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 47.

    @stereotonic

    Exactly my point. If It was MY child, I'd like to decide whether I want more kids toys, or this vaccine. Whether I want fancier nappies, or this vacinne.

    I'm fairly sure we can make these decisions ourselves.

    Price doesn't 'need addressing'. If we all had the choice, and no-one bought the drug, the company would drop their prices. They sell at what we're willing to pay.

  • rate this
    +2

    Comment number 46.

    @36 eeyore

    Your happy for it to be on private prescription?. . . . . .So only the poor kid's die or lose limbs? In that case, I hope you never fall on hard times and it affect you or yours.

    @42 cjno1

    Yes, I know that! But if the gvt hadn't squandered our taxes over the last 50 years, we wouldn't be in this situation. I don't care about adults but kids are our future and they should be priority!

  • rate this
    +4

    Comment number 45.

    If parents are worried I'm sure it will be available at a price that is within the means of most people. Almost certainly less than a new game on the xbox or ps3. People buy non-essential stuff all the time and think that they are essential. One less computer game or a week of no fags for a immunization against the small chance of meningitis B. Parents can make the choice for themselves.

  • rate this
    -1

    Comment number 44.

    It isn't the drug company's, Novartis's, fault. Here's why:
    1. Government regulations greatly inflate R&D costs.
    2. Government regulates the innovative competition out of the market place, giving us less choice.
    3. Government approval & funding via NHS means the government, not us, picks the winners & losers, and then pays inflated prices.

    Want better cheaper vaccines? Have less government.

  • rate this
    +4

    Comment number 43.

    I understand that the NHS has a finite budget, so how about they make it available if parents want to pay for it?

    That way it costs me the father of two, but I'll pay it gladly; but won't hurt the tax payers who don't have kids.

    Is it just me or do our government and the bodies that advise them just lack all common sense some times?!

  • rate this
    +15

    Comment number 42.

    @39 stereotonic

    The fact is that everything in life costs money to someone, somewhere. If the NHS grant this vaccine, sure some lives will be saved, but they have a limited budget, so other lives will be lost. You can't just say "CHOOSE LIFE!". How much is a life worth? If it cost £1m to save Tilly's life should we do it? What about £100m? £1bn? You need to draw the line somewhere.

  • rate this
    0

    Comment number 41.

    I can understand how the decision whether to implement medication into the NHS is taken - and to be rational requires objectivety. I.e. Cost effectiveness. But really it's time that the NHS was a bottom up body rather than handed budgets to work with. Considering the amount of tax payers money spent on expenses, defence etc one would have thought more money could be made available for the NHS.

  • rate this
    -1

    Comment number 40.

    'They will argue that the committee has not adequately assessed the appalling lifelong burden of meningitis.'

    The drug itself doesn't appear to have been fully assessed either.....remember Thalidomide and what happened with that? It's not just about cost it's about safety as well....and you can't cure everything for a child or anyone else. Tragedies happen

  • rate this
    -10

    Comment number 39.

    @33 Craig

    Yes. You deal in numbers and money as an economist, but this is LIFE we're talking about. How can you compare the two??? What if it were YOUR child? Would you just accept that it's too expensive so your happy to let your child die or lose a limb in the name of money????
    To me, it's a no brainer . . .Life every time. . . .Why do the pharma's charge so much? This needs addressing

  • rate this
    0

    Comment number 38.

    Ahhh, the best treatment for the rich alone. Drug companies, don't you just love 'em?

  • rate this
    -2

    Comment number 37.

    Medical advances shouldn't be hamstrung by excessive regulation as they are now. Industrialised nations' improved resistance to disease owes much to vaccines. Prosperity, which increases as a society becomes more libertarian, have been highly correlated with improved health. The best way to improve a population’s health is to make it freer, making us more prosperous, thereby making us healthier.

  • rate this
    +1

    Comment number 36.

    I agree that the vaccine be available on a private prescription basis. This is a valid and easy way to make the vaccine available. But for those hammered by the Coagulations benefits squeeze it is going to be a major problem. Also if the vaccine is made available on this basis, then those vaccinated must be within a clinical trial to answer the questions raided in FWs article.

  • rate this
    +7

    Comment number 35.

    Strange how one HYS mentions "offered with a surcharge" and gets a highest rated vote, I mention "means testing" to help the poorest, and I'm now in negative.

  • rate this
    -2

    Comment number 34.

    The vaccine isn't proven to be overly effective.....


    ...no comparable country seems to be taking it up either....



    ...the manufacturers are charging an unnecessarily high price for it....



    ....the Govt. are wasting billions re-disorganising the NHS in prep for privatisation....



    ....& the British public blame the staff, not the politicos & fat cats......

  • rate this
    +25

    Comment number 33.

    Top comments - outraged parents ranting about 'big bad corporations' (who they buy from every day).

    Lowest comments - people who have studied economics and understand efficient allocation of resources (and therefore saving the most lives).

    As an economist, looks like this ones heading down...

  • rate this
    -7

    Comment number 32.

    Tilly Lockey is a stunning child. . . . . . Don't tell me her limbs weren't worth a few pounds! I'd be happy to part with my portion of tax to give a child like her the medication she needed to save her life and limbs. . . . . . .We need to be asked what is important, and EVERY childs life is important. They are our future

  • rate this
    +2

    Comment number 31.

    Whilst every child's life is important they have to use the limited resources in the most effective way. If you give every child the menigitis jab then there would have to be cut backs in other areas.
    Of course we could all just pay another 2% tax to cover it and similar services?

  • rate this
    +1

    Comment number 30.

    These children and their parents have no choice or defence against this disease. We are 'curing' & providing medication for people making life choices to be ill.

    I've stopped smoking & I struggle with food. I have an under active thyroid. It's not easy, but I have children. My choice is their future, our community. That motivates me.

    The NHS should be about need, not choice.

  • rate this
    +4

    Comment number 29.

    Typical perverse priorities. This vaccine could easily be afforded if the NHS stopped providing free non-emergency treatment to anyone who is not a permanent and legal UK resident or an EHIC card holder, and make all sex-change operations and IVF treatment fully chargeable to the patient. The priority should be to preserve life and health.

  • rate this
    -6

    Comment number 28.

    You cannot measure the life of a child by a QALY! It is the most precious thing in the world to those parents. I accept that that the 'envy of the world' - our NHS - cannot afford it for all. So, some of us must pay.

 

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