NICE has recommended NHS funding for Viread (tenofovir) for hepatitis B, currently the only antiviral agent that shows no drug resistance after two years.

Viread is an oral antiviral medication that inhibits the replication of the hepatitis B virus. It has been shown to be at least as effective as other currently recommended options and a cost-effective antiviral strategy.

Drug resistance is a common barrier to successful long-term therapy. Tenofovir is the only antiviral agent for hepatitis B treatment that, in its registrational trials, shows no resistance after two years.

“Chronic hepatitis B is a major health problem and a life-threatening disease. Many patients require long-term therapy and it is important that treatments demonstrate consistent efficacy, established long-term safety profile and robust drug resistance, all of which Viread is able to offer,” commented Professor Graham Foster, Consultant Hepatologist at Barts and The London NHS Trust.

Tenofovir received approval in the European Union for the treatment of chronic hepatitis B infection in adults in April 2008, and has already been approved for use in Scotland and Wales by two independent Healthcare Technology Assessment groups.

Dr Gillian Leng, NICE Deputy Chief Executive, said: “One hundred times more infectious than HIV, Hepatitis B can have a serious impact on a person’s quality of life, and those with the disease are more likely to develop serious liver problems such as cirrhosis and cancer. This guidance means that patients with the virus will have another treatment option available to combat the problem of viral resistance to other drug therapies.”

Sandoz has launched its recombinant granulocyte colony-stimulating factor (G-CSF) Zarzio (filgrastim) in the UK.

Zarzio is approved as a treatment for neutropenia (low white blood cell count) associated with chemotherapy treatment or advanced HIV infection and the mobilisation of peripheral blood progenitor cells.

Zarzio has been shown to have an efficacy and safety profile comparable with Neupogen, currently the most widely prescribed treatment, but is 10% less expensive.

It is the only filgrastim preparation to be supplied with a novel needle safety device that contributes significantly to protecting health professionals against needlestick injuries.

Paul Tredwell, Head of Biopharmaceuticals, Sandoz Ltd, said: “Zarzio will be the third biosimilar product launched by Sandoz in the UK and reinforces Sandoz as the pioneer in this field and the largest producer of approved biosimilar products in the UK. As a division of Novartis, we have access to a global network of modern manufacturing facilities – including in Austria, where this product is manufactured.”

The treatment of neutropenia is estimated to cost the NHS £60 million annually. Sandoz predicts that Zarzio could save the NHS an estimated £1.5 million each year – money that could be reinvested in other areas of unmet clinical need in the NHS.

NICE has issued a recommendation for the use of MabThera (rituximab) in the UK’s most common form of leukaemia, chronic lymphocytic leukaemia (CLL).

The final guidance recommends rituximab in combination with fludarabine and cyclophosphamide (FC) chemotherapy for previously untreated patients with CLL.

This follows a recent recommendation by the Scottish Medicines Consortium (SMC) for MabThera in the same indication.

The addition of rituximab to FC chemotherapy has been proven to halt progression of the disease by 10.5 months longer, and more than doubles the number of CLL patients achieving complete remission compared to chemotherapy alone.

Professor John Gribben, Consultant Haematologist and Medical Oncologist, Barts and The London NHS Trust, commented: “The ability to add rituximab to chemotherapy is a major advance in the way we can treat chronic lymphocytic leukaemia. Where previously our goal was just to improve symptoms, for the first time we now have a treatment combination that is capable of producing much higher remission rates and more durable responses.”

More than 20,000 people in the UK are living with CLL and there are an estimated 3,700 new cases every year.

Jane Barnard, Chair of the CLL Support Association, said: “This is great news for CLL patients, many more of whom will now have the potential to gain additional time in remission and relief from debilitating symptoms such as extreme fatigue and the pain and discomfort of swollen glands.”

The European Commission has issued its final report following an EU investigation into competition within the pharma sector.

The 18-month inquiry found that seven-month delays to the entry of generic products had cost healthcare systems up to 20% more than was necessary.

The report concludes that a single EU community patent and patent litigation system will help to prevent many of these delays.

The EC has also announced a further investigation into various major companies, including Servier, Krka and Teva, which have been accused of forming agreements to delay the launch of generic products.

The investigation, led by Competition Commissioner Neelie Kroes, focused on a sample of medicines that faced patent expiry between 2000 and 2007. The EFPIA has welcomed what it describes as a “more balanced” view of the issues facing the sector.

“We must have more competition and less red tape in pharmaceuticals,” said Neelie Kroes. “The sector is too important to the health and finances of Europe’s citizens and governments to accept anything less than the best. When it comes to generic entry, every week and month of delay costs money to patients and taxpayers.”

The Commission says that a unified patent litigation system in Europe will reduce this “red tape” and prevent conflicting judgements that lead to delays.

The report also urged each country to accelerate the approval of generics, suggesting that this could be achieved by automatically granting pricing and reimbursement status to generic versions of drugs that already have this status.

EFPIA President Arthur Higgins said: “We have stated consistently that complex and divergent regulatory barriers are the primary cause of market entry delay for both generic and innovative medicines. We are pleased that the final report recognises this reality.”

Too many people with rheumatoid arthritis (RA) are not being diagnosed or treated quickly enough, according to a report published by the National Audit Office (NAO).

The report points out that delay in treatment is detrimental to patients’ health, their quality of life and, with three quarters of people of working age when diagnosed, the economy.

The estimated cost to the economy of sick leave and work-related disability for people with rheumatoid arthritis is £1.8 billion a year.

The NAO estimates that approximately 580,000 adults in England currently have the disease with a further 26,000 new cases diagnosed each year. It argues that better coordinated services would lead to earlier identification of new cases, productivity gains for the economy, and improved outcomes for patients.

Amyas Morse, the head of the National Audit Office, said: "Patients with this debilitating and distressing disease are not identified or treated quickly enough and this dramatically affects long-term outcomes and people’s ability to remain in work. The NHS should take a more coordinated approach to identifying people with symptoms of early rheumatoid arthritis, so that they get access to specialist care quickly and receive support and advice to help them manage and live with the disease."

Early diagnosis is the key to the successful treatment of rheumatoid arthritis (ideally within three months of symptom onset), but public awareness of the disease is low. Between half and three quarters of people with rheumatoid arthritis delay seeking medical help from their GP for three months or more following symptom onset and around a fifth delay for a year or more.

The disease is difficult to diagnose and requires specialist knowledge; and few GPs have the specialist expertise required to diagnose rheumatoid arthritis, which can lead to further delays, with patients on average visiting their GP four times before being referred to a specialist for diagnosis and treatment.

The average length of time from symptom onset to treatment is nine months, compared to the clinically recommended period of three months, and this has not improved in the past five years.

Healthcare planners may have been given misleading figures of the potential number of swine flu deaths, say the authors of new research published in the British Medical Journal.

The proportion of people who die due to infection during an influenza outbreak – known as the case fatality ratio – is calculated by dividing the number of deaths by the total number of cases in the same time period.

Early data from the current swine flu pandemic suggested that the new influenza A (H1N1) virus causes mild disease, with case fatality ratios of around 0.5%, or 5 deaths per 1000 people infected.

However, the researchers from the MRC Centre for Outbreak Analysis & Modelling at Imperial College London, say this ratio may not be accurate.

The researchers suggest that this inaccuracy could be because the total number of deaths is being underestimated as the cause of death is not correctly attributed to swine flu.

Other suggested reasons are that the number of cases are underestimated as people with milder symptoms may not be tested or visit a doctor at all, leaving only the most severe to be reported, or that the ’snapshot’ calculation does not take account of the time delay between infection and death, leading to the false impression that the infection is actually becoming more severe as the pandemic progresses.

Dr Tini Garske, from the MRC Centre at Imperial College London, said: “Accurately predicting the severity of this swine flu pandemic is a very tricky business, and our research shows that this can only be achieved if data is collected according to well designed study protocols and analysed in a more sophisticated way than is frequently being performed at present.

“If we fail to get an accurate prediction of severity, we will not be providing healthcare planners, doctors and nurses, with the information that they need to ensure they are best prepared to fight the pandemic as we head into the flu season this autumn.”

Many people would rather have a postcode lottery than a nationally-based NHS, research suggests.

A survey by the Social Market Foundation (SMF) showed that while people say they want a nationally-based NHS, when asked how resources should be allocated in their area the public supports locally-tailored services.

As part of its two-year research project examining the future of the health service in a world of technological change, an ageing population and rising consumer demand, the SMF, with Ipsos-MORI, conducted opinion polling to find out public views on variation in the NHS, followed up with a series of discussion groups to explore people’s views in greater depth.

When questioned, around 75% of people said they want a service based on national standards, with treatments only available if they are available across the whole country. However, when taken through an exercise in allocating resources, all groups chose to offer specialist services for particular local needs, rather than improving national standards.

People are willing to accept that different healthcare services may be delivered in different areas if there is greater involvement in decision making, the poll showed, and this feeling is strongest among those on low incomes.

Only 20% thought decisions about what is available on the NHS should be made solely by professionals. However, few people were willing to give up their time to get involved – most thought it was more important to have a say when things went wrong.

Commenting on the report, David Furness, Health Project Leader at the SMF, said: “The crisis in public finances means that health services will be severely stretched in the years ahead. Efficiency will only be improved with a greater focus on local priorities. Our research shows that people will accept local variation in the NHS if they feel their views are taken into account – fears about postcode lotteries are largely misplaced.”

He added: “Cutbacks in public service budgets will inevitably mean some tough choices about what is available on the NHS. Many people accept that this will mean that some things will no longer be funded by the NHS, with a real focus on what is clinically effective.”

Inadequate supplies could mean that some people are denied access to the swine flu vaccine, WHO has warned.

A series of recommendations have been released by the WHO’s Strategic Advisory Group of Experts (SAGE) to ensure best use of the vaccines available. These include vaccinating healthcare professionals, pregnant women and those with chronic medical conditions first.

SAGE emphasised that since the spread of the pandemic virus is considered unstoppable, every effort should be made to ensure that all countries have access to the vaccine.

In a press conference, Dr Marie-Paule Kieny, Director of the Initiative for Vaccine Research, said that WHO intends to help achieve as much equity as is possible in the distribution of vaccines.

Dr Kieny added: “We are discussing with the industry and have already secured a number of donations from industry. We have also secured access to real-time production during the pandemic. WHO at the highest level is discussing with Governments to see how much they can do to help negotiate some doses with industry but also help finance these vaccines.

“Finally, but very importantly, we are also discussing with new manufacturers who have started to acquire the technology to make influenza vaccines in the past three years with technical and financial support from us, to help them accelerate their preparation and be able to produce some vaccines for their own country.”

A new report is calling for the Department of Health to hold a public consultation over the proposal for Automatic Generic Substitution.

In January 2010, under Automatic Generic Substitution, it is planned that the prescriber will lose the power to decide what medicine their patients ultimately receive.

The report, endorsed by a multidisciplinary group of healthcare professionals and patient groups, acknowledges that there are many cases where generic prescribing is appropriate – pointing out that it already accounts for 83% of all prescriptions in the UK, a level that has increased significantly over the last few years.

It asks, however, how much of a cost saving the NHS would actually make through Automatic Generic Substitution, and whether that will mean an increase in healthcare costs through poorer patient outcomes.

The report argues that as the prescriber knows the patient’s medical history, it should be at their discretion what medicine the patient is prescribed. It also suggests that the proposed ‘tick-box’ system to prevent substitution might not be adequate to safeguard patients.

Dr David Candy, Consultant Paediatric Gastroenterologist, Royal West Sussex NHS Trust, stated: “Children may be more vulnerable than adults to substituting one preparation for another. When I prescribe, I try to choose the most ‘child friendly’ preparation available taking into account the age of the child, and I would hope not to have my decision reversed.”

There is also concern as switching between medications has been shown to significantly reduce adherence to treatment, and it is known that poor adherence is associated with worse outcomes and increased costs for a variety of conditions.

The ABPI has suggested that if generic substitution is introduced certain classes of medication will be exempt, for example Narrow Therapeutic Index (NTI) medications, biologicals and biosimilars, controlled medicines, and modified and sustained release preparations. However, the report argues, there are many conditions where Automatic Generic Substitution could be detrimental to the patient’s health.

Mary Baker, President of the European Federation of Neurological Associations (EFNA), commented: “We are aware of patient concerns surrounding Automatic Generic Substitution and hope that the DH will give careful consideration to these in the consultation process.”

The report is available at: http://petitions.number10.gov.uk/genericsubst/.

Almost eight out of ten UK physicians (77%) consider Alzheimer’s disease to be undertreated in the UK, according to a new study presented at the 2009 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2009).

These perceptions confirm earlier research by the Audit Commission for Local Authorities and the NHS, which highlighted an uncertainty in diagnosing any form of dementia by GPs in the UK, with 40% of GPs reluctant to refer early for diagnosis.

According to the study, supported by Eisai and Pfizer, UK doctors feel the medical community hesitates in discussing the earliest stages of Alzheimer’s disease because of uncertainty.

“The National Dementia Strategy sets out a clear direction for dementia management and if adhered to closely, it could help the UK lead the way in Alzheimer’s disease care and management,” said Professor Roy Jones, Clinical Gerontologist and Geriatrician at The Research Institute for the Care of Older People, Bath. “Alzheimer’s disease needs to be tackled with the same force as the fight against cancer and we need to act now in order to halt this generational time bomb.”

Alzheimer’s disease, the most common type of dementia, affects nearly half a million people in the UK – a figure expected to double within twenty years.

According to IMPACT, Alzheimer’s disease is the most feared disease after cancer in the general population, while physicians and carers fear it even more than cancer.

In 2007, the annual cost of caring for people with Alzheimer’s disease was £11 billion, with dementia costing the UK economy over £17 billion a year – more than cancer, stroke and heart disease combined.

In contrast, in 2007, Alzheimer’s disease research received 3% of the funds spent on cancer, a disease that affects a similar number of people.