Putting a price on life - meningitis B vaccine refused

 
baby Carys was one of the first babies in the world to get a prototype MenB vaccine in a trial in 2006

Bacterial meningitis is perhaps the most feared of all childhood infections in Britain. It can kill or disable within hours of symptoms emerging.

So it may seem bizarre, even illogical, that the body that advises the government on immunisation should not recommend the introduction of a vaccine against the most common cause of the disease.

The Joint Committee on Vaccination and Immunisation (JCVI) has decided that a vaccine against meningitis B (MenB) is simply not cost-effective.

The vaccine has taken 20 years to develop and was licensed throughout Europe in January. Health committees in France and Spain are also considering the vaccine but no other country has yet recommended its introduction.

The JCVI is the vaccine equivalent of NICE, the body that advises the NHS on new medicines. Given that NHS resources are finite, each committee has to decide whether a new product is cost-effective. This is done by using an internationally recognised system known as quality-adjusted life years (QALY).

A QALY is an assessment of how many extra months or years of life of a reasonable quality a person might gain as a result of a treatment.

To be cost-effective, any new vaccine, cancer medicine or heart treatment should cost no more than £20-30,000 for every QALY it saves.

The JCVI has concluded that the MenB vaccine did not meet the economic criteria at any level. In other words, introducing the vaccine would not be a good use of limited NHS resources, which could be better spent elsewhere.

In January a European Commission-funded study concluded that the QALY system of assessing new treatments was flawed.

The announcement from the JCVI will provoke anger and dismay from charities and families affected by the disease. They will argue that the committee has not adequately assessed the appalling lifelong burden of meningitis.

You simply need to hear the story of seven-year-old Tilly Lockey from County Durham to appreciate the appalling nature of meningitis. She lost both her hands and some of her toes as a result of septicaemia - the blood poisoning that can result from meningitis.

Meningitis

  • Meningitis is an infection of the meninges - the membrane that surrounds the brain and spinal cord.
  • Meningococcal bacteria are common and carried harmlessly in the nose or throat by about 1 in 10 people.
  • They are passed on through close contact.
  • Anyone can get meningitis but babies and young children are most vulnerable.
  • Symptoms include a high fever with cold hands and feet, agitation, confusion, vomiting and headaches.

Her illness came on suddenly during the night when she was 15 months old. She was initially misdiagnosed as having an ear infection. By the time Tilly was admitted to hospital she was close to death.

"Meningitis is every parent's nightmare. To watch your child suffer like Tilly did was just terrible," said Tilly's mother Sarah Lockey. "If there is a vaccine out there that can prevent another family going through that it's got to be done."

Of course the JCVI is constrained by economic parameters that are ultimately set by the Treasury. If they recommended the introduction of the vaccine, it would mean that some other treatment - perhaps for asthma, diabetes or heart failure - would be rationed.

But given that the drug company Novartis has not yet set a price for its vaccine (trade name Bexsero), how is it possible for the JCVI to conclude that it is uneconomic?

Tilly Lockey Tilly Lockey

My understanding is that the committee looked at mathematical modelling to work out how much disease the vaccine might prevent and then balanced that against the likely cost of the vaccine and its implementation.

MenB cases fluctuate from decade to decade. We are currently in a trough - there were just over 600 laboratory-confirmed reports in England and Wales last year, compared with nearly 1,700 in 2000.

I am told that even assuming a huge peak of cases and a very low-priced vaccine, the jab did not meet the criteria for NHS cost-effectiveness.

Part of the problem is that the disease is sufficiently rare to make it impossible fully to assess the vaccine's effectiveness.

I followed one of the early trials in Oxfordshire in 2006 involving 150 babies, including Carys. Her mother Karla told me at the time: "Meningitis is the only illness apart from cancer that scares me. It would just put my mind at rest that there is a vaccine which can provide protection against it."

That trial showed the jab was safe and induced a strong antibody response to the meningitis bug. But the disease is sufficiently rare that it could not show how many cases it would prevent nationwide. The only way to find that out is by immunising hundreds of thousands of children.

That is why the JCVI said the available evidence "did not support definitive conclusions about the efficacy of Bexsero". It looks like the vaccine works but until huge numbers of children are immunised against MenB - and some are then exposed to the bug - will we know beyond all doubt.

Catch-22

Furthermore, the vaccine protects against about seven in 10 variants of the MenB bug so it will not completely eradicate the infection.

The other unknown is whether the vaccine will prevent healthy immunised children from spreading the bug to those who have not been vaccinated. That would be a huge benefit.

The vaccine can't be introduced until we know whether it will prevent most cases of MenB. But we won't know that unless the vaccine is introduced.

For Novartis and the researchers who have spent 20 years working on the vaccine, it is a depressing Catch-22 situation. Families affected by meningitis will regard it as a scandal that cost restrictions mean a vaccine-preventable illness will be allowed to go on killing and maiming children.

The JCVI is reluctant to give interviews on this. Little wonder given the flak it is likely to receive from charities, parents and paediatricians.

The director of immunisation at the Department of Health, Prof David Salisbury, did put his head above the parapet.

He said: "This is a very difficult situation where we have a new vaccine against meningitis B but we lack important evidence. We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person.

"We need to work with the scientific community and the manufacturer to find ways to resolve these uncertainties so that we can come to a clear answer."

But at present it is hard to see how those uncertainties can be resolved until a European country introduces the jab.

Britain was the first country in the world to introduce a vaccine against meningitis C in 1999 and it has led to a huge drop in cases.

That was seen as a bold step in protecting public health. But at present it looks unlikely that the NHS will repeat that with the MenB vaccine.

 
Fergus Walsh, Medical correspondent Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
    +1

    Comment number 307.

    It's a fallacy that if a tiny minority of children's lives can be saved then nothing else matters.

    Ethical considerations include the sustainability of supplanting natural deselection of weak immune systems with increased reliance on vaccinations from big Pharma. Also a lack of rigorous scientific studies to investigate the negative effects of vaccines in subjects with strong immune systems.

  • rate this
    0

    Comment number 306.

    Selly@305
    If we knew which 100 children were set to die, which 225 were set to lose mental / locomotor function for rest-of-life, how much would families be prepared to pay for immunisation, directly or by taking on debt (own or children's)?

    My guess is that together we could and would stump-up MULTIPLES of the allowed £40K per QALY. And that, even 'economically', mass coverage would 'pay'

  • rate this
    +1

    Comment number 305.

    What strikes me is this line: "To be cost-effective, any new vaccine... should cost no more than £20-30,000 for every [year of life] it saves"

    I have to agree with the reasoning from NICE. If this truly costs *more* than £30,000 for every year it adds to human life, yet putting that money elsewhere would save *more* lives, then I'm all for the saving of more lives.

  • rate this
    0

    Comment number 304.

    In Japan they have stopped the HPV vaccine due to the high number of side effects it causes, perhaps caution is the best way forward. Fergus says that we won't know if the vaccine works until it is used, but I don't think we should use our children as test subjects with all the dangers that entails

  • rate this
    -1

    Comment number 303.

    Adam @301
    'Let parents pay'
    Or the child?

    IF educated for democracy, every child valued as citizen, equal rights backed by equal income (part notional for infrastructure, health, education, defence, etc.; part for self, administered first by parents in direct care, progressively by self with maturity), THEN perhaps 'fair enough' to pay for own 'health luxuries'

    Perhaps. For till practice?

  • rate this
    +2

    Comment number 302.

    As long as it doesnt harm children to have so many vax-we should do it .Children are innocent and their potential undiscovered. Spend on them. Makes more sense than 10 million more weight checks for 40-75 yr olds who should know better than to eat too much.

  • rate this
    +1

    Comment number 301.

    Allow the vaccine to be administered by the NHS, but charge parents for it if it's not deemed to be economically viable.

    That would end the situation whereby parents are given conflicting information by both the NHS and High Street pharmacies.

    All parents who care about their children will be willing to pay for the vaccine, and it shows how out of touch with the real world the NHS really is.

  • rate this
    -1

    Comment number 300.

    Point is to save child's life, not 'insure' against death

    Troubling in this debate, cries to abandon democracy as sham, so frail the vision & advocacy for democracy, as a reality, in equal partnership

    Deserted by 'the money' (in favour of New Labour), Tories joined deregulated merry-go-round, backed bail-out of gamblers, now seek credit in dead-cat bounce, the people asset-stripped

    Time to wake

  • rate this
    -2

    Comment number 299.

    292.dean watchman
    Nothing is free, especially medicine unfortunately.

    That is tragic about your daughter. Do you have home and or car insurance? Did you have insurance for your daughter? If not, why not? I'm trying to understand if you had insurance for the usual valuable things in your life, and if not why not for some things and not others - were there barriers preventing you, perhaps?

  • rate this
    +3

    Comment number 298.

    It seems odd to me, as a mere GP, that the Government is prepared to sanction vaccination for rotavirus and shingles, which are rarely life-threatening, and not meningitis B which can be much more serious.
    I read that Novartis has not set a price for the vaccine, but perhaps they would be prepared to reduce the price and forgo a portion of their profits?

  • rate this
    +1

    Comment number 297.

    286.nagivatorjan
    That's the point. We want a few people using it as possible, and only when truly needy. Too many people use it. Too many people live poor lifestyles because they mistakenly think they will have this wonderful safety net that will fix them for ever.

    Imagine how many more reckless motorists and car owners if we'd have if we had NHS for cars. It's the same principle with our bodies.

  • rate this
    0

    Comment number 296.

    @261. Without wishing to nit pick the comparative % of GDP spent on health care that you quote whilst being correct don't tell the whole story. They include both state & private provision. For the UK the NHS costs 8% of GDP and private 1.3%. Most European health services are hybrid with a state & private insurance element. The state % is much closer to the UK. I've used the German & French system.

  • rate this
    0

    Comment number 295.

    A question for Sally. Do you accept any taxation as being acceptable? For instance the provision of national defence, the police & a legal system? If no how are they to be paid for? Thank you.

  • rate this
    0

    Comment number 294.

    " putting a price on life "

    something 99.99% of us will never have to do .

    So lets not hammer those who do .when none of us will ever have to value anothers life .

  • rate this
    +2

    Comment number 293.

    Surely the volume of sales has an effect on the price i.e. it is not the cost of production of the drug but the cost of its development that affects the price. So,why not allow individuals the option of buying the drug privately on an organised collective basis? There would be a resulting an economy of scale that may reduce the cost to the NHS.

  • rate this
    +2

    Comment number 292.

    Having lost my 2 yr old grandaughter to meningitis on new years eve 3 yrs ago i would give anything no matter how much it costs rather than risk my grandson catching this terrible disease , i cant believe we are even talking about this so many people are affected from this every year i have seen what this has done to our family the vaccine should be given to every child FREE

  • rate this
    0

    Comment number 291.

    This is a complex issue though understandably those with direct experience hold strong views. Presumably those who feel strongly can pay to have the vaccine privately?

  • rate this
    +4

    Comment number 290.

    £42bn and rising for a faster train service with a dodgy business case. A recommended no for a potential life saving vaccine. To all those who doubt the speed, randomness and severity of meningitis B I hope you don't live through my daughter's experience. 6 pm a headache. midnight intensive care. 36 hours on life support. Luckily she survived and 5 years later is getting her life back on track.

  • rate this
    +3

    Comment number 289.

    Better spending the money on something that can actually save lives rather than v expensive cancer drugs that extend someone's life for just a couple of months. I'm sorry if that's sounds awful to some but this is from someone where various forms of cancer have torn my family apart.

  • rate this
    -3

    Comment number 288.

    very interesting article about a subject that actually affects people. shame bbc's first page is plastered with the royal baby "news".

 

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