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.”

Cancer death rates to ‘fall dramatically’

by JoelLane 25. September 2012 15:38

cancer research uk logo (resized) Death rates from cancer in the UK will fall by 17% by 2030, according to a new report from Cancer Research UK.

The biggest improvements will be seen in death rates for ovarian cancer and breast cancer in women, as well as in bowel and prostate cancer.

While a reduction in smoking has impacted on cancer incidence, most of the change is due to improved survival rates due to better diagnosis and treatment.

Overall, it is predicted that the age-adjusted mortality figure for cancer in 2030 will be 142 in every 100,000, compared to 170 in 2010.

Death rates from ovarian cancer are predicted to fall by 43% and female breast cancer by 28%. Strong improvements are also expected for bowel cancer (23%) and prostate cancer in men (16%).

However, the death rate from liver cancer is predicted to rise by 39% and that from oral cancer by 22%, due to a combination of lifestyle factors and increased life expectancy.

Professor Peter Sasieni, epidemiologist at the University of London, said: “For many cancers, adjusting for age, death rates are set to fall dramatically in the coming decades. And what’s really encouraging is that the biggest cancer killers – lung, breast, bowel, and prostate – are part of this falling trend.”

The Department of Health noted that it was aiming “to save 5,000 more lives every year by 2015 - and halve the gap in cancer survival between us and the best-performing countries in Europe”.

The commissioning landscape

by IainBate 30. August 2012 13:00

After April 2013, who will commission which health services?

The Commissioning landscape - Pharmaceutical Field The new NHS structure is designed to promote integrated care by making the roles of a number of different commissioners interlock. The GP-led clinical commissioning groups (CCGs) are the core of the system, responsible for dealing with most areas of patient need in the local community. Around that, however, three other commissioning bodies are engaged with supporting patient health and wellbeing:

  • the NHS Commissioning Board (NHSCB) is responsible for primary care and specialised services
  • local authorities are responsible for improving public health
  • Public Health England (PHE) is responsible for protecting and promoting health though intervention in health and social care services and public awareness.

A map of services

The Commissioning Board Authority’s Commissioning fact sheet for clinical commissioning groups maps the new health landscape by comparing the responsibilities of the four organisations. For each new commissioner, it lists the main functions and the similarities to other commissioners – thereby making the point that service integration is vital for effective care.

The fact sheet states that CCGs will need to work collaboratively with local authorities and the NHSCB – and that to do so, they may pool budgets or have joint commissioning arrangements. For example, it is suggested that responsibility for sexual health and for addiction-related services will need to be divided between the CCG and the local authority to avoid duplications or gaps in provision.

Clearly, the matrix of healthcare is a dynamic one that can be interpreted by local commissioners in a range of ways. The map is not a final one in any case: some details, including the specialised services covered by the NHSCB, are still to be confirmed by Parliament in the autumn.

Community healthcare

The fact sheet compares the responsibilities of CCGs and the NHSCB for commissioning patient care. It notes that local authorities will provide “public health advice” to CCGs, but will not commission at that level. The role of local authorities in commissioning social care is not covered, but is a further dynamic that CCGs will need to be aware of.

The core elements of CCG commissioning relate to: emergency care; out-of-hours primary medical care (where not covered by the GP contract); elective hospital care; community health (such as physiotherapy and continence services, but not health visiting or family nursing); rehabilitation; maternity and newborn care (except where intensive); paediatric care; mental health and learning disability care; and infertility treatment.

The core elements of NHSCB commissioning relate to: primary care through the GP contract; community pharmacy; primary ophthalmic care; all dental care; health services for people in prisons and other custodial institutions; health services for members of the armed forces; and specialised services.

The fact sheet draws out some detailed differences between the two lists in order to avoid confusion – for example, noting that health services for offenders in the community are covered by CCGs. Sometimes, as where the GP contract varies, certain services may be commissioned by the CCG in some localities and by the NHSCB in others. None the less, overall there is a clear division of responsibilities.

Public health services

With the commissioning of public health services, the picture is significantly more complex. Responsibility is divided between the NHSCB, the local authority and Public Health England. In some cases – notably immunisation programmes – these services can relate to provision of medication. In other cases – notably epidemic preparedness – they can relate significantly to medicines management and other aspects of primary and secondary NHS care.

Public health services to be commissioned by the NHSCB include services for children from pregnancy to age 5. This responsibility will transfer to local authorities in 2015. It covers health visiting, family nurse partnership and responsibility for child health data. The NHSCB will also be responsible for immunisation and national screening programmes – both being areas of increasing NHS spend, as evidenced by recent investment in cervical cancer and prostate cancer screening and in vaccines against HPV and influenza. With hepatitis C vaccines on the market and HIV vaccines a real prospect, this area of medication will become increasingly crucial for the NHS.

Local authorities will be responsible for providing or commissioning a wide range of public health services that relate mostly to preventative measures and raising awareness, including: children’s public health for ages 5 to 19; sexual health; public mental health; obesity management; drugs, alcohol and smoking services; dental public health; and seasonal mortality. Active medical intervention, including medication, features strongly in the sexual health and drug, alcohol and smoking services to be provided; the transfer of sexual health services from NHS to local authority control is a major change in the provision of UK healthcare. Notably, however, HIV treatment will be commissioned by the NHSCB.

PHE is taking over the functions of the Health Protection Agency and will impact significantly on the health protection activities of CCGs, the NHSCB and local authorities. Sometimes all relevant health stakeholders will work together – for example, PHE has a strategic role in influenza and other epidemic preparedness, to which local authorities, CCGs and the NHSCB will contribute. PHE’s role also covers behaviour change campaigns around early diagnosis and other issues; public oversight of infection prevention and control; and general intelligence on health protection and improvement, including the current functions of the Cancer Registries. These initiatives will also impact on GP services.

Joined-up care

CCGs will be the glue in the new healthcare commissioning system: the first port of call when gaps or inequalities in service provision arise. While they cannot commission GP care, their close professional connection to it should ensure that what impacts on CCGs will be taken to heart by GPs. But given that austerity measures will dominate the NHS for the “foreseeable future” (in David Nicholson’s words), it is inevitable that funding and staffing shortages will create holes in the patchwork of the new health system. The pharmaceutical industry will thus need to be alert to partnership opportunities opening up at local and national levels.

SMC approves restricted use of prostate cancer drug

by IainBate 14. August 2012 14:35

SMC approves restricted use of prostate cancer drug - Pharamceutical Field The Scottish Medicines Consortium (SMC) has approved the restricted use of Janssen’s prostate cancer drug Zytiga (abiraterone acetate).

The treatment has been recommended as a treatment option for men with metastatic castration resistant prostate cancer who have received only one prior chemotherapy regimen.

Zytiga – which was discovered in the UK – has been shown to prolong the life of some patients by nearly five months when compared with placebo plus low dose prednisolone in clinical trials.

Martin Price, External Affairs Director at Janssen UK, said the pharmaceutical company had gone to “significant lengths” to find a solution that allows patients to be treated with the drug.

Annually there are more than 40,000 men diagnosed with prostate cancer in the UK. More than 10,000 men die of the disease – making prostate cancer the second most common cause of cancer deaths.

Dr Rob Jones, Senior Lecturer and Hon Consultant in Medical Oncology, Beatson West of Scotland Cancer Centre, called the decision to approve the restricted use of Zytiga “very good news”.

The treatment was approved for use in the NHS in England when NICE reversed its original recommendation back in June after Janssen had agreed a Patient Access Scheme with the DH.

NICE reverses decision on prostate cancer treatment

by IainBate 27. June 2012 12:13

NICE reverses decision on prostate cancer treatment - Pharmaceutical Field NICE’s decision to recommend the use of Zytiga (abiraterone) in final guidance to treat prostate cancer has left Janssen “delighted”.

The treatment originally failed to get backing from NICE in combination with prednisone or prednisolone after the Institute deemed it to be too expensive – despite its clinical benefits.

However, after Janssen provided additional patient data and a revised Patient Access Scheme (PAS), NICE said it was happy to recommend the treatment as an option for the NHS.

Martin Price, External Affairs Director, Janssen UK, said the company had gone to “significant lengths” to find a solution that allows patients to be treated with the “innovative, UK discovered medicine, routinely on the NHS”.

The decision to recommend the treatment has also been backed by Dr Heather Payne, Consultant Clinical Oncologist, University College London Hospitals. She commented: “This is good news for patients – for whom historically there have been few treatment options available – and also for the patients’ families.”

Zytiga may potentially extend the lives of patients by more than three months. It is now recommended in combination with prednisone or prednisolone as a treatment option for castration-resistant metastatic prostate cancer that has progressed on or after one docetaxel-containing therapy.

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.

Campaigners welcome Zytiga decision

by IainBate 16. May 2012 11:54

Pharma NICE Update NICE’s decision to recommend Janssen’s prostate cancer drug Zytiga (abiraterone) has been backed by patient groups.

Zytiga is now recommended in new draft guidance after further patient data and a revised Patient Access Scheme (PAS) convinced NICE to reconsider its previous rejection of the drug.

Dr Harpal Kumar, CEO of Cancer Research UK, said the decision is “wonderful news for patients” and believes the U-turn reflects “the public’s disappointment at the initial refusal”.

In February this year, NICE failed to recommend the treatment in combination with prednisone or prednisolone after deeming it to be too expensive – despite its clinical benefits.

At the time of the decision, Janssen said it would work closely with NICE to gain a positive recommendation. That included supplying a revised PAS and additional data on a subgroup of patients who may receive the most benefit from the cancer drug.

Janssen also submitted further information on the number of patients for whom Zytiga is licensed, enabling it to be considered under NICE’s end of life criteria.

Professor Johann de Bono from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, who led the pivotal trials of Zytiga, said he was “thrilled” the revised data has changed NICE’s original decision.

“Abiraterone acetate is one of only a handful of life-extending drugs for these men in the UK and, importantly, it can also improve quality of life,” he said. “Some of my patients have been taking abiraterone for several years through a clinical trial and are still pain free.”

Prostate cancer is the second most common cause of cancer deaths in UK men. More than 10,000 men die each year with a further 40,000 men diagnosed annually.

Jevtana too expensive for NICE

by IainBate 11. May 2012 11:38

Pharma NICE Update NICE has failed to recommend the use of Sanofi’s Jevtana (cabazitaxel) in final guidance in combination with prednisone or prednisolone as a second line treatment for prostate cancer.

Concerns were raised by NICE’s Appraisal Committee over the cost of the treatment and its side-effects, including haematological adverse events and diarrhoea.

Sir Andrew Dillon, Chief Executive of NICE, said the Committee queried the “nature of the health-related quality of life information” provided by Sanofi.

Sanofi had appealed the decision not to recommend the treatment however, this was dismissed on all points.

NICE recognised that Jevtana resulted in a mean improvement of greater than three months in mean overall survival. But the Committee considered that its cost per QALY gained would exceed £87,500 – considerably higher than the most expensive treatment it has recommended at £50,000.

Additionally, the numerous side-effects, such as fatigue, nausea, vomiting and constipation, associated with Jevtana raised concerns with the Appraisal Committee.

“We need to be sure that new treatments provide sufficient benefits to patients to justify the significant resources the NHS would need to make available,” said Sir Andrew.

“Although cabazitaxel can extend life for some patients, its price remains well above what the independent Committee appraising this drug considered acceptable, given the benefits it offers.”

J&J vice-chair quits pharma for Avon

by JoelLane 10. April 2012 13:02

McCoy resized Sherilyn McCoy, vice-chairwoman of Johnson & Johnson’s pharmaceuticals division, has quit pharma to become CEO of cosmetics giant Avon.

McCoy, who has been with J&J for 30 years, was considered a leading contender for the CEO role in February but was passed over in favour of Alex Gorsky.

The pharma industry veteran will need to turn Avon around: the iconic brand has been dogged by falling profits and a bribery investigation, and recently turned down a $10bn buyout offer from fragrance company Coty.

Fred Hassan, Avon’s lead director, said: “The board conducted an extensive search among many world-class candidates, and Sheri emerged as the clear choice to take Avon into the future.”

He praised McCoy’s “strategic and finely honed operational skills, significant turnaround track record, global experience and people leadership” as well as her “consistent record of outperforming against new challenges”.

At J&J, McCoy rose through various executive roles over 27 years to become chairwoman of the pharmaceuticals division in 2009, successfully focusing it on new products in areas of unmet medical need (including stroke prevention and prostate cancer) to see it through the patent expiry of several key products.

Though widely tipped to replace Bill Weldon as CEO this year, McCoy lost out to Alex Gorsky, vice-chairman of J&J’s executive committee.

“I am extremely honored and excited to join Avon – a great company with an iconic brand and so much clear potential,” said McCoy. “I look forward to working with the team to develop and execute a roadmap to achieve the next phase of growth for the company.”

McCoy replaces Andrea Jung, the longest-serving female executive of a Fortune 500 company, who commented: “We are thrilled to have someone of Sheri’s caliber assuming the leadership of Avon.”

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