NHS commissioning of biologics

Vedolizumab

Vedolizumab

I am on a biologic, vedolizumab, for my longterm condition.

I have been on it for 12 months.

I know that it is expensive but it has had an amazingly positive impact on the state of my condition and my health

But there is a crazy NHS commissioning issue for biologic users like myself.

If you do too well on them, then the NHS commissioners decide that you no longer need them and stop paying for them. As a patient this is madness. As a commissioner I understand the argument, but think it is a short-sighted one.

If I now come off my biologic, there are no other non biologic medication options available to me. I know this because I have discussed it at length with my consultant. I have had my condition for 30 years. Over time I have tried all the other medications and in the end they have all had severe side effects, including azathioprine giving me pancreatitis and asacol knocking out all my white blood cells. So if the financial argument wins, then i shall have no satisfactory medical options. Inevitably without medication, my condition will worsen and i shall end up back in hospital. This will cost more money than the medication would have.

The key learning for the NHS should be that now that biologics are becoming more established treatment options, the commissioning rules need adapting. The current guidelines for prescription are too inflexible.

Maybe commissioners need to talk more to patients like myself…?

It’s time I had a say in my medical treatment

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People have been talking about personalised medicine for ages. It’s all the rage in the NHS now with The 100,000 Genomes Project. This project is committed to sequencing 100,000 whole human genomes, from 70,000 patients, by the end of 2017 to help bring in better treatments.

This is because medical professionals are using genetic sequencing to enable them to separate people with similar symptoms into far narrower groups and target medicines at them. For example last year, researchers from the Wellcome Trust Sanger Institute determined that the most common and dangerous form of Leukaemia is actually eleven distinct diseases that respond differently to treatment. Now that the cost of analysing an individual’s DNA is significantly less expensive, it will become possible to link a person’s genes with specific medicines and even diets.

This is great news, in a world where, by way of example, less than 4% of cancer patients actually participate in a clinical trial. In other words fewer than one in twenty five patients contribute to developing the new knowledge about a condition that informs new treatment plans.

So the flaw in the personalised medicine plan is that the only person that the Government and the medical profession are not consulting is me – the patient!

Why not?

I am a patient living with a long-term condition, ulcerative colitis / crohns. I have had this for 30 years. I know a lot about my condition but I am never consulted on my treatment. I have had several different drugs over the years, from azathioprine – which gave me pancreatitis; asacol – which knocked out all my white blood cells, and salazopyrin, which never fully controlled my condition. Over the time my condition has gone up and down.

Now for many sensible reasons, drug dosage is very carefully controlled in any healthcare system and the drug companies are equally tightly regulated. But in a world of ever increasing healthcare problems and healthcare costs, it is time to relook at this approach.

I am on a biologic, vedolizumab, and it is working. I love it. However, it is working too well. I am classified to be in remission and so the NHS now wants to take it off me. If they do, then inevitably my condition will worsen. The NHS attitude is so binary. I am well or I am ill. I take the infusion or I don’t. Why can’t I have a smaller dose? It would cost less and it might work just as well. The answer is that the clinical trials have only led to approval for the drug based on a standard dose. This is therefore what NICE guidelines accept. But why shouldn’t I be allowed a say in this? It’s my body and I have been living with the condition, longer than any doctor treating me. In many ways I am an expert patient with living experience of the condition.

We need to change the approach. It’s time for the individualisation of drug dosage based on personal response patterns to drugs and not on old fashioned and out of date clinical trial methodologies. We need to bring in individual DNA based personalised medicine, and we need to drive active patient collaboration and participation in drug and treatment decisions. We can’t just leave this to the supposed professionals. We need to do 3 things:

  1. Enable patients to have a say in their treatment and in the drug choices and doses
  2. Enable different types of observational research study based on different levels of patient participation over different times.
  3. Establish formal expert patient councils to advise the NHS based on patients living with conditions or disease for long periods of time.

It’s time to get truly personal.

Should we tag all prescription drugs and pills now?

The scale of increase in medication usage across the world is frightening.

There are numerous disturbing facts that accompany this spread:

  1. The NHS drug bill rose by 8 per cent to £16.8 billion in 2016, up from £13 billion in 2011. 4 treatments now cost more than £1 billion per annum. Source Dec 2016 Times
  2. Half of women and 43% of men in England are now regularly taking prescription drugs. Source NHS 2014
  3. It is estimated that £300 million of NHS prescribed medicines are wasted each year
  4. Diabetes accounts for over 10% of the annual drug bill
  5. One in five do not take all their medicine according to a survey of 2,048 people carried out for an Omnicell report by ComRes in 2016
  6. The U.S. is 4.6% of the world’s population, yet consumes 80% of opioid painkillers
  7. Global spending on medicines is forecast to reach $1.4 trillion by 2020, an increase of between 29 percent and 32 percent from 2015, according to IMS Health

The increase itself is fairly well understood by people. The less well known problem is that the misuse of antibiotics can enable bacteria to develop resistance to them. A lot of antibiotic-resistant strains are popping out. If antibiotics stop working, we have no other defence against bacterial infections. When you take antibiotics, you are putting a tremendous selective pressure on the bacterial population. Randomly, a few bacteria of the billions you have, will be slightly more resistant to the antibiotic than others. This means they are more likely to survive your antibiotic doses, and in turn they could evolve in more and more resistant strains, until the antibiotic has no effect on them anymore.

The trick is poisoning these bacteria with the antibiotic faster and stronger than their efficiency of evolving resistance and replicating. That is, if a bacteria narrowly escapes death by antibiotic, and you give it a break so it has time to replicate, you end up having a growing infection with a quite resistant strain of bacteria. If you instead take your pill at the right time, you give it another chemical punch that will hopefully kill it before it managed to replicate significantly.

So given these facts, why are we not finding other ways to reduce the problems. One of these could be by throwing more energy at tagging prescription medicines to enable:

  1. better understanding of whether patients are following the courses and therefore protecting our long-term antibiotic resistance?
  2. healthcare providers to ensure that patients don’t waste or sell their drugs?
  3. more patients to take the drugs that reduce further healthcare costs?

As long ago as 2004 the FDA backed RFID tagging of prescription medicine to track drug products through the supply chain. Now there has been considerable progress made around drug packaging protection with RFID tags aimed at reducing counterfeiting and wastage. In 2015 The University of Vermont Medical Center in Burlington, Vt., announced that five million medications had been tracked using radio frequency identification technology. This allows a hospital to track reliably from ordering through dispensing through administration at the bedside, and so enhance patient safety.

This has been followed more recently with approval in the UK and US for prescription pills that contain RFID chips – in other words ingestible RFID microchip medicine. This came out of Proteus Digital Health’s Ingestion Event Marker (IEM). This can be embedded in a pill, and ingested to monitor the patient and their bodily health. The device will collect measurements such as heart rate, body position and activity. The IEM sends a signal to your smartphone; which then transmits the data to the doctor.

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It is still very early days for this technology, but given the scale of the problems outlined above, we need to adopt this quickly. First and foremost this should be about tracking drug usage. Once this is done then we can begin to explore the sunny uplands of prevention and bodily health checks.