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.”

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.”

NICE continues to back bone metastases drug

by IainBate 17. August 2012 14:35

Pharma NICE Update NICE has again backed Amgen’s Xgeva (denosumab) as a treatment option for patients with bone metastases from the majority of solid cancer tumours.

The final draft guidance recommends the treatment after NICE produced a review of available evidence and two separate stages of public consultation.

It continues to recommend Xgeva for the prevention of skeletal-related events in:

· people with bone metastases from breast cancer, and

· people with bone metastases from solid tumours who would otherwise be prescribed bisphosphonates.

The guidance also states that Xgeva must only be prescribed under the terms agreed in a Patient Access Scheme between Amgen and the DH.

Bone metastases occur when cancer spreads from its original tumour to the bone. This can lead to bones losing their strength and ultimately lead to skeletal-related events.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the condition “can severely affect a person’s quality of life” and stop individuals from completing everyday tasks.

NICE has now given consultees another opportunity to request a factual change to the draft guidance or lodge an appeal against its recommendation. If no appeals are received, final guidance will be issued later this year.

NICE launches second consultation on Xgeva

by IainBate 12. June 2012 14:24

Pharma NICE Update NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE launches second consultation on Xgeva

by IainBate 12. June 2012 14:24

Pharma NICE Update NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE recommends bone cancer treatment

by IainBate 30. March 2012 14:14

Pharma NICE Update NICE has recommended the use of Xgeva (denosumab) in draft guidance for certain cancer patients whose disease has spread to their bones.

The recommendation covers patients with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the condition can have a “major impact on quality of life” and is therefore “pleased” to recommend the treatment.

The guidance stipulates that Xgeva should only be prescribed under the terms of an agreed Patient Access Scheme between Amgen and the DH.

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

The spine, pelvis, hip, upper leg bones and skull are most commonly affected by bone metastases with symptoms including pain, and weakening and eventual destruction of the bone.

The majority of patients with the condition are currently treated with bisphosphonates. NICE’s independent Appraisal Committee considered Xgeva as an alternative to standard treatment options where bisphosphonates are not used.

It noted that in clinical trials where Xgeva was directly compared to standard treatment options it improved skeletal-related outcomes. It was also shown to be more clinically effective in patients with breast, prostate and non-small cell lung cancer.

The initial recommendation is now open for consultation.

EC approves Xgeva

by iain 18. July 2011 12:03

The European Commission (EC) has granted a marketing authorisation for Xgeva (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumours.

The decision is based on three Phase III trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs.

Willard Dere, Senior Vice President and International Chief Medical Officer at Amgen, says the injection “promises to make a real difference” to cancer patients.

Xgeva was also granted an additional year of data and market exclusivity since the indication was considered new, and based on the significant clinical benefits when compared with existing therapies.

The SRE clinical trials spanned more than 50 types of tumour in excess of 5,700 patients. The trials demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid.

“Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today's approval of XGEVA marks a real advance,” said Professor Ingo Diel, Institute for Gynecological Oncology, SPGO, Mannheim, Germany.

“In clinical trials XGEVA demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer.”

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European Xgeva application approved

by diana 24. May 2011 13:51

The CHMP has given a positive opinion for the marketing authorisation of Xgeva (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases.

The decision is based on three Phase III trials that demonstrated Xgeva provided a clinically meaningful improvement in preventing SREs compared to Zometa (zoledronic acid).

Willard Dere, Senior Vice President and International Chief Medical Officer, Amgen, says the treatment has the “potential to make a meaningful difference” for cancer patients.

Bone metastases occur in more than 1.5 million patients with cancer worldwide with approximately 50-70% of those experiencing debilitating SREs.

If approved by the European Commission, Amgen would receive a marketing authorisation in all EU Member States. The Committee also recommended granting Xgeva an additional year of data and market exclusivity in Member States, since the indication was considered significantly new, and based on the significant clinical benefit of the product when compared with existing therapies.

Xgeva is currently approved in the US for the prevention of SREs in patients with bone metastases from solid tumours.

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