NICE has issued draft guidance advising against NHS funding for dronedarone (Multaq) to treat atrial fibrillation.

The evidence provided to the independent appraisal committee indicates that dronedarone is less effective and costs considerably more than existing treatments for controlling atrial fibrillation.

Interested parties now have an opportunity to comment on the draft recommendations made by the independent appraisal committee.

Andrew Dillon, Chief Executive of NICE said: “NICE is keen to provide guidance which can help people with atrial fibrillation, but we need to be sure that any treatment we recommend offers real additional benefits for patients – and we need to be confident that those benefits justify the cost to the NHS. In this case, dronedarone costs more, and has not been shown to be more effective, than other treatments for atrial fibrillation.

“The manufacturer’s own data indicated that dronedarone was the least effective of currently used anti-arrhythmic drugs for controlling atrial fibrillation. The drug is much more expensive than existing treatments and the evidence suggests that on balance it offers little additional health benefit.”

The committee also considered information from patients and clinical specialists which indicated that, even though dronedarone doesn’t work as well as existing treatments for atrial fibrillation, it may have fewer side effects so would be welcomed as an alternative option. However, the committee noted that the evidence provided was collected over a relatively short period and it was less certain what the longer-term side effects of dronedarone would be.

“This uncertainty, alongside the drug’s lower effectiveness and higher cost meant that the committee was not able to recommend dronedarone,” Dillon added.

The CHMP has issued a positive opinion for GSK’s Revolade (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

The CHMP has recommended the marketing authorisation of eltrombopag in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, such as corticosteroids and immunoglobulins therapies.

Eltrombopag may also be considered as a second-line treatment for adult patients where surgery to remove their spleen is contraindicated.

“Eltrombopag is an innovative treatment for thrombocytopenia in patients with chronic ITP. This once-a-day tablet is able to stimulate platelet production and reduce the risk of bleeding in a difficult-to-treat disease,” said Paolo Paoletti, SVP and Global Head of Oncology Research and Development, GSK. “Eltrombopag is another example of our continued investment in R&D and our long-term commitment to improving the lives of patients.”

ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.

Eltrombopag is the first oral platelet generator. It stimulates the proliferation and differentiation of megakaryoctes, resulting in an increase in platelet counts.

The positive opinion from CHMP was based on two Phase 3 clinical trials and two open-label studies in adults who have previously received treatment for chronic ITP. The studies showed that the patients treated with eltrombopag (plus the standard of care) experienced significant increases in platelet counts, a reduction in the incidence of bleeding and an improvement in quality of life, compared with those receiving placebo (plus the standard of care).

Orphan designation was granted by the European Commission for eltrombopag for the treatment of ITP on 3 August 2007.

GSK is to join other private sector companies in partnering with the NHS and higher education bodies to provide health education and training.

The new Health Innovation and Education Clusters (HIECs) are cross-sector partnerships between NHS organisations, higher education and private sector companies.

Through joint working, HIECs will provide professional education and training. They aim to promote innovation in healthcare by speeding up the adoption of research.

The 17 initial HIECs have been chosen by an Independent Award Panel from many applicants. The Government is investing over £11m to set up the projects in the next year, and just under £10 million in year 2.

Health Minister Ann Keen said: “HIECs are special partnerships that draw on the wealth of skills and experience of their members to improve the development of high-quality care and services by quickly bringing the benefits of research and innovation directly to patients.

“These projects will attract and encourage the best talent, who can recognise and rapidly adopt new and innovative healthcare and treatment.”

Sir Alan Langlands, Hairman of the Independent Award Panel, said: “The standard of applications has been really high and we have been impressed by the high-profile names that want to be involved in improving NHS care. HIECs will drive up quality standards in education and training and ensure fast adoption of innovation for the benefit of local people.”

The HIEC concept was developed from the recommendation in the NHS Next Stage Review that commissioning and provision of health education and training be separated. The overall responsibility for commissioning education will remain with the SHAs.

The CHMP has issued a recommendation supporting the use of Prolia (denosumab) to treat osteoporosis in postmenopausal women at increased risk of fractures, and men with prostate cancer undergoing hormone ablation therapy.

If the drug is approved by the European Commission, manufacturer Amgen would receive marketing authorisation for Prolia in all EU Member States.

“Nearly two decades ago, Amgen researchers described a fundamental biochemical pathway that controls bone remodelling,” said Roger M. Perlmutter, Executive Vice President of Research and Development at Amgen. “Armed with this information, our scientists identified a targeted therapy that acts via this normal control mechanism to reduce bone loss.

“With its ability to significantly reduce fractures at key skeletal sites throughout the body, a favourable benefit-risk profile, and convenient dosing every six months, Prolia addresses an important unmet medical need.”

The CHMP positive opinion was based on data from six Phase 3 trials that showed Prolia’s ability to increase bone mineral density. Two studies in osteoporosis and prostate cancer demonstrated that Prolia reduced the incidence of fractures when administered as a subcutaneous injection twice-yearly.

The FREEDOM study in 7,868 women with postmenopausal osteoporosis showed that those receiving Prolia experienced a 68% reduction in the risk of suffering a new vertebral (spine) fracture, compared to those receiving placebo. This group also had a 40% reduction in the risk of a hip fracture and a 20% reduction in the risk of a non-vertebral fracture.

The Hormone AbLation Therapy study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed that patients treated with Prolia experienced a 62% reduction in the risk of suffering a new vertebral fracture compared to placebo at 36 months.

Prolia is also under regulatory review in the US, Switzerland, Australia and Canada in a similar indication.

MSD (the UK division of Merck) is to acquire the biologics business of the Avecia group.

Avecia Biologics is a contract manufacturing organisation with specific expertise in microbial-derived biologics, based in the UK.

“At Merck we continue to execute on our strategy of expanding our biopharmaceutical expertise and manufacturing capacity,” said John T. McCubbins, Senior Vice President, Biologics and Therapeutic Protein Operations, Merck Manufacturing Division. “This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems.”

Under the terms of the agreement, Merck will acquire Avecia Biologics Limited and all its assets, including all the company’s process development and scale-up, manufacturing, quality and business support operations located in Billingham, UK.

In addition to honouring all Avecia Biologics’ contractual commitments, Merck has announced that it plans to engage in discussions with individual customers relating to their specific ongoing and future biological process development and manufacturing needs after the transaction is closed.

“Over the past ten years, Avecia Biologics has built and established an enviable reputation for bioprocess development and timely delivery of quality biopharmaceutical ingredients for our customers,” said Steve Bagshaw, President, Avecia Biologics. “This acquisition recognises these successes and now provides the exciting opportunity to focus on advancing Merck’s broad early and mid-stage portfolio of biologic candidates.”

The closing of the transaction is subject to regulatory approval.

The All-Party Parliamentary Thrombosis Group (APPTG) has welcomed the DH’s decision to mandate venous thromboembolism (VTE) prevention in the Operating Framework for the NHS in 2010/11.

The All-Party Group has been campaigning for the inclusion of VTE prevention as a key step in reducing up to 25,000 annual avoidable deaths and saving the NHS over half a billion pounds a year.

The DH announcement follows the publication of the APPTG annual survey of acute Trusts in England. It found that only 41% of Trusts are able to demonstrate that all hospital inpatients are being risk-assessed and are receiving appropriate preventative treatment as recommended by the Chief Medical Officer and NICE.

Crucially, the move to mandate VTE prevention was supported by over three quarters of Trusts – 77% thought this would be the most effective way to drive compliance with VTE prevention policies at the ward level.

The DH decision will apply to all Strategic Health Authorities, which will be able to recoup money paid to hospitals for procedures where patients have not been risk-assessed for VTE.

Professor Beverley Hunt, Medical Director, Lifeblood: The Thrombosis Charity, said:

“Our campaign for reducing deaths from hospital-acquired VTE has always recognised that mandating VTE prevention is critical to ensuring all patients are risk-assessed and given appropriate prophylaxis. We are pleased VTE has finally been given the priority it deserves, and we can now begin to make a real impact in reducing the estimated 25,000 unnecessary deaths that occur from the condition each year.”

Dr Richard Taylor MP, Vice-Chair of the All-Party Parliamentary Thrombosis Group, added: “We are delighted the Government has responded to the growing momentum of the medical profession in its support for mandating VTE prevention. The challenge will now be to ensure that mandatory policies are audited by a meaningful indicator, so that compliance with risk-assessment and thromboprophylaxis policies is measured on a national scale.”

Teva UK has launched generic co-beneldopa (Levodopa/Benserazide) capsules in a variety of strengths.

“We’re delighted to be launching co-beneldopa capsules,” said Kim Innes, Commercial Director, Teva UK Limited. “This product fits well with our range and strengthens our position as the UK’s leading generics supplier. It comes hot on the heels of diamorphine hydrochloride (HCL) powder for injection, oxcarbazepine tablets and topiramate tablets, which were added to our product portfolio during the last quarter.”

Co-beneldopa is a dopaminergic drug indicated for treatment of symptoms of Parkinson’s disease. It is a generic version of Madopar (co-beneldopa), which is manufactured by Roche.

“At the moment over 50% of scripts are written by brand. If all scripts were written and dispensed generically the potential saving to the NHS would be over £341,000 annually,” added Kim Innes.

Teva is one of the UK’s top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid- and liquid-dose injectable and respiratory medicines to healthcare professionals.

A new treatment which could extend the lives of a specific group of cancer patients will be available on the NHS.

In the final draft of guidance published by the National Institute for Health and Clinical Excellence (NICE), the drug, trabectedin is recommended as a treatment for certain patients with advanced soft tissue sarcoma.

NICE reversed its original decision not to recommend the drug after the manufacturer, PharmaMar, agreed to meet the costs of trabectedin if it is needed beyond the fifth cycle of treatment. The independent appraisal committee also applied NICE’s criteria for evaluating life-extending, end of life treatments.

In line with the NICE technology appraisals process this final draft of the guidance is now with consultees who have the opportunity to appeal against the proposed recommendation. Final guidance will be published next year.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We are delighted the Independent Appraisal Committee has been able to recommend trabectedin in its draft guidance. It has certainly not been an easy decision to make; soft tissue sarcoma is a rare cancer and the evidence was limited.

“However, treatment options for this type of cancer are limited and in the last 20 years there have been no major developments to treat the advanced stages of this disease. Being able to recommend trabectedin for use on the NHS represents a step forward in the care of this group of patients who may have very few treatment options left.”

According to this latest draft guidance, NICE recommends the use of trabectedin as a treatment for people with advanced soft tissue sarcoma if treatment with anthracyclines and ifosfamide has failed they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide.

Roger Wilson, Director of Sarcoma UK, said: “I am delighted that trabectedin has been approved. This is the end of a challenging process for sarcoma patients and the doctors who treat them, as well as for NICE. This drug benefits a large proportion of the small number of patients who receive it.

“I have long believed that trabectedin has a significant part to play in the treatment of advanced soft tissue sarcoma. The manufacturer, PharmaMar, deserves praise for its determination to get this drug approved and it must be thanked too for its constructive approach to making the treatment accessible to patients in the UK.”

Soft tissue sarcomas are tumours that develop in the soft, supporting tissue in the body, such as fat, muscle and blood vessels and can occur anywhere in the body. It affects around 2,000 people a year in the UK and it is thought that between 500 and 600 people live with advanced soft tissue sarcoma in England and Wales.

Trabectedin works by damaging the DNA in cancer cells, making them unable to grow and spread. Research shows the drug can extend life by at least three months more than other treatments currently available on the NHS.

The cost of Roche/Chugai’s Avastin, followed by concerns about its efficacy and side-effect profile, are the most common factors preventing oncologists’ use of the drug for non-small-cell lung cancer treatment.

These were the factors most frequently cited by 224 oncologists surveyed in Germany, France, Italy, Spain and the UK, as part of research conducted by Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues.

The new Special European Physician & Payer Forum report entitled Targeted Therapies for NSCLC: How High are the Barriers to Displacing Avastin in Europe? finds that Avastin is used more often for non-small-cell lung cancer in the first and second line in France and Germany than in Italy and Spain. The drug is not recommended for use within the UK’s NHS.

However, over the next 12 months, surveyed oncologists in Italy and Spain expect to increase first-line use of targeted agents such as Avastin, OSI Pharmaceuticals/Roche/Chugai’s Tarceva and AstraZeneca’s Iressa. According to the report, Tarceva is the second-most commonly prescribed targeted therapy in the first line after Avastin.

While Avastin, Tarceva and Iressa have shown modest efficacy in select patient populations, other agents in late-stage development have struggled to reach the non-small-cell lung cancer drug market. Three targeted therapies – Bristol-Myers Squibb/Eli Lilly/Merck KGaA’s Erbitux, AstraZeneca’s Zactima and Pfizer’s figitumumab – experienced recent setbacks in ongoing Phase III clinical trials or in receiving approval from the European Medicines Agency.

“The landscape for non-small-cell lung cancer will shift over the next several years as oncologists and payers grapple with the role of maintenance/consolidation therapy, increasing uptake of targeted therapies in the first-line setting and with the potential launch of new biologic agents,” said Decision Resources Director Madhuri Borde.

NICE has revealed that, due to data uncertainties, it is unable to recommend Alimta (pemetrexed) for the maintenance treatment non-small-cell lung cancer.

The draft guidance has been issued for consultation and the manufacturer, Eli Lilly, now has an opportunity to consider and respond to comments made by the independent Appraisal Committee.

Lung cancer is one of the most common cancers in the UK, with around 38,000 people diagnosed every year. Maintenance treatment after first-line treatment is a new concept in lung cancer care and is not currently practised in the UK.

The goals of maintenance treatment are to prolong the period of remission after first-line chemotherapy and increase the likelihood of being able to receive second-line chemotherapy.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “In September NICE recommended pemetrexed as a first line treatment for non-small-cell lung cancer and we are disappointed not to have been able to recommend the drug as a maintenance treatment as well.

“The committee felt that there were many uncertainties in the data and analysis provided by the manufacturer. These uncertainties led the committee to conclude that, on current evidence, the cost of the drug related to the benefits it brings means that pemetrexed would not be a good use of NHS money.”

NICE’s preliminary recommendations are available for public consultation until 19 January 2010 at http://guidance.nice.org.uk/TA/WaveCRS2/47. Comments received during the consultation will be considered by the Committee and the next draft guidance will be issued after this date.

Until NICE issues final guidance, NHS bodies have been advised to make decisions locally on the funding of treatments under appraisal.