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Amgen fails to provide Prolia data

Wednesday, July 28th, 2010

NICE has closed an appraisal of Amgen’s Prolia (denosumab) due to a lack of information about the drug’s cost effectiveness.

The appraisal into whether Prolia is a suitable treatment for therapy-induced bone loss in patients with non-metastatic prostate cancer was terminated after manufacturer Amgen declined to provide any clinical or cost effectiveness data.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “When an appraisal is terminated, we issue advice to the NHS stating that ‘NICE is unable to recommend the use of the technology’. This advice sets out an explanation provided by the manufacturer as to why they did not submit evidence and will offer advice on what to do next. NHS organisations should take into account the reasons why no evidence of denosumab’s clinical and cost-effectiveness was submitted when considering their local use of the drug.”

“Of course, if the manufacturer decides to submit the evidence in the future, NICE will then take the opportunity to review our advice to the NHS,” she added.

Another NICE appraisal of Prolia, evaluating the drug as a treatment for therapy-induced bone loss in non-metastatic breast cancer, has been removed from the Institute’s work programme, because the drug has not received a separate marketing authorisation for this indication.

NICE issued draft guidance last month recommending Prolia as a treatment for the prevention of osteoporotic fractures in post-menopausal women, and is also currently assessing the drug for bone metastases treatment in cancer.

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MabThera gets NICE recommendation

Wednesday, July 28th, 2010

A treatment for the most common form of leukaemia in the UK has been recommended by NICE.

MabThera (rituximab) will now be available in combination with chemotherapy drugs fludarabine and cyclophosphamide for the treatment of relapsed or refractory chronic lymphocytic leukaemia.

Following an appeal earlier this year, MabThera can also be used by patients who have previously used the drug during a clinical trial, or in combination with other chemotherapy drugs in trials, at a lower dose.

Despite the recommendation, NICE confirmed it will continue to research MabThera.

“We want to ensure rituximab is routinely available in the NHS for those patients who may benefit most from it, including those who had already been treated with the drug during a clinical trial but at a lower dose than usual or in combination with other chemotherapy regimens,” said Clinical and Public Health Director at NICE Professor Peter Littlejohns.

“Where rituximab has been recommended in the context of research, this is because of a lack of evidence relating to the treatment’s efficacy in those instances. Hopefully, there will be more research in these areas to help NICE develop firmer recommendations when this guidance is updated.”

Approximately 2,400 people are diagnosed with chronic lymphocytic leukaemia in the UK each year.

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NICE backs cancer treatments

Wednesday, July 28th, 2010

NICE has recommended two new convenient cancer treatments in their final guidance.

Roche’s Xeloda (Capecitabine) has been recommended in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Iressa (gefitinib) has also been given the go-ahead for first-line treatment of locally advanced or metastatic non-small-cell lung cancer.

NICE said that Iressa, which has been proposed as a patient access scheme by AstraZeneca, offers patients added convenience in its oral form. It also noted the Xeloda tablet would allow patients less time in hospitals connected to infusion pumps.

Health Technology Evaluation Centre Director Dr. Carole Longson hoped the new treatments would help the thousands of people suffering from the conditions in the UK each year.

“Non-small-cell lung cancer and gastric cancer can both be devastating conditions, with gastric cancer affecting approximately 8,200 people in the UK every year and non-small-cell lung cancer approximately 38,000,” she said. “We are very pleased to be able to recommend both capecitabine and gefitinib for use on the NHS.”

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Cancer fund ‘could save hundreds of lives’

Tuesday, July 27th, 2010

An extra £50 million is to be made available to help patients access innovative new cancer drugs, the Government has revealed.

This fund, due from October, precedes the promised Cancer Drugs Fund due to commence in April next year. Doctors will be put in charge of deciding how the funding is spent based on the advice of cancer specialists.

The announcement coincides with the publication of a report by National Cancer Director Professor Sir Mike Richards, which shows the UK’s uptake of new drugs falls behind other European countries.

Minister for Universities and Science David Willetts said: “The UK is a world leader in researching and developing innovative medicines to improve health and save lives. The swift uptake of new treatments within the NHS is vital so patients can benefit, and I welcome Professor Richards’ recommendation that we need to do more to achieve this.

“Sustaining the rapid adoption of new advances is also important to promote research and development by the life sciences industry. Through the Office for Life Sciences, my department is committed to working with the Department of Health to ensure that the changes we are making to the NHS deliver both health and economic benefits.”

While the research showed good provision of drugs such as statins in the UK, the country had a low ranking for access to drugs for dementia, multiple sclerosis and newer cancer drugs. However, many of these cancer drugs have not been approved by NICE.

Andrew Dillon, Chief Executive of NICE, told the BBC: “There will always be exceptions to our recommendations which are justified on clinical grounds. A national fund to meet the cost of these exceptional cases, administered in a consistent way, complements NICE guidance and we are happy to work with the new arrangements.”

Patient groups have also welcomed the new fund. Nick Turkentine, Chief Operating Officer for the James Whale Fund for Kidney Cancer, said: “For the past four years we have been pleading in front of juries of PCT administrators to allow patients to have proven, innovative cancer drugs that clinicians want to prescribe. Today’s accelerated plans to pay for an emergency drug fund could save hundreds of lives as long as these clinically led regional panels do not hold up proceedings.”

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NICE to review guidance on Vidaza for MDS

Tuesday, July 27th, 2010

NICE has promised to re-appraise the use of Vidaza (azacitidine) in patients with higher-risk myelodysplastic syndrome (MDS) – a group of debilitating bone marrow diseases.

The decision has come following months of campaigning on the part of MDS charities and patient groups.

The NICE appeal panel has requested that the appraisal committee reconsider the guidance it originally issued on azacitidine, taking account of low-dose chemotherapy as well as best supportive care as comparisons for cost-effectiveness. The committee will also examine data on quality of life provided by the MDS UK Patient Support Group.

David Hall, Chairman of the MDS UK Patient Support Group, said: “We welcome this decision by NICE to re-appraise azacitidine and believe it has been brought about by the weight of patient, expert and clinical opinion behind the arguments put to the appeal panel. We only wish that the appraisal committee had considered these points in its initial appraisal and made this life-extending therapy available to patients from early this year. Instead patients are still waiting to see if they will be thrown a lifeline.”

NICE recommended that azacitidine should not be provided through the NHS on cost-effectiveness grounds in March 2010, but said that it recognised the drug was clinically effective and that it should be seen as a life-extending end-of-life treatment. In June the decision was appealed by eight organisations, including three patient groups and four healthcare professional bodies.

MDS which can lead to complications such as recurrent or life-threatening infections or bleeding and can progress to acute myelogenous leukemia (AML), which has an average survival period of a few months only.

Azacitidine is the only licensed medicine proven to prolong survival for people with higher risk MDS and has been shown to improve patients’ quality of life substantially, reduce dependence on blood transfusions and is less toxic than chemotherapy.

The NICE announcement coincided with the launch of a Government cancer treatments fund of £50 million to be available to patients until the full promised £200 million fund comes into effect from April 2011.

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US GSK rep bonuses to be decided by customers

Tuesday, July 27th, 2010

Customer feedback will play a central role in deciding the bonuses that sales representatives working at GSK’s US subsidiary will receive, as part of a new scheme to be implemented from 2011 onwards.

The company is implementing a compensation system that will rely on the customer service provided by the sales professional, as well as adherence to the company’s values of transparency, integrity, respect and patient-focus.

It is part of a wider effort on the part of GSK to better target its sales staff based on the changing needs of healthcare professionals (HCPs).

“The US healthcare marketplace is changing significantly in response to demand by patients, healthcare providers and payers for higher quality care, lower costs and better health outcomes,” said Deirdre Connelly, President of North America Pharmaceuticals at GSK.

“Physicians have been telling us they want to see fewer sales professionals, and those they do see need to provide greater value in helping improve patient health. In response, we are changing the way we sell our medicines and vaccines in order to deliver the value our customers demand, in a transparent way, with integrity and respect for the patient,” she added.

GSK is hoping to align its sales efforts with the needs of US HCPs working in large health systems or integrated delivery networks where decisions on purchasing are made from a central office.

“We’ve spent a good deal of time listening to our customers, and they are asking us for more information about reimbursement, disease education and support for improving patient health,” Deirdre Connelly concluded.

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NHS bureaucracy making PASs unworkable

Tuesday, July 27th, 2010

Onerous paperwork could end up costing the NHS millions of pounds in missed reimbursements from patient access schemes (PASs), a report has shown.

Deals to share the costs of expensive treatments with the NHS are now commonplace. But lengthy required procedures often see deadlines and repayments missed.

A study of 31 PCTs in England showed more than 50% of the costs had not been recovered on two of the first four PASs – bortezomib and sunitinib.

The DH insisted it was aiming to make repayments as easy as possible. But study leader Steve Williamson said the complex procedures within the NHS were making the PASs unmanageable.

The consultant pharmacist at Northumbria Healthcare NHS Foundation Trust said: “We’re delighted to have these schemes because they allow patients access to drugs but they have not been executed very well.”

He added that deadlines needed to be more flexible and that the NHS should introduce a basic template for reimbursement instead of individual company paperwork.

“For example with bortezomib, in principle this is a very good scheme because if it doesn’t work you get the money back, but if for some reason you miss making one claim within the timeframe allowed it costs £12,000,” he said.

The report went on to conclude that NHS staff time is spent on tracking patients and filling in the correct forms and that “PASs can be difficult to manage within current NHS financial arrangements”.

With seven-out-of-ten respondents admitting they did not have the capacity to begin more schemes, the report also suggested the NHS may refuse future PASs. However, the DH insisted it will continue with PASs but said PCTs should create their own system for managing the rebates.

“We have – through the National Institute for health and Clinical Excellence (NICE) – now set up an expert advisory panel with strong NHS representation which is consulted when schemes are proposed and which provides advice to the department on their implementability,” a spokesperson said.

“Primary care trusts and hospital trusts need to agree locally between them how any rebates paid by drug companies are dealt with.”

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EMA restricts use of modafinil

Tuesday, July 27th, 2010

The EMA has recommended the restricted use of modafinil for narcolepsy use only.

The review by the CHMP was initiated due to a number of safety concerns relating to psychiatric disorders, skin and subcutaneous tissue reactions, as well as significant off-label use and potential for abuse.

As a result, the committee said modafinil should no longer be considered as a treatment for idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder.

The CHMP’s recommendation has been forwarded to the EC for the adoption of a binding decision.

The committee reported the risk of the development of serious skin and hypersensitivity adverse reactions appeared to be higher in children than adults and concluded the product information should carry a recommendation saying it should not be prescribed to youngsters.

Particular cardiovascular risks with modafinil were also identified with the CHMP recommending its use be contraindicated in patients with uncontrolled moderate to severe hypertension, and in patients with cardiac arrhythmias.

Modafinil is manufactured by US biopharmaceutical company Cephalon, Inc.

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Companies hit by gender bias settlements

Tuesday, July 27th, 2010

Sanofi-Aventis and Novartis have been forced to agree multi-million settlements after female sales reps won gender bias cases in the US.

Novartis has agreed to pay $152.5 million to 5,600 female executives and Sanofi-Aventis a tenth of that amount to 5,200 reps.

As a result, both will be required to overhaul internal policies of pay and promotions for female sales force members. The settlement also requires Sanofi to increase females’ salaries if gender disparities are found.

The Novartis settlement, which followed a jury ordering the company’s US unit Novartis Pharmaceuticals Corp to pay $250 million in punitive damages in May, was described by lawyers as the largest gender discrimination case to go to trial in the US.

The Sanofi deal will be heard on August 3rd with the Novartis settlement scheduled for November 19th.

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GPs not ready to deliver reforms

Monday, July 26th, 2010

Dr James Quekett, Doctors.net.uk The majority of GPs do not feel ready to deliver the new commissioning services as outlined Andrew Lansley’s white paper.

Under the new system proposed by the health secretary, doctors will be responsible for commissioning all care for local communities. The reform aims to bring together the management of care with the management of resources to ensure patients’ wishes and needs are met.

A poll by networking site Doctors.net.uk revealed 83% of doctors do not feel adequately equipped to make the outlined changes to commissioning, with that figure rising to 93% amongst GPs who are at the forefront of implementing the reform.

Doctors.net.uk Medical Adviser, Dr James Quekett (left), said: “Naturally there is a lot of excitement about the white paper but also much uncertainty about the new plans for GP commissioning. With allocation of time, resource and funding still to be resolved, GPs are expressing concern about how the reform will work in practice, and are pointing out that for this to work all doctors need to be engaged and involved– not just GPs.”

In response, Doctors.net.uk has launched an online micro site dedicated to commissioning. It is designed to provide clear information about the planned reforms and to provide a trusted forum for doctors across general practice, public health and hospital-based services to collaborate online with ideas and examples of best practice.

The content of the site will include a concise summary of the key points made in the white paper and responses posted by key organisations including the BMA and King’s Fund, in addition to providing direct access to the white paper and relevant news articles, presentations and interviews.

“We can’t predict what the future outcome for GP commissioning will turn out to be but we can at least ensure that doctors are informed and involved throughout this intense period of change to give it the best chance of success,” added Dr Quekett.

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