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The politics of New-Fill
Currently, being able to access New-Fill (polylactic acid) in the UK for HIV-related facial lipoatrophy is akin to winning the lottery. Only eight treatment centres in five English cities currently offer New-Fill to their HIV patients - and many of those have extremely long waiting lists. If you don’t attend a clinic north of the Thames in London, or have not already been attending HIV clinics in Brighton, Birmingham, Manchester or Portsmouth for at least a year, you are unlikely to be able to get the NHS to treat your facial lipoatrophy, as it has already for around 500 fortunate HIV patients.
However, cogs are whirring amongst the powers that be that will hopefully change the current postcode lottery situation and may soon make the availability of New-Fill equitable, first throughout London, and then hopefully throughout England, and possibly in Wales and Scotland (which have their own HIV strategies). But, as Professor Brian Gazzard – Chair of the London HIV Consortium Advisory Group Drugs Sub-committee – points out, wearily: “There is a willingness to do it; it is the practicality of getting it done that is very difficult.”
In October, Dr. Simon Barton - Clinical Director of HIV and Genitourinary Medicine, at Chelsea and Westminster Hospital in London – spoke at the Autumn BHIVA (British HIV Association) Conference on the subject of ‘The Politics of New-Fill’. His presentation focussed on how clinicians at other HIV centres not currently accessing New-Fill might go about getting it; his words struck a chord with many of the attendees who were only too aware of the difficulties of getting the NHS to fund new treatments.
Dr. Barton’s interest and experience with New-Fill is important: not as someone who actually administers the treatment, but because of his political influence and power within the North West London NHS sector, which he represents on the aforementioned London HIV Consortium Advisory Group Drugs Sub-committee. He has also co-authored a scientific paper with Dr. Graeme Moyle on New-Fill treatment that is currently in press at HIV Medicine based on the results of the New-Fill trial at Chelsea & Westminster (first presented in 2002 at ICAAC in San Diego).1
The trial found that New-Fill improved facial appearance and reduced anxiety within 12 weeks. It is significant because it is the first randomised test of New-Fill. The French VEGA trial did not include a control group, but in the Chelsea and Westminster trial, the immediate vs. deferred study design made it possible to discern the effects of New-Fill on appearance and on psychological well-being compared to the effects of non-treatment. The study also showed that New-Fill is associated with few adverse events when administered in a clinic setting.
The patent for New-Fill is owned worldwide by the drug company Aventis, although the UK’s sole distributor is an organisation called MediPhill, who have a private clinic on Harley Street in London, and have treated more than 300 people with HIV-related lipoatrophy in the past two years.2 However, Dr. Barton and many others working in the field feel very strongly that New-Fill should be made available on the NHS to everyone with significant HIV-related facial wasting who is distressed by it.
ATU: One of the most interesting aspects of your BHIVA presentation was the comparison of where else in the world New-Fill is available for the treatment of HIV-related lipoatrophy. Apart from France - who reimburse HIV patients who access New-Fill privately - the UK is the only other country currently providing New-Fill for free, albeit within in a postcode lottery situation. Although Aventis are now filing for US FDA approval, Americans can only access New-Fill through private clinics in Mexico. In Germany, a court action is currently underway filed by people with HIV against their insurers to force them pay for New-Fill, and in Sweden the government reviews access to New-Fill on a case-by-case basis, which must be a slow and frustrating process. Although the situation in the UK is far from perfect, it does seem that we are ahead of rest of the world in providing this treatment for free. Why do you think this is so?
SB: Here in the UK, since the beginning on the AIDS pandemic, it has been the case that individuals in the right jobs, with the right agenda, can actually get things done. It has something to do with the right mix of patient power, clinicians who are able to talk to both patients and politicians, and politicians who are not afraid of a very difficult issue. I think the same is true with what’s happened now with New-Fill. We’ve had a number of people in the right positions in lead Primary Care Trusts (PCTs, the local NHS funding bodies), in clinical units, who share the view that patient choice and patient well-being is paramount, and who are making it happen. And making it happen despite the system, rather than through the system. New-Fill is here, it’s happened, and I think it would be very difficult to stop the momentum now.
ATU: The new - and hopefully influential - London HIV Consortium Advisory Group Drugs Sub-committee met in December. One of the items on the agenda was finding a way to deliver New-Fill across London in an equitable way. You sit on the committee, so could you explain why it postponed a decision on New-Fill, pending more information about cost, implementation and likely patient numbers?
SB: I don’t represent the committee, but I can give you my personal impressions. The problem with making New-Fill equitably available throughout London cannot simply be solved by the London HIV Commissioners funding the therapy itself, because not every area of London has a unit where someone can administer New-Fill : they would have to go and get trained. What we do know about New-Fill is that results appear to be better when given by someone with a lot of experience. So, do we then try and set up and train new people to administer New-Fill in every HIV treatment centre all across London, or do we scale-up New-Fill treatment at the centres that already have trained staff and facilities? I personally think we should scale-up, clear all the waiting lists, and deliver it to everybody who needs it - but we need more time to assess the costs and benefits. But rest assured that the fundamental questions are being worked-through. Expect news relatively soon, I would hope!
ATU: What you’re arguing for London-wide is what you have already done in North West London: made New-Fill available in Ealing, St. Mary’s and the Chelsea & Westminster and had other hospitals in the sector refer patients to one of those three centres.
SB: And my view is that the North West London sector has done it right! We decided that in order to focus on the skilled of delivery of New-Fill you need to have a small amount of people doing it, but within a system that allows access to everybody in that sector. So, right now, everyone can be treated in the North West London sector if they have severe facial lipoatrophy.
ATU: Outside of London, only clinics in Brighton, Manchester, Birmingham and Portsmouth provide New-Fill to their HIV patients. There is no access at all in Scotland, Wales or Northern Ireland. You’re talking about scaling-up in London, but there is the rest of the UK to consider.
SB: Part of the problem is that sexual health and HIV strategy and the commissioning arrangements only apply to England now. Scotland and Wales have drawn their own. What you’re alluding to is that there is a very fragmented approach to using New-Fill. But if there hadn’t been, it would never have happened, because there is no mechanism at Department of Health level to make it available nationally. Without NICE guidance we only have the BHIVA guidelines to guide the treatment of HIV-affected individuals.
ATU: How long do you think it will take for equity to exist in the delivery of New-Fill treatment throughout the UK? Do you think that it will ever happen?
SB: It shouldn’t be difficult to make a decision about whether or not New-Fill is a beneficial treatment at a national level. That decision has been taken locally by clinicians and HIV commissioners working together in a few areas. In areas where there are not the same priorities given to patient wellness, then I can easily see how individual HIV commissioners aren’t able to leverage the money from their respective PCTs. If the London HIV Consortium do decide to fund New-Fill treatment in an equitable fashion across London, then it would be hard for it not then to be rolled out across England… and it should end up, effectively, as national strategy. In the absence of NICE (the National Institute of Clinical Excellence, who provide guidelines on how to treat many diseases on the NHS) guidance we only have BHIVA guidelines to develop practice.
ATU: How much is New-Fill competing with the cost of new antiretrovirals, and will the holders of NHS purse-strings need much persuading that this treatment is not purely cosmetic?
SB: Certainly there’s a tension there with the cost of antiretroviral drugs but that’s the reason that the Drugs Sub-committee exists - to ensure that as drugs become available they are brought into prescribing patterns in London in an equitable, fair and rational basis. Most people I’ve discussed New-Fill with in London see it as a sensible, efficient use of resources which benefits patients’ wellbeing. If we only had enough money to treat people with antiretrovirals, then some New-Fill services would have to be restricted. But I don’t believe it’s an either/or situation – at least at the moment.
ATU: It sounds like there is still a long way to go before everyone in the UK who needs it can easily accessNew-Fill.
SB: Yes, and it is up to HIV commissioners to make it clear why they are not making it available. If it’s cost, fine, they need to lobby and get the collaboration and support to get the resources to deliver it. But if they don’t believe it’s a worthwhile treatment, let’s have a public debate about it being ‘only’ a cosmetic treatment, both amongst the HIV fraternity and also amongst the public at large. I don’t know how that would play out, but it would be a very interesting debate.
ATU: Given the current inequality in New-Fill availability, what advice can you give people with facial lipoatrophy living outside the current areas of provision in order to access New-Fill?
SB: First and foremost they can talk to their clinician even before they think they might need it. They should ask them, ‘If I had severe facial lipoatrophy, would you be able to get this for me?’ If the clinician says that it’s not available in their area, then they need to do what is right for them. It may be to write a strong letter to their local HIV commissioner – and your HIV clinic will be able to give you the name of your lead HIV commissioner. I’m sure it would be very helpful for those people to have written evidence they can take to their respective PCTs saying that New-Fill is a priority.
ATU: Theoretically, is it possible for someone to register at a centre providing New-Fill a year ahead of their needing it, just in case it is not available in their area?
SB: That’s a realistic option for what patients may choose to do. I think it’s the duty of a doctor to tell your patient what is the best treatment for them. If it’s not available in your local area, the right thing to do is to speak to your clinician. If the answer you get is that it is not going to be available in your area, you need to lobby for this to be the case, but to understand your options for accessing treatment elsewhere. This is not 'working the system' but finding your way through it, as an expert patient should.
References
1. Moyle GM et al. Polylactate (New-Fill) injections subjectively and objectively improve appearance and reduce anxiety and depression scores in HIV-positive persons with facial lipoatrophy: a randomised, open label, immediate vs. delayed therapy study. 42nd ICAAC, San Diego, abstract H-1934, 2002.
2. MediPhill Treatments Ltd, 40 Harley Street London, WC1. 0207 937 2377