Bronchitol recommended for cystic fibrosis

by IainBate 31. October 2012 10:37

Pharma NICE Update NICE has reversed its original decision on the use of Pharmaxis’ Bronchitol and now backs the use of the mannitol dry powder for treating cystic fibrosis in certain adult patients.

The final draft recommendation states Bronchitol may be used for patients who do not use inhaled standard treatment options, those for whom other osmotic agents are not considered appropriate and those whose lung function is rapidly declining.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the positive recommendation resulted from “helpful responses” during the initial consultation period.

The previous draft guidance concluded that Bronchitol could not be recommended as a treatment option for the NHS because of “gaps and uncertainties in the evidence of its effectiveness,” Professor Longson said. Concerns were also raised about the long-term effect on lung function.

But after analysing the responses during the initial consultation period, NICE’s Appraisal Committee now concludes that the treatment is a “good use of NHS resources”.

The final draft guidance is now with consultees, who have the opportunity to appeal against NICE’s recommendation. Final guidance is expected to be published in November 2012.

OTC medicines are derailing drug regimes

by JoelLane 30. October 2012 17:52

st-johns-wort-tincture-capsules web Widely prescribed drugs including insulin, warfarin and aspirin are less effective in patients who take herbal medicines and dietary supplements.

A systematic review of relevant studies showed that popular OTC products such as St John’s wort and magnesium and calcium supplements interact with many prescribed drugs.

The researchers have recommended that GPs find out and record any OTC medicine use by patients for whom they are prescribing.

The review covered 85 studies of interactions between prescribed medicines and herbal medicines or dietary supplements, finding 882 distinct interactions.

The prescribed drugs with the greatest number of reported interactions were warfarin, insulin, aspirin, digoxin and ticlopidine.

The herbal medicines and supplements with the most interactions were St John’s wort, magnesium, calcium, iron and ginkgo – found to interact with 147, 102, 75, 71 and 51 prescribed drugs respectively.

In 42% of cases, the drug interaction was caused by the OTC product altering the pharmacokinetics of the prescribed drug.

Where the interaction meant an outright contraindication (25% of cases), the most frequent involved treatments for gastrointestinal disorders (16.4%), followed by neurological disorders (14.5%).

Professor Edzard Ernst of the University of Exeter said: “We have to become vigilant and finally agree to monitor this sector adequately. Each individual doctor can contribute to this process by routinely including questions about alternative medicine use.”

Borg set to become European health chief

by IainBate 30. October 2012 15:20

Dr Tonio Borg - web Dr Tonio Borg looks set to take over as European Commissioner for Health and Consumer Affairs following John Dalli’s resignation from the post in mid-October.

The current deputy prime minister and minister of foreign affairs of Malta has been named by the Maltese government as their preferred candidate to fill the vacancy.

Speaking in the Times of Malta, Dr Borg said that “close contact” with European MPs is “crucial for the Commission to produce the best legislation possible for European citizens.”

A representative from Malta must fill the position until 2014 under the presidency of Portugal’s José Manuel Barroso.

Mr Dalli stood down from his position after an anti-fraud inquiry linked him to an attempt to influence tobacco legislation.

The European Union’s anti-fraud office found that a Maltese business attempted to use his contacts with Mr Dalli for financial gain. Mr Dalli categorically rejected the investigation’s findings.

Cell research points to breast cancer drug breakthrough

by JoelLane 29. October 2012 17:49

CRUK logo New research by UK scientists has identified distinct cell types that may be responsible for pre- and post-menopausal breast cancers.

A team at Cancer Research UK’s Cambridge Research Institute (CRI) has determined that the immature ‘progenitor’ cells in mammary glands are of two types, only one of which responds to oestrogen.

The discovery points to the potential for new chemotherapy drugs targeting the oestrogen-positive and oestrogen-negative progenitor cells – which are thought to cause breast cancer in older and younger women respectively.

Progenitor cells, which have the potential for a limited number of cell divisions, are likely ‘roots’ for tumours. The researchers found that some progenitor cells in the human breast have oestrogen receptors while others do not.

The oestrogen-positive progenitor cells survive better in low-oestrogen tissue such as the breast tissue of post-menopausal women, so it may be linked to tumour development in these women.

The oestrogen-negative progenitor cells have a similar genetic makeup to the cells of basal-like tumours – an aggressive form of breast cancer that mostly affects younger women.

Study author Dr John Stingl of the CRI said: “This exciting discovery reveals that mammary glands are much more complicated than scientists initially thought. Uncovering new types of ‘mother’ cells may explain why there are different types of breast cancer, and why young and older women tend to get different types.

“It could also provide new starting points for ways to diagnose and treat the disease in the future.”

Novartis flu vaccines halted in six EU countries

by JoelLane 29. October 2012 16:16

fluad (web) Two Novartis vaccines for seasonal influenza have been temporarily banned in six EU countries due to a suspected quality fault.

Batches of Agrippal and Fluad were reported by the company to contain tiny solid particles due to protein aggregation.

The ban on the two flu vaccines in Italy, France, Germany, Austria, Spain and Switzerland may delay vaccination programmes in some regions, though alternatives are available.

The safety and efficacy of the suspect batches has been affirmed by Novartis, and there is no contrary evidence: the ban is a precautionary measure.

The Italian Medicines Agency (AIFA), which is investigating the suspect batches on behalf of the EU, said the Swiss pharmaceutical company knew of the production fault three months before reporting it.

According to Novartis spokesman Eric Althoff, it was necessary for Novartis to investigate the suspect batches first.

The defect is a harmless by-product of the manufacturing process that does not affect the quality or safety of the vaccines, Althoff said.

Demand for seasonal flu vaccines has increased across the EU due to the increasing numbers of people in high-risk categories, such as the elderly and people with diabetes.

All EU member states will evaluate the potential impact of losing the Novartis vaccines on their seasonal flu vaccination programmes for the autumn.

Bone cancer drug gets NICE backing

by IainBate 29. October 2012 15:52

Pharma NICE Update Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”

Pod cast in lung treatment role

by IainBate 29. October 2012 08:58

Pharma NICE Update NICE has recommended the use of Novartis’ Tobi Podhaler tablets but failed to back Forest Laboratories UK’s Colobreathe tablets for treating cystic fibrosis patients with a pseudomonas lung infection.

The draft guidance recommends a nebulised version of Tobi Podhaler if it is considered appropriate when nebulised Colobreathe is contraindicated, not tolerated or has not produced adequate clinical response.

Tobi Podhaler tablets should also only be prescribed under the terms of an agreed patient access scheme between Novartis and the Department of Health.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Institute was “pleased to recommend” another treatment option for patients.

Cystic fibrosis is one of the UK’s most common life-threatening inherited diseases. It currently affects around 8,000 people – although more than two million people carry the faulty gene.

Sufferers are prone to lung infections by a range of pathogens. The aim of treatment is to clear the respiratory sections to maintain lung function whilst reducing inflammation and bacterial growth. Although there is no cure, treatment includes regular physiotherapy, antibiotics, and inhaled mucolytics through a nebuliser.

Tobi Podhaler is inhaled using a breath activated hand-held device which works by reducing the amount of bacteria in the lungs. NICE’s independent Appraisal Committee concluded the Podhaler was a cheaper and more effective option than a nebulised option.

However, the Committee said the economic analysis for Colobreathe was less effective and less costly than nebulised Tobi Podhaler. Additionally, analysis could not convey that Colobreathe is a cost-effective use of NHS resources.

The draft guidance is now open for consultation. NICE expects to publish final guidance in March 2013.

More GP treatment needed for children’s throat infections

by JoelLane 26. October 2012 16:43

sore throat Too many children are being admitted to hospital with throat infections that could be treated in primary care, according to a new study.

Researchers at Imperial College London found the number of children admitted to hospital with throat infections has increased by 76% over the past decade.

The increase correlates with a 115% increase in children’s short hospital stays (less than two days), and both point to over-reliance on A&E rather than GPs.

Children aged between one and four years showed the highest rates of acute admissions for throat infections.

The researchers did not find any evidence that the infections are more severe and thus demanding of secondary care.

The four-hour waiting time target in A&E is a major reason for the increase in admissions, the report said, with doctors making decisions under time pressure.

Difficulties in GP access were also identified as a factor in driving the use of A&E as a short cut to treatment.

Lead study author Dr Elizabeth Koshy commented: “Our findings relating to short hospital stays suggest that many of the children admitted with acute throat infections could have been effectively managed in the community.

“Our study highlights the need to urgently address the issue of healthcare access, with improved models of integrated care within primary and secondary care, to avoid potentially unnecessary hospital admissions for relatively minor infections.”

Scorecard delayed until end of the year

by IainBate 25. October 2012 17:14

Stephen Whitehead  Chief Executive of ABPI. The end to the ‘postcode lottery’ will have to wait a little longer. Hopes were raised earlier this year when the Department of Health unveiled plans to introduce an ‘innovation scorecard’. The scheme would prevent hospitals blacklisting expensive drugs recommended by NICE. Patients, regardless of their location, would be able to receive the latest treatments without delay.

The DH initially planned to have the scorecard “fully implemented by the Autumn.” But, after discussions with the NHS and the pharmaceutical industry, it now looks likely that the scorecard will not be in place until the end of the year.

Speaking exclusively to Pharmaceutical Field, a DH spokesperson said talks were still ongoing between the health service and pharma to “collect all the data and information needed to ensure the scheme is accurate and effective. It will be launched in the coming months.”

The new scheme is expected to work in three different ways:

  1. The innovation scorecard will allow patients and the public to see which NHS organisations have adopted the latest NICE guidance on recommended drugs and treatments.
  2. The NHS will no longer have an excuse not to provide patients with NICE recommended products. Treatments recommended by the Institute will now be automatically added on to local formularies, allowing doctors to prescribe more expensive treatments if they wish.
  3. A new group will be established to help the NHS overcome any barriers when implementing NICE guidance. The introduction of new medication or treatment may mean big changes in the
    way services are delivered. The group aims to spread best practice across the health service.

The DH added that NHS Trusts receive funding for each new NICE appraisal, so financial issues should not be used as a barrier to the uptake of innovative new treatments.

Speaking when the details were first announced in late August, then Health Minister Paul Burstow said the “new regime” would be a “catalyst for change”. He added that the DH is “determined to eradicate variation” across the uptake of NICE approved drugs. “NHS organisations must make sure the latest NICE approved treatments are available in their area, and if they are not, then they will now be responsible for explaining why not,” he said. “Being transparent with data like this is the hallmark of a 21st century NHS. It is
a fundamental tool to help healthcare professionals improve patient care.”

The introduction of the scorecard has been backed by the ABPI. Stephen Whitehead, ABPI Chief Executive, said it would be a “valuable tool” to support the latest NICE recommendations. “There is still a great deal of variation across the country on which treatments patients are able to access and so I am hopeful the scorecard will help highlight discrepancies which can then be addressed,” he said.

Whitehead called the scorecard a “definite step forward” in ensuring patients receive the latest treatments as quickly as their European counterparts. He said the existing system was bad news for the health of the nation which resulted in a lost opportunity to “drive efficiency savings through the use of medicines”.

The NHS Confederation was equally receptive to the introduction of the scorecard. But former Deputy Chief
Executive David Stout warned its implementation may cause “unnecessary bureaucracy” and stretch NHS finances even further. “It is also important to remember that the NHS is facing an unprecedented financial challenge and organisations must live within their means while providing high quality care,” he said. “The reality is we can only afford to provide new drugs or treatments where they are cost effective and demonstrably add real patient benefits. In a health system with no financial growth, any new costs have to be offset by savings elsewhere.”

Stout added that the introduction of the scorecard will only be a success if the NHS engages with local communities and clinicians to decide what local priorities are.

Innovation rewarded: Janssen, MSD and Takeda scoop top prizes

by IainBate 25. October 2012 16:45

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Prix Galien 1 Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
Prix Galien 2 The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
Prix Galien 3 The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”


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