NICE is as blinkered as ever: nothing has changed since 2010

June 25, 2015 at 6:34 pm | Posted in arthrits, rheumatoid arthritis, rheumatoid arthritis (RA) | Leave a comment
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In January 2010 I ‘reported’ that NICE were refusing to consider treatment of early RA with biologics because one had to ‘fail’ on two other DMARDS first, which would take a minimum of six months, more likely a year. NICE (amusing standing for National Institute for Clinical Excellence, actually have very little interest in clinical excellence; their job is to stop the NHS ‘spending too much’ on drugs etc.)

Now, five-and-a-half years later, after threatening to take biologics away from RA patients altogether because they weren’t ‘cost effective’, NICE has kindly decided to leave things as they are for the moment, according to to a joint press release from NRAS, Arthritis Care and the British Society of Rheumatology (BSR), which you can read here on the BSR website (and also on the NRAS and Arthritis Care sites).

I was pleased to see that Professor Simon Bowman, the President of the BSR, is saying pretty much what I was saying five-and-a-half years ago … because there’s a chance that people at NICE might actually listen to him! He says, quoting the press release:

‘It is false economy not to treat patients with moderate disease with biologic therapy when standard DMARDS fail, as these patients will be higher users of healthcare resources. These patients will require more attendance to primary and secondary care, and are more likely to develop co-morbidities such as osteoporosis, heart disease and have more surgery.’

The press release continues with more things I was saying back then: ‘They are also much more likely to lose their jobs, causing financial hardship […] The personal costs to the individual, the NHS, the impact on the rest of their family and the direct cost to the exchequer in lost productivity and benefits claims is massive.’

Judi Rhys, Chief Executive of Arthritis Care, added ‘NICE does not take account of costs such as reduced hospital bed days or the benefit of people getting back into work. We believe those with moderate RA require better access to these drugs. Not only will it improve lives, but it also makes economic sense.’

Here here! It’s good to see the charities fighting back in language that NICE might understand! Of course it won’t alter the problem that the NHS is completely ‘siloed’ from the Department for Work and Pensions who deal with benefits etc., social services etc. So as far as NICE is concerned, as long as the NHS is ‘saving money’, the fact that there are huge costs to individuals, businesses, the DWP etc. is really irrelevant.


December 12, 2014 at 12:03 pm | Posted in arthrits, fibromyalgia, joint pai, Me, rheumatoid arthritis, rheumatoid arthritis (RA) | 2 Comments
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Well, I meant to write this post about biosimilars weeks ago, but alas, I came back from London and fairly quickly went down with a really bad cold, which I’m still getting over now! It was bad enough, combined with the methotrexate/immunosuppression, to require antibiotics for the secondary infection and it hit chest and sinusses at the same time, so I’ve been feeling pretty poorly!

Luckily Clare at NRAS had asked to write a brief report about the conference for them – on slightly more serious lines than my last post, and I did that pretty much straight away after coming back, before the cold hit, and that included something about the biosimilars, which I’m going to reproduce here. So here we go:

The next talk I attended was ‘Biosimilars: realising the opportunity for the NHS and patients’. Biologic patents are soon to run out. Biosimilars are biologics too, but they are designed to be as similar as possible to the molecules of already successful biologics, reducing the need for as much expensive primary research as went into the original biologics. As they are not identical, and as these molecules are extraordinarily complex, they will still need to go through, and some are already going through clinical trials, because, as Professor Peter Taylor said in his talk, ‘minor structural differences can have disproportionately large effects in patients’.  However, there is a lack of education around biosimilars both among patients and clinicians, not to mention commissioners, so their introduction into the NHS could be a complex matter.

At the last minute there were no patients speaking in this talk due to some obscure ruling to do with the pharmaceutical company involved only speaking on panels with medically trained people.

First, Professor Peter Taylor, Norman Collison Chair of Musculoskeletal Science, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, gave a very clear and concise outline of what a biosimilar was. Carol Roberts, PresQIPP Director on NHS involvement in biosimilars was keen to reassure that ‘value’ was based on outcome and not just on price, although biosimilars could be a huge saving to the NHS, £3.8 million. (Actually given NHS budgets that didn’t sound that huge to me, but every little helps!) People with RA on biologics now will probably be pleased to hear that the intention at the moment is to only put new patients onto biosimilars, not to take people off biologics that are working for them and move them onto the cheaper drugs. Janice Mooney, Senior Lecturer in Primary Care, University of East Anglia and senior Rheumatology Nurse Practitioner, pointed out that all clinicians need to be educated in biosimilars, not just patients and consultants. Given that patients may only see a consultant once a year (or less) this is obviously essential!

There was some concern among patients in the room about safety, although to me biosimilars do seem like the logical next step in medication of RA – another audience member pointed out that there was a massive trust issue between patients and the NHS with a feeling that the NHS always went for price above effectiveness, which led to a feeling that if something was cheaper it couldn’t be as good. One person even wondered if there could be a backlash against these similar to that of GM foods a few years ago, if the press wasn’t properly educated. Janice Mooney responded that this was a key area where education was required. David Taylor pointed out that clinical trials were not enough to guarantee safety, due to rare risks, because of the small number of people involved in trials, so that safe and responsible introduction of the new drugs was also essential.

From my own persona point of view, and of course this didn’t get added into my serious report for NRAS, I’d just like to say ra ra ra, go biosimilars … especially as i might be needing them in a few years’ time!

And another one!

October 7, 2009 at 5:09 pm | Posted in rheumatoid arthritis (RA) | Leave a comment
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The EU are keeping busy with their approvals programme. Simponi (golimumab) is another biologic just approved for rheumatoid arthritis. It’s approved for moderate to severe R.A. either in conjunction with methotrexate or on its own.

More evidence that Abatacept IS effective in treating R.A.

October 7, 2009 at 3:15 pm | Posted in rheumatoid arthritis (RA) | Leave a comment
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Current NICE guidelines say that Abatacept (one of the many biologics, anti-TNFs) should not be used in R.A. patients who have not responded to other biologics. Now a Cochrane Review (a review designed to help policy makers and healthcare workers make decisions on what is and isn’t effective) says that Abatacept IS effective in R.A. treatment. NICE are already in the process of reviewing their current guidance, but a decision is not expected until June 2010. The review strongly recommends that for the moment Abatacept is not used WITH other biologics – but says nothing about use if other biologics have been tried and have failed, which suggests that perhaps NICE should be recommending it for those with rheumatoid arthritis who have failed on other anti-TNFs.

Like all anti-TNFs, how safe it is in the long term has not yet been established – because none of them have been around long enough, but the Cochrane review (by Dr. Lisa Maxwell in Ottawa) showed that patients given Abatacept were twice as likely to achieve a 50% improvement in symptoms such as pain and the number of tender and swollen joints.

In the meantime a study on intranasal administration of recombinant Human Cartilage glycoprotein-39 for treatment of R.A. has failed. Personally I don’t fancy a regular treatment via my nostrils … although if I had moderate to severe R.A. I guess I’d try anything once! However it didn’t show any improvement over placebo, so I dare say I will never need to try that one. Phew.

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