NICE has decided not to recommend Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) for kidney cancer.

Although NICE acknowledged that the drugs extend life by up to six months, it found that their benefits are too limited against the cost, in spite of offers from manufacturers Roche, Bayer and Wyeth to considerably cut prices for NHS patients.

The institute also rejected Pfizer’s Sutent (sunitinib) as a second line treatment, despite approving it as a first line treatment earlier in the year.

Professor Peter Littlejohns, Clinical and Public Health Director, said: “We are very aware that renal cancer is a devastating disease for the individual and their family. We recommended the use of sunitinib for first line renal cancer in March 2009, so one of these new treatments is now available.

“The evidence to support the use of the other first and second line treatments isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas. Our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost.”

The appeal against the decision from Roche, Wyeth Pharmaceuticals, James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support have not been upheld.

John Melville, General Manager of Roche UK, has called the decision “illogical” and claimed that the drug was turned down only because it is used in the treatment of other conditions. “This guidance goes against the spirit of end of life criteria,” Melville said.

NICE has issued final guidance recommending Erbitux (cetuximab) as a first line treatment for metastatic colorectal cancer (mCRC).

The guidance recommends cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and oxaliplatin (FOLFOX) within its licensed indication, but only when the primary colorectal tumour has been resected or is potentially operable, the metastatic disease is confined to the liver and is unresectable, and the patient is fit enough to undergo surgery if necessary.

Another condition of the recommendation is that the manufacturer, Merck Serono, will rebate 16% of the cost of cetuximab used on a per patient basis.

The drug is also recommended for use in a similar indication where the oxaliplatin is replaced with irinotecan (FOLFIRI) for patients who are unable to tolerate the former.

For those patients who meet the above criteria, NICE suggests that they should receive treatment with cetuximab for no more than 16 weeks, when the patient should be assessed for resection of liver metastases.

The guidance also specifies that patients with metastatic disease confined to the liver who receive cetuximab should have their treatment managed only by multidisciplinary teams that involve highly specialised liver surgical services.

Professor Peter Littlejohns, Clinical and Public Health Director, said: “Before making these recommendations the Appraisal Committee considered the manufacturer’s cost-effectiveness estimates and the proposed 16% rebate scheme, as well as the evidence on cetuximab successfully shrinking liver metastases enough so that they can be removed via surgery.

“The Committee concluded that under the specific circumstances outlined in the guidance the cost of cetuximab in relation to how well it works is an effective use of NHS resources. This guidance means that those patients who meet these criteria will have a further treatment option.”

The European Commission has approved Wyeth’s mTOR (mammalian target of rapamycin) inhibitor Torisel (temsirolimus) for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).

In the EU, Torisel is also indicated for the first line treatment of patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors.

“With this approval, Torisel will now be available to benefit patients with relapsed or refractory mantle cell lymphoma, for which there are few treatment options,” said Mikael Dolsten, President, Wyeth Research. “Wyeth is committed to providing much-needed medicines to patients with rare and difficult-to-treat diseases.”

MCL is a rare type of non-Hodgkin’s lymphoma (NHL) that accounts for approximately 6 per cent of NHL cases and has the lowest five-year survival of any type of lymphoma. Torisel received Orphan Medicinal Product designation for the treatment of MCL in the EU in November 2006.

The approval was based on the results of a phase III clinical study that showed patients with relapsed and/or refractory MCL treated with Torisel experienced a statistically significant improvement in median progression-free survival, compared with single-agent therapy selected by the investigator (4.8 months vs. 1.9 months).

“Relapsed and refractory mantle cell lymphoma is a difficult-to-treat disease, and the ability of Torisel to improve progression-free survival makes it an important new therapeutic option for patients living with this condition,” said Georg Hess, MD, Johannes Gutenberg-Universitat, Mainz, Germany, an investigator in the Torisel phase III clinical programme.

The National Institute for Health and Clinical Excellence (NICE) has recommended Toctino (alitretinoin) from Basilea as a cost-effective treatment option for adults with severe chronic hand eczema that has not responded to potent steroid creams.

Alitretinoin, a once-daily capsule, is the first licensed treatment for people with this condition and the only treatment proven in trials to be effective and well tolerated.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, said: “Eczema can have a huge impact on an individual, with the condition causing significant discomfort and in severe cases it can be painful. Scaling, blisters, redness and cracks in the skin are all common symptoms. Severe chronic hand eczema can affect a person’s ability to use their hands, as well as potentially impacting on work and social aspects of their lives.

“This new guidance recommending alitretinoin will offer hope to adults whose severe chronic hand eczema hasn’t been helped by strong topical corticosteroids.”

In the largest-ever Phase III clinical trial programme in chronic hand eczema, alitretinoin was the first treatment able to show effective clearing of severe chronic hand eczema unresponsive to potent topical corticosteroids, with clear or almost clear hands achieved in nearly 50% of patients treated with 30mg alitretinoin.

“The National Eczema Society welcomes the decision from NICE to recommend the use of alitretinoin for people with chronic hand eczema, which is a complex and difficult condition to treat,” said Margaret Cox, Chief Executive of the National Eczema Society. “People who have chronic hand eczema are severely disadvantaged since they are unable to use their hands normally. This may force people to take sick leave and even to give up their jobs completely in addition to restricting normal household and leisure activities.”

The NICE guidance also recommends that only dermatologists, or physicians with experience in both managing severe chronic hand eczema and the use of systemic retinoids, should start and monitor treatment with alitretinoin.

The EC has approved Xolair (omalizumab) in patients aged six to eleven years, providing a new treatment approach to nearly 35,000 children in the EU with uncontrolled severe persistent allergic asthma.

Asthma is estimated to affect 10% of children in Europe. It is also the most common cause of school absenteeism, and often leads to the need for oral corticosteroid use in children. Despite conventional therapy, severe asthma remains uncontrolled in more than 50% of children with the condition.

“When a chronic and serious disease like asthma affects children, it can have life-changing and even life-threatening consequences,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. “This EC approval of Xolair offers young asthma patients new hope against this disease, in line with the Novartis commitment to develop innovative respiratory health solutions that meet patients’ and physicians’ needs.”

The EC approval was based in part on a study presented at the European Respiratory Society Annual Congress in 2008. The study showed that Xolair reduced asthma attacks by 34% after 24 weeks of treatment and provided an overall reduction of 50% at one year in patients aged six to eleven years.

In another study, Xolair, when used in children aged six to eleven, was shown to significantly reduce the need for oral corticosteroids. Children taking Xolair also missed 46% fewer school days.

By targeting an antibody involved in the underlying mechanism of allergic asthma, Xolair can prevent the onset of debilitating symptoms such as shortness of breath and wheezing in severely affected patients.

Xolair was approved as an add-on therapy in the EU in 2005 for patients aged twelve and older with severe persistent allergic asthma.

MPs expect the private sector to play a greater role in healthcare provision in the future, a recent poll has shown.

The survey also revealed that younger and Conservative MPs are more likely to support a greater role for the private sector.

The poll of 150 MPs, conducted by Comres on behalf of BMI Healthcare, was commissioned to improve understanding of what MPs think about the future of healthcare in the UK.

Andrew Hawkins, Chief Executive of Comres, said: “The results help progress what, in the run-up to an election, is an important debate about the future of health provision in the UK. I do not believe there are many in the private healthcare sector that would support a switch to the US model. The UK already has a growing partnership between the public and the private healthcare sectors and we are pleased that so many MPs take a pragmatic view about how such a partnership can be further developed and how it can be used to meet the health needs of an increasingly ageing population.”

The poll showed that, of those surveyed, 72% of MPs born before 1950 believed that the current NHS model is sustainable for the next 60 years, but only 42% of MPs born after 1960 agreed.

There was also a regional split of views on this issue – 82% of MPs from the North believed the NHS is sustainable against 52% in the South.

Regarding NHS use of private hospitals, 77% of Conservatives, 47% of Labour and 55% of Lib Dem MPs agreed that if it reduced waiting times, the NHS should fund patients’ treatment through private providers.

A majority of Conservative MPs also supported the running of NHS hospitals by private providers where minimum standards of care are not met; co-payment, whereby patients will pay for part of their care privately; and income tax relief on private healthcare fees. In contrast, few Lib Dem and Labour MPs were in favour of these.

Mr Fawcett added: “In my view, the private sector is not advocating a root and branch reconstruction of health provision in this country, rather measures to widen patient choice and improve patient services and outcomes as part of a closer public-private partnership.”

General Healthcare Group is the parent company of BMI Healthcare, a private healthcare provider with acute care private patient hospitals and outpatient centres in 65 locations around the country and over 2,900 beds.

Parents and healthcare workers may refuse the H1N1 vaccine for themselves or their children due to fears about the risks of a novel vaccine.

The findings of a study published in Emerging Health Threats Journal have indicated that people are concerned that the risks of using a new vaccine may outweigh the benefits.

Researchers Natalie Henrich of the University of British Columbia and Bev Holmes of Simon Fraser University, Vancouver, Canada, conducted 11 focus groups in Vancouver in 2006 and 2007, before the onset of the current H1N1 pandemic. Participants were asked how willing they would be to accept a new vaccine in the event of a pandemic.

“Acceptance of novel vaccines during health crises is influenced by perceptions of a range of risks, including risk of infection, risk of becoming severely ill or dying if infected, and risk of serious side- and long-term effects of the vaccine,” said the report.

The focus groups were conducted to explore how people assess these risks and how these assessments relate to willingness to use novel vaccines in a pandemic.

The study found that “participants were hesitant to use the novel vaccines because of a low perception of risk of infection early in a pandemic coupled with the many uncertainties that surround new vaccines and the emerging infectious disease, and concern that unsafe pharmaceuticals may be rushed to market during the health crisis.”

The researchers believe that understanding people’s perceptions of the risks and willingness to use novel vaccines during a pandemic can help officials to promote disease control measures in ways that improve the likelihood of acceptance by the public and may increase uptake of an H1N1 vaccine.

The Department of Health (DH) plans to conduct a full, formal consultation on the arrangements for the implementation of Automatic Generic Substitution this Autumn.

This will be welcome news to many who have serious concerns about the clinical implications that compulsory generic substitution would have for patients.

The decision follows representations made by patients, healthcare professionals and pharmaceutical companies opposed on several grounds to the ABPI’s proposal, initially rejected but subsequently accepted by the DH, to introduce Automatic Generic Substitution in January 2010.

The intention to conduct a formal consultation will be welcomed by many stakeholders who have petitioned the DH to go public on the proposal to ensure that the practical impact of generic substitution on patient outcomes, as well as safety, concordance and the NHS medicines bill, is considered.

Earlier this year, the paper Automatic generic substitution: Clinical implications for patients highlighted the need for public consultation. The paper was written and endorsed by a multidisciplinary group of healthcare professionals and patient groups, while pharma manufacturer Norgine provided funding for the group.

In addition, a growing number of parties have signed a petition calling for public consultation, hosted at http://petitions.number10.gov.uk/genericsubst/.

Norgine’s COO, Peter Martin, said: “It is vital that all stakeholders continue to raise issues with the DH to ensure that all angles are covered in the proposed formal consultation. We will continue to work with industry partners, healthcare professionals, professional bodies and patient groups to ensure that all voices are heard. We want to ensure the best outcomes for the patients and for the taxpayer.

“It is hoped that these open discussions, focusing on the key area of patient safety, will prevent the proposal of Automatic Generic Substitution from being implemented in the UK.”

Warner Chilcott plc has agreed to purchase Procter and Gamble’s global pharmaceuticals business for an up-front cash payment of $3.1 billion.

Under the terms of the agreement, specialty pharmaceuticals company Warner Chilcott will acquire P&G’s portfolio of branded pharmaceutical products, including Asacol HD (mesalamine) Delayed-Release Tablets for ulcerative colitis, Actonel (risedronate sodium) for osteoporosis, and the co-promotion rights to Enablex (darifenacin) for the treatment of overactive bladder.

P&G’s prescription drug product pipeline and manufacturing facilities in Puerto Rico and Germany are also included in the deal. In addition, the majority of the 2,300 employees working on P&G’s pharmaceuticals business are expected to transfer to Warner Chilcott.

“The acquisition of the P&G pharmaceutical brands and employee talent is a transformational, strategic move for us,” said Roger Boissonneault, President and Chief Executive Officer of Warner Chilcott. “The acquisition transforms Warner Chilcott into a global pharmaceutical company, expands our presence in women’s healthcare, establishes us in the urology market in advance of the anticipated launch of our erectile dysfunction treatments, and adds gastroenterology therapies to our product portfolio.”

Bob McDonald, President and Chief Executive Officer of Procter & Gamble, extended special thanks to P&G’s pharmaceuticals employees. “These men and women have built a large and profitable global business which has improved millions of lives,” he said. “Their welfare was a key consideration in the choice of a buyer. We are deeply grateful to them and are glad they’ll be able to continue this work as part of another great company.”

Both companies expect the transaction to close by the end of the 2009 calendar year, pending necessary regulatory approvals.

Pharmacists have warned that patients are suffering due to ongoing stock shortages of over 50 branded medicines.

A third of pharmacies surveyed by Chemist and Druggist magazine said that stock issues are now beginning to affect patients directly.

Almost 90% of pharmacies polled said that they were “very concerned” by the shortage of medicines. Cases were reported of patients whose condition deteriorated while were waiting for their prescription – one patient needing admission to hospital.

Jeremy Holmes, Chief Executive of the Royal Pharmaceutical Society of Great Britain, said: “The current supply chain relies on medicines being available within 24 to 48 hours. When this doesn’t happen it causes stress and anxiety to those affected – and it is the patients who suffer most.”

The ABPI has also called attention to the problem. The Association has published figures from IMS Health which show that there is adequate supply of the drugs that are apparently suffering a shortfall, but these are not reaching pharmacies.

The issues have been caused by parallel exporting, which is where drugs are bought in the UK but sold abroad for a profit, resulting in a shortage for UK patients. Research by IMS Health has suggested that 11% of UK pharmacies are exploiting the system in this way.

An ABPI spokesperson said: “The UK pharmaceutical industry is committed to maintaining a reliable supply of medicines, and the ABPI is working with the Department of Health, the pharmacy professional and trade bodies, the British Association of Pharmaceutical Wholesalers and others, in order to find a sustainable solution.”