s highest mountain Kilimanjaro. You can follow their adventure on our facebook campaign page heart failure aware or on twitter by searching #HeartTrek2015

Here is a snippet of their Day 6 update


“We are sat at evening tea, after the hardest day yet – the Barranco Wall – Hard, hard day and all exhausted! We are feeling strong and MARVELLOUS though, and ready to head to Barafu Camp for summit start around midnight tomorrow. Trying not to think about that yet, but it is drawing near! We are extremely dirty and rocking some interesting hair doos! HOPE to have better signal for remainder of the trip, but can’t be sure!”

Today holds a steep descent into the bottom of the Great Barranco valley (3,900m.), sheltered by towering cliffs. A short climb up the famed Barranco Wall leads to an undulating trail on the south-eastern flank of
Kibo, with superb vistas of the Southern Icefields. The terrain is volcanic scree, with pockets of lush vegetation in sheltered hollows, and a powerful sense of mountain wilderness. Our next camp is at Karanga (4,000m.), the last water point on the approach to Barafu, in a narrow valley.

Raising awareness of heart failure is so important. Did you realise that 1 in 5 adults over the age of 40 will develop heart failure and the prognosis is worse than most forms of common cancer. Often referred to as the “cinderella syndrome” heart failure needs significant investments to ensure that people who suffer from it have the best quality of life due to access to the latest innovative therapies and help in self managing their conditions.