Life-saving drugs held up by cost-cutting

The Joint Committee on Vaccination and Immunisation, a Government advisory body, recommended in October last year that the vaccine against pneumococcal meningitis, the worst form of meningitis, should be given to all children routinely in the first months of life.

But almost a year later the Department of Health has still made no decision on when or whether the vaccine will be introduced.

The vaccine is the latest medicine caught up in Britain's drugs bureaucracy which is denying potential life-saving treatments to thousands of patients.

The charity CancerBacup yesterday published a dossier of 23 cancer drugs awaiting approval by the National Institute for Health and Clinical Excellence (Nice) for use in the NHS. The charity said that for many patients, the treatments would not be available in time to help them.

Nice will announce a fast-track system for assessing new drugs after a meeting of its board today. The institute is expected to agree an interim process for assessing drugs, which would be quicker and shorter, where there is clear evidence of their beneficial effect.

New vaccines are assessed by a separate arm of the drugs bureaucracy. The pneumococcal meningitis vaccine was licensed in the UK and Europe in 2001 but was not considered by the Joint Committee on Vaccination and Immunisation until 2004.

It has been given to children in the US since 2003 where cases of pneumococcal disease among children and adults have fallen by 80 per cent. It is also used in Canada and Australia.

In the UK, 60,000 adults develop pneumonia and 6,000 die each year. Experience from the US shows that giving the vaccine to children helps protect adults through herd immunity.

Linda Glennie, head of research at the Meningitis Research Foundation, said: "We feel we have been waiting a long time for this vaccine. It was licensed in Europe in 2001 and though the feedback we are getting [from the health department] is more positive we are not there yet."

The latest figures show there were 205 cases of pneumococcal meningitis in 2003. Half of those who survive the disease do so with serious disabilities including deafness and brain damage. They need life-long round-the-clock care, the cost of which can be millions of pounds. Although children at risk in the UK are entitled to the vaccine, there is no mechanism to ensure they get it.

Pneumococcal meningitis kills about the same number as Hib meningitis, against which there is already a vaccine given routinely, as part of the childhood vaccination programme.

But the pneumococcal vaccine is expensive, costing £30 a dose with up to four doses required. In the US three doses are given to children under one, with a later booster added. In the UK, officials are believed to be looking at the possibility of reducing the number of doses to cut costs.

"Cost is one of the main issues behind the delay. It would cost more than the existing vaccines in the childhood programme put together," Ms Glennie said.

A spokeswoman for the Department of Health said: "The Joint Committee on Vaccination and Immunisation has recommended in principle the introduction of pneumococcal vaccine for children, subject to further consideration of the following: the number of doses required and their timing to protect children; the price at which the department is able to secure the vaccine; and guarantees of the supply of the vaccine.

"We are seeking further advice from our independent experts about how we could introduce the vaccine; the number of doses that should be offered; and the appropriate age to vaccinate children. We have to ensure that our programme is based on sound scientific advice and that's why further evidence and data is being collected".

'The good thing is she has a positive outlook on what is a dark situation'

In June 2003 Melanie Hook, then aged 31 and a mother of two young children, fell ill with a chest infection. Two years later she is still in hospital, wholly incapacitated, and is destined to be on a ventilator for the rest of her life. The infection turned out to be pneumococcal meningitis.

"She needs absolutely everything doing for her. She is quadriplegic. She can't chew her food [it is passed through a tube directly into her stomach]. She can't breathe or talk. But the good thing is she has a very positive outlook on what is a dark situation," said her husband Craig, a civil engineer. Twice a week, Craig travels from the family home in Kettering, Northamptonshire, to London to visit Melanie in the Royal Hospital for Neurodisability in Putney, south-west London. Once a week he brings their children - Cameron, five, and Alastair, three - with him.

"They are stable, well-behaved children. That has helped me so much. Trying to be a single parent and do a job and visit Melanie - it's a full-on life, hard but enjoyable. But what I have to do is nothing to what she has to endure. To be stuck in bed in a lonely place doesn't bear thinking about."

Craig has been negotiating with Melanie's doctors for months to get her home and has been told she can go in six weeks time. Their home has been converted.

"I hate to think how much has been spent on Mel," Craig said. "She wants people to appreciate what can be done about meningitis - and also that there is a life when you're severely disabled."

Melanie communicates by blinking and has been yearning for more contact with her children. They have been reluctant to give her a hug in hospital, where she is attached to tubes and wires, but she is hoping they will feel easier about showing her affection back home.

Unavailable

Pneumococcal meningitis vaccine

It prevents pneumococcal meningitis (200 cases a year and up to 50 deaths) and helps prevent pneumonia (60,000 cases and 6,000 deaths). It has been approved by the Joint Committee on Vaccination and Immunisation but is awaiting a decision by the Department of Health. The vaccine would be given to all children. It costs £30 a shot and four shots are needed.

Herceptin (trastuzumab)

In patients treated for early breast cancer it reduces the risk of the disease returning by up to 50 per cent. It is still awaiting a licence in the UK, and must then be assessed by Nice. (It has a licence for use in advanced breast cancer). About 8,000 of the 40,000 women newly diagnosed with breast cancer would benefit. It costs £25,000 a year.

Xeloda (capecitabine)

This drug for bowel cancer avoids long hospital treatment. Awaiting approval by Nice in England but has already been approved in Scotland. It could benefit about 7,000 of the 30,000 who develop bowel cancer each year, and costs £2,000 a year.

Arimidex (anastrazole)

It reduces the risk of breast cancer returning in postmenopausal women who have had the disease. It is awaiting approval by Nice in England but has already been approved for use in Scotland. It would be suitable for 25,000 of the 40,000 who develop breast cancer each year, and costs £700 a year.

MabThera (rituximab)

A treatment for non-Hodgkin's lymphoma, which has reduced the size of tumours by 50 per cent in some patients. Awaiting approval by Nice in England but has already been approved for use in Scotland. About 9,000 patients are affected and it costs £5,000 per treatment cycle.

Velcade (bortezomib)

Treatment for myeloma, cancer of the bone marrow. It is awaiting approval by Nice. About 4,000 patients are affected and it costs £17,000 per patient.

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