CHMP passes judgement

by Admin 27. January 2014 10:44

The European Medical Agency (EMA)’s advisors have raised thumbs at three innovative treatments but blocked Novartis’ heart and Teva’s MS drugs.

The Committee for Human Medicinal Products (CHMP), a body advising the EMA on drug approval decisions, has positively recommended three new innovative treatments in its latest review, but delivered bad news for Novartis and Teva.

Of the clutch of new recommendations by the Committee, the three most innovative treatments are GlaxoSmithKline’s diabetes drug (Eperzan), Takeda’s schizophrenia treatment (Latuda) and Bayer’s Adempas for pulmonary hypertension.

Other drugs that also scored a thumbs up from the committee include two generics of Novartis drugs – 3M Health Care’s version of Exelon (for Alzheimer’s) and Teva’s incarnation of Zometa (for osteoporosis) – and a biosimilar of Merck Serono’s infertility drug, marketed by Finox Biotech as bemfola.

Novartis and Teva were less fortunate in the CHMP’s latest review, with the former’s drug for heart failure being rejected after results did not clearly demonstrate “clinical relevance”. Teva’s multiple sclerosis drug Nerventra – produced in collaboration with Active Biotech – was rejected for its unfavourable risk-benefit profile. Both companies are planning to appeal for re-examinations of their treatments in the coming months.

The EMA will now use these latest verdicts from the CHMP to inform its forthcoming decisions about marketing approval as it meets to discuss the new treatments seeking a place in Europe’s pharma scene. 

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Drugs | News

"Whole-stay doctor" for patients in hospital

by Admin 24. January 2014 12:32

Health secretary Jeremy Hunt has called for a greater ‘continuity of care’ in hospitals, with all patients having a “whole-stay doctor”.  

Ahead of a speech on ‘patients as people’ at the Guy’s and St Thomas’ Foundation Trusts, health secretary Jeremy Hunt stressed the importance of improving the continuity of care offered in hospitals by ensuring all patients had a named “whole-stay doctor”.

Hunt was restating one of the previous government’s recommendations, in response to the Francis inquiry, for all hospital patients be given a named, “whole-stay doctor” to increase the continuity of the care during their stay and “unblock bureaucracy”.

“There’s a lot of symbolism in putting names above beds,” said Hunt. “It tells patients there is someone where the buck stops and who they can contact if they are not happy.”

As part of the “whole-stay doctor” approach, patients should be discharged with a “proper handover to a named, accountable GP”, explained Hunt. He has also requested that Care Quality Commission inspectors begin checking that each patient had a named doctor listed above their bed during their hospital inspections.

The “whole-stay doctor” forms part of the government’s wider plans to tackle disjointed care and promote what it calls the ‘whole patient’ approach, shifting the NHS away from a “culture of volume and targets” towards one of a “continuity of care”.

Other changes will include the implementation of activity-based payment systems and tariff reform. The government is also exploring a more flexible approach to working times, preventing doctors having to ‘clock off’ to avoid breaching the European Working Time Directive despite their patient still requiring care.

The ‘whole patient’ approach and associated reforms have been broadly welcomed by some members of the healthcare industry, with Norman Williams, president of the Royal College of Surgeons, applauding the government’s “determination to bring back a more streamlined and compassionate approach to care”.   

Paul Flynn, the chair of the British Medical Association consultant’s committee, suggested that while “work patterns should promote and support continuity of patient care”, it was vital “that working patterns also safeguard the need for a healthy and productive work-life balance for doctors, as that is also crucial to protecting patient safety and care."


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News | NHS

HIV drug scores ViiV its first EU approval

by Admin 24. January 2014 11:11

ViiV Healthcare’s Tivicay gets a thumbs-up from the European Commission (EC), earning the HIV-focused joint-venture it’s first product approval.

The EC has granted approval for ViiV’s Tivicay (dolutegravir) as a combination treatment for HIV, earning the joint-venture its first product approval since its formation over four years ago.

ViiV Healthcare is a HIV-focused joint-ventured formed in 2009 by Pfizer and GlaxoSmithKline, with Shionogi – originator of dolutegravir – having joined the duo as a partner in 2012.

Tivicay is the first of the organisation’s products to achieve approval, with the EC recently green-lighting the tablet for use in combination with other anti-retrovial drugs to treat HIV sufferers aged 13 and over,

The approval was based on four clinical trials that recorded safety and efficacy when the drug was used by both treatment-naive and treatment-experienced HIV patients.

This EU nod follows Tivicay earning approval in August 2013 in the US, where the treatment is already predicted to become the leading HIV treatment by 2016.

Dr Dominique Limet, ViiV chief executive, said the approval was an “important advance, opening the door to new treatment combinations for people living with HIV in Europe.”

He also acknowledged the HIV patients and healthcare professionals whose participation had been vital in developing the treatment. “We aim to move forward together with them based on an absolute commitment to the HIV/AIDs global response,” he added.

ViiV expect to commence marketing Tivicay in the “immediate future”, although its arrival in different countries will depend on the timing of each nation’s pricing and reimbursement processes.       

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Drugs | News

Environment-tailored healthcare could save money

by Admin 23. January 2014 14:36

NHS England guidance has identified 20 interventions, tailored to commissioners’ environments, that could boost local health care services and ease the funding deficit.

A guidance document developed by NHS England has detailed the 20 interventions that the health body believes will have the highest chance of targeting service quality and closing the gap in funding within the health service.

The selected interventions, documented in the Any Town guidance, were chosen from an initial list of 500 considered by NHS England as a means of tackling the funding gap, which is currently expected to reach £30bn by 2020.

Professor Robert Harris, director of strategy at NHS England, said the governing body appreciated that current provisions were not tenable and the new interventions would offer more “radical changes” as a means of tacking the long-term financial concerns of the health service.

The twenty interventions are differentiated by their suitability for a commissioning group’s individual environment – urban, suburban or rural – with ideas ‘tailored’ to the areas where their maximum benefit will be experienced based on local health profiles and health needs.

For example, as urban areas tend to have a younger population with a higher prevalence of mental health issues and depression, psychiatric liaison services are suggested as an intervention to offer a higher net benefit to those commissioners operating in urban environments than others.

The 20 interventions are also categorised into “high impact interventions” – or those with proven success – and the “early adopter interventions” yet to be assessed. The latter suggestions include schemes such tele-consultations with GPs and 24-hour asthma services for children and young people.

The guidance document estimates that the suggested interventions could reduce suburban commissioners’ funding gaps by up to 58%, with urban and rural commissioners seeing an up to 56% and up to 40% reduction respectively.

While the guidance is as yet unpublished, it suggests that commissioners could soon be using environmentally-tailored interventions to reduce funding gaps while maintaining health services that cater to local demand.


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News | NHS

Novo Nordisk launches its shortest needle for diabetics

by Admin 23. January 2014 11:39

Measuring just 4mm, the NovoFine Plus is the shortest needle to be produced by Novo Nordisk in their quest to make diabetic injections less irksome.

Novo Nordisk, who launched the world’s first pen needle for insulin back in 1985, recently unveiled a new 4mm universal pen needle that it hopes will ease the process of insulin injecting for type-2 diabetics.

 “We know needle anxiety can be a real barrier when people with diabetes start insulin therapy,” said Jesper Kløve, senior vice president, Device R&D, Novo Nordisk, “and in some people this fear really compromises their treatment.”

“We’re pleased to provide this new option to people with diabetes”.

At a length of just 4mm and a width of two human hairs, the NovoFine Plus was designed based on patient concerns and can offer less painful injections. The needle uses SuperFlow technology to offer faster, but less forceful, injections, and can reduce the risk of intramuscular injection.  

Despite its small size, the needle is suitable for those with a high BMI and has been designed to reduce the risk of the needle bending or breaking during use, which Novo Nordisk hopes will improve the injection experience for diabetics.

While the NovoFine Plus is currently only available in Canada, Novo Nordisk promises these diminutive needles, which are compatible with all major pen devices, will be available in other countries in 2014 and 2015.   

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General | News

CQC has ‘turned around’, says Health Committee

by Admin 22. January 2014 12:26

The Health Committee’s recent report commends the CQC management’s efforts to ‘turn around’ the regulator.

Following their recent quarterly accountability session with the CQC, the Health Committee (HC) has released a report that commends the CQC’s progress and acknowledges its “renewed sense of purpose”.

Stephen Dorrell, chair of the HC, said the regulator “now understands that it exists to ensure that care providers meet basic standards and intervene when they do not”, welcoming the move away from  “superficial” inspections that “produced reports that bore little relation to reality”.

The CQC has been a case study in how not to run a regulator,” said Mr Dorrell, “but essential reforms implemented by the new management are turning the CQC around.”

Despite the general tone of approval for the CQC’s progress, the HC used the report to scrutinise some of the new practices, offering a number of recommendations and warnings for the regulator.

While the HC commended the recent adoption of a risk-based regulation, it warned the CQC against offering providers a reason to “regard being awarded a positive rating from the CQC as a mechanism for escaping scrutiny.”

The report also stressed the importance of using constantly-collected data on important provisions, especially inadequate staffing levels, as a trigger for inspections and suggested that the “detailed surveillance system” the CQC has put in place just the first step to gain an accurate picture of the state of services.

“The CQC must demonstrate that it can pick up on problems before they become known to the general public,” said Mr Dorrell. “If surveillance is perceived as slow, or reactive, it will not enjoy public confidence and credibility.”

The Committee raised concerns over the decision to give the CQC responsibility for overseeing the financial performance of adult social care providers, calling for the government to reconsider this decision.

The report also criticised the move to exclude chairs of NHS Trusts or Foundation Trusts from the new “fit and proper persons test” to be carried out by all care provider directors –“we do not believe this exclusion will be understood by the public,” said Mr Dorrell.

The CQC is now required to report to parliament regularly on its progress in recruiting 150 extra inspectors and will face another strategic review in three months time.


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News | NHS

NICE approval for Sanofi’s MS tablet

by Admin 22. January 2014 12:03

Sanofi earns a recommendation from NICE for oral MS drug following the watchdog’s demands for further evidence at the end of 2013.

NICE has finally stamped Sanofi’s Aubagio with a positive recommendation after the pharma company provided more evidence following the watchdog’s negative response in December 2013.

Sanofi, who acquired the oral MS drug via its purchase of Genzyme, will now see Aubagio offered as a cost-effective treatment on the NHS for certain adults with the relapsing-remitting form of Multiple Sclerosis (MS). As part of the agreement, Sanofi will to provide the drug at a discount price via a patient-access scheme, and it is believed the tablet will help treat eight out of ten adults with MS.

Aubagio is the first oral, once-daily, first-line therapy to be approved by NICE for treating MS and its approval has been met with enthusiasm from those in the health care industry.

Benjamin Turner at Barts Health NHS Trust said the approval was “great news for UK patients and especially those who cannot tolerate injections, as until now there have been limited treatment options open to them.”

Nick Rijke, director for policy and research at the MS Society, said the industry had been “waiting a long time for a tablet to be available for early stage MS, so this is excellent news.”

Aubagio is the third new treatment for MS to have entered the market in the past few years, with Novartis’ Gilenya having been NICE-approved as a second-line treatment and Biogen Idec's Tecfidera scoring a recommendation by the European Medicines Association.

Genzyme, the Sanofi-owned company behind Aubagio, has also got another MS treatment in the pipeline, with the injectable Lemtrada currently being appraised by NICE.  


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Drugs | News

New mental health strategy to tackle “unacceptable” standards

by Admin 21. January 2014 12:14

Deputy prime minister Nick Clegg unveils a new mental health strategy to tackle “unacceptable” standards.

During a recent mental health conference, deputy prime minister Nick Clegg unveiled a new national mental health strategy to serve as the government’s “bold and focused approach” to tackling the “unacceptable” standards of care.

“Some people with mental health problems are still being treated in a way that is frankly unacceptable,” said Clegg, before unveiling a new plan that the government hope will reduce the disparity between mental health and physical health care standards and tackle ongoing problems such as long treatment waiting times and  bed shortages.

The new “call to action”, entitled Closing the Gap: Priorities for Essential Change in Mental Health, outlines 25 areas to be targeted in a bid to improve the care available for those with mental health conditions.

Proposed changes include introducing waiting time standards for mental health patients by 2015, increasing the support for children with mental health issues, and investing more than £40m in pilots on better housing for people with mental health issues or learning disabilities.

Speaking at the conference, Clegg emphasised the vital role commissioners would play in improving standards, making a “very direct commissioners to see what we are saying and to act accordingly”.

“Commissioners have got to step up to the plate,” he said.

Stephen Dalton, chief executive of the NHS Confederation’s Mental Health network, said the government’s new plan had “real potential” but would only fulfill this if society “put our money where our mouths are and make sure we make progress in mental health much further and much faster.”

Paul Farmer, chief executive of the charity Mind, also spoke in support of the new plan but suggested that the bold ideas could be undermined by financial issues.

“[The new plan] comes at a time when NHS mental health services are under enormous pressure,” he said. “Funding for NHS mental health services has been cut for two consecutive years and, with no room for belt-tightening in an already underfunded service, the impact on patient care has been dramatic.”

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News | NHS

EC authorisation for first all-oral Hep C treatment

by Admin 21. January 2014 10:56

Gilead’s Sovaldi has been given the green light by the European Commission (EC), becoming the first all-oral treatment for chronic Hepatitis C in the EU.

Gilead Sciences’ drug Sovaldi (sofosbuvir), a once-daily oral treatment, was granted marketing authorisation by the EC following an accelerated assessment by the European Medicines Association thanks to the drug’s potential as a medicine of major public health interest.


The marketing authorisation from the EC follows closely on the heels of FDA approval for the drug in the US at the end of 2013, where analysts are already estimating Sovaldi sales could reach $1bn by the end of 2014.

With approximately 9 million people thought to currently be infected with Hepatitis C across Europe, the approval for Sovaldi is seen as “very welcome” explained Professor Graham Foster, professor of Hepatology at Queen Mary University of London.

“With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured,” he said.

John C Martin, chairman and chief executive officer at Gilead Sciences, said the EC authorisation was “an important step forward in the management of Hepatitis C in Europe, enabling more patients to have the benefit of a cure”.

“We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible,” he added. 

NHS England champions the role of the pharmacy in new campaign

by Admin 20. January 2014 11:38

NHS England is targeting “unnecessary” hospital admissions with a new campaign that urges the public to seek treatment early and highlights the role of the pharmacist in minor care.

An eight week public-awareness campaign entitled ‘The Earlier, The Better’ has been launched by the NHS in a bid to decrease the pressure on A&E and ensure patients understand their health care options, including the role of the community pharmacy.

The campaign – mounted across radio, online and print media – follows the NHS England’s urgent and emergency care review, published in November, that concluded the rise in “unnecessary” admissions could be decelerated by boosting public awareness on alternatives and highlighting the benefits of seeking early treatment.

As part of the public-awareness scheme the NHS will urge members of the public – especially the elderly – to seek treatment as soon as symptoms present to avoid health issues becoming more complex and requiring hospital admission.

Professor Keith Willet, director for acute care at NHS England, said he was “really pleased to see a serious attempt to reach out to the public on this issue.”

“’The message ‘the earlier, the better’ is crucial for our patients.  The NHS has not spent enough time broadcasting that message in the past,” he said.  

The campaign will educate patients on the potential alternatives to A&E or GPs surgeries when seeking advice, including the NHS 111 phone line and the NHS Choices website. A major element of the awareness campaign will be to highlight the role community pharmacies can play in providing medicine, advice and treatment for certain ailments.

Clare Howard, deputy chief pharmaceutical officer at NHS England, stressed the importance of the pharmacist in healthcare and suggested “more people could seek help from their Pharmacist when they first have a problem rather than waiting until it becomes more serious, or having to go to hospital when the problem could have been managed earlier.”

Members of the pharmaceutical industry have welcomed the support for the services offered by pharmacists, with David Branford, chair of the English Pharmacy Board, saying he was “delighted that NHS England has recognised the potential for pharmacy to be part of the solution to the challenges faced by urgent care in the NHS.”

“I see this campaign as the first step in a programme to maximise the use of pharmacists in primary and secondary care to help prioritise patient care,” he added.


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